SYSMEX XE-5000 Instruction 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

Code No. 461-2642-1 PRINTED IN JAPAN Date of Last Revision: December 2008

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

Revised July 2007 EU

Sysmex XE-5000 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 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

II Sysmex XE-5000 Instructions for Use

Revised April 2007

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................................ 8-6

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 maintenanc e and ins pe cti on check list....9-5 2

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

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Sysmex XE-5000 Instructions for Use III

Table of Contents

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 Installati on sp ace.................................... ....... ...... .11-37

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

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

IV Sysmex XE-5000 Instructions for Use

Revised April 2007

1. Introduction

CHAPTER 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.

Revised April 2007

Sysmex XE-5000 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, Kobe, Hyogo 651-0073 JAP AN

European Representative

SYSMEX EUROPE GmbH Bornbarch 1 D – 22848 Norderstedt, Germany Phone: +49 40 5 27 26-0 Fax: +49 40 5 27 26-100

SYSMEX AMERICA, Inc. 1 Nelson C. White Parkway, Mundelein, IL 60060 U.S.A. Phone: +1-847-996-4500 Fax: +1-847-996-4505

Asia-Pacific

SYSMEX ASIA PACIFIC PTE LTD. 2 Woodlands Sector 1, #01-06 Woodlands Spec trum, Singapore 738068 Phone: +65-6221-3629 Fax: +65-6221-3687

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

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Revised July 2007 EU

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.

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, 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.

Revised April 2007

Sysmex XE-5000 Instructions for Use 1-3

CHAPTER 1 Introduction

1.2 Protected names

Note:

Background information and practical tips.

• 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#

Revised April 2007

1-4 Sysmex XE-5000 Instructions for Use

CHAPTER 1 Introduction

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#

Note:

XE-5000 automatically analyzes NRBC if an analysis order is assigned to any of the WBC 5 differential counts or percent data.

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#

Revised April 2007 EU

17 EO#

Sysmex XE-5000 Instructions for Use 1-5

CHAPTER 1 Introduction

18 BASO# 19 IG% Immature Granulocyte Percent 20 IG# Immature Granulocyte Count 21 NRBC% 22 NRBC# 23 RET% 24 RET#

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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.

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.

Revised April 2007

Sysmex XE-5000 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 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.

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Revised April 2007

2.4 Electromagnetic compatibility (EMC)

This instrument complies with the following IEC (EN) standards.

• IEC61326-2-6:2005 (EN61326-2 -6:200 5) Electronic equipment for analysis, control and laborat ory 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, maintaini ng, 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

Revised April 2007

Sysmex XE-5000 Instructions for Use 2-3

CHAPTER 2 Safety Information

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.

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Revised July 2007

2.7 Quality control materials

2.8 Laser

CHAPTER 2 Safety Information

Caution!

• Do not inject or ingest.

• Follow directions on control ma terial package insert.

• Av oid letting the 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.

Revised July 2007

Laser Diode

NOTE:This caution label is located

inside the Laser Unit Cover.

Sysmex XE-5000 Instructions for Use 2-5

CHAPTER 2 Safety Information

2.9 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.

2.10 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!

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.

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Revised April 2007

2.11 Marking on the instrument

Main Unit - Front View

(1)

(2)

(3)

(4)

(5)

CHAPTER 2 Safety Information

(6)

(7)

(8)

(9)

(Inside)

(1)

WARNING

Be sure to set the stop bar when opening to avoid injury.

(2)

WARNING

Never touch the detector when the power of the Main Unit is turned ON. Otherwise, electrical shock may resu lt.

(3)

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.

Revised April 2007

Sysmex XE-5000 Instructions for Use 2-7

CHAPTER 2 Safety Information

(4)

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.

*1: After installing, remove the anti-sticking spacers.

(5)

RISK OF INFECTION

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

(6)

CAUTION

Always keep the switch in the analysis position.

(7)

WARNING

Never touch the detector when the power of the Main Unit is turned ON. Otherwise, electrical shock may resu lt.

(8)

WARNING

Do not remove this cover when the power to the Main Unit is ON. Doing so may result in injury.

(9)

WARNING

Do not put your fingers inside when the power to the Main Unit is ON. Doing so may result in injury.

2-8 Sysmex XE-5000 Instructions for Use

Revised April 2007

Main Unit - Rear View

(1)

• T o av oid 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.

CHAPTER 2 Safety Information

(1)

CAUTION

Fuse Rating

3.15A 250V

Time Lag

Revised July 2007

Sysmex XE-5000 Instructions for Use 2-9

CHAPTER 2 Safety Information

Sampler

(1)

Do not push in the rack by hand.

There is a small risk that such handling could cause a mismatch between sample numbers and analysis results.

Precautions on setting the

sampler

1. Check that the sample tubes fit smoothly into the rack.

2. Check that the rubber stoppers are firmly capped on the sample tube.

3. Insert the sample tube securely all the way to the bottom of the rack.

(1)

Pneumatic Unit - Front View

(1)

0.25 MPa regulator

(2)

RISK OF INFECTION

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

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Revised April 2007

Pneumatic Unit - Rear View

CHAPTER 2 Safety Information

(1)

Pneumatic Unit - Right View

(1)

CAUTION

Do not block the exhaust vent on the rear of the pneumatic unit.

(1)

WARNING

Instrument must be grounded.

Revised April 2007

Sysmex XE-5000 Instructions for Use 2-11

CHAPTER 2 Safety Information

2.12 Personnel

2.13 Computer viruses

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.

Warning!

This system has been tested prior to shipment and is virus free. But it may be infected with virus by improper application on lines of Internet or network. Please investigate and apply the corrective action for computer virus approved by your facility. Sysmex will not be held liable in the case that the customer’s computer is infected with a virus and therefore please take note of the following guidelines in prior .

The following cases are just for your reference. Please study the treatments according to the usage of your computer.

1. Use a virus checker program regularly to check

your system.

2. Do not install any other application program except

a virus protection software.

3. Do not open any file attached to a mail from an

unknown address. Perform a virus check.

4. Do not download from Internet files not concerned

with Sysmex.

5. Files contained in a shared folder should be

subjected to a virus check.

6. Make sure to carry out any virus protection

measures currently used in other computer systems.

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Revised April 2007

CHAPTER 3 Design and Function

3. Design and Function

3.1 Overview

7 6

1Main Unit

Analyzes and controls 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.

Revised April 2007

Sysmex XE-5000 Instructions for Use 3-1

CHAPTER 3 Design and Function

3.2 Main Unit

Front View

3 4

1 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.

2READY LED

Lights up when the Main Unit enters Ready status.

3 Manual aspiration pipette

Used to aspirate a sample in manual or capillary mode.

4 START switch

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

5 LCD screen

Displays the status of the Main Unit, sample ID number and analysis data.

6 Panel Keypad

Used to perform basic operation, such as inputting sample ID number, starting the sampler analysis an d se lec ti ng th e an al ysis par a me te r. For details, see “Panel k eypad” .

7 CP cover

This is the protection cover of cap piercing unit.

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Revised April 2007

CHAPTER 3 Design and Function

Rear View

14 15

16 17

3 4

5 6 7 8 9

10 11

18 19

20 21

22 23

13 25

1 Float switch connector

Connected to the float switch of each reagent.

2 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.

3 Fuse holder

This is a 250V, 3.15A (time lag) fuse.

Warning!

• To avoid electrical shock, disconnect supply before servicing.

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

4 AC power supply

Supplies power using the provided power cable.

5 ESE inlet nipple (ESE-1)

CELLSHEATH is aspirated via this nipple. Connected to the lower nipple of the CELLSHEATH float switch.

Revised April 2007 EU

Sysmex XE-5000 Instructions for Use 3-3

CHAPTER 3 Design and Function

6 SIM aspiration nipple (SIM-1)

STROMATOLYSER-IM is aspirated via this nipple. Connected to the lower nipple of the STROMATOLYSER-IM float switch.

7 SLS inlet nipple (SLS)

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

8 FFD reagent inlet nipple (FFD)

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

9 FBA inlet nipple (FBA)

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

10 SNR reagent inlet nipple (SNR)

STROMATOLYSER-NR (L) is aspirated via this nipple. Connected to the container of STROMATOLYSER-NR (L).

11 RED diluent inlet nipple (RED)

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

12 SIM air bubbles outlet nipple (SIM-2)

Air bubbles inside the float switch of STROMATOLYSER-IM are discharged via this nipple. Connected to the upper nipple of the STROMATOLYSER-IM float switch.

13 ESE air bubbles outlet nipple (ESE-2)

Air bubbles inside the float switch of CELLSHEATH are discharged via this nipple. Connected to the upper nipple of the CELLSHEATH float switch.

14 Air drier outlet nipple

Outputs pressure after removing dust or moisture by the air drier. Connected to the pressure supply nipple.

15 Air drier inlet nipple

Connected to the pressure outlet nipple of the Pneumatic Unit.

16 Air drier drain nipple

Connected to the drain outlet nipple.

17 Air drier

Removes dust or moisture from the a ir (at PRESSURE sid e) supplied b y th e Pneumatic U nit.

18 EPK inlet nipple (EPK-1)

CELLPACK is aspirated via this nipple. Connected to the lower nipple of the CELLPACK float switch.

19 Drain outlet nipple (D)

Water droplets from the air drier are discharged via this nipple to the waste line.

20 Vacuum supply nipple (V)

Connected to the vacuum outlet nipple of the Pneumatic Unit.

21 Waste level detection nipple (P2) 22 Waste level detection nipple (P1)

When the optional waste monitoring sensor is provided, the waste volume is monitored by detecting differential pressure between the waste level detection nipples P1 and P2. Connected to the detection tube of the waste container.

23 Pressure supply nipple (P)

Connected to the air drier outlet nipple.

24 Waste outlet nipple (W)

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

25 EPK air bubbles outlet nipple (EPK-2)

Air bubbles inside the float switch of CELLPACK are discharged via this nipple. Connected to the upper nipple of the CELLPACK float switch.

Revised April 2007 EU

3-4 Sysmex XE-5000 Instructions for Use

CHAPTER 3 Design and Function

Left Side View

1 2 3

4 5

1 0.16 MPa regulator

Adjusts the pressure to 0.16 MPa.

2 0.07 MPa regulator

Adjusts the pressure to 0.07 MPa.

3 0.03 MPa regulator

Adjusts the pressure to 0.03 MPa.

4 Air filter

Prevents dust from entering the bellows unit.

5 Bellows Unit

Adjusts the bellows pressure to -0.04 MPa.

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Sysmex XE-5000 Instructions for Use 3-5

CHAPTER 3 Design and Function

Right Side View

1 Handheld barcode scanner connector

Connected to the optional handheld barcode scanner required to input sample ID numbers.

2 IPU connector

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

1 2

Caution!

When connecting the communications cable (LAN cable) to the Information Processing Unit (IPU), there is a risk of damage to communications equipment due to static electrical charges on human body . Touch something else to discharge static before connecting the cable.

3 DP connector

Connected to the data printer.

4 Power Supply 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.

3-6 Sysmex XE-5000 Instructions for Use

Revised April 2007

CHAPTER 3 Design and Function

Front Interior

1 2

3 4

5 6 7

10 11

1 RF tuning meter

Displays the status of radio-frequency voltage for the IMI detector.

2 Reaction chamber

Prepares a diluted sample for analyzing WBC/BASO, 4DIFF, NRBC and RET. The sample is retained at a constant temperature for a certain period of time, and sent to the optical detector block.

3 Blood aspiration sensor

Monitors the aspiration status of whole blood in the sampler mode or the manual closed mode.

4 Sample rotor valve (SRV)

Measures the predetermined volume of the aspirated whole blood sample.

5 HGB detector block

Includes the HGB analyzer.

6 Whole blood aspiration pump

Aspirates a whole blood sample.

7 Whole blood aspiration motor

Drives the whole blood aspiration pump.

8 IMI detector block

Includes the IMI detector.

9 RBC detector block

Includes the RBC detector.

10 Sheath motor

Drives the sheath injector piston.

11 Sheath injector piston

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

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Sysmex XE-5000 Instructions for Use 3-7

CHAPTER 3 Design and Function

Left Interior

2 3

1 WBC detector block

Includes the WBC detector.

2 Reaction chamber mixing motor

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

3 Reaction chamber

Prepares a diluted sample for analyzing WBC/BASO, 4DIFF, NRBC and RET. The sample is retained at a constant temperature for a certain period of time, and sent to the optical detector block.

Caution!

Do not open the left cover unless the instruction is given by your Sysmex technical representative.

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3-8 Sysmex XE-5000 Instructions for Use

CHAPTER 3 Design and Function

Panel keypad

SHUTDOWN HELP

NUM./ALPH. ENTER

RETURN MORE

MANUAL

GHI4JKL5MNO

PRS1TUV2WXY

0 -/. C

SAMPLER

ABC8DEF

9 6 3

8101112

No. Function

Used to enter the sample ID No . in manual mode , capil lary mode, HPC mod e, body fl uid mode

and manual closed mode. The sample ID No. setting screen is displayed. In additional to the sample ID No., the discrete test profile and the analysis mode can be selected.

Used to start analysis in sampler mode.

When the sampler key is pressed, the sample ID No. setting screen is displayed, and you can set sample ID No., rack No., and tube position from which the analysis has to start.

Used to specify sample ID No. and menu No.

Used to delete one character during key entry, or to stop the alarm.

Used to input hyphen [-] during sample ID No. entry, or decimal point during numeric entry.

Used to confirm the entered sample ID No.

Used to change input modes.

Used to change the LCD screen, or to move the selected parameter.

Used to change the function menu display on the screen which has five or more selectable

function menu items. Used to cancel the execution of the menu and return to the status before selecting the menu.

In the presence of an error, pressing HELP will displa y the er ror messag e, probab le ca use and

corrective action to take. Used to execute the shutdown sequence.

Used to select the function menu displayed at the bottom of the LCD screen.

4 5

6 7

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Sysmex XE-5000 Instructions for Use 3-9

CHAPTER 3 Design and Function

Panel Keypad LCD

1 2 3

4 5 6

7 8 9

10 10 10 10

1 Displays the mode to be used next.

There are the following four kinds of modes.

• Manual mode (Normal mode: Displayed as “Manual”) (HPC analysis mode: Displayed as “HPC Manual”) (Body fluid analysis mode: Displayed as “BF Manual”)

• Capillary mode (displayed as “Capillary”)

• Sampler mode (displayed as “Sampler”)

• Manual closed mode (displayed as “Closed”)

2 Displays the discrete setting for next analysis.

There are the following five kinds of discrete settings.

• CBC (displayed as “C”)

• CBC+NRBC (displayed as “C N” )

• CBC+RET (displayed as “C R”)

• CBC+DIFF+NRBC (displayed as “CDN”)

• CBC+DIFF+NRBC+RET (displayed as “CDNR”)

3 Displays the status of the Main Unit.

Any of the following status is displayed.

• Ready

• Not Ready

• Running

• S-Ready

•Stat

• S-Not Ready

4 Displays the manual sample ID No. to be analyzed next. 5 Displays the sample ID No. for DP printing. 6 Displays the present error content which has the highest priority.

When the error under the display is reset, the error with the next highest priority is displayed. If several errors occur, press the HELP key, and select Error List from the function menu. All the errors are displayed.

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Revised April 2007 EU

CHAPTER 3 Design and Function

7 Displays the input status by numeric keys.

Alphabet and hyphen in addition to numerals can be used for sample ID No. By pressing the NUM./ALPH. key on the panel keypad, you can change the input mode in this order: “Numeric” → “Uppercase Alphabet” → “Lowercase Alphabet”. The display contents are as follows: Num: Numeric mode ALP: Uppercase Alphabet alp: Lowercase Alphabet

8 Displays the status of the DP.

DP: DP is connected and no error has occurred. No indication: DP is not connected. DP (reversing display): DP is set to be connected, but an error has occurred.

9 Displays the implementation status of X

Xm: X No indication: X

M QC is ON. M QC is OFF.

10 Displays the function menu.

The contents of the function menu differ with each other.

3.3 Pneumatic Unit

Front View

M QC.

1 Pressure Indicator 1 (0.25 MPa)

Indicates pressure to be supplied to the Main Unit. The normal range is 0.25 ±

0.03 MPa. If pressure comes out of the normal range, the instrument may not operate properly.

2 0.25 MPa regulator

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

3 Vacuum Indicator 2

Indicates vacuum to be supplied to the Main Unit. The normal range is -0.05 MPa or over. If vacuum is less than -0.05 MPa, the instrument may not operate properly.

4 Pneumatic unit trap chamber

Prevents reagent, etc. from flowing into the compressor when an abnormality has occurred in the instrument.

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Sysmex XE-5000 Instructions for Use 3-11

CHAPTER 3 Design and Function

5 Power supply 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.

Right Side View

1 2

3 4 5

1 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.

2 Fuse

This is a 250V, 3.15A (time lag) fuse.

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.

3 Power supply connector

Supplies power with the power cord provided.

4 Vacuum outlet nipple

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

5 Pressure outlet nipple

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

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Revised April 2007

CHAPTER 3 Design and Function

3.4 Sampler Unit

1 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.

2 Left rack pool

The rack shifts from the analysis line to this pool.

3 Blood volume monitoring sensor

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

4 Right rack pool

The racks are set in this pool. Up to 10 racks can be set at a time. Press the SAMPLER key to feed the rack automatically to the analysis line.

Caution!

Do not manually push (or move) the sample rack forward while instrument is in operation. There is a small possibility that sample numbers and analysis results could become misaligned.

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Sysmex XE-5000 Instructions for Use 3-13

CHAPTER 3 Design and Function

3.5 Information Proc essing Unit (IPU)

Front View

1 TFT display

SVGA compatible TFT multi-scan display.

2 Main body

IPU Main Unit of the personal computer.

3 Keyboard

Used to input data to the IPU.

4Mouse

Used to operate the various functions of 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.

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Revised April 2007

CHAPTER 3 Design and Function

Rear View

1 2

1 LP connector (LP: COM1)

Printer connector for printing out the ledgers.

2 GP connector (GP)

Printer connector for printing out the graphics.

3 Keyboard connector

Connector for the keyboard.

4 Main Unit connector (MAIN UNIT)

Connector for the XE-5000 Main Unit.

5 HOST connector (HOST: COM2)

Connector for the host computer.

6 Mouse connector

Connector for the mouse.

4 5

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Sysmex XE-5000 Instructions for Use 3-15

CHAPTER 3 Design and Function

Summary of the Information Processing Unit (IPU) display screen

1 2

3 4

1 Title bar

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

2 Menu bar

Displays the following:

• File • Report

• Edit • Settings

• View • Window

• Record • Help

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

Information

There may be some menu that cannot be selected, depending on the functions currently effective. Only menu items displayed in black may be selected.

3 Tool bar

The tool bar contains those pull down submenu items that are used comparatively often. Double-click the icon 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.

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Revised April 2007

CHAPTER 3 Design and Function

6 System status display area

The following status will be displayed:

• Main Unit status (Displays the status of up to 4 Main Units which can be connected to one IPU).

• Host computer connection status

3.6 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 reported.

Sampler mode

The sampler automatically mixes, aspirates and analyzes samples without removing their caps. Up to 100 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.

Note:

HPC analysis and body fluid analysis can only be performed in manual mode.

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Sysmex XE-5000 Instructions for Use 3-17

CHAPTER 3 Design and Function

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3-18 Sysmex XE-5000 Instructions for Use

Revised April 2007

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

Usage

4.3 CELLSHEATH

Intended Use

Storage and Shelf Life after first Opening

Revised June 2008

Store CELLPACK at +5 to +30°C or lo wer temperature and out of direct sunlight. If once frozen, mix it well after thawing. If the container is unopened, it may be use d 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.

CELLPACK is a reagent f or me asuring the numbers and siz es 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.

Sheath fluid for use in hematology analyzers.

Store CELLSHEATH at +5 to +30ºC or lower temperature and out of direct sunlight. If once frozen, mix it well after thawing. If the container is unopened, it may be use d up to the expiry date stated on the reagent container.

Sysmex XE-5000 Instructions for Use 4-1

CHAPTER 4 Reagents

Please refer to the product labeling (package insert or outer package) for the open stability.

Usage

CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).

4.4 STROMATOLYSER-FB

Intended Use

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

Storage and Shelf Life after first Opening

Store STROMATOLYSER-FB at +5 to +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.

4.5 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 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-4DL is a reagent used in combination with the specified dye solution (STROMATOLYSER-4DS) to classify WBC by the flow cytometry method, using a semiconductor laser.

4-2 Sysmex XE-5000 Instructions for Use

Revised April 2007

4.6 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.

4.7 STROMATOLYSER-NR(L)

CHAPTER 4 Reagents

Intended Use

Lyse reagent for the NRBC channel of hematology analyzers.

Storage and Shelf Life after first Opening

Store STROMATOLYSER-NR(L) at +2 to +35°C and out of direct sunlight. 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-NR(L) is a reagent using in combination with STROMATOLYSER-NR(S) to analy ze er y thr oblast co unt and ratio by the flow cytometry method, using a semiconductor laser.

Revised April 2007 EU

Sysmex XE-5000 Instructions for Use 4-3

CHAPTER 4 Reagents

4.8 STROMATOLYSER-NR(S)

Intended Use

Dye solution for the NRBC channel of hematology analyzers.

Storage and Shelf Life after first Opening

Store STROMATOLYSER-NR(S) at +2 to +35°C and out of direct sunlight. 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-NR(S) is a reagent using in combination with STROMATOLYSER-NR(L) to analyze erythroblast count and ratio by the flow cytometry method, using a semiconductor laser.

4.9 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.

4-4 Sysmex XE-5000 Instructions for Use

Revised April 2007 EU

4.10 STROMATOLYSER-IM

Intended Use

A lyse reagent for the IMI channel of hematology analyzers.

Storage and Shelf Life after first Opening

Store STROMATOLYSER-IM at +2 to +35°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-IM is a reagent for detecting immature cells by the RF/DC detection method.

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

CHAPTER 4 Reagents

Intended Use

Lyse reagent and dye solution for the RET channel of hematology analyzers.

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 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

RET SEARCH (II) is a reagent using in the combination of RET SEARCH (II) (diluent) and RET SEARCH (II) (dye solution) to analyze reticuloc yte s and opti c ally ana ly zed platelets by the flow cytometry method, using a semiconductor laser.

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Sysmex XE-5000 Instructions for Use 4-5

CHAPTER 4 Reagents

4.12 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 +15 to +30°C. Avoid e xposing 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, detector, whole blood aspiration line tube and other parts in the blood cell analysis instrument.

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Revised April 2007 EU

4.13 Control blood (e-CHECK(XE))

Intended Use

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

Warnings and Precautions

CHAPTER 4 Reagents

Risk of infection

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

Warning!

Potentially Infectious Material-All human source material used to manufacture this product was nonreactive for antigens to Hepatitis B9(HbsAg), negative by tests for antibodies to HIV(HIV-1/HIV-2) and Hepatitis C9(HCV), non-reactive 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.

Storage and Shelf Life after first Opening

Store control material as per product insert at +2 to +8°C. If unopened, e-CHECK(XE) may be used up to the expiration date shown on the container. Once opened, it should be used within 14 days.

4.14 Labeling

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.

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Sysmex XE-5000 Instructions for Use 4-7

CHAPTER 4 Reagents

4.15 Sym bols used on the labels

IVD

LOT 1234

22-Nov-2000

+NN C

-NN C

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

Revised April 2007 EU

4-8 Sysmex XE-5000 Instructions for Use

5. Before Using

5.1 Storage prior to transport and installation

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

Information

If the packaging has been damaged in any way, contact your Sysmex technical representative as soon as possib le.

• 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 XE-5000 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 93 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, leave enough 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.

Revised April 2007

Sysmex XE-5000 Instructions for Use 5-1

CHAPTER 5 Before Using

5.3 Peripherals

Caution!

• Turn the power switch of the 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”).

Note:

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

5.4 Additional components

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.

Waste sensor unit (option)

Informs the operator that the waste container is full.

Note:

The waste sensor unit is optional.

Revised April 2007

5-2 Sysmex XE-5000 Instructions for Use

Uninterruptible power suppl y (UPS) (option)

A backup power supply which allows the IPU to operate for a maximum of 5 minutes in the event of power failure. In case of momentary power interruption caused by a thunder storm, the UPS protects the IPU hard disk.

5.5 Basic equipment settings

CHAPTER 5 Before Using

Note:

The uninterruptible power supply (UPS) is optional.

Note:

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

Date and Time

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

Information

The date and time cannot be set from the XE-5000 setup program.

Brightness adjustment of panel keypad LCD screen

1. Open the front cover of the Main Unit.

1 0%

2. The LCD brightness can be adjusted using the brightness adjustment volume under the panel keypad. Turn to the right: Darker Turn to the left: Lighter

3. Close the front cover of the Main Unit.

Brightness adjustment volume

Darker Lighter

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Sysmex XE-5000 Instructions for Use 5-3

CHAPTER 5 Before Using

Blank page

5-4 Sysmex XE-5000 Instructions for Use

Revised April 2007

6. Operation

6.1 Summary of Main Unit operation

Various functions can be activated by selecting them from menus on the panel keypad of the Main Unit. On the LCD screen, the functions that are usable from each menu are displayed on submenu. Information such as the status of the instrument and the setting status of the next sample to be analyzed is displayed at the top of the screen.

Main Menu

Manual C D N R Ready POS ERR RBC 3.41 x10^6/uL HGB 9.9 g/dL HCT 31.3 % MCV 91.8 fL MCH 29.0 pg MCHC 31.6 g/dL PLT 191 x10^3/uL RET% 38.7 % RET# 0.1320 x10^6/uL NRBC 1.29 x10^3/uL

QC AutoRinse Maint Reagent

Next No.123456789012346 DP No. 123456789012345

PNo. 123456789012345 123456-01

WBC & 14.08 x10^3/uL NEUT 10.37 73.6 % LYMPH 2.19 15.6 % MONO 1.38 9.8 % EO 0.03 0.2 % BASO 0.11 0.8 % IG 0.05 0.6 % HPC x10^3/uL

Num DP Xm

The function menu of the main menu is displayed on the bottom of the main menu screen.

• If there are five or more function menus, press the MORE

key to display the remaining function menus.

• To select a function menu, press the corresponding

selection key below the LCD screen.

• To return to the main menu screen from another screen,

press the RETURN key.

CHAPTER 6 Operation

MANUAL

0 -/. C

NUM./ALPH. ENTER

SHUTDOWN HELP

RETURN MORE

Submenu selection

SAMPLER

ABC8DEF

GHI4JKL5MNO

PRS1TUV2WXY

Note:

To return to the main menu screen, depending on the currently displayed screen, it may be necessary to press the RETURN key several times.

When an item on the main menu is selected, the submenu available for that item is displayed. The following methods can be selected, depending on the submenu.

• When using a submenu of the function menu, press the

corresponding selection key below the LCD screen.

• If there is a submenu with a menu number, press the

number key for that menu number, or use the cursor keys to select the menu.

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-1

CHAPTER 6 Operation

Entering numbers and characters

Sample numbers or the like can be entered from the panel keypad. By pressing the NUM./ALPH. key on the panel keypad, you can change the input mode in this order: “Numeric” → “Uppercase Alphabet” → “Lowercase Alphabet”.

• Press the corresponding number keys to enter numbers.

• To enter characters, press the corresponding number key repeatedly until the intended character appears.

• Press the C key to delete a character.

• Press the ENTER key to confirm input.

6-2 Sysmex XE-5000 Instructions for Use

Revised April 2007

6.2 Main unit menu tree

CHAPTER 6 Operation

QC*

AutoRinse

Mainte.

Reagent

Logoff

Cal 1. Manual

Test

Exec. QC Xm STT/STP

Status

Sampler

1. Drain IMI

2. Air Bubble Removal

3. Clog Removal

4. Rinse Flowcell

5. Drain Waste

2. HGB/HCT

1. Sensor 1

2. Sensor 2

3. Counter

4. Pump

1. Rack Feed In

2. Rack Shift

3. Rack Feed Out

CP Barcode Motor

SRV Replenish

1. WB. Asp. Motor

2. RBC Sheath Injector

3. FCM Sheath Injector

4. Spits Motor

5. Mixing Motor

1. FFD

2. FFS

3. SNR

4. RED

5. FBA

6. EPK

7. ESE

8. SLS

9. SIM

* : “B-Check” will be displayed instead of “QC” in the body fluid mode.

“B-Check” means background check.

Revised June 2008

Sysmex XE-5000 Instructions for Use 6-3

CHAPTER 6 Operation

6.3 Summary of Information Processing Unit (IPU) operation

Caution!

• The Information Processing Unit (IPU) is to be used exclusively with the XE-5000 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.

• Double-click the icon on the tool bar.

• Click on the menu, then select the submenu item from the pull down.

• Double-click the icon on the menu screen.

6-4 Sysmex XE-5000 Instructions for Use

Revised April 2007

Dialog box

The dialog box is displayed when a specified menu or command button is selected.

6.4 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 List Last20

Report Host (HC)

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

Opens the data browser (only when the sample explorer is running). Closes the window. Overwrites and save 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 se arch win dow. Changes the tab title.

Displays or close the tool bar. Displays or close the sta tus 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 rec ord. Outputs the selected data as a file in CSV format.

Validates the displayed sample. Displays the pen din g work list. Displays the lat e st 20 samp les.

Transfers the selected analysis results to the host computer (HC). Prints the selected analysis results on a ticket printer (DP). Prints th e selected analysis results on a report printer (GP). Prints th e selected analysis resul ts on a ledger printer (LP). Prints the selected analysis results on a report printer (GP) with laboratory-use-only format.

CHAPTER 6 Operation

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-5

CHAPTER 6 Operation

Menu Submenu Menu Function

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 Reference Lim it CSV Output Setting Backup

Window Cascade

Tile Split

Help About XE-5000 Displays the application version. (To version display dialog box.)

Starts Setting/System. 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/Sampler Stop Limit Setting. Starts Setting/CSV Output Setting. Starts Setting/Backup.

Displays the pres en tly disp layed windows casc ade styl e. Displays par al le ls in above and below, left and right. Splits window display.

6.5 Alarm sound

6.6 Operator checks

1. Reagent check

In the XE-5000, three types of alarm sounds are used to alert the operator:

Key Entry Alarm (single beep)

Sounds about 0.1 second when a key is pressed on the panel keypad.

Input Error Alarm (short beep)

Sounds about 1 second when a wrong key is pressed on the panel keypad.

Analysis Error Alarm (long beep)

Sounds when an error occurs in the Main Unit and continues until the C key or HELP key is pressed on the panel keypad.

Make sure that there is a sufficient amount of reagent for the day’s samples. If the amount is insufficient, prepare replacement reagent. If reagent runs out during an analysis, 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 approximate number of cycles that can be analyzed per container of reagent.

6-6 Sysmex XE-5000 Instructions for Use

Revised April 2007

CHAPTER 6 Operation

●Samples Analyzed per Reagent Container

Reagent Abbreviation

CELLPACK EPK Approx. 660

CELLSHEATH ESE Approx. 7300

STROMATOLYSER-FBFBA Approx. 2750

STROMATOLYSER4DL

STROMATOLYSER4DS

STROMATOLYSERNR(L)

STROMATOLYSERNR(S)

SULFOLYSER SLS Approx. 10000

STROMATOLYSER-IMSIM Approx. 3200

RET SEARCH (II) (Diluent)

RET SEARCH (II) (Dye solution)

FFD Approx. 2750

FFS Approx. 2000

SNR Approx. 2000

RED Approx. 550

No. of cycles/

container

cycles

cycles Approx. 2000

cycles

cycles Approx. 550

cycles

Capacity

per

container

20.0 L

5 L

42 mL

3.6 L

43 mL

5 L

10 L

1 L

12 mL

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

●Replacing the Reagent

Caution!

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

• In handling a reagent that may have frozen, 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, make sure that no dust, dirt or bacteria comes into the container. Otherwise analysis may not be performed correctly.

After replacement of the reagent, perf orm automatic cleaning, check that the background count is low, then sta rt the sample analysis.

Revised July 2007 EU

Sysmex XE-5000 Instructions for Use 6-7

CHAPTER 6 Operation

2. Printer paper

3. Equipment

4. Sampler

5. Waste fluid

6.7 Turning ON the power

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

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”.

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

Information

Do not turn OFF the power of the Main Unit while displaying the message “PLEASE WAIT.”

Note:

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

6-8 Sysmex XE-5000 Instructions for Use

Revised April 2007

6.8 Logging on to the Information Processing Unit (IPU)

1. Apply the power of the IPU.

2. The Windows system starts up, and the user is automatically logged on to the Windows system as “XE-5000”.

3. The logon dialog box for the XE-5000 application program is displayed.

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

Information

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

• “m107m” 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”.

CHAPTER 6 Operation

6.9 Self-checks

Revised April 2007 EU

Note:

See “Chapter 5: Instrume nt 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.

The instrument performs a self-check operation automatically after the power of the Main Unit is turned ON. The following checks are performed in order: microprocessor check, temperature check, mechanical pa rts check and background check. If a failure occurs during a self-check, see “Chapter 10: Troubleshooting”.

Sysmex XE-5000 Instructions for Use 6-9

CHAPTER 6 Operation

Background check

WBC 0.10 [×103/µL] DIFF-WBC 0.20 [×103/µL] IMI-TOTAL 300 IMI# 5

3 6

/µL]

NRBC-WBC 0.20 [×10 RBC 0.02 [×10 HGB 0.1 [g/dL] PLT 5 [×103/µL] PLT-O 10 [×10

/µL] /µL]

For the background check, the background check screen will appear. Then, the background value is chec ked by repeating the background check for up to 3 times. If the background value is less than or equal to that shown in the table, the background check is completed .

If the background value does not become lower than the specified value, the message “Background Error” will be displayed on completion of the background check. The “+” mark will indicate on the background check screen f or the parameter which did not become lower than the specified value.

Caution!

In the case of a background err or, the analysis can be performed by selecting “OK” on the function menu. However, the measured values tend to be higher and correct results may not be obtained for some analysis parameters.

Maint C D N R Not Ready

Next No.123456789012346 DP No. 123456789012345

<Background Check> RBC 0 x10^6/uL HGB 0 g/dL PLT 0 x10^3/uL PLT-O 0 x10^3/uL WBC 0 x10^3/uL DIFF-WBC 0 x10^3/uL NRBC-WBC 0 x10^3/uL IMI-Total 0 IMI# 0

Retry

Num DP Xm

Note:

• When a background error occurs, the error parameter will be displayed on the screen.

• The progress status of background check is indicated with an asterisk.

• During the background check, “Background Check” is displayed in the sample No. column.

In the case of a background error, select “Retry” on the function menu of the Background Check screen to perform a background check again. If the value is not lower than the acceptable background value, “+” is displayed to the right of the value. To resolve background error, see “Chapter 10: Troubleshooting”.

6-10 Sysmex XE-5000 Instructions for Use

Revised July 2007

6.10 Pressure and vacuum gauges check

The pressure and vacuum gauges should reach their

PRESSURE

VACUUM

specified levels approximately 30 seconds after the power of the Main Unit is turned ON. Confirm that the gauges indicate the values shown below. If they do not, adjust them to the acceptable range. (Only the pressure can be adjusted on the Pneumatic Unit. See “Chapter 9: Cleaning and Maintenance” for adjustment procedure.)

Pressure 0.25±0.03 MPa Vacuum -0.05 MPa or higher

6.11 Logging on the Main Unit

CHAPTER 6 Operation

Manual C D N R Not Ready

Logon Name Password

Next No.123456789012346 DP No. 123456789012345

Num DP Xm

When the background check is completed, the logon screen is displayed on the Main Unit LCD screen. Enter the registered logon name and password, and select the “OK” on the function menu of the logon screen.

Use the and keys to changeover the input parameter. By executing logon, the menu corresponded to the permission set at the Information Processing Unit (IPU) will become executable. See “Chapter 5: Instrument Setup” in the

Software Guide.

6.12 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.

6.13 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”.

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-11

CHAPTER 6 Operation

6.14 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 samples 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:

6.15 Analysis m ode

With the XE-5000, the analysis can be performed in six modes: manual, HPC, body fluid, capillary, sampler and manual closed modes.

• Manual, HPC and body fluid modes In these modes, the caps of sample tubes are manually removed and each sample is aspirated via the whole blood 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, HPC and body fluid modes.

• Sampler mode The sampler automatically mixes, aspirates and analyzes samples without removing their caps. Up to 100 samples can be loaded at a time and analyzed automatically.

Revised April 2007

6-12 Sysmex XE-5000 Instructions for Use

• 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, HPC and body fluid modes; mixing and continuous analysis can not be performed automatically.

6.16 Preparing sample analysis

Samples

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

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

• Sample volumes Manual, capillary and manual closed mode

CHAPTER 6 Operation

Note:

HPC analysis and body fluid analysis can only be performed in manual 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. 130 µL Approx. 130 µL Approx. 200 µL

HPC analysis and Body fluid analysis

Analysis mode HPC Body fluid Required S ample 1.0 mL or more 500 µL or more Aspirated Sample Approx. 130 µL Approx. 130 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 200 µL

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-13

CHAPTER 6 Operation

Sample tubes

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

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

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

Sample tube adapters

Adapter

Examples of suitable tubes

• VENOJECT II (TERUMO)

• Hemoguard (BD)

• VACUETTE (greiner)

• Monovette (SAR STE D T) 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.

If tubes have diameters of less than 14 mm, attach adapters to the rack.

Diameter of Sample Tube Adapter 12 mm Adapter No. 58 13 mm Adapter No. 56

14 mm None 15 mm None

Affix a barcode label

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 rack, make sure that all of the barcodes can be seen through the rack slits. The rack number barcod e labels come in 2 sheets as a set. So, affix another barcode label on the side face of the rack.

6-14 Sysmex XE-5000 Instructions for Use

Revised April 2007

Sample Tube

(Sample ID number bar code label)

61 mm

CHAPTER 6 Operation

Warning!

Affix the barcode label so that the bars on the label are horizontal when the rack is placed on the sampler. If the barcode label is affixed slanted, the potential of the misreading of the barcode label will be increased.

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

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

First Tube

Rack Right Side

Caution!

• 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 labels 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.

21 mm

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.

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-15

CHAPTER 6 Operation

Sample number input

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

• When using alphabetic characters in sample ID number setting, press NUM./ALPH. key to change to the alphabetic input mode. (Each time you press the NUM./ALPH. key, the input mode will change in the following order. “Numerical ”→ “Uppercase alphabetic” → “Lowercase alphabetic”.) Examples are given below: Ex. 1: For “SYSMEX” [1], [1], [1], [3], [3], [3],

[1], [1], [1], [6], [9], [9], [3], [3]

Ex.2: For “ABC” [8],[],[8],[8],[],[8],

[8],[8],

(If separators are required, press the key).

Ex.3: For “No-” [6], [6], [NUM./ALPH.], [6], [6],

[6], [NUM./ALPH.], [-/.]

(It is possible to change the input mode during input).

• When a sample ID number includes alphabetic characters or a hyphen, the digits after the first alphabet or hyphen as counted from the numerical last digit are added automatically. (1A-B98 is followed 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 left 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.

6-16 Sysmex XE-5000 Instructions for Use

Revised April 2007

6.17 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 disinfectant. If your hands or body are contaminated by blood, etc., you might be infected by pathogen, etc.

Refer to “Chapter 6: 6.23 HPC analysis” when performing HPC analysis, and to “Chapter 6: 6.24 Body fluid analysis” when performing body fluid analysis.

CHAPTER 6 Operation

Risk of infection

Note:

READY LED

Manual C D N R Not Ready

Sample No.

Mode

Discrete

Sample 1:Normal 2:HPC 3:Body Fluid

Next No.123456789012346 DP No. 123456789012345

123456789012345

1 2 3 Manual Capillary Closed

1 2 3 4 5 CBC CBC CBC CBC CBC DIFF DIFF NRBC NRBC NRBC RET RET

Num DP Xm

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

2. Press the MANUAL key on the Main Unit panel keypad. The Sample No. Setting screen will appear on the LCD.

3. Using the numeric keys, input the sample ID number. Or, read the barcode using a handheld barcode scanner (option).

4. When analysis mode is not set in manual mode, press the

key and change the set item to “Mode”. Then using the

and keys, set the manual mode.

5. Check the di sc re te s et t i ng, a n d if ne ce ssa ry, press key to change the set item to “Discrete”. Then using the and keys, set the discrete.

6. Use the key to change the setting parameter to “Sample”, then use the and keys to set to Normal.

7. After all the settings are completed, press the ENTER key to confirm.

Revised April 2007 EU

Sysmex XE-5000 Instructions for Use 6-17

CHAPTER 6 Operation

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

READY LED

START Switch

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

10. Hold the sample tube under the manu al aspir at ion pip ette so that the tip of the pipette is at the bott om of t he sa mple 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 remov e the sample tube, pull straight down to prevent bending the manual aspiration pipette. Otherwise the blood may scatter.

Note:

The manual aspiration pipette is automatically rins ed , 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.

6-18 Sysmex XE-5000 Instructions for Use

Revised July 2007

• If sample ID number is not set, they are 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.

6.18 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 disinfectant. If your hands or body are contaminated by blood, etc., you might be infected by pathogen, etc.

CHAPTER 6 Operation

Note:

[Sample ID]

Risk of infection

Preparing 1:5 dilution of the sample

Revised April 2007

Caution!

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

Prepare 1:5 diluted sample using the following materials.

• Diluent (CELLPACK)

• Microtube (MT-40, etc.)

• Pipette [40 µL] (SMI Micro Pettor 40 µL, Type 1058-D40 etc.)

• Pipette [160 µL] (SMI Micro Pettor 50-250 µL, Type 1200-J etc.)

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

• Diluent dispensing equipment (injector, etc.)

Sysmex XE-5000 Instructions for Use 6-19

CHAPTER 6 Operation

Sample analysis

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. Use a pipette (40 µL) to dispense 40 µL of blood into a microtube.

5. Cap and mix the microtube well.

READY LED

Capillary C D N R Not Ready

Sample No.

Mode

Discrete

Sample 1:Normal 2:HPC 3:Body Fluid

Next No.123456789012346 DP No. 123456789012345

123456789012345

1 2 3 Manual Capillary Closed

1 2 3 4 5 CBC CBC CBC CBC CBC DIFF DIFF NRBC NRBC NRBC RET RET

Num DP Xm

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

2. Press the MANUAL key on the Main Unit panel keypad. The Sample No. Setting screen will appear on the LCD.

3. Using the numeric keys, input the sample ID number. Or, read the barcode using a handheld barcode scanner (option).

4. When analysis mode is not set in capillary mode, press the key and change the set item to “Mode”. Then using the and keys to set the capillary mode.

5. Check the di sc re te s et t i ng, a n d if ne ce ssa ry, press key to change the set item to “Discrete”. Then using the and keys, set the discrete.

6. After all the settings are completed, press the ENTER key to confirm.

Information

HPC analysis and body fluid analysis are not possible in capillary mode.

6-20 Sysmex XE-5000 Instructions for Use

Revised April 2007 EU

CHAPTER 6 Operation

READY LED

START Switch

7. Rem ove the cap carefully in order not to spla sh the blood.

8. Hold the sample tube under the manual aspiration pipette so that the tip of the pipette is at the bott om of the sa mple tube; then press the START switch. Do not remove the microtube while the READY LED is blinking; sample is being aspirated.

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

Caution!

To remove the micr otube, pu ll straight do wn to pre v ent bending the manual aspiration pipette. Otherwise the blood may scatter.

Note:

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

10. When the READY LED turns on again, prepare a next sample and repeat steps 7-9.

6.19 Sample analysis in sampler mode

1. Make sure that the instrument is in READY status.

READY LED

2. Press the SAMPLER key on the Main Unit panel keypad.

Revised July 2007

Note:

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

• For the parameters that can be analyzed in capillary mode, see “Chapter 1: 1.3 Measurement parameters”.

• IMI channel analysis is not performed in capillary mode

The READY LED should be lit.

The Sampler Setting screen will appear on the LCD.

Sysmex XE-5000 Instructions for Use 6-21

CHAPTER 6 Operation

Manual C D N R Not Ready

Sample No.

Rack-Tube

Discrete

Start

Next No.123456789012346 DP No. 123456789012345

123456789012345

123456 - 01

1 2 3 4 5 CBC CBC CBC CBC CBC DIFF DIFF NRBC NRBC NRBC RET RET

Num DP Xm

3. Using the numeric keys, input the sample ID number.

4. Check the first sample rack number and tube position number. If it is necessary to change them, press the

key to change the set item; then input the numeral.

5. Check the di sc re te s et t i ng, a n d if ne ce ssa ry, press key to change the set item to “Discrete”. Then using the and keys, set the discrete.

6. Put the sample tubes in the rack, and set the rack in the right rack pool of the sampler. Up to 10 sample racks can be loaded at a time.

Caution!

If a sample is left in a stable condition for more than 4 hours and its blood cell and plasma are separated, 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.

7. From the Sampler Setting screen, select “Start” on the function menu or press the SAMPLER key again. The sampler analysis will start.

Caution!

• Do not touch or remove the cover of the CP Unit during 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 analys is.

• 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 rack.

Revised April 2007 EU

6-22 Sysmex XE-5000 Instructions for Use

CHAPTER 6 Operation

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.

• After sample No. or rack No. is input, move the cursor to the tube position. Otherwise, it is impossible to start the sampler analysis. Once the cursor is mo v ed, th e sampl er ana lysis ca n be sta rted even when the cursor is not at the tube position.

• HPC analysis and body fluid analysis are not possible in sampler mode.

Note:

When the SAMPLER key is pressed during sampler analysis, the sampler stops and STAT analysis (manual or capillary analysis) can be performed.

STAT analysis in sampler mode

8. When all of the racks have moved to the left rack pool of the sampler, the READY LED turns on.

1. Press the SAMPLER key to interrupt the sampler analysis. “STAT” appears at the upper left of the LCD screen. When the sampler analysis is interrupted and the message “STAT READY” appears at the upper left of the LCD screen, manual/capillary analysis can be performed.

2. Press the MANUAL key and input the sample ID number for the STAT analysis. Or, read the barcode using a handheld barcode scanner (option).

3. Analyze a sample in the same procedure as with ordinary analysis.

4. After the STAT analysis is completed, the message “ST AT READY” will appear at the upper left of the LCD screen again; press the SAMPLER key. The message “SAMPLER MODE” will appear on the LCD screen, and sampler analysis will resume.

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-23

CHAPTER 6 Operation

6.20 Sample analysis in manual closed mode

READY LED

Closed C D N R Not Ready

Sample No.

Mode

Discrete

Sample 1:Normal 2:HPC 3:Body Fluid

Next No.123456789012346 DP No. 123456789012345

123456789012345

1 2 3 Manual Capillary Closed

1 2 3 4 5 CBC CBC CBC CBC CBC DIFF DIFF NRBC NRBC NRBC RET RET

Num DP Xm

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

2. Press the MANUAL key on the Main Unit panel keypad. The Sample No. Setting screen will appear on the LCD.

3. Using the numeric keys, input the sample ID number. Or, read the barcode using a handheld barcode scanner (option).

4. When analysis mode is not set in closed mode, press the

key and change the set item to “Mode.” Then using the

and keys, set the closed mode.

5. Check the di sc re te s et t i ng, a n d if ne ce ssa ry, press key to change the set item to “Discrete. ” Then using the and keys, set the discrete.

6. Use the key to change the setting parameter to “Sample”, then use the and keys to set to Normal.

7. After all the settings are completed, press the ENTER key to confirm.

8. Mix the sample thoroughly by inverting the tube; then insert it into the far left position of the rack (tube position No. 1).

Information

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

• HPC analysis and body fluid analysis are not possible in manual closed mode.

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

10. Press the START switch to start the analysis. The rack is transferred to the aspiration point, and aspiration and analysis are performed automatically.

Revised April 2007 EU

6-24 Sysmex XE-5000 Instructions for Use

CHAPTER 6 Operation

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.)

11. When the READY LED is lit, remove the remaining rack in the analysis line, prepare the next samples, and repeat the steps 8-10.

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.

6.21 Di splay analysis results

Manual C D N R Ready POS ERR RBC 3.41 x10^6/uL HGB 9.9 g/dL HCT 31.3 % MCV 91.8 fL MCH 29.0 pg MCHC 31.6 g/dL PLT 191 x10^3/uL RET% 38.7 % RET# 0.1320 x10^6/uL NRBC 1.29 x10^3/uL

QC AutoRinse Maint Reagent

Next No.123456789012346 DP No. 123456789012345

PNo. 123456789012345 123456-01

WBC & 14.08 x10^3/uL NEUT 10.37 73.6 % LYMPH 2.19 15.6 % MONO 1.38 9.8 % EO 0.03 0.2 % BASO 0.11 0.8 % IG 0.05 0.6 % HPC x10^3/uL

Num DP Xm

The analysis results – numeral information of latest samples can be displayed on the Main Menu screen of the Main Unit LCD. The Main Menu screen is made up of five pages that can be

switched using and keys.

Caution!

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

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-25

CHAPTER 6 Operation

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

6.22 Analysis result output

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.

Information

Analysis results in body fluid analysis mode cannot be validated automatically, so they are not subject to automatic output, regardless of the setting.

6-26 Sysmex XE-5000 Instructions for Use

Revised April 2007

6.23 HPC analysis

Summary of HPC analysis

Specimen type

CHAPTER 6 Operation

Intended Use:The HPC (hematopoietic progenitor cell)

parameter on the IMI Channel on the Sysmex XE-5000 for in vitro diagnostics is used as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples.

Information

Please take into consideration the clinical picture when using the HPC parameter. The clinician must make the final judgment in the use of the HPC results.

Peripheral blood (PB) Umbilical cord blood (UCB)

Analys is parameters

Anticoagulants

Environment temperature

HPC#: The count of cells appearing in the Hematopoietic

Progenitor Cell (HPC) area of the IMI channel. The sample type is peripheral blood collected from PBSCT (peripheral blood stem cell harvesting) patients.

EDTA (Studies were performed on EDTA-3K)

20 – 30ºC

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-27

CHAPTER 6 Operation

HPC analysis mode

The discriminated particles are displayed in red as an immature cell.

The RBCs, WBC ghosts and discriminated particles are displayed in blue.

The particles in the HPC detection area are displayed in magenta(pink).

When cord blood or peripheral blood are analyzed in HPC analysis mode, the HPC# is displayed.

Sample analysis in HPC analysis mode

The HPC mode needs to be selected on the Main Unit, prior to performing the HPC analysis. The method for selecting HPC analysis mode and performing the analysis is explained below.

Information

When leukemia samples are analyzed, cells other than HPC may appear in the HPC area.

Note:

The HPC detection area exists as a special area on the IMI scattergram.

Risk of infection

Information

• Samples should be measured immediately after being drawn.

• Prior to sample analysis, ensure that the white blood cell (WBC) concentration is no greater than the linearity limit stated in this manual. The HPC result can be used if it is within the HPC linearity limit.

6-28 Sysmex XE-5000 Instructions for Use

Revised April 2007

READY LED

CHAPTER 6 Operation

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

2. Press the MANUAL key on the Main Unit panel keypad. The Manual Sample No. Setting screen will appear on the LCD.

Manual C D N R Not Ready

Sample No.

Mode

Discrete

Sample 1:Normal 2:HPC 3:Body Fluid

Next No.123456789012346 DP No. 123456789012345

123456789012345

1 2 3 Manual Capillary Closed

1 2 3 4 5 CBC CBC CBC CBC CBC DIFF DIFF NRBC NRBC NRBC RET RET

Num DP Xm

3. Using the numeric keys, input the sample ID number. Or, read the barcode using a handheld barcode scanner (option).

4. When analysis mode is not set in manual mode, press the

key and change the set item to “Mode.” Then using the

and keys, set the manual mode.

Information

HPC analysis is only performed in manual mode. It cannot be performed in sampler, capillary or manual closed modes.

5. Use the key to change the setting parameter to Discrete, then use the and keys to set to any of the

following. 4 CBC+DIFF+NRBC 5 CBC+DIFF+NRBC+RET

Information

The IMI detector is used for HPC analysis. HPC analysis is not possible if the discrete setting does not include DIFF analysis.

6. Use the key to change the setting parameter to “Sample”, then use the and keys to set to HPC.

7. After all the settings are completed, press the ENTER key . The analysis preparation sequence is performed.

Revised April 2007 EU

Sysmex XE-5000 Instructions for Use 6-29

CHAPTER 6 Operation

Information

• If the analysis order is already complete, and HPC analysis mode is set, HPC analysis is performed regardless of the results of the analysis order.

• The basic analysis procedure is the same as that for normal mode, but HPC analysis requires preparation of the IMI detector, and of the reaction system for the reagents. The analysis preparation sequence is performed automatically. The time taken to complete the analysis preparation sequence varies according to the installation environment, but does not exceed approximately four minutes.

• In HPC analysis mode, analysis ready status is maintained for approximately three minutes from the last operation. If the Main Unit performs no operation during this time interval, the analysis preparation sequence will start automatically before the next sample analysis.

• Use the reset sequence to return from HPC analysis mode to normal mode. The time taken to complete the sequence varies according to the installation environment.

Note:

The patient ID must be registered in the work list in order to display consecutive data for HPC#. Use any of the methods below to register the patient ID. For details, see “Chapter 2: Work List” in the Software Guide.

• Query the host computer for analysis information.

• Register under patient registration.

8. Once the HPC analysis preparation sequence is complete, the READY LED lights, and the Main Unit enters HPC analysis ready status.

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

Information

Sample should be mixed gently.

Revised April 2007

6-30 Sysmex XE-5000 Instructions for Use

CHAPTER 6 Operation

READY LED

START Switch

10. Remove the cap carefully in order not splash the blood.

11. Hold the sample tube under the manual a spir ati on pipet te so that the tip of the pipette is at the bott om of the sa mple tube; then press the START switch. Do not remove the sample tube while the READY LED is blinking; sample is being aspirated.

Information

• Analysis requires an adequate sample volume. Correct analysis results cannot be obtained if the instrument does not aspirate an adequate sample volume. For required sample volumes, see “Chapter 6: 6.16 Preparing sample analysis”.

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

Caution!

To remov e the sample tube, pull straight down to prevent bending the manual aspiration pipette. Otherwise the blood may scatter.

Display analysis results

Revised July 2007

Note:

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

13. Once analysis is complete, set “Sample” to “Normal” on the Sample No. Setting screen to return to nor ma l mo de.

Information

• If the value of HPC# is low, we recommend performing multiple analysis.

• A sample to be used fo r any purpose other than HPC analysis should be analyzed in normal mode.

• Abnormal judgments and sampler stop conditions do not apply to HPC#.

HPC# analysis results are displayed on the main menu screen of the Main Unit LCD screen. The results are also displayed on the sample explorer and data br owser screens of the Information Processing Unit (IPU). Analysis results analyzed in HPC analysis mode are marked with an “H” to the left of the sample No. on the Main Unit LCD screen. “H” is displayed in the analysis mode display on the sample explorer and data browser screens.

Sysmex XE-5000 Instructions for Use 6-31

CHAPTER 6 Operation

Note:

Analysis results for HPC# are not displayed if the analysis was performed in normal mode.

The sample explorer and data browser screens display HPC rank. HPC rank is indicated as shown below. +++: Displayed if the conditions for “+++” indication, as set

on the Rank Limit setting screen, are satisfied.

++: Displayed if the conditions for “++” indication, as set on

the Rank Limit setting screen, are satisfied.

+: Displayed if the conditions for “+” indication, as set on

the Rank Limit setting screen, are satisfied.

-: Displayed if none of the conditions for “+++”, “++” and “+” indication, as set on the Rank Limit setting screen, are satisfied.

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. See also “Chapter 5: Instrument Setup” in the Software Guide for the setting of HPC rank limits.

Reference intervals

Information

The laboratory should perform additional testing if more specific or sensitive limitation information is needed.

In normal pediatric and adult populations there is an absence to extremely low levels of HPC. Sysmex recommends that each laboratory establish its own expected reference intervals based upon the laboratory’s patient population. The CLSI document* C28-A2 contains guidelines for determining reference intervals and intervals for quantitative laboratory tests.

* : How to Define and Determine Reference Intervals in the

Clinical Laboratory; Approved Guideline - Second Edition, CLSI document C28-A2, (ISBN P56238-269-I), CLSI (Clinical and Laboratory Standards Institute), 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2000.

Revised April 2007

6-32 Sysmex XE-5000 Instructions for Use

6.24 Body fluid analysis

Summary of body fluid analysis

Specimen type

Analysis parameters

CHAPTER 6 Operation

The body fluid analysis mode of the XE-5000 uses the 4DIFF scattergram and the RBC distribution obtained from a specialized analysis sequence to calculate and display the WBC counts, mononuclear cell (MN)/ polymorphonuclear cell (PMN) counts and percentages, and RBC (RBC-BF) counts found in the body fluid.

Serous fluids, synovial fluids, cerebrospinal fluids (CSF) with EDTA, as needed.

Information

Since fibrin may be precipitated when measuring body fluid, add EDTA anticoagulant in the measurement as necessary.

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

Sample analysis under body fluid analysis mode

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

READY LED

1. Make sure that the instrument is in READY status.

2. Press the MANUAL key on the Main Unit panel keypad.

Revised August 2008 EU

Risk of infection

Information

Samples should be measured immediately after being drawn.

The READY LED should be lit.

The Manual Sample No. Setting screen will appear on the LCD.

Sysmex XE-5000 Instructions for Use 6-33

CHAPTER 6 Operation

Manual C D N R Not Ready

Sample No.

Mode

Discrete

Sample 1:Normal 2:HPC 3:Body Fluid

Next No.123456789012346 DP No. 123456789012345

1 2 3 Manual Capillary Closed

1 2 3 4 5 CBC CBC CBC CBC CBC DIFF DIFF NRBC NRBC NRBC RET RET

123456789012345

Num DP Xm

3. Using the numeric keys, input the sample ID number. Or, read the barcode using a handheld barcode scanner (option).

4. When analysis mode is not set in manual mode, press the

key and change the set item to “Mode.” Then using the

and keys, set the manual mode.

Information

Body fluid analysis is only performed in manual mode. It cannot be performed in sampler, capillary or manual closed modes.

5. Use the key to change the setting parameter to Discrete, then use the and keys to set to any of the

following. 4 CBC+DIFF+NRBC 5 CBC+DIFF+NRBC+RET

Information

• In body fluid analysis, the discrete setting must include DIFF analysis.

• Whichever of the above discrete settings is chosen, it will change to CBC+DIFF when the ENTER key is pressed to confirm the input.

6. Use the key to change the setting parameter to “Sample”, then use the and keys to set to Body fluid.

7. After all the settings are completed, press the ENTER key to confirm.

Information

When the ENTER key is pressed, the input sample number is us ed as the order key to qu e ry the ana ly s is 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.

6-34 Sysmex XE-5000 Instructions for Use

Revised April 2007 EU

WBC-BF 0.001 [×103/µL]

RBC-BF 0.003 [×10

/µL]

CHAPTER 6 Operation

8. When the ENTER key is pressed, a background check is run at the same time. Background check analysis is repeated three times for the background check. If the background value is lower or equal to that shown in the table on the left, the background check is completed.

If the background value does not become lower or equal to the specified value, the message “Background Error” will be displayed on completion of the background check.

Information

In the case of a “Background Error”, the analysis can be performed by selecting “OK” on the function menu. However, the measured values tend to be higher and correct results may not be obtained.

In the case of a “Background Error”, select “Auto Rinse” on the function menu of the Background Check screen to perform an automatic cleaning. If the value after the automatic cleaning is not lower than the acceptable background value, “+” is displayed to the right of the value. To resolve background error, 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. Analysis orders will not be accepted from a transportation system (if one is connected).

9. 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.

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

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-35

CHAPTER 6 Operation

Information

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

READY LED

START Switch

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

12. Hold the test 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 test tube while the READY LED is blinking; sample is being aspirated.

Information

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

Caution!

To remov e the sample tube, pull straight down to prevent bending the manual aspiration pipette. Otherwise the blood may scatter.

Note:

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

6-36 Sysmex XE-5000 Instructions for Use

Revised July 2007

WBC-BF 1.000 [×103/µL] RBC-BF 1.000 [×106/µL]

CHAPTER 6 Operation

14. Once analysis is complete, set Sample to Normal on the Sample No. Setting screen to return to normal mode.

Caution!

If either of the analysis v alues from body f luid analysis (WBC-BF and RBC-BF) is high, there is the possibility of carryover on the analysis results for the next sample. If analysis results for WBC-BF and RBC-BF exceed the v alues in the tab le on the left, the “Ex ecute Background chec k” error is displa yed, asking operater to perform a background check before analyzing the next sample. Analyze the ne xt sample after perf orming the background check by pressing the “B-Check” function menu on the Main Unit. 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 normal mode fo r analyzing hu man b lo od.

• Body fluid analysis is not compatible with negative judgment.

• Body fluid analysis results are not subject to X

control.

Display analysis results

BF Manual C D Ready

RBC-BF 0.000 x10^6/uL WBC-BF 0.000 x10^3/uL MN 0.000 x10^3/uL ---.-% PMN 0.000 x10^3/uL ---.-%

Next No. 19750112 DP No.

FNo. 19750111

Num DP Xm

The analysis results of Body fluid analysis mode are di splay ed on the main menu screen of the Main Unit LCD screen. The results are also displayed on the sample explorer and data browser screens (the Body Fluid tab) of the Information Processing Unit (IPU). Analysis samples analyzed in body fluid analysis mode are marked with an “F” mark to the left of the sample No. on the Main Unit LCD screen.

B-Check AutoRinse Maint Reagent

“F” is displayed in the analysis mode display column of the sample explorer and data browser screens.

Revised July 2007

Sysmex XE-5000 Instructions for Use 6-37

CHAPTER 6 Operation

Information

• Analysis results from the analysis performed without canceling an “Execute Background check” error are marked with an “F” mark on a red background on the IPU, and an asterisk “*” is displayed on the left of the “F” mark on the main unit LCD screen.

• Results analyzed in body fluid analysis mode are not subject to automatic validation, regardless of the automatic validation setting. Check the display status of the “F” mark and perform validation carefully.

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.

6.25 Timer processing

Recovery procedure

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 any operation within a preset amount of time. When the backlight on the LCD of the Main Unit is kept on for the specified time, brightness becomes darker in order to protect the LCD screen. For the setting method, see “Chapter 5: Instrument Setup” in the Software Guide.

• When the start switch is pressed, the brightness of the LCD screen resets. The Pneumatic Unit also resets at the same time.

• When a numeric key on the panel keypad is pressed, the brightness of the LCD screen resets. The Pneumatic Unit also resets at the same time.

START Switch

6-38 Sysmex XE-5000 Instructions for Use

Revised April 2007

6.26 Shutdown

CHAPTER 6 Operation

Information

As for the timer mode, the Pneumatic Unit and the LCD screen interlock. When you press the START switch or a numeric key, both the timer modes will restart at the same time.

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 continuously, shut it down at least once every 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.

Main Unit shutdown

Manual C D N R Not Ready

It will take approx. 15 minutes

READY LED

START Switch

CELLCLEAN

Next No.1 DP No.

Set CELLCLEAN to the pipette

and press Start Switch

CAUTION:Do not use detergents other than CELLCLEAN.

Cancel

Num DP Xm

1. Press the SHUTDOWN key on the Main Unit panel keypad.

2. The shutdown screen appears on the Main Unit LCD screen.

To cancel shutdown, press the RETURN key or select “Cancel” on the function menu of the Set CELLCLEAN Message Screen to 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 sta tus.

Revised April 2007

Sysmex XE-5000 Instructions for Use 6-39

CHAPTER 6 Operation

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 scatter.

Note:

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

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

6. When the shutdown sequence is completed, the message “Turn OFF Main Unit” will appear.

7. If you wish to complete the analysis, turn OFF the Main Unit power in the current status .

Note:

If you wish to continue an analysis with the Main Unit left ON, select “Restart” on the function menu of the Shutdown Completion screen. After executing an automatic rinse and background check, the system returns to the READY status.

6-40 Sysmex XE-5000 Instructions for Use

Revised July 2007

Logging off from the XE-5000 application program

To change a user, logoff from the XE-5000, and then logon again.

CHAPTER 6 Operation

1. From the “file(F

2. The Logoff confirmation dialog box will be displayed.

3. Click “Yes” or “No”.

Closing the XE-5000 application

1. To close the XE-5000 application, click on “Close” from

2. The Exit confirmation dialog box will be displayed.

3. Click “Yes” or “No”.

Shutting down the Windows system

1. Use the mouse to click on the Start button on the task bar

)” menu, select “Logoff (L)”.

Yes: The system will perform the Logoff procedure and

the XE-5000 Logon dialog box will be displayed.

No: Logoff procedure will be canceled.

the “File (F

)” menu.

Yes: The application will end. No: The application quit operation will be canceled.

in the window to display the Start menu, then select

“Shutdown (U

)”.

The dialog box for Windo w s shutdown will appear on the screen.

Revised July 2007

2. Select “XE-5000 Logoff”, then click on “OK” to display the Windows logon screen. Select “Shut down”, then clic k on “OK” to shut down the Information Processing Unit (IPU) and turn the power Off. Select “Restart”, then click on “OK” to restart the Information Processing Unit (IPU) and automatically logon to Windows as XE-5000 user after the restart is complete. Click on “Cancel” to close the Windows shutdown dialog box and return to the state which preceded its opening. Click on “Help (H

)” to display the Help screen. (The

Windows 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 saved improperly and the system may get damage.

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

Sysmex XE-5000 Instructions for Use 6-41

CHAPTER 6 Operation

Blank page

6-42 Sysmex XE-5000 Instructions for Use

Revised April 2007

7. Quality control

7.1 Quality control materials

CHAPTER 7 Quality control

Quality control is performed in order to monitor an instrument's performance over time. e-CHECK(XE) is the quality control material recommended by Sysmex to monitor the performance of XE-5000 analyzer. As the manufacturer, our recommendation is in accordance with th e CLIA st andard of 2 levels of control, once everyday of instrument operation or as your laboratory policy dictates. It should be noted that for troubleshooting purposes, additional control runs may be necessary.

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

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

Revised June 2008

There are two QC methods for t he XE-5000, 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 analysis is used to evaluate analyzer performance.

• L-J control: Control blood is analyzed on ce 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

average of batches of samples (usually 20) using Bull’s a lgorithm, and plots t he resulting value as control data.

Sysmex XE-5000 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. Start quality control from the Information Processing Unit (IPU).

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: This method performs two consecutive 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: Se ts the new settings.

7-2 Sysmex XE-5000 Instructions for Use

Revised April 2007

X-barM control setting

CHAPTER 7 Quality control

1. From the Main Menu screen on the Main Unit, select “QC” on the function menu. The QC Menu screen will appear.

2. From the QC Menu screen, select “Xm STT/STP” on the function menu.

• If Xm is displayed in the upper right of the LCD screen,

it indicates that X

M control is ON.

• If Xm is not displayed in the upper right of the LCD

screen, it indicates that X

M control is OFF.

Information

Even if X-barM control is canceled in this menu when “Execute X-barM control” is set in the IPU, X-barM control is executed automatically after the power is turned on again. Use the menu only when you analyze a sample in which control error may occur.

Settings for X

M control can be changed as described below.

1. Start quality control from the Information Processing Unit (IPU).

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.

Revised April 2007

Sysmex XE-5000 Instructions for Use 7-3

CHAPTER 7 Quality control

Limit setting

4. Perform X-barM setting. The setting parameters are as follows: X-barM: Sets whether or not to use X

M control.

Click the “Control” radio button to use and the “Not Control” radio button not to use this QC.

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: Se ts the new settings.

1. Start quality control from the Information Processing Unit (IPU).

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.

7-4 Sysmex XE-5000 Instructions for Use

Revised April 2007

SYSMEX XE-5000 Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

1. Introduction

1.1 Hazard information in this manual

1.2 Protected names

1.3 Measurement parameters

2. Safety Information

2.1 Specified conditions of use

2.2 General information

2.3 Installation

2.4 Electromagnetic compatibility (EMC)

2.5 Avoidance of infection

2.6 Handling of reagents

2.7 Quality control materials

2.8 Laser

2.9 Maintaining the instrument

2.10 Disposal of waste fluids, disposables and instruments

2.11 Marking on the instrument

2.12 Personnel

2.13 Computer viruses

3. Design and Function

3.1 Overview

3.2 Main Unit

3.3 Pneumatic Unit

3.4 Sampler Unit

3.5 Information Proc essing Unit (IPU)

3.6 Analysis mode

4. Reagents

4.1 General information

4.2 CELLPACK

4.3 CELLSHEATH

4.4 STROMATOLYSER-FB

4.5 STROMATOLYSER-4DL

4.6 STROMATOLYSER-4DS

4.7 STROMATOLYSER-NR(L)

4.8 STROMATOLYSER-NR(S)

4.9 SULFOLYSER

4.10 STROMATOLYSER-IM

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

4.12 CELLCLEAN

4.13 Control blood (e-CHECK(XE))

4.14 Labeling

4.15 Sym bols used on the labels

5. Before Using

5.1 Storage prior to transport and installation

5.2 Preparation

5.3 Peripherals

5.4 Additional components

5.5 Basic equipment settings

6. Operation

6.1 Summary of Main Unit operation

6.2 Main unit menu tree

6.3 Summary of Information Processing Unit (IPU) operation

6.4 Information Processing Unit (IPU) menu bar

6.5 Alarm sound

6.6 Operator checks

6.7 Turning ON the power

6.8 Logging on to the Information Processing Unit (IPU)

6.9 Self-checks

6.10 Pressure and vacuum gauges check

6.11 Logging on the Main Unit

6.12 Auto output settings check

6.13 Quality control

6.14 Conditions for sample analysis

6.15 Analysis m ode

6.16 Preparing sample analysis

6.17 Sample analysis in manual mode

6.18 Sample analysis in capillary mode

6.19 Sample analysis in sampler mode

6.20 Sample analysis in manual closed mode

6.21 Di splay analysis results

6.22 Analysis result output

6.23 HPC analysis

6.24 Body fluid analysis

6.25 Timer processing

6.26 Shutdown

7. Quality control