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.