Vous êtes sur la page 1sur 345

AUTOMATED

HEMATOLOGY ANALYZER
MEK-6400J/K

If you have any comments or suggestions


on this manual, please contact us at:
www.nihonkohden.com 0614-900355
CONTENTS

Contents
GENERAL HANDLING PRECAUTIONS .............................................................................. i
WARRANTY POLICY ......................................................................................................... ii
RESPONSIBILITIES PROFESSIONAL USERS ............................................................. ii
EMC Related Caution ........................................................................................................ iii
Conventions Used in this Manual and Instrument ............................................................. v
Warnings, Cautions and Notes ................................................................................ v
Explanations of the Symbols in this Manual and Instrument ................................... vi
Text Conventions in this Manual .................................................................. vii

Section 1 General ...............................................................................1.C1


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
Consumables ................................................................................................................ 1.13
General Safety Information ........................................................................................... 1.14
General ................................................................................................................ 1.14
Installation .......................................................................................................... 1.14
Reagents ............................................................................................................. 1.15
Measurement ...................................................................................................... 1.16
Maintenance ....................................................................................................... 1.16

Section 2 Preparation ........................................................................2.C1


Environmental Requirements ......................................................................................... 2.2
Initial Preparation ........................................................................................................... 2.3
Inventory .............................................................................................................. 2.3
Standard Accessories .......................................................................................... 2.3
Unpacking ............................................................................................................ 2.4
Waste Disposal Requirements ............................................................................. 2.4
Installation Flowchart ..................................................................................................... 2.5
Connecting an External Instrument to the Analyzer ....................................................... 2.6
Connecting a PC .................................................................................................. 2.7
Connecting a Printer ............................................................................................. 2.7
Connecting a Card Printer .................................................................................... 2.8
Connecting a Hand-held Bar Code Reader ........................................................... 2.8
Operator's Manual MEK-6400 C.1
CONTENTS

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 .............................................................................................. 2.13
Detergent Tube .......................................................................................... 2.14
Lysing Reagent Tube ................................................................................. 2.15
Waste Fluid Tube ....................................................................................... 2.15
Loading Recording Paper in the WA-640VK Printer Unit (Option) ................................... 2.16
Turning Power On/Off .................................................................................................... 2.17
Check Before Turning Power On .......................................................................... 2.17
Turning On the Power .......................................................................................... 2.17
Checking the Date and Time Settings ................................................................. 2.18
Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL) ......... 2.19
Check After Turning On the Power ....................................................................... 2.21
Daily Shutdown ................................................................................................... 2.21
Checking List Before Turning the Power Off .............................................. 2.21
Turning the Power Off ................................................................................ 2.21
Check List After Turning Power Off ............................................................ 2.22
Check List Before Long Term Storage ....................................................... 2.22
Checking Daily Accuracy .............................................................................................. 2.23
Measuring Background Noise .............................................................................. 2.23
Measuring Background Noise In Closed Mode .......................................... 2.23
Measuring Background Noise in Open Mode ............................................. 2.25
Results ...................................................................................................... 2.27
Measuring Hematology Control ........................................................................... 2.28

Section 3 Changing Settings ............................................................3.C1


General ........................................................................................................................... 3.3
Assigning Users and Passwords .................................................................................... 3.4
General ................................................................................................................. 3.4
Displaying the USERS Screen ............................................................................. 3.4
Adding a User ...................................................................................................... 3.6
Changing a User ................................................................................................... 3.8
Deleting a User .................................................................................................... 3.9
Assigning an ID to a Sample ......................................................................................... 3.11
Displaying the ID Screen ..................................................................................... 3.11
Entering a 4 Digit Numeric ID .............................................................................. 3.12
Entering a 13 Character Alphanumeric ID ............................................................ 3.12
Not Assigning an ID ............................................................................................ 3.14
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

C.2 Operator's Manual MEK-6400


CONTENTS

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 .......................................................... 3.38
Changing Settings for Card Printer ...................................................................... 3.43
Changing Format for PC ...................................................................................... 3.45
Changing the USB Settings ................................................................................ 3.47
Selecting Language ....................................................................................................... 3.48
Selecting Units .............................................................................................................. 3.49
Selecting Unit Type .............................................................................................. 3.49
Counting Unit Table ................................................................................... 3.50
Customizing Units ............................................................................................... 3.50
Changing Sound and Screen Brightness Settings ......................................................... 3.51
Changing Various Settings for Analyzer Power On ........................................................ 3.52
Setting Auto Priming/Cleaning ....................................................................................... 3.54
Using Reagent Management .......................................................................................... 3.56
Setting the Warning Level .................................................................................... 3.56
When the Reagent Management Warning is Displayed ........................................ 3.58
Initializing Settings ........................................................................................................ 3.61
Factory Default Settings ...................................................................................... 3.63

Section 4 Measurement .....................................................................4.C1


General ........................................................................................................................... 4.2
Sampling Mode .................................................................................................... 4.2
Dilution Mode ....................................................................................................... 4.2
Sample Type ........................................................................................................ 4.3
Single and Double Counting ................................................................................. 4.3
ID Numbers .......................................................................................................... 4.4
Alarm Display ....................................................................................................... 4.4
Data Storage ........................................................................................................ 4.4
Printing and Sending Data .................................................................................... 4.4
PLT Recount ........................................................................................................ 4.5
Recount when Out of Panic Range ....................................................................... 4.5
Counting Special Case Samples .......................................................................... 4.5
Measurement in Closed Mode ........................................................................................ 4.6
Preparing a Sample .............................................................................................. 4.6
Measuring a Sample in Closed Mode ................................................................... 4.7
Measurement in Normal Dilution Mode ....................................................... 4.7
Measurement in Low/High Dilution Mode .................................................... 4.9

Operator's Manual MEK-6400 C.3


CONTENTS

Measurement in Open Mode .......................................................................................... 4.12


Measuring a Venous Sample in Normal Dilution Mode ......................................... 4.12
Preparing a Venous Sample ...................................................................... 4.12
Measuring a Venous Sample ..................................................................... 4.13
Measuring a Pre-Dilution Sample ........................................................................ 4.15
Preparing a Pre-Dilution Sample ............................................................... 4.15
Measuring a Pre-Dilution Sample .............................................................. 4.16
Measuring a Venous Sample in Low/High Dilution Mode ..................................... 4.18
Performing Auto Recount ............................................................................................... 4.20
Recount on Alarm ............................................................................................... 4.20
Recount on PLT Count ........................................................................................ 4.20
Recount when Out of Panic Range ................................................................................ 4.21
Description of the RESULTS Screen ............................................................................. 4.23
Numeric Data ...................................................................................................... 4.24
Measuring Units ........................................................................................ 4.24
Displaying H and L Out of Range Marks ................................................... 4.24
Over Message .......................................................................................... 4.24
Histograms .......................................................................................................... 4.25
Vertical Axis Type for the Histogram ......................................................... 4.25
Adjusting Axes Scale ................................................................................ 4.25
RBC (Red Blood Cell) Distribution Histogram ............................................ 4.25
PLT (Platelet) Distribution Histogram ........................................................ 4.26
WBC (White Blood Cell) Distribution Histogram ........................................ 4.26
Flags ................................................................................................................... 4.27
Flag Codes ................................................................................................ 4.27
Flag Names .............................................................................................. 4.28
Alarm Display ...................................................................................................... 4.30
Printing and Sending Results ........................................................................................ 4.31
Auto Printing/Sending after Measurement ........................................................... 4.31
Printing by Pressing [Print] Key .......................................................................... 4.31
Sending Data to PC ............................................................................................. 4.31

Section 5 Handling Data ....................................................................5.C1


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 a Saved Data ................................................................. 5.6
Searching for Data .......................................................................................................... 5.8
Printing and Sending Data ............................................................................................. 5.12
Automatic Printing and Sending Data after Measurement ................................... 5.12
Printing and Sending Stored Data ....................................................................... 5.12
Printing or Sending Single Data ................................................................ 5.12
Printing or Sending Multiple Data .............................................................. 5.13
Printing or Sending Data for All Samples of a Single Day ......................... 5.15
Deleting Data ................................................................................................................. 5.18
Deleting Single Data ............................................................................................ 5.18
Deleting Multiple Data ......................................................................................... 5.19
Deleting All Stored Data ...................................................................................... 5.20

C.4 Operator's Manual MEK-6400


CONTENTS

Section 6 Quality Control ..................................................................6.C1


General ........................................................................................................................... 6.3
When to Run QC .................................................................................................. 6.3
QC Methods ......................................................................................................... 6.3
Control Material .................................................................................................... 6.4
Quality Control Procedures ............................................................................................ 6.5
Guidelines for Running Controls ........................................................................... 6.5
Control Material Guidelines .................................................................................. 6.5
_
X-R Program ................................................................................................................... 6.6
General ................................................................................................................. 6.6
_
Overview of X-R Program and Quality Control Procedure .......................... 6.6
_ _
Calculation of X and R ................................................................................ 6.6
_
Calculation of Upper and Lower Limits of X and R ...................................... 6.7
_
X-R Graph Example ................................................................................... 6.8
_
How to Read the X-R Graph ...................................................................... 6.10
Data Outside the Limits ............................................................................ 6.10
Changing the Quality Control Settings ................................................................. 6.11
Counting the Hematology Control ........................................................................ 6.13
_
Handling X-R Data ............................................................................................... 6.16
_
Displaying the X-R Data List (HISTORY) ................................................... 6.16
_
Displaying the Detailed X-R Measurement Data ........................................ 6.17
_
Printing, Sending or Deleting X-R Data ................................................................ 6.19
_
Printing, Sending or Deleting X-R Data Individually ................................... 6.19
_
Printing, Sending or Deleting X-R Data Consecutively .............................. 6.20
_
Deleting All Stored X-R Data ..................................................................... 6.21
_
Displaying CV Values of the Stored X-R Data ............................................ 6.22
_
Handling X-R Graphs ........................................................................................... 6.23
_
Changing the X-R Limits ...................................................................................... 6.24
L & J Program (Levey and Jennings) ............................................................................ 6.26
General ................................................................................................................ 6.26
Overview of L & J Program and Quality Control Procedure ....................... 6.26
Calculation of Upper and Lower Limits ...................................................... 6.27
How to Read the L & J Graph ................................................................... 6.27
Data Outside the Limits ............................................................................ 6.27
Changing the Quality Control Settings ................................................................. 6.28
Counting the Hematology Control ........................................................................ 6.28
Handling L & J Data ............................................................................................ 6.31
Displaying the L & J Data List (HISTORY) ................................................ 6.31
Displaying the Detailed L & J Measurement Data ..................................... 6.32
Printing, Sending or Deleting L & J Data ............................................................. 6.33
Printing, Sending or Deleting L & J Data Individually ................................ 6.33
Printing, Sending or Deleting L & J Data Consecutively ............................ 6.34
Deleting All Stored L & J Data .................................................................. 6.36
Displaying CV Values of the Stored L & J Data ......................................... 6.37
Handling L & J Graphs ........................................................................................ 6.38
_ _
XB (X Batch) Program ................................................................................................... 6.40
General ................................................................................................................ 6.40
_
Overview of XB ......................................................................................... 6.40
_
Calculation of XB ...................................................................................... 6.40

Operator's Manual MEK-6400 C.5


CONTENTS
_
Handling XB Data ................................................................................................ 6.42
_
Handling XB Graph .............................................................................................. 6.44
_
Setting XB Initial Values and Limits .................................................................... 6.45
_
XDCV Program ............................................................................................................. 6.47
General ................................................................................................................ 6.47
_
Uses of the XDCV Program ..................................................................... 6.47
_
Handling XDCV Data .......................................................................................... 6.48
Displaying the Total Mean and CV of All Stored Data .......................................... 6.49

Section 7 Calibration ..........................................................................7.C1


General ........................................................................................................................... 7.2
When to Calibrate ................................................................................................. 7.2
Note on the Calibration Procedure ........................................................................ 7.3
Calibration in Closed Mode ............................................................................................. 7.4
Calibration in Open Mode and Pre-Dilution Mode ........................................................... 7.7
Calibration in Open Mode ..................................................................................... 7.7
Calibration in Pre-Dilution Blood Mode ................................................................ 7.10
Displaying the Calibration Measurement Data List ........................................................ 7.14
Displaying and Printing Calibration Data History ............................................................ 7.18
HGB/HCT Calibration with Human Blood ....................................................................... 7.20
Measurement with the Analyzer .......................................................................... 7.20
HGB Measurement with a Spectrophotometer .................................................... 7.20
HCT Measurement with a Microhematocrit Centrifuge ......................................... 7.21
Determining the HGB and HCT Calibration Coefficient ........................................ 7.21

Section 8 Error Messages and Troubleshooting ............................8.C1


General ........................................................................................................................... 8.2
Alarm Messages ............................................................................................................ 8.5
Invalid Data Identifier ........................................................................................... 8.5
Flag Indication ...................................................................................................... 8.5
Alarm Messages with Alarm Codes ..................................................................... 8.6
Other Alarm Messages ........................................................................................ 8.7
System Error Messages ................................................................................................. 8.8
Inaccurate Counting and Other Problems ....................................................................... 8.9

Section 9 Maintenance ......................................................................9.C1


General ........................................................................................................................... 9.3
Disposing of Waste ............................................................................................... 9.4
Disposing of 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 ............................................................................................. 9.8
Inside Panel Components .............................................................................................. 9.10
Before Maintenance Procedure ..................................................................................... 9.11

C.6 Operator's Manual MEK-6400


CONTENTS

Strong Cleaning ................................................................................................... 9.11


Draining Measurement Baths and Sub Baths ...................................................... 9.12
Turning Power Off ................................................................................................ 9.13
Daily Maintenance Procedures ...................................................................................... 9.14
Checking Reagents and Other Consumables ...................................................... 9.14
Checking the Appearance of the Analyzer .......................................................... 9.14
Disinfecting the Surface of the Analyzer ................................................... 9.15
Cleaning the Surface of the Analyzer ........................................................ 9.15
Checking the Reagents Connection Tubes .......................................................... 9.15
Checking the Power Cord and Grounding Lead .................................................... 9.15
Checking the External Instrument Connection .................................................... 9.15
Checking the Power On ....................................................................................... 9.16
Calibrating the Touch Screen ..................................................................... 9.16
Checking the Date and Time ............................................................................... 9.16
Clock Accuracy ......................................................................................... 9.17
Checking Daily Accuracy .................................................................................... 9.17
Checking Measurement Baths and Sub Baths .................................................... 9.17
Checking Pump Tube ........................................................................................... 9.17
Weekly/Every 300 Counts Maintenance Procedures ..................................................... 9.18
Checking/Cleaning Filters ................................................................................... 9.18
Monthly/Every 1,000 Counts Maintenance Procedures ................................................. 9.19
Replacing Filters ................................................................................................. 9.19
Materials Required .................................................................................... 9.19
Procedure ................................................................................................. 9.19
Checking and Cleaning Measurement Baths and Sub Baths ............................... 9.21
Materials Required .................................................................................... 9.21
Procedure ................................................................................................. 9.21
Checking and Cleaning/Replacing the Rinse Unit and Cap Pierce Nozzle ........... 9.23
Materials Required .................................................................................... 9.23
Procedure ................................................................................................. 9.24
Every Four Months/Every 3,000 Counts Maintenance Procedures ............................... 9.27
Checking and Cleaning/Replacing the Sampling Nozzles .................................... 9.27
Materials Required .................................................................................... 9.27
Procedure ................................................................................................. 9.27
Replacing Pump Tube .......................................................................................... 9.31
Materials Required .................................................................................... 9.31
Procedure ................................................................................................. 9.31
As-Required Maintenance Procedures ........................................................................... 9.34
Removing a Clog from the Aperture .................................................................... 9.34
Cleaning Aperture Caps ...................................................................................... 9.35
Materials Required .................................................................................... 9.35
Procedures ................................................................................................ 9.35
Checking the Prime Function .............................................................................. 9.39
Checking the Drain Function ............................................................................... 9.39
Checking the Cleaning Function .......................................................................... 9.39
Checking the Circuit ............................................................................................ 9.39
Checking the Sensor Monitor Screen .................................................................. 9.41
Checking the External Instruments Function ...................................................... 9.42
Printers ..................................................................................................... 9.42

Operator's Manual MEK-6400 C.7


CONTENTS

Hand-held Bar Code Reader ...................................................................... 9.42


PC ............................................................................................................. 9.42
Decontamination Protocol ................................................................................... 9.43
Procedure ................................................................................................. 9.44
Storing and Transporting the Analyzer ................................................................. 9.46
Preparing the Analyzer for Long Term Storage or Transport ....................... 9.46
Using the Analyzer after Storage .............................................................. 9.48
Preparing the Analyzer for Short Term Transport ....................................... 9.49

Section 10 Reference ........................................................................ 10.C1


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
Special Key Operations for Servicing ............................................................................ 10.6
Bar Codes for Using Hand-held Bar Code Reader ......................................................... 10.7
Using Bar Codes ................................................................................................. 10.7
Changing the Settings ......................................................................................... 10.8
Bar Code Setup Menu ......................................................................................... 10.9
Interference Substances ............................................................................................. 10.20
Data and Symbol Display ............................................................................................ 10.23
Specifications ............................................................................................................. 10.25
Measured Parameters, Ranges and Reproducibility to Specimen from
Venous Blood .......................................................................................... 10.25
Standardization Analysis Method ............................................................ 10.25
Detection Method .................................................................................... 10.26
Dilution Ratio ........................................................................................... 10.26
Counting Time ......................................................................................... 10.26
Display .................................................................................................... 10.26
Data Storage ........................................................................................... 10.26
Environmental Conditions ........................................................................ 10.26
Power Requirements ............................................................................... 10.26
Dimensions and Weight ........................................................................... 10.27
Electromagnetic Compatibility ................................................................. 10.27
Safety ..................................................................................................... 10.27
Standard Accessories ................................................................................................. 10.28
Options ........................................................................................................................ 10.30
Consumables .............................................................................................................. 10.32

C.8 Operator's Manual MEK-6400


GENERAL HANDLING PRECAUTIONS

This device is intended for use only by qualified medical personnel.


Use only Nihon Kohden approved products with this device. Use of non-approved products or
in a non-approved manner may affect the performance specifications of the device. This
includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode
leads, input boxes and AC power.

Please read these precautions thoroughly before attempting to operate the instrument.

1. To safely and effectively use the instrument, its operation must be fully understood.

2. When installing or storing the instrument, take the following precautions:


(1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures,
poorly ventilated areas, and dust, saline or sulphuric air.
(2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport.
(3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.
(4) The power line source to be applied to the instrument must correspond in frequency and voltage to product
specifications, and have sufficient current capacity.
(5) Choose a room where a proper grounding facility is available.

3. Before Operation
(1) Check that the instrument is in perfect operating order.
(2) Check that the instrument is grounded properly.
(3) Check that all cords are connected properly.
(4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other
problems.
(5) All circuitry used for direct patient connection must be doubly checked.
(6) Check that battery level is acceptable and battery condition is good when using battery-operated models.

4. During Operation
(1) Both the instrument and the patient must receive continual, careful attention.
(2) Turn power off or remove electrodes and/or transducers when necessary to assure the patients 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.

Operators Manual MEK-6400 i


9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or
location of electrodes and/or transducers to avoid possible burn to the patient.

10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator
discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.

WARRANTY POLICY
Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one
year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are
excluded from the warranty.

NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period,
provided these products are used as prescribed by the operating instructions given in the operators and service manuals.

No other party is authorized to make any warranty or assume liability for NKCs 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 operators manual must be followed, especially
the following points.
Storage and stability of reagents
Handling of reagents
Instrument installation
Connection of all tubes to inlets and outlets
Connection of all tubes to reagents and waste container
Checking the amount of reagents and waste fluid
Calibration
Quality control
Maintaining and servicing

If deviating from the instructions, the professional user does it at the risk and liability of the laboratory and only after
validation by the laboratory. Nihon Kohden has no responsibility over such deviations.

ii Operators Manual MEK-6400


EMC RELATED CAUTION
This equipment and/or system complies with the International Standard EN61326-1 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 EN61326-1,
can cause harmful interference to the equipment and/or system or cause the equipment and/or system to
fail to perform its intended function or degrade its intended performance. Therefore, during the operation
of the equipment and/or system, if there is any undesired deviation from its intended operational
performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing
to use the equipment and/or system.

The following describes some common interference sources and remedial actions:

1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station
or cellular phone:
Install the equipment and/or system at another location if it is interfered with by an emitter source
such as an authorized radio station. Keep the emitter source such as cellular phone away from the
equipment and/or system.

2. Radio-frequency interference from other equipment through the AC power supply of the equipment
and/or system:
Identify the cause of this interference and if possible remove this interference source. If this is not
possible, use a different power supply.

3. Effect of direct or indirect electrostatic discharge:


Make sure all users and patients in contact with the equipment and/or system are free from direct or
indirect electrostatic energy before using it. A humid room can help lessen this problem.

4. Electromagnetic interference with any radio wave receiver such as radio or television:
If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or
system as far as possible from the radio wave receiver.

If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden
Corporation subsidiary or distributor for additional suggestions.

This equipment complies with International Standard EN55011 (1999) Group 1, Class B. Class B
EQUIPMENT is equipment suitable for use in domestic establishments and in establishments directly
connected to a low voltage power supply network which supplies buildings used for domestic purposes.

The CE mark is a protected conformity mark of the European Community. The products herewith comply
with the requirements of the IVD Directive 98/79/EEC.

Operators Manual MEK-6400 iii


NOTE about Waste Electrical and Electronic Equipment (WEEE) directive 2002/96/EEC
For the member states of the European Union only:
The purpose of WEEE directive 2002/96/EEC 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 at the end of its working life.

iv Operators Manual MEK-6400


Conventions Used in this Manual and Instrument

Warnings, Cautions and Notes

Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

WARNING
A warning alerts the user to the possible injury or death associated with the use or misuse of the
instrument.

CAUTION
A caution alerts the user to possible injury or problems with the instrument associated with its use or
misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other
property.

NOTE
A note provides specific information, in the form of recommendations, prerequirements, alternative
methods or supplemental information.

Operators Manual MEK-6400 v


Explanations of the Symbols in this Manual and Instrument
The following symbols found in this manual/instrument bear the respective descriptions as given.
On panel
Symbol Description Symbol Description

AC power off
Attention, consult operator's manual
(Disconnection from the mains)

AC power on
Inlet
(Connection to the mains)

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

Memory card socket


Clean
(Read data from store)

Eject key (Tube holder open) Alternating current

Count Equipotential terminal

ISOTONAC3
Fuse (time lag)
(diluent)

CLEANAC
Year of manufacture
(detergent)

HEMOLYNAC3N
Serial number
(hemolysing reagent)

IN VITRO DIAGNOSTIC
WASTE IVD MEDICAL DEVICE
The products marked with this symbol
The CE mark is a protected apply to the European WEEE directive
conformity mark of the European 2002/96/EEC and require separate waste
Community. The products herewith collection. For Nihon Kohden products
comply with the requirements of the labeled with this symbol, contact your
IVD Directive 98/79/EEC. Nihon Kohden representative for
disposal at the end of its working life.

vi Operators Manual MEK-6400


On screen and recorded data
Symbol Description

When displayed beside WBC or RBC measured value: Sample error


When displayed beside HGB measured value: Dirty measurement baths
When displayed beside WBC measured value: Poor hemolyzation
When displayed beside HGB measured value: HGB voltage adjustment error
When displayed beside MCHC measured value: Abnormal MCHC
When displayed beside HGB measured value: HGB circuit error/WBC measured
value is OVER
When displayed beside RBC and PLT measured values: PLT-RBC interference

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, When displayed beside LY%, MO% or GR% measured values: Flags (refer to
F3, F4 Explanation of the RESULTS Screen in Section 4)

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 Presentation Examples
Screen name Regular, UPPERCASE MENU screen
Touch screen keys Regular, UPPERCASE QUALITY CONTROL
Regular, Mixed-Case, enclosed within
Field names <Dilute mode>
carats < >
Regular, Mixed-Case, enclosed within
Hard keys (Panel keys) [Clean]
brackets
Regular, Mixed-Case, enclosed within
Screen Message Priming
quotation marks

Operators Manual MEK-6400 vii


1
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
Consumables .................................................................................................................................................... 1.13
General Safety Information ............................................................................................................................... 1.14
General ................................................................................................................................................... 1.14
Installation .............................................................................................................................................. 1.14
Reagents ................................................................................................................................................ 1.15
Measurement .......................................................................................................................................... 1.16
Maintenance ........................................................................................................................................... 1.16

Operator's Manual MEK-6400 1.1


1. GENERAL

Introduction

The MEK-6400J/K Automated Hematology Analyzer is designed for


simultaneous 18-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. The
analyzer is also provided with a cap pierce unit, with which a sample in a
capped tube can be measured in closed mode. An optional printer allows full
reports.

The analyzer automatically cleans the remaining blood from the sampling
nozzle, so it is safe and there is no risk of touching the blood. The analyzer has
self-check, quality control and other programs to provide reliable data
management system.

To achieve full performance, thoroughly read this operators manual before


operating the analyzer.

To use the analyzer safely and effectively and keep it in optimum condition,
please follow the operating and maintenance instructions in this manual.

NOTE
Use only Nihon Kohden parts and accessories to assure maximum
performance from your instrument.

Measured Parameters
WBC: White Blood Cell Count
RBC: Red Blood Cell Count
HGB: Hemoglobin Concentration
HCT: Hematocrit (%)
MCV: Mean Corpuscular Volume (fL)
MCH: Mean Corpuscular Hemoglobin (pg)
MCHC: Mean Corpuscular Hemoglobin Concentration (g/dL)
PLT: Platelet Count
LY%: Lymphocyte Percent
MO%: Monocyte Percent
GR%: Granulocyte Percent
LY: Lymphocyte Count
MO: Monocyte Count
GR: Granulocyte Count
RDW: Red Blood Cell Distribution Width
PCT: Platelet Crit
MPV: Mean Platelet Volume
PDW: Platelet Distribution Width

1.2 Operators Manual MEK-6400


1. GENERAL

1
Features

Simultaneous 18 parameter measurement


The analyzer simultaneously measures 18 parameters. WBC is differentiated
into 3 parameters, lymphocyte, monocyte and granulocyte. WBC, RBC and
PLT are measured by electrical resistance detection method.

Infection prevention
You can perform measurement without removing the cap of the sample tube
by using the closed mode. You have no worries about touching blood.

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 L 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 L) can be measured. The sample needs to be
diluted before measurement. 30 L of the venous blood can also be
measured. This sample does not need to be diluted before measurement.

Operator's Manual MEK-6400 1.3


1. GENERAL

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.

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 XDCV 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 Operators Manual MEK-6400


1. GENERAL

1
Panel Description

Front Panel

7 9

10
1
2 11
3
4
5
6 12

13
15
14
16

No. Name Description


1 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 [Power] key on the front panel
2 Power lamp
are turned on.
Turns the analyzer power on or off when the [Main power] switch on the rear panel is turned
3 Power key on. When the power is turned on, priming and self-check are automatically performed, and
the READY screen appears.
4 Auto print key Switches the printing mode between automatic and manual for the printer.
5 Feed key Feeds paper of the printer while held down.
6 Print key Prints displayed data on the printer.
Auto print mode
7 Lights when automatic printing mode is selected.
lamp
8 LCD display Displays various messages, measured data and touch screen keys.
Stops operation when pressed during operation. Returns to the READY screen when pressed
9 Reset key
while changing settings. Use this key only when an error occurs.
Cleans the fluid path, aperture and manometer with detergent. Automatically primes after
10 Clean key cleaning the fluid path. Press this key when clogging occurs, the manometer becomes dirty
or bubbles occur in the manometer.
11 Eject key For closed mode only. Opens the tube holder to set the sample tube.
For closed mode only. Holds a sealed vacuum blood collecting tube. Press the [Eject] key to
12 Tube holder
open. After measurement, the holder automatically opens.
For open mode only. Aspirates the sample. Dispenses the diluent when in the pre-dilution
13 Sampling nozzle
blood mode.
14 Count switch For open mode only. Aspirates the sample and starts counting.
Printer unit
15 Thermal array printer. Prints out measured data and sample ID no. (optional)
(WA-640VK)
For the recording paper of the WA-640VK printer unit. To open, pull the upper left corner
16 Printer door
(optional).
Operator's Manual MEK-6400 1.5
1. GENERAL

Right Side Panel

1 2 3 4

No. Name Description


ISO3
1 Inlet for the ISOTONAC3 diluent.
Diluent inlet
CLN
2 Inlet for the CLEANAC detergent.
Detergent inlet
HEMO3N
3 Inlet for the Hemolynac3N lysing reagent.
Lysing reagent inlet
WASTE Outlet for waste such as used lyse, detergent and aspirated
4
Waste outlet samples.

1.6 Operators Manual MEK-6400


1. GENERAL

Rear Panel 1

5
6
7
8

1 9
2
3 10
11
4

No. Name Description


Supplies the power to the analyzer when it is turned on. Under
1 Main power switch
normal conditions keep this switch turned on.
Contains the time lag fuse. To replace the fuse, contact your
2 Fuse holder
Nihon Kohden distributor.
AC SOURCE
3 Connects the AC power cord to supply AC power to the analyzer.
AC source socket
Equipotential ground Connects the ground lead to the equipotential ground terminal on
4
terminal the wall for earth grounding.
Connects to the optional hand-held bar code reader.
ZK-820V Supplies the power to the bar code reader when connected.
5
Bar code reader socket Power supply voltage: 5 V DC (pin 9: 5 V, pin 5: GND)
Rated current: 200 mA
6 Serial port 1 Connects to the optional WA-460V/461V card printer or PC.
7 Serial port 2 Connects to the optional WA-460V/461V card printer or PC.
8 Printer socket 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
9 USB socket
analyzer. For details on the DMS, contact your Nihon Kohden
representative.
10 Memory card socket Insert a memory card when you upgrade the software.
11 Memory card eject button Press this button when you eject a memory card.

Operator's Manual MEK-6400 1.7


1. GENERAL

Caution Labels on the Analyzer

Refer to Connecting Tubes in Section 2.

NOTE
Replace the filters periodically.
When attaching the filter joint assembly, be careful not to
bend or damage the filter packing at the bottom of the
measurement bath.
When there is a leakage, check that there is no scratch or
damage to the circumference of the filter.

Refer to warnings and cautions in


Refer to warnings and cautions in
Connecting an External Instrument to
Connecting the Power Cord and
the Analyzer in Section 2.
Grounding the Analyzer in Section 2.

1.8 Operators Manual MEK-6400


1. GENERAL

1
Flowchart of Screens
Power ON CHECKING READY
Measuring background noise
(When "Background measurement at power on" is
set to YES on the SETTINGS screen)

READY Measurement RESULTS


READY (OK key)
ID (SET key)
ID
MENU ID
CALIBRATION
RESULTS
CAL CLOSED Measurement for calibration Results
CAL HISTORY
CAL DATA LIST
CV
CAL OPEN
Same as CAL CLOSED

CAL Pre-dil
Same as CAL CLOSED

DATA
DETAILS
EDIT
EDIT ID
SEARCH SEARCH RESULTS
DETAILS

QC (QUALITY CONTROL)

X-R or L & J (NORMAL) X-R or L & J Measurement Results


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

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-6400 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
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 Operators Manual MEK-6400


1. GENERAL

1
Basic Operations

Screen Information
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.
Shortcut key For details, refer to Assigning Operators and Passwords in Section 3.

Screen name 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-6400 1.11


1. GENERAL

Using Touch Screen Keys


NOTE
Do not use a sharp object to press the mark. 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 purple keys to display


another screen

Press the keys with triangle


to display a selection list to
select an item

Select a setting by
pressing a check box

Press purple keys to display


another screen

1.12 Operators Manual MEK-6400


1. GENERAL

1
Consumables

For information on ordering parts, accessories, reagents, controls, calibrators,


and consumables, refer to Option and Consumables in Section 10.

Operator's Manual MEK-6400 1.13


1. GENERAL

General Safety Information

General

WARNING
Always wear rubber gloves to protect yourself from infection when
handling and measuring blood samples.

CAUTION
Use only Nihon Kohden recommended reagents and consumables.
Otherwise the measurement result cannot be guaranteed and
incorrect reagent concentration can cause equipment damage.
Avoid blood sample or reagent contact with the skin. If it contacts
the skin or eyes, wash thoroughly with water and see a physician
immediately.

Installation

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.
Install the analyzer outside the patient environment. If it is installed
inside the patient environment, the patient or operator may receive
electrical shock.
Do not use the analyzer near an ESU. Noise from the ESU may
cause the analyzer to malfunction.
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
Only use the provided power cord. Using other power cords may
result in electrical shock or injury to the operator.
Connect only the specified instruments to the analyzer by following
the specified procedure. Failure to follow this warning may result
in electrical shock or injury to the operator, and cause fire or
instrument malfunction.

1.14 Operators Manual MEK-6400


1. GENERAL

In order to avoid any safety hazard, only connect personal 1


computers which are approved by IEC 60950.
The analyzer should only be connected to an external instrument
which complies with the CISPR 11 (Edition 4.1: 2004), Group 1 and
Class B standard.
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 patient or operator may receive
electrical shock or injury.
Use two people and be careful when moving the analyzer.
Otherwise, you may throw out your back or cause injury from
dropping the analyzer.

Reagents
CLEANAC3

WARNING
Do not allow CLEANAC3 detergent to come into contact with acid.
Contact with acids can cause the release of poisonous chlorine
gas.
Do not swallow the CLEANAC3 detergent. If swallowed, see a
physician immediately.

CAUTION
If the CLEANAC3 detergent contacts the skin, eyes or mouth, wash
thoroughly and immediately with water and see a physician.

CLEANAC

WARNING
Do not swallow the CLEANAC detergent. If swallowed, see a
physician immediately.

Hemolynac3N

WARNING
Do not swallow the Hemolynac3N lysing reagent. If swallowed, see a
physician immediately.

Operator's Manual MEK-6400 1.15


1. GENERAL

CAUTION
If the Hemolynac3N lysing reagent contacts the skin, eyes or mouth,
wash thoroughly and immediately with water and see a physician.

Measurement

CAUTION
When an alarm occurs, the acquired data may not be correct,
especially when ! or sample error message appears. Do not use
the data for diagnosis. Recount the sample.

Maintenance

WARNING
Potential Biohazard. Observe all biosafety and chemical hazard
precautions for waste disposal. Operators are responsible for
disposing of waste in accordance with local, state, and federal
regulations.
Be careful not to directly touch any place where blood is or may
have contacted.
Protect yourself from infection before cleaning and doing
maintenance.
The sampling nozzles and cap pierce nozzle are sharp and
potentially contaminated with infectious materials. Be careful when
handling the sampling nozzles and cap pierce nozzle.

CAUTION
Do not handle any parts other than specified in this manual.
Gloves should be worn during the maintenance procedures. They
should be powder-free as powder may cause instrument problems.
Turn off the main power before doing maintenance. Otherwise, the
operator may receive electrical shock.
Perform strong cleaning before disposing of the analyzer.
When disposing of the analyzer, remove the sampling nozzles and
cap pierce nozzle from the analyzer and dispose of them following
your local laws for disposing of medical waste.

1.16 Operators Manual MEK-6400


Section 2 Preparations 2

Environmental Requirements ............................................................................................................................. 2.2


Initial Preparation ............................................................................................................................................... 2.3
Inventory .................................................................................................................................................. 2.3
Standard Accessories .............................................................................................................................. 2.3
Unpacking ................................................................................................................................................ 2.4
Waste Disposal Requirements ................................................................................................................. 2.4
Installation Flowchart ......................................................................................................................................... 2.5
Connecting an External Instrument to the Analyzer ............................................................................................ 2.6
Connecting a PC ...................................................................................................................................... 2.7
Connecting a Printer ................................................................................................................................ 2.7
Connecting a Card Printer ........................................................................................................................ 2.8
Connecting a Hand-held Bar Code Reader ............................................................................................... 2.8
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 .................................................................................................................................. 2.13
Detergent Tube .............................................................................................................................. 2.14
Lysing Reagent Tube ..................................................................................................................... 2.15
Waste Fluid Tube ........................................................................................................................... 2.15
Loading Recording Paper in the WA-640VK Printer Unit (Option) ....................................................................... 2.16
Turning Power On/Off ........................................................................................................................................ 2.17
Check Before Turning Power On .............................................................................................................. 2.17
Turning On the Power .............................................................................................................................. 2.17
Checking the Date and Time Settings ..................................................................................................... 2.18
Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL) ............................................. 2.19
Check After Turning On the Power ........................................................................................................... 2.21
Daily Shutdown ....................................................................................................................................... 2.21
Checking List Before Turning the Power Off .................................................................................. 2.21
Turning the Power Off .................................................................................................................... 2.21
Check List After Turning Power Off ................................................................................................ 2.22
Check List Before Long Term Storage ........................................................................................... 2.22
Checking Daily Accuracy .................................................................................................................................. 2.23
Measuring Background Noise ................................................................................................................. 2.23
Measuring Background Noise In Closed Mode .............................................................................. 2.23
Measuring Background Noise in Open Mode ................................................................................. 2.25
Results ......................................................................................................................................... 2.27
Measuring Hematology Control ............................................................................................................... 2.28

Operator's Manual MEK-6400 2.1


2. PREPARATIONS

Environmental Requirements

WARNING
Install the analyzer outside the patient environment. If it is installed
inside the patient environment, the patient or operator may receive
electrical shock.

CAUTION
Use this analyzer under the following conditions.
Temperature: 15 to 30C (59 to 86F)
Humidity: 30 to 85%
Air pressure: 70 to 106 kPa
70 kPa air pressure equals to 3,000 m above sea level. Do not use the
analyzer over 3,000 m above sea level.

Operate the analyzer in a room with a temperature range of 15 to 30C. Keep


the temperature of diluent and lysing reagent within this temperature in order
to obtain reliable data.

No measurement can be done in dusty areas because the aperture for


specimen aspiration is very fine and can get clogged. Therefore, install the
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
15 cm ventilation.
Side
When there is any problem in the analyzer, turn off the main power
Top view immediately and disconnect the power cord from the AC outlet. Take the
analyzer out of service and check for damage.

2.2 Operators Manual MEK-6400


2. PREPARATIONS

Initial Preparation
2
Inventory
Confirm that the analyzer shipment contains the following:
Celltac Hematology Analyzer
Standard accessories
Reagents
Controls and Calibrator
Operators 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-6400J or 1.0 A time-lag
amps 220 to 240 V for MEK-6400K (2)
Filter assy (2)
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 CLEANAC3, marked white, 0.4 m
18 L container cap (2)
18 L tube assy
Cleanac tube assy for CLEANAC
2 L container with cap (2) for CLEANAC3 and waste
Hemolynac3 cap
Hemolynac3 tube assy, marked yellow
MEK cap (2)
Tube assy (6100) for CLEANAC3
18 L container cock
Waste tube assy

Visually inspect these items for damage. If there is any damage, contact your
Nihon Kohden representative.

Operator's Manual MEK-6400 2.3


2. PREPARATIONS

Unpacking
Remove the analyzer from the shipping container and visually inspect for
damage. If there is any damage, contact your Nihon Kohden representative. Use
two people when lifting or moving the analyzer.

CAUTION
Use two people and be careful when moving the analyzer. Otherwise,
you may throw out your back or cause injury from dropping the
analyzer.

Waste Disposal Requirements

WARNING
Potential Biohazard. Observe all biosafety and chemical hazard
precautions for waste disposal. Operators are responsible for
disposing of waste in accordance with local, state, and federal
regulations.

CAUTION
Waste container must be stored at the same level or below the
analyzer, never above.
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.

2.4 Operators Manual MEK-6400


2. PREPARATIONS

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-6400 2.5


2. PREPARATIONS

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.

WARNING
For operator safety, equipotential grounding of all instruments must
be performed. Consult with a qualified biomedical engineer.

When more than one electrical instrument is used, there may be electrical
potential difference between the instruments. Potential difference between
instruments may cause current to flow to the patient connected to the
instruments, resulting in electrical shock (micro shock).

Always perform equipotential grounding when required. It is often required in


the operating room, ICU room, CCU room, cardiac catheterization room and X-
ray room. Consult with a biomedical engineer to determine if it is required.

CAUTION
Connect only the specified instruments to the analyzer by following
the specified procedure. Otherwise electrical leakage current may
harm the operator.
In order to avoid any safety hazard, only connect personal
computers which are approved by IEC 60950.
The analyzer should only be connected to an external instrument
which complies with the CISPR 11 (Edition 4.1: 2004), Group 1 and
Class B standard.
Before connecting instruments, make sure that the power is turned
off. Otherwise the operator may receive electrical shock.

2.6 Operators Manual MEK-6400


2. PREPARATIONS

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
2
measurement.
Serial ports
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.
USB port

CAUTION
In order to avoid any safety hazard, only connect personal
computers which are approved by IEC 60950.
The analyzer should only be connected to an external instrument
which complies with the CISPR 11 (Edition 4.1: 2004), Group 1 and
Class B standard.
Only use the 3-prong power cord for the PC.

Connect the serial cable to the PC and the serial port or USB port on the
analyzer. For changing the transfer and communication format, refer to
Changing Output Format in Section 3.

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.

WA-710V/712V printer
SEIKO EPSON VP type
Printer socket 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.

Operator's Manual MEK-6400 2.7


2. PREPARATIONS

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 printers 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

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.

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
Bar code socket CODE 128

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.
2.8 Operators Manual MEK-6400
2. PREPARATIONS

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 2
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-6400 2.9


2. PREPARATIONS

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 other 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.

AC source socket

Equipotential Grounding

WARNING
For operator safety, equipotential grounding of all instruments must
be performed. Consult with a qualified biomedical engineer.

When more than one electrical instrument is used, there may be electrical
potential difference between the instruments. The potential difference between
the instruments may cause current to flow to the patient connected to the
instruments, resulting in electrical shock (micro shock).

Always perform equipotential grounding when required. It is often required in


the operating room, ICU room, CCU room, cardiac catheterization room and X-
ray room. Consult with a biomedical engineer to determine if it is required.

When equipotential grounding is required, connect the equipotential ground


terminal on the rear panel of the analyzer to the equipotential ground terminal
on the wall (equipotential grounding system) with the equipotential grounding
lead (potential equalization conductor).

Equipotential ground terminal

2.10 Operators Manual MEK-6400


2. PREPARATIONS

Connecting Tubes and Installing Reagents


2
In order for the analyzer to operate correctly, you must install all reagent and
waste tubing before the power is turned ON.

Materials Required
Powder-free gloves, lab coat, safety glasses
ISOTONAC3 diluent
CLEANAC detergent
CLEANAC3 detergent
Hemolynac3N lysing reagent
Reagent inlet tubings and waste outlet tubing
Waste container (or appropriate drain)
2 L container
Lint-free cloth

CAUTION
Use only Nihon Kohden recommended reagents. Otherwise the
measurement result cannot be guaranteed and incorrect reagent
concentration can cause equipment damage.

Diluent (ISOTONAC3)
NOTE
If the diluent contacts the skin or eyes or is swallowed, wash
immediately and thoroughly with water.
Use the diluent at room temperature (15 to 30C).
If frozen, warm the diluent at room temperature (15 to 30C) and stir
it sufficiently.
When the temperature of the diluent decreases to less than 15C, it
may influence WBC differential parameters (LY, MO, GR), but not
influence the WBC count.

Detergent
CLEANAC3

WARNING
Do not allow CLEANAC3 detergent to come into contact with acid.
Contact with acids can cause the release of poisonous chlorine
gas.
Do not swallow the CLEANAC3 detergent. If swallowed, see a
physician immediately.

Operator's Manual MEK-6400 2.11


2. PREPARATIONS

CAUTION
If the CLEANAC3 detergent contacts the skin, eyes or mouth, wash
thoroughly and immediately with water and see a physician.

NOTE
Store the detergent at room temperature (15 to 30C).
If frozen, warm the detergent at room temperature (15 to 30C) and
stir it sufficiently.

CLEANAC

WARNING
Do not swallow the CLEANAC detergent. If swallowed, see a
physician immediately.

NOTE
Store the detergent at room temperature (15 to 30C).
If frozen, warm the detergent at room temperature (15 to 30C) and
stir it sufficiently.

Lysing Reagent
Hemolynac3N

WARNING
Do not swallow the Hemolynac3N lysing reagent. If swallowed, see a
physician immediately.

CAUTION
If the Hemolynac3N lysing reagent contacts the skin, eyes or mouth,
wash thoroughly and immediately with water and see a physician.

NOTE
If the Hemolynac3N lysing reagent is frozen during shipment or low
temperature storage, background noise may increase. In this case,
leave the lysing reagent at 25 to 30C for 2 days and shake well.
Before use, make sure there are no bubbles in the reagent.

2.12 Operators Manual MEK-6400


2. PREPARATIONS

Connecting Tubes
NOTE
Do not squeeze or bend the tubes. Otherwise the analyzer may be
2
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 the lysing reagent, diluent and
detergent.

Waste container

Diluent
Lysing reagent
Detergent

Diluent Tube
NOTE
Place the diluent container at the same level as the analyzer.

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.


18 L container cap
Diluent tube 18 L tube assy
(marked blue) 3. Connect the end of the diluent tube to the 18 L tube
assy.

4. Put the 18 L tube assy into the diluent container and


Diluent (18 L) tighten the 18 L container cap.

Operator's Manual MEK-6400 2.13


2. PREPARATIONS

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 CLEANAC3 detergent. For other


purposes, use CLEANAC detergent.

CLEANAC Detergent
1. Connect the detergent tube (marked green) to the CLN
inlet on the right side panel.

2. Pass the detergent tube through the 18 L container


cap.

3. Connect the end of the detergent tube to the cleanac


18 L container cap tube assy.
Detergent tube
Cleanac tube assy
(marked green)
4. Put the cleanac tube assy into the CLEANAC
container and tighten the 18 L container cap.
CLEANAC detergent (5 L)

CLEANAC3 Detergent
1. Pour the CLEANAC3 detergent into the 2 L
container. Use the 18 L container cock for pouring the
diluent.

2. Connect the cleanac tube 8 (marked white) to the CLN


Cleanac tube 8 (marked white) inlet on the right side panel.

MEK cap 3. Pass the cleanac tube 8 through the MEK cap.
Tube assy (6100)
4. Connect the end of the cleanac tube 8 to the tube assy
(6100).

CLEANAC 3 detergent 5. Put the tube assy (6100) into the 2 L container of the
in 2 L container CLEANAC3 detergent and tighten the MEK cap.

2.14 Operators Manual MEK-6400


2. PREPARATIONS

Lysing Reagent Tube


Hemolynac3N
1. Replace the lysing reagent cap with the Hemolynac3 2
cap and tighten the cap.

2. Connect the Hemolynac3 tube assy (marked yellow)


to the HEMO3N inlet on the right side panel.

3. Put the other end of the tube into the lysing reagent
container through the Hemolynac3 cap.
Hemolynac3 tube assy
(marked yellow)
Hemolynac3 cap 4. When using the reagent tray, place the lysing reagent
container on the upper shelf of the reagent tray.
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) 3. Connect the waste tube to the waste tube assy.
Waste tube assy
4. Insert the waste tube assy into the 2 L container (waste
Waste container container) and tighten the MEK cap.

Operator's Manual MEK-6400 2.15


2. PREPARATIONS

Loading Recording Paper in the WA-640VK Printer Unit (Option)

NOTE
The WA-640VK 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 to feed the recording paper.

5. Lift up the recording paper and close the printer door.

6. Cut the recording paper.

2.16 Operators Manual MEK-6400


2. PREPARATIONS

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.
Main power switch
2. Set the printer power switch ON.

3. Press the [Main power] switch on the rear panel to ON. The [Main power
lamp] on the front panel lights.

Always leave the main power ON except for storage and transportation of
the analyzer.

Main power lamp 4. Press the [Power] key on the front panel ON. The [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.

Power lamp Power key

Operator's Manual MEK-6400 2.17


2. PREPARATIONS

When there is an error, the Fail appears on the screen.

After priming operation is completed, the READY screen appears. The analyzer
is ready for counting.

NOTE
If the error message appears, refer to Alarm Messages in Section 8.

Checking the Date and Time Settings


Date and time 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.

2.18 Operators Manual MEK-6400


2. PREPARATIONS

Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL)
The fluid path inside the analyzer must be cleaned after installation or long-
term storage. Perform PRIME ON INSTALL on the OPERATIONS screen. For
2
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-6400 2.19


2. PREPARATIONS

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.

2.20 Operators Manual MEK-6400


2. PREPARATIONS

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
2
according to Section 8 Messages and Troubleshooting.

Item Check
Turning on the power There is no fire, smoke or smell.
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.
Perform PRIME ON INSTALL on the
After long term storage
OPERATIONS screen.

NOTE
At the start of the day, check that the date and time settings are
correct.

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


Main power lamp 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.

Power lamp Power key

Operator's Manual MEK-6400 2.21


2. PREPARATIONS

Main power switch

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.

2.22 Operators Manual MEK-6400


2. PREPARATIONS

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. When using the analyzer in
closed mode, measure background noise in closed mode. When using the
analyzer in open mode, measure background noise in open mode. Background
noise increases in the following cases.

Problem Countermeasure
Old diluent. Germs begin to breed in the Replace diluent.
diluent 6 months after opening.
Dust in the diluent container. Replace diluent.
Extremely high or low diluent Adjust diluent temperature to 15 to
temperature (normal range is 15 to 30C). 30C.
The sampling nozzle is clogged and Replace the sampling nozzle with a
bubbles occur in the sub bath. new one.

There are two ways to measure background noise. One is by pressing the
[ Count] switch. 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 Background Noise In Closed Mode


Measuring by Pressing the [ Count] Switch
1. Select Closed for <Sampling mode> on the READY screen.

Eject key 2. Press the [ Eject] key on the front panel. The tube holder opens.

3. Set an empty tube in the tube holder.

Operator's Manual MEK-6400 2.23


2. PREPARATIONS

4. Close the tube holder. Diluent is measured. If the tube holder is closed
without setting a tube, measurement is not performed.

5. The tube holder opens automatically after finishing diluent measurement.


The result is displayed.

Measuring on the BACKGROUND Screen


1. Check that Closed is selected for <Sampling mode> and press the MENU
key on the READY screen.

2. Press the OTHER key on the MENU screen.

2.24 Operators Manual MEK-6400


2. PREPARATIONS

3. Press the BACKGROUND key on the OTHER screen.

The Measure background noise? message appears on the screen.

4. Press the YES key to measure background noise. The result is displayed
after the measurement is complete.

Measuring Background Noise in Open Mode


Measuring by Pressing the [ Count] Switch
1. Select Open for <Sampling mode> on the READY screen.

2. Press the [ Count] switch 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 switch

Operator's Manual MEK-6400 2.25


2. PREPARATIONS

Measuring on the BACKGROUND Screen


1. Check that Open is selected for <Sampling mode> and 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.

2.26 Operators Manual MEK-6400


2. PREPARATIONS

The Measure background noise? message appears on the screen.

4. Press the YES key to measure background noise. The result is displayed 2
after the measurement is complete.

Results
The result is displayed on the screen after measurement.

Background measurement result when Background measurement result when


performed on the BACKGROUND performed by the [ Count] switch
screen

Make sure that the values are less than or equal to the following values.
WBC: 0.2 (103/L)
RBC: 0.05 (106/L)
HGB: 0.1 (g/dL)
PLT: 10 (103/L)

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.

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.

Operator's Manual MEK-6400 2.27


2. PREPARATIONS

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.

CAUTION
Use hematology control before the expiration date.
Do not use hematology control when the top layer is slightly red or
the whole hematology control is red, because the red blood cells in
the control are hemolyzed.
Do not freeze the hematology control because this hemolyses it.
Use and store the hematology control with extreme care according
to its instructions.

1. Gently take out the hematology control from the refrigerator.

2. Bring to room temperature by rolling the hematology control vial between


the palms of the hands.

3. Turn the hematology control vial upside down at least 30 times to


thoroughly mix the plasma and red blood cells.

4. Select Open for <Sampling mode> on the READY screen.

5. 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.

Sampling nozzle

Count switch

Put the sampling


nozzle to this level

6. Press the [ Count] switch on the front panel. The hematology control is
aspirated and counting is performed.

2.28 Operators Manual MEK-6400


2. PREPARATIONS

After counting, the result appears on the screen.

7. 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-6400 2.29


Section 3 Changing Settings
General .............................................................................................................................................................. 3.3 3
Assigning Users and Passwords ........................................................................................................................ 3.4
General .................................................................................................................................................... 3.4
Displaying the USERS Screen ................................................................................................................. 3.4
Adding a User .......................................................................................................................................... 3.6
Changing a User ...................................................................................................................................... 3.8
Deleting a User ........................................................................................................................................ 3.9
Assigning an ID to a Sample ............................................................................................................................. 3.11
Displaying the ID Screen ........................................................................................................................ 3.11
Entering a 4 Digit Numeric ID .................................................................................................................. 3.12
Entering a 13 Character Alphanumeric ID ................................................................................................ 3.12
Not Assigning an ID ................................................................................................................................ 3.14
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 .............................................................................................. 3.38
Changing Settings for Card Printer .......................................................................................................... 3.43
Changing Format for PC .......................................................................................................................... 3.45
Changing the USB Settings .................................................................................................................... 3.47
Selecting Language ........................................................................................................................................... 3.48
Selecting Units .................................................................................................................................................. 3.49
Selecting Unit Type ................................................................................................................................. 3.49
Counting Unit Table ....................................................................................................................... 3.50
Customizing Units ................................................................................................................................... 3.50
Changing Sound and Screen Brightness Settings ............................................................................................. 3.51
Changing Various Settings for Analyzer Power On ............................................................................................. 3.52
Setting Auto Priming/Cleaning ........................................................................................................................... 3.54

Operator's Manual MEK-6400 3.1


Using Reagent Management ............................................................................................................................. 3.56
Setting the Warning Level ........................................................................................................................ 3.56
When the Reagent Management Warning is Displayed ............................................................................ 3.58
Initializing Settings ............................................................................................................................................ 3.61
Factory Default Settings .......................................................................................................................... 3.63

3.2 Operators Manual MEK-6400


3. CHANGING SETTINGS

General

Before starting measurements, assign an ID to a sample, change any necessary


settings, such as measurement mode, upper and lower limits, date and time. 3

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 READY, MENU or


RESULTS screen.

Set the following items on the SETTINGS screen. You can also initialize
settings on the SETTINGS screen.

Item Description
SAMPLE TYPE 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 or
MEASUREMENT 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 you local language.
UNITS Select the units for parameters.
Adjust the volume of alarms or buzzer and adjust the
SOUND/LCD
screen brightness.
OPERATION Set the functions to be operated at analyzer power on.
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 Assigning Users and
Passwords section.

Operator's Manual MEK-6400 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.

Service: For servicing the analyzer. Can enter any screen and change
Status bar 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 user. Adding or deleting a
user can only be performed by a lab technician or service 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:
Celltac: 6400
USER: 0000

Celltac is selected as the default setting.

Displaying the USERS Screen


1. Press the SETTINGS key on the MENU screen.

3.4 Operators Manual MEK-6400


3. CHANGING SETTINGS

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 [ 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 SETTINGS screen.

4. Press the OK key on the SETTINGS screen to return to the MENU screen.

Operator's Manual MEK-6400 3.5


3. CHANGING SETTINGS

Adding a User
A new user can only be added by either a lab technician or service user. Up to 8
users can be registered (including the factory default users).

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 the <Name> box (up
to 8 alphanumerics).

Select 123 or ABC to select numbers or letters. The keys change


to reflect your selection.

Cursor Cursor

Clears the
character at the
cursor position

Move cursor

Clears all entered


characters

Keys for entering numbers Keys for entering letters

3.6 Operators Manual MEK-6400


3. CHANGING SETTINGS

On the alphabet and symbol keypad, the letters change in the following
order every time a key is pressed.

Key Corresponding Characters

ABC A B C A 3
DEF D E F D
GHI GHIG
JKL J K L J

MNO M N O M
PQRS P Q R S P

TUV T U V T

WXYZ W X Y Z W
.@,/ .@,/.

Symbols !?-;:()!

3. Select Other user or Lab technician for the type of user from the
selection list in the <Type of user> box.

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

Operator's Manual MEK-6400 3.7


3. CHANGING SETTINGS

6. Press the Enter key. The cursor moves to the <Re-enter password> box.

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

Changing a User
1. Select the desired user on the USERS screen.

Current user

2. Press the CHANGE key. The PASSWORD window is displayed.

3.8 Operators Manual MEK-6400


3. CHANGING SETTINGS

Clears all entered numbers

Returns to the USERS


screen

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.

When the wrong password is entered, the Incorrect password message


appears. Enter the correct password.

Deleting a User
Deleting a user can only be performed by either a lab technician or service user.

NOTE
FACTORY, Celltac and USER are the default settings and cannot be
deleted.

1. Select the user to be deleted on the USERS screen.

Operator's Manual MEK-6400 3.9


3. CHANGING SETTINGS

2. Press the DELETE key. The Delete user? message is displayed.

3. Press the YES key to delete the selected user. The user is deleted and the
screen returns to the USERS screen.
Press the NO key to not delete the selected user.

3.10 Operators Manual MEK-6400


3. CHANGING SETTINGS

Assigning an ID to a Sample

All samples must have an ID. Otherwise, you cannot identify which samples the
displayed or saved data corresponds to. All saved and displayed data is 3
identified by an ID number.

After 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.

You can enter up to 13 characters, but the last 4 digits must be numbers.

When using the 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.

You can also choose to not assign an ID to a sample, such as in background


noise measurement.

To edit an ID of already saved data, refer to Editing ID in Section 5.

Displaying the ID Screen


1. Press the ID key on the MENU or RESULTS screen or the SET key in the
<ID> box on the READY screen to display the ID screen.

Operator's Manual MEK-6400 3.11


3. CHANGING SETTINGS

ID box

Resets the ID to 0001.

Select YES or NO for using ID

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. Check that <Use ID> is set to YES.

2. Enter a 4 digit-ID with the numeric keys on the screen. When the Reset key
is pressed, the number is reset to 0001.

Entering a 13 Character Alphanumeric ID


1. Check that <Use ID> is set to YES.

2. Press 13 DIGITS key in the <ID> box to display the keypad for entering
letters.

3.12 Operators Manual MEK-6400


3. CHANGING SETTINGS

3. Select 123 or ABC key to select numbers or letters. The keys


change to reflect your selection.

The entered ID appears here


Cursor Cursor
3

Clears the character at


the cursor position

Move cursor

Resets the ID to 0001

Keys for entering numbers Keys for entering letters

4. Enter an ID with the keypad. The entered number or letter appears in the
<ID> box. In the last 4 digits, only the numbers can be entered.

On the alphabet and symbol keypad, the letters change in the following
order every time a key is pressed.

Key Corresponding Characters

ABC A B C A
DEF D E F D
GHI GHIG
JKL J K L J

MNO M N O M
PQRS P Q R S P

TUV T U V T

WXYZ W X Y Z W
.@,/ .@,/.

Symbols !?-;:()!

Operator's Manual MEK-6400 3.13


3. CHANGING SETTINGS

Not Assigning an ID
To not assign an ID, select NO for <Use ID>.

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.

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 Hand-held 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.

3.14 Operators Manual MEK-6400


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 3
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-6400 3.15


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
Cursor

Entered label appears in


this box

Clears the character at


the cursor position

Move cursor

Clears all entered


characters

Returns to the SAMPLE TYPE list screen

Keys for entering numbers Keys for entering letters

3.16 Operators Manual MEK-6400


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.
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

Resets the selected


sample type label to
the default setting

Operator's Manual MEK-6400 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


Default Setting Variable
Parameter
Lower Limit Upper Limit Range
WBC (103/L) 4.0 9.0 0 to 99.9
6
RBC (10 /L) 3.80 5.30 0 to 14.99
HGB (g/dL) 12.0 18.0 0 to 29.9
HCT (%) 36.0 56.0 0 to 99.9
MCV (fL) 80.0 100.0 20.0 to 199
MCH (pg) 27.0 32.0 10.0 to 50.0
MCHC (g/dL) 32.0 36.0 10.0 to 50.0
3
PLT (10 /L) 120 380 0 to 1490
LY% 11.0 49.0 0 to 99.9
MO% 0.0 9.0 0 to 99.9
GR% 42.0 85.0 0 to 99.9
3
LY (10 /L) 0.4 4.4 0 to 99.9
3
MO (10 /L) 0 0.8 0 to 99.9
GR (103/L) 0 0.3 0 to 99.9
RDW (%) 10.0 16.5 0 to 50.0
PCT (%) 0.10 1.00 0 to 2.90
MPV (fL) 5.0 10.0 0 to 20
PDW (%) 12.0 18.0 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 Operators Manual MEK-6400


3. CHANGING SETTINGS

2. Press the NORMAL RANGE key on the SETTINGS screen to display the
NORMAL RANGE screen.

3. Select the sample type in the <Sample type> box.

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-6400 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 Operators Manual MEK-6400


3. CHANGING SETTINGS

Changing Sensitivity and Threshold

General
For measuring nonhuman blood, the sensitivity and threshold should be
3
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


Sensitivity Threshold
Parameter
Default Range Default Range
WBC 5 1 to 15 4 1 to 15
RBC 5 1 to 15 AUTO 1 to 15, AUTO
PLT 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-6400 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 the <Sample type> box.

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 Operators Manual MEK-6400


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: 3


i) 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 the
<Sample type> box.

2. Press the OK key to return to the SENS/THRESH screen.

Operator's Manual MEK-6400 3.23


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) Particle Volume Range (fL) Optimum Sensitivity
400 200 to 600 1
200 100 to 300 2
130 70 to 200 3
100 50 to 150 4
80 40 to 120 5
70 35 to 100 6
60 30 to 90 7
50 25 to 80 8
45 20 to 70 9

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

0 Threshold

If the plateau is too short or cannot be obtained, increase sensitivity and


repeat this procedure.

No plateau Plateau is too short


Counted value Counted value

0 0
Threshold Threshold
3.24 Operators Manual MEK-6400
3. CHANGING SETTINGS

Changing Measurement Settings

The following items can be set for measurement.

Items Description Settings Default 3


Measurement count Select to count a sample either once or twice. Single or Double Single
Display alarm on Select whether or not to display an alarm when Yes or No No
recount recounting a sample.
PLT recount threshold Select the threshold under which a sample is recounted 100,000/L or 100,000/L
for the PLT parameter. Refer to PLT Recount in 50,000/L
Section 4.
Pre-dilution volume Select the pre-dilution blood measuring volume. 10 L or 20 L 20 L
Continue dilute mode Select whether or not to continue measurement in the Yes or No No
same dilution mode.
Recount if panic Select whether or not recount the sample when the Yes or No Yes
value measured value is out of the panic value range.
High dilute mode for Select dilution mode for panic value recount with high High or Higher Higher
panic value recount dilution. Refer to Recount when Out of Panic Range in
Section 4.
Continuous Select whether or not to continue measurement without On or Off Off
measurement auto cleaning of fluid path 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 MEASUREMENT key on the SETTINGS screen to display the


MEASUREMENT screen.

Operator's Manual MEK-6400 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 to display alarm upon auto recount to
distinguish the problem.

Alarm message displayed when <Display


alarm on recount> is set to Yes

3.26 Operators Manual MEK-6400


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 100,000/L.
3
Pre-dilution volume
Select the pre-dilution blood measuring volume.

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.

Continuous measurement
Set this setting to Yes only when measuring many samples continuously in
the same dilution mode.

No: The analyzer automatically primes the fluid path after each
measurement.
Yes: Measurement is performed for 10 counts without auto priming after each
measurement. After the tenth count, the fluid path is cleaned with
detergent. If there is no measurement for 2 minutes after the last
measurement, the analyzer is automatically primed.

Operator's Manual MEK-6400 3.27


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: 1 to 31
Hour: 0 to 23
Minute: 0 to 59

To change the settings, the type of user must be either lab technician or service.

1. Press the SETTINGS key on the MENU screen.

2. Press the DATE & TIME key on the SETTINGS screen to display the DATE
& TIME screen.

3.28 Operators Manual MEK-6400


3. CHANGING SETTINGS

3. Select the date format in the <Date format> box.

NOTE
The selected date format is also used in stored data, printing,
sending and history. 3

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-6400 3.29


3. CHANGING SETTINGS

Changing Display Format

You can select the following display format settings for RESULTS and DATA
screens.

Item Description Settings Default


Display Select the number of parameters to be displayed 8 or 18 18
parameters on the RESULTS and DATA DETAILS screen.
Histogram Select whether or not to display histograms and Normal, Wide or None Normal
the display size on the RESULTS and DATA
DETAILS screen.
Histogram Y-axis Select the vertical axis on the histogram on the Count or Percentage Count
RESULTS and DATA DETAILS screen.
Display WBC Select whether or not to display the borderline of Yes or No No
histogram lines differential parameters on the WBC histogram on
the RESULTS and DATA DETAILS screen.
Adjust histogram Adjust RBC histogram horizontal axis scale, 50 to 200% 100
scale WBC, RBC and PLT histogram vertical axis scale
on the RESULTS and DATA DETAILS screen.
DATA screen Select sequence number or sample type to be SEQ# or Sample type SEQ#
items displayed on the DATA screen.
DATA screen Select the display parameters for the DATA LY%, MO%, GR%, LY, LY%, MO%, GR%
display items screen. Up to three parameters can be selected. MO, GR, RDW, PCT,
MPV, PDW (CRP and RF
are not available)
Select flags to Select flags to be highlighted in red. All flags PLT clumps,
display in red PLT-RBC interfere

To change the settings, the type of user must be either lab technician or service.

1. Press the SETTINGS key on the MENU screen.

3.30 Operators Manual MEK-6400


3. CHANGING SETTINGS

2. Press the DISPLAY key on the SETTINGS screen to display the DISPLAY
screen.

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-6400 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: 18 Display Parameters: 18 Display Parameters: 18


Histogram: Normal Histogram: Wide Histogram: None

Display Parameters: 8 Display Parameters: 8 Display Parameters: 8


Histogram: Normal Histogram: Wide 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> <Percentage>
[Count] [%]
100%

[fL] [fL]
The horizontal axis represents the blood cell volume.
(fL = 1 10-15 L)

3.32 Operators Manual MEK-6400


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
Monocyte Granulocyte distribution
distribution

Second page of the DISPLAY


screen

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-6400 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 flag(s) which were selected for this setting, the ID number
of the result appears in red on the DATA screen.
Fourth page of the DISPLAY screen

ID is displayed in red

3.34 Operators Manual MEK-6400


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 3
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-6400 3.35


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 INT PRINTER: WA-640VK thermal printer


EXT PRINTER: Printer connected to the printer socket
USB port SERIAL PORT 1: External device connected to the serial port 1
SERIAL PORT 2: External device connected to the serial port 2
USB: External device connected to the USB port

4. Change the settings by referring to the following sections.

5. Press the OK key to return to the OUTPUT screen.

6. Press the OK key to return to the SETTINGS screen.

3.36 Operators Manual MEK-6400


3. CHANGING SETTINGS

Changing Print Format for Internal Printer


You can set the following items for the optional internal thermal array printer.

Item Description Settings Default


Auto output after Select whether or not to automatically print data after Yes or No Yes 3
measurement measurement.
Print with [Print] key Select whether or not to print data when you press the Yes or No Yes
[Print] key on the front panel or PRINT key on the screen.
Print external data Select whether or not to print received data from an Yes or No Yes
external device.
Print parameters Select number of parameters for printing numeric data. 8 or 18 18
Print WBC histogram Select whether or not to print WBC histogram. Yes or No Yes
Print RBC histogram Select whether or not to print RBC histogram. Yes or No Yes
Print PLT histogram Select whether or not to print PLT histogram. Yes or No Yes
Print radar graph Select whether or not to print numeric result with normal Yes or No Yes
range in a radar graph.
Print flags Select whether or not to print the flags when they appear. Yes or No Yes
Select parameters to print Select whether or not to print a normal range graph for On or Off for Off for all
normal range graph each parameter. each parameter parameters

1. Press the INT PRINTER key on the OUTPUT screen.

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 3

Operator's Manual MEK-6400 3.37


3. CHANGING SETTINGS

To change normal range print settings on page 3, select on or off by


touching the check box for each parameter.

3. Press the OK key to return to the OUTPUT screen.

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.


When using a WA-710V/712V printer or EPSON VP printer, set the following
items.
Item Description Settings Default
Auto output after Select whether or not to automatically print data after Yes or No Yes
measurement measurement.
Print with [Print] key Select whether or not to print data when you press the Yes or No Yes
[Print] key on the front panel or PRINT key on the screen.
Printer type Select EPSON VP for printer type. EPSON VP, EPSON PM or EPSON VP
CANON BJ
EPSON VP paper Select the width of the recording paper. Wide (10 inches) Wide
width Narrow (normal recording 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 Yes
Print flags Select whether or not to print the flags when they appear. Yes or No Yes
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 66
length (lines/page)
Print format Select to print numerical data only, numerical data and Numeric, Num + hist or Radar Num + hist
histogram or radar graph. graph
Print parameters Select number of parameters for printing numeric data. 8 or 18 18
Available only when Numeric is selected for <Print
format>.
Print measurement Select whether or not to print measurement date & time. Date & time, Date only, Date &
date & time Available only when Numeric is selected for <Print Time only or None time
format>.
Print normal range Select whether or not to print normal range settings for all Numeric, Graphic or None None
parameters. Available only when Num + hist is selected
for <Print format>.
Print header Select to print header or not. Available only when Num + Off or up to 46 characters can be Off
Hist or Radar graph is selected for <Print format>. entered.
Print flags Select whether or not to print flags when they appear. Yes or No Yes
Available only when Num + hist is selected for <Print
format>.
Samples/page Select one or two data to be printed per page. Available 1 or 2 1
only when Num + hist is selected for <Print format>.
Print auto analysis Select whether or not print auto analysis findings. Yes or No Yes
findings Available only when Radar graph is selected for <Print
format>.

3.38 Operators Manual MEK-6400


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 3
CONTROL screen.

When using an EPSON PM or CANON BJ printer, set the following items.


Item Description Settings Default
Auto output after Select whether or not to automatically print data Yes or No Yes
measurement after measurement.
Print with [Print] Select whether or not to print data when you press Yes or No Yes
key the [Print] key on the front panel or PRINT key on
the screen.
Printer type Select EPSON PM when using EPSON PM printer EPSON VP, EPSON PM or CANON BJ EPSON VP
or select CANON BJ when using CANON PIXUS
printer.
Print format Select to print numerical data only, numerical data Numeric, Num + hist or Radar graph Num + hist
and histogram or radar graph.
Print parameters Select number of parameters for printing numeric 8 or 18 18
data. Available only when Numeric is selected for
<Print format>.
Print measurement Select whether or not to print measurement date & Date & time, Date only, Time only or Date & time
date & time time. Available only when Numeric is selected for None
<Print format>.
Print normal range Select whether or not to print normal range settings Numeric, Graphic or None None
for all parameters. Available only when Num +
hist is selected for <Print format>.
Print header Select to print header or not. Available only when Off or up to 46 characters can be Off
Num + hist or Radar graph is selected for entered.
<Print format>.
Print flags Select whether or not to print flags when they Yes or No Yes
appear. Available only when Num + hist is
selected for <Print format>.
Samples/page Select one or two data to be printed per page. 1 or 2 1
Available only when Num + hist is selected for
<Print format>.
Print auto analysis Select whether or not print auto analysis findings. Yes or No Yes
findings Available only when Radar graph is selected for
<Print format>.

Operator's Manual MEK-6400 3.39


3. CHANGING SETTINGS

1. Press the EXT PRINTER key on the OUTPUT screen.

2. Select the connected printer type in the <Printer type> box.

3. Select the settings by touching the check box. Change the setting pages by
pressing the PREV or NEXT key.

Setting screens for using WA-710V/712V or EPSON VP type with paper width Narrow

First page Second page

3.40 Operators Manual MEK-6400


3. CHANGING SETTINGS

Setting screens for using WA-710V/712V or EPSON VP type with paper width Wide or EPSON PM or CANON BJ

First page for WA-710V/712V or EPSON VP First page for EPSON PM or


type with paper width Wide CANON BJ type
3

Press this key to display the


screen for setting the page length.
Refer to the following page.

Second page
When Numeric is selected When Num + hist is When Radar graph is
for <Print format> selected for <Print format> 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>

Operator's Manual MEK-6400 3.41


3. CHANGING SETTINGS

To change the <Paper length> setting when using WA-710V/712V or


EPSON VP type printer with paper width Wide, enter the value using the
numeric keys and press the Enter key to register the value.

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 the <Print header> box to display the screen
for entering the header.

Cursor

Entered characters appear


in this box

Clears the character at


the cursor position

Move cursor

Clears all entered


characters

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.

3.42 Operators Manual MEK-6400


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 Settings Default
3
Format Select WA-450V or WA-460V. WA-450V, WA-460V, PC or PC
Other*
Auto output Select whether or not to automatically print data Yes or No Yes
after on the card printer after measurement.
measurement
Print with Select whether or not to print data on the card Yes or No No
[Print] key printer when you press the [Print] key on the front
panel or PRINT key on the screen.
Output with Select whether or not to send data to the card Yes or No Yes
SEND key printer to print when you press the SEND key on
the screen.
Parameters Select the number of parameters for printing 8, 18 or 19 18
numeric data.
Date format Select the date format for printing. YY/MM/DD or DD/MMM/YY DD/MMM/YY
Baud rate Select the data transmission speed. 1200, 2400, 4800, 9600 or 9600 bps
19200 bps
Data bits Select data bits. 7 or 8 bits 8 bits
Parity Select parity bit. Even, Odd, or None Even
Stop bits Select stop bits. 1 or 2 bits 1 bit
The following items are available only for WA-460V card printer.
ID digits Select the number of digits for printing ID. 4 or 13 13
Print parameter Select to print all parameter names, WBC All, Diff only or None None
names differential parameter names only, or no names.
Top space Select the number of blank lines at the top of the 1 to 50 lines 5
recording paper.
Left space Select the amount of blank space at the left side 0 to 26 characters 0
of the recording paper.
Row size Select the width of the row. 5 to 60 fifths of an inch 10
(X/5 inches)
* Other is only used when the MEK-6400 hematology analyzer is replacing another Nihon Kohden hematology
analyzer in a system. For details, contact your Nihon Kohden representative.

1. Press the SERIAL PORT 1 or SERIAL PORT 2 key to which the card printer
is connected on the OUTPUT screen.

Serial port 1

Serial port 2

Operator's Manual MEK-6400 3.43


3. CHANGING SETTINGS

2. Select WA-460V or WA-450V in the <Format> box 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 the
<External device> box and select the card printer type in the <Format>
box.

3. Select the settings by pressing the item option box. Change the setting
pages by pressing the PREV or NEXT key.

Third page for WA-450V or


Second page for WA-460V Second page for WA-450V fourth page for WA-460V

3.44 Operators Manual MEK-6400


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.
3
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 Settings Default


Format Select PC. WA-450V, WA-460V, PC
PC or Other*
Auto output after Select whether or not to automatically output data Yes or No Yes
measurement after measurement.
Print with [Print] Select whether or not to print data when you Yes or No No
key press the [Print] key on the front panel or PRINT
key on the screen.
Output with SEND Select whether or not to send data when you Yes or No Yes
key press the SEND key on the screen.
Version Select the format version for PC. The format V02-02 or V04-01 V04-01
version is specified in the Data Communication
Protocol of the analyzer. For details, contact your
Nihon Kohden representative.
Output histograms Select whether or not to output histograms to PC. Yes or No No
Baud rate Select the data transmission speed. 1200, 2400, 4800, 9600 bps
9600 or 19200 bps
Data bits Select data bits. 7 or 8 bits 8
Parity Select parity bit. Even, Odd, or None Even
Stop bits Select stop bits. 1 or 2 bits 1
* Other is only used when the MEK-6400 hematology analyzer is replacing another Nihon Kohden
hematology analyzer in a system. For details, contact your Nihon Kohden representative.

Operator's Manual MEK-6400 3.45


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.

Serial port 1

Serial port 2

3. Select PC in the <Format> box.

When the PC is connected to the serial port 2, select Other in the


<External device> box and select the PC in the <Format> box.

4. Select the settings by touching the check box.

Second page Third page

5. Press the OK key to return to the OUTPUT screen.


3.46 Operators Manual MEK-6400
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
3
Nihon Kohden representative.

Item Description Settings Default


Analyzer name When two analyzers are connected to the DMS on a PC, it Unit 1 or Unit 2 Unit 1
is necessary to set a device name for the analyzer when
sending data in USB.

Auto output after Select whether or not to automatically output data after Yes or No Yes
measurement measurement.
Output with SEND key Select whether or not to send data when you press the Yes or No Yes
SEND key on the screen.

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.

Operator's Manual MEK-6400 3.47


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 your local language or ENGLISH.

4. Press the OK key to return to the SETTINGS screen.

3.48 Operators Manual MEK-6400


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 3
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.


Operator's Manual MEK-6400 3.49
3. CHANGING SETTINGS

Counting Unit Table


Parameter JAPAN USA SI SIMOD MIXED
9 9
WBC 2
10 /L 3
10 /L 10 /L 10 /L 109/L
RBC 104/L 106/L 1012/L 1012/L 1012/L
HGB g/dL g/dL g/L mmol/L* g/L
HCT % % % % %
MCV fL fL fL fL fL
MCH pg pg pg fmol pg
MCHC g/dL g/dL g/L mmol/L* g/L
9
PLT 4
10 /L 3
10 /L 3
10 /L 10 /L 109/L
NE% % % % % %
LY% % % % % %
MO% % % % % %
EO% % % % % %
BA% % % % % %
NE 102/L 103/L 109/L 109/L 109/L
LY 102/L 103/L 109/L 109/L 109/L
MO 102/L 103/L 109/L 109/L 109/L
EO 102/L 103/L 109/L 109/L 109/L
BA 102/L 103/L 109/L 109/L 109/L
RDW % % %CV %CV %CV
PCT % % % % %
MPV fL fL fL fL fL
PDW % % % %CV %
* 1 mmol/L = 1.611 g/dL

Customizing Units
You can select unit for each parameter as shown in the table below.

Item Settings Default


2 3 9
WBC 10 /L, 10 /L, 10 /L 103/L
RBC 104/L, 106/L, 1012/L 106/L
HGB g/dL, g/L, mmol/L g/dL
HCT %, L/L %
3 4 9
PLT 10 /L, 10 /L, 10 /L 103/L
RDW %, %CV %
PDW %, %CV %

1. On the UNITS screen, select User in the <Units> box.

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

3.50 Operators Manual MEK-6400


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 3
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 the <Measurement count sound> box to turn on or


off the count sound during counting sample.

4. Adjust the volume using the arrow keys in the <Volume> box.

5. Select Light or Dark for the screen brightness.

6. Press the OK key to return to the SETTINGS screen.


Operator's Manual MEK-6400 3.51
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 Settings Default


Background noise check Select whether or not to perform background Yes or No No
at power on measurement during checking after power on.
Initial sampling mode Select closed or open mode. When the power is Open or Closed Closed
turned off, the sampling mode returns to this setting.
Sampling nozzle position Select the sampling nozzle position for open mode. High or Low High
Select High when using sample tube and select
Low when using sample container.
Reset auto ID at power on Select whether or not to reset ID to 0001 when the Yes or No Yes
power is turned off.

1. Press the SETTINGS key on the MENU screen.

2. Press the OPERATION key on the SETTINGS screen to display the


OPERATION screen.

3.52 Operators Manual MEK-6400


3. CHANGING SETTINGS

3. Select the settings by touching the check box of the desired setting.

4. Press the OK key to return to the SETTINGS screen.

Operator's Manual MEK-6400 3.53


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.

3.54 Operators Manual MEK-6400


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) 3
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.

Operator's Manual MEK-6400 3.55


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 SETTINGS screen.

3.56 Operators Manual MEK-6400


3. CHANGING SETTINGS

3. Select On in the <Use reagent management> box 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

Operator's Manual MEK-6400 3.57


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.

3.58 Operators Manual MEK-6400


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 REPLACE ALL key when replacing all
reagents.

The confirmation window appears.

Operator's Manual MEK-6400 3.59


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.

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.

3.60 Operators Manual MEK-6400


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. 3

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.

Operator's Manual MEK-6400 3.61


3. CHANGING SETTINGS

3. Press YES to start initializing. If you press NO, initializing is canceled and
the screen returns to the SETTINGS screen.

3.62 Operators Manual MEK-6400


3. CHANGING SETTINGS

Factory Default Settings


Setting Screen Setting Item Default Settings
Normal, Male, Female, Child, Infant, Other 1,
Other 2, Other 3, Other 4, Control
SAMPLE TYPE Sample type labels
(Normal and Control are selected for the
sample type selection list)
3
Parameter Lower Limit Upper Limit
WBC (103/L) 4.0 9.0
RBC (106/L) 3.80 5.30
HGB (g/dL) 12.0 18.0
HCT (%) 36.0 56.0
MCV (fL) 80.0 100.0
MCH (pg) 27.0 32.0
MCHC (g/dL) 32.0 36.0
PLT (103/L) 120 380
NORMAL RANGE LY% 11.0 49.0
MO% 0.0 9.0
GR% 42.0 85.0
LY (103/L) 0.4 4.4
MO (103/L) 0 0.8
GR (103/L) 0 0.3
RDW (%) 10.0 16.5
PCT (%) 0.10 1.00
MPV (fL) 5.0 10.0
PDW (%) 12.0 18.0
Parameter Sensitivity Threshold
WBC 5 4
SENS/THRESH RBC 5 AUTO
PLT 5
Auto threshold (RBC) On
Measurement count Single
Display alarm on recount No
PLT recount threshold 100,000/L
Pre-dilution volume 20 L
MEASUREMENT Continue dilute mode No
Recount if panic value Yes
High dilute mode for panic value
Higher
recount
Continuous measurement Off
DATE & TIME Date format DD/MM/YY
Display parameters 18
Histogram Normal
Histogram Y-axis Count
Display WBC histogram lines No
Adjust histogram scale
RBC horizontal axis 100
DISPLAY
WBC vertical axis 100
RBC vertical axis 100
PLT vertical axis 100
DATA screen items SEQ#
DATA screen display items LY%, MO%, GR%
Select flags to display in red PLT clumps, PLT-RBC interfere

Operator's Manual MEK-6400 3.63


3. CHANGING SETTINGS

Setting Screen Setting Item Default Settings


Internal Printer Auto output after measurement Yes
Print with [Print] key Yes
Print external data Yes
Print parameters 18
Print WBC histogram Yes
Print RBC histogram Yes
Print PLT histogram Yes
Print radar graph Yes
Print flags Yes
Select parameters to print normal range graph Off for all parameters
External Printer Auto output after measurement Yes
Print with [Print] key Yes
Printer type EPSON VP
EPSON VP paper width Wide
Print histogram Yes
Print flags Yes
EPSON VP page length (lines/page) 66
Print format Num + hist
Print parameters 18
Print measurement date & time Date & time
Print normal range None
Header Off
OUTPUT Print flags Yes
Samples/page 1
Print auto analysis findings Yes
Port 1, Port 2 External device (Port 2 only) Other
Format PC
Auto output after measurement Yes
Print with [Print] key No
Output with SEND key Yes
Version V04-01
Output histograms No
Baud rate 9600 bps
Data bits 8 bits
Parity Even
Stop bits 1 bit
Parameters 18
Date format DD/MMM/YY
ID digits 13
Print parameter names None
Top space 5
Left space 0
Row size 10
USB Analyzer name Unit 1
Auto output after measurement Yes
Output with SEND key Yes

3.64 Operators Manual MEK-6400


3. CHANGING SETTINGS

Setting Screen Setting Item Default Settings


LANGUAGE Language English
UNITS Units USA
Measurement count sound On
SOUND/LCD Volume 3
Screen brightness Light 3
Background noise check at
No
power on
OPERATION Initial sampling mode Closed
Sampling nozzle position High
Reset auto ID at power on Yes
1st 0:00 No
2nd 0:00 No
AUTO CLEANING
3rd 0:00 No
4th 0:00 No
Name Factory Celltac User
USERS Type of user Service Lab technician Other user
Password 6400 0000
Use reagent management No
Waste Warning: 9.5 L Bottle size: 10.0 L
REAGENT MANAGEMENT Diluent Warning: 0.5 L Bottle size: 18.0 L
Reagent
Detergent Warning: 0.15 L Bottle size: 5.0 L
Lysing reagent Warning: 15 mL Bottle size: 500 mL
QC method X-R
Save QC meas data on DATA
No
QC SETTINGS screen
Send data after QC measurement No
X limit calculation 3 SD

Operator's Manual MEK-6400 3.65


3. CHANGING SETTINGS

Setting Screen Setting Item Default Settings


Parameter X INITIAL VALUE X LIMIT R INITIAL VALUE R LIMIT
WBC (103/L) 7.9 0.8 0.8 1.6
RBC (106/L) 4.81 0.18 0.18 0.36
HGB (g/dL) 14.0 0.4 0.4 0.8
HCT (%) 42.3 2.5 2.5 5.0
MCV (fL) 88.0 3.0 3.0 6.0
MCH (pg) 29.1 1.5 1.5 3.0
MCHC (g/dL) 33.1 2.0 2.0 4.0
X-R Normal
PLT (103/L) 251 40 40 80
LY% 35.3 5.0 5.0 10.0
MO% 4.8 3.0 3.0 6.0
GR% 59.9 5.0 5.0 10.0
RDW (%) 13.9 2.0 2.0 4.0
PCT (%) 0.14 0.05 0.05 0.10
MPV (fL) 5.4 2.0 2.0 4.0
PDW (%) 17.1 2.0 2.0 4.0
Parameter X INITIAL VALUE X LIMIT R INITIAL VALUE R LIMIT
WBC (103/L) 2.1 0.6 0.6 1.2
RBC (106/L) 2.32 0.14 0.14 0.28
HGB (g/dL) 6.1 0.3 0.3 0.6
HCT (%) 18.6 2.0 2.0 4.0
MCV (fL) 80.0 3.0 3.0 6.0
MCH (pg) 26.3 1.5 1.5 3.0
MCHC (g/dL) 32.8 2.0 2.0 4.0
X-R Low
PLT (103/L) 67 20 20 40
LY% 64.3 6.0 6.0 12.0
MO% 8.2 2.0 2.0 4.0
GR% 27.5 6.0 6.0 12.0
RDW (%) 15.0 2.0 2.0 4.0
PCT (%) 0.04 0.02 0.02 0.04
MPV (fL) 6.6 2.0 2.0 4.0
PDW (%) 17.7 2.0 2.0 4.0
Parameter X INITIAL VALUE X LIMIT R INITIAL VALUE R LIMIT
WBC (103/L) 21.2 1.6 1.6 3.2
RBC (106/L) 2.90 0.23 0.23 0.46
HGB (g/dL) 18.6 0.5 0.5 1.0
HCT (%) 55.5 3.0 3.0 6.0
MCV (fL) 94.0 3.0 3.0 6.0
MCH (pg) 31.5 1.5 1.5 3.0
MCHC (g/dL) 33.5 2.0 2.0 4.0
X-R High
PLT (103/L) 485 70 70 140
LY% 21.1 5.0 5.0 10.0
MO% 1.5 2.0 2.0 4.0
GR% 77.4 5.0 5.0 10.0
RDW (%) 13.3 2.0 2.0 4.0
PCT (%) 0.20 0.07 0.07 0.14
MPV (fL) 4.1 2.0 2.0 4.0
PDW (%) 16.3 2.0 2.0 4.0
Parameter X INITIAL VALUE X LIMIT
MCV (fL) 89.5 2.7
XB
MCH (pg) 30.5 0.9
MCHC (g/dL) 33.8 1.0

3.66 Operators Manual MEK-6400


Section 4 Measurement
General .............................................................................................................................................................. 4.2
Sampling Mode ........................................................................................................................................ 4.2
Dilution Mode ........................................................................................................................................... 4.2
Sample Type ............................................................................................................................................ 4.3
Single and Double Counting ..................................................................................................................... 4.3 4
ID Numbers .............................................................................................................................................. 4.4
Alarm Display .......................................................................................................................................... 4.4
Data Storage ............................................................................................................................................ 4.4
Printing and Sending Data ........................................................................................................................ 4.4
PLT Recount ............................................................................................................................................ 4.5
Recount when Out of Panic Range ........................................................................................................... 4.5
Counting Special Case Samples .............................................................................................................. 4.5
Measurement in Closed Mode ............................................................................................................................ 4.6
Preparing a Sample ................................................................................................................................. 4.6
Measuring a Sample in Closed Mode ....................................................................................................... 4.7
Measurement in Normal Dilution Mode ........................................................................................... 4.7
Measurement in Low/High Dilution Mode ....................................................................................... 4.9
Measurement in Open Mode ............................................................................................................................. 4.12
Measuring a Venous Sample in Normal Dilution Mode ............................................................................. 4.12
Preparing a Venous Sample .......................................................................................................... 4.12
Measuring a Venous Sample ......................................................................................................... 4.13
Measuring a Pre-Dilution Sample ............................................................................................................ 4.15
Preparing a Pre-Dilution Sample ................................................................................................... 4.15
Measuring a Pre-Dilution Sample .................................................................................................. 4.16
Measuring a Venous Sample in Low/High Dilution Mode .......................................................................... 4.18
Performing Auto Recount .................................................................................................................................. 4.20
Recount on Alarm ................................................................................................................................... 4.20
Recount on PLT Count ............................................................................................................................ 4.20
Recount when Out of Panic Range .................................................................................................................... 4.21
Description of the RESULTS Screen ................................................................................................................. 4.23
Numeric Data .......................................................................................................................................... 4.24
Measuring Units ............................................................................................................................ 4.24
Displaying H and L Out of Range Marks ....................................................................................... 4.24
Over Message .............................................................................................................................. 4.24
Histograms ............................................................................................................................................. 4.25
Vertical Axis Type for the Histogram ............................................................................................. 4.25
Adjusting Axes Scale ................................................................................................................... 4.25
RBC (Red Blood Cell) Distribution Histogram ................................................................................ 4.25
PLT (Platelet) Distribution Histogram ............................................................................................ 4.26
WBC (White Blood Cell) Distribution Histogram ............................................................................. 4.26
Flags ...................................................................................................................................................... 4.27
Flag Codes ................................................................................................................................... 4.27
Flag Names .................................................................................................................................. 4.28
Alarm Display ......................................................................................................................................... 4.30
Printing and Sending Results ............................................................................................................................ 4.31
Auto Printing/Sending after Measurement ............................................................................................... 4.31
Printing by Pressing [Print] Key .............................................................................................................. 4.31
Sending Data to PC ................................................................................................................................ 4.31
Operator's Manual MEK-6400 4.1
4. MEASUREMENT

General

Sampling Mode
The analyzer has two sampling modes, open mode and closed mode. In closed
mode, you set a sample in a capped tube into the tube holder. In open mode,
you put the sampling nozzle into a sample container which contains whole
blood and press the [ Count] switch. Pre-dilution samples cannot be
measured in closed mode.

Sampling nozzle

Tube holder [ Count] switch

Front panel in closed mode Front panel in open mode

Dilution Mode
There are five dilution modes: normal, pre-dilution, low dilution, high dilution
and higher dilution modes. For pre-dilution blood measurements, you can
specify the pre-dilution blood measuring volume (10 L or 20 L) on the
MEASUREMENT screen of the SETTINGS screen. Refer to Changing
Measurement Settings in Section 3. In normal dilution mode, 30 L sample
volume is measured.

When a blood samples WBC seems to be high, the sample can be measured in
high or higher dilution mode. In high dilution mode, 10 L of blood sample is
aspirated and diluted three times the usual dilution ratio. In higher dilution
mode, 5 L of blood sample is aspirated and diluted six times the usual
dilution ratio.

When a blood samples WBC or PLT seems to be low, the sample can be
measured in low dilution mode in which 55 L of blood sample is aspirated
and diluted half the usual dilution ratio.

4.2 Operators Manual MEK-6400


4. MEASUREMENT

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.

Single Counting Double Counting

Press the count switch Press the count switch

Counting First counting

Display sample data Second counting

NO
Deviation between the two sample data?

YES

Third counting

Display mean value

Operator's Manual MEK-6400 4.3


4. MEASUREMENT

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 may not be correct,
especially when the ! or sample error message appears. Do not
use the alarmed data.

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.

4.4 Operators Manual MEK-6400


4. MEASUREMENT

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/L.

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.

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 membranes 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/L.
Operator's Manual MEK-6400 4.5
4. MEASUREMENT

Measurement in Closed Mode

WARNING
Always wear rubber gloves to protect yourself from infection when
handling and measuring blood samples.

NOTE
Pre-dilution samples cannot be measured in closed mode.

Preparing a Sample
Use the vacuum blood sample tubes which contain 2 mL of EDTA-2K
anticoagulant. The following vacuum sample tubes can be used. For details,
contact your Nihon Kohden representative. The blood samples using these
sample tubes can be counted without removing the cap.

Manufacturer Description Qty


Nihon Kohden Sampling tube T440B 75 12.3 (for 2 mL)
VENOJECT VT-052DK 75 12.4 (for 2 mL)
TERUMO
VENOJECT II VP-DK052 78 13.2 (for 2 mL)
NIPRO NEO-TUBE NT-EK0205 75 12.3 (for 2 mL)
BECTON DICKINSON VACUTAINER 360004 75 13 (for 2 mL)

NOTE
Attach a label on the vacuum sample tube so it does not come off.

Prepare 2 mL of collected sample blood in the sample tube.

Sample tube

Needle holder

Needle

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.

4.6 Operators Manual MEK-6400


4. MEASUREMENT

NOTE
Check that the sample is between 1.0 to 2.0 mL.
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 4
sample. This causes the total WBC count to decrease.
Keep the blood samples in room temperature. Do not keep them in
a refrigerator.
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.
Gently and thoroughly shake the blood sample again before
measurement.
Do not stir the sample excessively because it generates unwanted
bubbles and cause hemolyzation.
Do not use aggregated or coagulated blood. Otherwise the analyzer
may be damaged.
Wipe the blood off the sample cap when counting the same sample
again.

Measuring a Sample in Closed Mode


Measurement in Normal Dilution Mode
1. Agitate the sample and anticoagulant thoroughly by turning the sample
tube 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 and
check that Normal is selected for <Dilute mode> and Closed is selected
for <Sampling mode>.

Displays ID screen
for setting sample ID

Displays sample type selection


list

Displays dilution mode selection


list

Operator's Manual MEK-6400 4.7


4. MEASUREMENT

Eject key 3. Press the [ Eject] key on the front panel to open the tube holder.

4. Set the vacuum sealed sample tube in the tube holder.

5. Close the tube holder. Measurement automatically starts after the tube
holder closes.

The tube holder automatically opens after finishing the measurement.

If you close the tube holder without setting a sample tube, measurement is
not performed.

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 the Explanation 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 another sample tube is set in the


tube holder and the tube holder is closed. When measuring the same sample
again, set the same ID on the ID screen and count the sample.

4.8 Operators Manual MEK-6400


4. MEASUREMENT

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 in a different dilution mode 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 4
details, refer to Recounting the Sample when Out of Panic Range later in this
section.

Measurement in Low/High Dilution Mode


When a blood samples WBC seems to be high, the sample can be measured in
high dilution mode. In high dilution mode, 10 L of blood sample is aspirated
and diluted three times the usual dilution ratio. In higher dilution mode, 5 L
of blood sample is aspirated and diluted six times the usual dilution ratio.

When a blood samples WBC or PLT seems to be low, the sample can be
measured in low dilution mode in which 55 L of blood sample is aspirated
and diluted half the usual dilution ratio.

1. Agitate the sample and anticoagulant thoroughly by turning the sample


tube 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 and
check that Closed is selected for <Sampling mode>.

3. Select High, Higher or Low for <Dilute mode>.

Displays dilution mode


selection list

Operator's Manual MEK-6400 4.9


4. MEASUREMENT

Eject key 4. Press the [ Eject] key on the front panel to open the tube holder.

5. Set the vacuum sealed sample tube in the tube holder.

6. Close the tube holder. Measurement automatically starts after the tube
holder closes.

The tube holder automatically opens after finishing the measurement.

If you close the tube holder without setting a sample tube, measurement is
not performed.

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 the Explanation 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.

4.10 Operators Manual MEK-6400


4. MEASUREMENT

The ID is automatically incremented when another sample tube is set in the


tube holder and the tube holder is closed. 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. 4

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-6400 4.11


4. MEASUREMENT

Measurement in Open Mode

WARNING
Always wear rubber gloves to protect yourself from infection when
handling and measuring blood samples.

Both venous and pre-dilution samples can be measured in open mode.

Sample in any type of container can be measured in open mode. 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.

Measuring a Venous Sample in Normal Dilution Mode


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.

4.12 Operators Manual MEK-6400


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> and Open is selected
for <Sampling mode>.

Displays ID screen
for setting sample ID

Displays sample type


selection list

Displays dilution mode


selection list

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
Sampling nozzle bottom of the sample container.

NOTE
Count switch Do not let the sampling nozzle touch the bottom of the sample
container. This may prevent aspiration of the sample.
Put the sampling
nozzle to this level
3. Press the [ Count] switch. The sample is aspirated and measurement
starts. The Measuring message appears on the screen.

Operator's Manual MEK-6400 4.13


4. MEASUREMENT

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 Explanation 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 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.

4.14 Operators Manual MEK-6400


4. MEASUREMENT

Measuring a Pre-Dilution Sample


Preparing a Pre-Dilution Sample
NOTE
Carefully perform the following procedures to collect and dilute
pre-dilution blood from an earlobe or a finger tip. When pre-dilution
blood is measured, data accuracy depends on careful performance
4
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.
When using a sahli pipette, clean and completely dry it before use.
Pre-dilution samples cannot be measured in closed mode. Open
mode must be selected.

You can select pre-dilution blood measuring volume (10 or 20 L) 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 and
check that Open is selected for <Sampling mode>.

2. Select Pre-dil for <Dilute mode>. The DISPENSE key appears on the
screen.

Sampling nozzle
3. Put the sampling nozzle into an empty sample cup so that the tip of the
Count switch sampling nozzle touches near the rim of the sample cup as shown in the
figure.

4. Press the DISPENSE key on the READY screen. A 2 mL of the diluent is


Put the sampling
nozzle at this point dispensed into the sample cup.

Operator's Manual MEK-6400 4.15


4. MEASUREMENT

5. Collect 10 or 20 L of whole blood with a sahli pipette or micro pipette.

Sahli pipette
NOTE
When wiping the blood off the surface of the sahli pipette or micro
pipette, take extreme care not to wipe the blood inside the sahli
pipette or micro pipette.
Micro cap

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


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
Sampling nozzle
touch the bottom of the sample cup.

NOTE
Count switch
Do not press the sampling nozzle too hard against the bottom of
the sample cup. This decreases the aspirating volume.
Put the sampling In pre-dilution mode, about 1 mL of sample is aspirated. Make sure
nozzle to
this level that the sampling nozzle is near the bottom of the sample cup so
that the correct volume of the sample can be aspirated.

4.16 Operators Manual MEK-6400


4. MEASUREMENT

2. Press the [ Count] switch. The sample is aspirated and measurement


starts.

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 Explanation of the RESULTS
Screen section. (Display format differ according to the settings. For details 4
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 and measure the sample.

The ID is automatically incremented when the [ Count] switch 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-6400 4.17


4. MEASUREMENT

Measuring a Venous Sample in Low/High Dilution Mode


When a blood samples WBC seems to be high, the sample can be measured in
high dilution mode. In high dilution mode, 30 L of blood sample is aspirated
and diluted three times the usual dilution ratio. In higher dilution mode, 25 L
of blood sample is aspirated and diluted six times the usual dilution ratio.

When a blood samples WBC or PLT seems to be low, the sample can be
measured in low dilution mode in which 55 L of blood sample is aspirated
and diluted half the usual dilution ratio.

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 and
check that Open is selected for <Sampling mode>.

3. Select High, Higher or Low for <Dilute mode>.

Displays dilution mode


selection list

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
Sampling nozzle bottom of the sample container.

NOTE
Count switch Do not let the sampling nozzle touch the bottom of the sample
container. This may prevent aspiration of the sample.
Put the sampling
nozzle to this level
5. Press the [ Count] switch. The sample is aspirated and measurement
starts. The Measuring message appears on the screen.

4.18 Operators Manual MEK-6400


4. MEASUREMENT

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 Explanation 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 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-6400 4.19


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 either 50,000 or
100,000/L as the threshold under which a sample is recounted. For normal
operation, select 100,000/L. To change the setting, refer to Changing
Measurement Settings in Section 3.

4.20 Operators Manual MEK-6400


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 4
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.

Cancels recount and the first measurement data is stored


in memory

Instruction for recount appears

Operator's Manual MEK-6400 4.21


4. MEASUREMENT

2. In closed mode:
Close the tube holder with the sample tube inserted in the tube holder.
Measurement automatically starts after the tube holder closes.

In open mode:
i) Put the sampling nozzle into the sample container so that the tip of the
Sampling nozzle sampling nozzle comes near but does not touch the bottom of the
sample container.

Count switch ii) Press the [ Count] switch. The sample is aspirated and measurement
with high dilution starts. The Measuring message appears on the
Put the sampling
screen.
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.

3. 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.

4. Repeat step 2. 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.

4.22 Operators Manual MEK-6400


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.
4
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 Sample type

Measurement
date and time
Changes sample information
2nd page: Dilution mode
WBC histogram

3rd page: Sampling mode


RBC histogram
Numeric result
Alarmed
parameters are
displayed in red PLT histogram 4th page: Sequence number

5th page: User


Displays the READY screen
Displays the ID screen to
Outputs the data to the device change ID for the next sample
selected on the OUTPUT screen

This key appears when the data has flags. This key appears when the data has alarm
Press to display the flag window. messages. Press to display the ALARM screen.

Operator's Manual MEK-6400 4.23


4. MEASUREMENT

Numeric Data

RESULTS screen when only the 18 RESULTS screen when only the 8
parameter numeric data is displayed parameter numeric data is displayed

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 Units Parameter Units


WBC 103/L HCT %
LY% % MCV fL
MO% % MCH pg
GR% % MCHC g/dL
3
LY 10 /L PLT 103/L
MO 103/L RDW %
3
GR 10 /L PCT %
6
RBC 10 /L MPV fL
HGB g/dL PDW %

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. Refer to Specifications in Section 10 for measurable range.

4.24 Operators Manual MEK-6400


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.
4
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.
<Counted Value> <Percentage>
RESULTS screen with wide [%]
[Count]
histogram display 100%

[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 (red blood cell distribution width) is automatically calculated from the
RBC distribution histogram.

Standard deviation of red blood cell volumes (SD)


RDW (%)=
Mean cell volume (MCV)

The RDW indicates the deviation ratio of the red blood cell volumes on the
histogram.

100 200
SD SD
MCV

Operator's Manual MEK-6400 4.25


4. MEASUREMENT

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.

10 20
SD SD
MPV

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%: Lymphocyte percent


MO%: Monocyte percent
GR%: Granulocyte percent
LY: Lymphocyte count
MO: Monocyte count
GR: Granulocyte count

Lymphocyte distribution
Monocyte Granulocyte distribution
distribution

4.26 Operators Manual MEK-6400


4. MEASUREMENT

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.

4
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.

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
Operator's Manual MEK-6400 4.27
4. MEASUREMENT

F2: The lymphocyte distribution is not discriminated

Granulocyte distribution

Possible causes:
Small number of lymphocytes

F3: The granulocyte distribution is not discriminated

Lymphocyte distribution

Possible causes:
The blood 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 ISOTONAC3 and Hemolynac3N were used.

F4: The lymphocyte, monocyte and granulocyte distributions are not


discriminated

Possible causes:
Reagents other than ISOTONAC3 and Hemolynac3N were used.

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.

4.28 Operators Manual MEK-6400


4. MEASUREMENT

Flag Name Appears when Display on the RESULTS Screen


WBC
Leukocytosis WBC is above normal range H
Leukopenia WBC is below normal range L
Poor hemolysis Too may RBC ghost !
RBC ghost Too may RBC ghost F1
Cant analyze LY Lymphocyte cannot be analyzed F2 4
Cant analyze GR Granulocyte cannot be analyzed F3
Cant diff WBC WBC cannot be differentiated F4
Eosinophilia Too many eosinophil

RBC
Erythrocytosis RBC is above normal range H
Anemia HGB is below normal range L
Anisocytosis RDW is above 20.0%
Microcytosis MCV is below normal range L
Macrocytosis MCV is above normal range H
Hypochromia MCHC is below normal range L
Abnormal MCHC MCHC is below 26.0 g/dL or above 38.0 g/dL

PLT
Thrombocytosis PLT is above normal range H
Thrombocytopenia PLT is below normal range L
PLT clumps RBC ghost is more than 300
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-6400 4.29


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 may not be correct,
especially when ! or sample error messages appear. Do not use
the data for diagnosis. Recount the sample.

Alarms appear in red

4.30 Operators Manual MEK-6400


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.

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.

To perform auto print on the internal printer, set <Auto output after
Print key measurement> on the INT PRINTER screen of the OUTPUT screen to Yes or
press the [ auto print] key on the front panel to on.

Auto print To perform auto print on the external printer, set <Auto output after
key measurement> on the EXT PRINTER screen of the OUTPUT screen to Yes or
press the [ auto print] key on the front panel to on.

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.

Internal printer

Printing by Pressing [Print] Key


When the [ Print] key on the front panel is pressed on the RESULTS screen,
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.

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-6400 4.31


4. MEASUREMENT

Printing Example
WA-640VK internal printer

Settings on the INTERNAL PRINTER screen


of the SETTINGS screen
Print parameters: 18
Print WBC histogram: Yes
Print RBC histogram: Yes
Print PLT histogram: Yes
Print radar graph: Yes Numeric
Select parameters to print normal range graph: measured values
On for all parameters

WBC histogram

RBC histogram

PLT histogram

Radar graph
Normal range upper limit

Measured value

Normal range lower limit

Normal range graph


Normal range lower limit

Normal range upper limit

Measured value

4.32 Operators Manual MEK-6400


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 Only the measured numeric values are printed 4

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 Normal range limits

Operator's Manual MEK-6400 4.33


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 lower limit Normal range upper limit

Measured value

4.34 Operators Manual MEK-6400


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

Auto analysis
findings

Radar graph

Measured value
Normal range lower limit Normal range upper limit

Operator's Manual MEK-6400 4.35


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 a Saved Data ..................................................................................................... 5.6 5
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-6400 5.1


5. HANDLING DATA

General

The analyzer stores all measured and calculated data for the latest 400 samples
and histograms of up to 50 samples. The stored data can be printed, transferred
to a personal computer and deleted. Sample IDs can be edited.

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 Operators Manual MEK-6400


5. HANDLING DATA

Displaying Numerical Data and Histograms

Displaying the Latest Measured Data


You can retrieve the latest measurement result from the READY screen.

4
Press the RESULTS key on the READY screen.

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-6400 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 memory.

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 key on the MENU screen to display the DATA screen. The
numeric data for the latest 4 samples is listed.

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
Asterisk (*) indicates that
SETTINGS screen. Refer to Changing
the data has histograms
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
Up to 100 pages can be
created. 100/100 is the
latest data page and 1/100
is the oldest data page.

Displays older data Displays newer data

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 Operators Manual MEK-6400


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. 4

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 screen.

4. Press the OK key to return to the MENU screen.

Operator's Manual MEK-6400 5.5


5. HANDLING DATA

Editing ID and Sample Type of a Saved Data

You can change the ID and sample type of any saved data.

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 EDIT screen.

5.6 Operators Manual MEK-6400


5. HANDLING DATA

3. To edit ID:
i) Press the EDIT key in the <ID> box to display the ID EDIT 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.
4

To change the sample type of the selected data:


Select the sample type from the sample type selection list in the <Sample
type> box.

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-6400 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 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 the <ID> box 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 the <Search by ID> box. When No is selected in the <Search
by ID> box, the entered ID is deleted.
iii) Press the OK key to return to the SEARCH screen.
5.8 Operators Manual MEK-6400
5. HANDLING DATA

To specify measurement date:


i) Press the SET key in the <Date> box to display the screen for setting
dates.

Cursor

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:


i) Select the sample type from the sample type selection list in the
<Sample type> box. 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-6400 5.9


5. HANDLING DATA

To specify flags:
i) Press the SET key in the <Flags> box 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.

The search starts and the search results appear on the screen. The SEARCH
RESULTS screen provides the same functions as the DATA screen.

5.10 Operators Manual MEK-6400


5. HANDLING DATA

4. Press the OK key to return to the DATA screen.

Operator's Manual MEK-6400 5.11


5. HANDLING DATA

Printing and Sending Data

You can print one or more stored data on the following optional printers.

Printer Printing Data


Card Printer Numeric data
Internal Printer Numeric data and histograms
External Printer 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 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 screen, press the ID key of a desired data to print or send.

5.12 Operators Manual MEK-6400


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.

Printing or Sending Multiple Data


On the 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 screen, press the PRINT key to print or press the SEND key to
send the data. The Select first data message appears.

Displays other data

Operator's Manual MEK-6400 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 screen.

Total number of selected data


The number of data currently printed/sent

5.14 Operators Manual MEK-6400


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.
4
NOTE
When printing on the WA-710V/712V or EPSON VP printer, <EPSON
5
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-6400 5.15


5. HANDLING DATA

The screen shows the dates of the stored data and the number of data of
each day.

Date keys

Arrow keys to 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 When sending

5.16 Operators Manual MEK-6400


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.

The number of data currently printed/sent Total number of data for the
selected date

When printing or sending is complete, the screen returns to the DAILY


OUTPUT screen.

Operator's Manual MEK-6400 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.

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 Operators Manual MEK-6400


5. HANDLING DATA

Deleting Multiple Data


1. On the DATA screen, press the DELETE key. The Select first data message
appears.

Displays 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-6400 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 Operators Manual MEK-6400


Section 6 Quality Control
General .............................................................................................................................................................. 6.3
When to Run QC ...................................................................................................................................... 6.3
QC Methods ............................................................................................................................................ 6.3
Control Material ........................................................................................................................................ 6.4
Quality Control Procedures ................................................................................................................................ 6.5
Guidelines for Running Controls ............................................................................................................... 6.5
Control Material Guidelines ...................................................................................................................... 6.5 6
_
X-R Program ...................................................................................................................................................... 6.6
General .................................................................................................................................................... 6.6
_
Overview of X-R _ Program and Quality Control Procedure ............................................................... 6.6
_
Calculation of X and R.................................................................................................................... 6.6
_
Calculation of Upper and Lower Limits of X and R .......................................................................... 6.7
_
X-R Graph Example ....................................................................................................................... 6.8
_
How to Read the X-R Graph .......................................................................................................... 6.10
Data Outside the Limits ................................................................................................................ 6.10
Changing the Quality Control Settings ..................................................................................................... 6.11
Counting the Hematology Control ............................................................................................................ 6.13
_
Handling X-R Data ................................................................................................................................... 6.16
_
Displaying the X-R Data List (HISTORY) ....................................................................................... 6.16
_
Displaying the Detailed X-R Measurement Data ............................................................................ 6.17
_
Printing, Sending or Deleting X-R Data .................................................................................................... 6.19
_
Printing, Sending or Deleting X-R Data Individually ....................................................................... 6.19
_
Printing, Sending or Deleting X-R Data Consecutively ................................................................... 6.20
_
Deleting All Stored X-R Data ......................................................................................................... 6.21
_
Displaying CV Values of the Stored X-R Data ................................................................................ 6.22
_
Handling X-R Graphs ............................................................................................................................... 6.23
_
Changing the X-R Limits .......................................................................................................................... 6.24
L & J Program (Levey and Jennings) ................................................................................................................ 6.26
General ................................................................................................................................................... 6.26
Overview of L & J Program and Quality Control Procedure ........................................................... 6.26
Calculation of Upper and Lower Limits .......................................................................................... 6.27
How to Read the L & J Graph ....................................................................................................... 6.27
Data Outside the Limits ................................................................................................................ 6.27
Changing the Quality Control Settings ..................................................................................................... 6.28
Counting the Hematology Control ............................................................................................................ 6.28
Handling L & J Data ................................................................................................................................ 6.31
Displaying the L & J Data List (HISTORY) .................................................................................... 6.31
Displaying the Detailed L & J Measurement Data ......................................................................... 6.32
Printing, Sending or Deleting L & J Data ................................................................................................. 6.33
Printing, Sending or Deleting L & J Data Individually ..................................................................... 6.33
Printing, Sending or Deleting L & J Data Consecutively ................................................................ 6.34
Deleting All Stored L & J Data ...................................................................................................... 6.36
Displaying CV Values of the Stored L & J Data ............................................................................. 6.37
Handling L & J Graphs ............................................................................................................................ 6.38

Operator's Manual MEK-6400 6.1


_ _
XB (X Batch) Program ....................................................................................................................................... 6.40
General ................................................................................................................................................... 6.40
_
Overview of XB ............................................................................................................................. 6.40
_
Calculation of XB .......................................................................................................................... 6.40
_
Handling XB Data .................................................................................................................................... 6.42
_
Handling X-B Graph ................................................................................................................................ 6.44
_
Setting X-B Initial Values and Limits ........................................................................................................ 6.45
_
XDCV Program ................................................................................................................................................ 6.47
General ................................................................................................................................................... 6.47
_
Uses of the XDCV Program ......................................................................................................... 6.47
_
Handling XDCV Data .............................................................................................................................. 6.48
Displaying the Total Mean and CV of All Stored Data .............................................................................. 6.49

6.2 Operators Manual MEK-6400


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 laboratorys


protocol or procedures manual. Refer to your laboratorys standard operating
procedures and/or a quality assurance plan to check for and ensure proper
6
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
_
XDCV

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 section.

Operator's Manual MEK-6400 6.3


6. QUALITY CONTROL

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.

6.4 Operators Manual MEK-6400


6. QUALITY CONTROL

Quality Control Procedures

Guidelines for Running Controls


Quality Control (QC) procedures must be carried out in accordance with your
laboratorys 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 6
specimens.
Verify that control results are within the laboratorys 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 laboratorys 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 laboratorys
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.

Operator's Manual MEK-6400 6.5


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 (n2).
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
Perform the quality control measurement at a fixed time every day.
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.
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.

NOTE _
Only use the MEK-3D Hematology Control for the X-R program.

_ _
Calculation of X and R
X R
X= R= k
k

X: Mean for one day R: Difference for one day


X: Mean for k days R: Difference for k days

6.6 Operators Manual MEK-6400


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) =


6

Lower limit of X (LCL) =

= Standard deviation estimate


u = Truth estimate

The upper limit of R is as follows.

Upper limit of R (UCL) =

_
Relation between n and d2 (for X) or d2 and d3 (for R)

n d2 1/d2 d3
2 1.128 0.8862 0.853
3 1.693 0.5908 0.888
4 2.059 0.4857 0.880
5 2.326 0.4299 0.864
6 2.534 0.3946 0.848
7 2.704 0.3698 0.833
8 2.847 0.3512 0.820
9 2.970 0.3367 0.808
10 3.078 0.3249 0.797

Operator's Manual MEK-6400 6.7


6. QUALITY CONTROL
_
X-R Graph Example
Following are example data and plotted graphs for RBC.

Obtained Data
Day X R
First Second
1 4.82 4.76 4.79 0.06
2 4.79 4.80 4.80 0.01
3 4.80 4.85 4.83 0.05
4 4.71 4.77 4.74 0.06
5 4.80 4.89 4.85 0.09
6 4.82 4.83 4.83 0.01
7 4.77 4.74 4.76 0.03
8 4.77 4.80 4.79 0.03
9 4.68 4.74 4.71 0.06
10 4.91 4.92 4.92 0.01
11 4.73 4.77 4.75 0.04
12 4.79 4.80 4.80 0.01
13 4.77 4.73 4.75 0.04
14 4.77 4.82 4.80 0.05
X = 4.794 R = 0.0393
n = 2, d2 = 1.128, d3 = 0.853

_
X graph:

Upper limit of X

4.794 + 1.88 0.0393

4.868

Lower limit of X

4.794 1.88 0.0393

4.720

R graph:

Upper limit of R

3.27 0.0393

0.129

6.8 Operators Manual MEK-6400


6. QUALITY CONTROL

Graph X for RBC

4.90
Upper limit of X

4.80 X: Mean of all X values

Lower limit of X

4.70
6

Graph R for RBC


Upper limit of R

0.10

0.05 R: Mean of all R values

Operator's Manual MEK-6400 6.9


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.

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.

6.10 Operators Manual MEK-6400


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. 6
Item Description Settings Default
QC method Select either X-R or L & J for the quality control method. X-R or L & J X-R
Save QC meas data on Select whether or not to save the hematology control
Yes or No No
DATA screen measurement data on the DATA screen.
Select whether or not to automatically send the hematology
Send data after QC
control measured data to the connected instrument after each Yes or No No
measurement
measurement.
X limit calculation Select either 2 SD or 3 SD for X limit calculation. 2 SD or 3 SD 3 SD

_
When the X-R keys do not appear on the QC screen, change the quality control
method.

1. Press the QC key on the MENU screen to display the QC screen.

2. Press the QC SETTING key.

L & J keys

Operator's Manual MEK-6400 6.11


6. QUALITY CONTROL
_
3. Change necessary settings. Select X-R in the <QC method> box.

_
4. Press the OK key to return to the QC screen. Check that X-R keys are
displayed on the screen.

_
X-R keys

6.12 Operators Manual MEK-6400


6. QUALITY CONTROL

Counting the Hematology Control


To ensure accuracy, observe the following cautions.

CAUTION
Perform the quality control measurement at a fixed time every day.
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. 6
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.

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.

Operator's Manual MEK-6400 6.13


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.

3. Select the sampling mode in the <Sampling mode> box.

_
Displays X-R graph screen.
_
Refer to the Handling X-R
Returns to the QC screen Graphs section.
_
Displays X-R history screen. Refer to the
_
Handling X-R History section.

4. When measuring in closed mode:


Set the sample tube containing the hematology control in the tube holder
and close the tube holder.

When measuring in open mode:


Sampling nozzle Put the sampling nozzle into the sample container containing the
hematology control and press the [ Count] switch.

Count switch

Put the sampling


nozzle to this level

6.14 Operators Manual MEK-6400


6. QUALITY CONTROL

5. 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.

Operator's Manual MEK-6400 6.15


6. QUALITY CONTROL

_
To print the displayed X-R data on the optional 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.

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.

6. 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 Displays older data Displays newer data

6.16 Operators Manual MEK-6400


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,
6
<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.

Operator's Manual MEK-6400 6.17


6. QUALITY CONTROL

To print the 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 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.

6.18 Operators Manual MEK-6400


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.
6
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.
Operator's Manual MEK-6400 6.19
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.

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.

6.20 Operators Manual MEK-6400


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.
6

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.

Operator's Manual MEK-6400 6.21


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.

To print the 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.

2. Press the OK key to return to the HISTORY screen.


6.22 Operators Manual MEK-6400
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.
Operator's Manual MEK-6400 6.23
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

6.24 Operators Manual MEK-6400


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:


6
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.

Operator's Manual MEK-6400 6.25


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
4.80 Mean
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
Perform the quality control measurement at a fixed time every day.
Store the 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.
Do not use the control after the expiration date. If you use control
after the expiration date, the obtained graphs are not reliable.

NOTE
Only use the MEK-3D Hematology Control for the L & J program.

6.26 Operators Manual MEK-6400


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 + 3


Lower limit (3S) = X 3
X = mean = standard deviation

How to Read the L & J Graph


6
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.
Operator's Manual MEK-6400 6.27
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 the <QC method> box 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.

CAUTION
Perform the quality control measurement at a fixed time every day.
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.
Do not use control after the expiration date. If you use control after
the expiration date, the obtained L & J graphs are not reliable.

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.

6.28 Operators Manual MEK-6400


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.

3. Select the sampling mode in the <Sampling mode> box.

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 History section.
Operator's Manual MEK-6400 6.29
6. QUALITY CONTROL

4. When measuring in closed mode:


Set the sample tube containing the hematology control in the tube holder
and close the tube holder.

When measuring in open mode:


Sampling nozzle Put the sampling nozzle into the sample container containing the
hematology control and press the [ Count] switch.

Count switch

5. After the measurement, the measurement data appears on the screen. The
Put the sampling
nozzle to this level 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.

6.30 Operators Manual MEK-6400


6. QUALITY CONTROL

To print the displayed L & J data on the optional 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.

6
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.

6. 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 Displays older data Displays newer data

Operator's Manual MEK-6400 6.31


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 [ 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.
6.32 Operators Manual MEK-6400
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.

Operator's Manual MEK-6400 6.33


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.

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.

6.34 Operators Manual MEK-6400


6. QUALITY CONTROL

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.

Operator's Manual MEK-6400 6.35


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.

The Delete 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.

6.36 Operators Manual MEK-6400


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 [ 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.

2. Press the OK key to return to the HISTORY screen.


Operator's Manual MEK-6400 6.37
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.

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.
6.38 Operators Manual MEK-6400
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.

6
3. Press the OK key to return to the previous screen.

Operator's Manual MEK-6400 6.39


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 XDCV program in conjunction with the XB program.
_
(Refer to the XDCV 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.
2
X (B, i) = X (B, i 1) + SGN [F] (F/N)

F = SGN [Xj X (B, i 1)] Xj X (B, i 1)


_
X (B, i) = XB of present batch Xj = Each data in batch
_
X (B, i-1) = XB of previous batch SGN [ ] = Sign function
N = Number of samples in batch

_ _
The XB value of the previous batch is required to calculate XB of the present
_
batch. There are two methods of obtaining the initial XB value of the batch
before Batch 1.
1) Use the past obtained value for the same facility.
2) The simple method is to substitute the mean values of MCV, MCH and
_
MCHC for each initial XB value of the batch before Batch 1.

NOTE _ _
If the mean value is used as the initial XB value, the XB value to be
obtained gradually comes closer to a real or true value as the
samples increase in number.
_
After about 100 samples are counted, the reliability of the XB value is
ensured. Usually, the mean values are somewhere near these values:
MCV: 89.5, MCH: 30.5, MCHC: 33.8
6.40 Operators Manual MEK-6400
6. QUALITY CONTROL
_
The XB values are plotted on the screen.

Management Initial
limit value value

_
The average of XB is used as the initial value. The initial value will also be 6
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/mL 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.

Operator's Manual MEK-6400 6.41


6. QUALITY CONTROL
_
Handling XB Data
1. Press the QC key on the MENU screen to display the QC screen.

_ _
2. Press the XB key on the QC screen to display the XB screen.

_
The XB screen of the stored measured data is displayed on the screen.

6.42 Operators Manual MEK-6400


6. QUALITY CONTROL

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 [ 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 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.

Operator's Manual MEK-6400 6.43


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

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 [ 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.

_
2. Press the OK key to return to the XB screen.

6.44 Operators Manual MEK-6400


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

Operator's Manual MEK-6400 6.45


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.

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.

6.46 Operators Manual MEK-6400


6. QUALITY CONTROL

_
XDCV 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: X Daily mean value of daily sample data 6
CV: Coefficient of Variation (%)

Standard deviation
CV = 100 (%)
XD

2
(X X)
Standard deviation =
N 1

X = average
X = measured value
N = measured times

_
Uses of the XDCV 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 XDCV value can be used for quality control.
_
The XDCV 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.

Operator's Manual MEK-6400 6.47


6. QUALITY CONTROL
_
Handling XDCV Data
1. Press the QC key on the MENU screen to display the QC screen.

_ _
2. Press the XDCV key on the QC screen to display the XDCV 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.

6.48 Operators Manual MEK-6400


6. QUALITY CONTROL

To print the displayed data on the printer, press the [ Print] key on the
front panel.

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
6
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 XDCV screen.

_
2. Press the OK key to return to the XDCV screen.

Operator's Manual MEK-6400 6.49


Section 7 Calibration
General .............................................................................................................................................................. 7.2
When to Calibrate .................................................................................................................................... 7.2
Note on the Calibration Procedure ............................................................................................................ 7.3
Calibration in Closed Mode ................................................................................................................................. 7.4
Calibration in Open Mode and Pre-Dilution Mode ................................................................................................ 7.7
Calibration in Open Mode ......................................................................................................................... 7.7
Calibration in Pre-Dilution Blood Mode .................................................................................................... 7.10
Displaying the Calibration Measurement Data List ............................................................................................. 7.14
Displaying and Printing Calibration Data History ................................................................................................ 7.18
7
HGB/HCT Calibration with Human Blood ........................................................................................................... 7.20
Measurement with the Analyzer .............................................................................................................. 7.20
HGB Measurement with a Spectrophotometer ......................................................................................... 7.20
HCT Measurement with a Microhematocrit Centrifuge ............................................................................. 7.21
Determining the HGB and HCT Calibration Coefficient ............................................................................ 7.21

Operator's Manual MEK-6400 7.1


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-3DN hematology control (normal). This calibrator must be used
within 3 days after opening, stored at 35 to 46F (2 to 8C) 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 laboratorys


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
instruments performance.

7.2 Operators Manual MEK-6400


7. CALIBRATION

Note on the Calibration Procedure


Calibration can be performed in both closed and open sampling modes. Only
calibrating in closed mode is necessary. When calibration is performed in
closed mode, the new calibration coefficient is also applied to open mode and
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 open mode and pre-
dilution blood mode.

Calibration in closed blood mode must be performed before calibration in open


mode and pre-dilution blood mode.
7
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.

Operator's Manual MEK-6400 7.3


7. CALIBRATION

Calibration in Closed Mode

CAUTION
Use the hematology control within three days after opening.
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.
Do not freeze the hematology control because this hemolyses it.
Use and store the hematology control with extreme care according
to its instructions.

1. On the READY screen, check that Closed is selected for <Sampling


mode>.

2. On the MENU screen, press the CALIBRATION key to display the


CALIBRATION screen.

3. Press the CLOSED key to display the CAL-CLOSED screen.

If the sampling mode is different from the mode selected in step 1, a


message appears to change the sampling mode on the READY screen. In
such a case, repeat steps 1 to 3 and make sure to select Closed for the
sampling mode.

7.4 Operators Manual MEK-6400


7. CALIBRATION

Eject key 4. Prepare the MEK-3DN hematology control sample in a sample tube. (If the
hematology control is taken from a refrigerator, wait at least 10 minutes
after the control temperature reaches room temperature.)

5. Press the [ Eject] key on the front panel to open the tube holder and set
the sample tube containing the hematology control.

6. Close the tube holder. The hematology control is measured.

After measurement, the measured data and the Use this data for
calibration? message appear on the screen.

7. 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 hematology control
again.

Operator's Manual MEK-6400 7.5


7. CALIBRATION

8. Measure the hematology control until you obtain at least 3 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 hematology
control measurement

Cursor

Move cursor

Numeric keys
Displays other parameters

9. In the <Data> field, enter the median of the assay value listed in the assay
sheet which is attached to the hematology control.
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.

10. Press the OK key to display the CALIBRATION screen.

11. Display the READY screen and measure the hematology control. Check
that the acquired data is the same as the assay value listed in the assay
sheet.

Reference
The new calibration coefficient is calculated from the equation below.

Calibrator assay value


New calibration coefficient = Previous calibration coefficient
Mean measured value

7.6 Operators Manual MEK-6400


7. CALIBRATION

Calibration in Open Mode and Pre-Dilution Mode

When calibration is performed in closed mode, the new calibration coefficient


is also applied to open mode and 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 open mode and pre-dilution blood mode.

Calibration in closed blood mode must be performed before calibration in open


mode and pre-dilution blood mode.

7
CAUTION
Use the hematology control within three days after opening.
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.
Do not freeze the hematology control because this hemolyses it.
Use and store the hematology control with extreme care according
to its instructions.

If the hematology control is taken from a refrigerator, wait at least 10 minutes


after the control temperature reaches room temperature.

Calibration in Open Mode


1. On the READY screen, check that Open is selected for <Sampling mode>.

2. On the MENU screen, press the CALIBRATION key to display the


CALIBRATION screen.

Operator's Manual MEK-6400 7.7


7. CALIBRATION

3. Press the OPEN key to display the CAL-OPEN screen.

If the sampling mode is different from the mode selected in step 1, a


message appears to change the sampling mode on the READY screen. In
such a case, repeat steps 1 to 3 and make sure to select Open for the
sampling mode.

4. Put the sampling nozzle into the hematology control vial so that the tip of
the sampling nozzle comes near but does not touch the bottom of the vial.
Sampling nozzle

NOTE
Do not let the sampling nozzle touch the bottom of the vial. This may
Count switch
prevent aspiration of the sample.

Put the sampling


nozzle to this level 5. Press the [ Count] switch. The hematology control is aspirated and
measurement starts.

7.8 Operators Manual MEK-6400


7. CALIBRATION

After measurement, the measured data and the Use this data for
calibration? message appear on the screen.

6. 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 hematology control
again.

7. Measure the hematology control until you obtain at least 3 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 hematology
control measurement

Cursor

Move cursor

Numeric keys
Displays other parameters

Operator's Manual MEK-6400 7.9


7. CALIBRATION

8. In the <Data> field, enter the median of the assay value listed in the assay
sheet which is attached to the hematology control.
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. Display the READY screen and measure the hematology control. Check
that the acquired data is the same as the assay value listed in the assay
sheet.

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. Calibration in venous
blood mode must be performed before calibration in pre-dilution blood mode.

The relationship between the calibration coefficient in pre-dilution blood


mode and the measured value is shown in the equation below.
Calibration coefficient Calibration coefficient in
Measured value after Measured value in
in closed mode pre-dilution blood mode
calibration in pre-dilution = pre-dilution blood
blood mode mode 1000 1000

1. Prepare the hematology control sample for pre-dilution mode. Refer to


Preparing a Pre-Dilution Sample in Section 4.

2. On the READY screen, check that Open is selected for <Sampling mode>
and Pre-dilute is selected for <Dilute mode>.

When Pre-dil is selected


for <Dilute mode>, the
DISPENSE key appears

7.10 Operators Manual MEK-6400


7. CALIBRATION

3. On the MENU screen, press the CALIBRATION key to display the


CALIBRATION screen.

7
4. Press the PREDILUTION key to display the CAL Pre-dil screen.

If the sampling mode is different from the mode selected in step 2, a


message appears to change the sampling mode on the READY screen. In
such a case, repeat steps 2 to 4 and make sure to select Open for the
sampling mode.

5. 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.
Sampling nozzle

NOTE
Count switch Do not let the sampling nozzle touch the bottom of the container.
This may prevent aspiration of the sample.
Put the sampling
nozzle to
this level

Operator's Manual MEK-6400 7.11


7. CALIBRATION

6. Press the [ Count] switch. The hematology control sample is aspirated


and measurement starts.

After measurement, the measured data and the Use this data for
calibration? message appear on the screen.

7. 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 hematology control
sample again.

7.12 Operators Manual MEK-6400


7. CALIBRATION

8. Measure the hematology control until you obtain at least 3 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 hematology
control measurement

Cursor

Move cursor
7

Numeric keys
Displays other parameters

9. In the <Data> field, enter the median of the assay value listed in the assay
sheet which is attached to the hematology control.
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.

10. Press the OK key to display the CALIBRATION screen.

11. Display the READY screen and measure the hematology control. Check
that the acquired data is the same as the assay value listed in the assay
sheet.

Operator's Manual MEK-6400 7.13


7. CALIBRATION

Displaying the Calibration Measurement Data List

Up to 15 hematology control measured data can be saved and displayed on the


CAL DATA LIST screen. The mean and CV of all hematology control
measurement can be displayed. You can also delete the measured data.

1. Press the CALIBRATION key on the MENU screen.

2. Select the sampling mode.

3. Press the CAL DATA key. The hematology control measured data is listed
on the screen.

7.14 Operators Manual MEK-6400


7. CALIBRATION

The mean of all stored


Sampling mode
calibration measurement
data

Displays CV values of calibration measurement data Displays older data Displays newer data

To delete one data:


i) Select the time key of the data to be deleted.

ii) Press the DELETE key. The confirmation message appears on the
screen.

iii) Press the YES key to delete the selected data. If you press NO, the
process is canceled.

Operator's Manual MEK-6400 7.15


7. CALIBRATION

To delete consecutive data:


i) Press the DELETE key. The Select first data message appears.

ii) Find the first desired data using the arrow keys and press the time key
of the data.
The Select last data message appears.
iii) Find the last data using the arrow keys and press the time key of the
data. All data between the first and last selected time will be deleted.
The Delete selected data? message appears.

iv) Press the YES key. The selected data is deleted and the screen returns to
the CAL DATA LIST screen.
If you press NO, the process is canceled and the screen returns to the
CAL DATA LIST screen.

7.16 Operators Manual MEK-6400


7. CALIBRATION

To display the mean and CV of the measured data:


i) Press the CV key on the CAL DATA LIST screen.

ii) Press the OK key to return to the CAL DATA LIST screen.

4. Press the OK key to return to the CAL screen.

Operator's Manual MEK-6400 7.17


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.

2. Select the sampling mode.

7.18 Operators Manual MEK-6400


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 Displays newer data

Use the arrow keys to view other data.


To print the data on the 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.

4. Press the OK key to return to the CALIBRATION screen.

Operator's Manual MEK-6400 7.19


7. CALIBRATION

HGB/HCT Calibration with Human Blood

When calibrating with human blood, use both of the following measurement
methods.
1. Measurement with the MEK-6400 hematology analyzer
2. Measurement with a spectrophotometer and microhematocrit centrifuge

Calculate the HGB/HCT value with these methods and then calculate the
calibration coefficient.

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.


64458: Molecular weight of HGB
64458 200
29.3 =
44 1000 1 10 200: 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
7.20 Operators Manual MEK-6400
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. 7

Putty RBC WBC PLT


B Capillary tube
A

7. Calculate each HCT according to the following formula.


B
HCT= 100 (%)
A

8. Calculate the mean value of the two HCT values.

Determining the HGB and HCT Calibration Coefficient


1. Fill in each blank in the following table to obtain the HCT calibration
coefficient.
NOTE
Whenever calibrating the HGB/HCT, write down the current
calibration coefficient on the table because the coefficient shows the
variation of the precision in the analyzer.

Operator's Manual MEK-6400 7.21


7. CALIBRATION

Manual Manual IM
Sample No. Data = 100 (%)
Measurement (M) Measurement (I) M

1
2
3
4
5
6
7
8
9
10
Mean among the 8 data excluding the highest one data and
(%)
lowest one data (A)
Current calibration coefficient (B)
Revised calibration coefficient (C)

C = B (1 A )
100

(M): Spectrophotometer and microhematocrit centrifuge


(I): MEK-6400 Hematology Analyzer

2. Calibrate the hematology analyzer by changing the calibration coefficient


setting to the revised calibration coefficient (C) in the previous table.

a) Press the CALIBRATION key on the MENU screen to display the


CALIBRATION screen.

b) Press the CLOSED key on the CALIBRATION screen to display the


CAL CLOSED screen.
NOTE
Write down the current settings before changing them.

c) In the <Cal> field of the desired parameter, enter the new calibration
coefficient.

d) Press the OK key to return to the CALIBRATION screen.

7.22 Operators Manual MEK-6400


Section 8 Messages and Troubleshooting
General .............................................................................................................................................................. 8.2
Alarm Messages ................................................................................................................................................ 8.5
Invalid Data Identifier ............................................................................................................................... 8.5
Flag Indication ......................................................................................................................................... 8.5
Alarm Messages with Alarm Codes ......................................................................................................... 8.6
Other Alarm Messages ............................................................................................................................ 8.7
System Error Messages .................................................................................................................................... 8.8
Inaccurate Counting and Other Problems ........................................................................................................... 8.9

Operator's Manual MEK-6400 8.1


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. For alarm details, press the DETAILS
key to display the ALARM screen.

8.2 Operators Manual MEK-6400


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.

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 Alarm message

Operator's Manual MEK-6400 8.3


8. MESSAGES AND TROUBLESHOOTING

System error message display


When a system error is detected, the following 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
Explanation of the RESULTS Screen in Section 4.

Alarmed parameter displayed in red

8.4 Operators Manual MEK-6400


8. MESSAGES AND TROUBLESHOOTING

Alarm Messages

CAUTION
When an alarm occurs, the acquired data may not be correct,
especially when the ! or sample error message appears. Do not
use the alarmed data.

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.
8
Perform this procedure two or more times so that the diluent
replaces the CLEANAC3 detergent inside the analyzer.

Invalid Data Identifier


Identifier Possible Cause/Criteria Countermeasure
Check that the temperature of the diluent is
? is displayed to the right of
Abnormal sample between 15 and 30C. Then recount the sample.
WBC or RBC measured value
Water and alcohol cannot be measured.
? is displayed to the right of The WBC measurement bath is
Clean the measurement bath.
HGB measured value dirty.
! is displayed to the right of WBC counting error. Poor
WBC measured value hemolyzation.
! is displayed to the right of Check the analyzer by counting the hematology
HGB voltage adjustment error.
HGB measured value control. Then recount the sample.
! is displayed to the right of Abnormal RBC. Error occurred
MCHC measured value when diluting the sample.
Check the internal circuit by referring to
* is displayed to the right of
Error in the circuit. Checking the Circuit in Section 9. If an error is
HGB measured value
detected, refer to the Service Manual.
* is displayed to the right of Check the analyzer by counting the hematology
PLT-RBC interference
RBC or PLT measured value control. Then recount the sample.
WBC and PLT counting error.
C is displayed to the right of Check the analyzer by counting the hematology
Platelet coagulated. (Poor
WBC and PLT measured values control. Then recount the sample.
hemolyzation and low PLT)

Flag Indication
Identifier Possible Cause/Criteria Countermeasure
F1 is displayed to the right of LY%
RBC ghost
measured value
Check the analyzer by counting the
F2 is displayed to the right of LY%
Lymphocyte cannot be analyzed hematology control. Then recount the
or MO% measured value
sample.
F3 is displayed to the right of GR%
Granulocyte cannot be analyzed Refer to Flags in Explanation of the
measured value
RESULTS Screen in Section 4.
F4 is displayed to the right of LY%,
WBC cannot be differentiated
MO% or GR% measured value
H is displayed to the right of The measured value is above the

measured value normal range.
L is displayed to the right of The measured value is below the

measured value normal range.
Operator's Manual MEK-6400 8.5
8. MESSAGES AND TROUBLESHOOTING

Alarm Messages with Alarm Codes


Messages Possible Cause/Criteria Countermeasure
A001: No diluent Replace the diluent, detergent or lysing
Out of diluent, detergent or lysing
A005: No detergent reagent. Then press the PRIME key on the
reagent.
A007: No lysing reagent OPERATIONS screen.
Insufficient diluent in the manometer Add the diluent or check that the connection
A009: WBC priming error
or the connection tube is out of tube is connected properly. Perform counting
A010: RBC priming error
position. again after priming or cleaning the analyzer.
A021: WBC level 1 Erroneous operation during WBC Press the [Clean] key to perform cleaning.
A022: WBC level 2 counting. Then recount the sample.
If the alarm still occurs, perform strong
A023: WBC level 3 The WBC aperture cap is clogged. cleaning, clean the aperture cap and replace
the pump tube.
A024: WBC bubble 1
A025: WBC bubble 2 Press the [Clean] key to perform cleaning.
Air bubbles in WBC manometer.
A026: WBC bubble 3 Then recount the sample.
A027: WBC bubble 4
Press the [Clean] key to perform cleaning.
Then recount the sample.
A029: WBC clog The WBC aperture cap is clogged. If the alarm still occurs, perform strong
cleaning, clean the aperture cap and replace
the pump tube.
Prepare the sample and measure again.
A030: WBC sample error Abnormal sample Check that the temperature of the diluent is
between 15 and 30C.
Check the grounding, and separate the
A031: WBC noise 2
Noise is detected during counting. analyzer from other equipment and their
A032: WBC noise 1
power sources. Then recount the sample.
The upper part of the manometer is
A036: WBC upper manometer
dirty. WBC manometer sensor output Press the [Clean] key to perform the
dirty
is low. cleaning. Then press STRONG CLEAN on
The lower part of the manometer is the OPERATIONS screen to perform the
A037: WBC lower manometer
dirty. WBC manometer sensor output strong cleaning.
dirty
is low.
A041: RBC level 1 Erroneous operation during RBC Press the [Clean] key to perform cleaning.
A042: RBC level 2 counting. Then recount the sample.
If the alarm still occurs, perform strong
A043: RBC level 3 The RBC aperture cap is clogged. cleaning, clean the aperture cap and replace
the pump tube.
A044: RBC bubble 1
A045: RBC bubble 2 Press the [Clean] key to perform cleaning.
Air bubbles in RBC manometer.
A046: RBC bubble 3 Then recount the sample.
A047: RBC bubble 4
Press the [Clean] key to perform cleaning.
Then recount the sample.
A049: RBC clog The RBC aperture cap is clogged. If the alarm still occurs, perform strong
cleaning, clean the aperture cap and replace
the pump tube.
Prepare the sample and measure again.
A050: RBC sample error Abnormal sample Check that the temperature of the diluent is
between 15 and 30C.
A051: RBC noise 2 Check the grounding, and separate the
A052: PLT noise 1 Noise is detected during counting. analyzer from other equipment and their
A053: PLT noise 3 power sources. Then recount the sample.

8.6 Operators Manual MEK-6400


8. MESSAGES AND TROUBLESHOOTING

Messages Possible Cause/Criteria Countermeasure


The upper part of the manometer is
A056: RBC upper manometer
dirty. RBC manometer sensor output Press the [Clean] key to perform the cleaning.
dirty
is low. Then press STRONG CLEAN on the
The lower part of the manometer is OPERATIONS screen to perform the strong
A057: RBC lower manometer
dirty. RBC manometer sensor output cleaning.
dirty
is low.
The WBC measurement bath is
A061: HGB voltage low Clean the measurement bath.
dirty.
Turn the power off. Wait for about 10 minutes
A062: HGB voltage high HGB voltage adjustment error.
and then turn the power on to start counting.
If the alarm still occurs, contact your Nihon
A063: HGB circuit error Error in the HGB circuit.
Kohden representative.
The analyzer cannot operate because
A072: Tube holder open Close the tube holder.
the tube holder is open.
Open mode cannot be selected
Remove the sample tube and close the tube
A073: Tube in the holder because the sample tube is set in the 8
holder.
tube holder.
Measurement is performed at
A091: Room temperature high
temperatures over 30C. Perform measurement at temperatures between
Measurement is performed at 15 and 30C.
A092: Room temperature low
temperatures below 15C.
A093: Internal temperature Turn the power off. Wait for about 10 minutes
high and then turn the power on. Display the
SENSOR MONITOR screen on the OTHER
screen and check that alarm is not displayed
A094: Internal temperature low Internal temperature is abnormal.
for <Temperature>.
If there is an alarm for <Temperature> or the
A095: Power supply temp high same alarm still occurs, contact your Nihon
Kohden representative.
A101: Internal printer error Internal printer error. Contact your Nihon Kohden representative.
A102: No paper (Internal
No paper in the internal printer. Set the new roll of recording paper.
printer)
A103: External printer error External printer error. Refer to the printer manual.
A104: No paper (External Set the new set of recording paper. Refer to the
No paper in the external printer.
printer) printer manual.

Other Alarm Messages


Messages Possible Cause/Criteria Countermeasure
Error occurred during background Press the [Count] switch and measure
Background noise check failed
noise measurement. background noise again.
The measurement is performed more Check or replace the cap pierce nozzle and
Check cap pierce nozzle
than 1,000 times in closed mode. reset the operation history.
Check filters, baths and sub baths and reset
Measurement is performed more than
Check filters, baths and sub baths the operation history. Replace filters if
1,000 times.
necessary.
Measurement is performed more than Check rinse unit and reset the operation
Check rinse unit
1,000 times. history.
Measurement is performed more than Check sampling nozzle and reset the
Check sampling nozzle
3,000 times. operation history.
Re-enter the calibration coefficient and all
other settings. Then sample counting can
The backup data is inappropriately
Check settings be performed. If the error still occurs,
changed.
contact your Nihon Kohden representative
for battery replacement.
Measurement is performed more than Replace the pump tube and reset the
Replace pump tube
3,000 times. operation history.

Operator's Manual MEK-6400 8.7


8. MESSAGES AND TROUBLESHOOTING

System Error Messages

Messages Possible Cause/Criteria Countermeasure


E001: DILUTER INITIALIZE The MD-640V combination syringe
ERROR pump unit cannot be initialized.
E002: BLOOD SAMPLING The MD-640V combination syringe
ERROR pump unit does not aspirate the
E003: DILUTER ERROR sample.
E021: SAMPLER INITIALIZE The MS-640V sampler unit cannot
ERROR be initialized.
The MS-640V sampler unit does not Turn the power off then on.
E022: SAMPLER ERROR
function. If the alarm still occurs, write down the
E041: SUB BATH INITIALIZE The sub bath of the MC-640V error code and contact your Nihon Kohden
ERROR measuring unit cannot be initialized. representative.
The sub bath of the MC-640V
E042: SUB BATH ERROR
measuring unit doe not function.
The MP-640V pump unit does not
E101: BATH DRAIN ERROR
drain the measurement baths.
E120: WATCH DOG TIMER
Internal communication error.
ERROR
Analog-Digital converter error on the
E121: A/D CIRCUIT ERROR
UT-7162 AMP CONTROL board.
Re-enter the calibration coefficient and all
other settings. Then sample counting can be
E122: CHECK SETTINGS The backup data is inappropriately performed. If the error still occurs, contact
changed. your Nihon Kohden representative for
battery replacement.
E123: MEMORY ERROR Delete the stored data.
Turn the power off then on.
If the alarm still occurs, write down the
E124: CIRCUIT ERROR Circuit error.
error code and contact your Nihon Kohden
representative.
The pressed position and operating Calibrate the touch screen. Refer to Section
position do not match. 9.
E126: TOUCH PANEL ERROR Press the [Reset] key. If the problem still
Circuit error. occurs, turn off the analyzer, wait about 10
seconds, then turn it on again.
E141: CAP PIERCE The MS-641V cap pierce unit cannot
INITIALIZE ERROR be initialized.
E142: CAP PIERCE RISING The MS-641V cap pierce unit cannot
ERROR be raised. Turn the power off then on.
E144: CAP PIERCE The tube holder opened during If the alarm still occurs, write down the
OPERATION ERROR measurement. error code and contact your Nihon Kohden
E145: TUBE HOLDER representative.
The tube holder cannot be opened.
OPERATION ERROR
E146: CAP PIERCE RINSE The MS-641V cap pierce unit cannot
ERROR be moved to the rinsing position.

8.8 Operators Manual MEK-6400


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 Possible Cause/Criteria Countermeasure


Insufficient grounding. Make sure the ground is sufficient.
Noise interference during Equipment near the analyzer is Separate the analyzer from other equipment
A
counting generating noise. and their power sources.
Noise in the power line. Use a different power line.
Dirty diluent. Replace the diluent.
Dirty sub bath, measurement bath and Clean the sub bath, measurement bath and
filters. filters. Refer to Section 9. 8
Dirty aperture caps. Clean the aperture caps. Refer to Section 9.
Poor contact of external electrode to
B High background noise Firmly tighten the measurement bath.
the socket of the analyzer.
Press the [Clean] key to clean the fluid path
using the CLEANAC detergent. Perform the
The fluid path and diluent tube are
strong cleaning with CLEANAC3 detergent
dirty.
by selecting STRONG CLEAN on the
OPERATION screen.
Stir the sample sufficiently without creating
Insufficient stirring of sample.
bubbles.
Dirty sub bath and/or measurement Clean the sub bath and/or measurement bath.
Poor reproducibility of
C bath. Refer to Section 9.
blood cell count
Dirty aperture caps. Clean the aperture caps. Refer to Section 9.
Reduce the background noise. Refer to
High background noise.
Problem B.
Water leaks from inside Pump tube is broken. Replace the pump tube. Refer to Section 9.
D
the analyzer Filter is clogged. Replace the filter. Refer to Section 9.
Poor reproducibility of The WBC measurement bath is dirty. Clean the measurement bath. Refer to Section
E
HGB value 9.
Incorrect LCD display Circuit error. Press the [Reset] key. If the problem still
F Analyzer repeats same occurs, turn off the analyzer, wait about 10
operation seconds, then turn it on again.
Paper jammed. Remove the jammed paper. Refer to the
printer manual.
G No printing Circuit error. Press the [Reset] key. If the problem still
occurs, turn off the analyzer, wait about 10
seconds, then turn it on again.
The pressed position and operating Calibrate the touch screen. Refer to Section 9.
position do not match.
The touch screen keys do
H Circuit error. Press the [Reset] key. If the problem still
not function
occurs, turn off the analyzer, wait about 10
seconds, then turn it on again.

Operator's Manual MEK-6400 8.9


8. MESSAGES AND TROUBLESHOOTING

Problem Possible Cause/Criteria Countermeasure


Priming starts suddenly Power cord is not connected properly. Connect the power cord properly.
(When noise interferes with
the analyzer program, Equipment near the analyzer is Separate the analyzer from other equipment
I
priming automatically starts generating noise. and their power sources.
and the READY screen
appears.) Noise in the power line. Use a different power line.

The date and time setting is not Set the correct date and time setting on the
correct. DATE & TIME screen. Refer to Section 3.
The time displayed on the Check the date and time setting on the
J upper right corner of the DATE & TIME screen and turn off and on
The backup battery is old.
screen is not correct. the power of the analyzer. If the time is
(The backup battery lifetime is about
incorrect, replace the backup battery with a
6 years.)
new one. Contact your Nihon Kohden
representative.

8.10 Operators Manual MEK-6400


Section 9 Maintenance
General .............................................................................................................................................................. 9.3
Disposing of Waste .................................................................................................................................. 9.4
Disposing of 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 ................................................................................................................................. 9.8
Inside Panel Components ................................................................................................................................. 9.10
Before Maintenance Procedure ......................................................................................................................... 9.11
Strong Cleaning ...................................................................................................................................... 9.11
Draining Measurement Baths and Sub Baths .......................................................................................... 9.12
9
Turning Power Off .................................................................................................................................... 9.13
Daily Maintenance Procedures .......................................................................................................................... 9.14
Checking Reagents and Other Consumables .......................................................................................... 9.14
Checking the Appearance of the Analyzer .............................................................................................. 9.14
Disinfecting the Surface of the Analyzer ....................................................................................... 9.15
Cleaning the Surface of the Analyzer ............................................................................................ 9.15
Checking the Reagents Connection Tubes .............................................................................................. 9.15
Checking the Power Cord and Grounding Lead ........................................................................................ 9.15
Checking the External Instrument Connection ......................................................................................... 9.15
Checking the Power On ........................................................................................................................... 9.16
Calibrating the Touch Screen ......................................................................................................... 9.16
Checking the Date and Time ................................................................................................................... 9.16
Clock Accuracy ............................................................................................................................ 9.17
Checking Daily Accuracy ........................................................................................................................ 9.17
Checking Measurement Baths and Sub Baths ........................................................................................ 9.17
Checking Pump Tube .............................................................................................................................. 9.17
Weekly/Every 300 Counts Maintenance Procedures ......................................................................................... 9.18
Checking/Cleaning Filters ....................................................................................................................... 9.18
Monthly/Every 1,000 Counts Maintenance Procedures ..................................................................................... 9.19
Replacing Filters ..................................................................................................................................... 9.19
Materials Required ........................................................................................................................ 9.19
Procedure ..................................................................................................................................... 9.19
Checking and Cleaning Measurement Baths and Sub Baths ................................................................... 9.21
Materials Required ........................................................................................................................ 9.21
Procedure ..................................................................................................................................... 9.21
Checking and Cleaning/Replacing the Rinse Unit and Cap Pierce Nozzle ............................................... 9.23
Materials Required ........................................................................................................................ 9.23
Procedure ..................................................................................................................................... 9.24
Every Four Months/Every 3,000 Counts Maintenance Procedures .................................................................... 9.27
Checking and Cleaning/Replacing the Sampling Nozzles ........................................................................ 9.27
Materials Required ........................................................................................................................ 9.27
Procedure ..................................................................................................................................... 9.27
Replacing Pump Tube .............................................................................................................................. 9.31
Materials Required ........................................................................................................................ 9.31
Operator's Manual MEK-6400 9.1
Procedure ..................................................................................................................................... 9.31
As-Required Maintenance Procedures .............................................................................................................. 9.34
Removing a Clog from the Aperture ........................................................................................................ 9.34
Cleaning Aperture Caps .......................................................................................................................... 9.35
Materials Required ........................................................................................................................ 9.35
Procedures ................................................................................................................................... 9.35
Checking the Prime Function .................................................................................................................. 9.39
Checking the Drain Function ................................................................................................................... 9.39
Checking the Cleaning Function .............................................................................................................. 9.39
Checking the Circuit ................................................................................................................................ 9.39
Checking the Sensor Monitor Screen ...................................................................................................... 9.41
Checking the External Instruments Function ........................................................................................... 9.42
Printers ......................................................................................................................................... 9.42
Hand-held Bar Code Reader .......................................................................................................... 9.42
PC ................................................................................................................................................ 9.42
Decontamination Protocol ....................................................................................................................... 9.43
Procedure ..................................................................................................................................... 9.44
Storing and Transporting the Analyzer ..................................................................................................... 9.46
Preparing the Analyzer for Long Term Storage or Transport ........................................................... 9.46
Using the Analyzer after Storage .................................................................................................. 9.48
Preparing the Analyzer for Short Term Transport ........................................................................... 9.49

9.2 Operators Manual MEK-6400


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
9
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
Protect yourself from infection before cleaning and doing
maintenance.
Be careful not to directly touch any place where blood is or may
have contacted.

CAUTION
Gloves should be worn during the maintenance procedures. They
should be powder-free as powder may cause instrument problems.

Operator's Manual MEK-6400 9.3


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
Follow your local laws for disposing of medical waste.

WARNING
Dispose of the blood sample and replaced parts by following your
local laws for disposing of infectious medical waste.
Always wear rubber gloves to protect yourself from infection when
handling waste.

Disposing of the Analyzer

CAUTION
Perform strong cleaning before disposing of the analyzer.
Remove the sampling nozzles and cap pierce nozzle from the
analyzer and dispose of them following your local laws for
disposing of medical waste.

When disposing of the analyzer, contact your Nihon Kohden representative.

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 distributors 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 distributor or representative.

9.4 Operators Manual MEK-6400


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 (open mode), 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) 9
Check measurement baths and sub baths
Check pump tube

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 and check cap pierce nozzle

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

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 OPE HISTORY screen to keep
track of maintenance.

Operator's Manual MEK-6400 9.5


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 cap
pierce nozzle.

When the filters, measurement baths, sub baths, pump tube, rinse unit, sampling
nozzles and cap pierce nozzle are used more than the following number of
sample counts, the ALARM screen appears to prompt you to check and/or
replace them.

Filters, measurement baths and sub baths: 1,000 counts


Pump tube: 3,000 counts
Rinse unit: 1,000 counts
Sampling nozzles: 3,000 counts
Cap pierce nozzle: 1,000 counts

1. Press the OTHER key on the MENU screen to display the OTHER screen.

2. Press the OPE HISTORY key to display the OPE HISTORY screen.

9.6 Operators Manual MEK-6400


9. MAINTENANCE

The first page displays the software version, installed language, hardware
version, total operating time (hours) and total number of counts.

The second page displays the number of counts for filters, measurement
baths, sub baths, pump tube, rinse unit, sampling nozzles and cap pierce
nozzle.

After checking and replacing the filters, measurement baths, sub baths,
pump tube, rinse unit, sampling nozzles and cap pierce nozzle, reset the
counts to zero by pressing the RESET key.

3. Press the OK key to return to the OTHER screen.

Operator's Manual MEK-6400 9.7


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 OK No
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
3
WBC: 0.2 (10 /L)
Measure background noise RBC: 0.05 (106/L)
HGB: 0.1 (g/dL)
PLT: 10 (103/L)
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 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 and check cap pierce nozzle
Every four months or 3,000 counts, whichever comes first
Check sampling nozzles
Replace pump tube

9.8 Operators Manual MEK-6400


9. MAINTENANCE

Check Item OK No
As required
Clean aperture caps
Remove clog from aperture
Check prime function
Check draining function
Check cleaning function
Enter the value
3
WBC: 7.6 to 8.4 (10 /L)
RBC: 1.52 to 1.68 (106/L)
MCV: 85 to 115 (fL)
PLT: 152 to 168 (103/L)
HGB ON: 1.5 to 4.5 V
Check circuit
HGB OFF: <0.5 V
WBC sensitivity
9
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: 17.7 to 18.3 V
RBC: 17.7 to 18.3 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
Check sensor Diluent: >3.5 V
monitor Lysing reagent: >3.5 V
WBC manometer Upper: <1.5 V
WBC manometer Lower: <1.5 V
With RBC manometer Upper: <1.5 V
reagent RBC manometer Lower: <1.5 V
Diluent: <1.5 V
Lysing reagent: <1.5 V
HGB unit
MC unit
Power board
Check printer function
Check bar code reader function
Check communication function between analyzer and PC.
Decontamination protocol
Storing and transporting analyzer

Operator's Manual MEK-6400 9.9


9. MAINTENANCE

Inside Panel Components

WBC measurement bath


RBC measurement bath
Sampling nozzles
Sub baths

Rinse unit

Cap pierce nozzle

Aperture caps

Filters Pump tube

CAUTION
Do not handle any parts other than specified in this manual.

9.10 Operators Manual MEK-6400


9. MAINTENANCE

Before Maintenance Procedure

Before turning the analyzer power off for maintenance, perform strong cleaning
and drain fluid from the measurement baths and sub baths.

When background counts are out of specification or the clogging message


frequently appears, perform strong cleaning to clean the analyzer more
thoroughly with CLEANAC3 detergent containing sodium hypochlorite.

Strong Cleaning
1. Press the OPERATIONS key on the MENU screen to display the
OPERATIONS screen.
9

2. Press the STRONG CLEAN key on the OPERATIONS screen.

Operator's Manual MEK-6400 9.11


9. MAINTENANCE

3. Replace the CLEANAC detergent with CLEANAC3 detergent. Refer to


Connecting Tubes and Installing Reagents in Section 2.

4. 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 instruction to replace the CLEANAC3 detergent with


CLEANAC detergent appears.

5. Replace the CLEANAC3 detergent with CLEANAC detergent and press


the OK key. The screen returns to the READY screen.

6. 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.

9.12 Operators Manual MEK-6400


9. MAINTENANCE

2. Press the DRAIN BATHS key on the OPERATIONS screen. The Drain
baths? message appears.

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 main power before doing maintenance. Otherwise, the
operator may receive electrical shock.

Press the [Power] key while holding down the [Reset] key. The power turns off
without cleaning. Check that the power lamp is off.

Operator's Manual MEK-6400 9.13


9. MAINTENANCE

Daily Maintenance Procedures

Checking Reagents and Other Consumables

CAUTION
Use only Nihon Kohden recommended reagents. Otherwise the
measurement result cannot be guaranteed and incorrect reagent
concentration can cause equipment damage.

Check that the following Nihon Kohden specified reagents are used.
ISOTONAC3 diluent
CLEANAC detergent
CLEANAC3 detergent (For STRONG CLEAN only)
Hemolynac3N hemolysing reagent

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 is or may
have contacted.
Protect yourself from infection before cleaning and doing
maintenance.

CAUTION
Turn off the main power before disinfection or cleaning the analyzer.
Otherwise, the operator may receive electrical shock.

9.14 Operators Manual MEK-6400


9. MAINTENANCE

Disinfecting the Surface of the Analyzer

NOTE
Disinfect the sampling nozzle before every maintenance because
infectious blood may be adhered to it.

Wipe the analyzer with a cloth moistened with disinfecting ethanol. Disinfect
the sampling nozzle (open mode) thoroughly because it touches blood.

Cleaning the Surface of the Analyzer

CAUTION
Never use organic solvents such as thinner or acetone because they
damage the enclosure of the analyzer.
9

NOTE
When wiping the analyzer with a cloth moistened with water, wring
out the cloth to prevent water from entering the analyzer.

1. Dilute a neutral detergent with water.

2. Wipe off the dirt with a soft cloth moistened with the diluted neutral
detergent.

3. Wipe the analyzer with a dry soft cloth.

Checking the Reagents 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.

Operator's Manual MEK-6400 9.15


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 [ Eject] key while holding down the [ Reset] key. The
TOUCH SCREEN CALIBRATION screen appears.

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.

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

9.16 Operators Manual MEK-6400


9. MAINTENANCE

Clock Accuracy
At an operating temperature of 25C, the accuracy of the clock IC of the
analyzer is about 52 seconds per month.

At storage temperatures between 20 and +60C, 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


9
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.

Operator's Manual MEK-6400 9.17


9. MAINTENANCE

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.

9.18 Operators Manual MEK-6400


9. MAINTENANCE

Monthly/Every 1,000 Counts Maintenance Procedures

Replacing Filters
Materials Required
Powder-free gloves, lab coat, safety glasses
Phillips screwdriver
Tweezers

Procedure
Replace the filters when they are clogged, dirty and/or after every 1,000 sample
counts.

1. Replace the CLEANAC detergent with CLEANAC3 detergent.


9
2. Press the STRONG CLEAN key on the OPERATIONS screen to perform
strong cleaning. Refer to Before Maintenance Procedure earlier in this
section.

3. Replace the CLEANAC3 detergent with CLEANAC detergent.

4. 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.

5. Press the [Power] key while holding down the [Reset] key to turn the power
off. Check that the power lamp is off.

6. Remove the three screws on the rear panel and one screw on the right side
panel. The two screws marked with A only need to be loosened and not
removed.

7. Slide the right side cover to the rear direction and then pull it toward you
to remove the cover.

Operator's Manual MEK-6400 9.19


9. MAINTENANCE

8. Remove the 2 filter joint assemblies by turning the tube


connectors.

Air trap

RBC measurement bath


Filter joint

Filter
9. 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.

10. Reattach the filter joint assemblies to the bottom of the RBC measurement
Filter packing 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.

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.

11. Reattach the right side cover and fasten it with the three screws on the rear
panel and one screw on the right side panel.

12. Press the [Power] key to turn on the power. The analyzer starts priming the
fluid pathway.

13. 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 OPE HISTORY screen to reset the counts to zero.

14. Fill in the Maintenance Check Sheet.

15. Measure background noise at least twice.

16. Run quality controls before running patient samples.

9.20 Operators Manual MEK-6400


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 glasses
Phillips and flat-blade screwdrivers
CLEANAC3 detergent
Dry lint-free cloth

Procedure
NOTE 9
Be careful not to damage the measurement baths and sub baths.

1. Replace the CLEANAC detergent with CLEANAC3 detergent.

2. Press the STRONG CLEAN key on the OPERATIONS screen to perform


strong cleaning. Refer to Before Maintenance Procedure earlier in this
section.

3. Replace the CLEANAC3 detergent with CLEANAC detergent.

4. 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.

5. Press the [Power] key while holding down the [Reset] key to turn the power
off. Check that the power lamp is off.

6. Remove the three screws on the rear panel and one screw on the right side
panel. The two screws marked with A only need to be loosened and not
removed.

7. Slide the right side cover to the rear direction and then pull it toward you
to remove the cover.

Operator's Manual MEK-6400 9.21


9. MAINTENANCE

Steps 13, 14 Step 9 8. Check the WBC and RBC measurement baths and sub
Sub baths WBC meas bath baths. If there is any blood or dust on them, remove and
Tube joint
Cap clean them taking the following steps.

9. Remove the tube joint connected to the WBC


measurement bath by turning the knurl joint.

10. Remove filter joints on the RBC and WBC measurement


bath assemblies by turning the tube connectors.

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.

13. Remove the cap from the left side of the WBC sub bath.

14. Remove the sub baths by pushing them to the left, then
pulling them toward you.

15. Soak the measurement baths and sub baths in


CLEANAC3 detergent for about 10 minutes.

16. Rinse the measurement baths and sub baths with water
and wipe them with a dry lint-free cloth.
Filter joints
Meas baths 17. Reattach the sub baths to their original positions.
Step 10 Reattach the cap (which was removed in step 13) to the
Screws
Steps 11, 12 left side of the WBC sub bath to fasten the sub baths.

18. Reattach the measurement baths so that the sub bath is in


Shaft
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.

19. Tighten the screws which were loosened in step 11 to


fasten the measurement baths.
NOTE
Aperture Before tightening the screws, check and remove any
dirt or rust on and around the screws. If dirt or rust
Tab is present, noise alarm may occur during
measurement.

Round indent 20. Reconnect the filter joints to the RBC and WBC
measurement bath assemblies by turning the tube
connectors.

9.22 Operators Manual MEK-6400


9. MAINTENANCE

21. Reattach the tube joint to the WBC measurement bath by turning the knurl
joint.

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 were cleaned, the bath counter will
have to 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 OPE HISTORY screen to reset the counts to zero. 9

25. Fill in the Maintenance Check Sheet.

26. Measure background noise at least twice.

27. Run quality controls before running patient samples.

Checking and Cleaning/Replacing the Rinse Unit and Cap Pierce Nozzle
Check and clean the rinse unit and cap pierce nozzle once a month or every
1,000 sample counts whichever comes first.

WARNING
The cap pierce nozzle is sharp and potentially contaminated with
infectious materials. Be careful when handling the cap pierce nozzle
and performing this procedure.

Materials Required
Powder-free gloves, lab coat, safety glasses
Phillips and flat-blade screwdrivers
Cotton swabs
CLEANAC3 detergent
Lint-free pad
New cap pierce nozzle (when required)

Operator's Manual MEK-6400 9.23


9. MAINTENANCE

Procedure
1. Replace the CLEANAC detergent with CLEANAC3 detergent.

2. Press the STRONG CLEAN key on the OPERATIONS screen to perform


strong cleaning. Refer to Before Maintenance Procedure earlier in this
section.

3. Replace the CLEANAC3 detergent with CLEANAC detergent.

4. 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.

5. Press the [Power] key while holding down the [Reset] key to turn the power
off. Check that the power lamp is off.

6. Remove the three screws on the rear panel and one screw on the right side
panel. The two screws marked with A only need to be loosened and not
removed.

7. Slide the right side cover to the rear direction and then toward you to
remove the cover.

8. Slide the sampling nozzle plate to the right.

Sampling nozzle plate

9.24 Operators Manual MEK-6400


9. MAINTENANCE

9. Check the following parts for dirt or blood clot. Remove blood or salt
crystals on the rinse unit and the tip of the cap pierce nozzle with a cotton
swab or lint-free pad moistened with CLEANAC3 detergent.
Cap pierce nozzle
Rinse unit (top view) (top view)

Rinse unit
(bottom view seen from
the front panel side) 9

Cap pierce nozzle


(bottom view seen from the front panel
side with the tube holder opened)

If the cap pierce nozzle is damaged or dirt/blood cannot be removed,


replace the cap pierce nozzle with a new one.

Cap pierce nozzle

To replace the cap pierce nozzle:


1) Turn the cap pierce nozzle 90 counterclockwise.

Joint
2) Remove the joint from the cap pierce nozzle.

3) Pull the cap pierce nozzle up to remove it.

4) Reattach the joint to the new cap pierce nozzle.

5) Insert the cap pierce nozzle into the cap pierce nozzle
guide and turn the cap pierce nozzle 90 clockwise.

Cap pierce nozzle guide

Operator's Manual MEK-6400 9.25


9. MAINTENANCE

10. Reattach the right side cover and fasten it with the three screws on the rear
panel and one screw on the right side panel.

11. Press the [Power] key to turn on the power. The analyzer starts priming the
fluid pathway.

12. If the rinse unit and cap pierce nozzle were checked and cleaned, the rinse
unit and cap pierce nozzle counter will have to be reset. To reset the
counter, press the RESET key for <Rinse unit> and <Cap pierce nozzle> on
the OPE HISTORY screen to reset the counts to zero.

13. Fill in the Maintenance Check Sheet.

14. Measure background noise at least twice.

15. Run quality controls before running patient samples.

9.26 Operators Manual MEK-6400


9. MAINTENANCE

Every Four Months/Every 3,000 Counts Maintenance


Procedures

Checking and Cleaning/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 9
and performing this procedure.

Materials Required
Powder-free gloves, lab coat, safety glasses
Phillips and flat-blade screwdrivers
Cotton swabs
CLEANAC3 detergent
Lint-free pad
New sampling nozzle(s) (when required)

Procedure
1. Replace the CLEANAC detergent with CLEANAC3 detergent.

2. Press the STRONG CLEAN key on the OPERATIONS screen to perform


strong cleaning. Refer to Before Maintenance Procedure earlier in this
section.

3. Replace the CLEANAC3 detergent with CLEANAC detergent.

4. 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.

5. Press the [Power] key while holding down the [Reset] key to turn the power
off. Check that the power lamp is off.

Operator's Manual MEK-6400 9.27


9. MAINTENANCE

6. Remove the three screws on the rear panel and one screw on the right side
panel. The two screws marked with A only need to be loosened and not
removed.

7. Slide the right side cover to the rear direction and then toward you to
remove the cover.

8. Slide the sampling nozzle plate to the right.


Sampling nozzle plate

9. 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 CLEANAC3 detergent.

Sampling nozzles
9.28 Operators Manual MEK-6400
9. MAINTENANCE

If the sampling nozzle is damaged or dirt/blood cannot be removed, replace


the sampling nozzle with a new one.

To replace sampling nozzles:


Sampling nozzle plate 1) Push down the sampling nozzle plate as far as it goes. The sampling
should be about here 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.

Sampling nozzle screw 2) Remove the sampling nozzle screw from each of the
sampling nozzle.
NOTE
Be careful not to drop the screws into the analyzer.

Sampling nozzle 3) Turn the sampling nozzle 90 clockwise.

White joint

4) Remove the joint from each sampling nozzle.

NOTE
Diluent may flow out from the sampling nozzle when
the joint is removed.

5) Pull the sampling nozzle up to remove it.

Black joint

Operator's Manual MEK-6400 9.29


9. MAINTENANCE

6) Insert each new sampling nozzle into the sampling nozzle


guide, attach the joint and turn the sampling nozzle 90
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 7) Raise the sampling nozzle plate to the original position.


nozzle guide

10. Reattach the right side cover and fasten it with the three screws on the rear
panel and one screw on the right side panel.

11. Press the [Power] key to turn on the power. The analyzer starts priming the
fluid pathway.

12. If the sampling nozzles were checked and cleaned, the sampling nozzle
counter will have to be reset. To reset the counter, press the RESET key for
<Sampling nozzle> on the OPE HISTORY screen to reset the counts to zero.

13. Fill in the Maintenance Check Sheet.

14. Measure background noise at least twice.

15. Run quality controls before running patient samples.

9.30 Operators Manual MEK-6400


9. MAINTENANCE

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.

Materials Required
Powder-free gloves, lab coat, safety glasses
Phillips screwdriver

Procedure 9
1. Replace the CLEANAC detergent with CLEANAC3 detergent.

2. Press the STRONG CLEAN key on the OPERATIONS screen to perform


strong cleaning. Refer to Before Maintenance Procedure earlier in this
section.

3. Replace the CLEANAC3 detergent with CLEANAC detergent.

4. 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.

5. Press the [Power] key while holding down the [Reset] key to turn the power
off. Check that the power lamp is off.

6. Remove the three screws on the rear panel and one screw on the right side
panel. The two screws marked with A only need to be loosened and not
removed.

7. Slide the right side cover to the rear direction and then toward you to
remove the cover.

Operator's Manual MEK-6400 9.31


9. MAINTENANCE

8. Check the pump tube for water droplets and leaks. If any droplet or leak is
Pump tube found, replace the tube with a new one by using the following steps.

Pump cover
9. Remove the pump cover by removing the two screws on the cover.

Screws

Tube holder 10. Pull out the white tube joint from the tube holder and pull out the pump
Black tube by turning the pump rotator counterclockwise. Then pull the black
tube joint out of the tube holder.

White
Pump rotator

11. Remove the white and black tube joints and replace the pump tube.

12. Return the white tube joint to the original position and push the pump tube
Tube holder
into the tube guide by turning the rotator counterclockwise.

Pump rotator

White

Tube guide

Pump tube

9.32 Operators Manual MEK-6400


9. MAINTENANCE

Tube holder 13. Return the black tube joint to the original position.

White
NOTE
Black
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.
Make sure the joints are held properly by the tube holder as shown
Pump rotator below. Otherwise, the pump tube may be damaged or the life of the
pump tube will be shortened.
Tube holder
9

Tube joint

14. Replace the pump cover.

15. Reattach the right side cover and fasten it with the three screws on the rear
panel and one screw on the right side panel.

16. Press the [Power] key to turn on the power. The analyzer starts priming the
fluid pathway.

17. If the pump tube was replaced, the pump tube counter will have to be reset.
To reset the counter, press the RESET key for <Pump tube> on the OPE
HISTORY screen to reset the counts to zero.

18. Fill in the Maintenance Check Sheet.

19. Measure background noise at least twice.

20. Run quality controls before running patient samples.

Operator's Manual MEK-6400 9.33


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.

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.

9.34 Operators Manual MEK-6400


9. MAINTENANCE

Cleaning Aperture Caps


Materials Required
Powder-free gloves, lab coat, safety glasses
Phillips and flat-blade screwdrivers
Dry cloth or tissue paper
CLEANAC3 detergent
Microscope

Procedures
For daily cleaning of the aperture caps, press the [ Clean] key on the front
panel.

However, if the CLOG message frequently appears or the background count is


high, clean the aperture caps as directed in the following procedure.
9
NOTE
The aperture caps are behind the measurement baths.

1. Replace the CLEANAC detergent with CLEANAC3 detergent.

2. Press the STRONG CLEAN key on the OPERATIONS screen to perform


strong cleaning. Refer to Before Maintenance Procedure earlier in this
section.

3. Replace the CLEANAC3 detergent with CLEANAC detergent.

4. Remove the diluent tube from the ISO3 diluent inlet and the hemolysing
reagent tube from the HEMO3N inlet on the right side panel.

5. Remove the detergent tube from the 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.

6. Press the DRAIN ALL key on the OPERATIONS screen.


Waste container

Operator's Manual MEK-6400 9.35


9. MAINTENANCE

A confirmation message appears on the screen.

7. 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.

8. After draining, press the [Power] key while holding down the [Reset] key to
turn the power off. Check that the power lamp is off.

9. Remove the three screws on the rear panel and one screw on the right side
panel. The two screws marked with A only need to be loosened and not
removed.

10. Slide the right side cover to the rear direction and then toward you to
remove the cover.

9.36 Operators Manual MEK-6400


9. MAINTENANCE

11. Remove the tube joint connected to the WBC measurement


bath by turning the knurl joint.

12. Loosen the screws fastening the measurement baths. (The


screws cannot be removed from the measurement baths.)

13. Remove the measurement baths by pulling them toward you


Step 11 to remove them from the aperture and then pulling them
WBC meas bath downward. If necessary, remove filter joints on the RBC and
Tube joint
WBC measurement bath assemblies by turning the tube 9
connectors.

Screws
Steps 12, 13

14. 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.

15. Carefully rinse the aperture cap. Remove all protein build-up, especially
from the inside. The condition of the aperture cap can be checked with a
100 microscope.

16. If a clog or dust still remains in the aperture caps, soak the aperture caps in
CLEANAC3 detergent for about an hour.

CAUTION
Handle the aperture caps with care. They can be damaged if a sharp
object is used to clean them.

17. Rinse the aperture caps with water and replace them in the
original positions. Make sure that the black O-ring is facing
the hole (analyzer side).

NOTE
When replacing the aperture cap, do not push the
aperture cap with your ball of finger. Otherwise, the
Black O-ring aperture cap may be broken.
Black O-ring

Operator's Manual MEK-6400 9.37


9. MAINTENANCE

Shaft 18. 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.

19. Tighten the screws which were loosened in step 12 to


fasten the measurement baths.

Aperture
NOTE
Before tightening the screws, check and remove any
Tab
dirt or rust on and around the screws. If dirt or rust is
present, noise alarm may occur during measurement.
Round indent
Reconnect the filter joints to the RBC and WBC
measurement bath assemblies by turning the tube
connectors if they were removed in step 13.
WBC measurement bath
Tube joint
20. Reattach the tube joint to the WBC measurement bath by
turning the knurl joint.

21. Reattach the right side cover and fasten it with the three
screws on the rear panel and one screw on the right side
panel.

22. Press the [Power] key to turn on the power. The analyzer
starts priming the fluid pathway.

23. Fill in the Maintenance Check Sheet.

24 Measure background noise at least twice.

25. Run quality controls before running patient samples.

9.38 Operators Manual MEK-6400


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.
9

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 analyzers electrical circuit.

1. Press the OTHER key on the MENU screen.

Operator's Manual MEK-6400 9.39


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.

3. Check that the results are in the following ranges.

Normal range
WBC: 7.6 to 8.4 (103/L)
RBC: 1.52 to 1.68 (106/L)
MCV: 85 to 115 (fL)
PLT: 152 to 168 (103/L)
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.


9.40 Operators Manual MEK-6400
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

Operator's Manual MEK-6400 9.41


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: <1.5 V
3. WBC: 17.7 to 18.3 V
4. RBC: 17.7 to 18.3 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)

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.

9.42 Operators Manual MEK-6400


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
B A
X=
A

Example: 9
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:
5.25 0.5
X=
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.

Operator's Manual MEK-6400 9.43


9. MAINTENANCE

Procedure
1. Press the OPERATIONS key on the MENU screen to display the
OPERATIONS screen.

2. Replace the CELANAC detergent with CLEANAC3 detergent.

3. Press the STRONG CLEAN key on the OPERATIONS screen. The


confirmation message appears.

4. 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.

5. Wipe down all analyzer surfaces with 0.5% sodium hypochlorite solution.

6. 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.

9.44 Operators Manual MEK-6400


9. MAINTENANCE

Certification of Decontamination
This instrument
Type: MEK-
Serial Number:

Has been decontaminated according to the Nihon Kohden recommended


protocol.
Date: : :

Laboratory Supervisor 9

Name:
Signature:

Certification of Decontamination
This instrument
Type: MEK-
Serial Number:

Has been decontaminated according to the Nihon Kohden recommended


protocol.
Date: : :

Laboratory Supervisor

Name:
Signature:

Operator's Manual MEK-6400 9.45


9. MAINTENANCE

Storing and Transporting the Analyzer


Preparing the Analyzer for Long Term Storage or Transport
The fluid pathway can become clogged with salt deposits and reagent residue if
the analyzer is not rinsed and drained before a period of inactivity.

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. Replace the CELANAC detergent with CLEANAC3 detergent.

3. Press the STRONG CLEAN key on the OPERATIONS screen. The


confirmation message appears.

9.46 Operators Manual MEK-6400


9. MAINTENANCE

4. 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.

5. Remove the diluent tube from the ISO3 diluent inlet and the hemolysing
reagent tube from the HEMO3N inlet on the right side panel. Remove the
detergent tube from the detergent container and put it into the waste
container.

Do not disconnect the waste tube from the WASTE outlet.

NOTE
Make sure that the waste tube is correctly connected.
Waste comes out from the CLN inlet when DRAIN ALL is performed.
To handle the diluent, detergent, hemolysing reagent and waste 9
Waste container containers, follow the instructions on each package label.

6. Press the DRAIN ALL key on the OPERATIONS screen. A confirmation


message appears on the screen.

7. 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.

8. After draining is complete, connect the spare tubes to the ISO3, CLN 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.)
Waste container

NOTE
Make sure that all tubes are fully submerged in the distilled water.

9. Press the [ Clean] key on the front panel to prime the analyzer with the
Cleaning kit distilled water.

10. Repeat steps 5 to 7.

Operator's Manual MEK-6400 9.47


9. MAINTENANCE

11. Press the [Main power] switch on the rear panel to turn the main power off.

12. Wipe down the analyzer surfaces with a non-abrasive detergent solution
then with a 0.5% sodium hypochlorite solution.

13. Wipe the analyzer surface with a soft cloth moistened with tap water. Wring
out the cloth thoroughly.

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.

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.

9.48 Operators Manual MEK-6400


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.

Operator's Manual MEK-6400 9.49


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
Special Key Operations for Servicing ................................................................................................................ 10.6
Bar Codes for Using Hand-held Bar Code Reader .............................................................................................. 10.7
Using Bar Codes ..................................................................................................................................... 10.7
Changing the Settings ............................................................................................................................. 10.8 10
Bar Code Setup Menu ............................................................................................................................. 10.9
Interference Substances ................................................................................................................................. 10.20
Data and Symbol Display ................................................................................................................................ 10.23
Specifications ................................................................................................................................................. 10.25
Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood .................. 10.25
Standardization Analysis Method ................................................................................................ 10.25
Detection Method ........................................................................................................................ 10.26
Dilution Ratio .............................................................................................................................. 10.26
Counting Time ............................................................................................................................. 10.26
Display ....................................................................................................................................... 10.26
Data Storage ............................................................................................................................... 10.26
Environmental Conditions ........................................................................................................... 10.26
Power Requirements ................................................................................................................... 10.26
Dimensions and Weight .............................................................................................................. 10.27
Electromagnetic Compatibility ..................................................................................................... 10.27
Safety ......................................................................................................................................... 10.27
Standard Accessories ..................................................................................................................................... 10.28
Options ........................................................................................................................................................... 10.30
Consumables .................................................................................................................................................. 10.32

Operator's Manual MEK-6400 10.1


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 Operators Manual MEK-6400


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 Microcytic blood (Microcythemia)

PLT LO* PLT LO*


PLT HI* PLT HI*

amplitude
PLT RBC amplitude 9
PLT RBC (volume) (volume)
PLT RBC PLT RBC
volume range volume range volume range volume range 10
Fig. A Fig. B
Count

Macro platelet

PLT HI*
PLT LO*: Lower threshold
PLT LO*
PLT HI*: Upper threshold
PLT RBC amplitude
(volume)
PLT RBC
volume range 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-6400 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
Cyanmet-
hemoglobin

Non-cyan
surfactant

Oxidized hemoglobin

500 520 540 560 580


Wavelength (nm)

10.4 Operators Manual MEK-6400


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 g/dL g/dL g/dL g/dL g/dL g/dL g/dL
SAHLI SAHLI SAHLI SAHLI SAHLI SAHLI SAHLI SAHLI
5.0 31.3 7.0 43.8 9.0 56.3 11.0 68.8 13.0 81.3 15.0 93.8 17.0 106.3 19.0 118.8
5.1 31.9 7.1 44.4 9.1 56.9 11.1 69.4 13.1 81.9 15.1 94.4 17.1 106.9 19.1 119.4
5.2 32.5 7.2 45.0 9.2 57.5 11.2 70.0 13.2 82.5 15.2 95.0 17.2 107.5 19.2 120.0
5.3 33.1 7.3 45.6 9.3 58.1 11.3 70.6 13.3 83.1 15.3 95.6 17.3 108.1 19.3 120.6
5.4 33.8 7.4 46.3 9.4 58.8 11.4 71.3 13.4 83.8 15.4 96.3 17.4 108.8 19.4 121.3
5.5 34.4 7.5 46.9 9.5 59.4 11.5 71.9 13.5 84.4 15.5 96.9 17.5 109.4 19.5 121.9
5.6 35.0 7.6 47.5 9.6 60.0 11.6 72.5 13.6 85.0 15.6 97.5 17.6 110.0 19.6 122.5
9
5.7 35.6 7.7 48.1 9.7 60.6 11.7 73.1 13.7 85.6 15.7 98.1 17.7 110.6 19.7 123.1
5.8 36.3 7.8 48.8 9.8 61.3 11.8 73.8 13.8 86.3 15.8 98.8 17.8 111.3 19.8 123.8 10
5.9 36.9 7.9 49.4 9.9 61.9 11.9 74.4 13.9 86.9 15.9 99.4 17.9 111.9 19.9 124.4
6.0 37.5 8.0 50.0 10.0 62.5 12.0 75.0 14.0 87.5 16.0 100.0 18.0 112.5 20.0 125.0
6.1 38.1 8.1 50.6 10.1 63.1 12.1 75.6 14.1 88.1 16.1 100.6 18.1 113.1 20.1 125.6
6.2 38.8 8.2 51.3 10.2 63.8 12.2 76.3 14.2 88.8 16.2 101.3 18.2 113.8 20.2 126.3
6.3 39.4 8.3 51.9 10.3 64.4 12.3 76.9 14.3 89.4 16.3 101.9 18.3 114.4 20.3 126.9
6.4 40.0 8.4 52.5 10.4 65.0 12.4 77.5 14.4 90.0 16.4 102.5 18.4 115.0 20.4 127.5
6.5 40.6 8.5 53.1 10.5 65.6 12.5 78.1 14.5 90.6 16.5 103.1 18.5 115.6 20.5 128.1
6.6 41.3 8.6 53.8 10.6 66.3 12.6 78.8 14.6 91.3 16.6 103.8 18.6 116.3 20.6 128.8
6.7 41.9 8.7 54.4 10.7 66.9 12.7 79.4 14.7 91.9 16.7 104.4 18.7 116.9 20.7 129.4
6.8 42.5 8.8 55.0 10.8 67.5 12.8 80.0 14.8 92.5 16.8 105.0 18.8 117.5 20.8 130.0
6.9 43.1 8.9 55.6 10.9 68.1 12.9 80.6 14.9 93.1 16.9 105.6 18.9 118.1 20.9 130.6

Operator's Manual MEK-6400 10.5


10. REFERENCE

RS-232C Data Transfer

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
Use only the specified power cord for the PC.
In order to avoid any safety hazard, only connect personal
computers which are approved by IEC 60950.
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.

For details about the RS-232C data transfer and format, refer to the Technical
Reference Manual of Data Communication Protocol. To obtain this manual,
you must sign the license agreement.

Special Key Operations for Servicing

The following key operations are only for service personnel.

Keys Operation
Reset + power key ON The power turns on without priming operation.
Reset + power key OFF The power turns off without cleaning operation.
Reset + count Circuit check starts and displays the HGB voltage value.
Reset + clean Priming of the measurement unit starts.
Reset + eject Displays the TOUCH SCREEN CALIBRATION screen.
Feed + power key ON Test printing
Auto print + print Prints the displayed data on the printer.

10.6 Operators Manual MEK-6400


10. REFERENCE

Bar Codes for Using Hand-held Bar Code Reader

Using Bar Codes

NB
A bar code consists of narrow bars (NB), wide bars (WB), narrow spaces (NS)
WB 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
WS equivalent), the bar code label of the sample can be read by the bar code reader
NS 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. 9
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 10
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 margin

start character data check digit stop character

Operator's Manual MEK-6400 10.7


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.10.10 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.10.10) in the setup mode will reset
the bar code reader to the factory settings.

6. Reading Cancel setting bar code (on p.10.10) 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.10.10) from top to bottom. Beepers
sounds five times.
2. Read the OFF of ITF on p.10.10.
3. Read the Complete setting bar code .
4. Turn off the bar code reader to complete the settings.

10.8 Operators Manual MEK-6400


10. REFERENCE

Bar Code Setup Menu


Start Setting and Complete Setting Codes

2 Initialize

Complete setting
3
Cancel
Start setting

Settings for bar codes


Bar code type setting

10

Operator's Manual MEK-6400 10.9


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.10.20). (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.

10.10 Operators Manual MEK-6400


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-6400 10.11


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.

10.12 Operators Manual MEK-6400


10. REFERENCE

Function setting
Selection of trigger switch operation mode

10
Beeper and LED setting

Operator's Manual MEK-6400 10.13


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.10.20).
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.

10.14 Operators Manual MEK-6400


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.10.20).
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.10.20).
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-6400 10.15


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

Identification Identification Identification


Bar code type
code A code B code C
JAN/EAN-13 F 4 E
JAN/EAN-8 FF 4 E
UPC-A A 4 E
UPC-E E 4 E
CODABAR N 3 F
CODE39 M 0 A
ITF I 1 I
Industrial 2 of 5, IATA H 2 S
CODE93 L 8 G
CODE128 K 5 C

10.16 Operators Manual MEK-6400


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.10.20).
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-6400 10.17


10. REFERENCE

Setting for RS-232C


Baud rates

Data length

Stop bit

Communication protocol

10.18 Operators Manual MEK-6400


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-6400 10.19


10. REFERENCE

Interference Substances

WBC: 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 37C in a water bath for 30 minutes and measure
the sample immediately.
RBC: Leukemia
An increase in WBC in leukemia patient causes increase in RBC.
Agglutinated RBC
Agglutinated RBC may decrease RBC count. This can be checked by abnormal MCH and MCHC values and
examination of the stained blood film.
Cold agglutinins
IgM immunoglobulins which are elevated in clod agglutinin disease may decrease RBC and PLT counts and
increase MCV.
Hemolysis
When RBC is hemolyzed, RBC is decreased.
HGB: 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.

10.20 Operators Manual MEK-6400


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. 9
RDW: RDW is determined from RBC value. Therefore, the limitations for RBC also affect RDW value.
Agglutinated RBC 10
Agglutinated RBC may decrease RBC count and erroneous RDW. This can be checked by abnormal MCH and
MCHC values and examination of the stained blood film.
Nutritional deficiency or blood transfusion
Iron and/or cobalamin and/or folate deficiency may increase RDW.
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-6400 10.21


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.

10.22 Operators Manual MEK-6400


10. REFERENCE

Data and Symbol Display

The following table shows the relationship between the data classification and
display.

Classification Data Display Symbol Display Description


Data cannot be
None None Data cannot be analyzed.
analyzed
Abbreviated alarm
Measurement
message (see the None Error found during measurement.
alarm
table below)
Measurement error due to surrounding temperature out
Measurement ? beside numeric
Data displayed of specified range. Measured data is displayed but
alarm data
measurement accuracy is not reliable.
Out of OVER message
None Out of measuring range.
measuring range displayed
Abnormal flag detected in the sample. Measurement
accuracy is not reliable due to abnormal cell. 9
When WBC flag appears, all WBC parameters are
affected by the abnormal cell. * is displayed 10
Data with low *, ! or C
Data displayed beside the parameter which is greatly affected.
reliability beside numeric data
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 H or L beside
Data displayed Out of normal range setting.
range numeric data

Abbreviated alarm messages


Abbreviation
Displayed beside Displayed beside Code No. Alarm message
WBC data RBC data
LEVEL1 A021 WBC fluid level 1
LEVEL2 A022 WBC fluid level 2
LEVEL3 A023 WBC fluid level 3
BBL1 A024 WBC bubble 1
BBL2 A025 WBC bubble 2
BBL3 A026 WBC bubble 3
BBL4 A027 WBC bubble 4
CLOG A029 WBC clogged
NOISE2 A031 WBC hardware noise
NOISE1 A032 WBC software noise
LEVEL1 A041 RBC fluid level 1
LEVEL2 A042 RBC fluid level 2
LEVEL3 A043 RBC fluid level 3
BBL1 A044 RBC bubble 1
BBL2 A045 RBC bubble 2
BBL3 A046 RBC bubble 3
BBL4 A047 RBC bubble 4
CLOG A049 RBC clogged
NOISE2 A051 RBC hardware noise
NOISE1 A052 RBC software noise

Operator's Manual MEK-6400 10.23


10. REFERENCE

The following table shows the relationship between the flags and symbols.

Parameters
Flag Flag Class. LY% MO% GR%
WBC RBC HGB HCT MCHC PLT
LY# MO# GR#
PLT-RBC Interference * *
RBC/PLT
PLT Clumps C C
WBC OVER Other *
Abnormal MCHC !
Specimen
Poor hemolyzation !

The following table shows the relationship between the alarm messages and
symbols.

Parameters
Alarm message Code No. LY% MO% GR%
WBC RBC HGB HCT MCHC PLT
LY# MO# GR#
WBC SAMPLE ERROR A030 ?
RBC SAMPLE ERROR A050 ? ?
HGB VOLTAGE LOW A061 ?
HGB VOLTAGE HIGH A062 !
HGB CIRCUIT ERROR A063 *

10.24 Operators Manual MEK-6400


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.
Reproducibility to Specimen from
Measured Parameters Measuring Range Venous Blood
(CV: Coefficient of Variation)
WBC: White blood cell count 0 to 59 103/L* within 2.0%CV (4.0 to 9.0 103/L)
within 5.0%CV (WBC: 4.0 to 9.0 103/L,
LY%: Lymphocyte percent 0 to 99.9%
LY%: 20 to 45%)
within 12.0%CV (WBC: 4.0 to 9.0 103/L,
MO%: Monocyte percent 0 to 99.9%
MO%: 2 to 10%)
within 5.0%CV (WBC: 4.0 to 9.0 103/L,
GR%: Granulocyte percent 0 to 99.9%
GR%: 40 to 70%)
LY: Lymphocyte count 0 to 59 103/L*
9
MO: Monocyte count 0 to 59 103/L*
GR: Granulocyte count 0 to 59 103/L*
10
RBC: Red blood cell count 0 to 14.9 106/L within 1.5%CV (5.0 106/L)
HGB: Hemoglobin concentration 0 to 29.9 g/dL within 1.5%CV (16 g/dL)
HCT: Hematocrit 0 to 99.9%
MCV: Mean cell volume 20 to 199 fL within 1.0%CV (70 to 120 fL)
MCH: Mean cell hemoglobin 10 to 50 pg
MCHC: Mean cell hemoglobin concentration 10 to 50 g/dL
RDW: Red blood cell distribution width 0 to 50%
PLT: Platelet count 0 to 1490 103/L within 4.0%CV (3.0 103/L)
PCT: Platelet crit 0 to 2.9%
MPV: Mean platelet volume 0 to 20.0 fL
PDW: Platelet distribution width 0 to 50%
* In panic value recount: 0 to 599 103/L

Standardization Analysis Method


WBC: ICSH1988 ICSH: The assignment of values to fresh blood used for calibrating automated blood
cell counters. Clin Lab Haematol, 10:203-212, 1988
RBC: ICSH1988 ICSH: The assignment of values to fresh blood used for calibrating automated blood
cell counters. Clin Lab Haematol, 10:203-212, 1988
HGB: NCCLS H15-A2 H15-A2: Reference and Selected Procedures for the Quantitative Determination of
Hemoglobin in Blood Second Edition; Approved Standard (1994)
HCT: NCCLS H7-A2 H7-A2: Procedure for Determining Packed Cell Volume by the Microhematocrit
Method Second Edition; Approved Standard (1993)
PLT: Brecher & Cronkite Method: Morphology and enumeration of human blood platelets, J Appl Physiol 3 365 (Dec)
1950; Brecher G, Cronkite EP

Operator's Manual MEK-6400 10.25


10. REFERENCE

Detection Method
Blood cell count: Electrical resistance detection
Hemoglobin: Surfactant method (colorimetric method)
Hematocrit: Histogram calculation
WBC population: Histogram calculation
Platelet crit: Histogram calculation
RBC distribution width: Histogram calculation
Platelet distribution width: Histogram calculation

Dilution Ratio
Venous blood
Sample volume: 30 L in normal dilution mode, about 50 L in low dilution mode, 10 L in high dilution mode,
5 L in higher dilution mode
WBC/HGB: 200:1 (in normal dilution mode)
RBC/PLT: 40,000:1 (in normal dilution mode)
Pre-dilution blood
Sample volume: 10 L 20 L
WBC/HGB: 1200:1 600:1
RBC/PLT: 240,000:1 120,000:1

Counting Time
Closed mode: about 90 s/sample (from measurement start to data display)
Open mode: about 60 s/sample (from measurement start to data display)

Display
Display: 5.7 inch, color LCD with backlight and touch screen keys
Resolution: 240 320 dots
Screen size: approx. 86 115 mm
Display contents: Numerical data, histograms, measuring conditions, alarm message and other messages, touch screen
keys

Data Storage
Numerical data for all counted parameters for up to 400 samples and histograms for up to 50 samples

Environmental Conditions
Storage temperature: 20 to 60C
Operating temperature: 15 to 30C
Storage humidity: 10 to 95%
Operating humidity: 30 to 85% (Non-condensing)
Storage atmospheric pressure: 70 to 106 kPa
Operating atmospheric pressure: 70 to 106 kPa
Operating altitude: less than 3000 m

Power Requirements
Power requirements: MEK-6400J: 110 to 127 V 10% AC, 50/60 Hz
MEK-6400K: 220 to 240 V 10% AC, 50/60 Hz
Power consumption: less than 120 VA

10.26 Operators Manual MEK-6400


10. REFERENCE

Dimensions and Weight


Dimensions: 230 W 450 D 383 H (mm)
Net weight: approx. 18 kg

Electromagnetic Compatibility
IEC 61326-1 Edition 1.0: 2002 (Annex A)
EN 61326: 1997/ Amendment 3: 2003

CISPR11 Edition 4.1: 2004, Group 1, Class B


EN 55011: 1998 Amendment 1: 1999, Group 1, Class B

The power supply short interruption test is performed through the transformer which has at least three times the power
capacity as the instrument.

Safety
Safety standards: IEC 61010-1 Edition 2.0: 2001 9
EN 61010-1: 2001
IEC 61010-2-101: 2002 10
EN 61010-2-101: 2002
IEC 61010-2-081: 2002
EN 61010-2-081: 2002

According to the type of protection against electrical shock: CLASS I EQUIPMENT


According to the degree of protection against harmful ingress of water: IPX0 (Ordinary EQUIPMENT)
According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR, OR WITH OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of FLAMMABLE
ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR
NITROUS OXIDE
According to the mode of operation: CONTINUOUS OPERATION
EQUIPMENT types (classification): Indoor stationary EQUIPMENT
Pollution Degree: 2 EQUIPMENT

Requirements for marking of IN VITRO DIAGNOSTIC instruments: EN1658: 1996

Operator's Manual MEK-6400 10.27


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 and options, specify the
supply code no. When the supply code no. is not provided with the
accessory, specify the code no.

1 2 3 4

5 6 7

8 9 10 11

12 13 14 15

16 17 18

10.28 Operators Manual MEK-6400


10. REFERENCE

No. Description Qty Code no. Supply code no.


1 Power cord 1
2 Ground lead 1
9
Fuse 2.0 A time-lag (for MEK-6400J) 2 338867
3 10
Fuse 1.0 A time-lag (for MEK-6400K) 2 274026
4 Filter assy set (2 pcs/set) 1 6144-001907D T802
5 Pump tube (N) assy 1 YS-001B1 T462
6 Sampling nozzle 1
Diluent tube, 1.5 m (marked blue) 1
7 2114-064875C T409*1
Detergent tube for CLEANAC, 1.5 m (marked green) each
Waste tube, 0.4 m (marked red)
8 1 2114-082383B T464A*2
Cleanac tube 8 for CLEANAC3, 0.4 m (marked white)
9 18 L container cap 2 6114-000047C T723A
10 18 L tube assy 1 YS-002B5 T461
11 Waste tube assy 1 6144-001979B
12 Cleanac tube assy 1 0214-011645
13 2 L container 2
14 Hemolynac3 cap 1 2114-081963A T447A
15 Hemolynac3 tube assy (marked yellow) 1 YK-00004 T473
16 MEK cap 2 2114-074258 T469
17 Tube assy (6100) 1 2144-012812C T470A
18 18 L container cock 1 299053A T723

* 1 When this tube is ordered for replacement, the tube length is 1.4 m.
* 2 When this tube is ordered for replacement, the tube length is 1.5 m

Operator's Manual MEK-6400 10.29


10. REFERENCE

Options

NOTE
Use only Nihon Kohden specified parts and accessories to assure
maximum performance from your instrument.
When ordering the following accessories and options, specify the
supply code no. When the supply code no. is not provided with the
accessory, specify the code no.

WA-640VK 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)


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
POWER
as follows.
RELEASE

PAPER OUT

FORWARD

REVERSE

RELEASE
DIP SW 1 Settings DIP SW 1 Settings
1 OFF 5 ON
2 OFF 6 ON
3 OFF 7 OFF
4 OFF 8 OFF

WA-461V Card Printer Specifications


Printing method: Shuttle impact dot matrix
Power requirements: +24 V DC
Operating temperature: 5 to 40C
Operating humidity: 30 to 85%
Dimensions: 180 W 190 D 101 H (mm)
Net weight: 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.
10.30 Operators Manual MEK-6400
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.
9
4. Take the card from the card printer when printing is complete.
10
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 hand-
held 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 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-6400 10.31


10. REFERENCE

Consumables

NOTE
When ordering the following options/consumables, specify the
supply code. When the supply code is not provided with the options
or consumables, specify the model or code number.

1 2 3 4 5

6 7 8 9 10
C975

C962

11 12 13 14

15 16 17 20 21

22 23, 24 25 26

27 28 29

10.32 Operators Manual MEK-6400


10. REFERENCE

No. Description Packing unit Supply code no.


1 Sample container set, MEK-435 200 pcs 5 T435
2 Recording paper for WA-640VK, RQW58-2 10 rolls A819B
3 Diluent ISOTONAC3, MEK-640 18 L T436D
Detergent CLEANAC3, MEK-620 T438D
4 5L
Detergent CLEANAC, MEK-520 T438
5 Hemolysing reagent HEMOLYNAC3N, MEK-680 500 mL 3 T498
Hematology control
MEK-3DN 2 mL 3 T455 9
6
MEK-3DL 2 mL 3 T455L
MEK-3DH 2 mL 3 T455H 10
7 Hemoglobin filter assy set, YZ-0024 10 pcs T802
8 Pump tube (N) assy, YS-001B1 1 pcs T462
9 Hematology data card for WA-460V/461V card printer 100 cards 4 copies C976
Hematology data sheet for WA-710V/712V printer, narrow type 1000 sheets C975
10
Hematology data sheet for WA-710V/712V printer, wide type 2000 sheets C962
11 Hemolynac3 tube assy 1 T473
12 Hemolynac3 cap 1 T447A
13 Cleanac tube 8 (1.5 m) 1 T464A
14 Connection tube (5.0 m), 2114-080786D 1 T463
15 18 L diluent container cock 1 T723
16 Tube assy (6100) 2 T470A
17 MEK cap 1 T469
18 Reagent bottle set, YZ-0066 1 T466A
19 Cleaning bottle kit, YZ-0252 1 T414
20 Sampling nozzle, 6144-901144C, YZ-0341 2
21 Cap pierece nozzle, 6144-902223C, YZ-0342 1
22 Sample cup (5.0 mL), TA-8 500 pcs T857
23 Micro pippettes, DRUMMOND (20 L) 100 pcs T812
24 Micro pippettes, DRUMMOND (10 L) 100 pcs T813
25 Sahli pipette, (0.02 mL), 2430302 1 T421
26 Cotton swabs 100 pcs
27 Vacuum sample tube 100 pcs T440B
28 VENOJECT needle, 22G MN-2238M (Terumo) 100 pcs
29 VENOJECT holder, XX-VP010HR (Terumo) 20 pcs

Operator's Manual MEK-6400 10.33

Vous aimerez peut-être aussi