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CHAPTER 4

Reagents

4-8

Sysmex XE-5000 Instructions for Use

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vi

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d A

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ri

l 20

07 

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4.15 Symbols used on the labels

EC

REP

22-Nov-2000

-NN

 

C

+NN  C

LOT

1234

IVD

Xn

In Vitro Diagnostic

Consult instructions for use

Lot-number

Use by

Storage temperature

CE conformity sign as per directive
98/79/EC

Hazardous Class in EU

Manufacturer

Authorized representative in
the European community

Summary of Contents for XE-5000

Page 1: ...alibration CHAPTER 9 Cleaning and Maintenance CHAPTER 10 Troubleshooting CHAPTER 11 Technical Information CHAPTER 12 Warranty CHAPTER 13 Index SYSMEX CORPORATION KOBE JAPAN Copyright 2006 2008 by SYSMEX CORPORATION All rights reserved No part of this manual may be reproduced in any form or by any means whatsoever without prior written permission of SYSMEX CORPORATION Code No 461 2642 1 PRINTED IN ...

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Page 3: ... 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...

Page 4: ... 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 ...

Page 5: ...g 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 functio...

Page 6: ... of the XE 5000 11 1 11 2 Possible sample interferences 11 9 11 3 Interface protocol 11 10 11 4 Program version 11 10 11 5 Principles 11 11 11 6 Contents of the packages 11 32 11 7 Check before installation 11 36 11 8 Grounding 11 36 11 9 Installation environment 11 36 11 10 Installation space 11 37 Chapter 12 Warranty 12 1 Chapter 13 Index 13 1 ...

Page 7: ...e 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 det...

Page 8: ... 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 Spectrum 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 ...

Page 9: ...others Warning High risk Ignoring this warning could result in personal injury to the operator Caution Hot Indicates a potential risk of burns or other physical damage in the event of incorrect operation or failure to observe the content Caution Ignoring this warning could result in property damage or incorrect results To avoid damage and incorrect measuring results this caution must be followed I...

Page 10: ... 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 1 WBC 2 RBC 3 HGB 4 HCT 5 ...

Page 11: ...e Hemoglobin Equivalent 37 IPF Immature PLT fraction 6 Body Fluid Mode Parameters 1 WBC BF WBC body fluid 2 MN Mononuclear cell percent 3 MN Mononuclear cell count 4 PMN Polymorphonuclear cell percent 5 PMN Polymorphonuclear cell count 6 RBC BF RBC body fluid 24 Pre Diluted Mode Parameters 1 WBC 2 RBC 3 HGB 4 HCT 5 MCV 6 MCH 7 MCHC 8 PLT 9 NEUT 10 LYMPH 11 MONO 12 EO 13 BASO 14 NEUT 15 LYMPH 16 MO...

Page 12: ...CHAPTER 1 Introduction 1 6 Sysmex XE 5000 Instructions for Use Revised April 2007 EU 18 BASO 19 IG Immature Granulocyte Percent 20 IG Immature Granulocyte Count 21 NRBC 22 NRBC 23 RET 24 RET ...

Page 13: ...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 ...

Page 14: ...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 ...

Page 15: ...inciple 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 sam...

Page 16: ...nd 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 M...

Page 17: ...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 ...

Page 18: ...ing maintenance Information When performing maintenance use only the tools specially provided for such work All cleaning and maintenance procedures as described in this manual must be observed for optimal performance Risk of infection Use of gloves is strongly recommended when handling waste fluids or instrument consumables Wash your hands thoroughly following maintenance Warning Waste fluids inst...

Page 19: ...k may result CAUTION 1 Dye solution replacement method For SNR always replace dye solution and lyse reagent simultaneously For RED always replace dye solution and diluent simultaneously For FFS the message Replace FFS is displayed after the analysis of 2000 cycles When doing so always press Reagent or Confirm after replacing with new FFS 2 When the message Execute Rinse Flowcell is displayed alway...

Page 20: ...e the instruments are rinsed with diluent before shipping from the factory Background count may be high immediately after unpacking so rinse thoroughly RISK OF INFECTION In principle all parts and surfaces of the instrument must be regarded as infective Always keep the switch in the analysis position WARNING Never touch the detector when the power of the Main Unit is turned ON Otherwise electrical...

Page 21: ...se 2 9 Revised July 2007 Main Unit Rear View 1 1 CAUTION 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 ...

Page 22: ...e 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 0 25 MPa regulator RISK OF INFECTION In principle all parts and surfaces of the instrument must be regarded a...

Page 23: ...Sysmex XE 5000 Instructions for Use 2 11 Revised April 2007 Pneumatic Unit Rear View 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 1 P V ...

Page 24: ...e 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 progra...

Page 25: ...ceives 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...

Page 26: ...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 and selecting the analysis parameter For details see Panel keypad 7 CP cover This is the protection cover of cap piercing unit Warning ...

Page 27: ...e rear panel of the Pneumatic Unit 3 Fuse holder This is a 250V 3 15A time lag fuse 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 Warning To avoid electrical shock disconnect supply before servicing For the continued protection against risk of fire replace...

Page 28: ...e 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 air at PRESSURE side supplied by the...

Page 29: ...Side View 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 1 2 3 4 5 ...

Page 30: ...e IPU using the provided cable 3 DP connector Connected to the data printer 4 Power Supply Switch Turns the power ON and OFF 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 Note Do...

Page 31: ...tors 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 d...

Page 32: ... 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 3 2 1 ...

Page 33: ... key entry or to stop the alarm 5 Used to input hyphen during sample ID No entry or decimal point during numeric entry 6 Used to confirm the entered sample ID No 7 Used to change input modes 8 Used to change the LCD screen or to move the selected parameter 9 Used to change the function menu display on the screen which has five or more selectable function menu items 10 Used to cancel the execution ...

Page 34: ...g 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...

Page 35: ...occurred 9 Displays the implementation status of XM QC Xm XM QC is ON No indication XM QC is OFF 10 Displays the function menu The contents of the function menu differ with each other 3 3 Pneumatic Unit Front View 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 oper...

Page 36: ...onnector 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 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 Wa...

Page 37: ... 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 instr...

Page 38: ...in body IPU Main Unit of the personal computer 3 Keyboard Used to input data to the IPU 4 Mouse 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 1 2 3 4 ...

Page 39: ...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 3 1 2 5 6 4 ...

Page 40: ...cked over the menu item 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 4 Tab The names of windows indicating menu icons are displayed When there are several windows select a desired tab to change over the windows 5 Wind...

Page 41: ...ipette 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 aspi...

Page 42: ...CHAPTER 3 Design and Function 3 18 Sysmex XE 5000 Instructions for Use Revised April 2007 Blank page ...

Page 43: ...fer to the product labeling package insert or outer package for the open stability Usage CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing DC Detection With the addition of the specified lyse reagent for hemoglobin concentration determination it can also be used to analyze hemoglobin concentration 4 3 CELLSHEATH Intended Use Sheath fluid f...

Page 44: ...ate 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 Sto...

Page 45: ...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 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 uno...

Page 46: ...h 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 th...

Page 47: ...a reagent for detecting immature cells by the RF DC detection method 4 11 RET SEARCH II diluent RET SEARCH II dye solution 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 expi...

Page 48: ...C Avoid exposing direct sunlight or the chlorine component may deform and lose its effectiveness depending upon the period of exposure 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 Warning 1 Avoid contact with skin and eyes 2 In case ...

Page 49: ...n 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 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 manufact...

Page 50: ...ymbols used on the labels EC REP 22 Nov 2000 NN C NN C LOT 1234 IVD Xn In Vitro Diagnostic Consult instructions for use Lot number Use by Storage temperature CE conformity sign as per directive 98 79 EC Hazardous Class in EU Manufacturer Authorized representative in the European community ...

Page 51: ... 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 cab...

Page 52: ...t option Informs the operator that the waste container is full 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 Note The ledger printer color graphic printer and data printer are optional Refer to the corresp...

Page 53: ...on Processing Unit IPU Brightness adjustment of panel keypad LCD screen 1 Open the front cover of the Main Unit 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 Note The uninterruptible power supply UPS is optional Note This chapter only explains the settings...

Page 54: ...CHAPTER 5 Before Using 5 4 Sysmex XE 5000 Instructions for Use Revised April 2007 Blank page ...

Page 55: ... 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 Note To return to the main ...

Page 56: ...pad 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 ...

Page 57: ...te Exec QC Xm STT STP Cal 1 Manual 2 HGB HCT Logoff Reagent 2 Air Bubble Removal 3 Clog Removal 4 Rinse Flowcell 5 Drain Waste 1 Drain IMI 2 FFS 3 SNR 4 RED 5 FBA 6 EPK 7 ESE 8 SLS 9 SIM 1 FFD Sampler Test Status 2 Sensor 2 3 Counter 4 Pump 1 Sensor 1 2 Rack Shift 3 Rack Feed Out 1 Rack Feed In Motor Barcode CP Replenish SRV 2 RBC Sheath Injector 3 FCM Sheath Injector 4 Spits Motor 5 Mixing Motor ...

Page 58: ...the submenu item from the pull down Double click the icon on the menu screen 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 Note The men...

Page 59: ...Restore Download First Upper Lower Last Output CSV format 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 co...

Page 60: ...nt is completed The following shows the approximate number of cycles that can be analyzed per container of reagent 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 Limit CSV Output Setting Backup Starts Setting System Starts Setting Auto Validate Starts Sett...

Page 61: ...LYSER 4DS FFS Approx 2000 cycles 42 mL STROMATOLYSER NR L SNR Approx 2000 cycles 3 6 L STROMATOLYSER NR S Approx 2000 cycles 43 mL SULFOLYSER SLS Approx 10000 cycles 5 L STROMATOLYSER IM SIM Approx 3200 cycles 10 L RET SEARCH II Diluent RED Approx 550 cycles 1 L RET SEARCH II Dye solution Approx 550 cycles 12 mL Caution Use reagent that has been left at room temperature 15 30 C for at least 24 hou...

Page 62: ...e that the left and right rack pools and analysis line are clear 5 Waste fluid Discard any waste fluid that has collected in a waste container if applicable For the procedure for disposing of waste see Chapter 9 Cleaning and Maintenance 6 7 Turning ON the power 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 Informatio...

Page 63: ...should be correctly managed If you forget the User Name or Password contact your Sysmex technical representative 6 9 Self checks 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 parts check and background check If a failure occurs during a self che...

Page 64: ... is not lower than the acceptable background value is displayed to the right of the value To resolve background error see Chapter 10 Troubleshooting Caution 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 for some analysis parameters Note When a background erro...

Page 65: ...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...

Page 66: ...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 fin...

Page 67: ...lant 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 HPC analysis and Body fluid analysis Sampler mode Note HPC analysis and body fluid analysis can only be performed in manual mode Analysis mode Manual Capillary Manual Closed Required Sample 1 0 mL or more 40 µL or more 1 0 mL or more Aspirated Sampl...

Page 68: ...ure 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 barcode labels come in 2 sheets as a set So affix another barcode label on the side face of the rack Diameter a 12 15 mm Length b ...

Page 69: ...els on the sample tube Assure labels are flat and smooth against the tube without creases or flaring Assure label does not peel off the tube Sample tubes with barcode labels affixed must slide smoothly in and out of the racks Information Affix the rack number barcode label in line with the sample tube barcode label If the barcode is affixed in the area for the blood volume sensor the volume of sam...

Page 70: ...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 ar...

Page 71: ... 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 Risk of infection 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 ...

Page 72: ...ADY LED turns off and a short beep sounds two times remove the sample tube 12 When the READY LED turns on again prepare the next sample and repeat steps 8 11 Caution 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 Informatio...

Page 73: ...ed after the input of the sample ID number Real time Request Manual Mode Sample ID When the sample ID number is incremented automatically for each analysis the analysis order and patient information are not inquired Risk of infection 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 dis...

Page 74: ... 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 discrete setting and if necessary press key to change the set item to Discrete Then using the and keys set the discrete 6 After all the setti...

Page 75: ...6 19 Sample analysis in sampler mode 1 Make sure that the instrument is in READY status 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 Caution To remove the microtube pull straight down to prevent bending the manual aspiration pipette Otherwise the blood may scatter Note The manual aspiration pipette is automatica...

Page 76: ...ted correct analysis results may not be obtained due to insufficient mixing Therefore in case of analyzing such samples make sure to mix the samples thoroughly before setting them on the sampler 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...

Page 77: ...h ordinary analysis 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 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 ...

Page 78: ...en 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 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 ...

Page 79: ...yed 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 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 b...

Page 80: ...ware 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 valida...

Page 81: ... cord blood samples Specimen type Peripheral blood PB Umbilical cord blood UCB Analysis parameters 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 Anticoagulants EDTA Studies were performed on EDTA 3K Environment temperature 20 30ºC Information P...

Page 82: ...ial area on the IMI scattergram The discriminated particles are displayed in red as an immature cell The particles in the HPC detection area are displayed in magenta pink The RBCs WBC ghosts and discriminated particles are displayed in blue Risk of infection 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 ...

Page 83: ...to set to any of the following 4 CBC DIFF NRBC 5 CBC DIFF NRBC RET 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 Information HPC analysis is only performed in manual mode It cannot be performed in sampler capillary or manual closed modes Informatio...

Page 84: ...s 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 rese...

Page 85: ...formation 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 Information Analysis requires an adequate sample volume Correct analysis results cannot be obtained if the instrument does not aspirate an adequate sampl...

Page 86: ...e See also Chapter 5 Instrument Setup in the Software Guide for the setting of HPC rank limits 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 determinin...

Page 87: ...sis 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 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 Information Since fibr...

Page 88: ...al mode It cannot be performed in sampler capillary or manual closed modes 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 Information When the ENTER key is pressed the input sample number is used as the order key to query the analysis ...

Page 89: ...background error see Chapter 10 Troubleshooting 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 Information In the case of a Background Error the analysis can be performed by selecting OK on the...

Page 90: ... sample tube 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 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 anal...

Page 91: ... 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 values in the table on the left the Execute Background check error is displayed asking operater to perform a background check before analyzing the next sample Analyze the next sample after performing the background check by pressing the B Che...

Page 92: ...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 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 ...

Page 93: ... CELLCLEAN to the manual aspiration pipette as shown in the figure then press the START switch in that status While the READY LED is blinking and the buzzer is sounding aspiration is in progress Keep holding CELLCLEAN in the current status 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 res...

Page 94: ...t 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 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 rinsed and does not need to...

Page 95: ... button on the task bar in the window to display the Start menu then select Shutdown U The dialog box for Windows shutdown will appear on the screen 2 Select XE 5000 Logoff then click on OK to display the Windows logon screen Select Shut down then click 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 Processin...

Page 96: ...CHAPTER 6 Operation 6 42 Sysmex XE 5000 Instructions for Use Revised April 2007 Blank page ...

Page 97: ...ials Use control blood Use e CHECK XE for the control blood 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 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 once and the result is used as ...

Page 98: ... 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 Can...

Page 99: ...d in the upper right of the LCD screen it indicates that XM control is OFF Settings for XM 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 Information Even if X barM control is canceled in this menu when...

Page 100: ...C X barM Setting Sets the number of samples in a batch by discrete 5 After completing settings click on OK Cancel or Apply OK Sets the new settings and closes the dialog box Cancel Cancels the new settings and closes the dialog box Apply Sets the new settings Limit setting 1 Start quality control from the Information Processing Unit IPU 2 Click the Setting button The QC Setting dialog box will be ...

Page 101: ... After completing settings click on OK Cancel or Apply OK Sets the new settings and closes the dialog box Cancel Cancels the new settings and closes the dialog box Apply Sets the new settings 7 4 Quality control analysis QC analysis in manual mode 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 t...

Page 102: ... with reference to Chapter 6 6 19 Sample analysis in sampler mode After analysis is completed the results are recorded automatically in the file designated by the barcode QC analysis in manual closed mode QC analysis can be performed in closed mode if control blood is used 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 ...

Page 103: ...NTROL appears the analyzed data is more than 3 times the limit 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 Next No 123456789012346 DP No 123456789012345 Manual Normal Not Ready X1 X2 Mean Judge WBC RBC HGB HCT MCV MCH MCHC 7 71 4 54 12 ...

Page 104: ...rt quality control from the Information Processing Unit IPU The QC Rader chart screen will appear 2 Click the Control tab 3 If multiple Main Units are connected select the Main Unit which performed the quality control 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 bloo...

Page 105: ...h the QC data range selection function click Delete Data To cancel the delete click Undelete Operation Result key Moves the cursor one plot to the left key Moves the cursor one plot to the right Shift key Expands the selected range to the left The cursor does not move Shift key Expands the selected range to the right The cursor does not move Mouse left click Moves the cursor to the mouse pointer l...

Page 106: ...Ledger LP L is selected from the Output P menu the selected area of the control data is printed as a ledger format If no range is specified the control data at the current cursor position is printed HC Output to Host Computer 1 Use the range selection function to specify the control data from the QC chart to output to the host computer 2 When Host Computer HC H is selected from the Output P menu t...

Page 107: ... dialog box will be displayed 3 Select the name of the file that you wish to load 4 Click Open O to display the saved lot information and QC data Click Cancel to cancel the load Information The C drive is used for system programs Use a drive other than C for saving data Information When load is executed previously stored QC data are imported from memory stick and displayed temporarily When the QC ...

Page 108: ...hart 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 If there are data beyond limits it is judged as an L J control or X control error If there is no data outside the control limits run the X L J control again If that result is within the control limits there...

Page 109: ... the data to an external storage device 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 When the control material is to...

Page 110: ...ck OK to register the input lot information and close the new lot dialog box Click Cancel to cancel the register and close the new lot dialog box 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 Information Do not register a same lot No to multiple lots If a ...

Page 111: ... the file from the folder selection that is displayed Select the desired file by clicking 5 Click the radio button of the parameter you wish to read Lot No Reads the control blood lot number Exp Day Reads the control blood expiry date 6 Click OK to execute reading and return to the new lot dialog box Click Cancel to cancel reading and return to the new lot dialog box 7 Click OK in the new lot dial...

Page 112: ...file information will be displayed in the upper section of the dialog box Manual setting 1 Click a parameter you wish to set in the list The selected parameter will be displayed in the Manual Setting column at the upper right of the dialog box 2 Input the setting values under Target Limit range If is displayed in the limit range column it means that the percentage form is currently used If is disp...

Page 113: ...ed are rounded up UL upper limit LL lower limit Range UL and LL Target X Limit 100 1 4 5 million is input as the first RBC control data The variable target will be set at 4 50 and the QC Chart will show the values in the figure on the right 2 4 45 million is input as the second RBC control data The variable target remains the same because the denominator N 1 in the equation X N 1 is 1 in this inst...

Page 114: ...ot be entered on the QC Chart and the message Reanalyze sample will be displayed Setting variable target 1 Click a parameter you wish to set in the list 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 Information When Variable Target is selected for quality control set the limi...

Page 115: ...he target or limit for the selected parameter based on the control data selected with the range selection function in the chart Click Cancel to cancel the auto calculation procedure Information The automatic calculation of Target Limit according to auto setting employs the control data selected by the range selection function in the chart If no range is specified it is calculated from one control ...

Page 116: ... The Read Assay dialog box will appear The new lot information to be imported will be displayed on the right side of the dialog box 4 Click the Target and or Limit check box to select If the file location is not on a CD ROM click on the Browse button for the folder containing the file then select the file from the drive selection that is displayed 5 Click OK to read the assay values for the select...

Page 117: ...ll be displayed 2 The list will be displayed in the present order Select the parameter to be changed reordered 3 Click the Move Up or Move Down button to change the order of the selected parameter Move Up The selected parameter scrolls up by one line 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 ord...

Page 118: ...mation dialog box will appear 3 When two or more Main Units are connected to one IPU click the Inst ID combo box and select the instrument in which you wish to display a list of file information 4 Click the Mode combo box and select the analysis mode in which you wish to display a list of the file information 5 Click Close to close the dialog box Note It is impossible to change the file informatio...

Page 119: ...ta varies with time HGB and HCT calibration should be checked When abnormal QC data occur as a result of instrument problem reagent degradation or degeneration of control blood however do not perform calibration 8 2 Samples used for calibration For calibration use five to ten samples of fresh normal blood that meets the following conditions Blood of a healthy person who is not taking any medicine ...

Page 120: ...nd returns the system to the Main Menu screen Cancel Returns the system to the Automatic Calibration screen And the operation can be continued Entering reference values 1 Using the and keys move the cursor to select the line in which you wish to enter the value Note When the Calibration on the function menu is not displayed on the Main Menu screen press the MORE key to change over the function men...

Page 121: ...value is analyzed by the XE 5000 1 Using the and keys move the cursor to select the line to analyze 2 Carry out the analysis in manual or manual closed mode 3 After completion of analysis the analysis result will appear and the cursor will move to the next line When one or more samples of HGB and HCT are analyzed each average is calculated automatically and displayed in the AVG column of the Autom...

Page 122: ...ue you wish to recalculate 2 Select Exclude on the function menu of the Automatic Calibration screen The line on the data will disappear and the cursor will move to the next line The averages of the reference value analysis value and compensation rate will be calculated again and displayed Executing the calibration Update the compensation rate to the new compensation rate calculated from the avera...

Page 123: ...samples for abnormalities such as abnormal blood coagulation blood cell morphology patient medicinal use and old blood If no abnormality is found on the samples contact your Sysmex technical representative Note Comp in the right of the screen is calculated as follows The new compensation rate is calculated as follows When the new compensation rate exceeds the following allowable range the Calibrat...

Page 124: ...samples three times each by the standard method to obtain average HGB and HCT values 2 Mix the same samples sufficiently and analyze them in manual or manual closed mode with the Main Unit XE 5000 3 When there is a difference between the data obtained by XE 5000 analysis and the reference values obtained by the standard method calculate new calibration values using the following equation Example A...

Page 125: ...ibration values 1 Using the and keys move the cursor to select HGB or HCT 2 Using the numeric keys enter the calibration value obtained by calculation 3 Press the ENTER key The entered value is set and the cursor will move to the next parameter Note When the Calibration on the function menu is not displayed on the Main Menu screen press the MORE key to change over the function menu Execute Next No...

Page 126: ...ibration 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 If after re calibration the analysis values are still outside the allowable range or if abnormal data is found check the samples for abnormalities such as abnor...

Page 127: ...er menu will be displayed 2 Double click the Calibration History icon on the controller menu The Calibration History screen appears Deleting calibration history Calibration history can be deleted 1 From the Calibration History screen select a record to delete by clicking on it 2 From Record R on the menu bar select Delete D or double click the Delete icon on the tool bar 3 The Confirm Delete dialo...

Page 128: ...CHAPTER 8 Calibration 8 10 Sysmex XE 5000 Instructions for Use Revised April 2007 Blank page ...

Page 129: ...of the SRV As needed maintenance Clean the manual rinse cup Clean the sample rotor valve tray Clean the piercer tray Removing Clogs Clog Removal Sequence Clean the IMI detector aperture Clean the RBC detector aperture Remove flow cell air bubbles in the optical detector block Clean the flow cell in the optical detector block Replace the waste container option Supplies replacements Replace reagents...

Page 130: ...ration is in progress Keep holding CELLCLEAN in the current status 4 After the READY LED turns off and buzzer stops remove the CELLCLEAN Note When the analyzed sample exceeds 500 samples in a day the message prompted to shutdown will appear Caution Be sure to execute shutdown to clean the instrument Otherwise analysis may not be performed correctly To execute shutdown use CELLCLEAN only Warning CE...

Page 131: ...ge shows 0 2 Turn the trap chamber counterclockwise and remove 3 Discard the fluid then reattach the chamber Make sure there is a float ball inside 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 Risk of infection W...

Page 132: ...after completion of the operation wash your hands with disinfectant If your hands are contaminated by blood you might be infected by pathogen etc Warning Be sure to set the stop bar when opening to avoid injury 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...

Page 133: ...completely removed from the manual aspiration pipette there is a possibility that the manual aspiration pipette may bend when the sample rotor valve is removed Caution Do not pull out the valve excessively This is to prevent excess force from applying to the tube that is connected to the rear fixed valve Information When removing the fixed valve reagent can leak from the tube Have a paper towel re...

Page 134: ...tor valve in the reverse order of disassembly And gently push up the manual rinse cup with both hands Note The valves are in close contact with each other They can be easily removed when you lightly pull gently twist then slide them Caution Take care not to inflict flaws or scratches on the sample rotor valve surfaces Do not use each valve with dust or dirt adhered on its surface These can cause b...

Page 135: ... metal knob positioned between the stoppers Confirm the metal knob is placed between the stoppers If it is not malfunction can occur Make sure that the manual rinse cup is pushed all the way up with the manual aspiration pipette inserted If the power is ON with the rinse cup staying lowered Rinse Motor Error will occur making it impossible to continue the operation Information If you spill reagent...

Page 136: ...pipette 4 Remove the manual rinse cup in the order of 1 2 and 3 5 Wash the manual rinse cup with running water 6 Make sure that no dirt remains in the manual rinse cup and wipe off moisture 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 Warning Be...

Page 137: ...rted If the power is turned on with the manual rinse cup lowered an error will occur making it impossible to continue operation Risk of infection When cleaning the sample rotor valve tray 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 Warning Before operating with the front cover o...

Page 138: ...until the pressure gauge points at 0 2 Open the Main Unit front cover 3 Remove the CP cover Caution After installing the tray make sure that the pipette fixing screw is not loose If an analysis is made with the screw loosened air bubbles can enter the pipette and affect the data Information Install the sample rotor valve tray properly as to the face bottom and direction Tray Risk of infection When...

Page 139: ... message indicating clogging is displayed press the HELP key on the Main Unit panel keypad The HELP screen will appear 2 If you select OK on the function menu of the HELP screen the clog removal sequence will start You can also execute the clog removal sequence by the following procedure 1 Select Maint on the function menu of the main menu screen The Maintenance Sequence screen will appear 2 Using...

Page 140: ...de the IMI detector is drained 4 Turn OFF the power of the Main Unit and Pneumatic Unit and wait several minutes until the pressure gauge points at 0 5 Open the Main Unit front cover 6 Open the IMI detector cover and check that the sample is drained Risk of infection When cleaning the aperture always wear gloves After completion of the operation wash your hands with disinfectant If your hands are ...

Page 141: ...g the detector chamber take care not to apply excessive force to the tube that is connected to the detector chamber 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 Caution Be sure to use CELLCLEAN...

Page 142: ...it and wait several minutes until the pressure gauge points at 0 2 Open the Main Unit front cover and front right cover 3 Open the RBC detector cover Rotate the cover holder and keep the cover open Risk of infection When cleaning the aperture 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 patho...

Page 143: ...heath nozzle reagent can leak from the detector chamber Place gauze or the like under the detector chamber Otherwise leakage or electrical shock may result As a sheath nozzle is easy to bend do not drop or apply impact on it When removing the detector chamber or sheath nozzle take care not to apply excessive force to the tube that is connected to the detector chamber Otherwise analysis may not be ...

Page 144: ...ng procedure 1 Loosen the four fixing screws 2 Pull up the cap on the detector chamber and move it in the direction as shown in the figure 3 Apply CELLCLEAN on the brush provided and dab by lightly prodding the brush against the aperture 4 Return the cap to the original position on the detector chamber 5 Close the detector cover Then close the Main Unit front cover and front right cover 6 Turn ON ...

Page 145: ...the air bubble removal sequence the Execution screen will be displayed on the LCD screen 9 11 Cleaning the flow cell in the optical detector block When the message Execute Rinse Flowcell is displayed the flow cell in the optical detector may be dirty In this case execute the flow cell rinse sequence by the following procedure 1 Press the HELP key on the Main Unit panel keypad The HELP screen will ...

Page 146: ...l out the cap straight up with the tubes connected 4 Insert the cap with the tubes to a new waste container straight in and tighten the cap When an empty container is used 1 Turn OFF the power of the Main Unit and Pneumatic Unit and make sure that the pressure gauge indicates 0 2 Prepare an empty waste container and remove the cap 3 Remove the tube from the full waste container 4 Insert the tube i...

Page 147: ... has been designated as a replacement If the reagent has not been designated as a replacement nothing appears in this column 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 Error Message New Reagent Replace Container EPK CELLPACK Replace Cont...

Page 148: ...enu to delete all of the read information and return to the previous screen Information When scanning or entering expired reagent an Expired Reagent message will be displayed as shown in box and the information is not updated Select OK on the function menu of the Expired Reagent screen to return to the Reagent setting screen If the barcode which was read is not a reagent barcode a beep sounds and ...

Page 149: ...t blank Amounts Numbers and a decimal point period can be entered for this item This column may also be left blank Note While the Manual Input screen is open it is also possible to use the handheld barcode scanner to read the barcodes that are affixed to the reagent A barcode can also be read for a reagent that is different from the screen that is currently displayed When a different reagent s bar...

Page 150: ...lue within the entry range when OK is selected from the function menu in step 5 Reagent name Entry range Reagent name Entry range EPK 0 99 FFS 0 999 ESE 0 0 99 9 SIM 0 0 99 9 SLS 0 0 99 9 SNR 0 0 99 9 FBA 0 0 99 9 RED 0 0 99 9 FFD 0 0 99 9 Information When OK is selected a check is made using the dates entered for the expiry date and expiry date after reagent is opened If any reagents have passed ...

Page 151: ... left at room temperature 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 correct analysis results may not be obtained After opening a reagent container make sure that no dust...

Page 152: ...ont cover 3 Remove the empty STROMATOLYSER 4DS from the holder 4 Remove the cap of the empty STROMATOLYSER 4DS and pull out the pipe straight up 5 Open the cap of new STROMATOLYSER 4DS and insert the pipe straight in and close the cap 6 Insert it all the way into the holder 7 Close the Main Unit front cover SHUTDOWN HELP SAMPLER RETURN MORE N U M A L P H E N T E R M A N U A L QZ 0 C PRS 1 TUV 2 WX...

Page 153: ...MATOLYSER NR L 3 Remove the cap of the empty STROMATOLYSER NR L Information The FFS must be replaced every 2 000 times analysis an error will appear Always select OK after replacing the FFS SHUTDOWN HELP SAMPLER RETURN MORE N U M A L P H E N T E R M A N U A L QZ 0 C PRS 1 TUV 2 WXY 3 GHI 4 JKL 5 MNO 6 7 ABC 8 DEF 9 Warning Before operating with the front cover open be sure to set the stop bar Othe...

Page 154: ... way into the holder 9 Close the Main Unit front cover 10 Press the HELP key on the Main Unit panel keypad The HELP screen will appear 11 If you select OK on the function menu of the HELP screen the Reagent setting screen will appear See Chapter 9 9 13 Replacing and registering reagents for explanation of the Reagent setting screen Information Insert the STROMATOLYSER NR S all the way into the hol...

Page 155: ...m the holder remove the cap and pull out the pipe straight up 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 When replacing RET SEARCH II dye solution always wear gloves If dye solution comes in touch with your skin it will stain your skin blue and the stain will be hard to remove Should it adhere to your skin i...

Page 156: ...pad The HELP screen will appear 11 If you select OK on the function menu of the HELP screen the Reagent setting screen will appear See Chapter 9 9 13 Replacing and registering reagents for explanation of the Reagent setting screen Information Insert the RET SEARCH II dye solution all the way into the holder If it slants air bubbles could enter making it impossible to obtain correct analysis result...

Page 157: ...aution When replacing STROMATOLYSER IM always wear gloves Use reagent that has been left at room temperature 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 Make sure there is no dust etc sticking to the joint between the reagent container and the one touch coupling Use alcohol is...

Page 158: ...ontainer and engage it on spout kit fixture No 3 Push it all the way in to avoid the reagent container from collapsing 7 Prior to connecting the quick connector to the SIM cubitainer spout wipe the inside area of the quick connector and the 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 Pu...

Page 159: ...g display function This function displays on the Information Processing Unit IPU the replacement history for the reagents registered with the reagent registration function See Chapter 9 9 13 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 Le...

Page 160: ...ars 2 Double click the Reagent Log icon on the Controller menu The Reagent Replacement Log screen appears Entering comments Comments concerning the registered reagents can be entered Information When the number of reagent replacement log exceeds 1 000 the system automatically deletes the oldest data Information Comments cannot be edited or deleted after they are entered However additions may be ma...

Page 161: ...The entered comment is discarded and the dialog box is closed Delete Stored reagent replacement records can be deleted 1 From the Reagent Replacement Log screen select a record to delete by clicking on it 2 Select Delete D on the Record R or press the Delete key 3 The Confirm Delete dialog box appears 4 Click OK to delete the selected record and close the dialog box Click Cancel to cancel deletion...

Page 162: ...Reagent Replacement Log screen All The reagent replacement records saved for all dates are displayed Select The reagent replacement records for the selected term are displayed Enter the dates to select in the respective entry boxes Information The older of the two dates can be entered in either the right or left entry box when selecting dates A check is made of the entered dates when the cursor is...

Page 163: ...e 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 Note The contents to be printed are linked with the filter If a comment has been entered it is printed on the following line Information The system uses C drive It is recommended to save files to the D drive or to a USB Memory S...

Page 164: ...l be automatically transferred after converting into a space in the output file Even when a save process is terminated due to the lack of space in the drive or other reasons the previous data saved before the error happens will be kept and retained Information The remaining reagent volume is calculated based on the container volume which was registered If an incorrect container volume is entered t...

Page 165: ...ts shown below The values are rounded down to the nearest unit If a reagent has been used and the remaining reagent volume is reduced the display is reduced in the units shown below Note 0 zero is not displayed for the reagent amounts When the amount is reduced to less than the smallest display unit is displayed No error occurs even if the reagent amount becomes 0 Example of remaining reagent disp...

Page 166: ...nt container content volume EPK L 1 L 20 0 L ESE L 0 5 L 20 0 L SLS L 0 5 L 5 0 L FBA L 0 5 L 5 0 L FFD L 0 5 L 5 0 L FFS mL 10 mL 42 mL SIM L 0 5 L 10 0 L SNR L 0 1 L 3 6 L RED L 0 1 L 1 0 L Risk of infection When replacing the piercer always wear gloves Also after completion of the operation wash your hands with disinfectant If your hands are contaminated by blood you might be infected by pathog...

Page 167: ...t which are connected to the rinse cup and piercer 5 Install the fixing board to the piercer using three screws Information Another tube is installed inside one tube The replacement part of this inner tube is attached to the new piercer set Remove the inner tube together with the outer tube Warning Be sure to install the piercer fixing board The piercer needle may pop out during operation and caus...

Page 168: ...and piercer support and tighten the fixture lock screw 2 Loosen slightly the screw A on the piercer fixing board Slide the rinse cup and press it against the slider surface then fix the rinse cup with three fixing screws Fixture lock screw Fixing screws Slider Piercer support Information After tightening the fixture lock screw by hand retighten it with a screwdriver Slider Fixing screw Piercer sup...

Page 169: ...d and unable to hold the sample tube replace it in the following procedure Caution When installing the piercer cover and CP cover take care not to have the tube caught or bent Otherwise analysis may not be performed correctly Piercer fixing board Rubber joint Rinse cup Piercer Tube Risk of infection When replacing the hand clipper always wear gloves And after completion of the analysis be sure to ...

Page 170: ...move the F bracket from the new hand clipper and attach the fixing plate just removed on the new hand clipper for mixing 5 Install the new hand clipper to the original position using screws removed in step 3 Please note Hand clipper for mixing uses fixing plate Hand clipper for piercing uses F bracket 6 Install the CP cover 7 Close the front cover Information In case of connecting to the HST Syste...

Page 171: ...w rubber plate in the reverse order 6 Install the hand clipper to the original position 7 Install the CP cover 8 Close the front cover Risk of infection When replacing the rubber plate No 39 always wear gloves And after completion of the analysis be sure to wash your hands with disinfectant If your hands are contaminated by blood you might be infected by pathogen etc Warning Before operating with ...

Page 172: ...Turn OFF the power of the Main Unit Pneumatic Unit and IPU and disconnect the power cord of the Pneumatic Unit 2 Remove the fuse cap holder Remove the fuse cap holder at the right face of the Pneumatic Unit by turning it counterclockwise using a flat tip screwdriver 3 Replace the fuse and attach the fuse cap holder Pneumatic Unit Warning To avoid electrical shock disconnect supply before servicing...

Page 173: ...emove the HEPA filter and replace it with a new one Pay attention to the installation direction 4 Install the filter cover and fix it with the screws Warning For the continued protection against risk of fire replace only with fuse of the specified type and current ratings Risk of infection When replacing the HEPA filter always wear gloves And after completion of the analysis be sure to wash your h...

Page 174: ...ssure or vacuum as described below Displaying the pressure or vacuum 1 Select TEST on the function menu of the main menu screen of the Main Unit The Test menu screen will appear 2 Select Status on the Test function menu The Status screen will appear 3 From the Status menu screen select Sensor 1 on the function menu The Sensor 1 screen will appear The Sensor 1 screen displays pressure temperature H...

Page 175: ... MPa 4 Check that the pressure displayed on the Sensor 1 screen is the predetermined pressure 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 Information If the difference between the pressure values displayed o...

Page 176: ...ressure 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 16 MPa regulator to lock Adjusting the pressure to 0 07 MPa This pressure is used to discharge waste fluid and mix the sample 1 Display the Sensor 1 screen on the LCD screen See Chapter 9 9 21 Displaying the pressure or vacuum 2 Pull...

Page 177: ...elease the lock 3 Adjust the pressure while watching the pressure displayed on the Sensor 1 screen To increase the pressure turn the knob clockwise Normal range 0 03 0 001 MPa 4 Check that the pressure displayed on the Sensor 1 screen is the predetermined pressure 5 If the displayed pressure does not match the predetermined pressure adjust it by repeating the operations 3 and 4 6 When the adjustme...

Page 178: ...ted connect it securely Adjusting the vacuum to 0 04 MPa This vacuum is used to transfer fluid between the chambers 1 Display the Sensor 1 screen on the LCD screen See Chapter 9 9 21 Displaying the pressure or vacuum 2 Loosen the locking nut for the bellows unit 3 Adjust the pressure while watching the pressure displayed on the Sensor 1 screen To increase the pressure turn the knob clockwise Norma...

Page 179: ...LYSER NR L SNR 210A lyse 3 6 L 064 2891 2 STROMATOLYSER NR S SNR 810A dye 43 mL 904 1151 1 SULFOLYSER SLS 220A 5 L 934 0671 6 STROMATOLYSER IM SIM 220A 10 L 984 1621 1 RET SEARCH II RED 700A diluent 1 L dye 12 mL 834 0162 1 CELLCLEAN CL 50 50 mL Part Number Description Refer to 971 0583 5 PIERCER SET NO 1 XE STANDARD Chapter 9 9 16 366 1792 2 TUBE HOLDER NO 56 WHITE Chapter 6 6 16 366 1789 1 TUBE ...

Page 180: ...E Initial Daily Date Int Date Int Date Int Date Int Procedure Clean manual rinse cup Clean sample rotor valve tray Clean piercer tray Remove clogs Clog removal sequence Clean IMI detector aperture Clean RBC detector aperture Remove flow cell air bubbles in optical detector block Clean flow cell in the optical detector block Replace waste container Procedure Clean sample rotor valve REPLACEMENTS Da...

Page 181: ... indicated recovery procedure and the content of Chapter 10 10 4 Troubleshooting guide If the recovery procedure does not restore the system to normal condition contact your Sysmex technical representative 10 2 Error log The error log displays a maximum of 100 errors in order of their occurrence Older errors will automatically be deleted if the total number of errors exceeds 100 The error log cons...

Page 182: ... log can be deleted 1 From the Error Log screen select a record to delete by clicking on it 2 From Record R on the menu bar select Delete D or click on the Delete button on the tool bar 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 ...

Page 183: ...5 Clean The SRV 10 29 Close FCM Detect Cover 10 26 Close RBC Detect Cover 10 11 Control Entry Err 10 28 Control Expired 10 28 Data Error 10 26 DIFF Sampling Error 10 23 DIFF CH Error 10 25 DP Error 10 27 Env Temp High HPC 10 14 Env Temp Low HPC 10 14 Env Therm Sens ERR 10 14 Exchange Waste Tank 10 16 Execute Background check 10 26 Execute Rinse Flowcell 10 29 Execute Shutdown 10 29 Expired Reagent...

Page 184: ...gh HPC 10 14 IMI Reac Temp Low HPC 10 14 IMI RF Noise Error 10 24 IMI TD Therm Sens ERR 10 13 IMI TD Therm Sens ERR HPC 10 13 IMI Temp Stab ERR 10 14 IPU Communication Error 10 27 IPU Error 10 28 Laser Power Error 10 26 Laser Tube Aged 10 26 L J Limit Error 10 28 Low Blood Volume 10 17 Low Count Error 10 24 Mixing Motor Error 10 17 NRBC Sampling Error 10 23 NRBC CH Error 10 25 PLT CCSD Noise Error...

Page 185: ...SNR 10 15 Replace Piercer 10 29 RET Error 10 25 RET Sampling Error 10 23 RET CH Error 10 25 Rinse Motor Error 10 16 Sample Not Asp Error 10 17 Sampler Com Error 10 27 Sampler Start ERR BSNS 10 22 Sampler Start ERR SNS4 10 22 Sampler Start ERR SNS5 10 22 Set Piercer Cover 10 19 Setup Data Error 10 27 Short Sample 10 18 SRV Lower Position ERR 10 18 SRV Upper Position ERR 10 18 TC Com Error 10 27 Tub...

Page 186: ...ctor Temp High 10 13 FCM Detector Temp Low 10 13 IMI TD Therm Sens ERR 10 13 IMI TD Therm Sens ERR HPC 10 13 33 C RH Therm Sens ERR 10 13 40 C RH Therm Sens ERR 10 13 FCM RU Therm Sens ERR 10 13 FCM TD Therm Sens ERR 10 14 Env Therm Sens ERR 10 14 IMI Reac Temp High HPC 10 14 IMI Reac Temp Low HPC 10 14 Env Temp High HPC 10 14 Env Temp Low HPC 10 14 IMI Temp Stab ERR 10 14 3 Chamber Errors Replace...

Page 187: ...19 Rack Feed In Func Error 10 19 Rack Feed In Init ERR 10 19 Rack Shift Function ERR 10 20 Rack Shift Home Pos ERR 10 20 Rack Removed 10 20 Rack Move Error 1 10 20 Rack Move Error 2 10 20 Rack Move Error 3 10 20 Rack Feed Out Func ERR 10 21 Rack Feed Out Init ERR 10 21 Hand Init Position ERR 10 21 Hand Move Position ERR 10 21 Hand Upper Position ERR 10 21 Hand Lower Position ERR 10 21 Tube Inv Pos...

Page 188: ...r 10 24 RET Error 10 25 WBC BASO CH Error 10 25 DIFF CH Error 10 25 NRBC CH Error 10 25 RBC CH Error 10 25 PLT CH Error 10 25 RET CH Error 10 25 Data Error 10 26 Execute Background check 10 26 9 Laser Errors Laser Tube Aged 10 26 Laser Power Error 10 26 Close FCM Detect Cover 10 26 10 Subprocessor Errors TC Com Error 10 27 ID Unit Com Error 10 27 Sampler Com Error 10 27 11 Memory Errors RAM Error ...

Page 189: ...ata will be displayed 2 Not Ready error Sample analysis that are in progress will continue but when all analysis sequences have been completed the instrument will wait without executing the following analysis Not Ready and error messages will be displayed 3 Error caused by analysis failure Not Ready error There are two cases 1 Data added with error status is displayed and stored and 2 An error mes...

Page 190: ...R Status Not Ready Category Analysis Error Probable Cause 1 0 16 MPa pressure adjustment error 2 Defective 0 16 MPa regulator Corrective Action 1 Adjust pressure of 0 16 MPa Refer to Chapter 9 9 21 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 0 07 MPa ERROR Status Not Ready C...

Page 191: ...tic Unit trap chamber 3 Check the tube connection and nipple looseness Error messages Pressure Lower Error Status Emergency Stop Probable Cause 1 Pneumatic Unit power is OFF during the operation 2 Pressure connection tube is disconnected Corrective Action 1 Check the Pneumatic Unit power switch and the power cord connection 2 Check the pressure connection tube Error messages Close RBC Detect Cover...

Page 192: ...ange for HPC analysis mode Corrective Action 1 Wait until the temperature has stabilized inside the regulation range If this error is still displayed 30 minutes after switching to HPC analysis mode there is probably something defective in the system Contact your Sysmex technical representative In this case it is possible to perform analysis in normal mode even if the error persists Error messages ...

Page 193: ...rrective Action 1 Turn the power OFF then ON again If the error persists contact your Sysmex technical representative Error messages IMI TD Therm Sens ERR HPC Status Not Ready Category Analysis Error Probable Cause 1 One of the thermal sensors for IMI reaction chamber has broken Corrective Action 1 Turn the power OFF then ON again If the error persists contact your Sysmex technical representative ...

Page 194: ...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 Error messages Env Temp High HPC Env Temp Low HPC Status Not Ready Category Analysis Error Probable Cause 1 The ambient temperature in which the instrument is used is outside the the regulation range fo...

Page 195: ...ber SIM Error CBC can be analyzed Chamber FCM Sheath ERR Status Not Ready Probable Cause 1 Tubing between the reagent container and the Main Unit is bent clogged or disconnected Corrective Action 1 Check the tubing Press the HELP key on the Main Unit panel keypad A help message will be displayed Select OK on the function menu then aspirate reagent Error messages Waste Chamber 1 Error Waste Chamber...

Page 196: ... 1 Check the RBC seath injector piston Check that no fluid switch connector or tubing is touching the upper lower part of RBC sheath injector piston Then press the HELP key on the panel keypad of the Main Unit Select OK on the function menu to check the operation Error messages FCM Sheath Motor Error Status Not Ready Category Analysis Error Probable Cause 1 The load on the FCM sheath injector pist...

Page 197: ...ood sample Clumps present in blood sample Extremely low concentration blood 2 The parts below are clogged Piercer Sample rotor valve Whole blood aspiration line tubing 3 Tubing in the whole blood aspiration line is disconnected from the sampler Corrective Action 1 Check the whole blood sample and reanalyze it 2 Clean the sampler piercer SRV and whole blood aspiration line as follows 1 Perform the ...

Page 198: ...sumed that the piercer is clogged by clots replace the piercer Refer to Chapter 9 9 16 Replacing the piercer Note If the test tube is dirty or the barcode label is affixed on the lower area than the specified position the sampler unit cannot detect the blood volume Therefore even if the blood amount is insufficient the aspiration will be performed and the Short Sample error will occur Error messag...

Page 199: ...us Not Ready Probable Cause 1 CP cover has not been installed Corrective Action 1 Install the CP cover After the installation press the HELP key on the panel keypad of the Main Unit Then select OK on the function menu to check the operation Error messages Rack Feed In Func Error Status Not Ready Probable Cause 1 Rack feed in move position sensor has malfunctioned 2 The rack moves by irresistible f...

Page 200: ...dust Corrective Action 1 Remove dirt or dust Error messages Rack Removed Status Not Ready Probable Cause 1 While the hand clipper is catching the test tube during sampler analysis the rack moves by irresistible force Corrective Action 1 Remove the test tube from the hand clipper and return it to the rack Reinstall the rack and perform the analysis again Error messages Rack Move Error 1 Probable Ca...

Page 201: ...he operation Error messages Hand Upper Position ERR Hand Lower Position ERR Status Not Ready Probable Cause 1 Up down cylinder has malfunctioned Corrective Action 1 Perform test operation Before the test operation remove the test tube from the hand clipper and return it to the rack Check the hand s up down position for obstacles and press the HELP key on the panel keypad of the Main Unit Then sele...

Page 202: ...NS5 Status Not Ready Probable Cause 1 When there are racks remain on the positions other than the rack set position of the sampler analysis line the sample analysis has been started Corrective Action 1 Remove the racks from the analysis line and restart the analysis Error messages Rack Not Exist Category Message urging caution Probable Cause 1 There is no analysis rack in the right rack pool Corre...

Page 203: ... Probable Cause 1 Dirty aperture 2 Abnormal sample Corrective Action 1 Remove clogs Select Maint on the function menu of the Main Unit LCD screen Then select 3 Clog Removal on the Maintenance screen to execute the clog removal sequence If the error persists clean the detector aperture with the brush Refer to Chapter 9 9 9 Cleaning the RBC detector aperture 2 Perform the analysis again Error messag...

Page 204: ... Clogging at sample rotor valve SRV 4 Clogging at WB aspiration tube Corrective Action 1 Perform the analysis again 2 Clean the piercer 3 Clean the sample rotor valve SRV 4 Clean the WB aspiration tube Error messages HGB Error Category Analysis Error Probable Cause 1 Air bubbles are mixed in HGB analysis line Corrective Action 1 Perform auto rinse Select Auto Rinse on the function menu to execute ...

Page 205: ...r 9 9 11 Cleaning the flow cell in the optical detector block 2 Perform the analysis again 3 Check the sample using smear or visually Error messages RBC CH Error PLT CH Error Category Analysis Error Probable Cause 1 The number of RBC PLT channel particles exceeds the upper limit of display range because of external noise Corrective Action 1 Interrupt the noise source Keep the noise source away fro...

Page 206: ...d by carryover Corrective Action 1 Perform a background check Perform auto rinse if the problem is not solved by the background check Error messages Laser Tube Aged Category Message urging caution Probable Cause 1 Laser life is coming to end Analysis is possible Corrective Action 1 Turn the power OFF then ON again Check whether the error has been resolved If the error persists contact your Sysmex ...

Page 207: ...orrective Action 1 Turn the power OFF then ON again If the same error message is displayed again contact your Sysmex technical representative Error messages DP Error Probable Cause 1 No DP printer paper 2 DP is in offline status 3 DP power is OFF Corrective Action 1 Supply DP printer paper 2 Set the DP to the online status 3 Turn the DP power ON Error messages IPU Communication Error Status Not Re...

Page 208: ... Error Rack ID Read Error Probable Cause 1 Dirty ID barcode 2 Poorly printed ID barcode 3 Incorrect position of ID barcode Corrective Action 1 Check the ID barcode Refer to Chapter 6 6 2 ID barcode specifications Error messages Xm Limit Error L J Limit Error Xb Limit Error Probable Cause 1 XM or L J X control error has occurred For details of control error see Chapter 7 7 6 Troubleshooting control...

Page 209: ...d reset the counter of the SRV Refer to Chapter 9 9 3 Cleaning the sample rotor valve Error messages Execute Rinse Flowcell Category Message urging caution Probable Cause 1 It is time to rinse the flow cell in the optical detector Corrective Action 1 Rinse the flow cell in the optical detector Refer to Chapter 9 9 11 Cleaning the flow cell in the optical detector block Error messages Expired Reage...

Page 210: ...03 MPa 0 07 MPa Indicates source vacuum 0 04 MPa Indicates 0 04 MPa Temperature REACT CMB Indicates temperature of reaction unit REAG40 Indicates temperature of 40 C heater REAG33 Indicates temperature of 33 C heater IMI DTCT Indicates temperature of IMI detector block OPT DTCT Indicates temperature of optical detector block RBC DTCT Indicates temperature of RBC detector block ENVIRONMENT Indicate...

Page 211: ... unit oscillation time for the laser and the counter of the operation cycle After completion of the piercer replacement or the sample rotor valve SRV cleaning reset the operation cycle by the procedure described following 1 From the Main Menu screen on the Main Unit select Test on the function menu The Test Menu screen will appear 2 Select Status on the function menu of the Test Menu screen The St...

Page 212: ...V Indicates the analysis cycle after the SRV cleaning FCM MT Indicates the operation cycles of the FCM sheath motor RBC MT Indicates the operation cycles of the RBC sheath motor WB MT Indicates the operation cycle of the whole blood aspiration motor LASER Indicates the laser oscillation cycle BF MEAS Indicates the operation cycles in the body fluid analysis mode except background check BF BCHK Ind...

Page 213: ...ion cycle count of the SNR reagent pump RED Indicates the operation cycle count of the RED reagent pump SLS Indicates the operation cycle count of the SLS reagent pump SIM Indicates the operation cycle count of the SIM reagent pump 4 Select the reagent pump by moving the cursor with or key on the Pump screen 5 When you select OK on the function menu of the Pump screen then select OK again the high...

Page 214: ...T on the function menu The Test Menu screen will appear 3 Select Sampler on the function menu of the Test Menu screen The Sampler Test screen will appear 4 Select 2 Rack shift by moving the cursor with or key on the Sampler Test screen 5 Select Execute on the function menu of the Sampler Test screen Rack shift operation will start Check the sampler operation 6 To cancel the sampler test select Can...

Page 215: ...ress the RETURN key Barcode Select this program to test the ID read function 1 Place the barcoded tubes in a sampler analysis line 2 From the Main Menu screen on the Main Unit select TEST on the function menu The Test Menu screen will appear 3 Select Barcode on the function menu of the Test Menu screen The Barcode Test screen will appear 4 Select Start on the function menu of the Barcode Test scre...

Page 216: ...pleted 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 2 RBC Sheath Injector This program performs test operation of the RBC sheath injector and sets the motor in the correct initial position Execute this test when a RBC Sheath Motor Error occurs and analysis cannot be performed If the test is normally completed an...

Page 217: ...e 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 4 Rinse Motor This program performs test operation of the rinse cup motor and sets the motor in the correct initial position Execute this test when a Rinse Motor Error occurs and analysis cannot be performed If the test is normally ...

Page 218: ...g screen Normal range 1300 Revolution speed 2000 5 Approximately 30 seconds later the reaction chamber mixing motor will stop rotating and the test will be completed 6 To cancel the motor test select Cancel on the function menu or press the RETURN key SRV This program performs test operation of the sample rotor valve SRV and sets the valve in the correct initial position Execute this test when a S...

Page 219: ... kg Power supply Alternating current between 117 220 or 240 volts 10 50 60 cycles Power consumption Main Unit sampler unit Not exceeding 550 VA Pneumatic Unit Not exceeding 250 VA Type of protection Class I device Display range WBC 0 00 999 99 103 µL RBC 0 00 99 99 106 µL HGB 0 0 30 0 g dL HCT 0 0 100 0 PLT 0 9999 103 µL RET 0 00 99 99 RET 0 0000 0 9999 106 µL RBC BF 0 000 99 999 106 µL WBC BF 0 0...

Page 220: ...Throughput CBC Approx 150 samples hour CBC NRBC 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 ...

Page 221: ...r more IG 2 or more NRBC 25 0 or less or within 1 5 NRBC WBC 4 0 103 µL or more NEUT 8 0 or less 1 20 103 µL or more LYMPH 8 0 or less 0 60 103 µL or more MONO 20 0 or less 0 20 103 µL or more EO 25 0 or less or within 0 12 103 µL BASO 40 0 or less or within 0 06 103 µL IG 25 0 or less or within 0 12 103 µL IG 0 1 103 µL NRBC 25 0 or less or within 0 12 103 µL HPC 1 30 or less or within 0 015 103 ...

Page 222: ...75 0 or less or within 0 36 103 µL BASO 120 0 or less or within 0 18 103 µL IG 75 0 or less or within 0 36 103 µL IG 0 1 103 µL or more NRBC 75 0 or less or within 0 36 103 µL Precision reproducibility Body fluid analysis mode WBC BF 30 or less CSF 0 015 0 030 103 µL other than CSF 0 030 0 050 103 µL RBC BF 40 or less or Max Min 0 007 106 µL 0 003 0 050 106 µL Analysis parameters See Chapter 1 1 3...

Page 223: ...pler mode RET Within 20 or within 0 015 106 µL RET Within 20 or 0 3 RET IRF Within 30 or 10 IRF LFR Within 30 or 10 LFR MFR Within 30 or 10 MFR HFR Within 30 or 5 HFR Accuracy reticulocyte parameters Capillary mode RET Within 30 or within 0 025 106 µL RET Within 30 or 0 5 RET Accuracy reticulocyte parameter correlation RET r 0 90 or more RET r 0 90 or more Accuracy cell counts Body fluid analysis ...

Page 224: ...3 µL Linearity Capillary mode WBC Within 4 0 or within 0 4 103 µL 0 00 440 00 103 µL RBC Within 4 0 or within 0 06 106 µL 0 00 8 00 106 µL HGB Within 5 0 or 0 5 g dL 0 0 25 0 g dL HCT Within 4 0 or 2 0 HCT 0 0 75 0 HCT PLT Within 10 0 or within 20 103 µL 0 5000 103 µL the value may not fall within the above ranges depending on RBC concentration Linearity Body fluid analysis mode WBC BF Within 10 u...

Page 225: ...in 30 or within 10 IRF Mode disparity Capillary mode NEUT Within 9 0 NEUT LYMPH Within 9 0 LYMPH MONO Within 6 0 MONO EO Within 3 0 EO BASO Within 3 0 BASO IG Within 3 0 IG NRBC Within 3 0 NRBC Carryover WBC 1 0 or less WBC D 1 0 or less RBC 1 0 or less HGB 1 0 or less HCT 1 0 or less PLT 1 0 or less RBC O 1 Within 1 5 HPC 2 1 or less 1 RBC O is not an official analysis parameter RBC O is the RBC ...

Page 226: ...ograms 10 000 samples Scattergrams 10 000 samples Patient information For 5 000 patients Order information 1 000 samples Quality control X control L J control 300 points 20 files 51 parameters XM control 300 points 1 file 54 parameters Storage conditions for transportation Ambient temperature 10 60ºC Relative humidity 95 or less no condensation Information Use samples at 18 26 C or samples that ha...

Page 227: ...resent the red blood cell count may be reported falsely low Erythrocyte aggregation Cold agglutinin Microcytosis Fragmented erythrocytes Where the following are present the red blood cell count may be reported falsely high Leukocytosis Lymphocytes 100 000 µL Giant platelets Platelets 1 000 000 µL HGB Where the following are present the blood cell count may be reported falsely high Leukocytosis Lym...

Page 228: ...ryoprotein Cryoglobulin RET Where the following are present the reticulocyte count may be reported falsely high Erythrocyte aggregation Cold agglutinin Giant platelets Platelet aggregation Fragmented leukocytes Malaria Howell Jolly body 11 3 Interface protocol Data can be output in various formats via the serial interface or via the TCP IP network interface to the HOST computer For details contact...

Page 229: ...cy resistance with such detection coming in the form of electrical pulses Based on the size of these pulses a two dimensional distribution scattergram of the blood cell size and internal density can be drawn Various analysis data can be obtained by analyzing such distributions scattergram Hydro dynamic focusing DC Detection Inside the detector the sample nozzle is positioned in front of the apertu...

Page 230: ... light is received by the photodiode and the lateral scattered light and lateral fluorescent light are received by the photomultiplier tubes This light is converted into electrical pulses making it possible to perform detailed scattergram analysis 1 Forward scattered light and lateral scattered light When blood cells pass the light beam the light scatters from each cell in various directions This ...

Page 231: ...ssing is an assumed requirement this method is not really appropriate for automatic analysis Moreover since it uses cyanide compounds which are poisonous as reagents the liquid waste must be treated making the method undesirable from an environmental perspective Currently this is not an appropriate analysis method particularly as a large fully automatic instrument that discharges large amounts of ...

Page 232: ...ion STROMATOLYSER 4DL Reaction chamber 1 51 STROMATOLYSER NR L lyse reagent Reaction chamber 1 51 RET SEARCH II diluent Reaction chamber 1 204 STROMATOLYSER FB Reaction chamber 1 50 STROMATOLYSER IM IMI detector chamber 1 250 SRV Sampler 200 µL Manual 130 µL Whole blood aspiration pump FCM sheath injector piston M 2 1 mL 2 mL 1 mL 0 5 mL 3 0 µL 4 0 µL SULFOLYSER HGB Flow Cel 1 500 SRV CELLPACK RBC...

Page 233: ... measured by the sample rotor valve is diluted to a ratio of 1 500 with 1 9960 mL of CELLPACK and then sent to the RBC sample chamber as the diluted sample 3 The sheath injector piston sends 11 7 µL of diluted sample slowly to the 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 puls...

Page 234: ... as the diluted sample At the same time 0 5 mL of SULFOLYSER is added to hemolyze the red blood cells to make 1 500 diluted sample and the hemoglobin is converted into SLS hemoglobin 3 Light of wavelength 555 nm emitted from the light emitting diode passes through the lens and into the sample in the Hgb cell The concentration of SLS hemoglobin is analyzed as light absorbance and is calculated afte...

Page 235: ...on are calculated from the RBC HGB and HCT Mean cell volume MCV The MCV is calculated from the RBC and HCT using the following equation Mean cell hemoglobin MCH The MCH is calculated from the RBC and HGB using the following equation Mean cell hemoglobin concentration MCHC The MCHC is calculated from the HCT and HGB using the following equation HCT MCV fL 10 RBC 106 µL HGB g dL MCH pg 10 RBC 106 µL...

Page 236: ...ure is explained as follows 1 Blood is aspirated from the manual aspiration pipette to the sample rotor valve 2 18 µL of blood measured by the sample rotor valve is diluted with 0 882 mL of STROMATOLYSER 4DL and then sent to the reaction chamber as the diluted sample At the same time 18 µL of STROMATOLYSER 4DS is added to dilute the sample to a ratio of 1 51 After reacting for about 22 seconds in ...

Page 237: ... 2 18 µL of blood measured by the sample rotor valve is diluted to a ratio of 1 50 with 0 882 mL of STROMATOLYSER FB and then sent to the reaction chamber as the diluted sample After reacting for about 14 seconds in this condition the red blood cells are hemolyzed 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 ...

Page 238: ...ed with 0 5976 mL of STROMATOLYSER IM to a ratio of 1 250 and then sent to the IMI detector as the diluted sample After reacting for about 13 seconds in this condition the red blood cells are hemolyzed and the cytoplasm of white blood cells other than the immature granulocytes is released dissolved and are reduced in size 3 The diluted sample is aspirated via the aperture and 250 µL is accurately ...

Page 239: ...escent light After scattergram Analysis the 4DIFF scattergram displays the following classified populations red blood cell ghosts lymphocytes monocytes eosinophils immature granulocytes IG neutrophils and basophils In the WBC BASO scattergram the X axis represents the intensity of the lateral scattered light and the Y axis the intensity of the forward scattered light The WBC BASO analysis scatterg...

Page 240: ...analysis channel is a channel used to discriminate between immature and mature white blood cells 6 NRBC analysis NRBC analysis procedure The NRBC analysis is performed to classify and count the nucleated red blood cell population in the blood The NRBC analysis procedure is explained as follows Sample rotor valve CELLPACK Sample tube blood 18 μL Reaction chamber Optical detector block STROMATOLYSER...

Page 241: ...ed blood cells are stained 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 7 NRBC scattergram Through fluorescence flow cytometry method utilizing a semiconductor laser a two dimensional distribution of the forward scattered light and lateral flu...

Page 242: ...5 mL of RET SEARCH II diluent and then sent to the reaction chamber as the diluted sample At the same time 18 µL of RET SEARCH II dye solution is added to dilute the sample to a ratio of 1 204 After reacting for about 31 seconds in this condition the diluted sample is stained and analyzed by fluorescence flow cytometry 3 The sheath injector piston sends 2 8 µL of diluted sample to the optical dete...

Page 243: ...telets from each other and calculate reticulocyte ratio s reticulocyte count optical red blood cell count and platelet count Here the scattergram is divided into three RET zones based on the intensity of the fluorescent light and the ratio of the reticulocytes in each zone to the total number of reticulocytes is calculated Analysis parameters Reticulocyte Ratio Reticulocyte Count Low Fluorescence ...

Page 244: ...are found between two discriminators a lower discriminator LD and upper discriminator UD which are automatically set up between 25 75 fL and 200 250 fL respectively Particle size distributions are checked for abnormalities including abnormal relative frequencies at the different discriminator levels existence of two or more peaks and abnormal distribution widths The XE 5000 expresses the RBC distr...

Page 245: ...discriminator abnormal distribution widths and the existence of more than one peak PDW PLT Distribution Width With the peak height assumed to be 100 the distribution width at the 20 frequency level is PDW Units are expressed in fL femtoliters with 1 fL equal to 10 15 L P LCR Platelet Large Cell Ratio The P LCR is the ratio of large platelets from the 12 fL discriminator or larger It is calculated ...

Page 246: ...erns of particle size distributions whose counts are different can be viewed on the same scale Widths of particle size distributions can be compared intuitively Displays supported RBC and PLT particle size distributions Normal cell size range expressions With the peak of the normal cell size range found experimentally set as full scale rather than the peak of the particle size distribution set as ...

Page 247: ...alog signals into digital signals then computes the results RBC and PLT cell signals are sent to the applicable waveform processing circuits of the analog unit where noise is eliminated and the required blood cell signals are picked up The microcomputer unit converts the analog to digital converted cell signals into particle size distribution data and sends the data to the IPU The RF and DC signal...

Page 248: ...d by the process mentioned below Signals from the forward scattered light lateral scattered light and lateral fluorescent light are sent to the applicable waveform processing circuits of the analog unit where noise is eliminated and the required blood cell signals are picked up The microcomputer unit converts the analog to digital converted cell signals into scattergram data and sends the data to ...

Page 249: ... RBC amplification waveform processing circuit PLT amplification waveform processing circuit HGB conversion circuit CD unit Sampler drive circuit Power circuit Microcomputer unit SFL A D conversion circuit SSC A D conversion circuit FSC A D conversion circuit IMI A D conversion circuit RBC A D conversion circuit PLT A D conversion circuit HGB counting circuit Input output interface Temperature con...

Page 250: ...1 ASSY C3 XE 1 1 1 462 2121 3 AWL 1 1 1 462 2423 7 CUTTING PLIERS B 150 MM 1 1 1 266 7651 2 FUSE 250V4A 313004 N AMERICA 2 0 0 for PU 266 5106 0 FUSE 250V6 3A ST4 6 3A N1 N AMERICA 2 0 0 for Main Unit 266 5293 0 FUSE 250V3 15A NO 19195 EUROPE 0 4 4 for PU Main Unit 442 3362 0 RUBBER JOINT NO 22 3 3 3 343 2462 5 O RING NO 12 2 2 2 461 2640 4 XE 5000 Instructions for Use 1 0 0 461 2642 1 XE 5000 Ins...

Page 251: ...M 10 M 442 5055 4 TUBE POLYURETHANE 1 8 MM 3 4 MM 5 M 5 M 5 M 442 5338 7 TUBE POLYURETHANE 4 MMID 6 MMOD 5 M 5 M 5 M 442 5301 0 TUBE SILICONE 3 MMID 6 5 MMOD 1 M 1 M 1 M 442 6203 5 TUBE E PD 2 2 4 1 1 1 442 5333 9 TUBE POLYURETHANE 2 4 MM 4 MM 1 M 1 M 1 M 442 5415 7 TUBE TEFLON 1 0 MM 2 0 MM 1 M 1 M 1 M 442 6483 4 TUBE PHARMED 1 32 5 32 200 MM 200 MM 200 MM 442 5418 8 TUBE TEFLON 0 8 MMID 1 8 MMOD...

Page 252: ... 0 424 3705 2 BOTTLE STAND NO 17 1 1 1 367 1058 4 TRAY NO 27 1 1 1 367 1059 8 TRAY NO 28 1 1 1 367 1109 7 TRAY NO 26 WHITE 1 1 1 462 3122 1 CUBITAINER CAP OPENER NO 2 1 1 1 462 2852 7 HEX KEY TWH 13 2 5 MM 1 1 1 368 0079 6 RUBBER PLATE NO 39 4 4 4 322 4907 6 CP UNIT COVER A 1 1 1 322 4309 1 CP UNIT COVER B 1 1 1 442 4486 8 TUBE JOINT PD ML 1 1 1 063 7622 5 CDR1XE5X 1 1 1 Part number Description Qu...

Page 253: ...umber Description Quantity 117V 220V 240V 063 7952 3 OPSU 12 MAIN UNIT COMPLETE ASSY 117VAC 1 0 0 063 7953 7 OPSU 12 MAIN UNIT COMPLETE ASSY 220VAC 240VAC 0 1 1 073 2763 1 SAMPLE RACK PACKAGE ASSEMBLY WHITE 6 PACK 2 2 2 321 3106 8 CONNECTING ROD NO 7 2 2 2 348 3926 8 SCREW BINDING M4 6 SUS 3 3 3 368 9781 5 SPILL COVER NO 37 1 1 1 348 3612 0 SCREW FLAT M3 6 SUS 4 4 4 367 9161 1 BALL CATCHER TL 60 Z...

Page 254: ...cket is not provided with grounding use an adapter plug and ground the ground wire separately 11 9 Installation environment Use sample at an ambient temperature of 15 30ºC 20 30ºC for HPC analysis mode Relative humidity should be within the range of 30 85 If ambient temperature and relative humidity are not within the suggested range air condition the environment Avoid a place that can be extremel...

Page 255: ...r maintenance install the IPU on the right side of the Main Unit The Main Unit should be at least 25 cm away from the CRT of the IPU Provide a distance of at least 50 cm behind the instrument Component Width mm Depth mm Height mm Weight kg Main Unit 706 535 711 Approx 81 Sampler 580 377 195 Approx 12 Pneumatic Unit 195 395 333 Approx 15 5 706 535 711 ...

Page 256: ...CHAPTER 11 Technical Information 11 38 Sysmex XE 5000 Instructions for Use Revised April 2007 Blank page ...

Page 257: ...any of the reasons stated below Accidents and improper use of the instrument whether intentional or unintentional Failure to observe the usage operation servicing and maintenance described in the applicable Sysmex Instructions for Use Failure to use suitable reagents and replacements as specified for the product Information The warranty is no longer applicable if the customer has relocated the ins...

Page 258: ...CHAPTER 12 Warranty 12 2 Sysmex XE 5000 Instructions for Use Revised April 2007 Blank page ...

Page 259: ...e piercer tray 9 10 Cleaning the RBC detector aperture 9 14 Cleaning the sample rotor valve 9 4 Cleaning the sample rotor valve tray 9 9 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 4 7 CP Unit Test 10 35 D Deleting QC data 7 9 Design and Function 3 1 Detection principle 11 11 Display analysis...

Page 260: ...anual mode 7 5 QC analysis in sampler mode 7 6 QC assessment 7 8 QC data display 7 7 QC data range selection function 7 9 QC method setting 7 2 Quality control 6 11 7 1 Quality control analysis 7 5 Quality control materials 2 5 7 1 Quality control methods 7 1 R RBC PLT and HGB analysis 11 15 RBC PLT particle size distribution analysis 11 26 Read assay 7 20 Read File 7 14 Reagent replacement log di...

Page 261: ... 9 24 STROMATOLYSER FB 4 2 STROMATOLYSER IM 4 5 STROMATOLYSER IM SIM replacement procedure 9 29 STROMATOLYSER NR L 4 3 STROMATOLYSER NR L STROMATOLYSER NR S SNR replacement procedure 9 25 STROMATOLYSER NR S 4 4 SULFOLYSER 4 4 Summary of information processing unit IPU operation 6 4 Summary of Main Unit operation 6 1 Summary of the Information Processing Unit IPU display screen 3 16 Supplies and re...

Page 262: ...CHAPTER 13 Index Revised April 2007 13 4 Sysmex XE 5000 Instructions for Use Blank page ...

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