SYSMEX XE-5000 User manual

Automated Hematology Analyzer
XE-5000
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
SYSMEX CORPORATION
KOBE, JAPAN
Copyright © 2006 - 2008 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. 461-2642-1
PRINTED IN JAPAN
Date of Last Revision: December 2008

Table of Contents
Sysmex XE-5000 Instructions for Use I
Revised July 2007 EU
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 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) .......................2-3
2.5 Avoidance of infection...............................................2-3
2.6 Handling of reagents ................................................2-4
2.7 Quality control materials...........................................2-5
2.8 Laser ........................................................................2-5
2.9 Maintaining the instrument.......................................2-6
2.10 Disposal of waste fluids, disposables and
instruments...............................................................2-6
2.11 Marking on the instrument........................................2-7
2.12 Personnel ...............................................................2-12
2.13 Computer viruses ...................................................2-12
Chapter 3 Design and Function ..................3-1
3.1 Overview...................................................................3-1
3.2 Main Unit ..................................................................3-2
3.3 Pneumatic Unit.......................................................3-11
3.4 Sampler Unit...........................................................3-13
3.5 Information Processing Unit (IPU)..........................3-14
3.6 Analysis mode........................................................3-17
Chapter 4 Reagents......................................4-1
4.1 General information..................................................4-1
4.2 CELLPACK...............................................................4-1
4.3 CELLSHEATH ..........................................................4-1
4.4 STROMATOLYSER-FB.............................................4-2
4.5 STROMATOLYSER-4DL...........................................4-2
4.6 STROMATOLYSER-4DS ..........................................4-3
4.7 STROMATOLYSER-NR(L)........................................4-3
4.8 STROMATOLYSER-NR(S).......................................4-4
4.9 SULFOLYSER..........................................................4-4
4.10 STROMATOLYSER-IM.............................................4-5
4.11 RET SEARCH (II) (diluent)
RET SEARCH (II) (dye solution) ..............................4-5
4.12 CELLCLEAN ............................................................4-6
4.13 Control blood (e-CHECK(XE))..................................4-7
4.14 Labeling....................................................................4-7
4.15 Symbols used on the labels .....................................4-8

Table of Contents
II Sysmex XE-5000 Instructions for Use
Revised April 2007
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 Main Unit operation..............................6-1
6.2 Main unit menu tree..................................................6-3
6.3 Summary of Information Processing Unit (IPU)
operation...................................................................6-4
6.4 Information Processing Unit (IPU) menu bar............6-5
6.5 Alarm sound .............................................................6-6
6.6 Operator checks .......................................................6-6
6.7 Turning ON the power...............................................6-8
6.8 Logging on to the Information Processing
Unit (IPU)..................................................................6-9
6.9 Self-checks...............................................................6-9
6.10 Pressure and vacuum gauges check......................6-11
6.11 Logging on the Main Unit........................................6-11
6.12 Auto output settings check......................................6-11
6.13 Quality control.........................................................6-11
6.14 Conditions for sample analysis...............................6-12
6.15 Analysis mode........................................................6-12
6.16 Preparing sample analysis .....................................6-13
6.17 Sample analysis in manual mode...........................6-17
6.18 Sample analysis in capillary mode .........................6-19
6.19 Sample analysis in sampler mode..........................6-21
6.20 Sample analysis in manual closed mode ...............6-24
6.21 Display analysis results ..........................................6-25
6.22 Analysis result output .............................................6-26
6.23 HPC analysis..........................................................6-27
6.24 Body fluid analysis..................................................6-33
6.25 Timer processing....................................................6-38
6.26 Shutdown................................................................6-39
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........................................................7-7
7.6 Troubleshooting ......................................................7-12
7.7 Change lot..............................................................7-13
7.8 Lot No. ....................................................................7-13
7.9 Target/Limit.............................................................7-16
7.10 Display order...........................................................7-21
7.11 File Information.......................................................7-22

Table of Contents
Sysmex XE-5000 Instructions for Use III
Revised April 2007 EU
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................................8-6
8.6 Manual calibration ....................................................8-6
8.7 Calibration history.....................................................8-9
Chapter 9 Cleaning and Maintenance.........9-1
9.1 Execution of shutdown .............................................9-2
9.2 Removing fluid from the Pneumatic Unit
trap chamber ............................................................9-3
9.3 Cleaning the sample rotor valve...............................9-4
9.4 Cleaning the manual rinse cup.................................9-7
9.5 Cleaning the sample rotor valve tray........................9-9
9.6 Cleaning the piercer tray ........................................9-10
9.7 Removing clogs (clog removal sequence)..............9-11
9.8 Cleaning the IMI detector aperture.........................9-12
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 Replacing the waste container (option)..................9-18
9.13 Replacing and registering reagents........................9-19
9.14 Reagent replacement log display function..............9-31
9.15 Remaining reagent volume function.......................9-36
9.16 Replacing the piercer .............................................9-38
9.17 Replacing the hand clipper.....................................9-41
9.18 Replacing rubber plate No. 39................................9-43
9.19 Replacing the fuses................................................9-44
9.20 Replacing the HEPA filter (option)..........................9-45
9.21 Adjusting pressure and vacuum.............................9-46
9.22 Supplies and replacement parts.............................9-51
9.23 XE-5000 maintenance and inspection check list....9-52
Chapter 10 Troubleshooting........................10-1
10.1 HELP screen ..........................................................10-1
10.2 Error log..................................................................10-1
10.3 Error message list ..................................................10-3
10.4 Troubleshooting guide ............................................10-9
10.5 Test.......................................................................10-30

Table of Contents
IV Sysmex XE-5000 Instructions for Use
Revised April 2007
Chapter 11 Technical Information............... 11-1
11.1 Performance/specifications of the XE-5000............11-1
11.2 Possible sample interferences................................11-9
11.3 Interface protocol..................................................11-10
11.4 Program version ...................................................11-10
11.5 Principles..............................................................11-11
11.6 Contents of the packages.....................................11-32
11.7 Check before installation ......................................11-36
11.8 Grounding.............................................................11-36
11.9 Installation environment........................................11-36
11.10 Installation space..................................................11-37
Chapter 12 Warranty .................................... 12-1
Chapter 13 Index .......................................... 13-1

CHAPTER 1 Introduction
Sysmex XE-5000 Instructions for Use 1-1
Revised April 2007
1. Introduction
The Sysmex XE-5000 is an automated hematology analyzer
for in vitro diagnostic use in clinical laboratories.
The XE-5000 can analyze and output the results for 67
parameters.
WBCs, nucleated RBCs and reticulocytes are analyzed by the
optical detector 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 based on the
fluorescence flow cytometry method.
Hemoglobin (HGB) is analyzed by the HGB detector based on
the SLS hemoglobin determination method.
The existence of immature cells are analyzed by the IMI
detector based on the RF/DC detection method and the DIFF
channel using fluorescence flow cytometry.
Analysis data is displayed on the panel keypad LCD screen
and the screen of the Information Processing Unit (IPU).
Note:
Data generated by the XE-5000 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 there 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.

CHAPTER 1 Introduction
1-2 Sysmex XE-5000 Instructions for Use
Revised July 2007 EU
Contact Address
Manufacturer SYSMEX CORPORATION
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe, Hyogo 651-0073
JAPAN
Authorized Representative
European Representative
SYSMEX EUROPE GmbH
Bornbarch 1
D – 22848 Norderstedt, Germany
Phone: [phone]
Fax: [phone]
Americas 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
EC REP

CHAPTER 1 Introduction
Sysmex XE-5000 Instructions for Use 1-3
Revised April 2007
1.1 Hazard information in this manual
Note, Information, Caution and Warning statements are
presented throughout this manual to call attention to
important safety and operational information. Non-compliance
with this information compromises the safety features
incorporated in the analyzer.
Risk of infection
This symbol indicates a possible hazardous situation
which, if not avoided, may result in infection by
pathogens and others.
Warning!
High risk. Ignoring this warning could result in
personal injury to the operator.
Caution, Hot!
Indicates a potential risk of burns or other physical
damage in the event of incorrect operation or failure to
observe the content.
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.
Caution!
Indicates a potential risk of physical damage to
functions of the instrument caused by static electricity
discharge of the human body, in the event of incorrect
operation or failure to observe the content.

CHAPTER 1 Introduction
1-4 Sysmex XE-5000 Instructions for Use
Revised April 2007
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.
• CELLSHEATH is a trademark of Sysmex.
• SMI and SMI Micro/Pettor are registered trademarks of
Scientific Manufacturing Industries, Inc.
• VENOJECT and VENOJECT II are registered trademarks of
TERUMO Corporation.
• Windows is a registered trademark of Microsoft
Corporation.
Other trademarks referenced are property of their respective
owners.
TM and ® are not specified in this manual.
1.3 Measurement parameters
The XE-5000 can analyze the following 67 parameters:
37 Diagnostic Parameters
1WBC
2RBC
3HGB
4HCT
5MCV
6MCH
7 MCHC
8PLT
9RDW-SD
10 RDW-CV
11 PDW
12 MPV
13 P-LCR
14 PCT
15 NEUT%
16 LYMPH%
17 MONO%
18 EO%
19 BASO%
20 NEUT#
Note:
Background information and practical tips.

CHAPTER 1 Introduction
Sysmex XE-5000 Instructions for Use 1-5
Revised April 2007 EU
21 LYMPH#
22 MONO#
23 EO#
24 BASO#
25 IG% Immature Granulocyte Percent
26 IG# Immature Granulocyte Count
27 HPC# Hematopoietic Progenitor Cell Count
28 NRBC%
29 NRBC#
30 RET%
31 RET#
32 HFR
33 MFR
34 LFR
35 IRF Immature Reticulocyte Fraction
36 RET-He Reticulocyte Hemoglobin Equivalent
37 IPF Immature PLT fraction
6 Body Fluid Mode Parameters
1 WBC-BF WBC body fluid
2MN% Mononuclear cell percent
3MN# Mononuclear cell count
4PMN% Polymorphonuclear cell percent
5PMN# Polymorphonuclear cell count
6 RBC-BF RBC body fluid
24 Pre-Diluted Mode Parameters
1WBC
2RBC
3HGB
4HCT
5MCV
6MCH
7 MCHC
8PLT
9NEUT%
10 LYMPH%
11 MONO%
12 EO%
13 BASO%
14 NEUT#
15 LYMPH#
16 MONO#
17 EO#
Note:
XE-5000 automatically analyzes NRBC if an analysis
order is assigned to any of the WBC 5 differential
counts or percent data.

CHAPTER 1 Introduction
1-6 Sysmex XE-5000 Instructions for Use
Revised April 2007 EU
18 BASO#
19 IG% Immature Granulocyte Percent
20 IG# Immature Granulocyte Count
21 NRBC%
22 NRBC#
23 RET%
24 RET#

CHAPTER 2 Safety Information
Sysmex XE-5000 Instructions for Use 2-1
Revised April 2007
2. Safety Information
2.1 Specified conditions of use
The Sysmex XE-5000 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.
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.

CHAPTER 2 Safety Information
2-2 Sysmex XE-5000 Instructions for Use
Revised April 2007
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 a 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 a 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.

CHAPTER 2 Safety Information
Sysmex XE-5000 Instructions for Use 2-3
Revised April 2007
2.4 Electromagnetic compatibility (EMC)
This instrument complies with the following IEC (EN)
standards.
• IEC61326-2-6:2005 (EN61326-2-6:2005)
Electronic equipment for analysis, control and laboratory
use — EMC request.
• EMI (electromagnetic emission (= interference radiation))
Class A requirements are fulfilled.
• EMS (electromagnetic immunity (= resistance against
jamming))
For this issue the minimum requirements with regards to
immunity are fulfilled.
2.5 Avoidance of infection
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 of 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 disinfectant.

CHAPTER 2 Safety Information
2-4 Sysmex XE-5000 Instructions for Use
Revised July 2007
2.6 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!
• 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.

CHAPTER 2 Safety Information
Sysmex XE-5000 Instructions for Use 2-5
Revised July 2007
2.7 Quality control materials
2.8 Laser
Caution!
• Do not inject or ingest.
• Follow directions on control material package insert.
• Avoid lettingthe control material come in contact with
dust, dirt or bacteria.
• Control material must not be used after their
expiration date.
• Take care not to spill control material. If spilled, follow
your laboratory's prescribed cleaning and
decontamination procedures.
Warning!
The XE-5000 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.

CHAPTER 2 Safety Information
2-6 Sysmex XE-5000 Instructions for Use
Revised April 2007
2.9 Maintaining the instrument
2.10 Disposal of waste fluids, disposables and instruments
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.
Risk of infection
Use of gloves is strongly recommended when
handling waste fluids or instrument consumables.
Wash your hands thoroughly following maintenance.
Warning!
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.

CHAPTER 2 Safety Information
Sysmex XE-5000 Instructions for Use 2-7
Revised April 2007
2.11 Marking on the instrument
Main Unit - Front View
(1)
(2)
(3)
(3)
(1)
(8)
(9)
(6)
(2)
(5)
(7)
(4)*1 (Inside)
WARNING
Be sure to set the stop bar when opening
to avoid injury.
WARNING
Never touch the detector when the power
of the Main Unit is turned ON. Otherwise,
electrical shock may result.
CAUTION
1. Dye solution replacement method
• For SNR, always replace dye solution and lyse reagent simultaneously.
• For RED, always replace dye solution and diluent simultaneously.
• For FFS, the message “Replace FFS” is displayed after the analysis of
2000 cycles. When doing so, always press Reagent or Confirm after
replacing with new FFS.
2. When the message “Execute Rinse Flowcell” is displayed, always perform
Maintenance – 4. Rinse Flowcell.
3. To clean the IMI detector aperture, first run Maintenance – 1. Drain IMI,
then turn off the main unit power.

CHAPTER 2 Safety Information
2-8 Sysmex XE-5000 Instructions for Use
Revised April 2007
(4)
*1: After installing, remove the anti-sticking spacers.
(5)
(6)
(7)
(8)
(9)
CAUTION
When installing this instrument, remove the constant-pressure screw, then
take out the anti-sticking spacers which are inserted between the sample rotor
valves. At that stage, rinse the surface of each valve cleanly before setting
them in place.
The fluid channel inside the instruments are rinsed with diluent before
shipping from the factory. Background count may be high immediately after
unpacking, so rinse thoroughly.
RISK OF INFECTION
In principle, all parts and surfaces of the
instrument must be regarded as infective.
Always keep the switch in the analysis position.
WARNING
Never touch the detector when the power
of the Main Unit is turned ON. Otherwise,
electrical shock may result.
WARNING
Do not remove this cover when the power
to the Main Unit is ON. Doing so may
result in injury.
WARNING
Do not put your fingers inside when the
power to the Main Unit is ON. Doing so
may result in injury.