Celltac A MEK-6500, MEK-6500J, MEK-6500K Operator's Manual

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Automated

Hematology Analyzer

MEK-6500

0614-906126

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First Edition: 22 Oct 2012

OPERATOR’S MANUAL

Automated Hematology Analyzer MEK-6500

MEK-6500J MEK-6500K

0614-906126

If you have any comments or suggestions on this manual, please contact us at:

www.nihonkohden.com

Automated

Hematology Analyzer

MEK-6500

MEK-6500J MEK-6500K

In order to use this product safely and fully understand all its functions, make sure to read this manual before using the product.

Keep this manual near the instrument or in the reach of the operator and refer to it whenever the operation is unclear.

The contents of this manual are subject to change without notice.

The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Nihon Kohden.

Trademark

The mark printed on the SD card that is used in this instrument is a trademark. The company name and model name are trademarks and registered trademarks of each company.

Operator’s Manual MEK-6500 C.1

Contents

GENERAL HANDLING PRECAUTIONS ............................................................................. i

WARRANTY POLICY ......................................................................................................... ii

RESPONSIBILITIES – PROFESSIONAL USERS .............................................................. ii

EMC RELATED CAUTION ..................................................................................................iii

Conventions Used in this Manual and Instrument ............................................................. iv

Warnings, Cautions and Notes ................................................................................ iv

Explanations of the Symbols in this Manual and Instrument .................................... v

Text Conventions in this Manual .............................................................................. vi

Section 1 General ...................................................................................1.1

Introduction ...................................................................................................................... 1.2

Measured Parameters ........................................................................................... 1.2

Features ........................................................................................................................... 1.3

Panel Description ............................................................................................................. 1.5

Front Panel ............................................................................................................1.5

Right Side Panel ....................................................................................................1.6

Rear Panel ............................................................................................................. 1.7

Caution Labels on the Analyzer .......................................................................................1.8

Flowchart of Screens ....................................................................................................... 1.9

Basic Operations ...........................................................................................................1.11

Screen Information .............................................................................................. 1.11

Shortcut Function ................................................................................................1.11

Using Touch Screen Keys .................................................................................... 1.12

General Safety Information ............................................................................................1.13

General ................................................................................................................1.13

Installation ...........................................................................................................1.13

Measurement ....................................................................................................... 1.14

Reagents and Consumable ................................................................................. 1.14

Maintenance ........................................................................................................ 1.15

Disposal ...............................................................................................................1.15

Section 2 Preparation ............................................................................ 2.1

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

Initial Preparation .............................................................................................................2.3

Inventory ................................................................................................................2.3

Standard Accessories ............................................................................................ 2.3

Unpacking .............................................................................................................. 2.4

Installation Flowchart ....................................................................................................... 2.5

Connecting an External Instrument to the Analyzer ........................................................2.6

Connecting a PC ...................................................................................................2.7

Connecting a Printer ..............................................................................................2.8

Connecting a Card Printer ..................................................................................... 2.8

Connecting a Hand-held Bar Code Reader ...........................................................2.9

Connecting the Power Cord and Grounding the Analyzer .............................................2.10

C.2 Operator’s Manual MEK-6500

CONTENTS

Connecting the Power Cord .................................................................................2.10

Equipotential Grounding ...................................................................................... 2.10

Connecting Tubes and Installing Reagents .................................................................... 2.11

Materials Required ..............................................................................................2.11

Connecting Tubes ................................................................................................ 2.13

Diluent Tube ............................................................................................... 2.14

Detergent Tube .......................................................................................... 2.14

Lysing Reagent Tube .................................................................................2.15

Waste Fluid Tube .......................................................................................2.15

Loading Recording Paper in the WA-650VK Printer Unit (Option) .................................2.16

Preparing an SD Memory Card .....................................................................................2.17

Safety Information ................................................................................................2.17

Handling and Storage ................................................................................ 2.17

Data Processing ........................................................................................ 2.17

Inserting and Removing the SD Memory Card .................................................... 2.18

Turning Power On/Off ....................................................................................................2.19

Check Before Turning Power On .......................................................................... 2.19

Turning On the Power ..........................................................................................2.19

Checking the Date and Time Settings ................................................................. 2.20

Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL) .......2.21

Check After Turning On the Power .......................................................................2.22

Daily Shutdown .................................................................................................... 2.23

Checking List Before Turning the Power Off .............................................. 2.23

Turning the Power Off ................................................................................ 2.23

Check List After Turning Power Off ............................................................ 2.24

Check List Before Long Term Storage ....................................................... 2.24

Checking Daily Accuracy ............................................................................................... 2.25

Measuring Background Noise..............................................................................2.25

Measuring Background Noise in Closed Mode .........................................2.25

Measuring Background Noise in Open Mode ............................................ 2.28

Results ......................................................................................................2.30

Measuring Hematology Control ........................................................................... 2.31

Section 3 Changing Settings ................................................................3.1

General ............................................................................................................................ 3.3

Assigning Users and Passwords ...................................................................................... 3.4

General ..................................................................................................................3.4

Displaying the USERS Screen .............................................................................. 3.5

Adding a User ........................................................................................................3.6

Changing a User .................................................................................................... 3.9

Deleting a User ....................................................................................................3.10

Assigning an ID to a Sample .........................................................................................3.11

Displaying the ID Screen ..................................................................................... 3.12

Entering a 4 Digit Numeric ID .............................................................................. 3.12

Entering a 13 Character Alphanumeric ID ........................................................... 3.13

Using Bar Codes .................................................................................................3.14

Labeling and Selecting Sample Types ........................................................................... 3.15

Labeling Sample Types ........................................................................................ 3.15

Operator’s Manual MEK-6500 C.3

CONTENTS

Selecting Sample Types for the Sample Type Selection List ...............................3.17

Setting Normal Range Upper and Lower Limits ............................................................3.18

Default Settings of Upper and Lower Limits ........................................................ 3.18

Changing the Limits .............................................................................................3.18

Changing Sensitivity and Threshold .............................................................................. 3.21

General ................................................................................................................3.21

Factory Default Settings and Setting Range ............................................. 3.21

RBC Automatic Threshold .........................................................................3.21

Changing Sensitivity and Threshold .................................................................... 3.21

Displaying the Sensitivity and Threshold Setting History .....................................3.23

Determining Optimum Sensitivity ........................................................................3.24

Determining Optimum Threshold ......................................................................... 3.24

Changing Measurement Settings ..................................................................................3.25

Setting Date and Time ................................................................................................... 3.28

Changing Display Format .............................................................................................. 3.30

Changing Output Format ............................................................................................... 3.35

Changing Print Format for Internal Printer ........................................................... 3.37

Changing Print Format for External Printer .........................................................3.39

Changing Settings for Card Printer ...................................................................... 3.44

Changing Format for PC ...................................................................................... 3.46

Changing the USB Settings .................................................................................3.48

Changing the SD Memory Card Settings ............................................................3.49

Formatting the SD Memory Card ..............................................................3.50

Selecting Language ....................................................................................................... 3.51

Selecting Units ...............................................................................................................3.52

Selecting Unit Type .............................................................................................. 3.52

Counting Unit Table ...................................................................................3.53

Customizing Units ................................................................................................ 3.53

Changing Sound and Screen Brightness Settings ......................................................... 3.54

Changing Various Settings for Analyzer Power On ........................................................ 3.55

Setting Auto Priming/Cleaning .......................................................................................3.57

Using Reagent Management ......................................................................................... 3.59

Setting the Warning Level ....................................................................................3.59

When the Reagent Management Warning is Displayed ......................................3.61

Initializing Settings ......................................................................................................... 3.64

Factory Default Settings ...................................................................................... 3.66

Section 4 Measurement ......................................................................... 4.1

General ............................................................................................................................ 4.3

Sampling Mode ...................................................................................................... 4.3

Dilution Mode ......................................................................................................... 4.3

Sample Type .......................................................................................................... 4.4

Single and Double Counting ..................................................................................4.4

ID Numbers ...........................................................................................................4.5

Alarm Display ........................................................................................................4.5

Data Storage .........................................................................................................4.5

Printing and Sending Data ..................................................................................... 4.5

PLT Recount .......................................................................................................... 4.6

C.4 Operator’s Manual MEK-6500

CONTENTS

Recount when Out of Panic Range ....................................................................... 4.6

Counting Special Case Samples ........................................................................... 4.6

Measurement in Closed Mode .........................................................................................4.7

Preparing a Sample ...............................................................................................4.7

Measuring a Sample in Closed Mode .................................................................... 4.8

Measurement in Normal Dilution Mode ....................................................... 4.8

Measurement in Low/High Dilution Mode .................................................. 4.10

Measurement in Open Mode ......................................................................................... 4.13

Measuring a Venous Sample in Normal Dilution Mode .......................................4.13

Preparing a Venous Sample ...................................................................... 4.13

Measuring a Venous Sample ..................................................................... 4.14

Measuring a Pre-Dilution Sample ........................................................................ 4.16

Preparing a Pre-Dilution Sample ............................................................... 4.16

Measuring a Pre-Dilution Sample .............................................................. 4.17

Measuring a Venous Sample in Low/High Dilution Mode ....................................4.19

Performing Auto Recount ...............................................................................................4.21

Recount on Alarm ................................................................................................4.21

Recount on PLT Count ........................................................................................4.21

Recounting the Sample when Out of Panic Range ........................................................4.22

Description of the RESULTS Screen .............................................................................4.24

Numeric Data ....................................................................................................... 4.25

Measuring Units ........................................................................................4.25

Displaying H and L Out of Range Marks ................................................... 4.25

Over Message ........................................................................................... 4.25

Histograms ...........................................................................................................4.26

Vertical Axis Type for the Histogram .......................................................... 4.26

Adjusting Axes Scale ................................................................................. 4.26

RBC (Red Blood Cell) Distribution Histogram ........................................... 4.26

PLT (Platelet) Distribution Histogram .........................................................4.27

WBC (White Blood Cell) Distribution Histogram ........................................ 4.27

Flags ....................................................................................................................4.28

Flag Codes ................................................................................................ 4.29

Flag Names ............................................................................................... 4.30

Alarm Display ......................................................................................................4.31

Printing and Sending Results ........................................................................................4.32

Auto Printing/Sending after Measurement ........................................................... 4.32

Printing by Pressing [Print] Key ........................................................................... 4.32

Sending Data to PC .............................................................................................4.32

Section 5 Handling Data ........................................................................ 5.1

General ............................................................................................................................ 5.2

Displaying Numerical Data and Histograms ....................................................................5.3

Displaying the Latest Measured Data .................................................................... 5.3

Displaying Saved Data ........................................................................................... 5.4

Editing ID and Sample Type of Saved Data ..................................................................... 5.6

Searching for Data ...........................................................................................................5.8

Printing and Sending Data .............................................................................................5.12

Automatic Printing and Sending Data after Measurement ................................... 5.12

Operator’s Manual MEK-6500 C.5

CONTENTS

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

Section 6 Quality Control ...................................................................... 6.1

General ............................................................................................................................ 6.3

When to Run QC ................................................................................................... 6.3

QC Methods ..........................................................................................................6.3

Control Material ..................................................................................................... 6.3

Quality Control Procedures .............................................................................................. 6.4

Guidelines for Running Controls ............................................................................ 6.4

Control Material Guidelines ................................................................................... 6.4

X-R Program ....................................................................................................................6.5

General ..................................................................................................................6.5

Overview of X-R Program and Quality Control Procedure .......................... 6.5

Calculation of X and R ................................................................................ 6.5

Calculation of Upper and Lower Limits of X and R ...................................... 6.6

X-R Graph Example .................................................................................... 6.7

How to Read the X-R Graph ........................................................................6.9

Data Outside the Limits ............................................................................... 6.9

Changing the Quality Control Settings ................................................................6.10

Counting the Hematology Control .......................................................................6.12

Handling X-R Data .............................................................................................. 6.15

Displaying the X-R Data List (HISTORY)................................................... 6.15

Displaying the Detailed X-R Measurement Data ....................................... 6.16

Printing, Sending or Deleting X-R Data ............................................................... 6.18

Printing, Sending or Deleting X-R Data Individually .................................. 6.18

Printing, Sending or Deleting X-R Data Consecutively..............................6.19

Deleting All Stored X-R Data .....................................................................6.20

Displaying CV Values of the Stored X-R Data ...........................................6.21

Handling X-R Graphs...........................................................................................6.22

Changing the X-R Limits ...................................................................................... 6.23

L & J Program (Levey and Jennings) .............................................................................6.25

General ................................................................................................................6.25

Overview of L & J Program and Quality Control Procedure ...................... 6.25

Calculation of Upper and Lower Limits ...................................................... 6.26

How to Read the L & J Graph ....................................................................6.26

Data Outside the Limits ............................................................................. 6.26

Changing the Quality Control Settings ................................................................6.27

Counting the Hematology Control .......................................................................6.27

Handling L & J Data ............................................................................................ 6.30

Displaying the L & J Data List (HISTORY)................................................. 6.30

Displaying the Detailed L & J Measurement Data ..................................... 6.31

C.6 Operator’s Manual MEK-6500

CONTENTS

Printing, Sending or Deleting L & J Data ............................................................. 6.32

Printing, Sending or Deleting L & J Data Individually ................................ 6.32

Printing, Sending or Deleting L & J Data Consecutively............................6.33

Deleting All Stored L & J Data ...................................................................6.35

Displaying CV Values of the Stored L & J Data .........................................6.36

Handling L & J Graphs.........................................................................................6.37

XB (X Batch) Program ................................................................................................... 6.39

General ................................................................................................................6.39

Overview of XB ......................................................................................... 6.39

Calculation of XB ......................................................................................6.39

Handling XB Data ................................................................................................ 6.41

Handling XB Graph .............................................................................................. 6.43

Setting XB Initial Values and Limits .....................................................................6.44

XD•CV Program .............................................................................................................6.46

General ................................................................................................................6.46

Uses of the XD•CV Program .....................................................................6.46

Handling XD•CV Data .......................................................................................... 6.47

Displaying the Total Mean and CV of All Stored Data ..........................................6.48

Section 7 Calibration .............................................................................7.1

General ............................................................................................................................ 7.2

When to Calibrate ..................................................................................................7.2

Note on the Calibration Procedure ........................................................................ 7.3

Calibration in Closed Mode .............................................................................................. 7.5

Calibration in Open Mode and Pre-dilution Mode ............................................................ 7.9

Calibration in Open Mode ......................................................................................7.9

Calibration in Pre-Dilution Blood Mode ................................................................ 7.13

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 ....................................... 7.22

Section 8 Messages and Troubleshooting ...........................................8.1

General ............................................................................................................................ 8.2

Alarm Messages .............................................................................................................. 8.5

Invalid Data Identiﬁer .............................................................................................8.5

Flag Indication ....................................................................................................... 8.6

Alarm Messages with Alarm Codes....................................................................... 8.6

Other Alarm Messages ..........................................................................................8.8

System Error Messages ..................................................................................................8.9

Inaccurate Counting and Other Problems ......................................................................8.10

Section 9 Maintenance ..........................................................................9.1

General ............................................................................................................................ 9.3

Operator’s Manual MEK-6500 C.7

CONTENTS

Disposing of Waste and the Analyzer .................................................................... 9.4

Repair Parts Availability Policy .............................................................................. 9.4

Preventive Maintenance Schedule ................................................................................... 9.5

Maintenance Schedule .......................................................................................... 9.5

Displaying Operation History Screen ..................................................................... 9.6

Maintenance Check Sheet ............................................................................................... 9.9

Inside Panel Components .............................................................................................. 9.11

Before Maintenance Procedure ..................................................................................... 9.12

Strong Cleaning ...................................................................................................9.12

Draining Measurement Baths and Sub Baths......................................................9.13

Turning Power Off ................................................................................................9.14

Daily Maintenance Procedures ......................................................................................9.15

Checking Reagents and Other Consumables ..................................................... 9.15

Checking the Appearance of the Analyzer .......................................................... 9.15

Cleaning the Surface of the Analyzer ........................................................9.16

Disinfecting the Surface of the Analyzer ....................................................9.16

Checking the Reagent Connection Tubes ............................................................ 9.16

Checking the Power Cord and Grounding Lead ..................................................9.16

Checking the External Instrument Connection .................................................... 9.16

Checking the Power On ....................................................................................... 9.17

Calibrating the Touch Screen.....................................................................9.17

Checking the Date and Time ............................................................................... 9.18

Clock Accuracy .......................................................................................... 9.18

Checking Daily Accuracy .....................................................................................9.18

Checking Measurement Baths and Sub Baths ....................................................9.18

Checking Pump Tube ........................................................................................... 9.18

Every 200 Counts Maintenance Procedures ................................................................. 9.19

Performing Strong Cleaning ................................................................................ 9.19

Weekly/Every 300 Counts Maintenance Procedures ..................................................... 9.19

Checking/Cleaning Filters .................................................................................... 9.19

Monthly/Every 1,000 Counts Maintenance Procedures ................................................. 9.20

Replacing Filters ..................................................................................................9.20

Materials Required .................................................................................... 9.20

Procedure ..................................................................................................9.20

Checking and Cleaning Measurement Baths and Sub Baths .............................. 9.22

Materials Required .................................................................................... 9.22

Procedure ..................................................................................................9.22

Checking, Cleaning and Replacing the Rinse Unit and Cap Pierce Nozzle ........ 9.25

Materials Required .................................................................................... 9.25

Procedure ..................................................................................................9.25

Every Four Months/Every 3,000 Counts Maintenance Procedures ............................... 9.28

Checking, Cleaning and Replacing the Sampling Nozzles .................................. 9.28

Materials Required .................................................................................... 9.28

Procedure ..................................................................................................9.28

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

C.8 Operator’s Manual MEK-6500

CONTENTS

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

Section 10 Reference .............................................................................10.1

Operation Theory ...........................................................................................................10.2

Electric Cell Counting .......................................................................................... 10.2

Counting Method ....................................................................................... 10.2

Red Blood Cell and Platelet Counting ....................................................... 10.3

Principle of Hydraulic Operation .......................................................................... 10.3

Hemoglobin Measurement ..................................................................................10.4

Chemical Processing ................................................................................. 10.4

Spectrophotometric Measurement Method ...............................................10.4

Hemoglobin Conversion Table (g/dL ↔ %SAHLI) .......................................................... 10.5

RS-232C Data Transfer .................................................................................................. 10.6

General ................................................................................................................10.6

Connecting PC ....................................................................................................10.6

Socket Pin Assignment ..................................................................................................10.9

ZK-820V Bar Code Reader Socket ......................................................................10.9

Serial Port 1/Serial Port 2 .................................................................................... 10.9

Printer Socket ...................................................................................................... 10.9

USB Socket ....................................................................................................... 10.10

Bar Codes for Using Hand-held Bar Code Reader ...................................................... 10.11

Using Bar Codes ...............................................................................................10.11

Changing the Settings ....................................................................................... 10.12

Bar Code Setup Menu ....................................................................................... 10.13

Interference Substances ..............................................................................................10.24

Data and Symbol Display .............................................................................................10.27

Speciﬁcations ............................................................................................................... 10.29

Measured Parameters, Ranges and Reproducibility to Specimen from

Venous Blood ..................................................................................................... 10.29

Standardization Analysis Method ...................................................................... 10.29

Counting Time ................................................................................................... 10.30

Operator’s Manual MEK-6500 C.9

CONTENTS

Dilution Ratio ..................................................................................................... 10.30

Safety .................................................................................................................10.30

Electromagnetic Compatibility ........................................................................... 10.30

Environmental Conditions .................................................................................. 10.31

Power Requirements .........................................................................................10.31

Dimensions and Weight ..................................................................................... 10.31

Standard Accessories ..................................................................................................10.32

Options ........................................................................................................................10.34

Consumables ...............................................................................................................10.36

Operator’s Manual MEK-6500 i

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 oor. 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

specications, and have sufcient current capacity. (5) Choose a room where a proper grounding facility is available.

3. Before Operation

(1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is combined with other instruments to avoid misdiagnosis or other

problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models.

4. During Operation

(1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient.

5. To Shutdown After Use

(1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use.

6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is

not functioning properly, it should be clearly marked to avoid operation while it is out of order.

7. The instrument must not be altered or modied 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.

ii Operator’s Manual MEK-6500

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 debrillator, make sure that the instrument is protected against debrillator

discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.

WARRANTY POLICY

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

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

No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modication 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 modied, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, re, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identication marks have been removed.

In the USA and Canada other warranty policies may apply.

RESPONSIBILITIES – PROFESSIONAL USERS

This instrument must be used by a professional user with a full knowledge of operating this instrument, only for his/her intended use and according to the instructions for use. Instructions in the operator’s manual must be followed, especially the following points.

• Storage and stability of reagents

• Handling of reagents

• Instrument installation

• Connection of all tubes to inlets and outlets

• Connection of all tubes to reagents and waste container

• Checking the amount of reagents and waste uid

• 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.

Operator’s Manual MEK-6500 iii

EMC RELATED CAUTION

This equipment and/or system complies with the International Standard EN 61326-1 for electromagnetic

compatibility for electrical equipment and/or system for measurement, control and laboratory use. However,

an electromagnetic environment that exceeds the limits or levels stipulated in the EN 61326-1, can cause

harmful interference to the equipment and/or system or cause the equipment and/or system to fail to

perform its intended function or degrade its intended performance. Therefore, during the operation of the

equipment and/or system, if there is any undesired deviation from its intended operational performance,

you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the

equipment and/or system.

The following describes some common interference sources and remedial actions:

1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station

or cellular phone:

Install the equipment and/or system at another location if it is interfered with by an emitter source

such as an authorized radio station. Keep the emitter source such as cellular phone away from the

equipment and/or system.

2. Radio-frequency interference from other equipment through the AC power supply of the equipment

and/or system:

Identify the cause of this interference and if possible remove this interference source. If this is not

possible, use a different power supply.

3. Effect of direct or indirect electrostatic discharge:

Make sure all users and patients in contact with the equipment and/or system are free from direct or

indirect electrostatic energy before using it. A humid room can help lessen this problem.

4. Electromagnetic interference with any radio wave receiver such as radio or television:

If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or

system as far as possible from the radio wave receiver.

If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden

representative for additional suggestions.

This equipment complies with International Standard EN 55011: 1999 Group 1, Class B. Class B

EQUIPMENT is equipment suitable for use in domestic establishments and in establishments directly

connected to a low voltage power supply network which supplies buildings used for domestic purposes.

The CE mark is a protected conformity mark of the European Community. Products with the CE mark

comply with the requirements of In vitro Diagnostic Medical Device Directive 98/79/EC.

NOTE about Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC

For the member states of the European Union only:

The purpose of WEEE directive 2002/96/EC is, as a ﬁrst priority, the prevention of waste electrical and

electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such

wastes so as to reduce the disposal of waste.

Contact your Nihon Kohden representative for disposal.

iv Operator’s Manual MEK-6500

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 specic information.

WARNING

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

CAUTION

A caution alerts the user to possible injury or problems with the instrument associated with its use or

misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other

property.

NOTE

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

supplemental information.

Operator’s Manual MEK-6500 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 (Disconnection from the mains)

Attention, consult operator’s manual

AC power on (Connection to the mains)

Inlet

Main power lamp Outlet

“Off” only for part of the equipment Biohazard

“On” only for part of the equipment

ZK-820V

Bar code reader socket

Auto print

Serial port 1

Feed

Serial port 2

Print Printer socket

Reset USB socket

Clean SD card socket (Read data from store)

Eject key (Tube holder open) SD card slot

Count Alternating current

ISOTONAC•3 (diluent) Equipotential terminal

CLEANAC (detergent) Fuse (time lag)

CLEANAC•3 (detergent) Date of manufacture

HEMOLYNAC•3N (hemolysing reagent)

Serial number

WASTE

IVD

IN VITRO DIAGNOSTIC MEDICAL DEVICE

The CE mark is a protected conformity mark of the European Community. Products marked with this symbol comply with the requirements of the In vitro Diagnostic Medical Device Directive 98/79/EC.

Products marked with this symbol comply with the European WEEE directive 2002/96/EC and require separate waste collection. For Nihon Kohden products marked with this symbol, contact your Nihon Kohden representative for disposal.

vi Operator’s Manual MEK-6500

On screen and recorded data

Symbol Description

When displayed beside WBC or RBC measured value: Sample error When displayed beside HGB measured value: HGB low voltage

When displayed beside WBC measured value: Poor hemolyzation When displayed beside HGB measured value: HGB high voltage When displayed beside MCHC measured value: Abnormal RBC When displayed beside PLT measured value: High background noise

When displayed beside HGB measured value: HGB abnormal circuit/WBC measured value is OVER When displayed beside PLT measured value: PLT low value (below 50,000/μL)

When displayed beside WBC or PLT measured value: Platelet coagulation

When displayed beside any measured value: Above than the normal range

When displayed beside any measured value: Below than the normal range

F1, F2, F3, F4

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

Reagent level graph

Text Conventions in this Manual

In this manual, procedural instructions are explained in logical groups, using numbered steps. Illustrations and drawings appear where they are useful to the explanation. Text conventions are as follows:

Screen Name

The screen name is printed in uppercase, regular letters; for example, READY screen.

Touch Screen Keys

The screen has some touch screen keys which are pressure-sensitive. Pressing one of these touch screen keys initiates the action specied 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

Field names

Regular, Mixed-Case, enclosed within carats < >

Hard keys (Panel keys)

Regular, Mixed-Case, enclosed within brackets

[Clean]

Screen message

Regular, Mixed-Case, enclosed within quotation marks

“Priming”

Operator’s Manual MEK-6500 1.1

Introduction ..........................................................................................................................................................1.2

Measured Parameters ...............................................................................................................................1.2

Features ..............................................................................................................................................................1.3

Panel Description ................................................................................................................................................1.5

Front Panel ................................................................................................................................................ 1.5

Right Side Panel ........................................................................................................................................ 1.6

Rear Panel ................................................................................................................................................1.7

Caution Labels on the Analyzer ........................................................................................................................... 1.8

Flowchart of Screens ...........................................................................................................................................1.9

Basic Operations ...............................................................................................................................................1.11

Screen Information .................................................................................................................................. 1.11

Shortcut Function ....................................................................................................................................1.11

Using Touch Screen Keys ........................................................................................................................1.12

General Safety Information ................................................................................................................................ 1.13

General .................................................................................................................................................... 1.13

Installation ...............................................................................................................................................1.13

Measurement ..........................................................................................................................................1.14

Reagents and Consumable .....................................................................................................................1.14

Maintenance ............................................................................................................................................1.15

Disposal ................................................................................................................................................... 1.15

Section 1 General

1.2 Operator’s Manual MEK-6500

1. GENERAL

Introduction

The MEK-6500J/MEK-6500K Automated Hematology Analyzer is designed for simultaneous 19-parameter measurement. It provides quick counting, and all operations are performed automatically. You only need to put the sampling nozzle into a sample container which contains whole blood and press the [ Count] switch. Results and data are displayed on a color LCD screen. 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 on the sampling nozzle, so it is safe and there is no risk of touching the blood. The analyzer has selfcheck, quality control and other programs to provide reliable data management system.

To achieve full performance, thoroughly read this operator’s manual before operating the analyzer.

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

NOTE

Use only Nihon Kohden parts and accessories to assure maximum

performance from your instrument.

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-CV: Coefcient of Variation of the Red Blood Cell Distribution Width RDW-SD: Standard Deviation of the Red Blood Cell Distribution Width PCT: Platelet Crit MPV: Mean Platelet Volume PDW: Platelet Distribution Width

Operator’s Manual MEK-6500 1.3

1. GENERAL

Features

Simultaneous 19 parameter measurement

The analyzer simultaneously measures 19 parameters. WBC is differentiated into 3 parameters, lymphocyte, monocyte and granulocyte. WBC, RBC and PLT are measured by electrical resistance detection method.

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 uid is automatically treated.

Automatic sampling nozzle cleaning

The analyzer automatically cleans the remaining blood on the sampling nozzle. There is no risk of touching blood during measurement.

Automatic clog removal

The analyzer removes blood protein or dust particles from around the aperture caps to prevent clogging after each counting. Even if a clog occurs, the analyzer automatically removes the clog and recounts the sample.

High accuracy and reproducibility

The analyzer reduces counting error by automatically diluting samples and wiping the sampling nozzle. The analyzer provides high accuracy and reproducibility with a low dilution ratio of 200:1 of WBC, 40,000:1 of RBC and 360 µL of the diluted sample. Built-in circuits automatically compensate for cell miscount due to coincidence (simultaneous cell passage) and uid temperature variation. The aperture is shielded from external noise and clogging is prevented.

Color LCD screen with touch screen keys

The analyzer has a color TFT LCD with 240 × 320 pixel resolution which clearly displays the results and various messages. The touch screen allows easy and intuitive operation of the analyzer. The screen messages prompt the operator through the procedure.

Pre-diluted blood counting

Pre-diluted blood (10 or 20 µL) can be measured. The sample needs to be diluted before measurement. 30 µL of the venous blood can also be measured. This sample does not need to be diluted before measurement.

1.4 Operator’s Manual MEK-6500

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 x 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 XD•CV quality control.

Data management

The analyzer can store measurement data of up to 400 samples and histograms of up to 50 samples. Stored measurement data can be called up to be printed, deleted or transferred to an external devices.

Automatic priming and cleaning

The analyzer automatically primes the uid path when the power is turned on. The analyzer automatically cleans the uid path when the power is turned off.

Access restriction with password

Measurement conditions, such as calibration coefcient, 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.

Operator’s Manual MEK-6500 1.5

1. GENERAL

Panel Description

Front Panel

141312

8 9 10

No. Name Description

1 LCD display Displays various messages, measured data and touch screen keys. 2 Eject key For closed mode only. Opens the tube holder to set the sample tube.

3 Tube holder

For closed mode only. Holds a sealed vacuum blood collecting tube. Press the [Eject] key to open. After measurement, the holder automatically opens.

4 Sampling nozzle

For open mode only. Aspirates the sample. Dispenses the diluent when in the pre-dilution

blood mode. 5 Count switch For open mode only. Aspirates the sample and starts counting. 6 Main power lamp Lights when the [Main power] switch on the rear panel is tuned on.

7 Power lamp

Lights when the [Main power] switch on the rear panel and the [Power] key on the front

panel are turned on.

8 Power key

Turns the analyzer power on or off when the [Main power] switch on the rear panel is turned

on. When the power is turned on, priming and self-check are automatically performed, and

the READY screen appears.

9 Reset key

Stops operation when pressed during operation. Returns to the READY screen when pressed

while changing settings. Use this key only when an error occurs.

10 Clean key

Cleans the uid path, aperture and manometer with detergent. Automatically primes after

cleaning the uid path. Press this key when clogging occurs, the manometer becomes dirty

or bubbles occur in the manometer.

11 Auto print mode lamp Lights when automatic printing mode is selected. 12 Auto print key Switches the printing mode between automatic and manual for the printer. 13 Feed key Feeds paper of the printer while held down. 14 Print key Prints displayed data on the printer.

Printer unit (WA-650VK)

Thermal array printer. Prints out measured data and sample ID number (optional).

1.6 Operator’s Manual MEK-6500

1. GENERAL

Right Side Panel

1 2 3 4 5

No. Name Description

ISO3 Diluent inlet

Inlet for ISOTONAC•3 diluent

CLN Detergent inlet

Inlet for CLEANAC detergent

CLN3 Deteregent inlet

Inlet for CLEANAC•3 detergent

HEMO3N Lysing reagent inlet

Inlet for Hemolynac•3N lysing reagent

WASTE Waste outlet

Outlet for waste such as used lyse, detergent and aspirated samples

Operator’s Manual MEK-6500 1.7

1. GENERAL

Rear Panel

CAUTION

Connect only the speciﬁed instrument to the analyzer and follow the

speciﬁed procedure. Failure to follow this instruction may result in

electrical shock or injury to the operator, and cause ﬁre or instrument

malfunction.

No. Name Description

ZK-820V Bar code reader socket

Connects to the optional hand-held bar code reader. Supplies the power to the bar code reader when connected. Power supply voltage: 5 V DC (pin 9: 5 V, pin 5: GND)

Rated current: 200 mA 2 Serial port 1 Connects to the optional WA-460V/461V card printer or PC. 3 Serial port 2 Connects to the optional WA-460V/461V card printer or PC. 4 Printer socket Connects to an external printer (WA-710V/712V or other).

5 USB socket

Connects to a PC. The optional Data Management Software (DMS) needs to

be installed on the PC to receive data from the analyzer. For details on the

DMS, contact your Nihon Kohden representative. 6 SD memory card slot Insert an SD memory card.

Equipotential ground terminal

Connects the ground lead to the equipotential ground terminal on the wall for

earth grounding.

8 Main power switch

Supplies the power to the analyzer when it is turned on. Under normal

conditions keep this switch turned on.

9 Fuse holder

Contains the time lag fuse. To replace the fuse, contact your Nihon Kohden

representative.

AC SOURCE AC source socket

Connects the AC power cord to supply AC power to the analyzer.

1.8 Operator’s Manual MEK-6500

1. GENERAL

Caution Labels on the Analyzer

Refer to “Connecting Tubes” in Section 2.

Refer to “Inside Panel Components” in Section 9.

Refer to “Replacing Filters” in Section 9.

Refer to warnings and cautions in “Connecting the Power Cord and Grounding the Analyzer” in Section 2.

Refer to warnings and cautions in “Connecting an External Instrument to the Analyzer” in Section 2.

Operator’s Manual MEK-6500 1.9

1. GENERAL

Flowchart of Screens

Power ON

CHECKING

Measuring background noise (When “Background measurement at power on” is set to YES on the SETTINGS screen)

READY

Measurement

ID (SET key)

RESULTS

READY (OK key)

RESULTS

ID CALIBRATION

CAL Pre-dil (PREDILUTION)

CAL HISTORY

CAL CLOSED

CAL OPEN

Measurement for calibration

Results

CAL DATA LIST

Same as CAL CLOSED

DATA

EDIT

DETAILS

QC (QUALITY CONTROL)

X-R or L & J (NORMAL)

X-R or L & J (HIGH)

X-R or L & J (LOW)

DELETE X-R or L & J

Results

X-R or L & J Measurement

X-R or L & J (NORMAL) measurement results

HISTORY

DETAILS

GRAPH

Auto set initial and limit values

Set initial and limit values (Only for X-R)

XD CV

QC SETTINGS

GRAPH

Auto set initial and limit values

Set initial and limit values

TOTAL

Same as X-R or L & J (NORMAL)

SEARCH RESULTS

DETAILS

SD DATA

SEND

DELETE

DETAILS

SEARCH RESULTS

DETAILS

EDIT ID

1.10 Operator’s Manual MEK-6500

1. GENERAL

SETTINGS

SENS/THRESHOLD

EDIT

SAMPLE TYPE

NORMAL RANGE

MEASUREMENT

DISPLAY

HISTORY

DATE & TIME

OUTPUT

LANGUAGE

EXTERNAL PRINTER

SERIAL PORT 2

SERIAL PORT 1

USB

UNITS SOUND/LCD

BACKGROUND

OPERATIONS

PRIME ON INSTALL

PRIME

SENSOR MONITOR

INTERNAL PRINTER

OPERATION

AUTO CLEANING

USERS

PASSWORD ADD USER

INITIALIZE

CIRCUIT CHECK

REMOVE CLOG DRAIN BATHS DRAIN ALL

STRONG CLEAN

DAILY OUTPUT MAINTENANCE

OTHER

OPERATION HISTORY

REPLACE DILUENT

REPLACE DETERGENT REPLACE LYSING REAGENT RESET ALL REAGENT

MANAGE REAGENT

SERVICE (This screen is for service personnel when performing maintenance.)

Change level

EPSON VP page length Header

SD CARD

Format

Operator’s Manual MEK-6500 1.11

1. GENERAL

Basic Operations

Screen Information

Screen name

Check box

Page status bar

This example indicates that there are two pages. The displayed page is indicated by light blue.

Status bar

When the type of operator is service, the status bar is orange. When the type of operator is lab technician, the status bar is blue. When the type of operator is other user, the status bar is green. For details, refer to “Assigning Users and Passwords” in Section 3.

Date and time

Shortcut key

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

1.12 Operator’s Manual MEK-6500

1. GENERAL

Using Touch Screen Keys

NOTE

Do not use a sharp object to press the touch screen key. Use your ﬁnger.

Displays the selection list.

Selection list

Use arrow keys to move cursor.

Use the numeric keys to enter a value and press the Enter key to register the setting.

Go to the previous or next page.

Page status bar

Cursor (blue)

Select a setting by pressing a check box.

Press the keys with triangle to display a selection list to select an item.

Press bottom keys to display another screen.

Operator’s Manual MEK-6500 1.13

1. GENERAL

General Safety Information

General

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.

WARNING

Never use the analyzer in a hyperbaric oxygen

chamber. Failure to follow this warning may cause

explosion or ﬁre.

WARNING

Do not diagnose a patient based only on data

acquired by the analyzer. Overall judgement must

be performed by a physician who understands

the features, limitations and characteristics of the

analyzer and by reading the biomedical signals

acquired by other instruments.

WARNING

Do not use the analyzer near an ESU. Noise from

the ESU may cause the analyzer to malfunction.

Installation

WARNING

Install the analyzer outside the patient

environment (IEC 60601-1-1). If it is installed

inside the patient environment, the patient or

operator may receive electrical shock or injury.

For installation, contact your Nihon Kohden

representative.

CAUTION

Only use the provided power cord. Using other

power cords may result in electrical shock or

injury to the operator.

CAUTION

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

Connect only the speciﬁed instrument to the

analyzer and follow the speciﬁed procedure.

Failure to follow this instruction may result in

electrical shock or injury to the operator, and

cause ﬁre or instrument malfunction.

CAUTION

Before connecting or disconnecting instruments,

make sure that each instrument is turned off and

the power cord is disconnected from the AC

socket. Otherwise, the operator may receive

electrical shock or injury.

1.14 Operator’s Manual MEK-6500

1. GENERAL

Measurement

WARNING

Always wear rubber gloves to protect yourself

from infection.

CAUTION

When an alarm occurs, the acquired data might

not be correct, especially when “!” or “sample

error” message appears. Do not use the data for

diagnosis. Recount the sample.

CAUTION

Set the ID correctly. Otherwise, the examination

data may be mixed up with data of another

examination.

Reagents and Consumable

CAUTION

Only use Nihon Kohden speciﬁed reagents and

consumables. Otherwise the measurement result

cannot be guaranteed and incorrect reagent

concentration can cause equipment damaged.

CAUTION

Do not reuse disposable parts and accessories.

Hemolynac•3N CLEANAC

CAUTION

• Do not swallow Hemolynac•3N lysing reagent.

If swallowed, see a physician immediately.

• If lysing reagent contacts the skin, eyes or

mouth, wash thoroughly and immediately with

water and see a physician.

WARNING

Do not swallow CLEANAC detergent. If

swallowed, see a physician immediately.

CLEANAC•3

WARNING

If CLEANAC•3 detergent contacts the eyes, wash

immediately with plenty of water for at least 15

minutes and see a physician. The detergent can

cause blindness.

WARNING

• Do not allow CLEANAC•3 detergent to come

into contact with acid. Contact with acid can

release poisonous chlorine gas.

• Do not inhale the detergent. If inhaled, move

to fresh air, rest in a posture which allows easy

breathing and see a physician.

• Do not swallow the detergent. If swallowed,

rinse the mouth immediately. See a physician.

• If the detergent contacts the skin, wash

thoroughly and immediately with water and see

a physician.

• Wear rubber gloves or goggles to protect

yourself when handling the detergent.

Operator’s Manual MEK-6500 1.15

1. GENERAL

Maintenance

WARNING

• Be careful not to directly touch any place where

blood sample is or may have contacted.

• Always wear rubber gloves to protect yourself

from infection.

WARNING

The sampling nozzle and cap pierce nozzle are

sharp and potentially contaminated with

infectious materials. Be careful when handling the

sampling nozzle and cap pierce nozzle.

CAUTION

Turn off the analyzer main power before

maintenance. Otherwise, the operator may

receive electrical shock and the analyzer may

malfunction.

CAUTION

Do not remove any parts that are not speciﬁed in

this manual.

CAUTION

Before moving the analyzer, turn off the analyzer

main power and remove the AC power cord from

the outlet. Otherwise, the operator may receive

electrical shock.

Disposal

WARNING

• Dispose of the analyzer, replaced parts (such

as sampling nozzle and cap pierce nozzle),

waste ﬂuid and parts used for collecting sample

blood (such as needles, syringes and vials)

by following your local laws for disposing of

infectious medical waste (for incineration, melt

treatment, sterilization and disinfection).

• Before disposing of the analyzer, perform

strong cleaning and remove the sampling

nozzle and cap pierce nozzle from the analyzer.

If the above warning is not followed, it causes

infection or environmental contamination.

WARNING

Always wear rubber gloves to protect yourself

from infection.

CAUTION

If blood sample or reagent contacts the skin, eyes

or mouth, wash thoroughly and immediately with

water and see a physician.

Operator’s Manual MEK-6500 2.1

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

Initial Preparation ................................................................................................................................................. 2.3

Inventory .................................................................................................................................................... 2.3

Standard Accessories ...............................................................................................................................2.3

Unpacking .................................................................................................................................................2.4

Installation Flowchart ...........................................................................................................................................2.5

Connecting an External Instrument to the Analyzer ............................................................................................2.6

Connecting a PC .......................................................................................................................................2.7

Connecting a Printer ................................................................................................................................. 2.8

Connecting a Card Printer .........................................................................................................................2.8

Connecting a Hand-held Bar Code Reader ............................................................................................... 2.9

Connecting the Power Cord and Grounding the Analyzer .................................................................................2.10

Connecting the Power Cord ....................................................................................................................2.10

Equipotential Grounding ..........................................................................................................................2.10

Connecting Tubes and Installing Reagents .......................................................................................................2.11

Materials Required ..................................................................................................................................2.11

Connecting Tubes ....................................................................................................................................2.13

Diluent Tube ..................................................................................................................................2.14

Detergent Tube ..............................................................................................................................2.14

Lysing Reagent Tube ..................................................................................................................... 2.15

Waste Fluid Tube ........................................................................................................................... 2.15

Loading Recording Paper in the WA-650VK Printer Unit (Option) .....................................................................2.16

Preparing an SD Memory Card .........................................................................................................................2.17

Safety Information ...................................................................................................................................2.17

Handling and Storage ...................................................................................................................2.17

Data Processing ............................................................................................................................2.17

Inserting and Removing the SD Memory Card ....................................................................................... 2.18

Turning Power On/Off ........................................................................................................................................ 2.19

Check Before Turning Power On .............................................................................................................2.19

Turning On the Power .............................................................................................................................. 2.19

Checking the Date and Time Settings .....................................................................................................2.20

Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL) ........................................... 2.21

Check After Turning On the Power .......................................................................................................... 2.22

Daily Shutdown .......................................................................................................................................2.23

Checking List Before Turning the Power Off .................................................................................. 2.23

Turning the Power Off ....................................................................................................................2.23

Check List After Turning Power Off ...............................................................................................2.24

Check List Before Long Term Storage........................................................................................... 2.24

Checking Daily Accuracy ...................................................................................................................................2.25

Measuring Background Noise .................................................................................................................2.25

Measuring Background Noise in Closed Mode ............................................................................. 2.25

Measuring Background Noise in Open Mode ...............................................................................2.28

Results ..........................................................................................................................................2.30

Measuring Hematology Control ...............................................................................................................2.31

Section 2 Preparation

2.2 Operator’s Manual MEK-6500

2. PREPARATION

Environmental Requirements

WARNING

Install the analyzer outside the patient environment (IEC 60601-1-1).

If it is installed inside the patient environment, the patient or operator

may receive electrical shock or injury. For installation, contact your

Nihon Kohden representative.

• Operate the analyzer in the following conditions. Keep the temperature of diluent and lysing reagent within the temperature in order to obtain reliable data.

Temperature: 15 to 30°C (59 to 86°F) Humidity: 30 to 85% (noncondensing) Air pressure: 700 to 1060 hPa

• No measurement can be done in dusty areas because the aperture for specimen aspiration is very ne 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 uid on the analyzer. To prevent electrical problems or electric shock, avoid spillage in or around the analyzer because the uid is highly conductive.

• Select a stable, at 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.

• Make sure that there is more than 5 cm of space between the rear panel and the wall and 15 cm of space between the left panel and the wall for adequate ventilation.

• When there is any problem in the analyzer, turn off the main power immediately and disconnect the power cord from the AC outlet. Take the analyzer out of service and check for damage.

5 cm

15 cm

Side

Rear

Top view

Operator’s Manual MEK-6500 2.3

2. PREPARATION

Initial Preparation

Inventory

Conrm that the analyzer shipment contains the following:

• MEK-6500J or MEK-6500K Hematology Analyzer

• Standard accessories

• Reagents

• Controls and Calibrator

• Operator’s Manual

• Printer (optional)

• Hand-held Bar Code Reader (optional)

Standard Accessories

• Power cord

• Ground lead

• Fuse, 2.0 A time-lag amps 110 to 127 V for MEK-6500J or 1.0 A time-lag amps 220 to 240 V for MEK-6500K (2)

• Filter assy (3)

• Pump tube (N) assy

• Sampling nozzle

• Diluent tube, marked blue, 1.5 m

• Waste tube, marked red, 0.4 m

• Detergent tube for CLEANAC, marked green, 1.5 m

• Cleanac tube 8 for CLEANAC•3, marked white, 1.5 m

• 18 L container cap (3)

• 18 L waste tube assy 2

• 5 L tube assy (2)

• 2 L waste container

• Hemolynac•3 cap

• Hemolynac•3 tube assy, marked yellow

• 2 L waste tube assy

• MEK cap

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

2.4 Operator’s Manual MEK-6500

2. PREPARATION

Unpacking

Remove the analyzer from the shipping container and visually inspect for damage. If there is any damage, contact your Nihon Kohden representative.

NOTE

Use two people when lifting or moving the analyzer. Otherwise, you may

injure your back or be injured from dropping the analyzer.

Hold the bottom corners with two people to move the analyzer.

Operator’s Manual MEK-6500 2.5

2. PREPARATION

Installation Flowchart

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.

2.6 Operator’s Manual MEK-6500

2. PREPARATION

Connecting an External Instrument to the Analyzer

A personal computer and a card printer (WA-460V/461V or equivalent) can be connected to the serial port and a hand-held bar code reader can be connected to the bar code reader socket on the rear panel. An external printer can be connected to the printer socket. A PC can also be connected to the USB socket, but the optional Data Management Software must be installed on the PC to receive data from the analyzer. For details on the Data Management Software, contact your Nihon Kohden representative.

Before connecting the external instrument to the analyzer, make sure that the power on the instruments are turned off.

For changing the printing and communication format, refer to “Changing Output Format” in Section 3.

CAUTION

When several medical instruments are used together, ground all

instruments to the same one-point ground. Any potential

difference between instruments may cause electrical shock to the

operator.

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

Always perform equipotential grounding when required. It is often required in the operating room, ICU room, CCU room, cardiac catheterization room and X-ray room. Consult with a biomedical engineer to determine if it is required.

CAUTION

Connect only the speciﬁed instrument to the analyzer and follow the

speciﬁed procedure. Failure to follow this instruction may result in

electrical shock or injury to the operator, and cause ﬁre or instrument

malfunction.

CAUTION

Before connecting or disconnecting instruments, make sure that

each instrument is turned off and the power cord is disconnected

from the AC socket. Otherwise, the operator may receive electrical

shock or injury.

Operator’s Manual MEK-6500 2.7

2. PREPARATION

Connecting a PC

A locally purchased PC can be connected to the serial port or USB port on the rear panel. The measured data can be automatically transferred to the PC after measurement.

When the PC is connected to the USB port, the optional Data Management Software must be installed on the PC to receive data from the analyzer. For details on the Data Management Software, contact your Nihon Kohden representative.

Serial ports

USB port

Connect the serial cable to the PC and the serial port or USB port on the analyzer. For changing the transfer and communication format, refer to “Changing Output Format” in Section 3. For details on the RS-232C data transfer format, refer to “RS-232C Data Transfer” in Section 10.

NOTE

• Only connect a PC which complies with IEC 60950.

• Only use a 3-prong power cord for the PC.

2.8 Operator’s Manual MEK-6500

2. PREPARATION

Connecting a Printer

The following printers can be connected to the printer socket on the analyzer. For details on the type of printer that can be used with the analyzer, contact your Nihon Kohden representative.

• WA-710V/712V printer

• SEIKO EPSON VP type

• SEIKO EPSON PM type

• CANON PIXUS type

NOTE

Printer cannot be connected to the USB port on the analyzer.

Connect the printer cable to the printer and the printer socket on the analyzer. For changing the printing and communication format, refer to “Changing Output Format” in Section 3.

NOTE

Connect an external printer via bidirectional parallel interface complying

with IEEE1284 standard.

When the printer is connected to the analyzer and changing settings on the analyzer is complete, run self-test printouts before using the printer for the rst time to verify proper printer operation.

NOTE

The analyzer software automatically adjusts most print conditions for the

printer, including page width. Occasionally, a few settings may need to

be changed in the printer’s software for correct operation. If printing is

not what you expect, refer to the printer manual for guidance in making

adjustments.

Connecting a Card Printer

The WA-460V/461V card printer can be connected to the serial port on the analyzer. On the WA-460V/461V card printer, only the numeric data is printed. Histograms cannot be printed.

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.

Printer socket

Serial ports

Operator’s Manual MEK-6500 2.9

2. PREPARATION

Connecting a Hand-held Bar Code Reader

The optional BL-N60NK hand-held bar code reader can be used for reading the bar code label (up to 13 characters) on the sample tube. For details about the hand-held bar code reader, refer to the bar code reader manual.

The bar code reader can read the following codes:

• Industrial 2 of 5

• ITF

• JAN/EAN/UPC

• CODABAR (NW-7)

• CODE 39

• CODE 93

• CODE 128

Before turning on the analyzer power by pressing the [Power] key on the front panel, connect the bar code reader cable to the bar code socket on the rear panel.

When the bar code reader is connected, the power is supplied through pin 9 of the bar code reader socket.

NOTE

Do not connect instruments other than hand-held bar code reader to the

bar code reader socket.

To set the various settings for the hand-held bar code reader, read the bar code attached to the bar code reader manual with the hand-held bar code reader within 15 seconds after turning the bar code reader power on. After changing the settings, turn the bar code reader power off.

You can also use the bar codes in “Bar Codes for Using Hand-held Bar Code Reader” in Section 10.

Bar code socket

2.10 Operator’s Manual MEK-6500

2. PREPARATION

Connecting the Power Cord and Grounding the Analyzer

Connecting the Power Cord

CAUTION

Only use the provided power cord. Using other power cords may

result in electrical shock or injury to the operator.

Connect the provided power cord to the AC SOURCE socket on the rear panel and plug the cord into a 3-prong AC outlet.

Equipotential Grounding

CAUTION

When several medical instruments are used together, ground all

instruments to the same one-point ground. Any potential

difference between instruments may cause electrical shock to the

operator.

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

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).

Operator’s Manual MEK-6500 2.11

2. PREPARATION

Connecting Tubes and Installing Reagents

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

Materials Required

• Powder-free gloves, lab coat, safety goggles

• ISOTONAC•3 diluent

• CLEANAC detergent

• CLEANAC•3 detergent

• Hemolynac•3N lysing reagent

• Reagent inlet tubes and waste outlet tube

• Waste container (or appropriate drain)

• 2 L container

• Lint-free cloth

CAUTION

Only use Nihon Kohden speciﬁed reagents and consumables.

Otherwise the measurement result cannot be guaranteed and

incorrect reagent concentration can cause equipment damaged.

NOTE

• When setting and using a reagent, do not let dust enter the reagent

container. If dust gets in the analyzer, correct measurement data may

not be acquired or the analyzer may get damaged.

• If dust gets in a reagent container, wash the inside of the container with

reagent.

• The usage environment of the reagents is between 15 and 30°C.

Especially when using the diluent, temperatures outside the normal

range may cause unstable measurement data.

• Do not use reagent which is past the expiration date.

Diluent

ISOTONAC•3

NOTE

• Do not swallow diluent.

• If diluent contacts the skin or eyes or is swallowed, wash immediately

and thoroughly with water.

• Use diluent at room temperature (15 to 30ºC).

• If the diluent is frozen, warm it at room temperature (15 to 30ºC) and

stir it sufﬁciently.

• Handle the diluent as follows. Otherwise the measurement data may be

inaccurate due to background noise.

- Do not leave the diluent container with the diluent tube inserted and

the cap opened. Do not put the diluent tube on a desk.

2.12 Operator’s Manual MEK-6500

2. PREPARATION

- When changing the diluent, do not let dust or germs get inside the

diluent container.

- Do not mix fresh diluent and old diluent in the container.

- Use the diluent within 60 days after opening.

Detergent

CLEANAC

WARNING

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

immediately.

NOTE

• If CLEANAC detergent contacts the skin or eyes or is swallowed, wash

immediately and thoroughly with water.

• Store CLEANAC detergent at room temperature (15 to 30ºC).

• If CLEANAC detergent is frozen, warm it at room temperature (15 to

30ºC) and stir it sufﬁciently.

• Do not mix fresh detergent and old detergent in the container.

CLEANAC•3

WARNING

If CLEANAC•3 detergent contacts the eyes, wash immediately with

plenty of water for at least 15 minutes and see a physician. The

detergent can cause blindness.

WARNING

• Do not allow CLEANAC•3 detergent to come into contact with acid.

Contact with acid can release poisonous chlorine gas.

• Do not inhale the detergent. If inhaled, move to fresh air, rest in a

posture which allows easy breathing and see a physician.

• Do not swallow the detergent. If swallowed, rinse the mouth

immediately. See a physician.

• If the detergent contacts the skin, wash thoroughly and

immediately with water and see a physician.

• Wear rubber gloves or goggles to protect yourself when handling

the detergent.

NOTE

• Store CLEANAC•3 detergent at room temperature (15 to 30ºC).

• If CLEANAC•3 detergent is frozen, warm it at room temperature (15 to

30ºC) and stir it sufﬁciently.

• Do not leave the CLEANAC•3 detergent container with the detergent

tube inserted and the cap opened. This weakens the detergent and the

analyzer may not be cleaned adequately.

• Do not mix fresh detergent and old detergent in the container.

Operator’s Manual MEK-6500 2.13

2. PREPARATION

Lysing Reagent

Hemolynac•3N

CAUTION

• Do not swallow Hemolynac•3N lysing reagent. If swallowed, see a

physician immediately.

• If lysing reagent contacts the skin, eyes or mouth, wash thoroughly

and immediately with water and see a physician.

NOTE

• If Hemolynac•3N lysing reagent is frozen during shipment or low

temperature storage, background noise may increase. In this case,

leave the lysing reagent at 25 to 30ºC for 2 days and shake well. Before

use, make sure there are no bubbles in the lysing reagent.

• Do not mix fresh lysing reagent and old lysing reagent in the container.

• Use the lysing reagent within 90 days after opening.

Connecting Tubes

NOTE

• Do not squeeze or bend the tubes. Otherwise the tube is accidentally

removed or the analyzer may be damaged.

• Try to keep the diluent and detergent containers at the same level as

the analyzer.

• If necessary, cut the diluent tube and reagent tube to an appropriate

length when the length of the tube does not ﬁt. For the detergent, use

only the speciﬁed tubes.

• Follow the instructions on each package for handling the reagent.

• Be careful not to let dust enter lysing reagent, diluent and detergent.

• After connecting the tubes, take care not to block the air holes on the

caps.

Waste container

Diluent (ISOTONAC•3)

Detergent (CLEANAC)

Detergent (CLEANAC•3)

Lysing reagent (Hemolynac•3N)

2.14 Operator’s Manual MEK-6500

2. PREPARATION

Diluent Tube

Connect ISOTONAC•3 (18 or 20 L) to the analyzer.

NOTE

• Place the diluent container at the same level as the analyzer.

• Do not let dust or germs get inside the diluent container. Correct

measurement data cannot be obtained.

1. Connect the diluent tube (marked blue) to the ISO3 inlet on the right side panel.

2. Pass the diluent tube through the 18 L container cap.

3. Connect the end of the diluent tube to the 18 L tube assy 2.

4. Put the 18 L tube assy 2 into the diluent container and tighten the 18 L container cap.

Detergent Tube

NOTE

• Place the detergent containers at the same level as the analyzer.

• Only use the speciﬁed detergent tubes for the detergent.

For performing STRONG CLEAN, use CLEANAC•3 detergent (1 or 5 L). For other purposes, use CLEANAC detergent.

CLEANAC Detergent

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

2. Pass the detergent tube through the 18 L container cap.

3. Connect the end of the detergent tube to the 5 L tube assy.

4. Put the 5 L tube assy into the CLEANAC detergent container and tighten the 18 L container cap.

18 L container cap

18 L tube assy 2

ISOTONAC•3 diluent (18 L)

Diluent tube (marked blue)

18 L container cap

5 L tube assy

CLEANAC detergent (5 L)

Detergent tube (marked green)

Operator’s Manual MEK-6500 2.15

2. PREPARATION

CLEANAC•3 Detergent

NOTE

When using 1 L of CLEANAC•3, the 1 L tube assy (YZ-001B7) is

required. Contact your Nihon Kohden representative.

1. Connect the cleanac tube 8 (marked white) to the CLN3 inlet on the right side panel.

2. Pass the cleanac tube 8 through the 18 L container cap.

3. Connect the end of the cleanac tube 8 to the 5 L tube assy.

4. Put the 5 L tube assy into the CLEANAC•3 container and tighten the 18 L container cap.

Lysing Reagent Tube

Hemolynac•3N

1. Replace the lysing reagent cap with the Hemolynac•3 cap and tighten the cap.

2. Connect the Hemolynac•3 tube assy (marked yellow) to the HEMO3N inlet on the right side panel.

3. Put the other end of the tube into the lysing reagent container through the Hemolynac•3 cap.

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.

3. Connect the waste tube to the 2 L waste tube assy.

4. Insert the 2 L waste tube assy into the waste container and tighten the MEK cap.

NOTE

• Place the waste container at the same level as the analyzer.

• The waste is under pressure. Be sure that the waste tube is securely

placed in the waste container, ﬂow of waste is unobstructed, and all

analyzer components are located away from possible waste overﬂow.

CLEANAC•3 detergent (5 L)

Cleanac tube 8 (marked white)

18 L container cap

5 L tube assy

Hemolynac•3 cap

Hemolynac•3N lysing reagent

Hemolynac•3 tube assy (marked yellow)

2 L waste tube assy

Waste container (2 L)

Waste tube (marked red)

MEK cap

2.16 Operator’s Manual MEK-6500

2. PREPARATION

Loading Recording Paper in the WA-650VK Printer Unit (Option)

NOTE

• The WA-650VK printer unit is optional (built-in type).

• Only use the speciﬁed recording paper.

1. Open the printer door.

2. Set the recording paper in the paper tray in the direction as shown.

3. Insert the recording paper into the slot.

4. Press the [ Feed] key on the front panel until the recording paper comes out from the printer unit.

5. Put the paper through the opening of the door and close the door.

6. Cut the extra paper.

Operator’s Manual MEK-6500 2.17

2. PREPARATION

Preparing an SD Memory Card

Use an SD memory card to save measurement data.

NOTE

• Operation with a mini or micro SD card with conversion adapter cannot

be guaranteed.

• An SDHC or SDXC memory card cannot be used.

Safety Information

NOTE

For handling and safety information about SD memory card, refer to the

SD memory card manual together with this manual.

Handling and Storage

• Keep the SD memory card slot clean. If dust gets into the slot, the SD

memory card will not function.

• Do not handle the SD memory card while eating or drinking.

• Do not get the SD memory card wet.

• Do not give impact to the SD memory card by dropping or bending.

• Do not expose the SD memory card to direct sunlight or leave it in a

high temperature place.

Environmental Conditions

• Storage environment Temperature: –20 to +65°C (–4 to +149°F) Humidity: less than 95% (noncondensing)

• Operating environment: same as the analyzer

Data Processing

• Initialize the SD memory card on this analyzer. An SD memory card

that was initialized on another instrument cannot be used. Refer to

“Formatting the SD Memory Card” in Section 3.

• Do not use an unspeciﬁed instrument to save data to the SD memory

card. The card may become unusable for this analyzer.

• Do not remove the SD memory card, turn off the power, or press the

[Reset] key during data processing. This may damage the card.

2.18 Operator’s Manual MEK-6500

2. PREPARATION

Inserting and Removing the SD Memory Card

NOTE

• When inserting or removing the SD memory card, turn off the power

of the analyzer. The data in the card may get damaged or the analyzer

might not operate correctly.

• Do not bend the SD card or insert it at an angle. It may cause

malfunction on the analyzer.

Insert the SD memory card into the SD memory card slot so that the label on the card is toward the front.

When removing the SD memory card, push the card once. The card pops out.

Insert

Remove

Operator’s Manual MEK-6500 2.19

2. PREPARATION

Turning Power On/Off

Check Before Turning Power On

Check the following items before turning on the power.

Item Check

Accessories and consumables

Sufcient diluent, detergent and lysing reagent.

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 storage

Aperture caps are clean. Pump tube is not broken and not disconnected.

Turning On the Power

1. Conrm that the analyzer, printer (optional), and hand-held bar code reader (optional) power cords are connected to grounded power outlets.

2. Set the printer power switch ON.

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

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

the analyzer.

4. Press the [Power] key on the front panel ON. The green [Power lamp] lights and the screen illuminates within 15 to 30 seconds. Cleaning of the uid path, priming and circuit self-check are automatically performed.

2.20 Operator’s Manual MEK-6500

2. PREPARATION

When there is an error, “Fail” appears.

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

NOTE

If an error message appears, refer to “Alarm Messages” in Section 8.

Checking the Date and Time Settings

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.

Date and time

Operator’s Manual MEK-6500 2.21

2. PREPARATION

Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL)

The uid path inside the analyzer must be cleaned after installation or longterm storage. Perform PRIME ON INSTALL on the OPERATIONS screen. For details, refer to “Using the Analyzer after Storage” in Section 9.

1. Press the MENU key on the READY screen.

2. Press the OPERATIONS key on the MENU screen.

2.22 Operator’s Manual MEK-6500

2. PREPARATION

3. Press the PRIME ON INSTALL key on the OPERATIONS screen. A conrmation message appears on the screen.

4. Press the YES key to prime the analyzer.

Press the NO key to cancel the procedure and the screen returns to the

OPERATIONS screen.

After priming, the READY screen appears.

Check After Turning On the Power

Check the following items after turning on the power to start operating safely and properly. If any problem is detected, take the proper countermeasure according to Section 8 “Messages and Troubleshooting”.

Item Check

Turning on the power

There is no re, 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.

After long term storage

Perform PRIME ON INSTALL on the OPERATIONS screen.

NOTE

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

Operator’s Manual MEK-6500 2.23

2. PREPARATION

Daily Shutdown

To keep the analyzer in optimum condition, check and clean it after every use. If an error is found during check, clean or replace the item.

Checking List Before Turning the Power Off

• There is enough lysing reagent, diluent and detergent left in the containers.

• The waste container is empty.

• The waste tube is properly connected.

Turning the Power Off

To turn the power off, press the [Power] key on the front panel. The analyzer automatically performs cleaning and the “After cleaning, the power will automatically shut off.” message appears. After the cleaning is completed, the power is automatically turned off.

When the sample counts is over 200 when the power is turned off, a message prompts you to perform strong cleaning.

2.24 Operator’s Manual MEK-6500

2. PREPARATION

Press the YES key to perform strong cleaning. After strong cleaning is complete, the power turns off.

Press the NO key to not perform strong cleaning. The analyzer automatically performs cleaning and turns the power off.

To turn the main power off, press the [Main power] switch on the rear panel. Check that the [Main power lamp] on the front panel is off.

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

Check List After Turning Power Off

• There was no leakage during use.

• The outside enclosure of the analyzer is wiped off and clean.

• The uid 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 uid 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.

Operator’s Manual MEK-6500 2.25

2. PREPARATION

Checking Daily Accuracy

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 diluent 60 days after opening.

Replace diluent.

Dust in the diluent container. Replace diluent. Extremely high or low diluent

temperature (normal range is 15 to 30°C).

Adjust diluent temperature to 15 to 30°C.

The sampling nozzle is clogged and bubbles occur in the sub bath.

Replace the sampling nozzle with a 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.

2.26 Operator’s Manual MEK-6500

2. PREPARATION

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

3. Set an empty tube in the tube holder.

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 nishing 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.

Eject key

Operator’s Manual MEK-6500 2.27

2. PREPARATION

2. Press the OTHER key on the MENU screen.

3. Press the BACKGROUND key on the OTHER screen.

The “Measure background noise?” message appears on the screen.

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

2.28 Operator’s Manual MEK-6500

2. PREPARATION

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.

Measuring on the BACKGROUND Screen

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

Count switch

Operator’s Manual MEK-6500 2.29

2. PREPARATION

2. Press the OTHER key on the MENU screen.

3. Press the BACKGROUND key on the OTHER screen.

The “Measure background noise?” message appears on the screen.

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

2.30 Operator’s Manual MEK-6500

2. PREPARATION

Results

The background measurement result is displayed on the screen after measurement.

When the measurement is performed

on the BACKGROUND screen

When the measurement is performed

by the [ Count] switch

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

When measured on the BACKGROUND screen, “Fail” appears beside the parameter which is over the acceptable value.

Disregard the other parameter values because noise does not affect the other parameters.

If the values are greater than the values listed above, check the following items, press the [ Clean] key on the front panel to clean the uid path and recount the diluent.

• The diluent is clean.

• No bubbles in the diluent.

• The aperture caps are clean.

• The aperture caps are rmly attached.

• The measurement baths and sub baths are clean.

Operator’s Manual MEK-6500 2.31

2. PREPARATION

Measuring Hematology Control

For checking accuracy, use a MEK-3D hematology control which has the same conditions as human blood. Conrm that the obtained sample data is within the acceptable range on the assay sheet attached to the hematology control. For details, refer to Section 7 “Calibration”.

CAUTION

Use hematology control before the expiration

date.

CAUTION

Do not freeze the hematology control because

this hemolyses it.

CAUTION

Do not use hematology control when the top layer

is slightly red or the whole hematology control is

red, because the red blood cells in the

hematology control are hemolyzed.

CAUTION

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.

2.32 Operator’s Manual MEK-6500

2. PREPARATION

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

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-6500 3.1

General ................................................................................................................................................................3.3

Assigning Users and Passwords ......................................................................................................................... 3.4

General ...................................................................................................................................................... 3.4

Displaying the USERS Screen .................................................................................................................. 3.5

Adding a User ............................................................................................................................................ 3.6

Changing a User .......................................................................................................................................3.9

Deleting a User ........................................................................................................................................ 3.10

Assigning an ID to a Sample .............................................................................................................................3.11

Displaying the ID Screen .........................................................................................................................3.12

Entering a 4 Digit Numeric ID ..................................................................................................................3.12

Entering a 13 Character Alphanumeric ID............................................................................................... 3.13

Using Bar Codes .....................................................................................................................................3.14

Labeling and Selecting Sample Types ...............................................................................................................3.15

Labeling Sample Types ...........................................................................................................................3.15

Selecting Sample Types for the Sample Type Selection List ................................................................... 3.17

Setting Normal Range Upper and Lower Limits ................................................................................................3.18

Default Settings of Upper and Lower Limits ............................................................................................ 3.18

Changing the Limits ................................................................................................................................. 3.18

Changing Sensitivity and Threshold .................................................................................................................. 3.21

General .................................................................................................................................................... 3.21

Factory Default Settings and Setting Range ................................................................................. 3.21

RBC Automatic Threshold .............................................................................................................3.21

Changing Sensitivity and Threshold ........................................................................................................3.21

Displaying the Sensitivity and Threshold Setting History ........................................................................3.23

Determining Optimum Sensitivity ............................................................................................................3.24

Determining Optimum Threshold ............................................................................................................3.24

Changing Measurement Settings ......................................................................................................................3.25

Setting Date and Time .......................................................................................................................................3.28

Changing Display Format .................................................................................................................................. 3.30

Changing Output Format ................................................................................................................................... 3.35

Changing Print Format for Internal Printer ..............................................................................................3.37

Changing Print Format for External Printer .............................................................................................3.39

Changing Settings for Card Printer .........................................................................................................3.44

Changing Format for PC .........................................................................................................................3.46

Changing the USB Settings ..................................................................................................................... 3.48

Changing the SD Memory Card Settings ................................................................................................3.49

Formatting the SD Memory Card ..................................................................................................3.50

Selecting Language ...........................................................................................................................................3.51

Selecting Units ................................................................................................................................................... 3.52

Selecting Unit Type ..................................................................................................................................3.52

Counting Unit Table ....................................................................................................................... 3.53

Customizing Units ...................................................................................................................................3.53

Changing Sound and Screen Brightness Settings ............................................................................................3.54

Section 3 Changing Settings

3.2 Operator’s Manual MEK-6500

Changing Various Settings for Analyzer Power On ............................................................................................3.55

Setting Auto Priming/Cleaning ........................................................................................................................... 3.57

Using Reagent Management .............................................................................................................................3.59

Setting the Warning Level ........................................................................................................................3.59

When the Reagent Management Warning is Displayed ..........................................................................3.61

Initializing Settings .............................................................................................................................................3.64

Factory Default Settings .......................................................................................................................... 3.66

Operator’s Manual MEK-6500 3.3

3. CHANGING SETTINGS

General

Before starting measurement, assign an ID to the sample and change any necessary settings such as measurement mode, upper and lower limits, date and time.

You can also set a warning window to display when reagent or waste reaches the warning level.

Assign an ID on the ID screen which can be displayed from the READY, MENU or RESULTS screen.

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

Item Description

SAMPLE TYPE Label each sample type.

NORMAL RANGE

Set the upper and lower limits for each parameter. These limits are used as criteria to decide abnormal values (H and L marks).

SENS/THRESH

Set the sensitivity and threshold for WBC, RBC and PLT when measuring non-human blood.

MEASUREMENT

Set the settings related to measurement, including single or double sample counting, pre-dilution blood volume and continuing dilution mode.

DATE & TIME

Select the display format of the date and time and set the date and time.

DISPLAY Select the display format and histograms.

OUTPUT

Set the printing settings for using printer and

communication settings for using PC. LANGUAGE Select the language from English or your local language. UNITS Select the units for parameters.

SOUND/LCD

Adjust the volume of alarms or buzzer and adjust the

screen brightness.

OPERATION

Set the functions to be operated at analyzer power on and

select the number of digits and display position for the

ID. AUTO CLEANING Set the auto prime/clean time. USERS Set the users and passwords for operating the analyzer. INITIALIZE Initialize the settings to the factory default settings.

Set reagent management on the OTHER screen.

There are setting screens which can only be entered when the type of user is “Lab technician” or “Service”. For details, refer to the next “Assigning Users and Passwords” section.

3.4 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Assigning Users and Passwords

General

To prevent measuring with wrong measurement conditions, some screens and functions can only be entered or changed by a user with authority and a password. There are three levels of authority.

NOTE

Set the Users settings according to your facility’s conditions.

Service: For servicing the analyzer. Can enter any screen and change

any settings. The status bar on the screen is orange.

Lab technician: For changing settings. Can enter any screen and change any

settings except for the SERVICE screen. The status bar on the screen is blue.

Other user: Can only perform measurement and view data and settings.

The status bar on the screen is green.

The following screens cannot be entered by an Other user.

• INITIALIZE

• MAINTENANCE

• SERVICE

On the USERS screen, an Other user can only select a user. Only a lab technician or service user can add or delete a user.

On the USERS screen, the rst three users are preset and cannot be changed. “FACTORY” is for engineers servicing the analyzer. “Celltac” is for changing settings for the rst time after installing the analyzer. “USER” can only perform measurement and check measurement data. The passwords for “Celltac” and “USER” are as follows and these passwords cannot be changed. Celltac: 6500 USER: 0000

“Celltac” is the default setting.

Status bar

Operator’s Manual MEK-6500 3.5

3. CHANGING SETTINGS

Displaying the USERS Screen

1. Press the SETTINGS key on the MENU screen.

2. Press the USERS key on the SETTINGS screen. The USERS screen is displayed.

Current user

Registers a new user.

Deletes selected user.

Changes users.

To print the data on the USERS screen, press the [ Print] key on the front

panel.

NOTE

When printing on a WA-710V/712V or EPSON VP printer, <EPSON

VP paper width> must be set to “Wide” on the EXTERNAL PRINTER

screen of the SETTINGS screen and wide type paper must be set on

the printer. Refer to “Changing Print Format for External Printer” in

Section 3.

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

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

3.6 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Adding a User

Up to 8 users can be registered (including the factory default users).

NOTE

A new user can only be added by a lab technician or service user.

1. Press the ADD USER key on the USERS screen to display the ADD USER screen.

2. Use the displayed keyboard to enter the user name in the <Name> box (up to 8 alphanumerics).

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

to reect your selection.

Clears the character at the cursor position.

Move cursor.

Clears all entered characters.

Keys for entering numbers Keys for entering letters

Cursor

Switches between numbers and letters.

Operator’s Manual MEK-6500 3.7

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… DEF D → E → F → D… GHI G → H → I → G … 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 <Type of user>.

Selection list

4. Press the NEXT key. The password entry screen opens.

5. Enter the 4-digit password using the displayed numeric keys. The entered password appears as “

****

” in the <Password> box.

Clears all entered numbers.

Returns to the USERS screen.

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

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3. CHANGING SETTINGS

7. Re-enter the password and press the Enter key to conrm the password. The screen returns to the USERS screen and the new user is added to the user list.

Added user

Operator’s Manual MEK-6500 3.9

3. CHANGING SETTINGS

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. Enter the password for this user using the numeric keys on the window and press the Enter key. When the correct password is entered, the current user (indicated by the arrow on the screen) changes to the selected user.

Clears all entered numbers.

Returns to the USERS screen.

When the wrong password is entered, the “Incorrect password” message

appears. Enter the correct password.

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3. CHANGING SETTINGS

Deleting a User

NOTE

• A user can only be deleted by a lab technician or service user.

• FACTORY, Celltac and USER are the default settings and cannot be

deleted.

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

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

3. Press the YES key to delete the selected user. The password entry screen appears.

Press the NO key to cancel deleting. The screen returns to the USERS

screen.

4. Enter the password of the user to delete. When the correct password is entered, the user is deleted and “The user is deleted.” message is displayed.

Operator’s Manual MEK-6500 3.11

3. CHANGING SETTINGS

Assigning an ID to a Sample

All samples must have an ID. Otherwise, you cannot identify which samples correspond to the displayed or saved data. All saved and displayed data is identied by an ID number.

When you set an ID, the analyzer automatically assigns it to the next counted sample and increments the ID for each sample after that. Only the last 4 digits are incremented. When the last 4 digits are “9999”, the ID is incremented to “0000” for the next sample.

It is possible to enter an ID manually for each sample.

The ID can have up to 13 characters and the last 4 digits must be numbers.

It is also possible to not assign an ID to a sample, such as in background noise measurement.

When using an optional hand-held bar code reader (Keyence BL-N60NK or equivalent), the bar code label of the sample can be read by the bar code reader and this code is entered as the sample ID.

The position of the displayed ID can be selected from Auto, Right or Left. For details, refer to “Changing Various Settings for Analyzer Power On” in this section.

<Use ID> setting

ID display position ID No.

4 digits 13 digits

After pressing the Reset key

After measurement

Auto

Right aligned Left aligned 0001 Increments automatically.

Right

Right aligned

No ID assigned, assign an ID manually.

Left

Left aligned

ID not displayed

To edit an ID of already saved data, refer to “Editing ID and Sample Type of Saved Data” in Section 5.

3.12 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Displaying the ID Screen

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

ID box

The cursor moves as you touch a number.

Resets the ID to “0001”.

2. Press the OK key to return to the previous screen. (i.e. If the ID screen is displayed from the READY screen, the screen returns to the READY screen.)

Entering a 4 Digit Numeric ID

1. Select “4 DIGITS” for <ID digits> and an ID alignment position for <Use ID> on the OPERATION screen. Refer to “Changing Various Settings for Analyzer Power On” in this section.

2. Open the ID screen. Refer to “Displaying the ID Screen” in this section.

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

Operator’s Manual MEK-6500 3.13

3. CHANGING SETTINGS

Entering a 13 Character Alphanumeric ID

1. Select “13 DIGITS” for <ID digits> and an ID alignment position for <Use ID> on the OPERATION screen. Refer to “Changing Various Settings for Analyzer Power On” in this section.

2. Open the ID screen. Refer to “Displaying the ID Screen” in this section.

3. Enter numbers with the numeric keys. Press the “ABC …” key when entering letters. The entered number or letter appears in ID box. In the last 4 digits, only the numbers can be entered.

Cursor

The cursor moves as you touch a number.

The entered ID appears here.

Clears the character at the cursor position.

Move cursor.

Resets the ID to “0001”.

Cursor

Keys for entering numbers Keys for entering letters

Switches between numbers and letters.

On the alphabet and symbol keypad, the letters change in the following order

every time a key is pressed.

Key Corresponding Characters

3.14 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Using Bar Codes

The optional hand-held bar code reader (Keyence BL-N60RK or equivalent) can be used to read the sample bar code label to establish the Sample ID.

To enter the ID by using the hand-held bar code reader, display the READY, ID, RESULTS or ID EDIT screen and read the bar code of the sample.

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.

Operator’s Manual MEK-6500 3.15

3. CHANGING SETTINGS

Labeling and Selecting Sample Types

You can select the sample type before each measurement on the READY screen. You can label and select sample types to be displayed in the selection list on the READY screen and other setting screens.

Labeling Sample Types

You can label different sample types. Up to 10 sample types can be set, but one of them is xed 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.

3.16 Operator’s Manual MEK-6500

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. Each label can have up to 8 characters.

Switches between numbers and letters.

Cursor

Entered label appears in the 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

Operator’s Manual MEK-6500 3.17

3. CHANGING SETTINGS

6. Press the OK key to register the sample label and return to the SAMPLE TYPE list screen. The entered sample label is registered to the label position you have chosen in step 3.

When the CANCEL key is pressed, the entered label is cancelled and the

screen returns to the SAMPLE TYPE list screen.

When a sample type is selected and the RESET key is pressed on the

SAMPLE TYPE screen, the selected sample type label is reset to the factory default setting.

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

Selecting Sample Types for the Sample Type Selection List

You can set the sample types to be displayed in the sample type selection list. The sample type selection list appears on the READY, NORMAL RANGE, SENS/THRESH, DETAILS (EDIT) screen of the DATA screen and SEARCH screens.

Press the check box beside the sample type you want to enter for the sample type selection list.

To cancel, press the check box again.

Resets the selected sample type label to the default setting.

Sample type selection list

3.18 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Setting Normal Range Upper and Lower Limits

Each parameter has a normal range. Values outside the normal range can be automatically marked with an H (beyond the upper limit) or L (below the lower limit) mark. The upper and lower limits can be set individually for each parameter. You can set the upper and lower limits individually for different sample types.

Default Settings of Upper and Lower Limits

Parameter

Default Setting

Variable

Range

Lower Limit Upper Limit

WBC (103/µL) 4.0 9.0 0 to 99.9 RBC (106/µL) 3.76 5.70 0 to 14.99 HGB (g/dL) 12.0 18.0 0 to 29.9 HCT (%) 33.5 52.0 0 to 99.9 MCV (fL) 80.0 100.0 20.0 to 199 MCH (pg) 28.0 32.0 10.0 to 50.0 MCHC (g/dL) 31.0 35.0 10.0 to 50.0 PLT (103/µL) 150 350 0 to 1490 LY% 17.0 57.0 0 to 99.9 MO% 0.0 10.0 0 to 99.9 GR% 42.0 85.0 0 to 99.9 LY (103/µL) 0.7 5.1 0 to 99.9 MO (103/µL) 0 0.9 0 to 99.9 GR (103/µL) 1.7 7.7 0 to 99.9 RDW-CV (%) 11.6 14.0 0 to 50.0 RDW-SD (fL) 39.0 46.0 0 to 199 PCT (%) 0.16 0.33 0 to 2.90 MPV (fL) 7.0 11.0 0 to 20.0 PDW (%) 15.0 17.0 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.

Operator’s Manual MEK-6500 3.19

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 <Sample type>.

Sample type selection list

4. Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change.

Press the PREV or NEXT key to display other parameters.

Sample type key

Move cursor.

Numeric keys

Cursor

Change pages to display other parameters.

3.20 Operator’s Manual MEK-6500

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 nish changing the settings, press the OK key to return to the SETTINGS screen.

Operator’s Manual MEK-6500 3.21

3. CHANGING SETTINGS

Changing Sensitivity and Threshold

General

For measuring nonhuman blood, the sensitivity and threshold should be changed to match the characteristics of the blood. You can set the sensitivity and threshold individually for different sample types.

CAUTION

Use only the initial sensitivity or threshold settings for measuring

human blood. Do not change these settings.

Factory Default Settings and Setting Range

Parameter

Sensitivity Threshold

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.

3.22 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

2. Press the SENS/THRESH key on the SETTINGS screen to display the SENS/THRESH screen.

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

Sample type selection list

4. Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change.

Cursor

Sample type key

Move cursor.

Numeric keys

Operator’s Manual MEK-6500 3.23

3. CHANGING SETTINGS

5. To set the desired value: i) Enter the value using the numeric keys on the screen. ii) Press the Enter key to register the value at the cursor position.

To set the RBC auto threshold:

Select “On” for <Auto threshold>. When setting the value for RBC threshold, select “Off” for <Auto threshold>

and enter the value for RBC Threshold.

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

Displaying the Sensitivity and Threshold Setting History

The sensitivity and threshold setting history is stored for up to 6 history for each sample type and can be displayed on the HISTORY screen.

1. Press the HISTORY key on the SENS/THRESH screen to display the HISTORY screen.

Sample type key

Displays newer data.Displays older data.

The user who changed the sensitivity and threshold settings.

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.

3.24 Operator’s Manual MEK-6500

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 (at part of the curve). The optimum threshold is the center of the plateau.

Plateau

Counted value

Optimum threshold

Threshold

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

repeat this procedure.

Counted value

Threshold

No plateau

Plateau is too short

Counted value

Threshold

Operator’s Manual MEK-6500 3.25

3. CHANGING SETTINGS

Changing Measurement Settings

The following items can be set for measurement.

Item Description Setting Default

Measurement count Select to count a sample either once or twice. Single or Double Single Display alarm on

recount

Select whether or not to display an alarm when recounting a sample.

Yes or No No

PLT recount threshold

Select the threshold under which a sample is recounted for the PLT parameter. When “None” is selected, a sample is not recounted. Refer to “PLT Recount” in Section 4.

10 × 104/μL, 5 × 104/μL or None

10 × 104/μL

Pre-dilution volume Select the pre-dilution blood measuring volume. 10 μL or 20 μL 20 μL Measure twice with

pre-dilution

Select whether or not to dilute the sample for two measurements in pre-dilution mode.

Yes or No No

Continue dilute mode

Select whether or not to continue measurement in the same dilution mode.

Yes or No No

Recount if panic value

Select whether or not recount the sample when the measured value is out of the panic value range.

Yes or No Yes

High dilute mode for panic value recount

Select dilution mode for panic value recount with high dilution. Refer to “Recount when Out of Panic Range” in Section 4.

High or Higher Higher

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

1. Press the SETTINGS key on the MENU screen.

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

3.26 Operator’s Manual MEK-6500

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 signicant 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 rst count is used and the RBC and PLT histograms from the second count are used.

Display alarm on recount

When an alarm occurs during measurement, the sample is automatically recounted up to three times. You can set the alarm to display upon auto recount to help nd the problem.

Alarm message is displayed when <Display alarm on recount> is set to “Yes”.

Operator’s Manual MEK-6500 3.27

3. CHANGING SETTINGS

PLT recount threshold

The analyzer automatically recounts a sample when PLT is extremely low regardless of the <Measurement count> setting. You can set the threshold under which a sample is recounted. For normal operation, select 10 × 104/µL. When “None” is selected, a sample is not recounted.

Pre-dilution volume

Select the pre-dilution blood measuring volume.

Measure twice with pre-dilution

When set to “Yes”, the sample is diluted to measure twice in pre-dilution mode.

Continue dilute mode

To continue measurement with the same dilution mode (Normal, Pre-dilution, Low, High or Higher), select “Yes”. When “No” is selected, the dilution mode returns to Normal.

Recount if panic value

When set to “Yes”, a message asks whether or not to remeasure the sample when the measurement result is out of panic value range, “ ! ” is displayed beside the parameter, or an A031 or A032 (WBC noise) alarm occurs.

If you choose to remeasure, the sample is recounted with a different dilution mode. When the measurement result was lower than the panic value, the sample is recounted in low dilution mode. When the measurement result was higher than the panic value, the sample is recounted in the dilution mode which is set in <High dilute mode for panic value recount>.

High dilute mode for panic value recount

When “Yes” is set for <Recount if panic value> and the measurement result is higher than the panic value, the sample can be recounted in the high dilution mode which is set in <High dilute mode for panic value recount>. High: The sample is measured with dilution three times the usual dilution ratio. Higher: The sample is measured with dilution six times the usual dilution ratio.

3.28 Operator’s Manual MEK-6500

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.

Operator’s Manual MEK-6500 3.29

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.

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.

Cursor

Date format key

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.

3.30 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Changing Display Format

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

Item Description Setting Default

Display parameters

Select the number of parameters to be displayed on the RESULTS and DATA DETAILS screen.

8 or 19 19

Histogram

Select whether or not to display histograms and the display size on the RESULTS and DATA DETAILS screen.

Normal, Wide or None Normal

Histogram Y-axis

Select the vertical axis on the histogram on the RESULTS and DATA DETAILS screen.

Count or Percentage Count

Display WBC histogram lines

Select whether or not to display the borderline of differential parameters on the WBC histogram on the RESULTS and DATA DETAILS screen.

Yes or No No

Adjust histogram scale

Adjust RBC histogram horizontal axis scale, WBC, RBC and PLT histogram vertical axis scale on the RESULTS and DATA DETAILS screen.

50 to 200% 100

DATA screen items

Select sequence number or sample type to be displayed on the DATA screen.

SEQ# or Sample type SEQ#

DATA screen display items

Select the display parameters for the DATA screen. Up to three parameters can be selected.

LY%, MO%, GR%, LY, MO, GR, RDW-CV, PCT, MPV, PDW

LY%, MO%, GR%

Select ags to display in red

Select ags to be highlighted in red. All ags

Poor hemolysis, PLT clumps, Abnormal MCHC

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

1. Press the SETTINGS key on the MENU screen.

Operator’s Manual MEK-6500 3.31

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.

3.32 Operator’s Manual MEK-6500

3. CHANGING SETTINGS

Display parameters and Histogram

The RESULTS screen and DETAILS screen of the DATA screen display format differ according to the <Display parameters> and <Histogram> settings.

Display Parameters: 19 Histogram: Normal

Display Parameters: 19 Histogram: Wide

Display Parameters: 19 Histogram: None

Display Parameters: 8 Histogram: Normal

Display Parameters: 8 Histogram: Wide

Display Parameters: 8 Histogram: None

Histogram Y-axis

You can select the type of the vertical axis on the histograms. Count: The vertical axis on the graph represents numerical count values. Percentage: The vertical axis on the graph is xed 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.

[Count]

[fL]

[%]

100%

[fL]

The horizontal axis represents the blood cell volume. (fL = 1 × 10

-15

Operator’s Manual MEK-6500 3.33

3. CHANGING SETTINGS

Display WBC Histogram Lines

You can set to display vertical lines to separate WBC histogram into the 3 differential parameters.

Lymphocyte distribution

Monocyte distribution

Granulocyte distribution

Adjust Histogram Scale

You can adjust the horizontal and vertical axes for the RBC histogram and the vertical axis for the WBC and PLT histogram between 50 and 200%.

To adjust the axes, <Histogram Y-axis> must be set to “Count”.

RBC histogram horizontal axis 100% 50% 200%

RBC histogram vertical axis 100% 50% 200%

PLT histogram vertical axis 100% 50% 200%

Second page of the DISPLAY screen

3.34 Operator’s Manual MEK-6500

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 ags to display in red

When the result has ags 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.

Operator’s Manual MEK-6500 3.35

3. CHANGING SETTINGS

Changing Output Format

You can select the printers or external devices to which the data will be output. Also, you can automatically send the data to an assigned device after each measurement. To change the settings, the type of user must be either lab technician or service.

1. Press the SETTINGS key on the MENU screen.

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

Celltac A MEK-6500, MEK-6500J, MEK-6500K Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual