xe series - pre training manual - english - 02-05

Pre-Training Manual

SYSMEX AMERICA, INC.One Nelson C. White Pkwy.Mundelein, IL 60060Phone: 847-996-4500Fax: 847-996-4559Toll Free: 800-379-7639

Sysmex® XE-Series Automated Hematology Analyzers

Sysmex XE-Series Pre-Training Manual Document Number: MKT-50-1011, Revision 1, February 2005 Page 1 of 64

ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060 1-800-3SYSMEX (800-379-7639) WWW.SYSMEX.COM/USA

Sysmex® XE-Series Automated Hematology Analyzer

Document Number: MKT-50-1011

Revision 1 February 2005

© 2003, 2004, 2005 Sysmex America, Inc. All rights reserved. Not to be copied or distributed without expressed written permission from Sysmex America, Inc.



This Page Left Blank Intentionally.



Table of Contents

Page I. Welcome ------------------------------------------------------------------------------5 II. Instrument Overview ------------------------------------------------------- 9 - 12

• Parameters Analyzed -------------------------------------------------- 9 - 10 • Sample Processing ---------------------------------------------------------- 11 • Reagent Summary ----------------------------------------------------------- 12

III. Instrument Parts ---------------------------------------------------------- 13 - 30

• Main Unit ---------------------------------------------------------------------- 14 • Pneumatic Unit ---------------------------------------------------------------- 20 • Sampler Unit ------------------------------------------------------------------- 24 • IPU ------------------------------------------------------------------------------- 25 • Reagents ----------------------------------------------------------------------- 29

IV. Basic Operations Summary -------------------------------------------- 31 - 36 V. Sample Flow and Principles of Measurement --------------------- 37 - 50

• RF/DC Detection Method --------------------------------------------------- 37 • Hydro Dynamic focusing (Sheath Flow)/ DC detection method -- 38 • Flow Cytometry ------------------------------------------------------- 38 - 40 • SLS Hemoglobin Method --------------------------------------------------- 41 • Sample flow for RBC/PLT Analysis -------------------------------------- 42 • HGB Analysis ----------------------------------------------------------------- 43 • 4 DIFF and WBC/Baso Analysis ---------------------------------- 44 - 45 • IMI Analysis -------------------------------------------------------------------- 46 • NRBC Analysis --------------------------------------------------------------- 47 • RET Analysis ------------------------------------------------------------------ 48 • RBC/PLT Particle size Distribution Analysis ------------------- 49 - 50 • Adaptive Cluster Analysis System (ACAS ) ------------------- 51 - 54

VI. Flagging System ---------------------------------------------------------- 55 - 56 VII. Quality Control -------------------------------------------------------------- 57 - 62 VIII. Maintenance ----------------------------------------------------------------------- 63



Sysmex XE-Series Pre-training Manual

Welcome! This is your first step in your Sysmex XE-Series training provided by the Sysmex Training Center! The purpose of this manual is to prepare you for the training session you will attend at the Sysmex Training Center in Mundelein, Illinois. The manual provides basic information about the Sysmex XE-Series Hematology analyzers. Reading this entire manual and completing the reviews at the end of each section before coming to class will allow all participants in the training session to arrive with similar levels of knowledge. It will also allow class lectures to be more focused in order to provide more “hands-on” time with the analyzers. Please read this manual, complete each review, and bring it to the training session. It will be used for reviewing selected topics and preparing participants for in-class exercises.

North American Corporate Headquarters in Mundelein, Illinois



Sysmex America Inc. Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a leader in clinical laboratory systematization and solutions, including clinical diagnostics, automation and information systems. Sysmex enhances the laboratory’s ability to provide clinical information and increase productivity by integrating its advanced instrument technology, automation platforms, and information solutions into a customized laboratory system. The Sysmex solution – fully automated hematology, coagulation, and urinalysis instruments directly connected to scalable laboratory information systems – delivers the highest possible level of clinical accuracy, quality and reliability. Whether you analyze a few samples or a few thousand samples a day, Sysmex’s productivity tools will optimize your workflow, maximize your resources, improve your turnaround time and make your lab more competitive. Additional information about Sysmex America, Inc. can be found at www.sysmex.com/usa.



Instrument Overview

The XE-2100 is an automated hematology analyzer that performs CBC, WBC differentials, nucleated enumeration RBCs, immature granulocyte enumeration, and reticulocyte counts. Features of the XE-2100 & XE-2100D Parameters Analyzed

WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT RDW-CV, RDW-SD NEUT%, LYMPH%, MONO%, EO%, BASO%, NRBC%*, IG% NEUT#, LYMPH#, MONO#, EO#, BASO#, NRBC#*, IG% MPV, RET%*, RET#*, IRF*, PLT-O* HPC#* (optional)

* XE-2100 only



Features of the XE-2100 (continued) Parameters are either directly measured or calculated.

Direct measurements are performed in one of four separate detector blocks. These detector blocks are:

HGB RBC/PLT

WBC/BASO, DIFF, NRBC and RET IMI

The principles and technology used in these detector blocks will be explained in detail in the following pages. These principles include:

Hydrodynamic Focusing/DC RBC, PLT Sodium Lauryl Sulfate Hemoglobin Method HGB Flow Cytometry WBC/BASO Fluorescent Flow Cytometry NEUT, LYMPH, MONO, EO, IG, NRBC and RET Cumulative Pulse Height Detection HCT Radio Frequency/Direct Current HPC Histograms and Scattergrams The XE-2100 displays six scattergrams and two histograms for comprehensive review and screening of results:

Scattergrams: 4 DIFF, WBC/BASO, IMI, NRBC, RET and PLT-O

Histograms: RBC, PLT

IP (Interpretive Program) Messages There are 41 interpretive messages (called IP messages) that assist the laboratory in screening for abnormal samples that may need verification. These messages are generated based on the XE-2100’s analysis of all parameters, histograms and scattergrams.



Sample Processing The XE-2100 has four modes in which a sample can be analyzed. A summary of these modes and their respective sample volumes is described below.

MODE SAMPLE TUBE CLOSED/OPEN

DESCRIPTION SAMPLE VOLUME

Auto Mode Closed XE mixes sample, pierces tube and aspirates sample

200 µL

Closed Manual Mode Closed Operator mixes sample; XE pierces tube and aspirates

200 µL

Manual Mode Open Operator mixes sample and removes stopper; XE aspirates

130 µL

Capillary Mode Open Operator prepares 1:5 dilution of sample, mixes and removes stopper; XE aspirates and multiplies results by 5

130 µL of a 1:5 dilution; 40µL (patient sample) recommended minimum amount for dilution

Throughput Throughput on the XE-2100 is 150 samples per hour with CBC, DIFF and NRBC ordered, and 113 samples per hour with CBC, DIFF, NRBC and RET ordered. Quality Control The XE-2100 has 20 control files available for quality control. Each control file holds 300 data points. In addition to these 20 files, there is one Xm file (weighted moving average of normal patient population). Quality control will be discussed later in this manual. The commercial controls designed for use with the XE-2100 are stabilized cell preparations produced from human blood components. These controls are used to evaluate the accuracy of the CBC, Differential, including IG, NRBC, HPC and Reticulocyte parameters. Patient Data Storage The XE-2100 stores data (including all histograms and scattergrams) for 10,000 samples. This includes all data, histograms, scattergrams, and cumulative reports. There is storage for up to 1000 samples on a worklist, and up to 5000 patient demographics.



Reagents The XE-2100 utilizes 9 reagents. The following table summarizes the reagents and their specific functions.

REAGENT FUNCTION VOLUME/CYCLE CBC/Diff + NRBC+RET CELLPACK RBC/PLT and Hgb diluent;

rinsing of instrument 30 mL

CELLSHEATH Used for hydrodynamic focusing in RBC/PLT

2.1 mL

STROMATOLYSER 4DL DIFF lysing reagent 1.8 mL STROMATOLYSER 4DS DIFF stain 1.8 µL STROMATOLYSER-FB Basophil diluent and lyse;

lyses all cells except basophils

1.8 mL

STROMATOLYSER-NR lyse (kit)

Lyses mature RBC and NRBC cytoplasm

1.8 mL

STROMATOLYSER –NR dye solution

Stains WBCs and NRBCs 1.8 µl

STROMATOLYSER-IM Used in IMI channel; lyses all mature myeloid cells and provides HPC counts and flagging information

3.1 mL

SULFOLYSER Hemoglobin lyse 0.5 mL RET SEARCH (II) diluent (kit)

Dilutes sample 1.8 mL

RET SEARCH (II) dye solution

Stains reticulocytes and platelets for analysis

1.8 µL



Instrument Parts

This section will give you a general overview of the parts of the XE-2100, as well as the function of each part.

The XE-2100 Work Station COMPONENT FUNCTION

Main Unit Contains mechanical hydraulic/electronic components for measurement XE-2100 Stand Alone: Supplies samples to Main Unit automatically

XE-Alpha: Sampler Unit replaced by Alpha Transport line that supplies samples to XE-2100 and moves racks on to SP-100.

Sampler Unit

XE-HST: Sampler Unit replaced by HST line which supplies samples to XE-2100 and moves racks on to SP-100.

IPU Contains computational components and data management control Power Supply Unit Supplies the operating power for the XE-2100 system Pneumatic Unit Supplies required pressure and vacuum for analysis

Printer Prints hard copy records of analysis including scattergrams, histograms and data lists (GP)

Pneumatic Unit

Graphic Printer Main Unit



Main Unit Components

COMPONENT FUNCTION 1. Front Cover Covers Main unit parts 2. “Ready” LED Lit when the Main Unit is Ready to aspirate a

sample 3. Manual Aspiration Pipette Used for open sample aspiration

(manual and capillary) 4. Start Switch Pressed to start analysis in manual (open),

capillary or manual closed modes 5. LCD Screen Displays status of Main Unit, Sample ID# and

analysis data. 6. Panel LCD keypad Used to select basic operations (sample ID

entry, help key, shutdown, auto mode sampler analysis, etc.)

7. CP cover Protection cover of sample tube piercing unit

Main Unit – Front View



Panel LCD Keypad The XE-2100 Main Unit is provided wit the panel keypad with 28 keys.

NAME FUNCTION

MANUAL Used when setting sample ID No. in manual made, capillary mode and manual closed mode. The Sampler ID No. setting screen is displayed. You can set an analysis mode and discrete, in addition to Sample ID No.

SAMPLER Used to start or cancel the sampler analysis. When the sampler analysis starts, the Sampler ID No. setting screen is displayed. You can set the Sampler ID No., Rack No. and Tube Position from which analysis is to start.

ENTER Used to confirm the entered Sample ID No. 0/QZ – 9/DEF Used to specify Sample ID No. and Menu No. -/. Used to input hyphen [-] during Sample ID No. entry or decimal point during

numeric entry. C Used to delete one character during key entry or to stop the alarm. NUM./ALPH. Used to change input modules from numeric to alpha characters.

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

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

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

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

SHUTDOWN Used to execute the shutdown sequence. HELP In the presence of an error, pressing HELP will display the error message and

correction method.

Panel Keypad



Front Interior

COMPONENT FUNCTION 1. RF Tuning Meter Indicates radio frequency power status for

DIFF and IMI detectors (service rep. use only)

2 Reaction chamber Where dilution and incubation of sample takes place before sending to detector block for measurement

3. Blood Aspiration Sensor Monitors whole blood aspiration in the sampler and manual closed modes

4. Sample Rotor Valve (SRV) Aliquots the whole blood sample for dilution 5. Hgb Detector Block Contains Hgb detector (cuvette): SLS-Hgb 6. Whole blood aspiration pump Aspirates whole blood sample 7. Whole blood aspiration motor Drives the whole blood aspiration pump 8. IMI Detector Block Contains IMI detectors (including transducer

chambers). RF/DC technology 9. RBC Detector Block Contains RBC/Plt detector. Sheath flow DC

technology 10. Sheath Motor Drives the sheath syringe 11. Sheath Injector Piston Injects a preset volume of 1:500 diluted

sample to the RBC /Plt detector

Main Unit – Front Interior



Right Panel Main Unit

COMPONENT FUNCTION 1. Hand held barcode reader connector

Connects hand held barcode reader for sample ID input

2. IPU connector Connects cable to the IPU 3. DP connector Connects to the data printer 4. Power Switch Turns power ON and OFF of Main Unit

Right Side View



Left Panel Main Unit

COMPONENT FUNCTION 1. 0.16 MPa regulator Adjusts the 0.16 MPa pressure 2. 0.07 MPa regulator Adjusts the 0.07 MPa pressure 3. 0.03 MPa regulator Adjusts the 0.03 MPa pressure 4. Air filter Prevents dust from entering bellows unit 5. Bellows Unit Adjusts Vacuum to -0.04 MPa

Left Side View



Left Interior Main Unit

COMPONENT FUNCTION 1. Reaction chamber mixing motor Mixes diluent and sample for 4DIFF,

WBC/BASO, NRBC and RET analysis 2. WBC detector Measures, identifies and enumerates

WBCs 3. Reaction chamber Where sample dilution and incubation

takes place

Left Interior



Pneumatic Unit Components

COMPONENT FUNCTION

1. Pressure Gauge (0.25 MPa) Indicates pressure supplied to Main Unit (normal range 0.24 - 0.26 MPa)

2. 0.25 MPa Regulator Regulates 0.25 MPa pressure supplied to Main Unit

3. Vacuum Gauge Indicates vacuum supplied to Main Unit (normally greater than 0.0533 MPa)

4. Vacuum Trap Chamber Prevents fluid from entering compressor if an instrument failure occurs (contains ball float)

5. Power Switch Supplies power to Pneumatic Unit (switch may remain ON, since Pneumatic Unit power is controlled by Main Unit power)

Pneumatic Unit – Front View



Pneumatic Unit Components (continued)

COMPONENT FUNCTION 1. Pneumatic Unit Control Connector Connects to Main Unit to control

Pneumatic Unit power 2. Fuse Time lag fuse 3. Power Connector A/C power cord connector 4. Pressure Outlet Nipple Connects with pressure inlet nipple on

Main Unit (air drier) to supply pressure to the Main Unit

5. Vacuum Outlet Nipple Connects with vacuum inlet nipple on Main Unit to supply vacuum to the Main Unit

Pneumatic Unit – Right View



Function of Pressure and Vacuum The pneumatic system of the XE-2100 uses specific kinds of pressure and vacuum to control various aspects of instrument operation, such as dilution, counting, rinsing and draining. The table below describes the Main Unit pressures and vacuum and their corresponding functions.

PRESSURE/VACUUM FUNCTION 0.25 MPa pressure 1. Open or close Master valves

2. Activate the air cylinder mechanisms for SRV, rinse cup, cap piercing and mixing unit

0.16 MPa pressure 1. Supply sheath reagent to detector block 0.07 MPa pressure 1. Activating Diaphragm pumps for dispensing

2. Air bubble mixing in transducer chambers and Hgb flow cell 3. Draining waste chambers or reagent chambers 4. Clog removal in transducer chambers

0.03 MPa pressure 1. Sheath flow system (RBC/PLT) -0.04 MPa Hg vacuum 1. Transfer fluid between chambers



Sampler Unit Components

COMPONENT FUNCTION 1. Analysis Line (measurement line) Sample rack is automatically shifted to

the left (once per cycle), ID label is read, and sample is aspirated by the cap piercer unit

2. Left Rack Pool (collection pool) Racks collect here after analysis 3. Blood Volume Sensor Monitors volume of blood in each sample

tube (if volume is low, sample is not analyzed)

4. Right Rack Pool (start pool) Racks to be analyzed are set here (up to 10 racks at one time); pressing SAMPLER START/STOP key will shift racks to analysis line

Sampler Unit



IPU Component

COMPONENT FUNCTION 1. Flat panel display Multi-sync LCD 2. Main body of IPU Main body of IPU 3. Keyboard Used to input data and commands to the IPU 4. Mouse Used to operate various functions of the IPU 5. Diskette Drive Used to read or save data from floppy disk 6. Writable CD-ROM Drive Used to save data on CD-ROM

(3) Keyboard

(2) Main Body

(4) Mouse

Front View

(5) Diskette Drive (6) Writable CD-ROM Drive

(1) Flat Panel Display



IPU Rear

COMPONENT FUNCTION 1. Power cord connector Connects the computer to an electrical

power outlet 2. Ethernet RJ-45 Connector Connects the Ethernet network 3. Mouse connector Connects the mouse 4. Monitor connector Connects a monitor 5. Keyboard connector Connects the keyboard 6. GP connector Printer connector for graphic printing 7. Host Connector Connector for host computer

Rear View

(1) Power cord Connector

(5) Keyboard Connector (4) Monitor Connector

(2) Ethernet Connector (Main Unit)

(3) Mouse Connector

(6) GP Connector (7) Host Connector (Ethernet)

Host Connector (RS232)



IPU Screen Display

SCREEN AREA DESCRIPTION 1. Title display area Displays instrument’s name, window name, and

amount of stored data 2. Menu area Displays the Menu item such as, File, Edit, View,

Record, Action, Report, Setting, Window and Help

3. Tool bar area Contains pull down submenu items 4. Tab The names of windows indicating menu buttons

are displayed. More than one tab can be designed.

5. Various windows Window operations are performed in these areas6. Window area Displays various operation or processing 7. System status display area Displays Main unit and Host computer

connection status

IPU Screen



Reagent Replacement When a reagent requires replacement on the XE-2100, the analyzer will display a two- or three-letter code identifying the reagent that is empty.

Note: It is recommended to wait until the reagent container is EMPTY before replacing the reagent.

STROMATOLYSER–NR (lyse and dye solution) must be replaced as a set. RET SEARCH (II) (diluent and dye solution) must be replaced as a set.

MESSAGE REAGENT TO REPLACE Replace Reagent Container EPK CELLPACK Replace Reagent Container ESE CELLSHEATH Replace Reagent Container FFD STROMATOLYSER-4DL Replace Reagent Container FFS STROMATOLYSER 4DS Replace Reagent Container FBA STROMATOLYSER-FB Replace Reagent Container SIM STROMATOLYSER-IM Replace Reagent Container SNR STROMATOLYSER-NR

(Lyse reagent, dye solution) Replace Reagent Container RED RET SEARCH (II)

(Diluent, dye solution) Replace Reagent Container SLS SULFOYSER With XE pro, there is a reagent log that keeps track of the reagents, including lot number and expiration date. Reagents can be entered by scanning with the hand held barcode reader or entered manually.



Basic Operations Summary

Start-Up 1. Check: Reagents Printer paper Remove racks from sampler Waste container (if used) 2. Power-on Sequence:

a. IPU (Information Processing Unit) XE IPU Log-on Screen must be displayed before powering-on the Main Unit. b. Main Unit (MU) c. Printer

Note: Leave Pneumatic Unit ON. 3. Log-on Sequence in IPU: Windows® 2000 a. Input user name b. Input password (if required) Windows® NT a. When ‘Begin Log on’ Screen displays, press [CTRL], [ALT] and [DELETE] simultaneously b. When ‘Log-on Information’ Screen displays, press [ENTER] c. Input user name d. Input password (if required) 4. Self-Checks are performed in the Main Unit: a. Microprocessor check b. Pressure check c. Temperature check d. Mechanical parts check e. Background check



Start-Up (continued)

5. Acceptable Background Limits:

WBC 0.1 x 103/µL DIFF-WBC 0.2 x 103/µL IMI-Total 0.3 x 103/µL IMI# 0.005 x 103/µL NRBC-WBC 0.2 X 103/µL RBC 0.02 x 106/µL HGB 0.1 g/dL PLT 5 x 103/µL PLT-O* 10 x 103/µL

*PLT-O is available on the XE-2100 only



Printouts When printing patient results to a graphic printer, there are several formats that can be used, depending on your preference. These formats are described as follows, and examples of these printouts are on the next four pages. Standard Printout Includes: Patient Information Parameter results 6 scattergrams (4DIFF, WBC/BASO, IMI*, NRBC*, RET* and PLT-O*) 2 histograms (RBC, PLT) RBC and PLT histograms displayed in relative height Interpretive Messages ( RBC, WBC or Platelet) * XE-2100 only Screen Printouts Some screens on the IPU display may be printed using the Print Screen key on the Keyboard or Hard Copy icon. With the GP Customize program in XE pro, reports can be built to specific requirements. See following examples:

1. Standard printout 2. Screen print (hard copy) 3. Chartable report in GP Customize



Example of Standard Printout



WBC/NRBC Tab in Browser



Example of a Chartable Report in CP Customize



Sample Flow and Principles of Measurement Detection Principle This instrument performs hematology analyses according to the RF/DC detection method, Hydro Dynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method. RF/DC Detection Method The RF/DC detection method detects the size of blood cells by changes in direct-current resistance and the density of the blood cell interior by changes in radio-frequency resistance. A blood sample is aspirated and measured, diluted to the specified ratio, and sent to the applicable detector chamber. Inside the detector chamber is a tiny hole called an “aperture”, on both sides of which are electrodes. Between the electrodes flow direct current and radio-frequency current. Blood cells suspended in the diluted sample pass through the aperture, changing the direct-current resistance and radio-frequency resistance between the electrodes. The size of the blood cells is detected via changes in the direct-current resistance, and the density of the blood cell interior (size of the nucleus and other information) is detected via changes in the radio-frequency 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 measurement data can be obtained by analyzing such distributions.

RF/DC Detection Method



Hydro Dynamic Focusing (DC Detection) Inside the detector, the sample nozzle is positioned in front of the aperture and in line with the center. After diluted sample is forced from the sample nozzle into the conical chamber, it is surrounded by front sheath reagent and passes through the aperture center. After passing through the aperture, the diluted sample is surrounded by back sheath reagent and sent to the catcher tube. This prevents the blood cells in this area from drifting back, and prevents the generation of false platelet pulses. The Hydro Dynamic Focusing method improves blood count accuracy and reproducibility. And because the blood cells pass through the aperture in a line, it also prevents the generation of abnormal blood cell pulses.

Flow Cytometry Method Using Semiconductor Laser Cytometry is used to analyze physiological and chemical characteristics of cells and other biological particles. Flow cytometry is used to analyze those cells and particles as they are passed through extremely small flows.

A blood sample is aspirated and measured, diluted to the specified ratio, and stained. The sample is then fed into the flow cell. This Hydro Dynamic Focusing mechanism improves cell count accuracy and reproducibility. And since the blood cell particles pass in a line through the center of the flow cell, the generation of abnormal blood pulses is prevented and flow cell contamination is reduced. A semiconductor laser beam is emitted towards the blood cells as they pass through the flow cell. The forward scattered light is received by the photodiode, and the lateral scattered light and lateral fluorescent light are received by the photomultiplier tube. This light is converted into electrical pulses, thus making it possible to obtain blood cell information.

Hydro Dynamic Focusing Mechanism

Hydro Dynamic Focusing Method



Forward Scattered Light and Lateral Scattered Light When obstacles, such as particles exist in the path of light, the light beam scatters from each obstacle in various directions. This phenomenon is called light scattering. By detecting the scattered light, it is possible to obtain information on cell size and material properties. Likewise, when a laser beam is emitted towards blood cell particles, light scattering occurs. The intensity of the scattered light depends of factors such as the particle diameter and viewing angle. This instrument detects forward scattered light, which provides information on blood cell size; and lateral scattered light, which provides information on the cell interior (such as the size of the nucleus). Lateral Fluorescent Light When light is emitted towards fluorescent material, such as stained blood cells, light of longer wavelength than the original light is produced. The intensity of the fluorescent light increases as the concentration of the stain becomes higher. By measuring the intensity of the fluorescence emitted, you can obtain information on the degree of blood cell staining. Fluorescent light is emitted in all directions; the XE-2100 detects the fluorescent light that is emitted sideways.

Flow Cytometry Method



Fluorescent Stain The XE-2100 uses Polymethine dye, a fluorescent dye or stain that is grouped with similar stains used on many flow cytometry systems. What makes Polymethine dye unique, and so well suited for counting reticulocytes, is its ability to penetrate cells and bind quickly, eliminating the need for a fixative or extended incubation times. Polymethine dye is also compatible with the laser, yielding sufficient fluorescence for detection and separation of cell populations. Polymethine dye is a basic dye that binds to the acidic components of blood, the DNA in cell nuclei and the RNA found in the cell cytoplasm. The amount of dye that is bound by each cell type is dependent upon the nucleic acid content of the cell. White blood cells will bind the most dye because of the large amount of DNA contained in the nucleus, while platelets will bind much less dye due to the small amount of RNA present and their smaller physical size. Red blood cells will bind trace amounts of dye and reticulocytes will bind varying amounts of dye depending on the amount of RNA they contain.

Nucleated Cells Large amounts of nucleic acids

Platelets Small amounts of RNA

Mature RBCs Trace amounts of residual nucleic acids

Reticulocytes Small amounts of RNA

Cells Stained with Polymethine Dye



SLS-Hemoglobin Method In the past, the mainstream methods for automatically measuring hemoglobin were the cyanmethemoglobin method and oxyhemoglobin method. But these methods have both advantages and disadvantages when they are used with a large, fully automatic instrument, such as the XE-2100. The cyanmethemoglobin method was recommended by the International Committee for Standardization in Hematology (ICSH) in 1966 as an international standard method. But since its hemoglobin conversion speed is slow and multiple-sample processing is an assumed requirement, this method is not really appropriate for automatic measuring. 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 liquid waste. In contrast, the hemoglobin conversion speed of the oxyhemoglobin method is fast, as blood hemoglobin is instantly converted into oxyhemoglobin. And since it does not use poisonous substances, such as cyanide, it is a suitable method for performing automatic analyses. It cannot, however, convert methemoglobin into oxyhemoglobin, which is not a problem for normal human blood, but will result in values that are lower than the true values for samples that contain large amounts of methemoglobin, such as control blood samples. The SLS-hemoglobin method is an analysis method that makes use of the advantages of the two aforementioned methods. As with the oxyhemoglobin method, the hemoglobin conversion speed of the SLS-hemoglobin method is fast and the method does not use poisonous substances, making it a suitable method for automation. And since it can be used to measure cyanhemoglobin, it can also accurately measure blood containing methemoglobin, such as control blood.



RBC/PLT and HGB Analysis RBC/PLT Analysis Procedure During RBC and PLT analyses, the red blood cells and platelets in the blood are analyzed. The procedure for analyzing RBC/PLT is explained here.

1. Blood is aspirated from the manual aspiration pipette to the sample rotor valve.

2. 4.0 µL of blood, 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 pulse height detection method.

RBC/PLT Analysis Procedure



HGB Analysis Procedure During an HGB analysis, the amount of hemoglobin in the blood is measured. The procedure for analyzing HGB is explained here.


2. 3.0 µL of blood, measured by the sample rotor value, is diluted to a ratio of 1:333 with 0.9970 mL of CELLPACK and then sent to the flow cell as the diluted sample. At the same time, 0.5 mL of SULFOLYSER is added to hemolyze the red blood cells, 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 measured as light absorbance, and is calculated by comparison with the absorbance of the diluent measured before the sample was added.

HGB Analysis Procedure



WBC Classification White blood cells (leukocytes) can be broadly classified as either lymphocytes, monocytes, or granulocytes. Granulocytes can be further classified as either neutrophils, basophils, or eosinophils, depending on the dye-affinity of the granules. The applicable analysis procedure is explained here. 4DIFF Analysis Procedure A 4DIFF analysis is used to identify and analyze the following white cell groups: lymphocytes, monocytes, eosinophils, neutrophils, including immature granulocytes, and basophils. The 4DIFF analysis procedure is explained here.


2. 18 µL of blood, measured by the sample rotor value, 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 this condition, the red blood cells are hemolyzed and the white 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.

4DIFF Analysis Procedure



WBC/BASO Analysis Procedure A WBC/BASO analysis is used to measure the number of white blood cells in the blood, as well as the number of basophils in the white cells. The WBC/BASO analysis procedure is explained here.


2. 18 µL of blood, measured by the sample rotor value, is diluted with 0.882 mL of STROMATOLYSER-FB to a ratio of 1:50, 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.



WBC/BASO Analysis Procedure



IMI Analysis Procedure IMI (immature myeloid information) indicates information on immature cells (granulocytes). The procedure for analyzing IMI is explained here.


2. 2.4 µL of blood, measured by the sample rotor value, is diluted 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 is reduced in size.

3. The diluted sample is aspirated, via the aperture, and 250 µL is accurately measured by the float-type manometer. Detection is performed via the RF/DC detection method.

IMI Analysis Procedure



NRBC Analysis Procedure An NRBC analysis is used to classify and analyze groups of nucleated red blood cells in the blood. The NRBC analysis procedure is explained here.


2. 18 µL of blood, measured by the sample rotor value, is diluted with 0.882 mL of STROMATOLYSER-NR lyse reagent, and then sent to the reaction chamber as the diluted sample. At the same time, 18 µL of STROMATOLYSER-NR dye solution is added to dilute the sample to a ratio of 1:51. After reacting for about 7 seconds in this condition, the red blood cells are hemolyzed and the white blood cells are stained.



NRBC Analysis Procedure



RET Analysis Procedure A RET analysis is used to classify and analyze groups of reticuylocytes and platelets in the blood. The RET analysis procedure is explained here.


2. 4.5 µL of blood, measured by the sample rotor value, is diluted with 0.8955 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, becoming the analysis sample.

3. The sheath injector piston sends 2.8 µL of diluted sample to the optical detector block.


RET Analysis Procedure



RBC Particle Size Distribution The RBC (red blood count) is a particle count 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-2100 expresses the RBC distribution width (RDW) according to the two methods shown below. RDW-SD With the peak height assumed to be 100%, the distribution width at the 20% frequency level is RDW-SD. Units are expressed in fL (femtoliters), with 1 fL equal to 10-15LL.

RDW-CV With point L1 and L2 found at a frequency of 68.26% of the total distribution area, RDW-CV is calculated from the following equation: L2 - L1 RDW-CV (%) = __________ x 1000 L2 + L1

RDW-CV Particle Size Distribution

RDW-SD Particle Size Distribution



PLT Particle Size Distribution Platelet particle size distributions are analyzed using three discriminators: a lower discriminator (LD) and an upper discriminator (UD), which are automatically set up between 2-6 fL and 12-30 fL, respectively; and a fixed discriminator, which is set at 12 fL. PLT particle size distributions are checked for abnormalities, including abnormal relative frequencies at the lower 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 (femotliters), with 1 fL equal to 10-15L. 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 as a ratio comparing the number of particles between the fixed discriminator and UD, to the number of particles between LD and UD.

MPV (Mean Platelet Volume) The MPV is calculated from the following equation: PCT (%) MPV (fL) = _______________ x 1000 PLT (x 103/µL) PCT: PCT is called the platelet hematocrit or platelet volume

ratio, and is weighted towards the PLT frequency.

P-LCR Particle Size Distribution



Adaptive Cluster Analysis System Principle of the XE-2100 Scattergram Analysis The XE-2100 employs Fluorescent Flow Cytometry technology using a semiconductor laser for identifying and enumerating WBC, DIFF including IG, NRBC and RET. When a laser beam is emitted to blood cell particles, light scattering occurs. This instrument detects forward scattered light for blood cell size information, lateral scattered light for intracellular information and lateral fluorescent light scatter for the fluorescent intensity of stained blood cells. The XE-2100 utilizes a mathematical statistics log to properly identify signals of each cell on the Flow detector block. Principle of the FLOW CYTOMETRY Scattergram Analysis Here we will explain this discrimination method (cluster analysis), using the DIFF channel as an example. Determination of the “Initial Centroid” The center of each cluster is set tentatively as “Initial Centroid” of each cell cluster. The“Initial Centroid” is determined on the XE-2100 by analyzing thousands of samples and is stored in the memory of the instrument. These are set for Ghost, Lymphocytes, Monocytes , Granulocytes and Eosinophils. (See Figure 1).

SSC

SFl

Initial Centroid of GHOST

Initial Centroid of Lymphocytes

Initial Centroid of Monocytes

Initial Centroid of Granulocytes

XE-2100XE-2100Adaptive Cluster AnalysisAdaptive Cluster Analysis

Initial Centroidof Eosinophils

XE-2100 Adaptive Cluster Analysis

Figure 1



Analysis of Signals When a signal (cell) is detected, the computer of the XE-2100 immediately calculates which area this signal belongs to (see Figure 2). The distance between the signal and each “Initial Centroid” of ghost, LYMPH, MONO, GRAN and EO is calculated. It is not the mathematical distance between two points of “Euclid space,” but the distance that is determined by the coefficient of correlation with its signal and the position of each “Initial Centroid.” This special distance is mathematically called “MAHALANOBIS distance.”

Identification of Signals After calculating this “MAHALANOBIS distance”, the XE calculates which “Initial Centroid” is close to the signal. In the case of Figure 2, since the signal is positioned most closely to the “Initial Centroid” of lymphocytes, the signal is identified as lymphocytes.

SSC

SFl

Secondary Centroid of Lymphocytes

Detected Signal

MahalanobisDistance

Figure 2 Calculation of MAHALANOBIS Distance



Analysis of Second Centroid The distance between “Initial Centroid of Lymphocytes” and the signal identified as a lymphocyte is analyzed to determine “Secondary Centroid” (see Figure 3). The next cell signal is examined, categorized and referred to this “Secondary Centroid” for cell classification. A new Centroid is determined with each new signal to assist with accurate identification.

After the first 500 detected cells, the centroid position for each population is maintained for the classification of the next 500 cells. The entire process is repeated up to 5 times for optimal cell identification and Final Centroid stable placement. The XE-2100 analyzes and identifies thousands of detected signals. Its computer algorithm “learns” the differential for each patient sample by identifying cells individually for optimal cell separation.

Review of Cluster Analysis of Scattergram

1. Analysis of 500 Cells with moving Centroids.

2. Placement of subsequent 500 cells for Optimized Centroid Placement.

3. Repetition of Steps 1 and 2, up to five times.

4. Final Determination of Cluster Appearance.

5. Analysis and Discrimination of approximately 32,000 Cells.

Signal identified as Lymphocyte

Secondary Centroid of Lymphocytes

SSC

SFl

Initial Centroid of Lymphocytes

Figure 3 Signal identification and determination of Secondary Centroid



Concept of Positive / Negative Identification and Interpretative Messages

Review of Interpretative Messages

Abnormal Messages - Numeric data out of limits

- Abnormal histogram or scattergrams

Suspect Messages - Abnormalities triggered by scattergrams and histogram algorithms

Interpretative messages consist of two types – abnormal and suspect messages. Abnormal messages consist of numerical data which exceeds user-defined limits. Abnormal histograms and scattergrams also give abnormal messages, but cannot be adjusted by the laboratory. Suspect messages are triggered by scattergram/histogram algorithms which cannot be adjusted by the laboratory. The suspect messages end in a ‘?’ to indicate the potential of finding that abnormality. Each laboratory must establish their own action plan to address these messages.



Flagging Summary The XE-2100 judges t he samples analyzed as POSITIVE or NEGATIVE according to each facility’s preset criteria. It also looks at the numerical data, particle size distributions and scattergrams on 32 parameters. With all this information, it generates flags/messages that are referred to as “IP” (Interpretative Program) Messages. NEGATIVE (green backlight) Sample has no analysis error nor IP messages. No technical intervention is needed. Results can be verified (autoverified) and released. POSITIVE (red backlight) Sample is abnormal according to the preset

numerical values and cell morphology criteria for analysis.

Positive results are further sub-categorized into three categories: Diff. Abnormality in WBC differential parameters Morph. Abnormal cell morphology Count. Abnormality in blood cell numerical count

In Data Browser, Double-click on POSITIVE box to view sub-categories. Two types of IP Messages: Abnormal IP message Sample is definitely abnormal. Operator can set criteria according to their facility’s priority. (Clinical ranges vs. Normal ranges) Abnormal IP messages have priority over Suspect messages. Suspect IP message Possibility the sample is abnormal. The following indicators may appear after the data: @ Data is outside the linearity limit.

* Data is doubtful.

+, - Data is outside reference limits. (Above indicators are in priority order.)

---- Data won’t appear due to analysis error

or abnormal sample.

++++ Data exceeds display limit.

No orders. Blank.

& Corrected result (may be seen in WBC, Lymph, PLT) Note: The instrument is a screening device that will help separate Negative and Abnormal

samples. Anytime an IP message is generated, further analysis or special measure or procedure should be taken. Each facility has to set up their own protocol on how to proceed in these situations.



Flagging Summary (continued) IP message are displayed on the:

• Data Browser screen

• WBC screen

• Graph screen

• Main screen flag area

The IP Messages are not displayed in the following cases: • Quality Control Analysis Data

• When PLT is “----“

• Calibration Analysis Data

• Background Check Data

• Blank Data

• <0.5 X 103/µL WBC ( no suspect )

• <0.5 X 106/µL RBC only RBC Abn. Distrib.” will be judged

• If error prevent parameter being calculated, IP Messages do not display (i.e. parameters display as “ “, “----“ and “ ++++” )

• For Capillary analysis, only CBC 8 parameter data is used for judgment. Only “Positive” IP messages display.

• For Discrete Analysis, parameters that are not analyzed by user settings are not used for judgement.



Quality Control The purpose of any quality control program is to detect a systematic error that may cause a normal patient to appear abnormal, or an abnormal patient to be undetected. To maintain the reliability of analyzed data, periodic monitoring of the stability of the instrument is required. Changes in stability that may affect patient results can only be detected by an operator familiar with quality control theories and practices, and the tools the instrument provides to assist in this process. This section overviews general considerations for establishing a quality control program, reviews quality control principles, and briefly discusses the XE-2100 quality control program. Details of the XE-2100 QC program will be covered during the training session. General Considerations There are three types of controls that can be used to monitor instrument stability. These could include commercially prepared products, retained patient specimens (patient controls), or a moving average program. Each laboratory must decide which types of control(s) to use. The choice is based on regulations (CAP, JCAH, Health Dept., etc.), cost, laboratory workload, and patient population. A summary of the three types of controls, the advantages and limitations of each, is listed on the following page. After the laboratory chooses the types of control(s) that will meet their individual needs, mean values and ranges around the mean values must be established for each parameter. These ranges should be narrow enough to detect a problem that may significantly affect patient results, but not so narrow as to force the operator to troubleshoot a “non-existent” problem, that is, a problem that will not affect result accuracy. Some labs set ranges of two standard deviations from the mean, others use three standard deviations, based on the relationship between specific parameters and their institution’s patient population. Several articles and books have been published describing the advantages and limitations of each. Because of today’s advanced electronic stability and exceptional instrument precision, the trend appears to be an increased use of 3 SD ranges without sacrificing the accuracy of results. (All further information in this section is based on the use of 3 SD.)



TYPE OF CONTROL WHY USE IT? ADVANTAGES LIMITATIONS

Commercial Control Verifies calibration Detects long-term drift Detects systematic and random error Verifies control after maintenance Serves as a means of controlling automated differential

Convenient Stable Can be used for all parameters

Cost Stabilization and purification change properties of cells; sacrifice characteristics of fresh whole blood for stability

Retained Patient Specimen

Detects within run changes early Serves as QC for the open and pre-dilute modes Helps determine if a problem exists with the commercial control material or if the problem is in the instrument

Easily available; analyze more frequently than a commercial control Good as a run-to-run and shift-to-shift control Transferability from primary instrument to back-up or satellite instrument

Low stability Not a control for WBC subpopulations (differential)

Moving Averages Detects problems due to reagent quality Detects problems with sample quality and handling Detects within run changes

Easily available More sensitive to subtle changes over long periods of time, particularly the RBC indices and WBC Constantly monitors instrument with minimal efforts

Depending on size and type of patient population, if may not detect the drifts and trends in the directly measured parameters, which tend to be population dependent, in a timely manner



Quality Control Principles If a quality control specimen could be analyzed under “perfect” conditions, one could expect to recover the mean values or targets each time the control was analyzed; however, variables exist in the “real” laboratory environment that prohibit these perfect conditions. The instrument maintenance schedule and individual stability and handling of the control material represent only a few of the day-to-day variables that affect the ability to recover the target when a control is analyzed. Therefore, the realistic goal when analyzing controls is to obtain results that fall within ranges established around the targets. Each range accounts for control stability and expected precision of the instrument for an individual parameter, and is defined by a lower limit and upper limit. A result exceeding a limit represents significant variation in instrument performance or control stability, and prompts the operator to take appropriate action. The procedures commonly used in a lab to establish new targets and limits for control materials may be based on methods developed in their laboratory in the past, or are dependent on the requirements of the hematology analyzer that is used. These procedures dictate that each time a new lot of commercial control is received or a fresh patient control is chosen, new targets and limits must be established either by entering ranges from a commercial control assay sheet into the instrument’s QC program, or from analyzing the control several times. Both methods continue to be used, but both have significant limitations. Values on an assay sheet are typically derived from data collected from a very limited number of labs that analyze the control before it is shipped to customers. The assay values do not account for the expected instrument-to-instrument variables such as precision, calibration, reagents and maintenance. To use the assay sheet values, one would have to assume that every instrument is exactly the same in all aspects. Analyzing a new control several times to determine the target values and standard deviations, and then calculating the new lower and upper limits for each parameter is a common practice. The resulting limits do reflect individual instrument variables; however, they may be very tight because they reflect performance of the control and instrument over a very short time period (maybe only a few days). These ranges do not account for variables, such as control stability and instrument precision, that may affect values during the time period the control will actually be used (typically a month). Additionally, the use of standard deviations to calculate a new range for every parameter on each new lot of control or new patient control is easy, but very time consuming. If an ideal method for setting up a control file could be proposed, the method would most likely include assaying the control several times over a period of days to establish an instrument specific target, and determining historical limits that will take into account the expected differences in instrument precision and control stability over an extended period of time. For example, historical limits for a normal commercial control can be determined from data collected from the analyzer over several months, to give instrument specific, long range limits.



Quality Control Principles (continued) Limits can be calculated using standard deviations. A simple, more efficient way to establish the same limits is by using the coefficient of variation. Standard deviation and coefficient of variation are closely related but have significant differences. SD = CV% x Mean <-----------------> CV% = SD x 100 100 Mean Standard deviation (SD) is an absolute measure of dispersion around a specific mean or target value. SD is determined by comparing each result used to calculate the mean, to the mean. Because SD is directly dependent on the mean value, it will change as the mean changes. The coefficient of variation (CV%) is also a measure of variability due to instrument precision and control stability, but the variation is expressed as a percentage rather than an absolute value, so it can be applied to any target value. The following example shows the relationship between SD and CV% when calculating limits. EXAMPLE 1 LOT A Hemoglobin X = 13.0 Normal Level SD = 0.2 CV% = 1.5% If a 3 standard deviation chart is desired: SD CV% 0.2 x 3 = 0.6 (3SD) 1.5% x 3 = 4.5% (3CV%) UL = 13.0 + 0.6 = 13.6 4.5% of mean results in limits of 13.0+ 0.6 ( 12.4 – 13.6 )



Quality Control Principles (continued) If the statistics were documented for each level of several lots of commercial controls, or for several patient controls, one would notice that the means and standard deviations tend to fluctuate, but the coefficients of variation remain constant. The CV%’s are constant because they reflect the overall precision of the instrument and performance of the control for each parameter regardless of the specific target values. Because the CV%’s are constant, historically determined limit %’s can be entered once into the control file for each level of control, and then be used by the instrument to automatically recalculate the upper and lower limits when a new target is set. The following example shows the application of the historical limit %s, the use of SD to determine a new range when the target value changes. EXAMPLE 2 Lot B Hemoglobin X = 13.4 Normal Level SD = 0.2 CV % = 1.5% For a 3 Standard Deviation chart: SD Historical Limit% 0.2 x 3 = 0.6 4.5% = ( CV% x 3 ) Previously entered into QC File UL = 13.4 + 0.6 = 14.0 LL = 13.4 - 0.6 = 12.8 4.5% of the new mean automatically Enter into QC File results in limits of 13.4 + 0.6 XE-2100 Quality Control As controls are analyzed on the XE-2100, data points are collected in a quality control file. Once a sufficient number of control points are collected, the operator programs the instrument to set the targets. If the historical limit %’s for a 3SD chart (3 CV%’s) have already been programmed in the file, the instrument will automatically recalculate and set the upper and lower limits for the targets. The following example illustrates the XE-2100 calculation of lower and upper limits for WBC’s on two lot numbers of commercial control. The example is based on a historical CV% for WBC of 1.3. Note: Recommended procedures for establishing new target values and historical

CV%’s and limit %’s will be discussed during the training session.



EXAMPLE Month: January Control: Lot A Target Value: 7.30 (established by averaging 10 analyses) Historical Limit %: CV% x SD = (1.3% x 3 ) = 3.9 New Range (calculated by the analyzer) Lower Limit (LL) = Target - (Limit % x Target) = 7.30 - (3.9% x 7.30) = 7.30 - 0.28 = 7.02 Upper Limit (UL) = Target + (Limit % x Target) = 7.30 + (3.9% x 7.30) = 7.30 + 0.28 = 7.58 Range for Lot A WBC is 7.02 - 7.58 Month: February Control: Lot B Target Value: 5.69 (established by averaging 10 analyses) Historical Limit %: CV% x SD =(1.3% x 3 ) = 3.9 New Range: LL = Target - (Limit % x Target) = 5.69 - (3.9% x 5.69) = 5.69 - 0.22 = 5.47 UL = Target + (Limit % x Target) = 5.69 + (3.9% x 5.69) = 5.69 + 0.22 = 5.91 Range for Lot B WBC is 5.47 - 5.91

Sys

mex

XE

-Ser

ies

Pre

-Tra

inin

g M

anua

l D

ocum

ent N

umbe

r: M

KT-

50-1

011,

Rev

isio

n 1,

Feb

ruar

y 20

05

Pag

e 63

of 6

4

ON

E N

ELSO

N C

. WH

ITE

PAR

KWAY

, MU

ND

ELEI

N, I

L 60

060

1-8

00-3

SYS

ME

X (8

00-3

79-7

639)

W

WW

.SYS

MEX

.CO

M/U

SA

XE-2

100

Mai

nten

ance

Che

cklis

t D

AIL

Y M

AIN

TEN

AN

CE:

M

onth

___

____

Y

ear _

____

_ D

aily

: 1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

Exe

cute

Shu

tdow

n

Che

ck T

rap

Cha

mbe

r Fl

uid

Leve

r

Initi

al:

A

s N

eede

d M

aint

enan

ce:

Proc

edur

e:

Dat

e/In

t.D

ate/

Int.

Cle

an m

anua

l rin

se c

up

Cle

an s

ampl

e ro

tor v

alve

tray

C

lean

pie

rcer

tray

R

emov

e cl

ogs

(Clo

g re

mov

al s

eque

nce)

C

lean

IMI d

etec

tor a

pertu

re

Cle

an R

BC

det

ecto

r ape

rture

R

emov

e flo

w c

ell a

ir bu

bble

s in

opt

ical

det

ecto

r blo

ck

Cle

an fl

ow c

ell i

n op

tical

det

ecto

r blo

ck

Rep

lace

was

te c

onta

iner

Ever

y 30

,000

Cyc

les

Mai

nten

ance

: Pr

oced

ure:

D

ate/

Int.

Dat

e/In

t. C

lean

sam

ple

roto

r val

ve

Rep

lace

Pie

rcer

Rep

lace

men

ts:

Proc

edur

e:

Dat

e/In

t.D

ate/

Int.

Rep

lace

reag

ents

R

epla

ce p

ierc

er

Rep

lace

han

d cl

ippe

r

R

epla

ce ru

bber

pla

te N

o. 3

9

R

epla

ce fu

ses

Rep

lace

HE

PA fi

lter

Sysm

ex XE

-Series P

re-Training Manual

Docum

ent Num

ber: MK

T-50-1011, Revision 1, February 2005

Page 64 of 64

ON

E NELSO

N C. W

HITE P

ARKW

AY, MU

ND

ELEIN, IL 60060 1-800-3SYS

ME

X (800-379-7639) WW

W.SYS

MEX

.CO

M/U

SA

This P

age Left Blank Intentionally.

xe series - pre training manual - english - 02-05

Documents