Page 1 CHAPTER 12 Warranty CHAPTER 13 Index SYSMEX CORPORATION KOBE, JAPAN Copyright © 2006 - 2008 by SYSMEX CORPORATION All rights reserved. No part of this manual may be Code No. 461-2642-1 reproduced in any form or by any means whatsoever PRINTED IN JAPAN without prior written permission of SYSMEX CORPORATION.
Page 3: Table Of Contents
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 Sysmex XE-5000 Instructions for Use...
Page 4 Quality control methods..........7-1 Preparation ............... 7-2 Quality control analysis..........7-5 QC data display ............7-7 Troubleshooting ............7-12 Change lot .............. 7-13 Lot No..............7-13 Target/Limit ............. 7-16 7.10 Display order............7-21 7.11 File Information............7-22 Sysmex XE-5000 Instructions for Use...
Page 5 9.20 Replacing the HEPA filter (option) ......9-45 9.21 Adjusting pressure and vacuum ......9-46 9.22 Supplies and replacement parts......9-51 9.23 XE-5000 maintenance and inspection check list ..9-52 Chapter 10 Troubleshooting ......10-1 10.1 HELP screen ............10-1 10.2 Error log..............
Page 6 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 ........
Page 7: Chapter 1 Introduction
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.
Page 8 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...
Page 9: Hazard Information In This Manual
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. Sysmex XE-5000 Instructions for Use...
Page 10: Protected Names
• 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 MCHC RDW-SD 10 RDW-CV 11 PDW...
Page 11 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...
Page 12 CHAPTER 1 Introduction 18 BASO# 19 IG% Immature Granulocyte Percent 20 IG# Immature Granulocyte Count 21 NRBC% 22 NRBC# 23 RET% 24 RET# Sysmex XE-5000 Instructions for Use...
Page 13: Chapter 2 Safety Information
CHAPTER 2 Safety Information 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.
Page 14: Installation
• 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. Sysmex XE-5000 Instructions for Use...
Page 15: Electromagnetic Compatibility (Emc)
• 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. Sysmex XE-5000 Instructions for Use...
Page 16: Handling Of Reagents
• 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. Sysmex XE-5000 Instructions for Use...
Page 17: Quality Control Materials
2.8 Laser 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.
Page 18: Maintaining The Instrument
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. Sysmex XE-5000 Instructions for Use...
Page 19: Marking On The Instrument
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. Sysmex XE-5000 Instructions for Use...
Page 20 Do not remove this cover when the power to the Main Unit is ON. Doing so may result in injury. WARNING Do not put your fingers inside when the power to the Main Unit is ON. Doing so may result in injury. Sysmex XE-5000 Instructions for Use...
Page 21 • 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. Fuse Rating 3.15A 250V Time Lag Sysmex XE-5000 Instructions for Use...
Page 22 3. Insert the sample tube securely all the way to the bottom of the rack. Pneumatic Unit - Front View 0.25 MPa regulator RISK OF INFECTION In principle, all parts and surfaces of the instrument must be regarded as infective. 2-10 Sysmex XE-5000 Instructions for Use...
Page 23 CHAPTER 2 Safety Information Pneumatic Unit - Rear View CAUTION Do not block the exhaust vent on the rear of the pneumatic unit. Pneumatic Unit - Right View WARNING Instrument must be grounded. Sysmex XE-5000 Instructions for Use 2-11...
Page 24: Personnel
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.
Page 25: Chapter 3 Design And Function
Prints a hardcopy of analysis results or screen of histograms, scattergrams, etc. Pneumatic unit Supplies pressure and vacuum used by the Main Unit. Sampler unit Supplies samples to the Main Unit automatically. Data printer (option) Prints analysis data in the examination ticket format. Sysmex XE-5000 Instructions for Use...
Page 26: Main Unit
Used to perform basic operation, such as inputting sample ID number, starting the sampler analysis and selecting the analysis parameter. For details, see “Panel keypad” . CP cover This is the protection cover of cap piercing unit. Sysmex XE-5000 Instructions for Use...
Page 27 AC power supply Supplies power using the provided power cable. ESE inlet nipple (ESE-1) CELLSHEATH is aspirated via this nipple. Connected to the lower nipple of the CELLSHEATH float switch. Sysmex XE-5000 Instructions for Use...
Page 28 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. Sysmex XE-5000 Instructions for Use...
Page 29 0.07 MPa regulator Adjusts the pressure to 0.07 MPa. 0.03 MPa regulator Adjusts the pressure to 0.03 MPa. Air filter Prevents dust from entering the bellows unit. Bellows Unit Adjusts the bellows pressure to -0.04 MPa. Sysmex XE-5000 Instructions for Use...
Page 30 Connected to the data printer. 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. Sysmex XE-5000 Instructions for Use...
Page 31 Includes the IMI detector. 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. Sysmex XE-5000 Instructions for Use...
Page 32 Caution! Do not open the left cover unless the instruction is given by your Sysmex technical representative. Sysmex XE-5000 Instructions for Use...
Page 33 In the presence of an error, pressing HELP will display the error message, probable cause 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. Sysmex XE-5000 Instructions for Use...
Page 34 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. 3-10 Sysmex XE-5000 Instructions for Use...
Page 35: Pneumatic Unit
If vacuum is less than -0.05 MPa, the instrument may not operate properly. Pneumatic unit trap chamber Prevents reagent, etc. from flowing into the compressor when an abnormality has occurred in the instrument. Sysmex XE-5000 Instructions for Use 3-11...
Page 36 Supplies vacuum to the Main Unit. Connects to the vacuum supply nipple of the Main Unit. Pressure outlet nipple Supplies pressure to the Main Unit. Connects to the air drier inlet nipple of the Main Unit. 3-12 Sysmex XE-5000 Instructions for Use...
Page 37: Sampler Unit
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. Sysmex XE-5000 Instructions for Use 3-13...
Page 38: Information Processing Unit (Ipu)
The IPU illustrations shown in this manual are for reference only. Refer to the manual included with the computer for the layout of connection ports and other details. For further details, contact your Sysmex technical representative. 3-14 Sysmex XE-5000 Instructions for Use...
Page 39 GP connector (GP) Printer connector for printing out the graphics. Keyboard connector Connector for the keyboard. Main Unit connector (MAIN UNIT) Connector for the XE-5000 Main Unit. HOST connector (HOST: COM2) Connector for the host computer. Mouse connector Connector for the mouse.
Page 40 Inactive tool bar buttons are displayed in gray. The names of windows indicating menu icons are displayed. When there are several windows, select a desired tab to change over the windows. Window (View) Operations are performed in these areas or windows. 3-16 Sysmex XE-5000 Instructions for Use...
Page 41: Analysis Mode
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. Sysmex XE-5000 Instructions for Use 3-17...
Page 42 CHAPTER 3 Design and Function Blank page 3-18 Sysmex XE-5000 Instructions for Use...
Page 43: Chapter 4 Reagents
4. Reagents 4.1 General information 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.
Page 44: Stromatolyser-Fb
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. Sysmex XE-5000 Instructions for Use...
Page 45: Stromatolyser-4Ds
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 analyze erythroblast count and ratio by the flow cytometry method, using a semiconductor laser. Sysmex XE-5000 Instructions for Use...
Page 46: Stromatolyser-Nr(S)
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. Sysmex XE-5000 Instructions for Use...
Page 47: Stromatolyser-Im
RET SEARCH (II) is a reagent using in the combination of RET SEARCH (II) (diluent) and RET SEARCH (II) (dye solution) to analyze reticulocytes and optically analyzed platelets by the flow cytometry method, using a semiconductor laser. Sysmex XE-5000 Instructions for Use...
Page 48: Cellclean
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 Warning! 1. Avoid contact with skin and eyes. 2. In case of skin contact, flush the area with water.
Page 49: Control Blood (E-Check(Xe))
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. Sysmex XE-5000 Instructions for Use...
Page 50: Symbols Used On The Labels
In Vitro Diagnostic Consult instructions for use Lot-number 1234 Use by 22-Nov-2000 +NN C Storage temperature -NN C CE conformity sign as per directive 98/79/EC Hazardous Class in EU Manufacturer Authorized representative in the European community Sysmex XE-5000 Instructions for Use...
Page 51: Chapter 5 Before Using
Sysmex technical representative. 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.
Page 52: Peripherals
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. Sysmex XE-5000 Instructions for Use...
Page 53: Basic Equipment Settings
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.
Page 54 CHAPTER 5 Before Using Blank page Sysmex XE-5000 Instructions for Use...
Page 55: Chapter 6 Operation
• 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. Sysmex XE-5000 Instructions for Use...
Page 56 • 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. Sysmex XE-5000 Instructions for Use...
Page 57: Main Unit Menu Tree
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. Sysmex XE-5000 Instructions for Use...
Page 58: Summary Of Information Processing Unit (Ipu) 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...
Page 59: Information Processing Unit (Ipu) Menu Bar
Prints the selected analysis results on a report printer (GP). Ledger (LP) Prints the selected analysis results on a ledger printer (LP). Report for Lab. Use Only Prints the selected analysis results on a report printer (GP) with laboratory-use-only format. Sysmex XE-5000 Instructions for Use...
Page 60: Alarm Sound
About XE-5000 Displays the application version. (To version display dialog box.) 6.5 Alarm sound 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.
Page 61 Otherwise analysis may not be performed correctly. After replacement of the reagent, perform automatic cleaning, check that the background count is low, then start the sample analysis. Sysmex XE-5000 Instructions for Use...
Page 62: Turning On The Power
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. Sysmex XE-5000 Instructions for Use...
Page 63: Logging On To The Information Processing Unit (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.
Page 64 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...
Page 65: Pressure And Vacuum Gauges Check
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”. Sysmex XE-5000 Instructions for Use 6-11...
Page 66: Conditions For Sample Analysis
6.15 Analysis mode 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...
Page 67: Preparing Sample Analysis
1.0 mL or more Approx. 130 µL Approx. 130 µL Aspirated Sample Sampler mode Diameter of Sample Tube 12 mm 15 mm Required Sample 1.0 to 5 mL 1.0 to 7 mL 200 µL Aspirated Sample Sysmex XE-5000 Instructions for Use 6-13...
Page 68 The rack number barcode labels come in 2 sheets as a set. So, affix another barcode label on the side face of the rack. 6-14 Sysmex XE-5000 Instructions for Use...
Page 69 • 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. Sysmex XE-5000 Instructions for Use 6-15...
Page 70 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...
Page 71: Sample Analysis In Manual Mode
6. Use the key to change the setting parameter to “Sample”, then use the keys to set to Normal. 7. After all the settings are completed, press the ENTER key to confirm. Sysmex XE-5000 Instructions for Use 6-17...
Page 72 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. 6-18 Sysmex XE-5000 Instructions for Use...
Page 73: Sample Analysis In Capillary Mode
• 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...
Page 74 “Discrete”. Then using the 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...
Page 75: Sample Analysis In Sampler Mode
1. Make sure that the instrument is in READY status. READY LED The READY LED should be lit. 2. Press the SAMPLER key on the Main Unit panel keypad. The Sampler Setting screen will appear on the LCD. Sysmex XE-5000 Instructions for Use 6-21...
Page 76 • Do not touch the rack on the analysis line during sampler analysis. • Make sure there is no dirt or foreign substance on the bottom of the rack. Also make sure there is no breakage or deformation of the rack. 6-22 Sysmex XE-5000 Instructions for Use...
Page 77 4. After the STAT analysis is completed, the message “STAT 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. Sysmex XE-5000 Instructions for Use 6-23...
Page 78: Sample Analysis 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. 6-24 Sysmex XE-5000 Instructions for Use...
Page 79: Display Analysis Results
• 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. Sysmex XE-5000 Instructions for Use 6-25...
Page 80: Analysis Result 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...
Page 81: Hpc Analysis
Summary of HPC analysis 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.
Page 82 • 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...
Page 83 6. Use the key to change the setting parameter to “Sample”, then use the keys to set to HPC. 7. After all the settings are completed, press the ENTER key. The analysis preparation sequence is performed. Sysmex XE-5000 Instructions for Use 6-29...
Page 84 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. 6-30 Sysmex XE-5000 Instructions for Use...
Page 85 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...
Page 86 Reference intervals 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.
Page 87: Body Fluid Analysis
CHAPTER 6 Operation 6.24 Body fluid analysis Summary of body fluid analysis 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.
Page 88 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...
Page 89 READY LED lights and the Main Unit enters body fluid analysis ready status. 10. Mix the contents of the test tube gently but thoroughly. Sysmex XE-5000 Instructions for Use 6-35...
Page 90 To remove 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 rinsed, and does not need to be wiped manually. 6-36 Sysmex XE-5000 Instructions for Use...
Page 91 “F” mark to the left of the sample No. on the Main Unit LCD screen. “F” is displayed in the analysis mode display column of the B-Check AutoRinse Maint Reagent sample explorer and data browser screens. Sysmex XE-5000 Instructions for Use 6-37...
Page 92: Timer Processing
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...
Page 93: Shutdown
START switch in that status. START Switch While the READY LED is blinking and the buzzer is sounding, aspiration is in progress. Keep holding CELLCLEAN in the current status. CELLCLEAN Sysmex XE-5000 Instructions for Use 6-39...
Page 94 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...
Page 95 CHAPTER 6 Operation Logging off from the XE-5000 application program To change a user, logoff from the XE-5000, and then logon again. 1. From the “file(F)” menu, select “Logoff (L)”. 2. The Logoff confirmation dialog box will be displayed. 3. Click “Yes” or “No”.
Page 96 CHAPTER 6 Operation Blank page 6-42 Sysmex XE-5000 Instructions for Use...
Page 97: Chapter 7 Quality Control
The control blood is specifically tailored to the analysis technology employed by the instrument. 7.2 Quality control methods There are two QC methods for the XE-5000, one using control blood and one using normal samples. QC using control materials • X control:...
Page 98: Preparation
5. After completing settings, click on “OK”, “Cancel” or “Apply”. Sets the new settings and closes the dialog box. Cancel: Cancels the new settings and closes the dialog box. Apply: Sets the new settings. Sysmex XE-5000 Instructions for Use...
Page 99 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. Sysmex XE-5000 Instructions for Use...
Page 100 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. Sysmex XE-5000 Instructions for Use...
Page 101: Quality Control Analysis
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 “Exec. QC” on the function menu. The QC Selection screen will appear. Sysmex XE-5000 Instructions for Use...
Page 102 Select the file by Lot No., mode and level into which you wish to save analysis results and press “Select” on the function menu. 4. Analyze control blood with reference to “Chapter 6: 6.20 Sample analysis in manual closed mode”. Sysmex XE-5000 Instructions for Use...
Page 103: Qc Data Display
The “+” and “-” signs in the judgment column indicate which parameters are outside the control limits and which are above or below the limits. (When analyzed data is more than 3 times the limit, “+” and “-” will be highlighted.) Sysmex XE-5000 Instructions for Use...
Page 104 4. Select the level of the control blood displayed in the radar chart. 5. Select the lot of the control blood displayed in the radar chart. 6. Select the analysis mode of the control blood. Sysmex XE-5000 Instructions for Use...
Page 105 QC chart screen is closed, so undo is possible. Once the tab has been changed or the QC chart has been closed, the plots can no longer be undeleted. Sysmex XE-5000 Instructions for Use...
Page 106 1. To save the QC-files on a removable media, place a memory stick in the USB slot and select a corresponding drive (F: or higher). 2. Click the “Save” button. The Save dialog box will be displayed. 7-10 Sysmex XE-5000 Instructions for Use...
Page 107 QC data will reappear. • When the load is executed, “Data loaded from a saved file is being displayed” message will be displayed on the QC chart screen. Sysmex XE-5000 Instructions for Use 7-11...
Page 108: Troubleshooting
Levy-Jennings chart (Control Tab). Control chart definition In the XE-5000, the Levy-Jennings method is used as a basic principle for reading the X/L-J control chart. If the latest control data point is outside the control limits, the last 20 (including the latest) data points are searched for a point that is outside the same limit as the latest data point.
Page 109: Change Lot
(a USB memory stick or CD- ROM etc.), then execute the change lot. Note: XE-5000 manages the control lots by using two data files; the current lot and the new lot. The current lot contains the daily routine Quality Control data, and the new lot is prepared when the QC material lot is being switched to the new lot of the control material.
Page 110 Read file 1. Insert the CD-ROM provided with the control blood into the CD-ROM drive in the Information Processing Unit (IPU). 2. Click the “Lot No.” button. The new lot dialog box will be displayed. 7-14 Sysmex XE-5000 Instructions for Use...
Page 111 7. Click “OK” in the new lot dialog box to register the restored lot information and close the new lot dialog box. Click “Cancel” to cancel the record and close the new lot dialog box. Sysmex XE-5000 Instructions for Use 7-15...
Page 112: Target/Limit
If (%) is displayed in the limit range column, it means that the percentage form is currently used. If (#) is displayed, it means that the numerical value form is currently used. See “Chapter 7: 7.3: Limit setting”. 7-16 Sysmex XE-5000 Instructions for Use...
Page 113 4.38 The variable target function is useful for setting control target values when the instrument is monitored using control blood (the analyzed values for which, unlike calibrator, are not reliable in an absolute sense). Sysmex XE-5000 Instructions for Use 7-17...
Page 114 Select a lot you wish to change or set: “Current” or “New”. 2. Click the “Variable Target” button. The selected parameters are set for variable target. The target column of the list is left blank for parameters set for variable target . 7-18 Sysmex XE-5000 Instructions for Use...
Page 115 Click “Cancel” to cancel the auto calculation procedure. Note: Automatic calculation is executed on the basis of the limit which was set in “Chapter 7: 7.3 Limit setting”. Sysmex XE-5000 Instructions for Use 7-19...
Page 116 5. Click “OK” to read the assay values for the selected data from the CD-ROM. Click “Cancel” to cancel the load. 6. Click “File Info” to check the entered Lot No. if desired (See “Chapter 7: 7.11 File Information”). 7-20 Sysmex XE-5000 Instructions for Use...
Page 117: Display Order
Move Down: The selected parameter scrolls down by one line. 4. Click “OK” to close the Display Order dialog box and display the chart with the altered order. Click “Cancel” to cancel the display order and close the Display Order dialog box. Sysmex XE-5000 Instructions for Use 7-21...
Page 118: File Information
5. Click “Close” to close the dialog box. Note: It is impossible to change the file information on the File Information screen. To set or change the file information, see “Chapter 7: 7.8 Lot No.”. 7-22 Sysmex XE-5000 Instructions for Use...
Page 119: Chapter 8 Calibration
Calibration is carried out by entering calibration values into the unit. Your Sysmex technical representative will perform initial calibration of your unit at installation. After the installation, the operator should make periodical calibration and proper quality control to maintain the accuracy.
Page 120: Automatic Calibration
CHAPTER 8 Calibration 8.4 Automatic calibration In the XE-5000, five fresh, normal blood samples are used for automatic calibration of HGB and HCT values. Executing the automatic calibration program 1. From the Main Menu screen on the Main Unit, select “Calibration”...
Page 121 “AVG” column of the Automatic Calibration screen (P2). When the values have been already set, the compensation rate is calculated automatically, and displayed in the “New” column of the Automatic Calibration screen (P2). Sysmex XE-5000 Instructions for Use...
Page 122 1. Select “Execute” on the function menu of the Automatic Calibration screen. The calibration will be executed, and the new compensation rate will appear in the “New” column. Sysmex XE-5000 Instructions for Use...
Page 123 “OK” on the function menu to return the system to the last screen. The automatic calibration can be continued. 2. Reanalyze the sample used for the calibration using the XE-5000. Confirm that the analysis value is within the allowable range and does not vary greatly from the reference value.
Page 124: Displaying The Last Sample Data
Current compensation rate × Reference mean New compensation rate = Instrument mean [Example] Average of HGB values from standard method = 15.6 g/dL Average of HGB values from XE-5000 analysis = 15.5 g/dL Old calibration value of HGB = 100.0% 15.6 × ×...
Page 125 Note: Input calibration values in the range 80.0 – 120.0 to the first decimal place. 3. Press the ENTER key. The entered value is set and the cursor will move to the next parameter. Sysmex XE-5000 Instructions for Use...
Page 126 Manual Calibration screen. The calibration can be continued. 4. Reanalyze the sample used for the calibration using the XE-5000. Confirm that the analysis value is within the allowable range and does not vary greatly from the reference value. Recalibrate if HGB and HCT values are consistently higher or lower overall than the reference value.
Page 127: Calibration History
3. The Confirm Delete dialog box will be displayed. 4. Click “OK” to delete the selected record and close the dialog box. Click “Cancel” to cancel deletion. Note: Multiple calibration histories cannot be selected nor deleted at a time. Sysmex XE-5000 Instructions for Use...
Page 128 CHAPTER 8 Calibration Blank page 8-10 Sysmex XE-5000 Instructions for Use...
Page 129: Chapter 9 Cleaning And Maintenance
Periodical SRV maintenance • Clean the sample rotor valve when the message “Clean the SRV” is displayed: Depending on the service contract, your Sysmex technical engineer will perform the cleaning of the SRV. As-needed maintenance • Clean the manual rinse cup.
Page 130: Execution Of Shutdown
Otherwise, it can damage your skin or clothes. After the READY LED turns off and buzzer stops, remove the CELLCLEAN. Note: The manual aspiration pipette is automatically rinsed, and does not need to be wiped manually. Sysmex XE-5000 Instructions for Use...
Page 131: Removing Fluid From The Pneumatic Unit Trap Chamber
Caution! If fluid collects everyday, the Main Unit may have a technical problem. Please contact your Sysmex technical representative. 1. Turn OFF the power of Pneumatic Unit and make sure that the Pneumatic Unit pressure gauge shows “0”. 2. Turn the trap chamber counterclockwise and remove.
Page 132: Cleaning The Sample Rotor Valve
1. Turn OFF the power of the Main Unit and Pneumatic Unit, and wait several minutes until the pressure gauge points at “0”. 2. Open the Main Unit front cover. 3. Remove the tray from the sample rotor valve. Sample rotor valve Tray Pipette fixing screw Sysmex XE-5000 Instructions for Use...
Page 133 • When removing the fixed valve, reagent can leak from the tube. Have a paper towel ready to wipe reagent. • When pulling out the valve, take care not to bend the manual aspiration pipette. Sysmex XE-5000 Instructions for Use...
Page 134 10. Make sure that the valve contact surfaces are thoroughly free from dirt or dust. 11. Assemble the sample rotor valve in the reverse order of disassembly. And gently push up the manual rinse cup with both hands. Sysmex XE-5000 Instructions for Use...
Page 135: Cleaning The Manual Rinse Cup
Risk of infection When cleaning the manual rinse cup, always wear gloves. After completion of the operation, wash your hands with disinfectant. If your hands are contaminated by blood, you might be infected by pathogen, etc. Sysmex XE-5000 Instructions for Use...
Page 136 7. Assemble the manual rinse cup in the reverse order of disassembly. Install so that the small tubes pass behind the manual rinse cup. 8. Gently push up the manual rinse cup all the way using both hands. Sysmex XE-5000 Instructions for Use...
Page 137: Cleaning The Sample Rotor Valve Tray
When removing the tray, take care not to loosen the Tray pipette fixing screw. If an analysis is made with the screw loosened, air Pipette fixing screw bubbles can enter the pipette and affect the data. Sysmex XE-5000 Instructions for Use...
Page 138: Cleaning The Piercer Tray
1. Turn OFF the power of the Main Unit and Pneumatic Unit, and wait several minutes until the pressure gauge points at “0”. 2. Open the Main Unit front cover. 3. Remove the CP cover. 9-10 Sysmex XE-5000 Instructions for Use...
Page 139: Removing Clogs (Clog Removal Sequence)
The Maintenance Sequence screen will appear. 2. Using the keys, move the cursor to select “3. Clog Removal”. 3. If you select “Execute” on the function menu of the Maintenance Sequence screen, the clog removal sequence will start. Sysmex XE-5000 Instructions for Use 9-11...
Page 140: Cleaning The Imi Detector Aperture
6. Open the IMI detector cover, and check that the sample is drained. IMI detector Warning! Never touch the detector when the power of the Main Unit is turned ON. Otherwise, electrical shock may result. 9-12 Sysmex XE-5000 Instructions for Use...
Page 141 Otherwise, analysis may not be performed correctly. 10. Close the detector cover and Main Unit front cover. 11. Turn ON the power of the Main Unit. 12. Background check starts automatically. Make sure that all background values are within acceptable. Sysmex XE-5000 Instructions for Use 9-13...
Page 142: Cleaning The Rbc Detector Aperture
“0”. 2. Open the Main Unit front cover and front right cover. 3. Open the RBC detector cover. Cover holder Rotate the cover holder, and keep the cover open. 9-14 Sysmex XE-5000 Instructions for Use...
Page 143 6. Insert the sheath nozzle into the detector chamber, and tighten the fixing screw. Caution! When closing the detector cover, take care not to bend the tube. Otherwise, analysis may not be performed correctly. Sysmex XE-5000 Instructions for Use 9-15...
Page 144 5. Close the detector cover. Then close the Main Unit front cover and front right cover. 6. Turn ON the power of the Main Unit. 7. Background check starts automatically. Make sure that all background values are within acceptable. 9-16 Sysmex XE-5000 Instructions for Use...
Page 145: Removing Air Bubbles From The Flow Cell In The Optical Detector Block
“Execute” on the function menu of the Maintenance Sequence screen, the flow cell rinse sequence will start. 4. During the flow cell rinse sequence, the Execution screen will be displayed on the LCD screen. Sysmex XE-5000 Instructions for Use 9-17...
Page 146: Replacing The Waste Container (Option)
2. Prepare an empty waste container and remove the cap. 3. Remove the tube from the full waste container. Tube 4. Insert the tube into a new waste container, and fix it using Tape a tape or the like. 9-18 Sysmex XE-5000 Instructions for Use...
Page 147: Replacing And Registering Reagents
If reagent information has been entered manually or by barcode, that reagent will be designated as a replacement automatically, and the cursor will move to that reagent. Lot No.: Displays the current lot number. Sysmex XE-5000 Instructions for Use 9-19...
Page 148 3. Select “Execute” on the function menu to register the reagent information and begin reagent aspiration. Select “Cancel” on the function menu to delete all of the read information and return to the previous screen. 9-20 Sysmex XE-5000 Instructions for Use...
Page 149 Amounts: Numbers and a decimal point (period) can be entered for this item. This column may also be left blank. Sysmex XE-5000 Instructions for Use 9-21...
Page 150 Select “OK” on the function menu of the Expired Reagent screen to return to the previous screen. Note: Selecting “Replace” on the function menu alternately designates the reagent as a replacement and removes the designation. 9-22 Sysmex XE-5000 Instructions for Use...
Page 151 Otherwise, analysis may not be performed correctly. • Take care not to spill a reagent. If it spills, wipe it off immediately using a wet cloth or the like. Otherwise, the floor could be stained. Sysmex XE-5000 Instructions for Use 9-23...
Page 152 6. Insert it all the way into the holder. 7. Close the Main Unit front cover. Information To prevent the sensor malfunction, replace the STROMATOLYSER-4DS (FFS) so that two FFS labels will face the same direction. 9-24 Sysmex XE-5000 Instructions for Use...
Page 153 This is to prevent discoloration of the instrument coat. 1. Prepare a new reagent and confirm that its expiration date has not expired. 2. Remove the cap of a new STROMATOLYSER-NR(L). 3. Remove the cap of the empty STROMATOLYSER-NR(L). Sysmex XE-5000 Instructions for Use 9-25...
Page 154 N U M . / A L P H . E N T E R for explanation of the Reagent setting screen. S H U T D O W N H E L P RETURN MORE 9-26 Sysmex XE-5000 Instructions for Use...
Page 155 SEARCH (II) diluent and tighten the cap. Loosen Tighten Empty 5. Open the Main Unit front cover. 6. Remove the empty RET SEARCH (II) dye solution from the holder, remove the cap, and pull out the pipe straight Sysmex XE-5000 Instructions for Use 9-27...
Page 156 N U M . / A L P H . E N T E R for explanation of the Reagent setting screen. S H U T D O W N H E L P RETURN MORE 9-28 Sysmex XE-5000 Instructions for Use...
Page 157 3. After opening the seal, check that there is an O-ring on O-ring the tip of the joint. 4. Pull the collar of the one-touch coupling up, and remove it from the empty reagent container. Collar One-touch coupling Sysmex XE-5000 Instructions for Use 9-29...
Page 158 SIM cubitainer spout with a lint-free gauze moistened with ethyl-alcohol. This cleaning will prevent contamination and lubricate the o-ring when connecting. 8. Pull up the collar of the quick connector. 9-30 Sysmex XE-5000 Instructions for Use...
Page 159: Reagent Replacement Log Display Function
Replacing and registering reagents” for explanation of the reagent registration function. Comments can be added to the data stored in the reagent replacement log. The log information can be printed out using a Ledger printer and output in a csv file. Sysmex XE-5000 Instructions for Use 9-31...
Page 160 However, additions may be made to a previously-entered comment, provided that the total number of characters remains 50 or fewer. The comments which had already been entered are not displayed in the dialog box. 9-32 Sysmex XE-5000 Instructions for Use...
Page 161 Filter The reagents and term for display on the Reagent Replacement Log screen can be set. 1. Select “Filter (F)” on the “Record (R)” menu of the Reagent Replacement Log screen. Sysmex XE-5000 Instructions for Use 9-33...
Page 162 Cancel: The set filter conditions are deleted and the dialog box is closed. The filter conditions are displayed in the title bar on the Reagent Replacement Log screen. 9-34 Sysmex XE-5000 Instructions for Use...
Page 163 Manually enter the name to save the file if the file name should be changed. 4. Click on “Save (S)” to save the reagent replacement record in csv format. Click “Cancel” to cancel the save operation. Sysmex XE-5000 Instructions for Use 9-35...
Page 164: Remaining Reagent Volume Function
If a reagent feeding unit or a similar device is used, it may not be possible to use the remaining reagent volume function. For reagents (SNR, RED) which include the dye and bottle as a set, the display indicates the volume in the bottle. 9-36 Sysmex XE-5000 Instructions for Use...
Page 165 “<” is displayed. No error occurs, even if the reagent amount becomes [Example of remaining reagent display] For ESE 4.6→4.5→4.0→... →1.5→1.0→0.5→ <0.5 Sysmex XE-5000 Instructions for Use 9-37...
Page 166: Replacing The Piercer
If your hands are contaminated by blood, you might be infected by pathogen, etc. Warning! Before operating with the front cover open, be sure to set the stop bar. Otherwise, the cover can drop down and injure your head. 9-38 Sysmex XE-5000 Instructions for Use...
Page 167 5. Install the fixing board to the piercer using three screws. Warning! Be sure to install the piercer fixing board. The piercer needle may pop out during operation and cause injuries. Piercer fixing board Sysmex XE-5000 Instructions for Use 9-39...
Page 168 2. Loosen slightly the screw A on the piercer fixing board. Press the rinse cup against this face. Slide the rinse cup and press it against the slider surface, then fix the rinse cup with three fixing screws. Slider Rinse cup 9-40 Sysmex XE-5000 Instructions for Use...
Page 169: Replacing The Hand Clipper
If your hands are contaminated by blood, you might be infected by pathogen, etc. Warning! Before operating with the front cover open, be sure to set the stop bar. Otherwise, the cover can drop down and injure your head. Sysmex XE-5000 Instructions for Use 9-41...
Page 170 F-bracket 6. Install the CP cover. Caution! When installing the CP cover, take care not to have the tube caught or bent. Otherwise, analysis may not be performed correctly. 7. Close the front cover. 9-42 Sysmex XE-5000 Instructions for Use...
Page 171: Replacing Rubber Plate No. 39
6. Install the hand clipper to the original position. 7. Install the CP cover. Caution! When installing the CP cover, take care not to have the tube caught or bent. Otherwise, analysis may not be performed correctly. 8. Close the front cover. Sysmex XE-5000 Instructions for Use 9-43...
Page 172: Replacing The Fuses
3. Replace the fuse and attach the fuse cap holder. Screwdriver Pneumatic Unit Specification Part No. Description Fuse Type 117 VAC 266-7651-2 FUSE 250V 4A Time Lag 313004 (N.AMERICA) 220/240 VAC 266-5293-0 FUSE 250V 3.15A Time Lag NO. 19195 (EUROPE) 9-44 Sysmex XE-5000 Instructions for Use...
Page 173: Replacing The Hepa Filter (Option)
3. Remove the HEPA filter and replace it with a new one. Pay attention to the installation direction. Information Install the HEPA filter with its groove facing downward. 4. Install the filter cover and fix it with the screws. Sysmex XE-5000 Instructions for Use 9-45...
Page 174: Adjusting Pressure And Vacuum
Pressure and vacuum from the Pneumatic Unit are adjusted to 0.25 MPa, 0.16 MPa, 0.07 MPa, 0.03 MPa, and -0.04 MPa by the XE-5000 Main Unit. The pressure and vacuum are monitored by pressure sensors. When an error occurs, an error message is displayed.
Page 175 5. If the displayed pressure does not match the predetermined pressure, adjust it by repeating the operations 3 and 4. 6. When the adjustment is completed, tighten the fixing screw while taking care not to allow the adjustment knob to rotate. Sysmex XE-5000 Instructions for Use 9-47...
Page 176 2. Pull out the knob for the 0.07 MPa regulator to release the lock. 3. Adjust the pressure while watching the pressure displayed on the Sensor 1 screen. To increase the pressure, turn the knob clockwise. High Normal range: 0.07 ± 0.001 MPa Adjustment knob 9-48 Sysmex XE-5000 Instructions for Use...
Page 177 5. If the displayed pressure does not match the predetermined pressure, adjust it by repeating the operations 3 and 4. 6. When the adjustment is completed, press the adjustment knob for the 0.03 MPa regulator to lock. Sysmex XE-5000 Instructions for Use 9-49...
Page 178 1. Pinch the tube that runs from the Pneumatic Unit to the Main Unit. If the vacuum increases to 0.05 MPa or more, there is leakage in the Main Unit. Contact your Sysmex technical representative. 2. Check the tube between the Main Unit and the Pneumatic Unit or inside the Pneumatic Unit.
Page 179: Supplies And Replacement Parts
FUSE 250V 3.15A NO. 19195 (EUROPE) Chapter 9: 9.19 443-2224-6 HEPA FILTER (WITH PRE) Chapter 9: 9.20 462-3520-5 TRANSDUCER BRUSH Chapter 9: 9.8 Chapter 9: 9.9 983-8861-9 FLOAT SWITCH NO. 25 ASSY (C1/5L) Chapter 9: 9.13 Sysmex XE-5000 Instructions for Use 9-51...
Page 180: Xe-5000 Maintenance And Inspection Check List
CHAPTER 9 Cleaning and Maintenance 9.23 XE-5000 maintenance and inspection check list 9-52 Sysmex XE-5000 Instructions for Use...
Page 181: Chapter 10 Troubleshooting
Follow the indicated recovery procedure and the content of Reset both the tube and rack. “Chapter 10: 10.4 Troubleshooting guide”. and press the[OK]key. If the recovery procedure does not restore the system to normal condition, contact your Sysmex technical representative. Cancel ERR List 10.2 Error log The error log displays a maximum of 100 errors in order of their occurrence.
Page 182 3. The Confirm Delete dialog box will be displayed. 4. Click “OK” to delete the selected record and close the dialog box. Click “Cancel” to cancel deletion. Note: Multiple error logs cannot be selected nor deleted at a time. 10-2 Sysmex XE-5000 Instructions for Use...
Page 183: Error Message List
FCM CCSD Noise Error ..........10-23 FCM Detector Temp High ..........10-13 FCM Detector Temp Low ..........10-13 FCM RU Temp High............10-13 FCM RU Temp Low ............10-13 FCM RU Therm Sens ERR..........10-13 Sysmex XE-5000 Instructions for Use 10-3...
Page 184 Rack Move Error 2 ............10-20 Rack Move Error 3 ............10-20 Rack Not Exist ............... 10-22 Rack Removed .............. 10-20 Rack Shift Function ERR ..........10-20 Rack Shift Home Pos. ERR ........... 10-20 10-4 Sysmex XE-5000 Instructions for Use...
Page 185 WBC/BASO Sampling Error .......... 10-23 WBC/BASO-CH Error ............ 10-25 Xb Limit Error..............10-28 Xm Limit Error..............10-28 Functional error message list 1. Pressure and Vacuum Errors 0.25 MPa ERROR ............10-10 0.16 MPa ERROR ............10-10 Sysmex XE-5000 Instructions for Use 10-5...
Page 186 Replace Container RED ..........10-15 Chamber EPK Error............10-15 Chamber ESE Error............10-15 Chamber SIM Error............10-15 Chamber FCM Sheath ERR .......... 10-15 Waste Chamber 1 Error ..........10-15 Waste Chamber 2 Error ..........10-15 10-6 Sysmex XE-5000 Instructions for Use...
Page 187 Rack Not Exist ............... 10-22 7. Volumetric Block Errors IMI Count Too Long ............10-22 IMI Count Too Short............10-22 8. Analysis Errors Background Error............10-23 RBC Sampling Error ............10-23 PLT Sampling Error ............10-23 Sysmex XE-5000 Instructions for Use 10-7...
Page 188 IPU Error ................ 10-28 13. ID Errors ID Read Error..............10-28 Rack ID Read Error ............10-28 14. QC Errors Xm Limit Error ..............10-28 L-J Limit Error ..............10-28 Xb Limit Error ..............10-28 10-8 Sysmex XE-5000 Instructions for Use...
Page 189: Troubleshooting Guide
4. Message urging caution If an analysis can be performed, but caution should be urged, a message will be displayed. When the need to urge caution no longer exists, the message will disappear. Sysmex XE-5000 Instructions for Use 10-9...
Page 190 1. Adjust pressure of 0.16 MPa. (Refer to Chapter 9: 9.21 Analysis Error Adjusting pressure and vacuum.) 2. If adjustment of 0.16 MPa pressure fails, the regulator is probably defective. Contact your Sysmex technical representative. Error messages: Probable Cause 0.07 MPa ERROR 1.
Page 191: Mpa Error
2. The cover sensor of IMI detector has failed. Not Ready Corrective Action 1. Close the IMI detector cover. If the error persists, the cover sensor is probably defective. 2. Replace the cover sensor of IMI detector: Contact your Sysmex technical representative. Sysmex XE-5000 Instructions for Use 10-11...
Page 192: 33°C Rh Temp High
If this error is still displayed 30 minutes after the power is Analysis Error turned ON, there is probably something defective in the system. Contact your Sysmex technical representative. In this case, CBC and RET can be analyzed even if the error persists.
Page 193: 40°C Rh Therm Sens Err
Corrective Action Category: 1. Turn the power OFF, then ON again. If the error persists, Analysis Error contact your Sysmex technical representative. In this case, it is possible to perform analysis in normal mode even if the error persists. Error messages: Probable Cause 33°C RH Therm Sens ERR...
Page 194 Press the HELP key on the Main Unit panel keypad. Select “OK” on the function menu to execute IMI temperature stabilization sequence. In this case, it is possible to perform analysis in normal mode even if the error persists. 10-14 Sysmex XE-5000 Instructions for Use...
Page 195: Chamber Epk Error
Especially check for dirt or clogging around the drain outlet. After the check, press the HELP key on the panel keypad of the Main Unit. A help message will be displayed. Select “OK” on the function menu, then empty the waste chamber. Sysmex XE-5000 Instructions for Use 10-15...
Page 196 Check that no fluid switch connector or tubing is touching Analysis Error the upper/lower part of the rinse cup. Then press the HELP key on the panel keypad of the Main Unit. Select “OK” on the function menu to check the operation. 10-16 Sysmex XE-5000 Instructions for Use...
Page 197 5. If the error still persists, it is assumed that the piercer is clogged by clots, replace the piercer. (Refer to Chapter 9: 9.16 Replacing the piercer.) 3. Reconnect the tubing. Sysmex XE-5000 Instructions for Use 10-17...
Page 198 Not Ready Corrective Action 1. Replace the blood aspiration sensor: Contact your Sysmex technical representative. As a tentative measure, alter the sampler stop conditions to allow sampler operation to continue. 10-18 Sysmex XE-5000 Instructions for Use...
Page 199 Error messages: Probable Cause Rack Feed In Init. ERR 1. Rack feed-in initial position sensor has malfunctioned due Status: to dirt or dust. Not Ready Corrective Action 1. Remove dirt or dust. Sysmex XE-5000 Instructions for Use 10-19...
Page 200 1. Reinstall the rack, and perform the analysis again. Error messages: Probable Cause Rack Move Error 3 1. When interruption is ready, the rack moves by irresistible force. Corrective Action 1. Reinstall the rack, and perform the analysis again. 10-20 Sysmex XE-5000 Instructions for Use...
Page 201 2. Although there is no test tube, the blood detection sensor detects that blood is found. Corrective Action 1. Remove dirt from the tube detection sensor. 2. Remove dirt from the blood volume sensor. Sysmex XE-5000 Instructions for Use 10-21...
Page 202 1. Air bubbles in volumetric block Category: Corrective Action Analysis Error 1. Perform auto rinse: Press the HELP key on the panel keypad of the Main Unit. Then select “OK” on the function menu to execute the auto rinse. 10-22 Sysmex XE-5000 Instructions for Use...
Page 203 2. Sudden noise interference IMI CCSD Noise Error Corrective Action FCM CCSD Noise Error 1. Interrupt the noise source. Category: Keep the noise source away from the Main Unit. Analysis Error 2. Perform the analysis again. Sysmex XE-5000 Instructions for Use 10-23...
Page 204 1. The level of RF signal noise is high. Category: Corrective Action Analysis Error 1. Perform the analysis again. If the error persists, contact your Sysmex technical representative. Error messages: Probable Cause RBC Bubble Error 1. Clogging at RBC detector or mixing of air bubbles...
Page 205 3. Clean the flow cell of optical detector block. (Refer to Chapter 9: 9.11 Cleaning the flow cell in the optical detector block.) 4. Remove the air bubbles from the flow cell of optical detector block. Sysmex XE-5000 Instructions for Use 10-25...
Page 206: Close Fcm Detect Cover
Laser Power Error 1. Deteriorated laser Category: Corrective Action Analysis Error 1. Perform the analysis again. If the error persists, contact your Sysmex technical representative. Error messages: Probable Cause Close FCM Detect Cover 1. Optical detector block cover is open.
Page 207 IPU and Main Unit again. 2. Turn OFF the power of the Main Unit, and connect the connection cable. Then turn ON the powers of the IPU and Main Unit. 3. Contact your Sysmex technical representative. Sysmex XE-5000 Instructions for Use 10-27...
Page 208 2. Start the XE program of the IPU. Then select “Retry” on the “Reconnect?” screen of the Main Unit. 3. Connect the connection cable, and select “Retry” on the “Reconnect?” screen of the Main Unit. 4. Contact your Sysmex technical representative. 13. ID Errors Error messages: Probable Cause ID Read Error 1.
Page 209: Execute Rinse Flowcell
Main Unit panel keypad. A help message will be Expired Reagent (SIM) displayed. Select “OK” on the function menu, then register Expired Reagent (SNR) the reagent on the displayed reagent setting screen. Expired Reagent (RED) Sysmex XE-5000 Instructions for Use 10-29...
Page 210: Test
CHAPTER 10 Troubleshooting 10.5 Test The XE-5000 is equipped with test processes for checking system operation and finding the causes of abnormalities occurring in the Main Unit. Note: The test program can only be executed when the Main Unit is ready. During analysis, a “Wait until READY”...
Page 211 3668 SHUT 2467 PIAS 1619 screen. DIFF 2076 NRBC 1643 FCM-MT 11131 The Counter screen will appear. 1528 RBC-MT 4706 WB-MT 7234 1887 LASER 43:26 BF-MEAS BF-BCHK Selected counter will be cleared. OK? Cancel Sysmex XE-5000 Instructions for Use 10-31...
Page 212 Counter screen, then select “OK” again, the highlighted parameter counter will be reset. When you wish to cancel the reset operation, select “Cancel” on the function menu and return to the Status Menu screen. 10-32 Sysmex XE-5000 Instructions for Use...
Page 213 Set the rack in place before executing the test. 1. Set the rack in place on the right rack pool. 2. From the Main Menu screen on the Main Unit, select “TEST” on the function menu. The Test Menu screen will appear. Sysmex XE-5000 Instructions for Use 10-33...
Page 214 3. Select “Sampler” on the function menu of the Test Menu screen. The Sampler Test screen will appear. 4. Select “3. Rack feed out” by moving the cursor with key on the Sampler Test screen. 10-34 Sysmex XE-5000 Instructions for Use...
Page 215 The barcode type will appear on the Label column. Start Cancel (NW7, ITF, JAN, CODE39 or CODE128) 5. To cancel the ID reading test, select “Cancel” on the function menu, or press the RETURN key. Sysmex XE-5000 Instructions for Use 10-35...
Page 216 Testing screen will appear. 5. When the analysis operations are completed, the motor will return to the initial position. 6. To cancel the motor test, select “Cancel” on the function menu, or press the RETURN key. 10-36 Sysmex XE-5000 Instructions for Use...
Page 217 Testing screen will appear. 5. When rinsing is completed, the motor will return to the initial position. 6. To cancel the motor test, select “Cancel” on the function menu, or press the RETURN key. Sysmex XE-5000 Instructions for Use 10-37...
Page 218 The sample rotor valve will start operation and perform volume determination. Then the valve will return to the initial position. 4. To cancel the SRV test, select “Cancel” on the function menu, or press the RETURN key. 10-38 Sysmex XE-5000 Instructions for Use...
Page 219: Chapter 11 Technical Information
CHAPTER 11 Technical Information 11. Technical Information 11.1 Performance/specifications of the XE-5000 Ambient temperature 15°C – 30°C Relative humidity 30% – 85% Dimensions of Main Width: 706 mm Unit Height: 711 mm (including Sampler Unit) Depth: 912 mm Weight of Main Unit Approx.
Page 220 Approx. 150 samples/hour CBC+WBC5DIFF+NRBC: Approx. 150 samples/hour CBC+WBC5DIFF+NRBC+RET: Approx. 113 samples/hour (if the RET analysis rate is 100%) CBC+RET: Approx. 113 samples/hour (if the RET analysis rate is 100%) Body fluid analysis: Approx. 38 samples/hour 11-2 Sysmex XE-5000 Instructions for Use...
Page 221 20% or less (actual CV%, not in 95% C.I., when PLT is 10 to 50 × /µL and IPF is 10% or more) *1: Within-Run Precision is based on 5 consecutive determinations of the sample. Sysmex XE-5000 Instructions for Use 11-3...
Page 222 Reproducibility C.V.25% or less (0.010 – 0.015 × 10 /µL) Reproducibility C.V.20% or less (0.016 – 0.025 × 10 /µL) Reproducibility C.V.15% or less (0.026 – 0.050 × 10 /µL) Reproducibility C.V.10% or less (0.050 × 10 /µL or more) 11-4 Sysmex XE-5000 Instructions for Use...
Page 223 IG%* r=0.80 or more NRBC% r=0.80 or more *1: Analyze 100 fresh samples that have immature granulocytes for XE-5000 and reference method (FCM) and manual countig method using NCCLSH-20A. Average of deviation from the standard instrument NEUT% Within ±3.0 NEUT%...
Page 224 *1: Guidance for Premarket Notification for Automated Differentlel Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA. Document issued: November 1, 2000. CDRH, FDA. 11-6 Sysmex XE-5000 Instructions for Use...
Page 225 International Committee for Standardization in Haematology (ICSH). Clin. Lab, Haemat 1994, 16,157–174. Carryover RBC-BF 0.3 % or less, or 0.003 × 10 /µL or less Body fluid analysis WBC-BF 0.3 % or less, or 0.001 × 10 /µL or less mode Sysmex XE-5000 Instructions for Use 11-7...
Page 226 X control (L-J control): 300 points × 20 files, 51 parameters control: 300 points × 1 file, 54 parameters Storage conditions for Ambient temperature: -10 – 60ºC transportation Relative humidity: 95% or less (no condensation) 11-8 Sysmex XE-5000 Instructions for Use...
Page 227: Possible Sample Interferences
- Erythrocyte aggregation (Cold agglutinin) - Microcytosis - Fragmented erythrocytes Where the following are present, the hematocrit value may be reported falsely high. - Leukocytosis (Lymphocytes>100,000/µL) - Severe diabetes - Uremia - Spherocytosis Sysmex XE-5000 Instructions for Use 11-9...
Page 228: Interface Protocol
TCP/IP network interface to the HOST computer. For details, contact your Sysmex technical representative. 11.4 Program version To check the current program version, select “About XE-5000 (A)” under “Help (H)” on the Information Processing Unit (IPU) menu bar.
Page 229: Principles
Because the blood cells pass through the aperture in a line, also generation of artifical pulses (interference) is prevented. Hydro Dynamic Focusing method improves the blood count accuracy and reproducibility by minimizing the coincidence error. Sysmex XE-5000 Instructions for Use 11-11...
Page 230 The intensity of the scattered light depends on factors such as the particle diameter and viewing angle. This instrument detects forward scattered light, which provides information on blood cell size and lateral scattered light, which provides information on the cell complexity. 11-12 Sysmex XE-5000 Instructions for Use...
Page 231 The intensity of the emitted fluorescent light indicates the degree of blood cell staining and as such the RNA and/or DNA concentration. Fluorescent light is emitted in all directions; the XE-5000 detects the fluorescent light that is emitted sideways. SLS-Hemoglobin method...
Page 232 HGB Flow Cel (1:500) Wavelength: 555 nm 11.7 µL analysis RBC detector 1 mL Hydro Dynamic Focusing (DC Detection) 3.0 µL CELLPACK 2 mL 4.0 µL RBC sample chamber (1:500) CELLSHEATH 2.1 mL Sheath injector piston 11-14 Sysmex XE-5000 Instructions for Use...
Page 233 RBC/PLT detector. 4. The RBC detector counts the RBC and PLT via the Hydro Dynamic Focusing (DC Detection). At the same time, the hematocrit (HCT) is calculated via the RBC pulse height detection method. Sysmex XE-5000 Instructions for Use 11-15...
Page 234 Hgb cell. The concentration of SLS-hemoglobin is analyzed as light absorbance, and is calculated after substruction of the absorbance of the diluent measured before the sample was added. 11-16 Sysmex XE-5000 Instructions for Use...
Page 235 HGB (g/dL) MCH (pg) = µ RBC ( 10 Mean cell hemoglobin concentration (MCHC) The MCHC is calculated from the HCT and HGB, using the following equation: HGB (g/dL) MCHC (g/dL) = HCT (%) Sysmex XE-5000 Instructions for Use 11-17...
Page 236 3. The sheath injector piston sends 40 µL of diluted sample to the optical detector block. 4. In the optical detector block, the sample is analyzed via flow cytometry method utilizing a semiconductor laser. 11-18 Sysmex XE-5000 Instructions for Use...
Page 237 3. The sheath injector piston sends 40 µL of diluted sample to the optical detector block. 4. In the optical detector block, the sample is analyzed via flow cytometry method utilizing a semiconductor laser. Sysmex XE-5000 Instructions for Use 11-19...
Page 238 3. The diluted sample is aspirated, via the aperture, and 250 µL is accurately measured by the float-type manometer. Detection is performed via the RF/DC detection method. 11-20 Sysmex XE-5000 Instructions for Use...
Page 239 (lymphocytes + monocytes + neutrophils + eosinophils). 4DIFF WBC/BASO Lymphocytes + Monocytes + Neutrophils + Eosinophils Lymphocytes Basophils Monocytes Neutrophils Basophils Eosinophils ghosts RBC ghosts Sysmex XE-5000 Instructions for Use 11-21...
Page 240 The NRBC analysis procedure is explained as follows: STROMATOLYSER-NR(L) STROMATOLYSER-NR(S) dye solution: 18 μL lyse reagent: 0.882 mL CELLPACK Sample rotor valve Optical detector Sample tube block (blood: 18 μL) Reaction chamber 11-22 Sysmex XE-5000 Instructions for Use...
Page 241 Y-axis the intensity of the Nucleated red blood cells forward scattered light. After scattergram analysis, the classified groups of red blood RBC ghosts cell ghosts, white blood cells and nucleated red blood cells are displayed. Sysmex XE-5000 Instructions for Use 11-23...
Page 242 3. The sheath injector piston sends 2.8 µL of diluted sample to the optical detector block. 4. In the optical detector block, the sample is analyzed via fluorescence flow cytometry utilizing a semiconductor laser. 11-24 Sysmex XE-5000 Instructions for Use...
Page 243 Particle count in reticulocyte zone Reticulocyte Count: RET% RET# = Low Fluorescence Ratio: LFR = 100 – HFR – MFR Middle Fluorescence Ratio: Particle count in MFR zone MFR = Particle count in reticulocyte zone Sysmex XE-5000 Instructions for Use 11-25...
Page 244 HFR: High Fluorescence Ratio IRF: Immature Reticulocyte Fraction RET-He (Reticulocyte Hemoglobin equivalent) : The RET-He is a unique parameter developed by Sysmex that is derived using the reticulocyte scattered light signals and a proprietary Sysmex calculation equation. IPF (Immature Platelet Fraction) :...
Page 245 The MPV is calculated from the following equation: PCT (%) MPV (fL) = 10000 µ PLT ( 10 PCT: PCT is called the platelet hematocrit or platelet volume ratio, and is weighted toward the PLT frequency. Sysmex XE-5000 Instructions for Use 11-27...
Page 246 The XE-5000 utilizes a conventional particle size distribution expression (normal expression) and a particle size distribution expression method that enables the user to obtain a large amount of information from the particle size distribution intuitively (normal cell size range expression).
Page 247 The light that is passed through the liquid in the hemoglobin flow cell is received by the photodiode, where it is photoelectrically converted. It is then converted from analog to digital signals, and sent to the IPU. Sysmex XE-5000 Instructions for Use 11-29...
Page 248 The microcomputer unit converts the analog-to-digital- converted cell signals into scattergram data and sends the data to the IPU. 11-30 Sysmex XE-5000 Instructions for Use...
Page 249 CHAPTER 11 Technical Information 12. Electrical system block diagram Sysmex XE-5000 Instructions for Use 11-31...
Page 250: Contents Of The Packages
Main Unit 442-3362-0 RUBBER JOINT NO. 22 343-2462-5 O-RING NO. 12 461-2640-4 XE-5000 Instructions for Use 461-2642-1 XE-5000 Instructions for Use/EU 461-2641-8 XE-5000 Software Guide 461-2643-5 XE-5000 Software Guide/EU 923-8092-8 POWER CORD NO.15 (C-2/ N.AMERICA) 11-32 Sysmex XE-5000 Instructions for Use...
Page 251 TUBE TEFLON 1.0 MM × 2.0 MM 442-6483-4 TUBE PHARMED 1/32 × 5/32 442-5418-8 TUBE TEFLON 0.8 MMID × 1.8 MMOD 903-0021-3 CONNECTING CABLE NO. 33 462-3141-1 CLEANING WIRE 063-4142-1 REAG SUPPLY UNIT NO. 4 Sysmex XE-5000 Instructions for Use 11-33...
Page 252 TRAY NO. 26 (WHITE) 462-3122-1 CUBITAINER CAP OPENER NO. 2 462-2852-7 HEX KEY TWH-13 2.5 MM 368-0079-6 RUBBER PLATE NO. 39 322-4907-6 CP UNIT COVER-A 322-4309-1 CP UNIT COVER-B 442-4486-8 TUBE JOINT PD-ML 063-7622-5 CDR1XE5X 11-34 Sysmex XE-5000 Instructions for Use...
Page 253 SCREW BINDING M4 × 6(SUS) 368-9781-5 SPILL COVER NO. 37 348-3612-0 SCREW FLAT M3 × 6(SUS) 367-9161-1 BALL CATCHER TL-60-Z-CR TYPE 2 Note: If you need to order supplies or replacement parts, please contact your local Sysmex representative. Sysmex XE-5000 Instructions for Use 11-35...
Page 254: Check Before Installation
CHAPTER 11 Technical Information 11.7 Check before installation The XE-5000 and associated equipment is installed by your Sysmex technical representative. In case relocation becomes necessary after installation, contact your Sysmex technical representative. Problems resulting from the relocation of the XE-5000 by anyone other than a Sysmex technical representative are not covered by the Warranty even if it is in the warranty period.
Page 255: Installation Space
25 cm away from the CRT of the IPU. Provide a distance of at least 50 cm behind the instrument. Width Depth Height Weight Component (mm) (mm) (mm) (kg) Main Unit Approx. 81 Sampler Approx. 12 Pneumatic Approx. Unit 15.5 Sysmex XE-5000 Instructions for Use 11-37...
Page 256 CHAPTER 11 Technical Information Blank page 11-38 Sysmex XE-5000 Instructions for Use...
Page 257: Chapter 12 Warranty
CHAPTER 12 Warranty 12. Warranty All Sysmex instruments are guaranteed against defects of material or manufacture for one year from the date of installation on the user’s premises. However, this warranty does not cover defects, malfunctions or damage arising for any of the reasons stated below.
Page 258 CHAPTER 12 Warranty Blank page 12-2 Sysmex XE-5000 Instructions for Use...
Page 259: Chapter 13 Index
Cleaning the sample rotor valve ......9-4 Interface protocol ..........11-10 Cleaning the sample rotor valve tray ....9-9 Introduction ............1-1 Closing the XE-5000 application......6-41 Computer viruses..........2-12 Conditions for sample analysis ......6-12 Contents of the packages ......... 11-32 Control blood (e-CHECK(XE)) ......
Page 260 QC analysis in manual mode ........7-5 Limit setting............7-4 QC analysis in sampler mode .......7-6 Load ..............7-11 QC assessment.............7-8 Logging off from the XE-5000 application QC data display.............7-7 program ............6-41 QC data range selection function......7-9 Logging on the Main Unit ........6-11 QC method setting ..........7-2...
Page 261 Timer processing ..........6-38 Troubleshooting ..........10-1 Troubleshooting (QC) ......... 7-12 Troubleshooting guide ........10-9 Turning ON the power .......... 6-8 Variable target ............ 7-17 Warranty ............. 12-1 WBC differential analysis........11-21 WBC classification ..........11-18 Sysmex XE-5000 Instructions for Use 13-3...
Page 262 CHAPTER 13 Index Blank page 13-4 Sysmex XE-5000 Instructions for Use...

SYSMEX XE-5000 Instruction Manual

Table of Contents

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

10.3 Error Message List

Chapter 11 Technical Information

Chapter 12 Warranty

Chapter 13 Index

Quick Links

Chapters

Troubleshooting

Need help?

Questions and answers

Related Manuals for SYSMEX XE-5000

Summary of Contents for SYSMEX XE-5000

Table of Contents