Sysmex XT-4000 User Manual [En]

Automated Hematology Analyzer

XT-4000i

Instructions for Use

CHAPTER 1 Introduction
CHAPTER 2 Safety Information
CHAPTER 3 Design and Function
CHAPTER 4 Reagents
CHAPTER 5 Before Using
CHAPTER 6 Operation
CHAPTER 7 Quality control
CHAPTER 8 Calibration
CHAPTER 9 Cleaning and Maintenance
CHAPTER 10 Troubleshooting
CHAPTER 11 Technical Information
CHAPTER 12 Warranty
CHAPTER 13 Index

KOBE, JAPAN

Copyright © 2008 - 2011 by SYSMEX CORPORATION

All rights reserved. No part of this manual may be
reproduced in any form or by any means whatsoever
without prior written permission of SYSMEX CORPORATION.

Code No. AN741742
PRINTED IN JAPAN
Date of Last Revision: November 2011

Table of Contents

Table of Contents

Chapter 1 Introduction............................... 1-1

1.1 Hazard information in this manual......................... 1-3

1.2 Protected names ................................................... 1-4

1.3 Information when using this manual...................... 1-4

1.4 Measurement parameters ..................................... 1-4

Chapter 2 Safety Information .................... 2-1

2.1 Specified conditions of use ................................... 2-1

2.2 General information............................................... 2-1

2.3 Installation ............................................................. 2-2

2.4 Electromagnetic compatibility (EMC) .................... 2-2

2.5 Avoidance of infection ........................................... 2-3

2.6 Maintaining the instrument .................................... 2-3

2.7 Handling of reagents ............................................. 2-4

2.8 Laser ..................................................................... 2-5

2.9 Disposal of waste fluids, disposables and

instruments............................................................ 2-5

2.10 Marking on the instrument..................................... 2-6

2.11 Personnel .............................................................. 2-8

2.12 Host Connection.................................................... 2-8

2.13 Computer viruses .................................................. 2-9

2.14 Use of other software .......................................... 2-10

2.15 CD Drive.............................................................. 2-10

Chapter 3 Design and Function ................ 3-1

3.1 Overview ............................................................... 3-1

3.2 Main Unit ............................................................... 3-2

3.3 Pneumatic Unit...................................................... 3-7

3.4 Sampler Unit ......................................................... 3-9

3.5 Information Processing Unit (IPU)....................... 3-10

3.6 System Status Display ........................................ 3-12

3.7 Analysis mode..................................................... 3-14

Chapter 4 Reagents ...................................4-1

4.1 General information............................................... 4-1

4.2 CELLPACK............................................................ 4-1

4.3 STROMATOLYSER-FB ......................................... 4-2

4.4 STROMATOLYSER-4DL ....................................... 4-2

4.5 STROMATOLYSER-4DS ....................................... 4-3

4.6 SULFOLYSER ....................................................... 4-3

4.7 RET SEARCH (II) (diluent).................................... 4-4

RET SEARCH (II) (dye solution) ........................... 4-4

4.8 CELLCLEAN ......................................................... 4-4

4.9 Control blood (e-CHECK or e-CHECK(XE)).......... 4-5

4.10 Labeling................................................................. 4-5

4.11 Symbols used on the labels .................................. 4-6

Revised December 2009

Sysmex XT-4000i Instructions for Use I

Table of Contents

Chapter 5 Before Using..............................5-1

5.1 Storage prior to transport and installation..............5-1

5.2 Preparation ............................................................5-1

5.3 Peripherals.............................................................5-2

5.4 Additional components ....................................... ...5-2

5.5 Basic equipment settings.......................................5-3

Chapter 6 Operation...................................6-1

6.1 Summary of Information Processing Unit (IPU)

operation................................................................6-1

6.2 Information Processing Unit (IPU) menu bar.........6-2

6.3 Operator checks.................. ... ... ... ..........................6-3

6.4 Turning ON the power............................................6-5

6.5 Logging on to the Information Processing Unit

(IPU) ......................................................................6-6

6.6 Self-checks ............................................................6-6

6.7 Auto output settings check..................... ... ... .... ... ...6-8

6.8 Quality control.... .... ... ... ... .... ...................................6-8

6.9 Conditions for sample analysis ..............................6-8

6.10 Analysis mode .......................................................6-9

6.11 Preparing sample analysis........................... .... ... ...6-9

6.12 Sample analysis in manual mode ........................6-13

6.13 Sample analysis in capillary mode.......................6-15

6.14 Sample analysis in sampler mode .......................6-18

6.15 Sample analysis in manual closed mode.............6-21

6.16 Display analysis results........................................6-24

6.17 Analysis result output...........................................6-24

6.18 Body fluid analysis....................................... .... ... .6-25

6.19 Timer processing ......... ... .... ... ... ...........................6 -3 0

6.20 Shutdown.............................................................6-30

Chapter 7 Quality control...........................7-1

7.1 Quality control materials . .... ...................................7-1

7.2 Quality control methods...................................... ...7-1

7.3 Preparation ............................................................7-2

7.4 Quality control analysis... .......................................7-5

7.5 QC data display .....................................................7-8

7.6 Troubleshooting....................................................7-14

7.7 Change lot ...........................................................7-15

7.8 Lot No. ...................... ... ... .... ... .............................. 7 -1 5

7.9 Target/Limit ..........................................................7-18

7.10 Display order........................................................7-23

7.11 File Information....................................................7-24

II Sysmex XT-4000i Instructions for Use

January 2009

Table of Contents

Chapter 8 Calibration .................................8-1

8.1 Calibration execution timing .................................. 8-1

8.2 Samples used for calibration ................................. 8-1

8.3 Reference values .................................................. 8-1

8.4 Automatic calibration ............................................. 8-2

8.5 Displaying the last sample data............................. 8-5

8.6 Manual calibration ................................................. 8-5

8.7 Calibration history ................................................. 8-8

Chapter 9 Cleaning and Maintenance ......9-1

9.1 Execution of shutdown .......................................... 9-3

9.2 Cleaning the Sampler Right Rack Pool, Left Rack

Pool, Analysis Line, and Sample Rack.................. 9-5

9.3 Cleaning the sample rotor valve............................ 9-5

9.4 Removing fluid from the trap chamber .................. 9-9

9.5 Cleaning the manual rinse cup............................ 9-10

9.6 Cleaning the sample rotor valve tray ................... 9-11

9.7 Cleaning the piercer tray ..................................... 9-12

9.8 Removing clogs (clog removal sequence) .......... 9-13

9.9 Cleaning the RBC detector aperture ................... 9-14

9.10 Removing air bubbles from the flow cell

in the optical detector block................................. 9-17

9.11 Cleaning the flow cell in the optical

detector block...................................................... 9-17

9.12 Drain waste fluid.................................................. 9-18

9.13 Rinse waste chamber.......................................... 9-18

9.14 Replacing the waste container (option)............... 9-20

9.15 Cleaning the Lower Tray of the Manual

Aspiration Pipette ................................................ 9-21

9.16 Replacing and registering reagents .................... 9-21

9.17 Expiry Date Check Function................................ 9-30

9.18 Reagent replacement log display function .......... 9-32

9.19 Remaining reagent volume function .................... 9-36

9.20 Replacing the piercer .......................................... 9-38

9.21 Replacing the hand clipper.................................. 9-41

9.22 Replacing rubber plate No. 39............................. 9-42

9.23 Replacing the fuses............................................. 9-43

9.24 Adjusting pressure and vacuum .......................... 9-44

9.25 Supplies and replacement parts ......................... 9-49

9.26 Replacing the instrument parts periodically ........ 9-50

9.27 XT-4000i maintenance and inspection

check list ............................................................. 9-51

Revised March 2010

Sysmex XT-4000i Instructions for Use III

Table of Contents

Chapter 10 Troubleshooting......................10-1

10.1 Help dialog box......................................... ... .... ... .10-1

10.2 Error log...............................................................10-2

10.3 Error message list................................................10-3

10.4 Troubleshooting guide..........................................10-7

10.5 Test ....................................................................10-23

Chapter 11 Technical Information.............11-1

11.1 Perfor m a nc e/s pe cif i cat ion s of the XT-400 0 i.........11-1

11.2 Possible sample interferences.............................11-6

11.3 Interface protocol.................................................11-7

11.4 Program version...................................................11-7

11.5 Principles .............................................................11-8

11.6 Contents of the packages ..................................11-25

11.7 Check before installation....................................11-29

11.8 Grounding..........................................................11-29

11.9 Installation environment.....................................11-29

11.10 Installation space ...............................................11-30

Chapter 12 Warranty ..................................12-1

Chapter 13 Index.........................................13-1

IV Sysmex XT-4000i Instructions for Use

January 2009

1. Introduction

CHAPTER 1 Introduction

The Sysmex XT-4000i is an automated hematology analyzer
for in vitro diagnostic use in clinical laboratories.
The XT-4000i can analyze and output the results for 39
parameters.
WBCs and reticulocytes are analyzed b y the optical det ector
block based on the fluorescence flow cytometry method
using semiconductor laser.
RBCs and platelet count are analyzed by the RBC detector
using the Hydro Dynamic Focusing method.
Hemoglobin (HGB) is analyzed by the HGB detector based
on the SLS hemoglobin determination method.
Analysis data is displayed on the Information Processing
Unit (IPU).

Note:

Data generated by the XT-4000i is not intended to
replace professional judgment in the determination of
a diagnosis or in monitoring patient therapy .

Note:

Operate the instrument as instructed. Reliability of test
results cannot be guaranteed if ther e are any
deviations from the instructions in this manual. If the
instrument fails to function properly as a result of
either the user’s operation not specified in the manual
or the user’s utilization of a program not specified by
Sysmex, the product warranty would not apply.

January 2009

Sysmex XT-4000i Instructions for Use 1-1

CHAPTER 1 Introduction

Contact Address

Manufacturer

Authorized Representative

EC REP

Americas

SYSMEX CORPORATION
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Ko be, Hyogo 651-0073
JAP AN

European Representative

SYSMEX EUROPE GmbH
Bornbarch 1
D – 22848 Norderstedt, Germany
Phone: [phone]
Fax: [phone]

SYSMEX AMERICA, Inc.
1 Nelson C. White Parkway,
Mundelein, IL 60060 U.S.A.
Phone: [phone]
Fax: [phone]

Asia-Pacific

SYSMEX ASIA PACIFIC PTE LTD.
2 Woodlands Sector 1,
#01-06 Woodlands Spectrum,
Singapore 738068
Phone: [phone]
Fax: [phone]

Ordering of Supplies and Replacement Parts

If you need to order supplies or replacement parts, please
contact your local Sysmex representative.

Service and Maintenance

Please contact the Service Department of local Sysmex
representative.

CE-mark

The IVD-system described in this manual is marked with a

CE-mark which confirms the observance of the essential

requirements of the following European directive:
98/79/EC IVD Directive

1-2 Sysmex XT-4000i Instructions for Use

January 2009

1.1 Hazard information in this manual

Note, Information, Caution and Warning statements are
presented throughout this manual to call att ention to
important safety and operational information. Non­compliance with this information comprom ises the safety
features incorporated in the analyzer.

This symbol indicates a possible hazardous situation
which, if not avoided, may result in infection by
pathogens and others.

High risk. Ignoring this warning could result in
personal injury to the operator.

CHAPTER 1 Introduction

Risk of infection

Warning!

Caution!

Ignoring this warning could result in property damage
or incorrect results. To avoid damage and incorrect
measuring results, this caution must be followed.

Information

Minor risk. Considerations that should be observed
when operating this instrument.

Note:

Background information and practical tips.

January 2009

Sysmex XT-4000i Instructions for Use 1-3

CHAPTER 1 Introduction

1.2 Protected names

• Sysmex is a registered trademark of SYSMEX

CORPORATION.

• STROMATOLYSER, CELLPACK, SULFOLYSER, RET

SEARCH and CELLCLEAN are registered trademarks of
SYSMEX CORPORATION.

• ISBT128 (International Society of Blood Transfusion) is

copyrighted by a nd is used u nder License Agr eement wit h
ICCBBA, Inc.

• Windows Vista is a registered trademark of Microsoft

Corporation.

Other trademarks referenced are prope rty of their respective
owners.
TM and ® are not specified in this manual.

1.3 Information when using this manual

• Unauthorized reproduction of the content of this manual,

in whole or in part, is prohibited.

• The contents of screens illustrated in this manual may

differ from the actual screens displayed on the instrument.

• Please note that the product m a y diff er from the content of

this manual, for reasons of product improvement.

1.4 Measurement parameters

The XT-4000i can analyze the following parameters:

WBC* Number of all leucocytes
RBC* Number of all erythrocytes
HGB* Hemoglobin concentration
HCT* Hematocrit value: Erythrocyte ratio of total

MCV* Mean erythrocyte volume in total sample
MCH* Mean hemoglobin volume per RBC
MCHC* Mean hemoglobin concentration of

PLT* Number of all platelets
NEUT% Neutrophil Perce nt
LYMPH% Lymphocyte Percent
MONO% Monocyte Percent
EO% Eosinophil Percent
BASO% Basophil Percent
NEUT# Neutrophil Count
LYMPH# Lymphocyte Count
MONO# Monocyte Count
EO# Eosinophil Count
BASO# Basophil Count

blood volume

erythrocytes

1-4 Sysmex XT-4000i Instructions for Use

January 2009

CHAPTER 1 Introduction

RDW-SD Calculated distribution width of

erythrocytes, standard deviation

RDW-CV Calculated distribution width of

erythrocytes, coefficient of variation

PDW Calculated distribution width of platelets
MPV Mean platelet volume
P-LCR Platelet-Large Cell Ratio
PCT Plateletcrit
RET%* Reticulocyte Percent
RET#* Reticulocyte Count
IRF Immature Reticulocyte Fraction
LFR Low Fluorescence Ratio
MFR Middle Fluorescence Ratio
HFR High Fluorescence Ratio

IG% Immature Granulocyte Percent
IG# Immature Granulocyte Co unt
RET-He Calculated from RET-Y and represents the

reticulocyte hemoglobin equivalent

WBC-BF WBC body fluid
RBC-BF RBC body fluid
MN% Mononuclear cell percent
MN# Mononuclear cell count
PMN% Polymorphonuclear cell percent
PMN# Polymorphonuclear cell count

*: Parameters analyzed in capillary mode.

January 2009

Sysmex XT-4000i Instructions for Use 1-5

CHAPTER 1 Introduction

Blank page

1-6 Sysmex XT-4000i Instructions for Use

January 2009

2. Safety Information

2.1 Specified conditions of use

The Sysmex XT-4000i is an automated hematology
analyzer for in vitro diagnostic use in clinical laboratories.
Only human blood, human body fluids or control blood
should be run. Any other use is regarded as non-specified.
Use only the reagents and rinse solutions mentioned in this
manual.
The specified conditions of use also entail the observance of
the cleaning and maintenance procedures described in
these instructions.

2.2 General information

Before operating this instrument, carefully read this manual,
and strictly follow its instructions.
Keep this manual for future reference after reading.

CHAPTER 2 Safety Information

Warning!

• Unpacking, installation, and confirmation of initial
operation must be done by Sysmex technical
representative.

• Keep your fingers, clothes and hair etc. away from
the instrument while it is in operation. There is a risk
of injury from becoming tangled or trapped in the
machinery.

• If the instrument emits an abnormal odor or smoke,
turn off the power switch immediately and disconnect
the power cord from the Main Unit. If the instrument
is used continuously in this condition, fire, electrical
shock or injury may result. Contact promptly your
Sysmex technical representative.

• Take care not to spill any fluids, or drop wire staples
or paper clips into the instrument. This might cause a
short circuit resulting in smoke emission. If such an
incident occurs, turn off the power switch
immediately and disconnect the power cord from the
Main Unit. Contact your Sysmex technical
representative.

• Do not remove the outer cover while the instrument
is in use. There is a risk of electrical shock or
instrument failure.

• Do not touch the electrical circuits inside the cover,
particularly if your hands are wet. Electrical shock
may result.

• Relocating instrument may require an adjustment
and confirmation. Please do not relocate this
instrument system by yourself. If you wish to move
this instrument to another location, please contact
your Sysmex technical representative.

January 2009

Sysmex XT-4000i Instructions for Use 2-1

CHAPTER 2 Safety Information

2.3 Installation

Warning!

• Never put the power plug in any socket other than
the specified voltage. When installing the instrument,
be sure to ground it, otherwise fire or electrical shock
may result.

• Take care not to damage the power cord, not to
place a heavy device on it and not to pull it forcibly,
otherwise the wire may break causing fire or
electrical shock.

• When connecting the instrument to a peripheral (host
computers and printer etc.), be sure to turn off the
power switch beforehand, otherwise electrical shock
or instrument failure may result.

Caution!

• Install the instrument in a place which is not subject
to water splash.

• Install the instrument in a place which is not subject
to adverse effects of high temperature, high humidity,
dust, direct sunlight, etc.

• Do not give the instrument strong vibration or impact.

• Install in a well-ventilated area.

• Do not install near devices that cause signal noise,
such as radios and centrifugal machines.

• Do not install the instrument near chemical storage
or a place where a gas is generated.

• Do not use this instrument in any operating
environment which has electro-conductive or
flammable gases, including oxygen, hydrogen and
anesthetic.

• This instrument was designed for indoor use only.

2.4 Electromagnetic compatibility (EMC)

This instrument complies to the following IEC (EN)
standards:

• IEC61326-2-6:2005 (EN61326-2-6:2006)

• EMI (Electromagnetic Interference)
For this standard the requirements of class A are fulfilled.

• EMS (Electromagnetic Susceptibility)
For this standard the minimum requirements with regards
to immunity are fulfilled.

2-2 Sysmex XT-4000i Instructions for Use

January 2009

2.5 Avoidance of infection

CHAPTER 2 Safety Information

Risk of infection

• In principle, all parts and surfaces of the instrument
must be regarded as infective.

• Never touch waste or parts having been in contact
with waste with bare hands.

• Should you inadvertently come in contact with
potentially infective materials or surfaces,
immediately rinse skin thoroughly with water, then
follow your laboratory’s prescribed cleaning and
decontamination procedures.

• Be careful when handling samples and control blood.
Use of personal protective equipment is strongly
recommended when operating, maintaining,
servicing or repairing the instrument.

• If patient samples or control material contact your
eyes, wash the area with plenty of water and
immediately contact a physician.

• Be careful when handling waste. If you get it on your
skin or clothes, wash with an antiseptic cleanser.

2.6 Maintaining the instrument

Risk of infection

Always wear protective clothing, gloves and
eyeglasses when performing maintenance or
inspection to prevent contact with blood contaminated
parts. Wash your hands thoroughly following
maintenance.

Information

When performing maintenance, use only the tools
specially provided for such work. All cleaning and
maintenance procedures as described in this manual
must be observed for optimal performance.

January 2009

Sysmex XT-4000i Instructions for Use 2-3

CHAPTER 2 Safety Information

2.7 Handling of reagents

Warning!

• Do not directly touch reagents. Reagents can cause
irritation of the eyes, skin and mucous membranes.

• Should you inadvertently come in contact with
reagent, immediately rinse skin thoroughly with
water.

• If a reagent should get in your eyes, immediately
rinse thoroughly with water and see a physician
immediately.

• If reagent is accidentally swallowed, follow
recommendations on Material Safety Dade Sheets
(MSDS) and see a physician immediately.

• CELLPACK diluent is electrically conductive. If
diluent is spilled inadvertently near electrical cables
or appliances, there is a risk of electrical shock.
Switch the instrument off, unplug it and remove the
liquid.

• CELLCLEAN is a strong alkaline detergent. It should
not come in contact with skin or clothing. If it
happens nevertheless, rinse skin or clothing with
plenty of water to avoid injury or damage.

• CELLCLEAN contains sodium hypochlorite. If
CELLCLEAN comes in contact with the instrument’s
surfaces, there may be a possibility of corrosion.
Immediately wipe up CELLCLEAN with a damp
cloth.

• Make sure the reagents used with the instruments
are kept level or below the Main Unit of the
instrument. Do not put reagents on top of the
instrument.

Caution!

• Do not inject or ingest.

• Follow directions on reagent containers.

• Avoid letting reagents come in contact with dust, dirt
or bacteria especially when installing new cubes.

• Reagents must not be used after their expiration
date.

• Handle reagents gently to avoid bubbling. Never
shake reagents. Do not use reagents immediately
after moving them.

• Take care not to spill reagents. If a reagent is spilled,
wipe up with a damp cloth.

2-4 Sysmex XT-4000i Instructions for Use

January 2009

2.8 Laser

CHAPTER 2 Safety Information

Warning!

The XT-4000i contains the semiconductor laser unit.
This semiconductor laser unit is shielded with the
shield box cover, and is provided with an interlock
system that prevents laser from oscillation if the cover
is removed. Do not open this cover, otherwise the
laser beam can damage your eyes.

Laser Diode

NOTE: This caution label is

located inside the
Laser Unit Cover.

2.9 Disposal of waste fluids, disposables and instruments

Risk of infection

Use of gloves is strongly recommended when
handling waste fluids or instrument consumables.
Wash your hands thoroughly following maintenance.

Warning!

• The computer has batteries installed inside to
maintain data in the memory chips. When the
computer is disposed of, please remove the
batteries. The danger of them exploding exists if they
are put into a fire.

• Waste fluids, instrument consumables and other
waste materials must be disposed of appropriately in
accordance with local laws, with due consideration of
medical, infectious and industrial wastes.

January 2009

Sysmex XT-4000i Instructions for Use 2-5

CHAPTER 2 Safety Information

2.10 Marking on the instrument

: This symbol indicates risk of infection. (See note.)

: This symbol indicates caution, risk of danger. (See note.)

Main Unit - Front View

(2)

(1)

(1)

WARNING

Do not remove this CP cover when the
Main Unit power is ON.

(2)

RISK OF INFECTION

In principle, all parts and surfaces of the
instrument must be regarded as infective.

(1)

(2)

(1)

WARNING

When working with the front cover open,
make sure that the stop bar is in place.

(2)

WARNING

Do not put your fingers inside to avoid
being injured.

2-6 Sysmex XT-4000i Instructions for Use

January 2009

Main Unit - Left View

(1)

Pneumatic Unit - Front View

CHAPTER 2 Safety Information

(1)

WARNING

- To avoid electrical shock, disconnect
supply before servicing.

- For the continued protection against
risk of fire, replace only with Fuse of
the specified type and current rating.

FUSE RATING

6.3A 250V
TIME-LAG

(1)

RISK OF INFECTION

In principle, all parts and surfaces of the
instrument must be regarded as infective.

(1)

Pneumatic Unit - Rear View

(1)

(1)

(2)

(1)

CAUTION

Do not close the air outlet on the rear of
Pneumatic Unit

(2)

WARNING

- To avoid electrical shock, disconnect
supply before servicing.

- For the continued protection against
risk of fire, replace only with Fuse of
the specified type and current rating.
This equipment must be GROUNDED.

January 2009

Sysmex XT-4000i Instructions for Use 2-7

CHAPTER 2 Safety Information

2.11 Personnel

2.12 Host Connection

Caution!

• This instrument may only be operated by trained
personnel having been instructed in its operation.

• Only appropriately trained persons must perform
maintenance and repair work. Follow
troubleshooting instructions in the manual.

• Unpacking, installation, and confirmation of initial
operation must be done by Sysmex technical
representative.

Caution!

When orders are downloaded from Host, start
operation after all orders of the racks to be analyzed
are completed to be downloaded. If the analysis is
started before the downloading is completed, the
analysis starts before the order is received depending
on the transfer speed. In that case, the order is
analyzed with the sample No. of the default settings.

2-8 Sysmex XT-4000i Instructions for Use

January 2009

2.13 Computer viruses

CHAPTER 2 Safety Information

Warning!

Although our software has already been checked for
computer viruses, the configuration of a specific user
environment may make it prone to computer virus
infections via the Internet or a network.
We recommend that our customers consider
computer virus countermeasures that suit their
computer operating environment. Customers that use
antivirus software in their operating environment
should take the following precautions.

1. Use the antivirus software to periodically check for
viruses.
(1) Use antivirus software designed for your

operating system to periodically check for
viruses.

(2) Disable the antivirus software during instrument

software operation as it may adversely affect

instrument operation.
(3) Disable functions that check file access.
(4) Disable firewalls and any other functions that

protect or control data transfers.

2. Do not install any software other than the antivirus
software.

3. USB memory sticks, CD-Rs and other external
memory devices should be checked for viruses
before use.

4. Do not open files attached to email or files of
unknown origin without first performing a virus
check.

5. Do not download files from the Internet or other
sources that are not required for instrument
operation. However, the virus definition files used
by the antivirus software are not subject to this
restriction.

6. Always check for viruses before accessing files in a
folder shared with other computers.

7. Check effectiveness of computer virus
countermeasures used on other computer systems
in your laboratory, and select the most effective for
use on this instrument.

8. The customer must take sole responsibility when
connecting to an external network (for example, the
Internet).

Revised December 2009

Sysmex XT-4000i Instructions for Use 2-9

CHAPTER 2 Safety Information

2.14 Use of other software

2.15 CD Drive

Warning!

• Do not install any software other than that
preinstalled on the instrument. And do not run any
other software on the instrument. However, this
restriction does not include the installation of
antivirus software.

• Note that we will accept no liability whatsoever for
any malfunctions arising from use of other software.

Caution!

If the CD drive is accessed while the Information
Processing Unit (IPU) is running, the drive tray may
open automatically.
Do not place anything in front of the tray. This may
upset samples or other objects that are in front of the
tray.

2-10 Sysmex XT-4000i Instructions for Use

Revised December 2009

3. Design and Function

3.1 Overview

CHAPTER 3 Design and Function

1

7

(XT-4000i)

1

7

2

34

65

2

34

85

(XT-4000i MCP)

1Main Unit

Analyzes samples.

2 Information Processing Unit (IPU)

Processes data which it receives from the Main Unit.

3 Ledger printer (option)

Prints lists of analysis information or results.

4 Color graphic printer (option)

Prints a hardcopy of analysis results or screen of histograms, scattergrams, etc.

5 Pneumatic unit

Supplies pressure and vacuum used by the Main Unit.

6 Sampler unit

Supplies samples to the Main Unit automatically.

7 Data printer (option)

Prints analysis data in the examination ticket format.

8 MCP (option) (Manual Cap Piercer) model: XT-MCP*

January 2009

Sysmex XT-4000i Instructions for Use 3-1

This is a special sample supply device for manual closed mode analysis.
* : In this instructions for use, MCP Unit refers to “model XT-MCP”

CHAPTER 3 Design and Function

3.2 Main Unit

Front View

5

4

1

2
3

1READY LED

Lights up when the Main Unit enters Ready status.

2 Manual aspiration pipette

Used to aspirate a sample in manual or capillary mode.

3 START switch

Used to start an analysis in manual, capillary or manual closed mode.

4 CP cover

This is the protection cover of cap piercing unit.

5 Front cover

Can be opened upward by hand. Open the cover to inspect or clean inside the Main
Unit.

Warning!

When inspecting inside the Main Unit with the front cover opened, be sure to set
the stop bar in advance, otherwise the cover can drop down and injure your head.

3-2 Sysmex XT-4000i Instructions for Use

January 2009

Rear View

10

CHAPTER 3 Design and Function

1
2

3

CC

4

56789

1 FBA inlet nipple

STROMATOLYSER-FB is aspirated via this nipple. Connected to the container of
STROMATOLYSER-FB.

2 FFD reagent inlet nipple

STROMATOLYSER-4DL is aspirated via this nipple. Connected to the container of
STROMATOLYSER-4DL.

3 IPU connector

The communication connector with the IPU. Connected to the connector of the IPU
using the provided cable.

4 Pneumatic Unit control output connector

Used as output connector for controlling ON/OFF of the Pneumatic Unit power.
Connected to the connector on the rear panel of the Pneumatic Unit.

5 Vacuum supply nipple (VACUUM)

Connected to the vacuum outlet nipple of the Pneumatic Unit.

6 Pressure supply nipple (PRESSURE)

Connected to the pressure outlet nipple of the Pneumatic Unit.

7 RED diluent inlet nipple

RET SEARCH (II) diluent is aspirated via this nipple. Connected to the container of
RET SEARCH (II) diluent.

8 SLS inlet nipple (SLS)

SULFOLYSER is aspirated via this nipple. Connected to the container of
SULFOLYSER.

9 Waste outlet nipple

Waste fluid is discharged via this nipple. Connected to the drain or the waste
container.

10 EPK inlet nipple

CELLPACK is aspirated via this nipple. Connected to the container of CELLPACK.

January 2009

Sysmex XT-4000i Instructions for Use 3-3

CHAPTER 3 Design and Function

Left Side View

1
2
3

1Main switch

Turns the power ON and OFF.

Note:

Do not turn the power ON and OFF repeatedly in a short period of time.
This can cause an overload to blow the fuse.

2Fuse holder

This is a 250V, 6.3A (time lag) fuse.

Warning!

• To avoid electrical shock, disconnect supply before servicing.

• For the continued pr otection against risk of fire, replace only with a fuse of the
specified type and current ratings.

3 AC power supply

Supplies power using the provided power cable.

3-4 Sysmex XT-4000i Instructions for Use

January 2009

Front Interior

CHAPTER 3 Design and Function

9

10 11

8
7

1

6

2

5

3
4

1 HGB detector block

Includes the HGB analyzer.

2 Sample rotor valve (SRV)

Measures the predetermined volume of the aspirated whole blood sample.

3 Whole blood aspiration motor

Drives the whole blood aspiration pump.

4 Whole blood mixing unit

Mixes the sample from the Sampler Unit, aspirates blood, then returns the sample to
the sample rack.

5 Vacuum regulator

Adjusts the bellows pressure to -0.04 MPa.

6 RBC detector block

Includes the RBC detector.

7 Pressure 0.07 MPa regulator

Adjusts the pressure to 0.07 MPa.

8 Pressure 0.16 MPa regulator

Adjusts the pressure to 0.16 MPa.

9 Trap Chamber

Prevents reagent, etc. from flowing into the compressor when a part failure has
occurred in the instrument.

10 Reaction chamber

This chamber prepares dilution samples for analyzing WBC/BASO, 4DIFF, and RET.
The samples are retained at a constant t emper ature f o r a fix ed period of time , and are
then sent to the optical detector block for analysis.

11 Reaction chamber mixing motor

Mixes a dilution sample for analyzing WBC/BASO, 4DIFF, and RET.

January 2009

Sysmex XT-4000i Instructions for Use 3-5

CHAPTER 3 Design and Function

Left Interior

2

1

1 Sheath injector piston

Supplies a specified amount of diluted sample (1:500) to the RBC detector.

2 Air drier

Removes dust and moisture from the air (at PRESSURE side) supplied by the
Pneumatic Unit.

Right Interior

2

1

1 WBC detector

Includes the WBC optical detector and Laser Unit.

2 FCM Sheath injector pi ston

Supplies a specified amount of diluted sample to the optical detector block.

3-6 Sysmex XT-4000i Instructions for Use

January 2009

3.3 Pneumatic Unit

Front View

CHAPTER 3 Design and Function

1

2

1 Pressure 0.25 MPa Regulator

Regulates the 0.25 MPa pressure to be supplied to the Main Unit.

2 Pilot Lamp

Illuminates when the Pneumatic Unit power is ON.

January 2009

Sysmex XT-4000i Instructions for Use 3-7

CHAPTER 3 Design and Function

Rear View

12

3
4

5

1 Pressure outlet nipple

Supplies pressure to the Main Unit. Connects to the air drier inlet nipple of the Main
Unit.

2 Vacuum outlet nipple

Supplies vacuum to the Main Unit. Connects to the vacuum supply nipple of the Main
Unit.

3Fuse holder

Replace with provided time lag type fuse. The rating will be different depending on the
instrument specification.

Specification Part No. Description Fuse Type

100 -117 VAC 266-5011-3 Fuse 250V 4A ST4-4A-N1 Time Lag
220 - 240 VAC 266-5293-0 Fuse 250V 3.15A No. 19195 Time Lag

Warning!

• To avoid electrical shock, disconnect supply before servicing.

• For the continued protection against risk of fire, replace only with fuse of the
specified type and current ratings.

4 Power supply connector

Supplies power with the power cord provided.

5 Pneumatic Unit control input connector

The input connector for controlling the Pneumatic Unit ON/OFF. Connects to the
Pneumatic Unit control output connector of the Main Unit.

3-8 Sysmex XT-4000i Instructions for Use

January 2009

3.4 Sampler Unit

CHAPTER 3 Design and Function

4

3

1 Blood volume monitoring sensor

Monitors the volume of blood in the sample tube. If the volume is insufficient, the
sample cannot be analyzed.

2 Right rack pool

The racks are set in this pool. Up to 5 racks can be set at a time. Click “Sampler
Start” to feed the rack au tomatically to the analysis line.

3 Left rack pool

The rack shifts from the analysis line to this pool.

4 Analysis line

A rack automatically shifts to the left once per cycle in an amount equivalent to one
sample. On this line, the ID is read and the sample is caught by the hand.

1

2

January 2009

Sysmex XT-4000i Instructions for Use 3-9

CHAPTER 3 Design and Function

3.5 Information Processing Unit (IPU)

Front View

1

2

1 Main body

IPU Main Unit of the personal computer.

2 Keyboard

Used to operate the IPU.

3 Mouse

Used to operate the IPU.

Information

The IPU illustrations shown in this manual are for reference only. Refer to the
manual included with the computer for the layout of connection ports and other
details.
For further details, contact your Sysmex technical representative.

3

3-10 Sysmex XT-4000i Instructions for Use

January 2009

CHAPTER 3 Design and Function

Summary of the Information Processing Unit (IPU) display screen

1
2
3
4

5

6

1 Title bar

Displays the instrument name, display window name, No. of stored data, etc.

2 Menu bar

There are submenus for each menu item. A pull down men u will be displayed when
the mouse is left clicked over the menu item.

Information

There may be some menu that cann ot be selected, depending on the functions
currently effective.
Only menu items displayed in black may be selected.

3Tool bar

The tool bar contains items that are used compar atively of ten. Clic k the bu ttons on the
tool bar will immediately execute that submenu action. Inactive tool bar buttons are
displayed in gray.

4Tab

The names of windows indicating menu icons are displayed.
When there are several windows, select a desired tab to change over the windows.

5 Window (View)

Operations are performed in these areas or windows.

6 System status display area

The following status will be displayed:

• Sample No.

•Error message

• Main Unit status

•Analysis mode

• Discrete

• X-barM status

• Host computer connection status

January 2009

Sysmex XT-4000i Instructions for Use 3-11

CHAPTER 3 Design and Function

3.6 System Status Display

The System status display area displays icons informing about
Main Unit status, Analysis mode, Discrete, X-barM status, and
Host computer connection status.
The meaning of each icon is shown below.

Main Unit status

(Green)

(Yellow)

(Red)

(Green)

(Yellow)

(Red)

Analysis mode

READY status

Analyzing

Analysis not possible/Not READY status

STAT READY status

Analysis interrupt received
(Switching to STAT analysis)

STAT analysis not possible

Manual mode

Manual closed mode

Capillary mode

Sampler mode

Body fluid mode

January 2009

3-12 Sysmex XT-4000i Instructions for Use

Discrete mode

X-barM status

CHAPTER 3 Design and Function

CBC

CBC+DIFF

CBC+DIFF+RET

CBC+RET

(Blue)

X-barM OFF

X-barM ON

(Orange)

Host computer connection status

Host computer communication possible

(Green)

Communicating with host computer

(Yellow)

Host computer communication not possible

(Red)

Note:

The Host computer connection status icon is displayed only when Host (HC)
Connect is set to ON at Host (HC) Setting. For setting procedure, refer to
“Chapter 5: Instrument Setup” in the Software Guide.

January 2009

Sysmex XT-4000i Instructions for Use 3-13

CHAPTER 3 Design and Function

3.7 Analysis mode

Manual mode

In manual mode, the cap of the sample tube is manually removed and each sample is
aspirated individually via the whole blood aspiration pipette.

Capillary mode

In capillary mode, the sample diluted to 1:5 is aspirated manually via the whole blood
aspiration pipette, analyzed, displayed and repor ted.

Sampler mode

The sampler automatically mixes, aspirates and analyzes samples without removing their
caps. Up to 50 samples can be loaded at a time and analyzed automatically.

Manual closed mode

In manual closed mode, the sampler is used to aspirate the sample, without opening the
cap of the sample tube. This mode is basically the same as manual mode; mixing and
continuous analysis can not be performed automatically.

Body fluid mode

The body fluid mode is exclusiv ely used f or measuring the number of b lood cells contained
in body fluid. Sample aspiration is performed in the same method as for the manual mode.

Note:

Body fluid analysis can only be performed in manual mode.

3-14 Sysmex XT-4000i Instructions for Use

January 2009

4. Reagents

4.1 General information

4.2 CELLPACK

Intended Use

CHAPTER 4 Reagents

All reagents used in this instrument are specialized reagents
for use in Sysmex instruments. Please do not use these
reagents for other purposes. Please follow the warnings for
handling and using each of the reagents correctly.

Note:

To ensure both customers safety and optimal system
performance, the manufacturer recommends that all
reagents boxes are placed at a level even with or
below the instrument base.

Diluent for use in hematology analyzers.

Storage and Shelf Life after first Opening

Store CELLPACK at +1 to +30°C and out of direct sunlight.
If once frozen, mix it well after thawing.
If the container is unopened, it may be used up to the expiry
date stated on the reagent container.
Please refer to the product labeling (package insert or outer
package) for the open stability.

Usage

CELLPACK is a reagent for measuring the numbers and
sizes of RBC and platelets by the hydro dynamic focusing
(DC Detection). With the addition of the specified lyse
reagent for hemoglobin concentration determination, it can
also be used to analyze hemoglobin concentration.

Revised August 2010

Sysmex XT-4000i Instructions for Use 4-1

CHAPTER 4 Reagents

4.3 STROMATOLYSER-FB

Intended Use

A lyse reagent for the WBC/BASO chann el of hematology
analyzers.

Storage and Shelf Life after first Opening

Store STROMATOLYSER-FB at +30°C or lower temperature
and out of direct sunlight.
If it freezes, mix it well after thawing.
If the container is unopened, it may be used up to the expiry
date stated on the reagent container.
Please refer to the product labeling (package insert or outer
package) for the open stability.

Usage

STROMATOLYSER-FB is a reagent for analyzing basophil
counts and WBC counts by the flow cytometry method,
using a semiconductor laser.

4.4 STROMATOLYSER-4DL

Intended Use

Diluent for the DIFF channel of hematology analyzers.

Storage and Shelf Life after first Opening

Store STROMATOLYSER-4DL at +2 to +35°C and out of
direct sunlight.
Do not use reagent that may hav e frozen.
If the container is unopened, it may be used up to the expiry
date stated on the reagent container.
Please refer to the product labeling (package insert or outer
package) for the open stability.

Usage

STROMATOLYSER-4DL is a reagent used in combination
with the specified dye solution (STR OMATOLYSER-4DS) to
classify WBC by the flow cytometry method, using a
semiconductor laser.

4-2 Sysmex XT-4000i Instructions for Use

January 2009

4.5 STROMATOLYSER-4DS

Intended Use

Dye solution for the DIFF channel of hematology analyzers.

Storage and Shelf Life after first Opening

Store STROMATOLYSER-4DS in a dark place at +2 to
+35°C.
Do not use reagent that may have frozen.
If the container is unopened, it may be used up to the expiry
date stated on the reagent container.
Please refer to the product labeling (package insert or outer
package) for the open stability.

Usage

STROMATOLYSER-4DS is a reagent used in combination
with the specified lyse reagent (STROMATOLYSER-4DL) to
classify WBC by the flow cytometry method, using a
semiconductor laser.

CHAPTER 4 Reagents

4.6 SULFOLYSER

Intended Use

A cyanide-free lyse reagent for the hemoglobin
determination in hematology analyzers.

Storage and Shelf Life after first Opening

Store SULFOLYSER at +1 to +30°C and out of direct
sunlight.
If it has frozen, thaw it in warm water at 30°C or below, and
mix it thoroughly before use.
If the container is unopened, it may be used up to the expiry
date stated on the reagent container.
Please refer to the product labeling (package insert or outer
package) for the open stability.

Usage

SULFOLYSER is a reagent used in combination with the
specified diluent to analyze the hemoglobin concentration
dissolved out of RBCs by the SLS-hemoglobin method.

January 2009

Sysmex XT-4000i Instructions for Use 4-3

CHAPTER 4 Reagents

4.7 RET SEARCH (II) (diluent)
RET SEARCH (II) (dye solution)

Intended Use

Diluent reagent and dye solution for the RET channel of
hematology analyz ers.

Storage and Shelf Life after first Opening

Store RET SEARCH (II) in a dark place at +2 to +35°C.
Do not use reagent that may hav e frozen.
If the container is unopened, it may be used up to the expiry
date stated on the reagent container.
Please refer to the product labeling (package insert or outer
package) for the open stability.

Usage

RET SEARCH (II) is a reagent using in the combination of
RET SEARCH (II) (diluent) and RET SEARCH (II) (dye
solution) to analyze reticulocytes and optically analyzed
platelets by the flow cytomet ry method, using a
semiconductor laser.

4.8 CELLCLEAN

Intended Use

CELLCLEAN is a strong alkaline detergent to remove lyse
reagents, cellular residuals and blood proteins remaining in
the hydraulics of Sysmex automated hematology analyzers.

Warnings and Precautions

Storage and Shelf Life after first Opening

Store CELLCLEAN in a dark place at +1 to +30°C.
Avoid exposing direct sunlight, or the chlorine component
may deform and lose its effectiveness, depending upon the
period of exposure.

Warning!

1. Avoid contact with skin and eyes.

2. In case of skin contact, flush the area with water.

3. In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice.

4. If accidentally swallowed, seek medical advice
immediately.

Usage

CELLCLEAN is a detergent to clean and remove cellular
residuals and blood proteins from the hydraulic systems,
detectors, whole blo od aspiration line tube a nd other parts in
the blood cell analysis instrument.

4-4 Sysmex XT-4000i Instructions for Use

January 2009

4.9 Control blood (e-CHECK or e-CHECK(XE))

Intended Use

e-CHECK and e-CHECK(XE) are hematology control
materials primarily for intralaboratory quality control of
automated, semiautomated and manual procedures that
measure components of blood. Additionally, e-CHECK and
e-CHECK(XE) can be used in external quality assessment.

Warnings and Precau tions

Risk of infection

When using control blood, use personal protective
equipment. After completion of the analysis , be sure to
wash your hands with an antiseptic cleanser.

Warning!

Potentially Infectious Material-All human source
material used to manufacture this product was non­reactive fo r ant ige ns to Hep ati tis B9(HbsAg) , neg at ive
by tests for antib odies to HIV(HIV-1/HIV-2) and
Hepatitis C9(HCV), non-reactiv e for HIR-1 RNA and
HCV RNA by licensed NAT, and non-reactive to
Serological Test for Syphilis(STS) using techniques
specified by the U.S Food and Drug Administration.
Because no known test method can assure complete
absence of human pathogens, this product should be
handled with appropriate precautions.

CHAPTER 4 Reagents

Storage and Shelf Life after first Opening

4.10 Labeling

January 2009

Store control material as per product insert at +2 to +8°C.
If unopened, e-CHECK and e-CHECK(XE) may be used up
to the expiration date shown on the container. Once opened,
it should be used within 7 days.

Important information about the handling of reagents and
quality control material is noted on the package insert and
containers. Please read the labels and package insert prior
to use.

Sysmex XT-4000i Instructions for Use 4-5

CHAPTER 4 Reagents

4.11 Symbols used on the labels

IVD

LOT 1234

22-Nov-2000

+NN C

-NN C

Xn

In Vitro Diagnostic

Consult instructions for use

Lot-number

Use by

Storage temperature

CE conformity sign as per directive
98/79/EC

Hazardous Class in EU

Manufacturer

EC REP

Authorized representative in
the European community

4-6 Sysmex XT-4000i Instructions for Use

January 2009

5. Before Using

5.1 Storage prior to transport and installation

• Once the instrument is delivered, chec k the condition of its
packaging as soon as possible.

Information

If the packaging has been damaged in any way,
contact your Sysme x technical represent ativ e as soon
as possible.

• Store the instrument as packaged in a dry place until
installation. Do not turn it over or store it upside down.

Information

A Sysmex technical representative will perform the
initial setup of this instrument. Thereafter, if you wish
to move it to another location, please contact your
Sysmex technical representative.

CHAPTER 5 Before Using

5.2 Preparation

• Install the XT-4000i in a dry and dust-free environment.

• It should be located in a space large enough to be used
safely. If additional equipment is to be connected to it,
further desk space will be required.

• The instrument weighs approximately 59 kg. Be sure to
use a table or desk that can support that amount of
weight.

• Leave a space of 50 cm or more between the walls and
the side, rear and top panels to allow for heat dissipation.
Also, leav e en ough space when installing for maintenance
and service work to be performed.

• Do not install this equipment near any devices that emit
high-frequency signals or noise (radios , centrifuges, etc.).

• The power cable for this instrument is 1.8 m long. Use a
nearby outlet that is designed for it.

January 2009

Sysmex XT-4000i Instructions for Use 5-1

CHAPTER 5 Before Using

5.3 Peripherals

Caution!

• Turn the power switch of th e instrument OFF before
connecting peripherals.

• Each peripheral device that is connected will need its
own power outlet. Do not plug multiple devices into
extensions and adaptors. Such wiring could cause
fire.

Ledger printer (option)
Color graphic printer (option)
Data printer (option)

(For the functions of the printers, see “Chapter 3: 3.1
Overview”).

5.4 Additional components

Note:

The ledger printer, color graphic printer and data
printer are optional.
Refer to the corresponding printer manuals for details
of their installation.

Stationary barcode scanner (option)

A stationary barcode scanner is used by installing it on the
sampler unit. It scans the barcode on the sample tube and
automatically inputs the sample and rack numbers.

Note:

The stationary barcode scanner is optional.

Handheld barcode scanner (option)

A handheld barcode scanner scans the barcode on the
sample tube and automatically inputs the sample number.

Note:

The handheld barcode scanner is optional.
Refer to the handheld barcode scanner manuals for
the connection method.

5-2 Sysmex XT-4000i Instructions for Use

January 2009

5.5 Basic equipment settings

Date and Time

Set the date and time accurately, using the Windows Vista
date and time adjustment function on the Information
Processing Unit (IPU).

CHAPTER 5 Before Using

Note:

This chapter only explains the settings related to the
initial operations. For more detailed information about
other settings, see “Chapter 5: Instrument Setup” in
the Software Guide.

Information

The date and time cannot be set from the XT-4000i
program.

January 2009

Sysmex XT-4000i Instructions for Use 5-3

CHAPTER 5 Before Using

Blank page

5-4 Sysmex XT-4000i Instructions for Use

January 2009

CHAPTER 6 Operation

6. Operation

6.1 Summary of Information Processing Unit (IPU) operation

Caution!

• The Information Processing Unit (IPU) is to be used
exclusively with the XT-4000i and can not be used as
a regular computer.

• Operation not covered in this manual or use of
programs not specified by Sysmex renders the
warranty invalid and may cause the Information
Processing Unit (IPU) to perform incorrectly.

Menu screen

The menu screen appears after the Information Processing
Unit (IPU) is turned on and the user logs in to the application
program.

Note:

The menu screen is customizable. Therefore, the
screen displays presented in this manual may differ
from the actual screen displays on the instrument.
For details of screen customization, see “Chapter 5:
Instrument Setup” in the Software Guide.

Menu selection

The following three methods may be used to select an item
on the menu.

• Click the button on the tool bar.

• Click on the menu, then select th e subme n u item from the
items on the screen.

• Double-click the icon on the menu screen.

Dialog box

The dialog box is displayed when a specified menu or

January 2009

Sysmex XT-4000i Instructions for Use 6-1

command button is selected.

CHAPTER 6 Operation

6.2 Information Processing Unit (IPU) menu bar

Menu Submenu Menu Function

File Open

Close
Save
Print
Log Off
Exit

Edit Select All

Find
Property

View Toolbar

Status Bar
Menu
QC
Work List
Sample Explorer
Data Browser

Record Sort

Filter
Auto Add
Manual Add
Delete
Backup
Restore
Download
First
Upper
Lower
Last
Output (csv format)

Action Validate

Pending Li st
Last20

Report Host (HC)

Ticket (DP)
Report (GP)
Ledger (LP)
Report for Lab. Use Only

Setting Date Format

Auto Validate
Auto Output
Discrete
Analysis Ordering
User Administration
Host (HC) Setting
Report (GP) Setting
Ledger (LP) Setting
Categories
Reference Interval
Units
DP Setting
DP Format
CSV Output Setting
Backup

Window Cascade

Tile
Split

Help About IPU...

Analyze Help

Opens the data browser (only when the sample explorer is running).
Closes the window.
Overwrites and saves the presently selected item record.
Prints the screen.
Logs off (To the logoff screen.)
Quits the application. (To the quit confirmation screen.)

Selects all records.
Displays the search window.
Changes the tab title.

Displays or closes the tool bar.
Displays or closes the status bar.
Starts Menu.
Starts QC.
Starts Work List.
Starts Sample Explorer.
Starts Data Browser.
Realigns the displayed patient records. (To sort condition input dialog box.)
Selects displayed patient record. (To filter condition input dialog box.)
Adds new records.
Adds new records.
Deletes selected record.
Backs up selected record to the hard disk or USB device.
Lists up information saved to the hard disk or USB device.
Downloads from the host computer.
Moves to the top record.
Moves to the previous record.
Moves to the next record.
Moves to the last record.
Outputs the selected data as a file in CSV format.
Validates the displayed sample.
Displays the pending work list.
Displays the latest 20 samples.
Transfers the selected analysis results to the host computer (HC).
Prints the selected analysis results on a ticket printer (DP).
Prints the selected analysis results on a report printer (GP).
Prints the selected analysis results on a ledger printer (LP).
Prints the selected analysis results on a report printer (GP) with
laboratory-use-only format.
Starts Setting/Date.
Starts Setting/Auto Validate.
Starts Setting/Auto Output.
Starts Setting/Discrete.
Starts Setting/Analysis Ordering.
Starts Setting/User Administration.
Starts Setting/Host (HC) Setting.
Starts Setting/Report (GP) Setting.
Starts Setting/Ledger (LP) Setting.
Starts Setting/Categories.
Starts Setting/Reference Interval.
Starts Setting/Item Attributes.
Starts Setting/Ticket (DP) Setting.
Starts Setting/Ticket (DP) Format.
Starts Setting/CSV Output Setting.
Starts Setting/Backup Setting.
Displays the presently displayed windows cascade style.
Displays parallels in above and below, left and right.
Splits window display.
Displays the application version. (To version display dialog box.)

Displays the Help dialog box.

January 2009

6-2 Sysmex XT-4000i Instructions for Use

6.3 Operator checks

1. Reagent check

CHAPTER 6 Operation

Make sure that there is a suf ficient amount of reagent fo r the
day’s samples. If the amount is insufficient, prepare
replacement reagent. If reagent runs out during an ana lysis ,
the system automatically stops and alerts the operator to
replace the insufficient reagent. Analysis cannot be
restarted until replacement is completed. The following
shows the approx imate number of cycles that can be
analyzed per container of reagent.

● Samples Analyzed per Reagent Container

Reagent Abbreviation

cycles/

container

CELLPACK EPK Approx. 570

cycles

No. of

STROMATOLYSER­4DL

STROMATOLYSER­4DS

SULFOLYSER SLS Approx. 1000

STROMATOLYSER-FBFBA Approx. 2500

RET SEARCH (II)
(Dye solution)

RET SEARCH (II)
(Diluent)

FFD Approx. 2500

cycles

FFS Approx. 900

cycles

cycles

cycles

RED Approx. 500

cycles
Approx. 500

cycles

Capacity

per

container

20.0 L

5 L

42 mL

500 mL

5 L

12 mL

1 L

• The number of cycles per container refers to the number
of cycles that can be run in CBC+DIFF+RET analysis
mode.

Note:

• One package of STROMATOLYSER-4DS contains
3 bags × 42 mL of reag e nt.

• RET-SEARCH (II) diluent and dye solution are
packed toget her in one package.

January 2009

Sysmex XT-4000i Instructions for Use 6-3

CHAPTER 6 Operation

2. Printer paper

● Replacing the Reagent

Caution!

• Use reagent that has been left at room temperature
(15–30°C) for at least 24 hours.

• In handling a reagent that may have froz en, follow
the precautions given on the package, otherwise
analysis may not be performed correctly.

• When replacing the reagent container, make sure
that no dust adheres to the cubitainer spout kit,
otherwise analysis may not be performed correctly.

• After opening a reagent container , ma ke sure that no
dust, dirt or bacteria comes into the container,
otherwise analysis may not be performed correctly.

After replacing the reagent, perform the background check
several times. Check that the backgrou nd counts are below
the criteria (see page 6-7), then start the sample analysis.

Make sure that there is a sufficient amount of printer paper
for the day’s samples.

3. Equipment

4. Sampler

5. Waste fluid

Check the tubings and cables. Make sure that the tubing is
not bent and the power cord is securely plugged into the
outlet.

Make sure that there are no racks in the analysis line.
Remove any rack from the line. Make sure that the left and
right rack pools and analysis line are clear.

Discard any waste fluid that has collected in a waste
container (if applicable).
For the procedure for disposing of waste, see “Chapter 9
Cleaning and Maintenance”.

6-4 Sysmex XT-4000i Instructions for Use

January 2009

6.4 Turning ON the power

CHAPTER 6 Operation

Turn ON the power switches in the following order: 1)
Printer, 2) IPU, 3) Main Unit (after the logon screen of the
IPU program appears).

Note:

The power for the Pneumatic Unit is controlled by the
Main Unit; thus, you can normally leave the Pneumatic
Unit power switch ON.

January 2009

Sysmex XT-4000i Instructions for Use 6-5

CHAPTER 6 Operation

6.5 Logging on to the Information Processing Unit (IPU)

1. Turn on the IPU.

2. The Windows Vista (operating system) starts up, and
the user is automatically logged on to the Windows Vista
as “XT”.

3. The logon dialog box for the XT-4000i application
program is displayed.

4. Input a User Name and Password, and click “OK”.
Logon will be performed with the input User Name and
Password. Operation will be possible within the
permission set for that User Name.
To discontinue Logon, click “Exit”.

6.6 Self-checks

Information

• Logon can be performed with “Admin” in the
condition set at the shipment from the factory.

• “m121m” is the password for the “Admin” user on
shipment from the factory.

• Before using the unit, set a user name, password,
and permission.
Also, change the password for “Admin”.

Note:

See “Chapter 5: Instrument Setup” in the Software
Guide for the setting and changing procedures of the
password and permission.

User Name and Password are very important for proper
system management and should be correctly managed.
If you forget the User Name or Password, contact your
Sysmex technical representative.

When the Main Unit power is turned ON, the following
operations are perf ormed in this order: self-check, Main Unit
control program download, initialization of mechanical and
hydraulic parts, a rinsing sequence, waiting for temperature
stabilization, and a background check. If an error message
appears during this flow of operations, see “Chapter 10
Troubleshooting”.

6-6 Sysmex XT-4000i Instructions for Use

January 2009

Waiting for temperature stabilization

Reaction
chamber

Reagent
heater

FCM
Detector
Block

Approx. 40°C

Approx. 40°C

Approx. 40°C

Target temperature
(Varies with room temperature)

Background check

WBC 0.10 [×103/μL]

3

3

/μL]

/μL]

WBC-D 0.20 [×10
RBC 0.02 [×106/μL]
HGB 0.1 [g/dL]
PLT 10 [×10
PLT-O 10 [×103/μL]

CHAPTER 6 Operation

The temperatures of the reaction chambers, reagent heater,
and Flow Cell Module detector block are displayed in the
Temperature Monitoring dialog box. The system waits for
these to stabilize at their target temperatures.
When they have stabilized at their target temperatures, the
Temperature Monitoring dialog bo x is closed automatically. If
the box has not closed 30 minutes after the power was
turned ON, there may be a problem with t he instrument. If
this happens, turn the power OFF and cont act your Sysmex
technical representative.

After the temperature has stabilized, a background check is
performed by repeating bac kgrou nd analysis f or a maximum
of 3 times. If the background value is at or below the values
shown in the table at the left, the background check is
completed.
If the background values are not at or below the acceptable
values, a “BACKGROUND ERROR” results, and a Help
dialog box appears.
V alues f o r parame ters not at or belo w th e acceptab le values
are displayed in red in the Background Check dialog box.

Information

In the case of “BACKGROUND ERROR”, the
analysis can be performed by clicking “Cancel” on
the Help dialog box. However, the measured values
tend to be higher and correct results ma y not be
obtained for some analysis parameters.

Note:

• The sample ID number for the background check
data is “BACKGROUNDCHECK”.

• Background chec k data which are not at or belo w the
acceptable values are handled as a sample error

January 2009

(Func.).

Sysmex XT-4000i Instructions for Use 6-7

CHAPTER 6 Operation

If the background values are not at or below the acceptable
value, clicking “OK” on the Help dialog box will close the
dialog box and start automatic rinse. If the background
values still do not drop to or below the acceptable values,
see “Chapter 10: Troubleshooting”.

6.7 Auto output settings check

If Auto Output is desired, before starting an analysis, make
sure that the instrument is set to automatically transmit/print.
See “Chapter 5: Instrument Setup” in the Software Guide.

6.8 Quality control

Quality control ensures the reliability of the instrument and
reagents. QC will be used for long-term monitoring of the
stability of analysis values. It can also detect problems early,
or prevent them entirely.
Always run the quality control before analyzing samples. For
details, see “Chapter 7: Quality control”.

6.9 Conditions for sample analysis

Sample types

Venous Blood and body fluids.
If using micro collection systems, follow the manufacturer
package inserts and use relevant standards for collecting
small samples.

Collection conditions

Blood is collected in EDTA anticoagulant. Analyze sa mples
within 4 hours of collection.
If it is not possible to analyze the sample within 4 hours,
store it in a refrigerator at 2-8°C until it can be analyzed.
Return a refrigerated sample to room temperature before
analyzing it (for at least 15 minutes). Next, mix the sample
for at least 2 minutes.

All performance claims given in this manual were
generated using samples in EDTA anticoagulant.
Results may be affected by the use of other
anticoagulants. Therefore, each laboratory should
develop protocols for handling samples collected in
these anticoagulants.

Note:

6-8 Sysmex XT-4000i Instructions for Use

January 2009

6.10 Analysis mode

CHAPTER 6 Operation

With the XT-4000i, the analysis can be performed in five
modes: manual, capillary, sampler, manu al closed and bod y
fluid modes.

• Manual mode

In Manual mode, the caps of sample tubes are manually
removed and each sam ple is aspirated via the whole b lood
aspiration pipette.

• Capillary mode

In capillary mode, an analysis is performed after diluting
the sample to 1:5 ratio. This mode is used in analyzing a
minute amount of blood collected from the earlobe or
fingertip. The method used to aspirate the sample is the
same as that used in manual and body fluid modes.

• Sampler mode

The sampler automatically mixes, aspirates and analyzes
samples without removing their caps. Up to 50 samples
can be loaded at a time and analyzed automatically.

• Manual closed mode

In manual closed mode, the sampler is used to aspirate
the sample, without opening the cap of the sample tube.
This mode is basically the same as manual mode; mixing
and continuous analysis can not be performed
automatically.

6.11 Preparing sample analysis

Samples

January 2009

• Body fluid mode

The body fluid mode is exclusively used for measuring the
number of blood cells contained in body fluid. Sample
aspiration is performed in the same method as for the
manual mode.

• Collect the specified amount of blood (corresponding to
the amount of EDTA anticoagulant).

• Using CELLPACK dispense d ahead of time, dilute the
sample to a 1:5 ratio for capillary mode.

• Sample volumes
Manual, capillary and manual closed mode

Analysis
mode

Required
Sample

Aspirated
Sample

Manual Capillary Manual Closed

1.0 mL or more 40 μL or more 1.0 mL or more

Approx. 85 μL Approx. 85 μL Approx. 150 μL

Sampler mode

Diameter of Sample Tube

12 mm 15 mm
Required Sample 1.0 to 5 mL 1.0 to 7 mL
Aspirated Sample 150 μL

Sysmex XT-4000i Instructions for Use 6-9

CHAPTER 6 Operation

Sample tubes

c

b

a

• For manual mode analysis, the length of the sample tube
should be 75 mm or shorter.

• Use the type of vacuum sampling tube shown be low for
sampler analysis and manual closed analysis.

Diameter (a) 12-15 mm
Length (b) 75 mm or shor ter
Length including cap (c) 82 mm or shorter

Examples of suitable tubes

• VENOJECT II (TERUMO)

• Hemoguard (BD)

• VACUETTE (Greiner)

• Monovette (SARSTEDT)
Do not use reusable caps.

Note:

When VENOJECT II blood collection tube is used, a
stopper No. 167 (367-2309-1) is required. For details,
contact your Sysmex technical representative.

Sample tube adapters

Adapter

Affix a barcode label

If tubes hav e diameter s of less tha n 14 mm, at tach adapt ers
to the rack.

Diameter of Sample Tube Adapter

12 mm Adapter No. 58 (WHITE)
13 mm Adapter No. 56 (WHITE)
14 mm None
15 mm None

Make sure that the label is in the proper location so that the
barcode can be correctly read. Affix the barcode label as
shown in the figure below.
Also, when setting a sample tube in the r ack , make sure that
all of the barcodes can be seen through the rack slits.
The rack number barcode labels come in 2 sheets as a set.
So, affix another barcode label on the side face of the rack.

6-10 Sysmex XT-4000i Instructions for Use

January 2009

Sample Tube

(Sample ID number bar code
label)

A

61 mm

21 mm

16 mm

Affix label so that bar code enters
range indicated by A.

Area for blood volume sensor
(Do not affix bar code label
here.)

Rack

(Rack number bar code label)

Second Tube First Tube

Rack
Right
Side

Affix the rack label between the
first and the second tubes,
aligning to the top of the rack.

21 mm

CHAPTER 6 Operation

Warning!

Affix the barcode label so that the bars on the label
are horizontal when the ra c k is placed on the samp ler.
If the barcode label is affixed slanted, the potential for
misreading the barcode label will be increased.

Caution!

• Use the check-digit as much as possible. If the
check-digit cannot be used, the po tential for incorrect
reading of the bar code label may be increased.

• Sample tubes with multiple labels, or labels which
are not flat and smooth against the tube , may cause
interference with sampling. The sampler is likely to
jam, and in extreme circumstances, the sampler may
not be able to properly release the tube back into its
original rack position. This could result in sample
misidentification.
To prevent this occurrence, it is recommended to:

- Affix labels in the correct position;

- Place no more than two la bels on the sample tube;

- Assure labels are flat and smooth against the
tube, without creases or flaring;

- Assure label does not peel off the tube;

- Sample tubes with barcode labels affixed must
slide smoothly in and out of the racks.

Information

• Affix the rack number barcode label in line with the
sample tube barcode label.

• If the barcode is affixed in the area for the blood
volume sensor, the volume of sample cannot be
accurately monitored.

• The barcode label must never protrude beyond the
bottom of the sample tube. If it does, the sample tube
may be picked up incorrectly, and the instrument
could be damaged.

January 2009

Sysmex XT-4000i Instructions for Use 6-11

CHAPTER 6 Operation

Sample number and Rack number input

• You can enter up to 15 alphanumeric characters and
hyphens f or the Sample ID number.

• When a sample ID number includes alphabet ic charact ers
or a hyphen, the digits af ter the f irst alphab et or h y phen as
counted from the numerical last digit automatically
increment.
(1A-B98 is follow ed by 1A-B99 and 1A-B00.)

• Rack number and tube position number can consist of
numerals only.

• Rack numbers (RACK NO.) increase by 1 as each new
rack arrives at the analysis line.

• The blood sample tube position number (TUBE POS. NO.)
shows the location of the tube on the rack.
Because the initial value is 1, this setting is not needed
when beginning the analysis with the sample on the far lef t
of the rack.

Information

Do not use zero as the sample ID number since the
result will not be stored. If the ID number is set to zero,
the short beep sounds during aspiration.

6-12 Sysmex XT-4000i Instructions for Use

January 2009

6.12 Sample analysis in manual mode

When analyzing samples, be sure to wear gloves.
After completion of the analysis, be sure to wash your
hands with an antiseptic cleanser.
If your hands or body are conta minated b y bl ood, etc. ,
you might be infect ed by pathogen, etc.

Refer to “Chapter 6: 6.18 Body fluid analysis” when
performing body fluid analysis.

1. Make sure that the instrument is in READY status.
The READY LED should be lit.

READY LED

CHAPTER 6 Operation

Risk of infection

Note:

2. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

3. Double-click the “Manual Sample No.” icon on the
Controller Menu, or click the “Manual” button on the
tool bar.
The Manual Sample No. dialog box will appear.

4. Input the sample ID number.

5. Check the discrete setting. If it is necessary to change
the setting, click the appropriate “Discrete” to set it.

6. If the analysis mode is not set to Manual, click “Manual”
for “Mode” to set it .

January 2009

Sysmex XT-4000i Instructions for Use 6-13

CHAPTER 6 Operation

READY LED

START
Switch

7. When all settings are completed, click “OK” or

“Cancel”.
OK: The input sample ID number, discrete, and

analysis mode are confirm ed , an d th e dia log
box is closed.

Cancel: The input sample ID number, discrete, and

analysis mode are canceled, and the dialog
box is closed.

8. Mix the sample tube thoroughly by inv erting the tube.

9. Remove the cap carefully in order not to splash the
blood.

10. Hold the sample tube under the manual aspiration
pipette so that the tip of the pipette is at the bottom of
the sample tube; then press the START switch.
Do not remove the sample tube while the READY LED is
blinking; the sample is being aspirated.

11. After the READY LED turns off (and a short beep
sounds two times), remove the sample tube.

Caution!

To remove the sample tube, pull straight down to
prevent bending the manual aspiration pipette,
otherwise the blood may spatter.

Note:

The manual aspiration pipett e is automatically
rinsed, and does not need to be wiped manually.

12. When the READY LED turns on again, prepare the next
sample and repeat steps 8 - 11.

Information

If a message calling for reagent replacement is
displayed du ring analysis, replace with ne w reagent.
If the replace reagent sequence is executed when
reagent amount is insufficient, bubbles may occur,
resulting in higher background value.

6-14 Sysmex XT-4000i Instructions for Use

January 2009

• If sample ID number is not set, they ar e automatically
assigned sequentially. (Automatic increment
function)

• When settings are made as shown below, analysis
order, etc. are inquired after the input of the sample
ID number.
Real time Request (Manual Mode)

• When the sample ID number is incremented
automatically for each analysis, the analysis order
and patient information are not inquired.

6.13 Sample analysis in capillary mode

When preparing a sample for capillary analysis, and
when analyzing a sample, be sure to wear gloves.
After completion of the analysis, be sure to wash your
hands with an antiseptic cleanser.
If your hands or body are conta minated b y bl ood, etc. ,
you might be infect ed by pathogen, etc.

CHAPTER 6 Operation

Note:

[Sample ID]

Risk of infection

Preparing 1:5 dilution of the sample

Prepare 1:5 diluted sample using the following materials.

• Diluent (CELLPACK)

• Microtube (MT-40, etc.)

• Pipette [40 μL]

• Pipette [160 μL]

• Diluent dispensing container (mayer, beaker, etc.)

• Diluent dispensing equipment (injector, etc.)

Caution!

Prepare and analyze the 1:5 diluted sample as soon
as possible after blood di spensing and dilution to
minimize platelet agglutination. Also, if diluent is
dispensed ahead of time, measurement errors are
generated because of e v aporation an d contamination ;
therefore, prepare new diluted sample each time an
analysis is performed.

January 2009

Sysmex XT-4000i Instructions for Use 6-15

CHAPTER 6 Operation

Sample analysis

READY LED

1. Rinse a diluent dispensing container (mayer, beaker,
etc.) with CELLPACK to remove dust, etc.

2. Dispense CELLPACK into the diluent dispensing
container.

3. Use a pipette (160 μL) to dispense 160 μL of CELLPACK
into a microtube.

4. Us e a pip et te (40 μL) to dispense 40 μL of blood into a
microtube.

5. Cap and mix the microtube well.

1. Ma ke sure that the instrument is in READY status.
The READY LED should be lit.

2. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

3. Double-click the “Manual Sample No.” icon on the
Controller Menu, or click the “Manual” button on the
tool bar.
The Manual Sample No. dialog box will appear.

4. Input the sample ID number.

5. Check the discrete setting. If it is necessary to change
the setting, click the appropriate “Discrete” to set it.

6. In capillary mode, only CBC or CBC+RET can be set.

6-16 Sysmex XT-4000i Instructions for Use

January 2009

READY LED

START
Switch

CHAPTER 6 Operation

7. If the analysis mode is not set to Capillary, click
“Capillary” for “Mode” to set it.

8. When all settings are completed, click “OK” or

“Cancel”.
OK: The input sample ID number, discrete, and

analysis mode are confirmed, and the dialog
box is closed.

Cancel: The input sample ID number, discrete, and

analysis mode are canceled, and the dialog
box is closed.

Information

Body fluid analysis is not possible in capillary mode.

9. Remove the cap carefully in order not to splash the
blood.

10. Hold the microtube under the manual aspiration pipette
so that the tip of the pipette is at the bottom of the
microtube; then press the START switch.
Do not remove the microtube while the READY LED is
blinking; sample is being aspirated.

11. After the READY LED turns off (and a short beep
sounds two times), remove the microtube.

Caution!

To remove the microtube, pull straight down to
prevent bending the manual aspiration pipette,
otherwise the blood may spatter.

Note:

The manual aspiration pipette is automatically
rinsed, and does not need to be wiped manually.

12. When the READY LED turns on again, prepare the next
sample and repeat steps 9-11.

Note:

• If sample ID number is not set, it is automatically
assigned sequentially. (Automatic increment
function)

• For the parameters that can be analyzed in
capillary mode, see “Chapter 1: 1.4 Measurement
parameters”.

January 2009

Sysmex XT-4000i Instructions for Use 6-17

CHAPTER 6 Operation

6.14 Sample analysis in sampler mode

1. Ma ke sure that the instrument is in READY status.
The READY LED should be lit.

READY LED

2. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

3. Double-click the “Sampler Sample No.” icon on the
Controller Menu, or click the “Sampler” button on the
tool bar.
The Sampler Sample No. dialog box will appear.

4. Input the sample ID number.

5. Check the rack number and tube posit ion numbe r f or the
initial sample. To make changes, click on the item to set
and then enter the numeric value.

6. Check the discrete setting. If it is necessary to change
the setting, click the appropriate “Discrete” to set it.

7. Put the sample tubes in the rack, and set the rack in the
right rack pool of the sampler.
Up to 5 sample racks can be loaded at a time.

6-18 Sysmex XT-4000i Instructions for Use

January 2009

CHAPTER 6 Operation

Caution!

If a sample is left in a stable condition for more than 4
hours and the blood cells and plasma are separa ted,
correct analysis results may not be obtained due to
insufficient mixing. Therefore, in case of analyzing
such samples, make sure to mix the samples
thoroughly before setting them on the sampler.

8. After a rack is set in the sampler, click “Sampler Start”
or “Cancel” on the Sampler Sample No. dialog box.
Sampler Start: The input sample ID number, rack

number, tube position number, and
discrete are confirmed. Th e Sam ple r
Sample No. dialog box is closed and
the Rack Number/Tube Position
Confirmation dialog box appears.

Cancel: The input sample ID number, rack

number, sample tube position number,
and discrete are canceled. The
Sampler Sample No. dialog box is
closed.

9. Check the rack number and tube position number in the
Rack Number/Tube Position Confirmation dialog box.
Then click “OK” or “Cancel”.
OK: The Rack Number/Tube Position Confirmation

dialog box is closed and sampler analysis
starts.

Cancel: The Rack Number/Tube Position Confirmation

dialog box is closed and the screen returns to
the Sampler Sample No. dialog box.

January 2009

Sysmex XT-4000i Instructions for Use 6-19

CHAPTER 6 Operation

Caution!

• Do not touch or remove the cover of the CP Unit
when the sampler is in operation.
You could be injured by the mechanical parts.
(If the cover is opened, analysis will be interrupted by
the monitoring switch.)

• Do not manually push (or move) the sample rack
forward during sampler analysis.
There is a small possibility that sample numbers and
analysis results could become misaligned.

• Do not touch the rack on the analysis line during
sampler analysis.

• Make sure there is no dirt or foreign substance on
the bottom of the rack. Also make sure there is no
breakage or deformation of the ra ck.

STAT analysis in sampler mode

Information

• When the manual closed mode is selected, it is
impossible to perform sampler analysis. To carry
out the sampler analysis, select the manual mode.

• Body fluid analysis is not possible in sampler
mode.

Note:

If the Sampler Sample No. di alog box is opened
during sampler analysis, the “Sampler Start”
button will be changed to a “Sampler Stop” button.
Clicking “Sampler Stop” will stop the sampler,
allowing STAT analysis (manual or capillary
analysis).

10. When all of the racks h a ve moved to the left rack pool of
the sampler, the READY LED turns on.

1. Open the Sampler Sample No. dialog box and click
“Sampler Stop”.
The Sampler Sample No. dialog box closes, the sampler
stops, and the system enters STAT READY stat us.
Manual or capillary analysis is possible.

2. Open the Manual Sample No. dialog box and input the
sample ID number for STAT analysis.

3. Analyze the sample by following the same pro cedu re as
for ordinary analysis.

6-20 Sysmex XT-4000i Instructions for Use

January 2009

4. When STAT analysis is completed, and the system has
returned to STAT READY status, open the Sampler
Sample No. dialog box. The button will have changed to
a “Sampler Restart” button. Clic k this button to resume
sampler analysis.

6.15 Sample analysis in manual closed mode

1. Make sure that the instrument is in READY status.
The READY LED should be lit.

READY LED

2. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

CHAPTER 6 Operation

3. Double-click the “Manual Sample No.” icon on the
Controller Menu, or click the “Manual” button on the
tool bar.
The Manual Sample No. dialog box will appear.

4. Input the sample ID number.

5. Check the discrete setting. If it is necessary to change
the setting, click the appropriate “Discrete” to set it.

6. If the analysis mode is not set to Closed, click “Closed”
for “Mode” to set it .

7. When all settings are completed, click “OK” or

“Cancel”.
OK: The input sample ID number, discrete, and

analysis mode are confirmed, and the dialog
box is closed.

Cancel: The input sample ID number, discrete, and

analysis mode are canceled, and the dialog
box is closed.

January 2009

Sysmex XT-4000i Instructions for Use 6-21

CHAPTER 6 Operation

Analyzing the Sample (when the Sampler is Attached)

1. Mix the sample thoroughly by inverting the tube; then
insert it into the far left position of th e r ack (tube position
No. 1).

Information

• In manual closed mode, a sample is not mixed
automatically. Be sure to perform mixing manually
before analysis.

• Body fluid analysis is not possible in manual closed
mode.

2. Set the rack at the rightmost position of the analysis line
in the sampler’s right r ack pool.

3. Press the ST ART s witch to start the analysis. The r ack is
transferred to the aspiration point, and aspiration and
analysis are performed automatically.

Caution!

Do not touch or remove the cover of the CP Unit
during sampler analysis.
You could be injured by the mechanical parts.
(If the cover is opened, analysis will be interrupted
by the monitoring switch.)

4. When the READY LED is lit, remove the remaining rack
in the analysis line, prepare the next sample, and repeat
the steps 1-3.

Information

If a message calling for reagent replacement is
displayed du ring analysis, replace with ne w reagent.
If the replace reagent sequence is executed when
reagent amount is insufficient, bubbles may occur,
resulting in higher background value.

6-22 Sysmex XT-4000i Instructions for Use

January 2009

Analyzing the Sample (when the Optional MCP is Attached)

1. Mix the sample tube thoroughly by inverting the tube.

2. Open the MCP cover and set the sample tube in place.

3. Close the MCP cover and press the START switch.

Caution!

• Be sure to close the MCP cover. Analysis cannot
be started if the cover is open.

• Sample aspiration is underway while the READY
LED is flashing. Do not open the MCP cov er during
this time.
(If the cover is o pened, the process of r eturning the
sample tube to the MCP is stopped. A warning
message appears and the alarm sounds.)

4. When the READY LED turns on, remove the MCP
sample tube. Prepare the next sample and repeat the
steps 1-3.

CHAPTER 6 Operation

Information

• If a message calling for reagent replacement is
displayed during analysis, replace with new
reagent. If the replace reagent sequence is
executed when reagent amount is insufficient,
bubbles may occur, resulting in higher background
value.

• To use sample tubes with 15 mm diameter, the
adapter must be removed.
For details, contact your Sysmex technical
representative.

January 2009

Sysmex XT-4000i Instructions for Use 6-23

CHAPTER 6 Operation

6.16 Display analysis results

The Data Browser screen on the IPU displays det ails of
analysis results.
For the display selection method and the display content,
see “Chapter 3: Stored Samples (Explorer)” and “Ch apter 4:
Data Browser” in the Software Guide.

6.17 Analysis result output

Caution!

• The Positive/Negative display is intended for use
only in the clinical laboratory and are not for pa tient
diagnosis.

• POSITIVE or ERROR judgments indicate the
possibility of sample abnormality. Such results
should be reviewed carefully and may require
further examination in accordance with the
protocol of your laboratory.

If automatic output has been set up, the analysis results will
be sent to the Graphic Printer, Data Printer and/or Host
Computer.
If automatic output has not been set up, the operator must
select the data and destination for output. See “Chapter 3:
Stored Samples (Explorer)” in the Software Guide.

6-24 Sysmex XT-4000i Instructions for Use

January 2009

6.18 Body fluid analysis

Summary of body fluid analysis

The body fluid analysis mode of the XT-4000i uses the
4DIFF scattergram and the RBC distribut ion obtained from a
specialized analysis sequence to calculate and display the
WBC (WBC-BF) counts, mononuclear cell (MN)/
polymorphonuclear cell (PMN) counts and percentages , and
RBC (RBC-BF) counts found in the body fluid.

Specimen type

Serous fluids, synovial flui ds, cerebrospinal fluid s (CSF) with
EDTA, as needed.

Analysis parameters

WBC-BF, RBC-BF, MN#, MN%, PMN#, PMN%

Sample analysis under body fluid analysis mode

To perform body fluid analysis, the body fluid analysis mod e
needs to be selected. The method for selecting body fluid
analysis mode and performing the analysis is explained
below.

CHAPTER 6 Operation

READY LED

Risk of infection

When analyzing samples, be sure to wear gloves.
After completion of the analysis, be sure to wash
your hands with an antiseptic cleanser.
If your hands or body are contaminated by blood,
etc., you might be infected by pathogen, etc.

Information

Samples should be measured immediately after
being drawn.

1. Make sure that the instrument is in READY status.
The READY LED should be lit.

2. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

January 2009

Sysmex XT-4000i Instructions for Use 6-25

CHAPTER 6 Operation

3. Double-click the “Manual Sample No.” icon on the
Controller Menu, or click the “Manual” button on the
tool bar.
The Manual Sample No. dialog box will appear.

4. Input the sample ID number.

5. Click “Body Fluid” for “Mode” to set the analysis mode.

6. When all settings are completed, click “OK” or

“Cancel”.
OK: The input sample ID number, discrete, and

analysis mode are confirm ed , an d th e dia log
box is closed.

Cancel: The input sample ID number, discrete, and

analysis mode are canceled, and the dialog
box is closed.

WBC-BF 0.001 [×103/μL]

6

RBC-BF 0.003 [×10

/μL]

Information

When “OK” is clicked, the input sample number is
used as the order key to query the analysis
information from the work list or from the host
computer. Patient information and sample
comments are acquired at that stage, but only the
six parameters of WBC-BF, RBC-BF, MN#, MN%,
PMN# and PMN% are analyzed, without reference
to the analysis order.

7. When “OK” is clicked, a backg r ound che ck is run at the
same time. If the background value is lower or equal to
that shown in the tab le on the left, th e bac kground ch eck
is completed.
(If the background v alue is higher th an that sho wn in the
table on the left, the value is displayed on a red
background.)

If the background values are not at or below the
acceptable values after background check is repeated
three times, a “BACKGROUND ERROR” results, and a
Help dialog box appears.

6-26 Sysmex XT-4000i Instructions for Use

January 2009

CHAPTER 6 Operation

Information

In the case of “BACKGROUND ERROR”, the
analysis can be performed by clicking “Cancel” on
the Help dialog box. However, the measured values
tend to be higher and correct results may not be
obtained.

If the background values are not at or below the
acceptable value, clicking “OK” on the Help dialog box
will close the dialog box and start automatic rinse. If the
background values still do not drop to or below the
acceptable values, see “Chapter 10: Troubleshooting”.

Information

• The basic analysis procedure is the same as for
normal mode, but for body fluid analysis it is
necessary to reliably eliminate background
influences. That is why the background check is
performed automatically.

• When the system is in body fluid mode, it cannot
perform QC analysis or calibration. Sampler
analysis and manual closed analysis are
unavailable.

8. If the result of the background check is such that the
background value is lower or equal to the acceptable
limit, the READY LED lights and the Main Unit enters
body fluid analysis ready status.

9. Mix the contents of the test tube gently but thoroughly.

Information

Excessive mixing can break blood cells in the body
fluid, making it impossible to obta in accurate r esults.
Take care not to mix sample excessively.

January 2009

Sysmex XT-4000i Instructions for Use 6-27

CHAPTER 6 Operation

READY LED

Analysis

Body Fluid

mode

Required
Sample

Aspirated
Sample

1.0 mL or more

Approx. 85 µL

START
Switch

10. Remove the cap carefully in order not to splash the
sample.

11. Hold the test tube under the manual aspir ation pipette so
that the tip of the pipette is at the bottom of the sample
tube; then press the START switch.
Do not remove the test tube while the READY LED is
blinking; sample is being aspirated.

Information

• Analysis requires an adequate sample volume.
Required sample volume is shown in the table on
the left. Correct analysis results cannot be
obtained if the instrument does not aspirate an
adequate sample volume.

12. After the READY LED turns off (and a short beep
sounds two times), remove the sample tube.

Caution!

To remove the sample tube, pull straight down to
prevent bending the manual aspiration pipette,
otherwise the blood may spatter.

Note:

The manual aspiration pipett e is automatically
rinsed, and does not need to be wiped manually.

13. When the READY LED turns on again, prepare the next
sample and repeat steps 9-12.
If you wish to complete body fluid analysis, click other
than “Body Fluid” (Either “Manual”, “Capillary” or
“Closed”) on the Manual Sample No. dialog box.

6-28 Sysmex XT-4000i Instructions for Use

January 2009

WBC-BF 1.000 [×103/μL]
RBC-BF 1.000 [×10

6

/μL]

CHAPTER 6 Operation

Caution!

If either of the analysis values from body fluid
analysis (WBC-BF and RBC-BF) is high, there is the
possibility of carryover on the analysis re sults f or the
next sample. If analysis results for WBC-BF and
RBC-BF exceed the values in the table on the left,
the “Execute Background check” error is displayed,
asking operater to perform a background check
before analyzing the next sample. Analyze the next
sample after performing the background check by
clicking “OK” on the Help dialog box.
Make sure to correct the “Execute Background
check” error before analyzing next sample.

Information

• Only analyze body fluid in body fluid analysis
mode. Always use other than body fluid mode for
analyzing human blood.

• Body fluid analysis is not compatible with negative
judgment.

• Body fluid analysis results are not subject to X

M

control.

Display analysis results

The analysis results of body fluid analysis mode are
displayed on th e samp le explorer and data browser screens
(the Body Fluid tab) of the Inf ormation Processing Unit
(IPU).
Samples analyzed in body fluid analysis mode are marked
with an “F” mark in the analysis mode display column of the
sample explorer and data browser screens.

Information

Analysis results from the analysis performed without
correcting an “Execut e Ba ckground check” error are
marked with an “F” mark on a red background on the
IPU.

January 2009

Sysmex XT-4000i Instructions for Use 6-29

CHAPTER 6 Operation

6.19 Timer processing

Recovery procedure

Note:

• Analysis parameter results other than WBC-BF,
RBC-BF, MN#, MN%, PMN# and PMN% are not
displayed, if the analysis was performed in the
body fluid analysis mode.

• Even if a patient ID is attached to the analysis
results obtained through body fluid analysis, the
results will not be subject to the cumulative data
display.

For details of the display methods on the Information
Processing Unit (IPU), see “Chapter 3: Stored Samples
(Explorer)” and “Chapter 4: Data Browser” in the Software
Guide.

When timer mode is used, the Pneumatic Unit power
automatically turns OFF if the Main Unit does not detect an y
operation within a preset amount of time.
For the setting method , see “Chapter 5: Instrument Set up” in
the Software Guide.

When the start switch is pressed, the Pneumatic Unit resets.

READY LED

START
Switch

6.20 Shutdo wn

By executing shutdown, the detector and dilution lines are
cleaned. Execute shutdown at the end of each day’s
analysis. When the instrument is used co ntinuously, perform
the shutdown procedure at least once e v ery 24 hours or 500
sample analysis.

Caution!

• Be sure to execute shutdown to clean the
instrument, otherwise analysis may not be
performed correctly.

• To execute shutdown, use CELLCLEAN only.

6-30 Sysmex XT-4000i Instructions for Use

January 2009

Main Unit shutdown

READY LED

START
Switch

CHAPTER 6 Operation

1. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

2. Double-click the “Shutdown” icon on the Controller
Menu.
The Shutdown dialog box will appear.

To cancel shutdown, click “Cancel” on the Shutdown
dialog box. The system will return to READY status.

3. Set CELLCLEAN to the manual aspiration pipette as
shown in the figure; then press the START switch in that
status.
While the READY LED is blinking and the buzzer is
sounding, aspiration is in progress. Keep holding
CELLCLEAN in the current status.

CELLCLEAN

Warning!

CELLCLEAN is a strong alkaline detergent. Pay
careful attention not to let it adhere to your body or
clothes. If CELLCLEAN adheres to your body or
clothes, wash it away immediately with plenty of
water, otherwise it can damage your skin or clothes.

4. After the READY LED turns off and buzzer stops,
remove the CELLCLEAN.

Caution!

When removing the CELLCLEAN container, pull it
down straight not to bend the manual aspiration
pipette, otherwise CELLCLEAN may spatter.

January 2009

Sysmex XT-4000i Instructions for Use 6-31

CHAPTER 6 Operation

Note:

The manual aspiration pipett e is automatically
rinsed, and does not need to be wiped manually.

5. The shutdown sequence in the Main Unit will start.

6. After the shutdown sequence is completed, the
Shutdown dialog box will be closed and “Please power
off the Analyzer” will appear on the P ow er Off dialog bo x.

7. If you wish to completely power off the analyzer, turn
OFF the Main Unit in the current status.
IPU can still be used.

Changing the user

Note:

If you wish to continue analysis with the Main Unit left
ON, select “Restart” on the Power Off dialog box.
The Power Off dialog box will be closed and the Main
Unit will be restarted.

To change a user, logoff from the XT-4000i, and then logon
again.

1. From the “file(F

)” menu, select “Logoff (L)”.

2. The Logoff confirmation dialog box will be displayed.

3. Click “OK” or “Cancel”.
OK: The system will perform the Logoff procedure

and the XT-4000i Logon dialog box will be
displayed.

Cancel: Logoff procedure will be canceled.

6-32 Sysmex XT-4000i Instructions for Use

January 2009

Closing the XT-4000i application

1. T o close t he XT-4000i application, click on “Close” from
the “File (F

)” menu.

2. The Exit confirmation dialog box will be displayed.

3. Click “OK” or “Cancel”.

OK: The application will end.
Cancel: The application quit operation will be canceled.

Shutting down the Windows Vista operating system

1. Click on the Start button on the task bar.
The Start menu will be displayed.

2. Select “Shutdown” on the Start menu.
The Shut Down dialog box for Windows Vista will be
displayed.

CHAPTER 6 Operation

3. Select “Shut Down”, then click on “OK” to shut down
the Information Processing Unit (IPU) and turn the
power Off.
Click on “Cancel” to close the Windows Vista shutdown
dialog box and return to the state which preceded its
opening.
Click on “Help (H

)” to display the Help screen. (The

Windows Vista shutdown dialog box closes).

Caution!

• Do not turn the power OFF while attempting the
shutdown preparation.
If the power is turned OFF during this task, the
data may be sa ved improperly and the system ma y
be damaged.

• Execute the power off at least once per week.
For details, contact your Sysmex technical
representative.

January 2009

Sysmex XT-4000i Instructions for Use 6-33

CHAPTER 6 Operation

Blank page

6-34 Sysmex XT-4000i Instructions for Use

January 2009

7. Quality control

Quality control is performed in order to monitor an
instrument’s performance over time. e-CHECK and
e-CHECK(XE) are the quality control materials
recommended by Sysme x to monitor the performance of XT­4000i analyzer. As the manuf acturer, our recommendation is
in accordance with the CLIA standard of 2 levels of control,
once ev eryday of instrument oper a tion or as your laboratory
policy dictates. It should be noted t hat for troubleshooting
purposes, additional cont ro l runs may be necessary.

7.1 Quality control materials

Use control blood.
Use e-CHECK or e-CHECK(XE) for the control blood.

CHAPTER 7 Quality control

Information

Do not use any material other than the specified
control blood. The control blood is specifically
tailored to the analysis technology employed by the
instrument.

7.2 Quality control methods

There are two QC methods for the XT-4000i, one using
control blood and one using normal samples.

QC using control materials

•X

control: Control blood is analyzed twice, and the

mean value of the two analyses is used to
evaluate analyzer performance.

• L-J control: Control blood is analyzed once and the
result is used as control data.
It can monitor changes over time.

QC using normal samples

•X

M control: This program calculates the summation

aver age of ba tches of sa mples (u sually 20)
using Bull’s algorithm, and plots the
resulting value as control data.

January 2009

Sysmex XT-4000i Instructions for Use 7-1

CHAPTER 7 Quality control

7.3 Preparation

QC method setting

Switch on the Information Processing Unit (IPU) and the
Main Unit and wait for them to turn into the Ready status.

1. Open the Quality Control files.

2. Click the “Setting” button.
The QC Setting dialog box will be displayed.

3. Click the “Control Method” tab.
The Control Method screen will be displayed.

4. Click the radio button to select the Control Method.
X-bar: T his method performs two consecutiv e analysis

of control blood, and takes the mean (average)
value as control data.

L-J: This method takes the data from a single

analysis of control blood as the control data.

5. After completing settings, click on “OK”, “Cancel” or

“Apply”.
OK: Sets the new settings and closes the

dialog box.

Cancel: Cancels the new settings and closes the

dialog box.

Apply: Sets the new settings.

7-2 Sysmex XT-4000i Instructions for Use

January 2009

X-barM control setting

CHAPTER 7 Quality control

1. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

2. Double-click the “X-barM” icon on the Controller Menu.
The status of the current X

M settings are shown in the

X-barM dialog box.

3. To execute X

M control, click the “ON” button. To cancel,

click the “OFF” button.

4. After completing settings, click on “OK” or “Cancel”.
OK: Sets the new settings and closes the dialog

box.

Cancel: Cancels the new settings and closes the dialog

box.

Settings for X

M control can be changed as described below.

1. Open the Quality Control files.

2. Click the “Setting” button.
The QC Setting dialog box will be displayed.

3. Click the “X-barM” tab.
The X-barM Setting screen will be displayed.

4. Perform X-barM setting.
Sets the number of samples in a batch by discrete.

5. After completing settings, click on “OK”, “Cancel” or

“Apply”.
OK: Sets the new settings and closes the

dialog box.

Cancel: Cancels the new settings and closes the

dialog box.

Apply: Sets the new settings.

January 2009

Sysmex XT-4000i Instructions for Use 7-3

CHAPTER 7 Quality control

Limit setting

1. Open the Quality Control files.

2. Click the “Setting” button.
The QC Setting dialog box will be displayed.

3. Click the “Limit Setting” tab.
The Limit Setting screen will be displayed.

4. Perform limit setting.
The setting parameters are as follows:

Limit Setting: Sets the limit dis play method.

“Differential (#)” is SD method

which calculates the QC limit value
as a numeral value with regard to
the aver age value (TARGET).
“Ratio (%)” is CV method which
calculates the QC limit value as a
percent with regard to the average
value (TARGET).

Auto Limit Se tting: Sets the limit condition used to set

limits automatically.
2SD: Sets the control limit as SD ×
2 (or when set, CV × 2).
3SD: Set the control limit as SD × 3
(or when set, CV × 3).
For inf ormation on auto limit setting,
see “Chapter 7: 7.9 Target/Limit”.

5. After completing settings, click on “OK”, “Cancel” or

“Apply”.
OK: Sets the new settings and closes the

dialog box.

Cancel: Cancels the new settings and closes the

dialog box.

Apply: Sets the new settings.

7-4 Sysmex XT-4000i Instructions for Use

January 2009

7.4 Quality control analysis

QC analysis in manual mode

CHAPTER 7 Quality control

Risk of infection

When analyzing control material, be sure to wear
gloves. After completion of the analysis, be sure to
wash your hands with an antiseptic cleanser. If your
hands or body are contaminated by blood, etc., you
might be infected by p athogen, etc.

Note:

X control analyzes the control material twice in
succession, and the average data is used. L-J, on
the other hand, uses the results from one analysis
as one control data.

1. Check that the READY LED on the Main Unit is lit.
If it is not lit, there is a possibility that an error has

occurred.

2. Double-click the “Controller” icon on the Menu screen.
The Controller Menu will be displayed.

3. Double-click the “QC Analysis” icon on the Controller
Menu.
The Select QC File dialog box will appear.

4. A list of the registered QC files is displayed in the Select
QC File dialog box, in the order of their QC file numbers.

5. Select a QC file and click “OK” or “Cancel”.
OK: The QC file selection is confirmed and the

Select QC File dialog box is closed. The QC
Analysis dialog box appears.

Cancel: The QC file selection is canceled and the

Select QC File dialog box is closed.

January 2009

Sysmex XT-4000i Instructions for Use 7-5

CHAPTER 7 Quality control

QC analysis in sampler mode

Note:

The analysis mode changes according to the
contents of the selected QC file. F rom the Select QC
File dialog box, select a QC file in which the analysis
mode is set to “Manual”.

6. Analyze control blood with ref e re nce to “Chapt er 6 : 6. 12
Sample analysis in manual mode”.

L-J Control can be performed in sampler mode if either a
specified control sample is used or barcode labels (f or QC
file use) are affixed on a sample t ube.

1. Prepare control blood.

2. Affix the barcode label to the correct position on the
sample tube.

3. Analyze control blood with ref e re nce to “Chapt er 6 : 6. 14

QC analysis in manual closed mode

QC analysis can be performed in closed mode if control
blood is used.

1. Check that the READY LED on the Main Unit is lit.

2. Double-click the “Controller” icon on the Menu screen.

3. Double-click the “QC Analysis” icon on the Controller

Note:

For instructions on how to affix barcode labels, see
“Chapter 6: 6.11 Preparing sample analysis”.

Sample analysis in sampler mode”.
After analysis is completed, the results are recorded
automatically in the file designated by th e barcode.

If it is not lit, there is a possibility that an error has
occurred.

The Controller Menu will be displayed.

Menu.
The Select QC File dialog box will appear.

7-6 Sysmex XT-4000i Instructions for Use

January 2009

CHAPTER 7 Quality control

4. A list of the registered QC files is displayed in the Select
QC File dialog box, in the order of their QC file numbers.

5. Select a QC file and click “OK” or “Cancel”.
OK: The QC file selection is confirmed and the

Select QC File dialog box is closed. The QC
Analysis dialog box appears.

Cancel: The QC file selection is canceled and the

Select QC File dialog box is closed.

Note:

The analysis mode changes according to the
contents of the selected QC file. F rom the Select QC
File dialog box, select a QC file in which the analysis
mode is set to “Close”.

6. Analyze control blood with ref er en ce t o “C hap ter 6: 6.15
Sample analysis in manual closed mode”.

January 2009

Sysmex XT-4000i Instructions for Use 7-7

CHAPTER 7 Quality control

7.5 QC data display

When quality control analysis is completed, the analysis
results are displayed in the QC Analysis dialog box.
According to the quality control method set with the IPU,
either the Xbar Control dialog box or the L-J Control dialog
box appears.
For X

control, the data in the Mean column in the Xbar
Control dialog box is used as control data.
For L-J control, the analysis values in the L-J Control dialog
box are used.

Xbar Control dialog box

L-J Control dialog box

In the QC Analysis dialog box, the da ta items which exceed
QC control upper or lower limits are shown with a yellow
background.
Data items which exceed QC control upper or lower limits b y
3 times or more are shown with a red background.
Click “Graph” to display and check the newest data which
was analyzed for quality control.

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January 2009

QC assessment

CHAPTER 7 Quality control

When the control data has been displayed, click “OK” or

“Cancel”.

OK: The QC Analysis dialog box is closed and the

control data is plotted on the quality control chart.

Cancel: The Cancel Confirmation dialog box appears.

Yes: The Cancel Confirmation dialog box is

closed. The analysis data is discarded and
the QC Analysis dialog box is closed.

No: The Cancel Confirmation dialog box is

closed. The screen returns to the QC
Analysis dialog box.

Detailed information on quality control can be displayed on

the QC Rader chart screen.

1. Open the Quality Control files.
The QC Rader chart screen will appear.

2. Click the “Control” tab.

January 2009

Sysmex XT-4000i Instructions for Use 7-9

CHAPTER 7 Quality control

QC data range selection function

3. If multiple Main Units are connected, select the Main
Unit which performed the quality control.

4. Select the level of the control blood to be displayed in
the radar chart.

5. Select the lot of the control blood to be displayed in the
radar chart.

6. Select the analysis mode of the control blood.

The QC data range selection function can be used to
perform the following operations from the QC chart screen.

• Select a range and display the Mean, SD, and CV.

• Select a range and use the data in the range to set

automatic targets and automatic limits.

• Select a range and delete the data within it.

• Select a range and output the contents to the GP, LP or

host computer.

Range selection procedure

Use the operations listed below to select a r ang e on the QC
chart screen.

Operation Result

[←] key Moves the cursor one plot to the left.
[→] key Moves the cursor one plot to the right.
[Shift] + [←] key Expands the selected range to the left.

The cursor does not move.

[Shift] + [→] key Expands the selected range to the right.

The cursor does not move.

Mouse left click Moves the cursor to the mouse pointer

location.
If a range was selected, the selection
changes to a single point.

[Shift] + Mouse left
click

Drag Selects a range.
[Ctrl] + [A] key Selects all data for the range.

Expands the selected range to the mouse
pointer location.
The cursor does not move.

The cursor moves to the position of the
newest data.

7-10 Sysmex XT-4000i Instructions for Use

January 2009

Deleting QC data

If there appears to be a problem with the QC analysis
results, or if incorrect control blood was used, the control
data can be deleted.

• To delete all control data selected with the QC data range
selection function, click “Delete Data”.

• To cancel the delete, click “Undelete”.

Output to printers or host computer

The selected range on the Control, Other1/Other2 and
X-barM charts can be output.

CHAPTER 7 Quality control

Information

Plots that have been deleted will disappear from the
display, but they are retained in internal data until the
tab is changed or the QC chart screen is closed, so
undo is possible.
Once the tab has been changed or the QC chart has
been closed, the plots can no longer be undeleted.

Graph print output

1. Use the range selection function to specify the range to

print from the QC chart.

2. When “Report (GP) (R

(P

)” menu, the selected area of chart is printed as a

)” is selected from the “Report

graph. (If no range is specified, the plot at the current
cursor position is printed).

Ledger print output

1. Use the range selection function to specify the control

data to print from the QC chart.

2. When “Ledge r (L P) (L

(P

)” menu, the selected area of the control data is

)” is selected from the “Report

printed as a ledger format. (If no range is specified, the
control data at the current cursor position is printed).

HC (Output to Host Computer)

1. Use the range selection function to specify the control

data from the QC chart to output to the host computer.

2. When “Host Computer HC(H

“Report (P

)” menu, the selected area of the control

)” is selected from the

data is output to the host computer. (If no range is
specified, the control data at the current cursor position
is output to the host computer).

January 2009

Sysmex XT-4000i Instructions for Use 7-11

CHAPTER 7 Quality control

Save

Save the lot information and QC data.

1. To save the QC-files on a removable medium, place a
memory stick in the USB slot and select a corresponding
drive (F: or higher).

2. Click the “Save” button.
The Save dialog box will be displayed.

3. Input the name of the file that you wish to save.

4. Click “Save (S

)” to save all reco rded lot inf ormation and
QC data under the input file name.
Click “Cancel” to cancel the save.

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January 2009

Load

CHAPTER 7 Quality control

Load QC data for review of previous stored QC-files.

1. Place the USB memory stick with the QC-files (*qcf into
the USB slot).

2. Click the “Load” button.
The Load dialog box will be displayed.

3. Select the name of the file that you wish to load.

4. Click “Open (O

)” to display the saved lot information
and QC data.
Click “Cancel” to cancel the load.

Information

• When load is executed, previously stored QC data
are imported from memory stick and displayed
temporarily. When the QC chart screen is closed
then opened again, the current lot information and
QC data will reappear.

• When the load is executed, “Data loaded from a
saved file is being displayed” message will be
displayed on the QC chart screen.

January 2009

Sysmex XT-4000i Instructions for Use 7-13

CHAPTER 7 Quality control

7.6 Troubleshooting

Control chart definition

This section explains actions to resolve errors which may
occur during quality control analysis.

• If the QC limits ha v e been e xceeded, and data is displa y ed
with a yellow or red background, click on the “Graph” in
the QC analysis dialog box and check the analysis data.
Click “OK” in the QC analysis dialog box to plot the data
on the QC chart. Use the radar chart to check the
parameters for which errors have occurred. Check the
detailed data on the dotted-line graph.
Click “Cancel” in the QC analysis dialog box to close the
box without plotting the data.

In the XT-4000i, the Levey-Jennings method is used as a
basic principle for reading the X

/L-J control chart. If the latest
control data point is outside the control limits, the last 20
(including the latest) data points are searched f or a point tha t
is outside the same limit as the latest data point. If there are
data beyond limits , it is judged as an L-J control (or X
error. If there is no data outside the control limit s, run the X

control)

/L­J control again. If that result is within the control limits, there
is no error. Natur ally, if the repeat control result is outside the
same limit as the previous result, the quality control is judged
abnormal.

How abnormality is displayed

Note:

The computing method to calculate control errors in
the X

/L-J control charts is the same as in the XM

(moving calculation) control chart.

If the quality control is judged abnormal, the relevant
parameter name appears backlit.

Example displays: Abnormality judged

Latest control data

WBC

20 or less

Example displays: No abnormality judged

Latest control data

WBC

20 or less

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January 2009

7.7 Change lot

CHAPTER 7 Quality control

When the change lot is ex ecuted, the QC da ta of the current
lot are deleted, and that of the new lot are moved to the
current lot file.
Click “Change Lot” to display the save confirmation dialog
box for the current lot data.
If saving is necessary, click “Yes (Y
confirmation dialog box to store the data in an external
storage device.

Information

When the change lot is ex ecuted, the QC data in the
current lot file are lost.
When it is necessary to store, save the data to an
external storage device ( a USB memory stick or CD­ROM etc.), then execute the change lot.

)” in the save

7.8 Lot No.

Note:

XT-4000i manages the control lots by using two data
files; the current lot and the new lot. The current lot
contains the daily routine Quality Control data, and
the new lot is prepared when the QC material lot is
being switched to the new lot of the control material.
When the control material is to be switched to the
new lot, register in the new lot the lot information by
using the “Lot No.” program (refer to the Section

7.8). Then, the new control material shall be
temporarily run using both the current lot and th e
new lot. After examining a few plots or days, if there
is no problem running the new control material,
execut e the “Change Lot” function to move the lot
information of the new lot to the current lot.

Assay values from new lots can be imported by reading the
files from CD-ROM (Read File Function) or by manual entry
via the keyboard.

Note:

The files which have been set or changed in the Lot
No. dialog box are recorded to the New Lot.

January 2009

Sysmex XT-4000i Instructions for Use 7-15

CHAPTER 7 Quality control

Manual entry

1. Click the “Lot No.” button.

The New Lot dialog box will be displayed.

2. Input lot information.

Lot No.: Inputs the control blood lot number.
Exp. Day: Inputs the control blood expiry date.

3. Click “OK” to register the input lot information and close

the new lot dialog box.
Click “Cancel” to cancel the register and close the new
lot dialog box.

Information

Do not register the same Lot No. to multiple lots.
If the same Lot No. is re gistered to multiple lots, data
may not be plotted to the target lot.

7-16 Sysmex XT-4000i Instructions for Use

Revised April 2009

Read file

CHAPTER 7 Quality control

1. Insert the floppy disk or the CD-ROM provided with the
control blood into the corresponding drive in the
Information Processing Unit (IPU).

2. Click the “Lot No.” button.
The new lot dialog box will be displayed.

3. Click the “Read File” button.
The Read File dialog box will be displayed.

4. The list of files stored on the floppy disk or the CD-ROM
will be displayed in Select Lot.
If the file is located in a folder other than d isplayed in the
dialog box, click the “Browse” button to display the
folder selection dialog box, then select the folder
containing the file.
Select the desired file by clicking.

5. Click the radio button of the parameter you wish to read.

Lot No.: Reads the control blood lot number.
Exp. Day: Reads the control blood expiry date.
Target/Limit: Reads the Target/Limit values for all the

items on the control blood.

6. Click “OK” to execute reading and return to the new lot
dialog box.
Click “Cancel” to cancel reading and return to the new
lot dialog box.

7. Click “OK” in the new lot dialog box to register the
restored lot information and close t he new lot dialog box.
Click “Cancel” to cancel the record and close the new
lot dialog box.

Revised April 2009

Sysmex XT-4000i Instructions for Use 7-17

CHAPTER 7 Quality control

7.9 Target/Limit

Set targets and limits for the file displayed.
Click the “Target/Limit” button on the Control, OTHER1/
OTHER2 or X-barM chart screen to display the Set Target/
Limit dialog box.
Instrument ID and file information will be displayed in the
upper section of the dialog box.

Manual setting

1. Click a parameter you wish to set in the list.
The selected parameter will be displayed in the Manual
Setting column at the upper right of the dialog box.

2. Input the setting values under “Target, Limit range”.
If (%) is displayed in the limit range column, it means
that the percentage f orm is currently used. If (#) is
displayed, it means t hat the numerical value form is
currently used.
See “Chapter 7: 7.3 Limit setting”.

7-18 Sysmex XT-4000i Instructions for Use

January 2009

Variable target

CHAPTER 7 Quality control

The variable target function serves to calculate a control
target value automatically from the data stored in the control
file. The variab le target function operates in both X
control and X

M when the target value is set as space.

/L-J

The variable target v alue calculated by this funct ion does not
appear in the Set Target/Limit dialog box. It appears only in
the Target column of the QC charts.

How target values are calculated

The target value calculation oper ation is explained in an
example using an empty file (file with no control data) as
follows:
In this example, the parameter selected is RBC, the target is
set at 0 and the limit (%) is set at 2.3%. The limits abo v e and
below this target are calculated from the following equation.
(The limit values thus obtained ar e rounded up. UL = upper
limit, LL = lower limit.)

Range (UL and LL) = Target X Limit(%) / 100

N=1, UL-TARGET=0.11
UL

RBC
LL

N=2, UL-TARGET=0.11
UL

RBC
LL

N=3, UL-TARGET=0.11
UL

RBC
LL

N=4, UL-TARGET=0.11
UL

RBC
LL

4.61

4.50

4.39

4.61

4.50

4.39

4.59

4.48

4.37

4.60

4.49

4.38

1. 4.5 million is input as the first RBC control data. The
variable target will be set at 4.50, and the QC Chart will
show the values in the figure on the right.

2. 4.45 million is input as the second RBC control data.
The variable target remains the same, because the
denominator (N-1) in the equation X/N-1 is 1 in this
instance.

3. 4.52 million is input as the third RBC control data. The
variable target changes to 4.48 (= (4.50 + 4.45) / 2).

4. 4.21 million is input as the fourth RBC control data. The
variable target, calcu l ated usin g all t hree of the p revious
control data, changes to 4.49 (= (4.50 + 4.45 + 4.52) / 3).

The variable target function is useful f or setting contr ol target
values when the instrument is monitored using cont rol b lood
(the analyzed values for which, unlike calibrator, are not
reliable in an absolute sense).

January 2009

Sysmex XT-4000i Instructions for Use 7-19

CHAPTER 7 Quality control

Va riable target function and erroneous data

In the X

/L-J control, there are restrictions on the import of
control data into the control chart to ensure the smooth
operation of the variable target function. The specific
restriction is that control data beyond three times the range
of the control range set in advance must not be imported.

Example:

LIMIT

The upper limits to import the control data
The upper limits for the control limit (UL)
The control target values (TARGET)
The lower limits for the control limit (LL)
The lower limits to import the control data

UL
RBC
LL

560
520
500
480
440

Assume that the control limits are the values given above,
with the implementation of X

/L-J control. If the control data is

5.21 million, the message “Check QC Chart” will be
displayed, but the data can be entered on the chart. If the
control data is 5.61 million howev er, it should not be entered
on the QC Chart, and the message “Reanalyze sample” will
be displayed.

Setting variable target

1. Click a parameter you wish to set in the list.

Information

• When “Variable Target” is selected for quality
control, set the limits manually or read the assay
values from the floppy disk or the CD-ROM.

• When “Current + New” is selected in the Lot
column, the target and limit range cannot be
changed or set using the “Target/Limit” button (it
is inactive).
Select a lot you wish to change o r set: “Cu rrent ” or
“New”.

2. Click the “Variable Target” button.
The selected parameters are set for variable target. The

target column of the list is left blank for parameters set
for variable target .

7-20 Sysmex XT-4000i Instructions for Use

Revised April 2009