Beckman Coulter COULTER HmX User guide

Download

Page 1

COULTER® HmX Hematology Analyzer with Autoloader

ECKMAN

OULTER

Special Procedures

and

Troubleshooting

HmX

COULTER

HmX

PN 4237522BA (May 2010)

Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821

Page 2

WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE.

HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS

WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:

WARNING - Can cause injury.

CAUTION - Can cause damage to the instrument.

IMPORTANT - Can cause misleading results.

BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

WARNING Risk of operator injury if:

r All doors, covers and panels are not closed and secured in place prior to and during instrument operation. r The integrity of safety interlocks and sensors is compromised. r Instrument alarms and error messages are not acknowledged and acted upon. r You contact moving parts. r You mishandle broken parts. r Doors, covers and panels are not opened, closed, removed and/or replaced with care. r Improper tools are used for troubleshooting.

To avoid injury:

r Keep doors, covers and panels closed and secured in place while the instrument is in use. r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. r Acknowledge and act upon instrument alarms and error messages. r Keep away from moving parts. r Report any broken parts to your Beckman Coulter Representative. r Open/remove and close/replace doors, covers and panels with care. r Use the proper tools when troubleshooting.

CAUTION System integrity might be compromised and operational failures might occur if:

r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s

computer with software authorized by Beckman Coulter.

r You install software that is not an original copyrighted version. Only use software that is an original copyrighted

version to prevent virus contamination.

IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter

distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.

Page 3

REVISION STATUS

Initial Issue, 6/99

Software version 1.0.

Issue B, 6/03

Changes were made to,

r comply with the EU IVD Directive (98/79/EC).

r change the company name from Coulter Corporation to Beckman Coulter Inc.

Note: Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page.

Issue BA, 5/10

Software Version 1.0.

Updates were made to the company corporate address.

Note: Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page.

PN 4237522BA

This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released to the Beckman Coulter website. For labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for your instrument.

iii

Page 4

REVISION STATUS

PN 4237522BA

Page 5

LEGAL NOTICES

REVISION STATUS, iii

CONTENTS, v

INTRODUCTION, ix

HOW TO USE YOUR COULTER® HmX HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET, ixi

ABOUT THIS MANUAL, ix

CONVENTIONS, x

HOT KEYS (SHORTCUTS), xi

LIST OF ICONS, xi

1 CALIBRATION, 1-1

1.1 CBC CALIBRATION - GENERAL, 1-1 Recommended Conditions, 1-1 When to Calibrate, 1-1 When to Verify, 1-1

1.2 CBC CALIBRATION PRELIMINARY PROCEDURES, 1-2

1.3 CBC CALIBRATION WITH S-CAL® CALIBRATOR, 1-3

1.4 WHOLE-BLOOD CALIBRATION, 1-7 Reference Values, 1-7 Whole-Blood Calibration Run, 1-8

2 REPRODUCIBILITY AND CARRYOVER, 2-1

2.1 REPRODUCIBILITY CHECK, 2-1 Procedure A, 2-1 Procedure B, 2-3

2.2 RETIC REPRODUCIBILITY CHECK, 2-5

2.3 CARRYOVER CHECK, 2-6

3 CLEANING PROCEDURES, 3-1

3.1 ZAP APERTURES, 3-1

3.2 BLEACH APERTURES AND FLOW CELL/DISINFECT, 3-1

3.3 CLEAN OUTSIDE OF BLOOD SAMPLING VALVE (BSV), 3-3

PN 4237522BA

3.4 CYCLE BSV, 3-5

3.5 CLEAN CASSETTES, 3-5

Page 6

CONTENTS

3.6 CLEAR FLOW CELL CLOG, 3-6 Error Messages, 3-6

PC1 - Partial Clog 1, 3-6 PC2 - Partial Clog 2, 3-6 FC - Full Clog, 3-6

Clearing Procedure, 3-6

3.7 CLEAN NEEDLE FORWARD SENSOR, 3-7

3.8 CLEAN SURFACES, 3-10

3.9 CLEAN VACUUM TRAP, 3-10

4 ADJUST/REPLACE PROCEDURES, 4-1

4.1 RESET THE SYSTEM, 4-1

4.2 SYSTEM TEST, 4-1

4.3 JAMMED CASSETTE REMOVAL, 4-2

4.4 ADJUST PRESSURE AND LOW VACUUM, 4-4

4.5 OPTIMIZE THE DMS HARD DISK, 4-5 Daily, 4-5 Weekly, 4-5 Monthly, 4-6

4.6 REPLACE APERTURE BLOCK O-RINGS, 4-7

4.7 REPLACE CHECK VALVES, 4-11

4.8 REPLACE FUSES, 4-13

4.9 REPLACE HEMOGLOBIN LAMP ASSEMBLY, 4-15

4.10 REPLACE NEEDLE ASSEMBLY, 4-17

4.11 REPLACE PINCH VALVES, 4-22

4.12 REPLACE REAGENT CONTAINERS, 4-24

4.13 REPLACE REAGENT PICKUP TUBES, 4-27

4.14 REPLACE TUBING, 4-30

4.15 REPLACE WASTE ASSEMBLY, 4-34

4.16 REPLACE WASTE CONTAINER, 4-37

5 TROUBLESHOOTING, 5-1

5.1 OVERVIEW, 5-1 Troubleshooting Figures, 5-2

PN 4237522BA

Page 7

5.2 TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS, 5-6

5.3 TROUBLESHOOTING THE AUTOLOADER MECHANISM, 5-14

5.4 AUTOLOADER CHECK PROCEDURES, 5-17 Check Autoloader Bed Sensors, 5-17 Check Tube Forward Sensor, 5-18

5.5 TROUBLESHOOTING DIFF THROUGH SCATTERPLOTS AND HISTOGRAMS, 5-19 DIFF STEP-BY-STEP TROUBLESHOOTING GUIDE, 5-20 CHECKLIST 1:DF1 SCATTERPLOT IS ABNORMAL, 5-21 CHECKLIST 1A: TOO MANY CELLS IN THE BOTTOMMOST AREA OF THE DF1 SCATTERPLOT, 5-22 CHECKLIST 1B: DF1 SCATTERPLOT SHOWS POOR SEPARATION BETWEEN LYMPHOCYTE AND NEUTROPHIL POPULATIONS, 5-22 CHECKLIST 1C: DF1 SCATTERPLOT HAS TOO MANY CELLS LINED UP ACROSS THE TOP LINE OF THE SCATTERPLOT, 5-23 CHECKLIST 1D: DF1 SCATTERPLOT IS NEARLY BLANK, 5-23 CHECKLIST 1E: DF1 SCATTERPLOT SHIFTED TO THE LEFT OR RIGHT, 5-23 CHECKLIST 1F: DF1 SCATTERPLOT SHIFTED TOWARD THE BOTTOM OR TOP, 5-24 CHECKLIST 2: DF2 OR DF3 SCATTERPLOT IS ABNORMAL, 5-24 CHECKLIST 3: VCS HISTOGRAMS APPEAR ABNORMAL, 5-25 CHECKLIST 3A: ABNORMAL VOLUME HISTOGRAM, 5-25 CHECKLIST 3B: ABNORMAL CONDUCTIVITY HISTOGRAM, 5-25 CHECKLIST 3C: ABNORMAL SCATTER HISTOGRAM, 5-26 CHECKLIST 4: ABNORMAL LATRON™ REAGENT VCS HISTOGRAMS, 5-27 CHECKLIST 4A: ABNORMAL LATRON REAGENT VOLUME HISTOGRAM, 5-27 CHECKLIST 4B: ABNORMAL LATRON REAGENT CONDUCTIVITY HISTOGRAM, 5-27 CHECKLIST 4C: ABNORMAL LATRON REAGENT SCATTER HISTOGRAM, 5-28

CONTENTS

PN 4237522BA

5.6 ERROR MESSAGES, 5-29

INDEX, INDEX-1

TRADEMARKS

vii

Page 8

CONTENTS

viii

PN 4237522BA

Page 9

CONTENTS

ILLUSTRATIONS

5.1 Instrument with Front Covers Removed, 5-3

5.2 Right Side of Instrument, 5-4

5.3 Left Side of Instrument, 5-5

5.4 Back of Instrument, 5-5

PN 4237522BA

Page 10

CONTENTS

PN 4237522BA

Page 11

TABLES

4.1 Check Valve Locations, Symptoms of Malfunction, 4-11

5.1 All Parameters Questionable, 5-6

5.2 All Counted Parameters Are Consistently Lower Than Normal, 5-8

5.3 All Counted Parameters Are Consistently Higher Than Normal, 5-9

5.4 WBC Only Is Higher Than Normal, 5-9

5.5 WBC Results Are Lower Than Normal, 5-10

5.6 Hgb Results Questionable, 5-11

5.7 RBC, PLT and MCV Only Are Affected, 5-12

5.8 WBC/RBC Baths Overflow, 5-13

5.9 Failure To Load or Unload Cassettes Properly, 5-14

5.10 Failure To Rock Bed Properly, 5-14

5.11 Failure To Move Cassettes Properly, 5-15

5.12 Failure of Cassette To Clasp Tubes, 5-15

5.13 Autoloader Needle Pierce and Retract Failures, 5-15

5.14 Tube Retract Failure, 5-16

5.15 Tube Available Sensor Failure, 5-16

5.16 System Error Messages - Symbols and Numbers, 5-29

5.17 System Error Messages - A and B, 5-32

5.18 System Error Messages - C, 5-33

5.19 System Error Messages - D through H, 5-38

5.20 System Error Messages - I, 5-41

5.21 System Error Messages - J through P, 5-43

5.22 System Error Messages - R, 5-45

5.23 System Error Messages - S, 5-47

5.24 System Error Messages - T, 5-49

5.25 System Error Messages - U, 5-50

5.26 System Error Messages - V through Z, 5-52

CONTENTS

PN 4237522BA

Page 12

CONTENTS

xii

PN 4237522BA

Page 13

This introductory section contains the following topics:

INTRODUCTION

r How to use your COULTER

Documentation set

r About this Manual

r Conventions

r Hot Keys

r List of Icons

HmX Hematology Analyzer with Autoloader

HOW TO USE YOUR COULTER® HmX HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET

Use the methods it uses, its specifications, and information on installation, safety and software options.

Use the Special Procedures and Troubleshooting Manual to run a calibration, perform reproducibility and carryover checks, and to clean, replace or adjust a component of the instrument. The troubleshooting tables appear at the back of the manual.

Use the Overview chapter to become familiar with the different parts of your system. Then go through the detailed step-by-step procedures of start up, running controls and samples, reviewing data and shutdown.

Use the Host Specifications Manual to locate information about transmission to a host computer.

Reference

Operator's Guide

manual for in-depth information about what the instrument does, the

for the day-to-day running of your instrument. Read the System

Use the Master Index to locate a subject in your documentation set.

See the Documentation page on the back cover of this manual for the contents of each manual. It can help you to determine quickly which manual contains the information you need.

ABOUT THIS MANUAL

Your HmX Hematology Analyzer with Autoloader Special Procedures and Troubleshooting manual provides in-depth information about how to run a calibration, how to perform reproducibility and carryover checks, how to clean, replace, or adjust a component of the instrument, and provides troubleshooting tables as diagnostic tools.

This information is organized as follows:

r Chapter 1, Calibration

Contains information on how to run a CBC calibration with COULTER S-CAL calibrator or whole blood.

r Chapter 2, Reproducibility and Carryover

Contains information on how to run reproducibility and carryover checks.

r Chapter 3, Cleaning Procedures

Contains specific procedures for cleaning the apertures, flow cell, vacuum trap, blood sampling valve, sensors, cassettes, surfaces, and for clearing a flow cell clog.

PN 4237522BA

xiii

Page 14

INTRODUCTION

CONVENTIONS

r Chapter 4, Adjust/Replace Procedures

r Chapter 5, Troubleshooting

r Use the index to easily locate specific information in this manual.

CONVENTIONS

This manual uses the following conventions:

r ITALICS indicate screen messages such as RESET THE SYSTEM or Press any key.

Contains procedures on how to reset the system, perform a system test, adjust pressure and low vacuum and optimize the DMS hard disk. This chapter also presents specific procedures for replacing reagent containers, the waste container, the waste assembly, pickup tubes, fuses, check valves, tubing, pinch valves, aperture block O-rings, the hemoglobin lamp, and the needle.

Contains a troubleshooting overview, charts for troubleshooting the CBC through unusual results, sections on troubleshooting the autoloader mechanism and autoloader check procedures, a guide for troubleshooting the diff through scatterplots and histograms, and an error message table.

Bold indicates

t a menu item such as

Run Samples

t or a function such as F3 Run.

r The software path to access the needed function or screen appears in a series separated

by double arrow heads. For example, the path to the Reagents set up screen is:

Special Functions tt Set Up tt System Set Up tt Reagents.

To select a menu item, highlight it then press Û.

r ë indicates a key (such as Û). r ë ë indicates to press and release the first key listed, then press and release the next

key listed.

r ë+ë indicates to press and hold the first key listed, then press the next key.

xiv

PN 4237522BA

Page 15

HOT KEYS (SHORTCUTS)

INTRODUCTION

HOT KEYS (SHORTCUTS)

É Go to the Access Screen. This is

Ì Print. Ý+Ê Move from the current screen to

Ñ Exit (unless the

Ò Save and/or return to the previous

LIST OF ICONS

only available when the Main Menu is displayed.

F3 Run window is

displayed, then the function of Ñ is Stop.)

screen.

Open the upper front door.

Open the lower front door.

Þ+ã Stops instrument beeping and

removes the error message at the bottom of the screen.

the Error file and back to the original screen.

Ý+Ñ Stop cycle.

Ý+C Clear the autoloader bed.

Close the upper front door.

Close the lower front door.

Open the right side door.

Remove the left side panel.

Print the screen for your logbook.

Close the right side door.

Check for leaks.

PN 4237522BA

Page 16

INTRODUCTION

LIST OF ICONS

xvi

PN 4237522BA

Page 17

1.1 CBC CALIBRATION - GENERAL

Calibration is a procedure to standardize the instrument by determining its deviation from calibration references and to apply any necessary correction factors.

Recommended Conditions

Beckman Coulter recommends that you perform the Calibration procedure:

r In the Primary mode.

r With the room temperature within ambient range (16-32°C, 60-90°F).

r Using S-CAL calibrator as an alternative to whole blood.

When to Calibrate

You should calibrate your instrument:

r At installation, before you begin analyzing samples.

r After you replace any component dealing with

t dilution preparation, such as the BSV

t primary measurement, such as an aperture.

r If your Beckman Coulter Representative suggests you calibrate.

CALIBRATION

When to Verify

You should verify the calibration of your instrument:

r As dictated by your laboratory procedures, local or national regulations.

r When controls begin to show evidence of unusual trends.

r When controls exceed the manufacturer’s defined acceptable limits.

r If the average ambient room temperature changes more than 10°F (5.5°C)

from the room temperature during your last calibration.

In the normal process of tracking data for an extended period of time, your laboratory can make a specific decision to recalibrate a given parameter. Never adjust to a specific value based on an individual sample result.

PN 4237522BA

Page 18

CALIBRATION

CBC CALIBRATION PRELIMINARY PROCEDURES

1.2 CBC CALIBRATION PRELIMINARY PROCEDURES

1. Make sure you have enough reagents to complete the entire procedure. Replace if necessary using the procedure in Heading 4.12, REPLACE REAGENT CONTAINERS.

2. Do you routinely shut down the HmX Hematology Analyzer with Autoloader for at least 30 minutes every 24 hours with COULTER CLENZ agent?

r If yes:

From the Access Screen, press Ë

Clean.

Note: As an alternative, you can shut down the instrument for 30 minutes, then start up.

r If no:

Follow the directions under Heading 3.2, BLEACH APERTURES AND FLOW CELL/DISINFECTto bleach the apertures.

cleaning

3. Bleach the aspiration system.

a. Put one part high-quality,

fragrance-free bleach (5% sodium hypochlorite) and one part distilled water in a cap-pierce tube.

b. Select

Special Functions tt

Diagnostics tt Operator Options tt Fluidic Tests tt

Clean Needle.

c. Press Û.

d. Follow the screen instructions.

4. Perform Startup.

5. Run commercial cell controls.

PN 4237522BA

Page 19

CBC CALIBRATION WITH S-CAL® CALIBRATOR

1.3 CBC CALIBRATION WITH S-CAL® CALIBRATOR

1. Take the S-CAL calibrator kit out of the refrigerator.

2. Remove one vial of S-CAL calibrator and one empty glass tube from the kit. Let the S-CAL calibrator warm at ambient temperature while you do steps 3 through 8.

3. Return the other unopened vial of S-CAL calibrator and empty glass tube to the refrigerator immediately.

°C

32 90

CALIBRATION

°F

4. Select

5. Press Í # OF ASPIRATIONS. Set to 11.

6. Press Ê

7. If there is data in the table:

8. Prepare the CBC Calibration screen.

Special Functions tt Calibration tt

CBC Calibration.

START PRIMARY.

a. Press Ð b. Press the ßto answer YES. c. Press Û.

r Enter the S-CAL calibrator

assigned values (from the package insert) on the REF. VALUES line.

r Enter the expiration date and the

lot number.

Note: You can enter or change these values anytime before, during, or after running S-CAL calibrator.

Del Table.

PN 4237522BA

Page 20

CALIBRATION

CBC CALIBRATION WITH S-CAL® CALIBRATOR

IMPORTANT Possible calibration error can occur if the S-CAL calibrator is inadequately mixed, handled

roughly, or allowed to sit at room temperature for too long.

r Complete the calibration procedure (steps 8-11) within 1 hour of opening the vial. r Take care in mixing. Inadequate mixing, or rough handling can cause incorrect results, resulting in

calibration error.

WARNING Risk of biohazardous contamination if you do not remove the cap from the S-CAL calibrator vial

properly. Use an absorbent material (such as guaze or paper wipes) to remove the cap from the vial of S-CAL calibrator. Any spray produced upon opening is absorbed by the guaze or paper wipe, avoiding accidental contact with the product.

9. Once the S-CAL calibrator equilibrates at ambient temperature (approximately 15 minutes after removal from refrigerator):

a. Roll the vial slowly back and forth

between the palms of the hands eight times in an upright position.

b. Invert the vial and again slowly roll

it back and forth eight times.

c. Gently invert the vial eight times.

d. Repeat this mixing procedure.

e. Inspect the vial contents to

determine that all the cells have been uniformly distributed. Repeat the mixing procedure if vial contents have not been totally distributed.

10. Transfer the S-CAL calibrator from the plastic vial to the glass tube using a pipet.

Do not fill the tube all the way to the top; leave a 1/4 inch air space.

11. Load the glass tube into a cassette and place the cassette into the loading bay.

PN 4237522BA

Page 21

12. After the cycles are complete, Press

Print to print the screen for your

Ì logbook. Press Ë È.

13. Assess the run:

a. Check for trending. If trending is

present, STOP. There could be an instrument problem. Call your Beckman Coulter Representative.

Run, Ñ Stop. Press

CALIBRATION

CBC CALIBRATION WITH S-CAL® CALIBRATOR

b. Verify that the %CV (coefficient of

variation) for each parameter does not exceed its limit. If any parameter exceeds its limit, STOP. There could be an instrument problem. Call your Beckman Coulter Representative.

%CV

WBC < RBC < Hgb < MCV < Plt < MPV <

2.5

2.0

1.5

2.0

5.0

3.0

PN 4237522BA

Page 22

CALIBRATION

CBC CALIBRATION WITH S-CAL® CALIBRATOR

IMPORTANT Misleading results could occur if you calibrate the MCV when the RBC FAC (Factor) %Diff is

above the limits shown in step 14. Do not calibrate the MCV if the RBC FAC %DIFF is above these limits.

14. Determine which calibration factors (if any) should be changed by checking the FAC%DIFF and DELTA DIFF values against these ranges.

Note: Disregard any minus signs on FAC%DIFF values.

r If both the FAC%DIFF and DELTA

DIFF values of a parameter fall below their lower limits, that

parameter does not need to be calibrated.

Note: If all parameter values fall

below the lower limits of both ranges, you are finished. Resume normal operation.

r If either the FAC%DIFF or DELTA

DIFF value of a parameter exceeds its upper limit, STOP. There could be an instrument problem. Call your Beckman Coulter Representative.

r If either the FAC%DIFF or DELTA

DIFF value of a parameter falls between its lower and upper limits that parameter should be calibrated. Continue to step 15.

Calibrate if

FAC% DIFF is:

WBC >1.25 AND <5.00 >0.10 AND <0.40 RBC >0.70 AND < Hgb >0.78 AND < MCV >1.18 AND < Plt >2.70 AND < MPV >5.00 AND <

2.00 >0.03 AND <0.09

3.00 >0.10 AND <0.40

2.50 >1.00 AND <2.00

9.00 >6.00 AND <20.0

20.00 >0.50 AND <2.00

Calibrate if

DELTA DIFF is

15. Is Select Function displayed? r If NO, press Ë

Run, Ñ Stop.

Press È.

r If YES, go to step 16.

16. Select the parameters to be calibrated. a. Press Í

b. Select

Optns.

Select Parameters.

c. Set YES for parameters you are

adjusting, NO for the others. Use the ßto toggle between YES and

NO.

d. Press È.

PN 4237522BA

Page 23

CALIBRATION

WHOLE-BLOOD CALIBRATION

17. Select

18. Press Ì

19. Verify calibration by cycling commercial

Transmit Factors.

The following message appears:

WARNING - DATA WILL BE CLEARED AFTER TRANSMISSION. DO YOU WANT TO PRINT DATA? Y/N

If you did not print the calibration screen in step 11, press

press

Print to print this final

calibration screen for your logbook. It reflects the new calibration factors for the parameters you adjusted.

cell control in the primary mode.

If any of the control level’s result is

outside of its Expected Range, run a second sample of the control.

r If the second sample is also outside

of the Expected Range, call your Beckman Coulter Representative.

y. Otherwise,

1.4 WHOLE-BLOOD CALIBRATION

This is an alternative to S-CAL calibrator.

Collect 20 normal, fresh whole-blood specimens. Be sure to collect enough to cycle each specimen three times on the HmX Hematology Analyzer with Autoloader and three times each on the reference instrument.

Reference Values

1. To establish your reference values, use these reference instruments and methods:

r WBC and RBC from the COULTER ZBI

used with ISOTON

r Hgb from hemiglobin cyanide spectrophotometric procedure which follows NCCLS

Standard H15-A.

r MCV from packed-cell volume (PCV) measured by a hematocrit procedure which

follows NCCLS Standard H7-A. Divide this value by the reference RBC count. No measurement of trapped plasma occurs.

r Plt from COULTER ZBI analyzer or equivalent particle counter used with ISOTON

II diluent.

2. Assess each of your 20 samples three times for each type of reference value:

r Three times on the Model ZBI analyzer or equivalent if you are calibrating for WBC

and RBC.

II diluent and ZAP-OGLOBIN® II lytic reagent.

™

analyzer or equivalent particle counter

PN 4237522BA

r Three times using the spectrophotometer if you are calibrating for Hgb.

Page 24

CALIBRATION

WHOLE-BLOOD CALIBRATION

r Three times using the hematocrit procedure if you are calibrating for MCV.

r Three times using the Model ZBI analyzer or equivalent if you are calibrating for Plt.

3. Average the 60 results for each test to find your reference values.

Whole-Blood Calibration Run

1. Select Special Functions tt Calibration tt CBC Calibration.

2. Press Í # OF ASPIRATIONS. Set to 3.

3. Press Ê

Start Primary.

4. If there is any data in the table:

a. Press Ð

Del Table.

b. Press the ß to select Yes. c. Press Û.

5. Enter your reference values on the REF. VALUES line at the bottom of the CBC Calibration screen.

Note: If the cursor is not on the REF. VALUES line, Press Ê

Run/Ref to get it there.

6. Load the 20 tubes of blood into cassettes and place the cassettes into the loading bay.

7. Assess calibration results and complete the procedure using steps 13-19 under Heading 1.3, CBC CALIBRATION WITH S-CAL® CALIBRATOR.

PN 4237522BA

Page 25

2.1 REPRODUCIBILITY CHECK

Use an unopened, normal-level, COULTER 5C® cell control for reproducibility studies (Procedure A). You can also use normal whole blood (Procedure B).

Procedure A

1. Select Special Functions tt Calibration tt

Reproducibility.

2. Do you want to check the reproducibility of the WBC differential?

r If yes, verify that

DIFF is ON.

REPRODUCIBILITY AND CARRYOVER

r If no, verify that

To change the state of

3. Press Í

4. Press Ê

5. Does the following message appear?

MODE REQUIRES EXISTING RUNS TO BE DELETED. ARE YOU SURE?: NO

r If this message appears:

r If this message does not appear, and

6. Follow the directions on the cell control package insert for storage, preparation and mixing.

# OF ASPIRATIONS. Set to 11.

START PRIMARY.

Press ß to answer YES. Press Û. The DMS deletes the old data.

there is data in the table: Press Û. Press copy of the data. When ready to delete the data, press Ð Press ß to answer YES. Press Û. The old data is deleted.

DIFF is OFF.

DIFF, Press Î.

Ì Print for a

Del Table.

PN 4237522BA

7. Load the cell control tube into a cassette with the bar-code label facing down and place the cassette into the loading bay.

Page 26

REPRODUCIBILITY AND CARRYOVER

Note: The first sample is automatically marked DEL and its results are not included in the calculations.

8. Check results.

r Verify that the %CV (coefficient of

variation) for each parameter does not exceed its limit.

r If you ran with the DIFF ON, check

the values on the Diff line at the bottom of the screen with these limits. This number represents the difference between the lowest and highest results within the run.

r If any result is OUT, call your

Beckman Coulter Representative.

%CV

WBC 2.5%

RBC 2.0%

Hgb 1.5%

MCV 2.0%

Plt 5.0%

MPV 3.0%

Max Range/Low to High

(check Diff line at bottom of screen)

LY% <4.8

MO% <

NE% <

EO% <

BA% <

3.2

4.8

1.6

9. Press your logbook.

Ì Print to print the screen for

PN 4237522BA

Page 27

Procedure B

1. Collect one tube of blood from a donor who:

r Is receiving no medication.

r Has normal hematologic parameters

(with a WBC count between 5 x

µL and 10 x 103µL).

r Has normal erythrocyte, leukocyte

and platelet morphology and

REPRODUCIBILITY AND CARRYOVER

r If you want to check reproducibility

on the WBC differential, the diff parameters values must fall within these ranges:

2. Select

3. Do you want to check the reproducibility

4. Press Í

5. Press Ê

6. Does the following message appear?

Special Functions tt Calibration tt

Reproducibility.

of the WBC differential?

r If yes, verify that

r If no, verify that

To change the state of

# OF ASPIRATIONS. Set to 11.

START PRIMARY.

MODE REQUIRES EXISTING RUNS TO BE DELETED. ARE YOU SURE?: NO

r If this message appears:

Press ß to answer YES. Press Û. The DMS deletes the old data.

DIFF is ON.

DIFF is OFF.

DIFF, Press Î.

Neutrophils 40 to 72%

Lymphocytes 17 to 45%

Monocytes 4 to 12%

Eosinophils 0 to 10%

Basophils 0 to 1%

PN 4237522BA

r If this message does not appear, and

there is data in the table: Press Û. Press copy of the data. When ready to delete the data, press Ð Press ß to answer YES. Press

Û. The old data is deleted.

Ì Print for a

Del Table.

Page 28

REPRODUCIBILITY AND CARRYOVER

7. Load the donor blood tube into a cassette and place the cassette into the loading bay.

Note: The first sample is automatically marked DEL and its results are not included in the calculations.

8. Check results.

r Verify that the %CV (coefficient of

variation) for each parameter does not exceed its limit.

r If you ran with the DIFF ON, check

the values on the Diff line at the bottom of the screen with these limits. This number represents the difference between the lowest and highest results within the run.

r If any result is OUT:

t Repeat the procedure with a

different blood sample.

t If they are still OUT, call your

Beckman Coulter Representative.

%CV

WBC 2.5% RBC 2.0% Hgb 1.5% MCV 2.0% Plt 5.0% MPV 3.0%

Max Range/Low to High

(check Diff line at bottom of screen)

LY% <4.8

MO% <

NE% <

EO% <

BA% <

3.2

4.8

1.6

PN 4237522BA

Page 29

9. Press Ì Print to print the screen for

your logbook.

2.2 RETIC REPRODUCIBILITY CHECK

1. Select Special Functions tt Calibration tt

Reproducibility.

2. Press Ì RETIC.

3. If there is data in the table:

a. Press Ð b. Press ß to answer YES. c. Press Û.

The old data is deleted.

4. Prepare a Retic whole blood/stain preparation according to the instructions in the Retic-Prep reagent kit. Incubate for at least 5 minutes.

Del Table.

REPRODUCIBILITY AND CARRYOVER

RETIC REPRODUCIBILITY CHECK

You can use this whole blood/stain preparation for up to 1 hour.

5. From the solution prepared in step 4, dispense 2 µL into the bottom of a clean tube. Immediately dispense 2 mL of clearing solution (Reagent B) into the tube. Wait for 30 seconds then analyze.

Repeat 30 times for a total of 31 runs.

6. The first sample in the run is automatically deleted. Check statistics at the bottom of the Reproducibility screen. The results must not exceed these limits:

If results exceed any limit, call your Beckman Coulter Representative.

Limits (whichever is greater

Mean Retic% SD Limit CV Limit

<1.00% <0.23

00-4.00 <0.23

01-15 +<0.68

"23%

"17%

"15%

PN 4237522BA

Page 30

REPRODUCIBILITY AND CARRYOVER

CARRYOVER CHECK

2.3 CARRYOVER CHECK

1. Select

Special Functions

Carryover.

tt Calibration

2. Press Ê START PRIMARY.

If the following message appears:

MODE REQUIRES EXISTING RUNS TO BE DELETED ARE YOU SURE?: NO

Press ß to answer YES. Press Û. The DMS deletes the data.

3. Select 2 normal whole blood samples. At least one of them should have a WBC count at the high end of normal (about

µL

10 x

4. Fill three tubes with diluent, then cap.

5. Load a cassette as follows:

r Put the two normal whole blood

samples in positions 1 and 2. Put the sample with the higher WBC count in position 2.

r Put the three tubes of diluent in the

remaining positions.

6. Place the cassette into the loading bay and wait until the cycles complete.

7. Check the lower right corner of the screen for CARRYOVER ACCEPTABLE.

If it is not acceptable, the parameter that is out of limits is flagged with an H:

r Repeat the procedure using

different normal bloods and three fresh tubes of diluent.

If results are still unacceptable, call your Beckman Coulter Representative.

PN 4237522BA

Page 31

8. Press Ì to print the carryover screen

for your logbook.

REPRODUCIBILITY AND CARRYOVER

CARRYOVER CHECK

PN 4237522BA

Page 32

REPRODUCIBILITY AND CARRYOVER

CARRYOVER CHECK

PN 4237522BA

Page 33

These are not routine procedures. Use them only if necessary for troubleshooting or before calibrating.

3.1 ZAP APERTURES

Zap the apertures when the instrument:

r Produces decreased cell counts.

r Produces increased MCV values.

r Produces increased voteouts.

r Fails to recover control values.

r Produces erratic MCV, RBC, WBC, or Plt counts.

CLEANING PROCEDURES

1. Select

2. Press Û. The instrument:

3. Wait until you see SELECT FUNCTION on the screen to continue running specimens.

Special Functions tt Diagnostics tt Operator Options tt Fluidic Tests tt

Multiple Aperture Zap.

r Fills the baths with cleaning agent.

r Activates the burn circuit.

r Activates alternating vacuum and pressure to bath apertures and flow cell.

r Fills the baths with diluent.

3.2 BLEACH APERTURES AND FLOW CELL/DISINFECT

1. Prepare a 30 mL solution of bleach and distilled water. Mix together:

r 15 mL of high quality,

fragrance-free bleach (5% sodium hypochlorite) and

r 15 mL of distilled water.

Label this container "A".

30 mL

1 : 1

PN 4237522BA

2. Put 30 mL of distilled water in a second container labeled "B".

30 mL

Page 34

CLEANING PROCEDURES

BLEACH APERTURES AND FLOW CELL/DISINFECT

3. Select Diluter Functions tt Disinfect.

4. Enter the maximum number of minutes that you want the bleach to stay in the HmX Hematology Analyzer. Range is 15 to 60 minutes. Default is 15 min.

5. Press Û.

6. When the screen displays:

Press any key when ready to aspirate bleach.

a. Open the upper front door.

b. Immerse the bleach probe in the

bleach solution (container A).

c. Press any key on the keyboard.

d. Wait until the instrument aspirates

all of the bleach solution then remove the empty container.

7. When the screen displays:

Press any key when ready to aspirate distilled water

a. Immerse the bleach probe in the

distilled water (container B).

b. Press any key on the keyboard.

c. Wait until the instrument aspirates

all of the distilled water then remove the empty container.

PN 4237522BA

Page 35

8. Close the upper front door.

The instrument:

r Disinfects for the designated

number of minutes.

Note: You can end this part of the disinfect cycle at any time by pressing Ì.

r Replaces the bleach solution with

cleaning agent.

r Starts up.

9. Wait until the screen displays SELECT FUNCTION before you touch any keys.

When you see SELECT FUNCTION, check that the Startup results are acceptable.

r If yes, you can resume your normal

operation.

CLEANING PROCEDURES

CLEAN OUTSIDE OF BLOOD SAMPLING VALVE (BSV)

r If no, repeat Startup.

3.3 CLEAN OUTSIDE OF BLOOD SAMPLING VALVE (BSV)

Use this procedure if there is an excessive buildup of cleaning agent on the outside of the BSV.

WARNING Biohazardous material might be contained in the BSV and its associated tubing and could cause

contamination unless handled with care. Avoid skin contact. Clean up spills immediately in accordance with acceptable laboratory procedures.

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Open the upper front door.

PN 4237522BA

Page 36

CLEANING PROCEDURES

CLEAN OUTSIDE OF BLOOD SAMPLING VALVE (BSV)

3. Cover the area under the BSV with several paper towels. Clean the outside with distilled water.

4. Dry the area with lint-free tissues.

5. Close the upper front door.

6. Return the Standby/Reset switch to the READY position.

PN 4237522BA

Page 37

3.4 CYCLE BSV

Use this procedure if the BSV is binding or exhibits irregular motion.

1. Open the upper front door.

CLEANING PROCEDURES

CYCLE BSV

2. Select

3. Close the upper front door.

Special Functions tt Diagnostics tt

Operator Options tt

Press Û.

Watch for smooth action. If the BSV continues to move irregularly or to bind, call your Beckman Coulter Representative.

3.5 CLEAN CASSETTES

WARNING

crystals (dried bleach, blood, diluent) can prevent the tubes from being held firmly in a Universal Cassette. This can cause the tubes to fall out of the cassette or be pierced off center. After cleaning cassettes, always rinse them thoroughly with water.

Risk of blood spills occurs when tubes fall or are pierced off center. Buildup of debris and

BSV Tests tt Cycle BSV.

PN 4237522BA

When you see crystal or blood buildup on a cassette:

1. Wash the cassette with soap or a 10% bleach solution (1 part 5% sodium hypochlorite with 9 parts distilled water).

2. Thoroughly rinse the cassette with warm tap water.

3. Examine to be sure all crystals and debris buildup are eliminated.

Page 38

CLEANING PROCEDURES

CLEAR FLOW CELL CLOG

3.6 CLEAR FLOW CELL CLOG

Error Messages

PC1 - Partial Clog 1

This indicates partial aperture (flow cell) and sample line clogs. A purge cycle occurs at the end of the cycle if PC1 is detected. Five-part diff results are not displayed. At the end of the third consecutive PC1, PC2 or FC error, the system halts.

PC2 - Partial Clog 2

This indicates clogs in the sheath system. A purge cycle occurs automatically when PC2 is detected. Five-part diff results are not displayed. At the end of the third consecutive PC1, PC2 or FC error, the system halts.

FC - Full Clog

This indicates a flow cell aperture clog only. A purge cycle automatically occurs when FC is detected. Five-part diff results are not displayed. At the end of the third consecutive PC1, PC2 or FC error, the system halts.

Clearing Procedure

Follow these steps to manually unclog the flow cell aperture.

1. Select

2. Press Ñ

Sample Analysis tt Run Samples.

a. Press Ï PURGE. Wait. Pres s Ï

again. Wait. Press Ï again. Wait.

b. Press Ê

START PRIMARY and cycle

a normal whole blood sample in the Primary mode. If the error message recurs, continue to step 2.

Exit then:

a. Select

Controls tt Control Run.

b. Press Ê File.

c. Select a Latex file. d. Press Ë

Run then Ì PRIMER.

e. Aspirate a solution of one part

high-quality, fragrance-free bleach and one part distilled water.

f. Aspirate distilled water.

3. Cycle a normal whole blood sample. If the error message recurs, call your Beckman Coulter Representative.

PN 4237522BA

Page 39

3.7 CLEAN NEEDLE FORWARD SENSOR

Clean the needle forward sensor when it is the corrective action for a related error message.

1. Bleach the aspiration system.

a. Put one part high-quality,

fragrance-free bleach (5% sodium hypochlorite) and one part distilled water in a cap-pierce tube.

CLEANING PROCEDURES

CLEAN NEEDLE FORWARD SENSOR

b. Select

c. Press Û.

d. Follow the screen instructions.

2. Put the instrument in STANDBY using the Standby/Reset switch.

3. Turn OFF the instrument using the On/Off switch on the back.

4. Unplug the power cord from the wall.

5. Open the upper then lower front doors.

WARNING Skin puncture from the needle, which might contain biohazardous material, could occur.

Handle the needle cartridge with extreme care. Always use the safety clip to remove and install the needle cartridge.

6. Attach the safety clip to the front support of the needle cartridge.

a. Without squeezing the safety clip,

Special Functions tt

Diagnostics tt Operator Options tt Fluidic Tests tt

fit the right edge of the safety clip into the groove on the right side of the front support of the needle

cartridge

Clean Needle.

PN 4237522BA

b. Slide the safety clip to the left

until its left edge snaps into the groove on the left side of the front support of the needle cartridge with a click.

c. Check that the safety clip is

securely attached to the needle assembly.

Page 40

CLEANING PROCEDURES

CLEAN NEEDLE FORWARD SENSOR

7. Pull out the needle cartridge and set it aside, being careful not to crimp any of the tubing. You do not need to disconnect any of the tubing.

8. Locate the needle forward sensor

PN 4237522BA

Page 41

9. Dip a swab in distilled water and gently wipe the sensor with it.

10. Use a swab and distilled water to clean the upper and lower grooves where the needle assembly fits.

H2O

CLEANING PROCEDURES

CLEAN NEEDLE FORWARD SENSOR

11. Replace the needle cartridge. Slide it into the grooves until it clicks in place.

Note: The silver lock spring at the bottom of the needle assembly is slightly raised when the needle assembly is properly inserted.

12. Remove the safety clip.

a. Slightly squeeze the safety clip to

move it a little to the right to separate the left side of the clip

from the needle assembly

b. Continue to move the clip to the

c to free it from the needle

right assembly.

PN 4237522BA

Page 42

CLEANING PROCEDURES

CLEAN SURFACES

13. Close the lower and upper front doors.

14. Plug the power cord back into the wall.

15. Return the On/Off switch to ON.

16. Return the Standby/Reset switch to the READY position.

3.8 CLEAN SURFACES

Clean the external and internal surfaces of the instrument with a damp cloth and distilled water. Wipe up reagent spills promptly. This prevents the buildup of corrosive deposits.

3.9 CLEAN VACUUM TRAP

WARNING The vacuum trap might contain residual biohazardous materials and could cause contamination

unless handled with care. Wear protective gear. Avoid skin contact. Clean up spills immediately. Dispose of the contents in accordance with your local regulations and acceptable laboratory procedures.

If you see:

r A warning message that the high

vacuum is out of range, and

r The vacuum trap

b has foam or liquid

in it, then

perform the following procedure:

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Open the right side door.

041993

PN 4237522BA

Page 43

3. Unscrew and remove the clear trap bottom.

4. Rinse it out with distilled water.

5. Dry with a lint-free tissue.

CLEANING PROCEDURES

CLEAN VACUUM TRAP

6. Check that

a. The white center post

stuck in the up position.

b. The white outer post

seats firmly against the black grommet

B is not

PN 4237522BA

Page 44

CLEANING PROCEDURES

CLEAN VACUUM TRAP

7. Making sure the threads are properly seated, screw the trap bottom back on, firmly.

Note: Do not overtighten.

8. Close the right side door.

9. Return the Standby/Reset switch to the READY position.

PN 4237522BA

Page 45

4.1 RESET THE SYSTEM

To reset the system:

1. Put the Standby/Reset switch in the STANDBY position.

2. Wait 15 seconds.

3. Return the Standby/Reset switch to the READY position.

ADJUST/REPLACE PROCEDURES

4.2 SYSTEM TEST

Use this procedure to check voltages, blood detectors, pressures, vacuums, temperatures and backgrounds. The system test cycle consists of three separate system test runs followed by a background count. Make sure all doors and panels are closed if you want a valid background count.

1. Select

Operator Options tt

2. Press Û.

Note: The results displayed when the screen is accessed are not from Startup. These results are from the previous System Test. Note the date and time at the bottom right of the screen.

3. Press Ë

Special Functions tt Diagnostics tt

System Test.

Run.

HmX

COULTER

HmX

PN 4237522BA

Any result that is out of limits appears in red.

Page 46

ADJUST/REPLACE PROCEDURES

JAMMED CASSETTE REMOVAL

4.3 JAMMED CASSETTE REMOVAL

1. With the Main menu displayed,

press Ý

If this clears the bed, resume operation.

2. If step 1 did not clear the bed:

a. Put the instrument in STANDBY

b. Turn OFF the instrument using the

c. Unplug the power cord from the

3. Open the upper then lower front doors.

+C.

using the Standby/Reset switch.

On/Off switch on the back.

wall.

CAUTION Sensor damage can occur if the cassette is moved to the right on the rocker bed. Only move

a cassette to the left.

4. Rotate the rocker bed forward to the pierce position.

5. Slide the cassette to the left side of the bed and lift the cassette off the bed. If the cassette does not move easily, go to step 8.

6. If there is a second cassette on the bed, repeat step 5.

7. If this clears the rocker bed, make sure the guide rail available sensor rocker bed and the two springs

c, cone-shaped tube

d in the middle of the

b in the

back of the rocker bed are not damaged. If damaged, STOP, call your Beckman Coulter Representative. If not damaged, go to step 10.

PN 4237522BA

Page 47

8. If you were unable to clear the rocker bed:

a. Try to slightly raise the front of the

cassette.

b. Very gently, push the cassette

toward the back of the rocker bed.

c. Lift the cassette up. You will hear a

click.

9. If this procedure clears the bed, make sure the guide rail, cone-shaped tube available sensor in the middle of the bed and the two springs in the back of the bed are not damaged. If damaged, STOP, call your Beckman Coulter Representative.

If you are still unable to remove the cassette from the bed, call your Beckman Coulter Representative.

ADJUST/REPLACE PROCEDURES

JAMMED CASSETTE REMOVAL

10. Close the lower and upper front doors.

11. Plug the power cord back into the wall.

12. Return the On/Off switch to ON.

13. Return the Standby/Reset switch to the READY position.

14. Put a tube in a cassette and place the cassette in the loading bay. Select

Special Functions tt Diagnostics tt

Operator Options tt Autoloader Test Routine.

Follow the instructions displayed on the screen.

15. Resume operation if no problems are reported on the screen. If an error displays, call your Beckman Coulter Representative.

Autoloader Tests tt

PN 4237522BA

Page 48

ADJUST/REPLACE PROCEDURES

ADJUST PRESSURE AND LOW VACUUM

4.4 ADJUST PRESSURE AND LOW VACUUM

If you see a 60 psi, high vacuum or Diff psi message, call your Beckman Coulter Representative.

If you see a low vacuum, 30 psi or sheath pressure error message:

1. Open the right side door.

2. Find the correct adjustment knob.

b LOW VACUUM c 30 PSI D SHEATH PRESSURE

041993

3. Do a System Test.

a. Select

Special Functions tt

Diagnostics tt Operator Options tt System Test.

b. Press Û. c. Press Ë

Run.

PN 4237522BA

Page 49

4. Watch the System Test reading. When INV changes to a numeric reading, turn the knob slowly

r clockwise to increase or

r counterclockwise to decrease.

Note: Only turn the knob when there is a numeric reading. You have three opportunities to adjust the numeric reading during a System Test cycle.

5. If you do not get the proper adjustment

Run

Run to repeat

to confirm

the first time, press Ë the System Test cycle.

6. Once you have made the correct adjustment, press your adjustment.

7. Close the right side door.

ADJUST/REPLACE PROCEDURES

OPTIMIZE THE DMS HARD DISK

4.5 OPTIMIZE THE DMS HARD DISK

The HmX Hematology Analyzer is equipped with the OPTune™ utility, a software utility that optimizes the hard disk of the DMS. Optimizing organizes files on your hard disk so that the DMS is faster and more efficient.

The OPTune utility performs three types of optimization: daily, weekly and monthly. The type it uses depends on how long it has been since you last reset your HmX Hematology Analyzer. The program keeps track of how long it has been between optimizations and performs only the functions necessary for that time period. When you have the OPTune utility enabled, the system runs the OPTune utility each time you reset your HmX Hematology Analyzer, but it will not optimize more than once a day.

Daily

The fastest method (less than a minute), this type leaves each file

r 100% defragmented

r sorted in ascending order by name

r in contiguous order.

Weekly

Takes about 50% longer than the daily method. Does everything the daily method does, plus it optimizes in the packed mode. It arranges the files on your hard drive so that they are end-to-end, with no space between them. Thus, new files are likely to be written to disk without being fragmented.

PN 4237522BA

Page 50

ADJUST/REPLACE PROCEDURES

OPTIMIZE THE DMS HARD DISK

Monthly

CAUTION Damage to the disk drive or data loss could occur if power is lost or interrupted during the

optimization procedure. Try to schedule this procedure when there is little likelihood of power interruption.

The most thorough method. Does everything the weekly method does, plus it physically arranges files on the disk in the same order as the sorted directory entries. This method takes longer, but increases efficiency when accessing many files in sequential order.

The OPTune utility initially takes about 45 minutes to an hour to optimize the hard drive. After that, daily optimization takes about 30 to 40 seconds. The OPTune utility reorganizes only those files that need it; it does not reoptimize unnecessarily.

If there is a hard disk failure during the optimization process, for example lost clusters or cross-linked files, the OPTune utility prompts you to continue. Answer Yes to go on with the process. However, if this happens more than once a week, record the incident in your DMS maintenance log or your logbook and call your Beckman Coulter Representative.

To enable the OPTune utility so that it automatically optimizes the hard disk when you reset the system:

1. Select

Special Functions tt Set Up tt System Set Up tt Optimize Hard Disk.

2. Enter Supervisor Password.

3. The system asks:

Do you want to automatically optimize the Hard Disk during powerup?

Verify that YES is displayed. If not, Press ß to toggle to YES.

4. Press Ò

Save/Esc.

If you always leave your system turned on, we recommend that you use the Reset the System procedure at least once a week allow the OPTune utility to run. See Heading 4.1, RESET THE SYSTEM.

When you reset the system, these DMS functions default to these conditions:

r Data Base storage: ON

r XB: ON

r AutoPrint: NONE

r AutoTransmit: OFF

Adjust the setting of these options as needed according to your laboratory's protocol.

PN 4237522BA

Page 51

4.6 REPLACE APERTURE BLOCK O-RINGS

This is not a routine procedure. Use it only when troubleshooting.

1. Drain the aperture baths:

ADJUST/REPLACE PROCEDURES

REPLACE APERTURE BLOCK O-RINGS

a. Select

b. Press Û and wait until SELECT

2. Put the instrument in STANDBY using the Standby/Reset switch.

3. Open the upper front door.

4. Unscrew and remove the retaining screw at the bottom of the bath. Turn screw to the left.

Special Functions tt

Diagnostics tt Operator Options tt Drain and Vent.

FUNCTION displays.

PN 4237522BA

Page 52

ADJUST/REPLACE PROCEDURES

REPLACE APERTURE BLOCK O-RINGS

CAUTION Risk of electrical damage to the instrument if the electrode wire is pulled loose. To avoid causing

electrical damage, DO NOT pull the electrode wire loose when you rotate the bath to the right. Do not tug or bend it excessively.

5. Gently rotate the bath out and to the right.

6. Inspect the housing around the O-ring for salt buildup. If there is any, rinse it off with distilled water. Dry it with a lint-free tissue.

PN 4237522BA

Page 53

7. Take out the aperture block:

a. Unscrew the white locking screw

under the aperture block.

Note: For the RBC bath, remove the tubing from the locking screw before unscrewing it.

b. Pull the aperture block out. Be

careful not to touch the aperture.

8. Replace all three O-rings.

ADJUST/REPLACE PROCEDURES

REPLACE APERTURE BLOCK O-RINGS

r Use tweezers to remove and replace

the little ones.

r Moisten the new O-rings with

distilled water before you install them.

9. Slide the aperture block back in place and tighten the white locking screw.

Note: For the RBC bath, reattach the tubing to the white locking screw after it is screwed in place.

PN 4237522BA

Page 54

ADJUST/REPLACE PROCEDURES

REPLACE APERTURE BLOCK O-RINGS

10. Rotate the bath back into position onto the large O-ring. Check for proper sealing all the way around the O-ring.

11. Replace and tighten the retaining screw.

12. Carefully dry the bath assembly and surrounding area with a lint-free cloth.

13. Check for and remove any fingerprints on the WBC bath.

PN 4237522BA

Page 55

14. Return the Standby/Reset switch to the READY position.

15. Rinse and drain the baths several times to check that the baths do not leak:

a. Select

Sample Analysis

Samples.

b. Press Ð RINSE. Wait. Press Ð

again. Wait. Press Ð again. Wait.

c. Press È then Ñ to return to the

Main menu.

16. Close the upper front door.

17. Perform Startup.

4.7 REPLACE CHECK VALVES

tt Run

ADJUST/REPLACE PROCEDURES

REPLACE CHECK VALVES

Check valves allow liquid or air to flow through in one direction only.

Replace a check valve if:

r It is clogged, or

r It lets liquid or air flow both ways.

Table 4.1 explains how to check for and find valves that might be clogged or open so that liquid or air can flow both ways.

Table 4.1 Check Valve Locations, Symptoms of Malfunction

Location Symptoms When Plugged Symptoms When Opened

DILUTER FRONT PANEL

In the 6-psi mixing bubble line to the lower left of the RBC bath.

In the 6-psi mixing bubble line to the lower left of the WBC bath.

In the line from the waste chamber to the outer waste container.

In the RBC drain line to the waste chamber.

No mixing bubbles during operating cycle. Erratic RBC and Plt counts.

No mixing bubbles during operating cycle. Erratic WBC and Hgb results.

Waste chamber does not drain. Hesitation in bath drain after count.

RBC bath does not drain. Possible backflow of drain line

Liquid in tubing from check valve to solenoid 7.

Liquid in tubing from check valve to solenoid 8.

Possible incomplete draining.

contents at the beginning of waste chamber drain. RBC and Plt carryover or background problem.

PN 4237522BA

Page 56

ADJUST/REPLACE PROCEDURES

REPLACE CHECK VALVES

Table 4.1 Check Valve Locations, Symptoms of Malfunction (Continued)

Location Symptoms When Plugged Symptoms When Opened

In the WBC bath drain line to the waste chamber.

In the line between the BSV and the Y-connector to the waste chamber.

In the line at the top of the RBC bath. No bleach enters the RBC bath during

In the line at the top of the WBC bath. No bleach enters the WBC bath during

In the needle waste chamber (VC3) drain line.

WBC bath does not drain. Possible backflow of drain line

No diluent enters the waste chamber through this line during draining.

the Bleach the Aperture procedure.

Needle Waste Chamber overflows into vacuum trap. Possible needle bellow overflow.

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Replace the malfunctioning check valve.

a. Record the direction in which the

valve is pointing while it is still in place.

contents at the beginning of waste chamber drain. WBC and Hgb carryover or background problem.

Possible diluent leak between the BSV sections.

Diluent might leak from check valve if RBC bath is overfilled.

Diluent might leak from check valve if WBC bath is overfilled.

Needle waste chamber drains sluggish because of back pressure in the line.

WARNING

contamination unless handled with care. Wear protective gear. Avoid skin contact. Clean up spills immediately. Dispose of valve and tubing according to your local regulations and acceptable laboratory procedures.

Biohazardous material might be contained in the check valves and associated tubing and could cause

b. Position the new check valve next

to the old check valve, making sure they are both pointing in the same direction.

c. Transfer the tubing, one at a time,

from the old to the new.

d. Compare to your drawing. Make

sure the new valve is pointing in the correct direction.

3. Return the Standby/Reset switch to the READY position.

4. Cycle a sample. Watch the check valve and ensure it is working properly and does not leak.

PN 4237522BA

Page 57

4.8 REPLACE FUSES

Use this procedure to replace fuses when a VDC (voltage) OUT OF RANGE error message displays.

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Turn OFF the instrument using the On/Off switch on the back.

3. Unplug the power cord from the wall.

WARNING Risk of shock when replacing fuse 10 because the capacitors still carry a charge after the

instrument is unplugged. If you are replacing fuse 10, wait 5 minutes to prevent getting shocked.

4. Lift the panel up and off the left side of the instrument.

ADJUST/REPLACE PROCEDURES

REPLACE FUSES

5. Based on the VDC indicated in the error message, identify the correct fuse using the charts below for 100/115 V and 220/240 V. Fuses are labeled as in the illustration.

FUSE FUNCTION

F1, F2 ac F3 5.6 Vdc F4 +5, +15, -15 Vdc F5 +24 Vdc F6 +12 Vdc F7 +240 Vdc F8 +300, 6.3 Vdc F9 +1350 laser power supply F10 2.5 A Pneumatic power supply

(back of instrument, lower right corner)

WARNING

100/115 V

F7 SLO BLO

.12A 4A 6.25A

F8 SLO BLO

.25A 2A 6.25A

F9 SLO BLO .4A

F4 SLO BLO

F5 SLO BLO

F6 SLO BLO 2A

F1 SLO BLO

F2 SLO BLO

F3 SLO BLO .5A

PN 4237522BA

Page 58

ADJUST/REPLACE PROCEDURES

REPLACE FUSES

FUSE FUNCTION

F1, F2 ac F3 5.6 Vdc F4 +5, +15, -15 Vdc F5 +24 Vdc F6 +12 Vdc F7 +240 Vdc F8 +300, 6.3 Vdc F9 +1350 laser power supply F10 1.5 A Pneumatic power supply

(back of instrument, lower right corner)

6. Unscrew the threaded fuse cap. Pull it out of its hole.

7. Remove the fuse from the cap and inspect it. If the fuse is burned out, replace it with a new one of the same type and rating:

a. Insert the fuse into the fuse cap.

b. Screw the fuse cap back in.

WARNING

220/240 V

F7 SLO BLO

.06A 2A 3.2A

F8 SLO BLO

.12A 1A 3.2A

F9 SLO BLO .2A

F4 SLO BLO

F5 SLO BLO

F6 SLO BLO 1A

F1 SLO BLO

F2 SLO BLO

F3 SLO BLO .25A

8. Rehang the panel:

a. Line up the panel with the side of

the instrument and a little above it.

b. Pull it down until you catch the

four pegs on the panel in the holes on the side of the instrument.

c. Check that you have caught all

four pegs. Be sure you cannot pull the panel out at the bottom.

9. Plug the power cord back into the wall.

10. Return the On/Off switch to ON.

11. Return the Standby/Reset switch to the READY position.

CAUTION If a fuse fails shortly after you put it in, turn OFF the instrument to prevent possible damage to

the instrument’s electrical system. Unplug the power cord from the wall outlet and call your Beckman Coulter Representative.

PN 4237522BA

Page 59

4.9 REPLACE HEMOGLOBIN LAMP ASSEMBLY

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Turn OFF the instrument using the On/Off switch on the back.

3. Unplug the power cord from the wall.

4. Open the upper front door.

WARNING if the hemoglobin lamp was lit it will be hot. You might be burned if you touch the lamp while it

is hot. Handle the hemoglobin lamp assembly by its bracket only .

5. Unplug the Hgb lamp connector.

ADJUST/REPLACE PROCEDURES

REPLACE HEMOGLOBIN LAMP ASSEMBLY

6. Carefully trace around the mounting bracket on the Diluter panel to make it easier to position the new lamp precisely.

5934090C

PN 4237522BA

Page 60

ADJUST/REPLACE PROCEDURES

REPLACE HEMOGLOBIN LAMP ASSEMBLY

7. Remove the two mounting screws that fasten the Hgb lamp assembly to the Diluter panel. Also remove the sweep-flow line bracket attached by the left screw.

8. Replace the Hgb lamp assembly with the new one.

9. Reattach the sweep-flow line bracket, then position the lamp bracket carefully within the traced lines. Replace the screws.

10. Plug in the connector.

11. Close the upper front door.

12. Plug the power cord back into the wall.

13. Return the On/Off switch to ON.

14. Return the Standby/Reset switch to the READY position.

15. Wait 15 minutes.

PN 4237522BA

Page 61

16. Select Special Functions tt Diagnostics tt

Operator Options tt

Press Û. Wait. r If the DMS displays OK, press È

to continue.

r If the DMS displays COULD NOT

ADJUST HGB LAMP, repeat step 16.

If the error message recurs, call your Beckman Coulter Representative

17. Perform Startup. Verify that the hemoglobin voltage is in range.

HGB Lamp Adjust.

4.10 REPLACE NEEDLE ASSEMBLY

WARNING Biohazardous material might be contained in components in this area and could cause

contamination unless handled with care. Wear protective gear and dispose of components in accordance with your local regulations and laboratory mandated safety procedures.

ADJUST/REPLACE PROCEDURES

REPLACE NEEDLE ASSEMBLY

1. Are you replacing the needle because it is bent?

r If no, go to step 2.

r If yes, go to step 3.

2. Clean the needle.

a. Put one part high-quality,

fragrance-free bleach (5% sodium hypochlorite) and one part distilled water in a cap-pierce tube.

b. Select Special Functions tt

Diagnostics tt Operator Options tt Fluidic Tests tt

c. Press Û.

d. Follow the screen instructions.

3. Bleed residual pressure from the system.

a. Select

b. Press Û.

c. Wait until SELECT FUNCTION

Special Functions tt

Diagnostics tt Operator Options tt Drain & Vent.

displays.

Clean Needle.

PN 4237522BA

Page 62

ADJUST/REPLACE PROCEDURES

REPLACE NEEDLE ASSEMBLY

WARNING Risk of puncture by the needle in the cartridge. Assure that proper technique is used to prevent

needle puncture. Only users trained by Beckman Coulter personnel should replace the needle. Use the following replacement procedure.

4. Put the instrument in STANDBY using the Standby/Reset switch.

5. Turn OFF the instrument using the On/Off switch on the back.

6. Unplug the power cord from the wall.

7. Open the upper then lower front doors.

8. Twist and disconnect the white fittings of needle tubing 1 and 3.

PN 4237522BA

Page 63

ADJUST/REPLACE PROCEDURES

REPLACE NEEDLE ASSEMBLY

WARNING The needle is very sharp. The used one might contain biohazardous material. Handle the needle

cartridge with extreme care. Always use the safety clip to remove and install the needle cartridge. This protects you from possible needle puncture.

9. Attach the safety clip to the front support of the needle cartridge.

a. Without squeezing the safety clip,

fit the right edge of the safety clip into the groove on the right side of the front support of the needle cartridge

b. Slide the safety clip to the left

until its left edge snaps into the groove on the left side of the front support of the needle cartridge with a click.

c. Check that the safety clip is

securely attached to the needle assembly.

10. Pull out the needle cartridge.

11. Use a cotton swab and distilled water to clean the upper and lower grooves where the needle assembly fits.

PN 4237522BA

H2O

Page 64

ADJUST/REPLACE PROCEDURES

REPLACE NEEDLE ASSEMBLY

WARNING Risk of puncture by the needle in the cartridge. During this procedure, always direct the needle

cartridge opening away from your person to prevent accidental injury. A safety clip comes attached to the new needle cartridge. If the safety clip is missing, attach one to the new needle cartridge before proceeding.

12. Remove the Aspiration Line B from the

center fitting on the old needle assembly. Use pliers to push the line up and off of the fitting. Be careful not to cut the tubing.

13. Transfer the Aspiration Line to the center fitting on the new needle assembly.

14. Dispose of the used needle assembly according to your laboratory's protocol.

15. Slide in the new needle cartridge until it clicks into place.

Note: The silver lock spring at the bottom of the needle assembly is slightly raised when the needle assembly is properly inserted.

PN 4237522BA

Page 65

16. Remove the safety clip.

a. Slightly squeeze the safety clip to

move it a little to the right

B to

separate the left side of the clip from the needle assembly.

b. Continue to move the clip to the

right

c to free it from the needle

assembly.

17. Connect the fittings of new needle tubings 1 and 3.

ADJUST/REPLACE PROCEDURES

REPLACE NEEDLE ASSEMBLY

18. Close the lower and upper front doors.

19. Plug the power cord back into the wall.

20. Return the On/Off switch to ON.

21. Return the Standby/Reset switch to the READY position.

22. Cycle a whole blood sample with known results to verify proper installation of the needle.

PN 4237522BA

Page 66

ADJUST/REPLACE PROCEDURES

REPLACE PINCH VALVES

4.11 REPLACE PINCH VALVES

This is not a routine procedure. Do this only when directed to by a Beckman Coulter Representative.

Note: Pinch valve numbers are printed next to each valve.

1. Select

Special Functions tt Diagnostics tt

Operator Options tt

Drain and Vent.

2. Press Û and wait until SELECT

FUNCTION displays.

3. Put the instrument in STANDBY using the Standby/Reset switch.

4. Make a drawing of the path the tubing takes through the nonfunctioning valve.

5. Remove the old pinch valve:

a. Disconnect the tubing that goes

through the pinch valve from their fittings.

PN 4237522BA

Page 67

b. Pull the tubing out of the pinch

valve. Use a deactivator clip to hold open the pinch valve when removing the I-beam tubing.

c. Remove the deactivator clip.

d. Using the pinch valve wrench, turn

the pinch valve about 1/4-turn until it snaps out.

ADJUST/REPLACE PROCEDURES

REPLACE PINCH VALVES

PN 4237522BA

6. Install tubing in new pinch valve:

a. Use a deactivator clip to hold open

the pinch valve.

b. Thread the I-beam tubing through

the pinch valve.

c. Remove the deactivator clip.

d. If there is a second piece of tubing,

thread it through the opening in the pinch valve.

Page 68

ADJUST/REPLACE PROCEDURES

REPLACE REAGENT CONTAINERS

7. Install the new pinch valve:

a. Line it up to start the twist 1/4-turn

from where you want the valve to end.

b. Push in and turn the valve until it

seats.

c. Attach the tubings to the fittings.

Check the drawing you made in step 4. Make sure the tubing is properly routed.

8. Return the Standby/Reset switch to the READY position.

9. Perform Startup.

10. Run a cycle. Make sure that the new pinch valve is correctly connected and there are no leaks.

4.12 REPLACE REAGENT CONTAINERS

IMPORTANT Contact or proximity could cause elevated background counts. Keep reagent lines away from

electrical lines or apparatus.

1. Record the new reagent information:

a. Select

b. Key in the new reagent

c. Press Ò to save the data and

d. Press Ñ to return to the Main

Special Functions tt Set Up tt

System Set Up tt

Reagents.

information, pressing Û after each item:

r lot number

r date reagent opened

Note: Pressing Û automatically gives you today’s date.

r expiration date

Note

: Do not forget to enter revised expiration dates where appropriate, for example, 60 days from date opened for Lyse and Pak, 90 days for Cleaner.

leave the reagent screen.

menu.

PN 4237522BA

Page 69

ADJUST/REPLACE PROCEDURES

REPLACE REAGENT CONTAINERS

IMPORTANT Pooling could cause contamination and elevated background counts. Do not pool reagents.

2. Turn OFF the compressor.

a. Select

b. Press Û. c. Press ß to select OFF. d. Press Û.

Note: Do not cycle the instrument during this procedure.

3. Open the new reagent container.

4. Unscrew the pickup tube assembly cap and slide the collar off the old reagent container.

Special Functions tt Diagnostics tt Operator Options tt Fluidics Tests tt Compressor ON/OFF.

PN 4237522BA

Page 70

ADJUST/REPLACE PROCEDURES

REPLACE REAGENT CONTAINERS

5. Lift the assembly straight up and out. Be careful not to touch the lower part of the assembly or let it touch any lab surfaces.

Note: If the lower part of the assembly does touch anything, flood with distilled water then wipe with a lint-free tissue.

6. Transfer the pickup tube assembly to the new reagent container and secure it.

a. Carefully put the pickup tube

assembly straight into the new reagent container and screw the cap in place.

b. Slide on the collar.

c. Tighten the cap.

7. Prime the lines.

a. Select

Diluter Functions tt Prime

Reagents.

and the reagent you have replaced.

b. Press Û.

8. Once priming is complete, press Ñ to return to the Main menu. Continue normal operation.

PN 4237522BA

Page 71

4.13 REPLACE REAGENT PICKUP TUBES

1. Turn OFF the compressor.

a. Select

b. Press Û. c. Press ß select OFF. d. Press Û.

Note: Do not cycle the instrument during this procedure.

2. Unscrew the pickup tube assembly cap and slide the collar off the reagent container.

Special Functions tt

Diagnostics tt Operator Options tt Fluidics Tests tt

Compressor ON/OFF.

ADJUST/REPLACE PROCEDURES

REPLACE REAGENT PICKUP TUBES

PN 4237522BA

Page 72

ADJUST/REPLACE PROCEDURES

REPLACE REAGENT PICKUP TUBES

3. Carefully lift the assembly from the container. Wait while the liquid from the tubing runs into the container.

4. Remove the tubing from the top of the old pickup tube assembly.

PN 4237522BA

Page 73

5. Attach the tubing to the top of the new pickup tube assembly. Be careful not to touch the lower part of the new assembly or let it touch any lab surfaces.

Note: If the lower part of the new assembly does touch anything, flood with distilled water then wipe with a lint-free tissue.

6. Secure the new pickup tube assembly to the reagent container.

a. Carefully put the pickup tube

assembly straight into the reagent container and screw the cap in place.

b. Slide on the collar.

ADJUST/REPLACE PROCEDURES

REPLACE REAGENT PICKUP TUBES

c. Tighten the cap.

PN 4237522BA

Page 74

ADJUST/REPLACE PROCEDURES

REPLACE TUBING

7. Check for leaks:

a. Select

Reagents.

and the reagent that corresponds to the pickup tube you replaced.

b. Press Û.

c. During the prime, check the tubing

connection for leaks.

8. Once priming is complete, press Ñ to

return to the Main menu. Continue normal operation.

4.14 REPLACE TUBING

Replace tubing if it is cracked, leaking, or has lost resilience at the pinch valves.

1. Select

2. Press Û and wait until SELECT

3. Put the instrument in STANDBY using

Special Functions tt Diagnostics tt

Operator Options tt

FUNCTION displays.

the Standby/Reset switch.

Diluter Functions

Drain and Vent.

tt Prime

4. Pull the tubing section from the two components it connects.

5. Measure new tubing of the same material, color code and bore size of the old tubing you just pulled off.

PN 4237522BA

Page 75

6. Push new tubing onto the two components it is to connect.

If you are replacing tubing onto a barbed fitting, be sure that the tubing goes over both barbs.

ADJUST/REPLACE PROCEDURES

REPLACE TUBING

If you are replacing the round (normally open) tubing in a pinch valve, remember to thread it through the end opening.

If you are replacing I-beam tubing:

a. Cut new tubing the same length as

the old tubing.

PN 4237522BA

Page 76

ADJUST/REPLACE PROCEDURES

REPLACE TUBING

b. Pull out the center rod of the pinch

valve. Insert a deactivator clip to wedge the channel open.

c. Thread the tubing straight down

through the pinch valve.

d. Inspect the tubing to see if it is

correctly threaded through both the top and bottom of the pinch valve. Use the dental mirror supplied with your HmX Hematology Analyzer.

PN 4237522BA

Page 77

e. Take the deactivator clip off the

pinch valve.

If you are replacing tubing that goes through a button pinch valve, just push the tubing through.

ADJUST/REPLACE PROCEDURES

REPLACE TUBING

7. Return the Standby/Reset switch to the READY position.

8. Perform Startup.

9. Run a cycle. Make sure the new tubing is correctly connected and does not leak.

PN 4237522BA

Page 78

ADJUST/REPLACE PROCEDURES

REPLACE WASTE ASSEMBLY

4.15 REPLACE WASTE ASSEMBLY

WARNING Biohazardous contamination could occur from contact with the waste assembly and its

associated tubing if not handled with care. Wear protective gear. Avoid skin contact. Clean up spills immediately. Dispose of the contents of the waste container according to your local regulations and acceptable laboratory procedures.

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Turn OFF the instrument using the On/Off switch on the back.

3. Disconnect the electrical connector by:

r Pressing the two lock releases

together, then

r Pulling the connector

c apart.

4. Unscrew the waste assembly cap and slide the collar off the waste container.

PN 4237522BA

Page 79

5. Carefully lift the assembly from the waste container. Wait while any residual waste liquid runs into the container.

ADJUST/REPLACE PROCEDURES

REPLACE WASTE ASSEMBLY

6. Remove the tubing from the old waste assembly.

7. Attach the tubing to the new waste assembly.

PN 4237522BA

Page 80

ADJUST/REPLACE PROCEDURES

REPLACE WASTE ASSEMBLY

8. Secure the new waste assembly to the waste container.

a. Carefully put the waste assembly

straight into the waste container and screw the cap in place.

b. Slide on the collar.

c. Tighten the cap.

9. Reconnect the electrical connector.

10. Return the On/Off switch to ON.

11. Return the Standby/Reset switch to the READY position.

PN 4237522BA

Page 81

4.16 REPLACE WASTE CONTAINER

1. Put the instrument in STANDBY using the Standby/Reset switch.

2. Turn OFF the instrument using the On/Off switch on the back.

ADJUST/REPLACE PROCEDURES

REPLACE WASTE CONTAINER

WARNING

3. Unscrew the waste assembly cap and

Biohazardous contamination could occur from contact with the old waste container and its

slide the collar off the full waste container.

PN 4237522BA

Page 82

ADJUST/REPLACE PROCEDURES

REPLACE WASTE CONTAINER

4. Lift the waste assembly straight up and out.

5. Transfer the waste assembly to the empty waste container and secure it.

a. Carefully put the waste assembly

straight into the empty waste container and screw the cap in place.

b. Slide on the collar.

c. Tighten the cap.

PN 4237522BA

Page 83

ADJUST/REPLACE PROCEDURES

REPLACE WASTE CONTAINER

6. Dispose of the biohazardous waste according to your laboratory's protocol.

7. Make sure you connected the waste assembly to the empty container correctly and that the connection is firm before every Startup.

8. Put the waste container in a place where the container and its tubing are safe from disturbance.

9. Return the On/Off switch to ON.

10. Return the Standby/Reset switch to the READY position.

CAUTION Incomplete drainage and overflow into the vacuum system can occur if the waste line is longer

than the recommended length. If it is necessary to increase the length of the waste line supplied, call your Beckman Coulter Representative before you make any modifications.

PN 4237522BA

Page 84

ADJUST/REPLACE PROCEDURES

REPLACE WASTE CONTAINER

PN 4237522BA

Page 85

5.1 OVERVIEW

Your best line of defense is to know what your HmX Hematology Analyzer does and how it sounds. Look through the pictures of Normal Sample Flow in Chapter 3 of the Reference manual. Then watch and listen while the instrument goes through its cycles.

If you later find your unit is not operating properly, you can begin to isolate the problem using two mutually reinforcing approaches:

1. If you find a series of unusual sample results, turn to the relevant Troubleshooting Table in this list.

Tab le Types of Results

5.1 All parameters questionable

5.2 All counted parameters are consistently lower than normal

5.3 All counted parameters are consistently higher than normal

5.4 WBC only is higher than normal

5.5 WBC results are lower than normal

TROUBLESHOOTING

5.6 Hgb results questionable

5.7 RBC, Plt and MCV only are affected

5.8 WBC/RBC baths overflow

Start at the top of the table and work your way down until you solve the problem. If you get to the bottom of the table and the problem still exists, call your Beckman Coulter Representative.

PN 4237522BA

Page 86

TROUBLESHOOTING

WARNING Biohazardous material might be contained in the components that you are troubleshooting and

could cause contamination unless handled with care. To avoid contamination from biohazardous materials, you should wear all your protective laboratory gear, including goggles or glasses, when you are troubleshooting and when you are operating the instrument normally.

2. If your unit does not sound right or gives other indications of a possible problem, you can watch how the instrument cycles a sample.

a. Open the upper front door.

b. Read down the list in the chart below and find, on the unit, where you will look for

each action.

c. Cycle a sample and watch each action. It may take several cycles to observe all the

actions.

d. If you find a problem, start your troubleshooting by turning to the listed reference.

Note: Information on how to troubleshoot the autoloader begins in Heading 5.3, TROUBLESHOOTING THE AUTOLOADER MECHANISM.

What action? Where to look Yes/No? Refer to

Did the instrument aspirate? BSV aspiration line Table 5.1

Did the BSV rotate? BSV center section Heading 3.3, CLEAN

OUTSIDE OF BLOOD SAMPLING VALVE (BSV) and Heading 3.4, CYCLE BSV.

Did baths fill with the dilution?

Did you see mixing bubbles? 7-10 large bubbles from bottom

Did the instrument add lytic reagent?

Was the sample pulled through the aperture?

Did the baths drain completely?

Did the baths rinse? Diluent in baths with higher level

Are parameter results unusually high or low?

Level in baths should be above the apertures

of baths in 5 bursts

Color change in the WBC bath Table 5.4

Drops coming into the vacuum isolator

Baths Table 5.1

in the WBC bath

Yes/No? Which parameters? Relevant table

Table 5.1

Table 5.2

Table 5.1

Troubleshooting Figures

Use Figure 5.1, Figure 5.2, Figure 5.3, and Figure 5.4 to locate components listed in the troubleshooting tables.

PN 4237522BA

Page 87

Figure 5.1 Instrument with Front Covers Removed

TROUBLESHOOTING

DO NOT STARE INTO BEAM

CAUTION

LASER LIGHT

1.0 MILLIWATT MAXIMUM CLASS II LASER PRODUCT 670 nm DIODE LASER

LYTIC REAGENT PUMPS

RBC APERTURE BATH

VACUUM ISOLATORS

WBC APERTURE BATH

HEMOGLOBIN LAMP

NEEDLE CARTRIDGE

NEEDLE FORWARD SENSOR

(UNDER NEEDLE CARTRIDGE)

TUBE PUSHER

ROCKER BED

STANDBY/RESET SWITCH

PN 4237522BA

SAMPLE VALVE (BSV)

RINSE BLOCK

LOADING BAY

RIGHT ELEVATOR

TUBE AVAILABLE SENSOR

LEFT ELEVATOR

GUIDE RAIL

BED SPRINGS

Page 88

TROUBLESHOOTING

Figure 5.2 Right Side of Instrument

VACUUM REGULATOR

SOLENOID PANEL

WBC DILUENT PUMP

RBC DILUENT PUMP

LASER

30 psi ADJUSTMENT KNOB

VACUUM TRAP

SHEATH PRESSURE ADJUSTMENT KNOB

SAMPLE PRESSURE ADJUSTMENT KNOB

PN 4237522BA

Page 89

Figure 5.3 Left Side of Instrument

WARNING

SLO

BLO

.12A 4A 6.25A

SLO

BLO

.25A 2A 6.25A

WARNING

SLO

BLO

.4A

.5A

TROUBLESHOOTING

FUSE PANEL

Figure 5.4 Back of Instrument

PN 4237522BA

POWER (ON/OFF) SWITCH

Page 90

TROUBLESHOOTING

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

5.2 TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.1 All Parameters Questionable

Sample only partially aspirated? r If you are in the Secondary mode, rerun the sample. Hold the vial against the

front of the aspirate probe until you hear the beep.

r If you are in the Primary mode:

t Select Special Functions tt Diagnostics tt Operator Options tt BSV

Tests tt

Press

Clean the outside of the BSV if rotation is hesitant. Follow the procedure in Heading 3.3, CLEAN OUTSIDE OF BLOOD SAMPLING VALVE (BSV).

t Check for kinks in the aspiration line. t Cycle a blood and check for a single bubble between blood and diluent. t Perform Clean Needle procedure.

1) Put one part high-quality, fragrance-free bleach (5% sodium

2) Select Special Functions tt Diagnostics tt Operator Options tt

3) Press Û.

4) Follow the screen instructions.

r Check the pneumatic tubing that goes through the pinch valves associated with

the Primary and Secondary mode aspiration pumps. Look for pinches, clogs or leaks.

t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace any problem tubing with tubing of the same diameter, length and

material.

r Check the operation of the pinch valves associated with the Primary and

Secondary mode aspiration pumps. Cycle a sample and watch for their movement. If they seem to be malfunctioning, call your Beckman Coulter Representative for assistance.

Sample sufficiently mixed? 1. Remix the sample.

2. Analyze the sample twice more. If the two results are equivalent but different

from the problem results, redraw and rerun the sample.

Cycle BSV.

Û and watch BSV action.

hypochlorite) and one part distilled water in a cap-pierce tube.

Fluidic Tests tt Clean Needle.

PN 4237522BA

Page 91

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.1 All Parameters Questionable (Continued)

TROUBLESHOOTING

No dilution gets to the baths?

Incomplete dilution gets to the baths?

Dilution enters the baths with many air bubbles?

Baths do not rinse completely at the end of the cycle?

r Cycle a sample and watch.

r Select Special Functions tt Diagnostics tt Operator Options tt BSV Tests tt

Cycle BSV.

Û and watch BSV action.

Press

Clean the outside of the BSV if rotation is hesitant. Follow the procedure in Heading 3.3, CLEAN OUTSIDE OF BLOOD SAMPLING VALVE (BSV).

r If your diluent supply is low, replace the container as in Heading 4.12, REPLACE

REAGENT CONTAINERS.

r Prime the pumps:

Select Diluter Functions tt

Press

Û.

r Verify that the rinse block is not screwed on too tightly. r Watch bath-filling action:

Select Sample Analysis tt

Press

Ð RINSE.

r Open the right side door to be sure there are no little bubbles in the conical tops

of the RBC and WBC diluent dispense pumps.

r Check Diluter tubing and fittings for leaks, clogs, pinches, and loose

connections. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

r Check the RBC and WBC diluent dispense pumps for leaks. r If pickup tubes are faulty, replace them as instructed under Heading 4.13,

REPLACE REAGENT PICKUP TUBES.

Prime Reagents tt Diluent.

Run Samples.

Is there a mixing bubble problem?

PN 4237522BA

Check mixing bubble action:

1. Open the upper front door.

2. Select Special Functions tt Diagnostics tt Operator Options tt Fluidic Tests tt Bubble Mix.

3. Press Û.

4. Watch the baths. You should see five bursts of 7 to 10 large bubbles rising from the bottom of each bath.

r Check that the yellow-striped mixing bubble tubing is free of pinches,

clogs and leaks. This tubing comes through fittings

FF16 for the RBC bath FF20 for the WBC bath

Replace problem tubing with tubing of the same color-code, bore-size, length and material.

r Make sure the check valves in the mixing bubble tubing are working

correctly. Heading 4.7, REPLACE CHECK VALVES, explains how to check and replace any faulty check valve.

Page 92

TROUBLESHOOTING

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.1 All Parameters Questionable (Continued)

Is the low vacuum out of range? r Check the lower right of the screen for an error message.

r If low vacuum is out of range, adjust it as in Heading 4.4, ADJUST PRESSURE

AND LOW VACUUM.

Was any bleach left in the aperture baths after you cleaned them?

Did the baths drain completely? r Watch for baths to drain:

r Go through a Startup:

t Select Diluter Functions tt Start Up.

Press

Û.

t When it finishes, repeat Startup.

r Follow normal Startup procedures.

t Select Sample Analysis tt Run Samples.

Press

Ð RINSE.

t Watch the baths.

r Press Ð again.

Watch to see if the pinch valves below the baths are working. If not, call your Beckman Coulter Representative for assistance.

r Check that the tubing the baths drain through is free of pinches, clogs and

leaks. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

Table 5.2 All Counted Parameters Are Consistently Lower Than Normal

BSV dirty? Follow procedures in Heading 3.3, CLEAN OUTSIDE OF BLOOD SAMPLING VALVE

(BSV).

Note: A small amount of crystallized cleaning agent on the outside of the BSV is normal. However, if you notice blood on the outside of the BSV, call your Beckman Coulter Representative for assistance in troubleshooting.

Is the low vacuum too low? r Check the lower right of the screen for an error message.

r If low vacuum is too low, adjust it as in Heading 4.4, ADJUST PRESSURE AND

LOW VACUUM.

PN 4237522BA

Page 93

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.3 All Counted Parameters Are Consistently Higher Than Normal

Low vacuum too high? r Check the lower right of the screen for an error message.

r If low vacuum is too high, adjust it as in Heading 4.4, ADJUST PRESSURE AND

LOW VACUUM.

TROUBLESHOOTING

Background count high?

Table 5.4 WBC Only Is Higher Than Normal

Mixing bubbles the problem? Follow steps under Is there a mixing bubble problem? in Troubleshooting Table 5.1.

1. Select Special Functions tt Diagnostics tt Operator Options tt System Test.

2. Press Û. Press Ë Run.

3. Wait for the background count results at the end of the cycle. Be sure all doors and panels are closed.

4. If the background is too high, check if:

r The diluent is cloudy, contaminated, or expired. r System cables are loose between components. r Any panels or doors are open. r Reagent lines are touching any electrical lines or equipment. r The wall socket is properly grounded. r Waste line is shielded from electrical lines. r There is interference from other electrical equipment close to the unit. r Bubbles are in the RBC or WBC bath. r External cables are properly shielded and away from all power lines. r Mixing bubbles are entering the baths correctly. Follow steps under Is

there a mixing bubble problem? in Troubleshooting Table 5.1.

Electronic problems? Follow procedures in Troubleshooting Table 5.3 under Background Count High?

Low vacuum too high? r Check the lower right of the screen for an error message.

r If low vacuum is too high, adjust it as in Heading 4.4, ADJUST PRESSURE AND

LOW VACUUM.

Lytic reagent running out, expired or past the open stability?

r Check lytic reagent level. r Check lytic reagent line.

r Check expiration date. Select Special Functions tt Set Up tt System Set Up tt

Reagents.

r Check when reagent was opened. If it is beyond the open stability limit,

replace it.

r Check that the lytic reagent cap is not cracked or off. r Change lytic reagent, if necessary. Follow the procedure in Heading 4.12,

REPLACE REAGENT CONTAINERS.

Does lytic reagent enter the bath without microbubbles?

BSV leaking diluent between the sections during a cycle?

Watch to see if a rush of microbubbles enters the bath with the lytic reagent.

r Check movement of pinch valve 1 located above the lytic reagent pumps. r Check the tubing in pinch valve 1 located above the lytic reagent pumps.

r Check and adjust the BSV thumbscrew for tightness. r Clean the outside of the BSV. Follow the procedure in Heading 3.3, CLEAN

OUTSIDE OF BLOOD SAMPLING VALVE (BSV).

PN 4237522BA

Page 94

TROUBLESHOOTING

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.5 WBC Results Are Lower Than Normal

WBC bath draining? r Watch for bath drain:

t Select Sample Analysis tt Run Samples.

Press

Ð RINSE.

t Look at the bath.

r Press Ð again.

Watch to see if pinch valve 6 below the WBC bath is working. If not,call your Beckman Coulter Representative for assistance.

r Check that the tubing the WBC bath drains through is free of pinches, clogs and

leaks. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

Mixing bubbles the problem? Follow procedures under Is there a mixing bubble problem? in Troubleshooting

Table 5.1.

Is the low vacuum too low? r Check the lower right of the screen for an error message.

r If low vacuum is too low, adjust it as in Heading 4.4, ADJUST PRESSURE AND

LOW VACUUM.

Is there a pinch, clog, or leak in the tubing between the WBC bath and its vacuum isolator?

r Check the tubing between the top of the WBC bath and its vacuum isolator

chamber, especially where the I-beam tubing goes through the pinch valve. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

r If you think the pinch valve is malfunctioning, call your Beckman Coulter

Representative for assistance.

PN 4237522BA

Page 95

TROUBLESHOOTING

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.6 Hgb Results Questionable

Hgb lamp off? r Check that the electrical wire from the lamp is plugged into the CBC module

panel.

r If necessary, replace the lamp as shown in Heading 4.9, REPLACE

HEMOGLOBIN LAMP ASSEMBLY.

Hgb lamp voltage needs adjusting?

Was the abnormally low Hgb caused by an incomplete aspiration in the Secondary mode?

Lytic reagent running out, expired, past the open stability period, or contaminated?

1. Select Special Functions tt Diagnostics tt Operator Options tt System Test.

2. Press Û. Press Ë Run.

3. If the Hgb lamp voltage (Hgb V) result is red: a. Select Special Functions tt Diagnostics tt Operator Options tt

HGB Lamp Adjust.

b. Press Û. Wait.

r If the DMS displays OK, press È to continue. r If the DMS displays COULD NOT ADJUST HGB LAMP, repeat the

adjustment. If the error message recurs, call your Beckman Coulter Representative.

Rerun the sample. Hold the vial against the front of the aspirate probe until you hear the beep.

r Check lytic reagent level. r Check lytic reagent line.

r Check expiration date. Select Special Functions tt Set Up tt System Set Up tt

Reagents.

r Check when reagent was opened. If it is beyond the open stability limit, replace

it.

r Check that the lytic reagent cap is not cracked or off. r Change lytic reagent, if necessary. Follow the procedure in Heading 4.12,

REPLACE REAGENT CONTAINERS.

WBC bath smudged? Wipe it off with a lint-free tissue.

PN 4237522BA

Page 96

TROUBLESHOOTING

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.7 RBC, PLT and MCV Only Are Affected

RBC or Plt counts higher than normal?

RBC or Plt counts lower than normal?

r Check background count and associated factors. Follow procedures in

Troubleshooting Table 5.3 under Background count high?

r Check for mixing bubble problems. Follow procedures under Is there a mixing

bubble problem? in Troubleshooting Table 5.1.

r See if the BSV is leaking diluent between the sections during a cycle.

t Check and adjust the BSV thumbscrew for tightness. t Clean the outside of the BSV. Follow the procedure in Heading 3.3, CLEAN

OUTSIDE OF BLOOD SAMPLING VALVE (BSV).

r Watch for bath drain:

t Select Sample Analysis tt Run Samples.

Press

Ð RINSE.

t Look at the bath.

r Press Ð again.

Watch to see if pinch valve 5 below the RBC bath is working. If not, call your Beckman Coulter Representative for assistance.

r Check that the tubing the RBC bath drains through is free of pinches, clogs and

leaks. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

r Check the lower right of the screen for a low vacuum error message. If the

vacuum is too low, follow steps in Heading 4.4, ADJUST PRESSURE AND LOW VACUUM.

r Check for mixing bubble problems. Follow procedures under Is there a mixing

bubble problem? in TroubleshootingTable 5.1.

r Check the tubing between the top of the RBC bath and its vacuum isolator

chamber, especially where the I-beam tubing goes through the pinch valve. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

t If you thing the pinch valve is malfunctioning, call your Beckman Coulter

Representative for assistance.

PN 4237522BA

Page 97

TROUBLESHOOTING

TROUBLESHOOTING CBC THROUGH UNUSUAL RESULTS

Table 5.7 RBC, PLT and MCV Only Are Affected (Continued)

Plt results erratic? r Check background count. Follow procedures in Troubleshooting Table 5.3 under

Background count high?.

r Check the sweep-flow line to the RBC bath to see if it is empty. If it is:

t Check diluent level and replenish diluent if it is low. Follow procedure in

Heading 4.12, REPLACE REAGENT CONTAINERS.

t Check the sweep-flow tubing for a leak at the RBC bath. r Check the diluent in the RBC bath. It should be above the level of the aperture. r Check to see if there is a thin steady stream of microbubbles flowing from the

brown-striped tubing up the back of the aperture. If so:

t Replace the check valve on that brown-striped tubing. The procedure is in

Heading 4.7, REPLACE CHECK VALVES.

MCV trending upward? Bleach the apertures. Follow the Bleach Apertures and Flow Cell procedure under

Heading 3.2, BLEACH APERTURES AND FLOW CELL/DISINFECT.

Table 5.8 WBC/RBC Baths Overflow

WBC/RBC baths overflow Check the WBC/RBC baths.

Select Sample Analysis tt

Press

Ð RINSE.

r Watch to see if the pinch valves below the baths are working. If not, call your

Beckman Coulter Representative for assistance.

r Check that the tubing the baths drain through is free of pinches, clogs and

leaks. t Remove clogs by connecting a closed syringe to the clogged tubing and

pulling open the syringe to remove the clog.

t Replace problem tubing with tubing of the same diameter, length and

material.

Run Samples.

PN 4237522BA

Page 98

TROUBLESHOOTING

TROUBLESHOOTING THE AUTOLOADER MECHANISM

5.3 TROUBLESHOOTING THE AUTOLOADER MECHANISM

Table 5.9 Failure To Load or Unload Cassettes Properly

The right elevator could not pick up the cassette or did not return to its home position?

The left elevator could not deliver the cassette or did not return to its home position?

Table 5.10 Failure To Rock Bed Properly

r Remove any cassettes from the load stack. r Check if the spring gates on both sides of the load stack are working properly by

pushing the springs to the sides and releasing.

r Check to see if the rollers on the gates are moving smoothly.

r Select Special Functions tt Diagnostics tt Operator Options tt Autoloader

Tests tt

Right Elevator Up/Down.

The gates should open as the elevator rises to the top.

r Call your Beckman Coulter Representative if the right elevator or the gates and

rollers are still not working properly.

r Remove any cassettes from the unload stack. r Check if the spring gates on both sides of the unload stack are working properly

by pushing the springs to the sides and releasing.

r Check to see if the rollers on the gates are moving smoothly.

r Select Special Functions tt Diagnostics tt Operator Options tt Autoloader

Tests tt

Left Elevator Up/Down.

The gates should not open as the elevator rises to the top.

r Call your Beckman Coulter Representative if the left elevator or the gates and

rollers are still not working properly.

The Autoloader bed will not rock?

r Select Sample Analysis tt Run Samples.

Press Ñ STOP. When Ê START PRIMARY.

SELECT FUNCTION appears on the status line, Press

r Select Special Functions tt Diagnostics tt Operator Options tt Autoloader

Tests tt

Rock the Bed.

r Inspect the Autoloader Bed

t Turn OFF the instrument. t Open the upper and lower front doors. t Look to see if any object is preventing the bed from rocking.

t Close the lower then upper front doors. t Turn ON the instrument.

r Call your Beckman Coulter Representative if the bed is not working properly.

PN 4237522BA

Page 99

Table 5.11 Failure To Move Cassettes Properly

TROUBLESHOOTING

TROUBLESHOOTING THE AUTOLOADER MECHANISM

No cassette on the bed but

CANNOT MOVE CASSETTE ON BED error displayed?

One or two cassettes on the bed that are not cleared?

Table 5.12 Failure of Cassette To Clasp Tubes

Cassette does not firmly clasp tubes.

Table 5.13 Autoloader Needle Pierce and Retract Failures

Incomplete needle pierce?

r Place a cassette on the loading gate.

Select Special Functions tt

Tests tt

Autoloader Test Routine.

r If the problem still exists, perform the Check Autoloader Bed Sensor procedure

under Heading 5.4, AUTOLOADER CHECK PROCEDURES.

r Perform the Jammed Cassette Removal procedure under Heading 4.3,

JAMMED CASSETTE REMOVAL.

r Inspect cassette for crystal or blood buildup. r Wash cassette with soap or 10% bleach solution (1 part 5% sodium

hypochlorite with 9 parts distilled water).

r Rinse thoroughly with warm tap water. r Examine to be sure all crystals and blood buildup are eliminated.

Diagnostics tt Operator Options tt Autoloader

r Select Sample Analysis tt Run Samples.

Press Ñ STOP. When

Ê START PRIMARY. r If the error recurs, select Ý+c to clear the bed.

SELECT FUNCTION appears on the status line, Press

r Try to process another cassette of samples.

r Call your Beckman Coulter Representative if the problem still exists.

Incomplete needle retract?

PN 4237522BA

r Select Sample Analysis tt Run Samples.

Press Ñ STOP. When

Ê START PRIMARY.

r If the error recurs, select Ý+c to clear the bed. r Look and see if the needle assembly is in the home position.

1) Turn OFF the instrument.

2) Open the upper and lower front doors.

3) Look at the needle assembly. Make sure it is in the home position

4) Close the lower then upper front doors.

5) Turn ON the instrument.

SELECT FUNCTION appears on the status line, Press

r Try to process another cassette of samples.

r Call your Beckman Coulter Representative if the problem still exists

Page 100

TROUBLESHOOTING

TROUBLESHOOTING THE AUTOLOADER MECHANISM

Table 5.14 Tube Retract Failure

Incomplete tube retract? r Select Sample Analysis tt Run Samples.

Press Ñ STOP. When SELECT FUNCTION appears on the status line, Press Ê START PRIMARY.

r If the error recurs, select Ý+c to clear the bed.

r Look at the tube in the cassette.

1) Turn OFF the instrument.

2) Open the upper and lower front doors. If the tube pusher is still together with the tube inside the cassette,

call your Beckman Coulter Representative.

3) Slide the cassette to the left and lift off the bed. Check to see if

r The tube is the correct size for the cassette. r The springs inside the cassette are damaged. r The label on the tube is stopping the tube from being pushed

back into the cassette.

4) Close the lower then upper front door.

5) Turn ON the instrument.

r Try to process another cassette of samples.

r Call your Beckman Coulter Representative if the problem still exists

Table 5.15 Tube Available Sensor Failure

Tube available sensor error? r Select Sample Analysis tt Run Samples.

Press Ñ STOP. When SELECT FUNCTION appears on the status line, Press Ê START PRIMARY.

r Select Ý+c. r Check the Tube Available sensor.

Press the cone-shaped tube available sensor in the middle of the bed. If the sensor is jammed, call your Beckman Coulter Representative.

PN 4237522BA

Beckman Coulter COULTER HmX User guide

Specifications and Main Features

Frequently Asked Questions

User Manual

COULTER® HmX Hematology Analyzer with Autoloader

WARNINGS AND PRECAUTIONS

WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:

WARNING Risk of operator injury if:

CAUTION System integrity might be compromised and operational failures might occur if:

REVISION STATUS

r comply with the EU IVD Directive (98/79/EC).

r change the company name from Coulter Corporation to Beckman Coulter Inc.

Updates were made to the company corporate address.

LEGAL NOTICES

CONTENTS

TRADEMARKS

ILLUSTRATIONS

TABLES

This introductory section contains the following topics:

INTRODUCTION

r About this Manual

r Conventions

r Hot Keys

r List of Icons

HOW TO USE YOUR COULTER® HmX HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET

Use the Host Specifications Manual to locate information about transmission to a host computer.

Use the Master Index to locate a subject in your documentation set.

ABOUT THIS MANUAL

This information is organized as follows:

CONVENTIONS

r Use the index to easily locate specific information in this manual.

This manual uses the following conventions:

r ITALICS indicate screen messages such as RESET THE SYSTEM or Press any key.

t or a function such as F3 Run.

To select a menu item, highlight it then press Û.

r ë+ë indicates to press and hold the first key listed, then press the next key.

HOT KEYS (SHORTCUTS)

Ì Print. Ý+Ê Move from the current screen to

LIST OF ICONS

Open the upper front door.

Open the lower front door.

Ý+Ñ Stop cycle.

Ý+C Clear the autoloader bed.

Close the upper front door.

Close the lower front door.

Open the right side door.

Remove the left side panel.

Print the screen for your logbook.

Close the right side door.

Check for leaks.

1.1 CBC CALIBRATION - GENERAL

Recommended Conditions

Beckman Coulter recommends that you perform the Calibration procedure:

r In the Primary mode.

When to Calibrate

You should calibrate your instrument:

r At installation, before you begin analyzing samples.

r After you replace any component dealing with

t dilution preparation, such as the BSV

t primary measurement, such as an aperture.

r If your Beckman Coulter Representative suggests you calibrate.

CALIBRATION

When to Verify

You should verify the calibration of your instrument:

r As dictated by your laboratory procedures, local or national regulations.

r When controls begin to show evidence of unusual trends.

r When controls exceed the manufacturer’s defined acceptable limits.

1.2 CBC CALIBRATION PRELIMINARY PROCEDURES

3. Bleach the aspiration system.

c. Press Û.

d. Follow the screen instructions.

4. Perform Startup.

5. Run commercial cell controls.

1.3 CBC CALIBRATION WITH S-CAL® CALIBRATOR

1. Take the S-CAL calibrator kit out of the refrigerator.

5. Press Í # OF ASPIRATIONS. Set to 11.

7. If there is data in the table:

8. Prepare the CBC Calibration screen.

c. Gently invert the vial eight times.

d. Repeat this mixing procedure.