Professional Documents
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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.
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.
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.
REVISION STATUS
Issue A, 1/04
LH 500 Software Version 1A. Manual derived from Online Help Version 1A.033081.
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.
PN 624602A iii
REVISION STATUS
iv PN 624602A
CONTENTS
INTRODUCTION, xvii
CONVENTIONS, xix
PN 624602A v
CONTENTS
2 STARTUP, 2-1
vi PN 624602A
CONTENTS
PN 624602A vii
CONTENTS
6 SHUTDOWN, 6-1
viii PN 624602A
CONTENTS
8 SETUP, 8-1
PN 624602A ix
CONTENTS
x PN 624602A
CONTENTS
9 TROUBLESHOOTING, 9-1
PN 624602A xi
CONTENTS
xii PN 624602A
CONTENTS
APPENDIX A, A-1
APPENDIX B, B-1
PN 624602A xiii
CONTENTS
REFERENCES, REFERENCES-1
INDEX, INDEX-1
TRADEMARKS
xiv PN 624602A
CONTENTS
ILLUSTRATIONS
1.1 COULTER LH 500, 1-1
7.1 Coulter Method, 7-1
7.2 FlowCell, 7-2
7.3 Loading Bay, 7-3
7.4 Aspiration Pump, 7-4
7.5 Waste Chamber, 7-5
7.6 BSV (CBC delivery), 7-6
7.7 Reagent Pump, 7-7
7.8 WBC Bath, 7-7
7.9 Flow Cell Aperture, 7-8
7.10 Sweep Flow, 7-10
7.11 DF 1 Scatterplot, 7-12
7.12 Retic Population, 7-12
9.1 Laser Safety Label, 9-1
9.2 Safety Labels on the TTM, 9-2
9.3 Laser Safety Labels for Bar-Code Reader on the LH 500 Hematology Analyzer, 9-3
9.4 Laser Safety Labels for LH 500 Power Sources, 9-3
2.1 Bar-Code Label Specifications, B-6
PN 624602A xv
CONTENTS
TABLES
1.1 CLIA Complexity Table, 1-2
1.2 Sample Stability, Room Temperature, 1-15
1.3 Sample Stability, Cold Temperature, 1-16
1.4 Reference Ranges, 1-18
9.1 Instrument Error Messages, 9-11
9.2 Workstation PC Errors, 9-36
2.1 Bar-Code Label Specifications, B-6
2.2 Code-Related Specifications, B-7
xvi PN 624602A
INTRODUCTION
Use the Reference manual for descriptions and figures of the main system components; its
specifications; information on installation; and software options. The Reference manual for
the LH 500 Series System is included in the online Help system; it is available in hard copy by
request.
Use the Special Procedures manual to run calibration and to clean, replace or adjust a
component on the instrument. This document is made up of procedures from the online Help
system; it is available in hard copy by request.
Use the Instructions for Use manual for the day-to-day operation of your instrument. This
document is made up of procedures from the online Help system; it includes Startup; running
controls and samples; reviewing data; Operation Principles; troubleshooting; Shutdown; and
the software on the Workstation. This document is available in hard copy by request.
Use the Master Index to easily locate a subject in your hard-copy Reference manual,
Instructions for Use manual or Special Procedures manual. The Master Index comes with the
hard copy of both the Instructions for Use manual and the Special Procedures manual.
Use the Host Transmission Specification to find the information needed to program the
transmission interface between the LH 500 Series System and your laboratory’s host
computer. This document comes with your LH 500 Series System.
See the Documentation page on the back cover of this manual for the contents of each manual.
It can help you to determine quickly in which manual the information you need is located.
PN 624602A xvii
INTRODUCTION
ABOUT THIS MANUAL
xviii PN 624602A
INTRODUCTION
ONLINE HELP SYSTEM
CONVENTIONS
This document uses the following conventions:
PN 624602A xix
INTRODUCTION
CONVENTIONS
xx PN 624602A
1SYSTEM OVERVIEW 1
1.1 INTENDED USE
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and
leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH
500 Analyzer also provides a semi-automated reticulocyte analysis.
The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal
system-generated parameters, from the patient who needs additional studies. These studies
include further measurements of cell size and cell distribution, or any other test that helps
diagnose the abormality.
Parameters
The systems measure these hematologic parameters of whole-blood specimens:
PN 624602A 1-1
SYSTEM OVERVIEW
INTENDED USE
*In the USA, the PDW and Pct parameters are Not for Diagnostic Use. The value for PDW is
used as an internal check on the reported platelet parameters Plt and MPV.1, 2, 3
Unless otherwise stated, all parameter results are shown in the US unit format throughout the
manuals.
Analyte
Reticulocyte Moderate
1-2 PN 624602A
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM 1
1.2 LH 500 SERIES SYSTEM
LH 500 Front View
Note: The above diagram is shown with the Needle Shield removed.
PN 624602A 1-3
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM
1-4 PN 624602A
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM 1
LH 500 Left Side View
Fuse Panel
PN 624602A 1-5
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM
1-6 PN 624602A
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM 1
LH 500 Right Side View
PN 624602A 1-7
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM
Workstation
The Workstation:
1-8 PN 624602A
SYSTEM OVERVIEW
LH 500 SERIES SYSTEM 1
Workstation Keyboard
to access Help
CD ROM Drive
PN 624602A 1-9
SYSTEM OVERVIEW
USING COMMAND CENTER
Select one of the following blue phrases to obtain information about an area on the Command
Center:
r Buttons
r Process Type field
r Bar-Code ID field
r Status area
r Predilute and Factor
r Run Type field
r User field
r Aspiration Mode
r Blood Detector
Application Buttons
The buttons on the Command Center enable you to access major Workstation functions:
Select To Access
Run Configuration application where you can quickly change defaults for
workflow preferences.
Patient application where you can review, report and modify existing patient
sample results and add new patient sample requests.
Quality Assurance application where you can review results for the various
quality assurance methods, such as controls, XB and calibration.
System Setup application where you can customize your LH 500 Series
Workstation to your laboratory workflow preferences, such as flagging limits
and decision rules.
1-10 PN 624602A
SYSTEM OVERVIEW
USING COMMAND CENTER 1
History Log Viewer application where you can review and comment on
messages posted to various electronic logbooks that identify history.
System Status application where you can view current details about the system.
The Shutdown Type window so you can logoff or shutdown your Workstation.
Starts system
Process Type
This field displays the current processing of the sample analysis data received from the
instrument. The instrument must be in a stop state before the process type can be changed.
The next time the Workstation receives data from the instrument, it stores it in the database
according to your selection.
PN 624602A 1-11
SYSTEM OVERVIEW
USING COMMAND CENTER
Bar-Code ID
1. Select this field.
2. Use the handheld scanner to scan the sample ID for the next sample cycled in Manual
aspiration mode or perform the following procedure:
a. Using the Workstation keyboard, type a sample ID that you want used for the next
Enter
IMPORTANT Risk of missing identifier. If you fail to send the sample ID to the instrument within 90
seconds of data entry in the Bar-code ID field, the sample ID provided is cleared. This minimizes the risk of
sample misidentification.
Status Area
Graphics appear in this area to provide status about the system.
This Means
The system is functioning properly. (GREEN)
The system recognized an event that might have caused it to stop processing,
but the automatic stop option was turned off. Check for additional status
graphics to indicate the nature of the event. You can also check the History
Logs for detailed messages. (YELLOW)
1-12 PN 624602A
SYSTEM OVERVIEW
USING COMMAND CENTER 1
An Analytical Station attached to the Workstation stopped processing and
sent a message to the Workstation that it should stop. Check the History Logs
for detailed messages.
The database is functioning improperly. Shut down and restart the
Workstation. If the problem persists, call your Beckman Coulter
Representative.
Last control results were outside the defined limits. Check the History Logs
for detailed messages.
Last batch of XB results was outside the defined limits. Check the History
Logs for detailed messages.
Example: When processing a sodium citrate tube to obtain a platelet count, set the dilutional
correction to 1.1.
Measured parameters RBC, HGB, WBC, and PLT are multiplied by the factor before
calculating the other parameters. HCT, MCH, MCHC and PCT will reflect the multiplier since
they are calculated from the four measured parameters.
Once the sample has been processed, the dilution factor returns to the default of 1.0.
Note: This feature can be used only in Manual Mode and will only run in CBC Mode.
Rule Type
These fields appear gray and inactive when you edit an existing rule.
identifies the type of rule you want to create. Select the type of rule you want to create:
PN 624602A 1-13
SYSTEM OVERVIEW
CASSETTE HANDLING
User
This field is a non-editable box that displays the current user ID.
Aspiration Mode
The mode (Automatic or Manual) used to aspirate the sample. The Workstation obtains this
information from the instrument, and you cannot edit it.
If the sample has not yet been cycled, this field appears blank.
2. To disable the Blood Detector, uncheck the box next to the blood detector on the
Command Center.
Note: The system flags all parameters with a P (partial aspiration) when samples are analyzed
with blood detectors disabled. P flagged control run results are automatically removed from
statistical calculations; there is no method to reintroduce the flagged runs into calculations.
1-14 PN 624602A
SYSTEM OVERVIEW
PRINTER 1
1.5 PRINTER
The LH 500 Series can print to any printer supported by Microsoft Windows® 2000 and
connected to your Workstation. You attach the printer to the back of your computer using a
printer cable. After attaching your printer, you must also set up your printer at the
Workstation.
If you have problems with your printer, read the documentation that came with your printer,
or contact the manufacturer of the printer.
Sample Stability
The following tables show the average results for specimens from five normal donors
collected in K3EDTA. The specimens were stored at room temperature and cold temperature.
For this study, room temperature was 70 - 75ºF (21-24ºC) and cold temperature was 37 -
39ºF (3-4ºC). Room temperature specimens were mixed for 22 inversions and then
immediately analyzed. Upon removal from the refrigerator, the cold specimens were mixed
for 22 complete inversions and analyzed within five minutes.
*T:1 hour T:4 hours T:8 hours T:24 hours T:48 hours
PN 624602A 1-15
SYSTEM OVERVIEW
PERFORMANCE CHARACTERISTICS
*T:1 hour T:4 hours T:8 hours T:24 hours T:48 hours
1-16 PN 624602A
SYSTEM OVERVIEW
PERFORMANCE CHARACTERISTICS 1
Table 1.3 Sample Stability, Cold Temperature
No suspect flags were present on the specimens up to 24 hours at room temperature and up
to 48 hours at cold temperature
PN 624602A 1-17
SYSTEM OVERVIEW
PERFORMANCE CHARACTERISTICS
Reference Ranges
A Normal Range study was conducted to assess the Reference Ranges for the LH 500 Series.
Whole-blood samples were collected from 123 donors (males and females). The selection of
donors was consistent with guidelines stated in NCCLS, C28-A.
1-18 PN 624602A
SYSTEM OVERVIEW
PERFORMANCE CHARACTERISTICS 1
The presence of certain interfering substances, as listed in this section, can also yield
misleading results.
ALL
Misleading results can occur if the specimen is not properly collected, stored or transported.
Beckman Coulter, Inc. recommends that you follow NCCLS or equivalent procedures to
ensure proper specimen collection, storage and transport. Always follow manufacturer's
recommendations when using microcollection devices for capillary specimen collection.
Misleading results can occur if specimens contain clots. Always use good laboratory practices
for inspecting specimens for clots and verifying results.
Misleading results can occur if the specimen is not properly mixed. Always use good
laboratory practices to ensure specimens are appropriately mixed. Do not bypass or
circumvent the automated mixing process used on the LH 500 Series.
WBC
Certain unusual RBC abnormalities that resist lysing, nucleated RBCs, fragmented WBCs,
agglutinated WBCs, any unlysed particles greater than 35 fL, very large or aggregated platelets
as when anticoagulated with oxalate or heparin, specimens containing fibrin, cell fragments,
or other debris such as pediatric and oncology specimens.41, 42, 43, 44 NRBCs, giant platelets,
platelet clumps, malarial parasites, precipitated elevated proteins, microlymphoblasts, very
small lymphocytes, fragmented white cells, agglutinated white cells, lyse resistant red cells,
unlysed particles > 35 fL in size.
RBC
Very high WBC count, high concentration of very large platelets, agglutinated RBCs, RBCs
smaller than 36 fL, specimens containing fibrin, cell fragments, or other debris such as
pediatric and oncology specimens.45, 46
Hgb
Very high WBC count, severe lipemia, heparin, certain unusual RBC abnormalities that resist
lysing, or anything that increases the turbidity of the sample such as elevated levels of
triglycerides.47
MCV
Very high WBC count, high concentration of very large platelets, agglutinated RBCs, RBC
fragments that fall below the 36-fL threshold, or rigid RBCs.48, 49, 50, 51
RDW
Very high WBC count, high concentration of very large or clumped platelets as in blood
anticoagulated with oxalate or heparin, RBCs below the 36-fL threshold, two distinct
populations of RBCs, RBC agglutinates, or rigid RBCs.52, 53, 54, 55
Plt
Very small red blood cells near the upper threshold, cell fragments, clumped platelets as with
oxalate or heparin, platelet fragments, or cellular debris near the lower platelet
PN 624602A 1-19
SYSTEM OVERVIEW
PERFORMANCE CHARACTERISTICS
threshold.56,_57,_58,_59 Giant platelets, platelet clumps, white cell fragments, electronic noise,
very small red cells, red cell fragments.
MPV
Known factors that interfere with the Plt count and shape of the histogram or known effects
of EDTA.60, 61, 62, 63
Hct
Known factors that interfere with the parameters used for computation: RBC and MCV.
MCH
Known factors that interfere with the parameters used for computation: Hgb and RBC.
MCHC
Known factors that interfere with the parameters used for computation: Hgb, RBC and MCV.
Diff Parameters
Known factors that affect the WBC count as listed above or high triglycerides that affect
lysing.64 Hypogranular granulocytes, agranular granulocytes, lyse resistant red cells, very
small or multi-population lymphocytes, elevated triglycerides, precipitated elevated proteins.
Reticulocytes
Erythrocyte inclusions stained by New Methylene Blue, if sufficiently numerous within a
sample, and some hemoglobinopathies (SS, SC) might affect the accuracy of the reticulocyte
enumeration.65
1-20 PN 624602A
2STARTUP 2
2.1 LOGGING OFF/ON THE WORKSTATION
Logging OFF
2. Select to confirm that you want to log off the current user name and display the
Log On window.
Logging ON
1. Type your user name that was defined by your laboratory administrator.
2. Type your password that was defined by your laboratory administrator. If you forget your
password, contact your laboratory administrator. Your laboratory administrator can reset
your password.
3. Select . The Workstation checks your password and starts the appropriate
applications.
2. Press .
3. If autoprint has been turned ON, startup results will automatically print.
4. To review your results, go to the Check Daily Test Results screen.
5. If background fails, on the command center select BACKGROUND as the process type
and repeat.
The Clean Cycle can be used in place of the regular Shutdown cycle. This function switches
the instrument to cleaning agent, waits 30 minutes and then automatically performs a Startup
cycle.
PN 624602A 2-1
STARTUP
CHECKING DAILY TEST RESULTS
2. The message Clean Cycle in progress. This cycle takes approximately 35 minutes. Please
wait is displayed. The Diluter changes the instrument to use cleaner, which takes
approximately two minutes. The system then waits for 30 minutes prior to the startup
cycle.
3. Verify your Daily Checks information.
a. Select .
b. Select a row indicating the date, time and type of test results you want to see. The
results appear on the window.
Note: Select only 1 row. Daily Checks results will not be displayed if you select more
than 1 row of results.
4. Check the reagent status, background status and subsystem status for any items that
failed.
4. Select to see the specific results for electronic, pressure/vacuum, Hgb voltage, and
temperature readings.
2-2 PN 624602A
STARTUP
CHECKING HGB VOLTAGE TEST RESULTS 2
PN 624602A 2-3
STARTUP
CHECKING HGB VOLTAGE TEST RESULTS
2-4 PN 624602A
3QUALITY CONTROL 3
3.1 QUALITY CONTROL OVERVIEW
Quality control includes monitoring routine performance and service in conjunction with the
use of controls and calibrators. You should routinely check results between quality control
analyses. The combination of these methods provides the assurance of complete quality
control.
The LH 500 Series incorporates multiple quality control techniques. For the CBC, CBC/DIFF
and RETIC parameters, the LH 500 Series uses the established technique of commercial
controls. The LH 500 Series uses a stabilized particle suspension, such as LATRON, to verify
flow cell alignment, gains, and CVs for flow cell volume, conductivity and light scatter. The
Workstation stores information about the control setup and control results in the DataBase.
The LH 500 Series also allows you to customize the way the Workstation displays control
results. Your laboratory can establish acceptance limits for control results based on the
control source, type and level, as well as the aspiration mode. This can help you better
understand control results and interpret them more quickly.
Beckman Coulter recommends that Quality Control checks be performed using patient or
commercial controls in both automatic (primary) and manual (secondary) modes at intervals
established by your lab. When using a commercial control, refer to the package insert to
determine which mode to use. Failure to recover Control values within your lab's expected
limits or the presence of unexplained shifts or trends in either mode of analysis should be
investigated. If Control problems in either mode cannot be resolved, call your Beckman
Coulter Representative.
CAUTION Possible system damage could occur if you aspirate anything except latex control or latex
primer using this function. Do not aspirate any other materials with this function.
PN 624602A 3-1
QUALITY CONTROL
CYCLING CONTROLS IN RETIC MODE
8. Press .
9. Select LATEX in the Run Type field.
CAUTION Running whole blood or control through the aspirate probe while in the Retic mode can damage
the system. Perform the pre-prep procedures according to the instructions below.
IMPORTANT Modifications to the pre-prep procedures or failure to follow these instructions may lead to
misleading or erroneous results. Perform the pre-prep procedures according to the instructions below.
IMPORTANT Misleading results can occur if Retic-C cell control is not prepared properly. Follow the
procedure on the package insert to properly warm, mix and prepare Retic-C cell control for anlysis.
1. Make sure:
a. Dispenser is fitted securely to the
Reagent B bottle.
b. Reagent fills the clear tubing
without any bubbles.
3-2 PN 624602A
QUALITY CONTROL
CYCLING CONTROLS IN RETIC MODE 3
IMPORTANT Dispensing Reagent A at an angle changes the dilution of the preparation. Dispense the
drops of Reagent A vertically.
PN 624602A 3-3
QUALITY CONTROL
CYCLING CONTROLS IN RETIC MODE
2. Press .
IMPORTANT To ensure accurate results, add the blood-stain mixture directly to the bottom of the tube;
do not allow the blood-stain mixture to run down the sides of the tube. To prevent drying of this small
amount, proceed immediately to the next step.
3-4 PN 624602A
QUALITY CONTROL
CYCLING CONTROLS IN RETIC MODE 3
IMPORTANT To ensure accurate results, allow Reagent B to run down the side of the tube so that no
foaming or bubbles occur, but rapidly enough to mix the control/stain mixture and Reagent B. Do not
perform any additional mixing.
5. Dispense Reagent B.
a. Place tube "B" with the
control/stain aliquot at a 30° angle
under the tip of the Reagent B
dispenser.
b. Dispense 2 mL of Reagent B into
the test tube "B". DO NOT MIX.
press .
PN 624602A 3-5
QUALITY CONTROL
CYCLING CBC/DIFF CONTROLS IN MANUAL ASPIRATION MODE
4. Press
5. Load the cassette with the control material.
6. Place the cassette firmly and securely into the loading bay. The instrument begins to
cycle the controls.
7. Review the control results.
IMPORTANT If you choose to run 5C Series controls in the manual aspiration mode, you must establish
your own target limits and ranges. The control is assayed for automatic aspiration mode only.
8. Press .
3-6 PN 624602A
QUALITY CONTROL
CONTROL CODES AND FLAGS 3
3.6 Reviewing Control Results
other parameter results and graphs. Use to add comments to a control run.
4. If you want to view the results and graphics for a specific latex run:
a. Select the control run you want to view in the table.
This To Do This
Adjust assigned values to the current mean values.
The following codes appear in place of results when the system cannot obtain results:
PN 624602A 3-7
QUALITY CONTROL
CONTROL CODES AND FLAGS
..... Incomplete computation. When this code occurs for a parameter result it
indicates an incomplete computation due to problems such as data
insufficiency.
When this code appears on all parameter results, it indicates a Power
Supply Failure. Check this condition and rerun the sample.
----- When this code appears for CBC parameter results and no average
histogram appears for the affected parameter, it indicates a total voteout.
If this code appears for WBC, the WBC subpopulation absolute numbers
appear as ..... since they are calculated from the white count and the WBC
result was non-numeric.
+++++ The result exceeds the instrument's reportable range. Follow your
laboratory’s policies for reviewing the sample.
IMPORTANT Incorrect results can occur. If the WBC, RBC, HGB, or PLT have +++++ when cycling in
Manual mode, run a blank cycle before analyzing the next test sample to prevent carryover to the next
sample. When cycling in Automatic mode, rerun the sample immediately following the one with the
+++++. Sample dilutions may also result in wrong differential results. The instrument will automatically set
to CBC mode when predilute is chosen.
::::: The instrument detected a clog in the flow cell. You must clear the clog and
rerun the sample.
????? Invalid data.
3-8 PN 624602A
QUALITY CONTROL
CONTROL CODES AND FLAGS 3
H Result is higher than your reference range. Follow your laboratory’s policies
for reviewing the sample.
L Result is lower than your reference range. Follow your laboratory’s policies
for reviewing the sample.
P Partial aspiration detected.
R Review the result according to your laboratory's protocol. When editing
parameter results, this flag requires special handling. Any parameter
derived from an R-flagged parameter cannot be recalculated until the
parameters with the R flags have been edited.
V Result corresponds to a single count-period voteout.
v Result is a parameter calculated from one with a single count-period
voteout. This flag overwrites +, *, and R flags.
You may want to look at the messages that appear on the Research Data window. The
Research Data window provides more detailed research data.
PN 624602A 3-9
QUALITY CONTROL
DELETING CONTROL DATA
1. Select an item in the control results grid on the right side of the window. If you want to
3-10 PN 624602A
QUALITY CONTROL
ADJUSTING CONTROL LIMITS 3
r If you want to delete all the information associated with a lot number, including the
setup information, select the lot number by selecting its file folder.
5. Select to delete the data. A message that asks you to confirm your request
appears.
6. Select to delete the data. The Workstation deletes the selected data. The data
cannot be retrieved.
5. Select to save the comments. For control runs, appears in the CMNT column
to indicate that it has a comment.
PN 624602A 3-11
QUALITY CONTROL
PROVIDING COMMENTS FOR QUALITY ASSURANCE
IQAP Setup
An IQAP participant number is assigned to you at the time you enroll in the program. This
participant number identifies your data set from all others. Ensure that your IQAP
participant number has been entered in your Workstation prior to downloading your data to
diskette.
WARNING This function will erase all data contained in the floppy disk. Select OK to continue, Cancel to
abort.
7. Select to begin copying the control information to the diskette in the IQAP
format.
IMPORTANT Wait until the drive indicator light is off before pressing the eject button to remove the diskette
from the a: drive.
3-12 PN 624602A
QUALITY CONTROL
XB ANALYSIS 3
8. After the download process is complete, remove the diskette from the a: drive and
immediately attach one of the pre-printed IQAP labels. Do not cover the sliding metal
door, the drive spindle, or the punched hole on the top right of the disk with the label.
9. Place the diskette in the pre-addressed mailer and send to IQAP.
10. If you wish to keep hard copies of the control folder results on record, print the contents
of the folders. Refer to the LH 500 Series Workstation Help as necessary.
Troubleshooting
If there is a problem downloading QC data to the diskette check the following:
r Make sure the diskette is inserted completely in the a: drive of the Workstation
computer.
r If you are using a blank diskette, make sure it has been formatted.
r If you are using a diskette from a LH 500 Series control or calibrator kit, try a different
diskette.
If all attempts to download are unsuccessful you can submit your control data to IQAP using
the Summary Data Entry Form or the COULTER Retic-C Control Data Entry Form. Refer to
the Data Entry chapter of the Interlaboratory Quality Assurance Program Procedure Manual
for specific instructions.
3.13 XB ANALYSIS
Overview
XB Analysis is a quality-control method that monitors instrument performance (calibration)
by tracking the MCV, MCH, and MCHC parameters of all patient samples. For more
information about XB Analysis, refer to the XB Analysis topic in the Reference Information
section of the Help.
Using XB
When using XB Analysis, it is important to process samples randomly; for example,
chemotherapy or neonate patient samples, if processed as a group, can cause XB to be OUT.
When XB Analysis is on, the Workstation compares the mean values with the target values
and the percent limits. If the mean values are within the percent limits of the target values,
then the XB is IN.
Setup Options
When you set up XB Analysis, you have options:
r You can specify that you want XB to automatically stop processing on an instrument.
Otherwise, XB status appears in the XB history log, and it is up to you to investigate it.
You should investigate any batch that is out of the XB limits.
r You can specify if you want to automatically print XB Analysis information.
PN 624602A 3-13
QUALITY CONTROL
XB ANALYSIS
6
r RBC value is less than 1.0 × 10
r Partial aspiration
r Non-numeric value for MCV, MCH, and MCHC
You can delete individual samples from the batch. The total number of deletes in a batch must
not exceed 5 out of a batch size of 20 for XB; otherwise, the batch means calculation becomes
invalid and is automatically removed from the Batch Means screen.
Reviewing XB Results
XB batch results and statistics of the batch previous to the last batch.
The window refreshes the results table, statistics and graphs based on the changes you made
3-14 PN 624602A
4SAMPLE ANALYSIS 4
4.1 COLLECTING SPECIMENS
Collect whole blood in a salt of EDTA according to tube manufacturer's instructions and
procedures in:
IMPORTANT Misleading results could occur if you fail to leave space at the top of the tube between the
sample and the stopper. Ensure you leave space at the top of the tube between the sample and the stopper
to facilitate mixing. Ensure, also, that the sample is properly mixed before analysis.
When preparing capillary specimens, follow the manufacturer's recommendations for the
microcollection device.
For Automatic aspiration mode, you need at least 1.0 mL of sample with proper proportion of
blood to anticoagulant.
For LH 500 Series systems, the instrument aspirates a maximum of 185 µL (0.185 mL) of
whole blood.
For Manual aspiration mode and Pre-dilute mode, the instrument aspirates approximately
125 µL (0.125 mL).
For Retic mode, 50 µL (0.50 mL) of whole blood is required for the preparation of the stained
sample. The instrument aspirates approximately 2 mL of a prepared diluted sample that was
originally made using 50µL (0.50 mL) of whole blood.
Note: For more information on handling and processing blood specimens, refer to NCCLS
publication H18-A. 6
Venipuncture Specimens
For CBC and DIFF:
r Run within 24 hours after collection if stored at room temperature (23.9°C or 75°F).
r Run within 48 hours after collection if stored at 2 to 8°C (35.6 to 46.4°F).
For Reticulocytes:
r Run within 24 hours after collection if stored at room temperature (23.9°C or 75°F).
r Run within 48 hours after collection if stored at 2 to 8°C (35.6 to 46.4°F).
Capillary Specimens
Follow the manufacturer's recommendations for the microcollection device.
PN 624602A 4-1
SAMPLE ANALYSIS
IDENTIFYING SAMPLES OVERVIEW
r Reading the cassette number and cassette position of each sample at the time it is cycled
r Reading the tube’s bar-code label automatically
r Allowing you to provide sample demographic information that includes optional
identifiers, such as a patient identifier
r Time-stamping sample results with the date and time they were analyzed.
r Reading the tube’s bar-code label when you use the handheld scanner
r Allowing you to provide sample demographic information that includes optional
identifiers, such as a patient identifier
r Time-stamping sample results with the date and time they were analyzed.
Setting Up Identifiers
As part of system setup, you must specify whether your laboratory wants the cassette number
and position, the tube’s bar-code label, or both used as a positive identifier. When you specify
a positive identifier, the system links it irrevocably to the date and time of instrument
analysis.
If you specify cassette number and position, ensure you provide enough demographic
information or use another identifier, such as the sample identifier, to distinguish sample
results since you may use a cassette number and position more than once throughout the day.
CAUTION Possible specimen leakage or clogging of the aspiration system can occur. Excessive piercing of
the sample tubes causes significant coring of the stopper. The number of pierces without problems can
vary slightly among sample tube types and manufacturers. Do not pierce a blood collection tube listed in
this document more than five times.
Your instrument contains a self-adjusting tube sensor. This tube sensor automatically adjusts
to various sizes of tubes in the same cassette. You do not need to manually change the
instrument tube sensor settings.
If your laboratory requires adapters or clips, contact your Beckman Coulter Representative.
4-2 PN 624602A
SAMPLE ANALYSIS
UNIVERSAL TUBE PROCESSING 4
4.5 Using Bar-Code Labels
Beckman Coulter recommends the use of bar-code labels for specimen identification.
Specimen tube bar-code labels provide sample identification. Bar-code label specifications are
in the Reference Information section of this help system.
If you use Interleaved 2-of-5 bar-code specimen labels, you must call your Beckman Coulter
Representative to set the number of digits on the label in the Analyzer.
PN 624602A 4-3
SAMPLE ANALYSIS
UNIVERSAL TUBE PROCESSING
Labeling Requirements
IMPORTANT Risk of misidentification. Use of poor quality, dirty, improperly placed or damaged bar-code
labels could keep the instrument from reading the bar-code labels. Ensure the bar-code labels are
undamaged. Ensure the bar-code labels conform to the specifications provided in the Bar-Code Label
Specifications topic.
Place the bar-code label so that the first bar of the bar-code symbol is at least 1/4 inch from
the tube cap.
4-4 PN 624602A
SAMPLE ANALYSIS
UNIVERSAL TUBE PROCESSING 4
4.6 Cassette Handling
WARNING Risk of personal injury. Forcing a tube into the cassette improperly could cause it to break. Do
not force a tube into a cassette. If a tube should break, use your laboratory’s safety procedure for cleaning
the broken glass.
IMPORTANT Sample misidentification could occur. If not using the appropriate bar-code labels on the
sample tubes, ensure you place the tubes in the proper cassette positions.
PN 624602A 4-5
SAMPLE ANALYSIS
UNIVERSAL TUBE PROCESSING
IMPORTANT Poor quality specimens may require inspection and special attention. Specimens that may
contain fibrin, cell fragments or other debris, or have been difficult to collect, such as, pediatric or oncology
specimens may require special handling. The LH 500 is an automated cell counter that uses triplicate
counting with strict voting criteria, and has proprietary flagging algorithms to confirm parameter results
prior to reporting. Rarely, a transient or partial aperture blockage may not be detected by any of these
processes. A partial aperture blockage may cause erroneous results, such as, WBC count lower than what
is actually present.
As with any analysis method in which a specimen of suspect quality is used, particular
attention should be given to the results. Verify the accuracy of results that are flagged and
review all results that exceed your laboratory's action limits.
IMPORTANT Changing the reporting units after initial setup may cause misleading results. Make sure the
reporting units currently selected for patient results are correct by checking any result in the database.
IMPORTANT A printer malfunction could cause you to report erroneous results. Check all printers attached
to your LH 500. Make sure they are working properly and all numbers are printing correctly.
IMPORTANT Operating the LH 500 Series with open doors or panels introduces electrical interference
which can cause misleading results. Operate the LH 500 Series with all doors and panels closed.
IMPORTANT Running out of reagent will cause erroneous results. The reagent sensors are designed to
alert you before you run out. If you disable reagent sensors, the message Reagent Sensors Off appears on
the screen and on graphic printouts. Carefully monitor the reagent’s level if you ever disable its sensor.
WARNING Risk of personal injury. If a problem occurs while the system is cycling, press the emergency
stop button and wait for the system to stop before you do anything to correct the problem. Attempting to
correct an instrument problem while the instrument continues to process samples could injure you.
IMPORTANT Misleading results can occur if specimens contain clots. Inspect specimens for clots and use
good laboratory practices for verifying results to ensure you do not receive misleading results.
1. Ensure your specimens have been collected, stored, and mixed properly.
2. On the Command Center, select AUTO ANALYSIS as the process type; C or CD as the
run type; and AUTO as the aspiration mode.
3. Load the cassettes.
4. Place the cassettes firmly and securely into the loading bay on the right side of the
Diluter.
Note: If AUTO MODE message appears in the instrument Status Box, the cassette will
4-6 PN 624602A
SAMPLE ANALYSIS
CYCLING SAMPLES IN MANUAL ASPIRATION MODE 4
6. The instrument will remain in automatic mode until is pressed.
IMPORTANT Poor quality specimens may require inspection and special attention. Specimens that may
contain fibrin, cell fragments or other debris, or have been difficult to collect, such as, pediatric or oncology
specimens may require special handling. The LH 500 is an automated cell counter that uses triplicate
counting with strict voting criteria, and has proprietary flagging algorithms to confirm parameter results
prior to reporting. Rarely, a transient or partial aperture blockage may not be detected by any of these
processes. A partial aperture blockage may cause erroneous results, such as, WBC count lower than what
is actually present.
As with any analysis method in which a specimen of suspect quality is used, particular
attention should be given to the results. Verify the accuracy of results that are flagged and
review all results that exceed your laboratory's action limits.
IMPORTANT Blood detectors are inactive in Manual mode. Sample and aspiration integrity are not checked.
To avoid misleading results, ensure complete immersion of the aspirator tip in the sample. Do not remove
the sample until you hear the beep.
IMPORTANT Misleading results can occur if specimens contain clots. Inspect specimens for clots and use
good laboratory practices for verifying results to ensure you do not receive misleading results.
3. Enter Sample Identifier into the bar-code field; and then press or . If
PN 624602A 4-7
SAMPLE ANALYSIS
CYCLING SAMPLES IN PRE-DILUTE MODE
IMPORTANT Poor quality specimens may require inspection and special attention. Specimens that may
contain fibrin, cell fragments or other debris, or have been difficult to collect, such as, pediatric or oncology
specimens may require special handling.
The LH 500 Series is an automated cell counter that uses triplicate counting with strict voting
criteria, and has proprietary flagging algorithms to confirm parameter results prior to
reporting. Rarely, a transient or partial aperture blockage may not be detected by any of these
processes. A partial aperture blockage may cause erroneous results, such as, WBC count
lower than what is actually present.
As with any analysis method in which a specimen of suspect quality is used, particular
attention should be given to the results. Verify the accuracy of results that are flagged and
review all results that exceed your laboratory’s action limits.
1. Prepare the dilution of blood and diluent appropriate to purpose of dilution with a
minimum of 150 µL total volume. Note: Use larger volumes of diluent and blood, if
available, to minimize the possibility of short sampling the dilution.
2. On the Command Center, select AUTO ANALYSIS as the process type.
3. Check the Pre-dilute checkbox and enter the factor.
Note: The instrument will automatically run the sample as a CBC in manual mode.
Command Center settings used prior to running a pre-dilute do not change.
4. Press .
7. Present the sample to the manual aspiration tip and immerse the tip into the sample.
Press sample bar.
IMPORTANT Incomplete aspiration will cause erroneous results. Tilt the tube as shown to ensure full
aspiration.
8. Remove the sample when you hear the beep and the System Status box displays
DILUTING.
4-8 PN 624602A
SAMPLE ANALYSIS
CHANGING RUN TYPE 4
Sample count results are automatically multiplied by the dilution factor for the final
results. The dilution factor used is displayed and printed next to mode as Cxdilution
facto Manual, eg Cx2.0 M. "Predilute" is also printed in the footer of the printout.
The CURRENT MODE message displays the run type you select.
2. To disable the Blood Detector, uncheck the box next to the blood detector on the
Command Center.
Note: The system flags all parameters with a P (partial aspiration) when samples are
analyzed with blood detectors disabled. P flagged control run results are automatically
removed from statistical calculations; there is no method to reintroduce the flagged runs
into calculations.
PN 624602A 4-9
SAMPLE ANALYSIS
ENABLING/DISABLING BLOOD DETECTOR
4-10 PN 624602A
5DATA REVIEW 5
5.1 REVIEWING SAMPLE RESULTS
2. If necessary, select to display the Results & Graphics window that contains:
r Parameters
r Flags and codes
r Suspect/definitive messages
r Histograms
r DataPlots
r Identification information.
3. If necessary, find the sample results you want to review.
4. Specify the way you want the window updated:
Keeps the current sample displayed. You can view the graphs,
demographics and detailed parameter results (including research
data) for the sample results as needed.
Select on the Results & Graphics window to display the Research Data window that
contains:
PN 624602A 5-1
DATA REVIEW
EDITING SAMPLE RESULTS
Double-click a histogram to see an enlarged version of it. Select to return to the normal
size.
IMPORTANT Incorrect results can occur if you estimate the number of cells from the distribution curves.
Curves show only the relative, not actual, number of cells in each size range. Do not estimate the number of
cells from the distribution curves.
5-2 PN 624602A
DATA REVIEW
REVIEWING PATIENT HISTORY 5
IMPORTANT Incorrect results or incorrect identification could lead to misleading results or
misidentification. Before saving edits, check that you typed them properly.
6. Select to save the edits in the database. The Workstation recalculates any derived
parameters and reapplies flagging limits. Decision criteria rules are not reapplied.
Reports with Pending status include a special message indicating the status. When all
tests complete processing, the report includes a special message that indicates the change
in status.
Flagging
The Workstation assigns priorities to flags. Critical flags (cH/cL) are the most important.
They are followed by action flags (aH/aL) and then default flags(H/L).
IMPORTANT Flagging is evaluated when the sample is analyzed. Flagging is reevaluated for a sample when
the results are manually edited, or when new results are received for a pending sample. Flagging is not
reevaluated upon a change of flagging limits for results already in the database. Delta Check and Reflex
Decision Rules are not reevaluated.
Beckman Coulter Inc. does not claim to identify every abnormality in all samples. Beckman Coulter
suggests using all available flagging options to optimize the sensitivity of instrument results. All flagging
options include reference ranges (H/L), action and critical limits, definitive flags, suspect flags, parameter
codes, delta checks, decision rules and system alarms. Beckman Coulter recommends avoiding the use of
single messages or outputs to summarize specimen results or patient conditions.
You can customize many of the flags to suit the needs of your laboratory. You can define:
PN 624602A 5-3
DATA REVIEW
PROCESSING RESULTS OVERVIEW
r Action limits that exceed the default limits. These appear with a unique aH (action high)
and aL (action low) flags
r Critical limits that exceed the action limits. These appear with a unique cH (critical
high) and cL (critical low) flags
r Limits (action) that force the display of definitive messages
r Limits that route results to a special Review Folder (Auto Validation).
Of course, you do not need to define these all at once, you can use the default set and
gradually add additional limits based on your laboratory's assessment.
You can also define rules (Reflex Manager) to identify sample results that meet a set of
criteria. For example, you can automatically generate the message "Perform Retic Count" in
the comment field if the Workstation receives a sample result with Hgb <= 10.5 or RBC <= 3.2
and MCV <= 65.
As part of your rule definition, you can specify where you want the results that satisfy the rule
to appear. For example, the Workstation can route results to special Reflex Manager, Delta
Check and Review folders.
5-4 PN 624602A
DATA REVIEW
FLAGS AND CODES 5
Processing Flagging Limits
The following flow chart illustrates how the system processes flagging limits.
PN 624602A 5-5
DATA REVIEW
FLAGS AND CODES
IMPORTANT The operating temperature influences the rate of kinetic reactions. The LH 500 Series should
be recalibrated whenever the ambient temperature changes by 10 degrees Fahrenheit.
IMPORTANT Flagging is evaluated when the sample is analyzed. Flagging is reevaluated for a sample when
the results are manually edited, or when new results are received for a pending sample. Flagging is not
reevaluated upon a change of flagging limits for results already in the database.
Beckman Coulter suggests using all available flagging options to optimize the sensitivity of instrument
results. All flagging options include reference ranges (H/L), action and critical limits, definitive messages,
suspect messages, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter
recommends avoiding the use of single messages or outputs to summarize specimen results or patient
conditions.
Flags appear to the right of the result. Codes appear in place of results when the system
cannot obtain results. When looking at codes and flags, look for patterns. For example, see if
all results show the same or related codes. If they do not, look at all the RBC parameters, then
the WBC parameters. For specific parameters, the flagging occurs as a result of the flagging
on other parameters.
Flags
IMPORTANT Incorrect results can occur. If the WBC, RBC, HGB, or PLT have + when cycling in Manual
mode, run a blank cycle before analyzing the next test sample to prevent carryover to the next sample.
When cycling in Automatic mode, rerun the sample immediately following the one with the +. Sample
dilutions may also result in wrong differential results. The instrument will automatically set to C run type
when predilute is chosen.
5-6 PN 624602A
DATA REVIEW
FLAGS AND CODES 5
+ Result exceeds linearity (reportable) range. Follow your laboratory's policies for
reviewing the sample.
aL Result is lower than your action low limits. Follow your laboratory’s policies for
reviewing the sample.
aH Result is higher than your action high limits. Follow your laboratory’s policies for
reviewing the sample.
cL Result is lower than your critical low limits. It is a critical value and requires
immediate attention. Follow your laboratory’s policies for reviewing the sample.
cH Result is higher than your critical high limits. It is a critical value and requires
immediate attention. Follow your laboratory’s policies for reviewing the sample.
D Result triggered a Delta Check rule as defined by your laboratory.
e Result has been calculated from a manually edited parameter. This flag overwrites
+, *, v, V and R flags.
E Result has been edited. This flag overwrites +, *, v, V and R flags.
H Result is higher than your reference interval high limit. Follow your laboratory’s
policies for reviewing the sample.
L Result is lower than your reference interval low limit. Follow your laboratory’s
policies for reviewing the sample.
P The instrument detected a partial aspiration during sample analysis or the blood
detectors are disabled.
R Review the result according to your laboratory's protocol. When editing parameter
results, this flag requires special handling. Any parameter derived from an
R-flagged parameter cannot be recalculated until the parameters with the R flags
have been edited. R flags may also indicate a system alarm has occured.
V Result corresponds to a single count-period voteout.
v Result is a parameter calculated from one with a single count-period voteout. This
flag overwrites +, *, and R flags.
You may want to look at the messages that appear on the Research Data window. The
Research Data window provides more detailed research data.
Codes
PN 624602A 5-7
DATA REVIEW
SUSPECT AND DEFINITIVE MESSAGES
----- When this code appears for CBC parameter results and no average histogram
appears for the affected parameter, it indicates a total voteout.
If this code appears for WBC, the WBC subpopulation absolute number results
appear as ..... since they are calculated from the white count and the WBC result
was non-numeric.
+++++ This result exceeds the instrument's operating range. Follow your laboratory’s
policies for reviewing the sample.
IMPORTANT Incorrect results can occur. If the WBC, RBC, HGB, or PLT have +++++ when cycling in
Manual mode, run a blank cycle before analyzing the next test sample to prevent carryover to the next
sample. When cycling in Automatic mode, rerun the sample immediately following the one with the +++++.
Sample dilutions may also result in wrong differential results. The instrument will automatically set to C run
type when predilute is chosen.
::::: The instrument detected a clog in the flow cell. PC1, PC2 or FC will be displayed
on the y-axis of the dataplot
IMPORTANT Beckman Coulter Inc. does not claim to identify every abnormality in all samples. Beckman
Coulter Inc. suggests using all available flagging options to optimize the sensitivity of instrument results.
All flagging options include reference ranges (H/L), action and critical limits, definitive flags, suspect flags,
parameter codes, delta checks, decision rules and system alarms. Beckman Coulter Inc. recommends
avoiding the use of single messages or outputs to summarize specimen results or patient conditions.
Suspect Messages
Suspect messages appear for sample results based on an abnormal cell distribution or
population. The system generates these messages according to an internal algorithm.
5-8 PN 624602A
DATA REVIEW
SUSPECT AND DEFINITIVE MESSAGES 5
All sample results with suspect messages automatically appear in the Review Folder. Review
the sample according to your laboratory's procedures. If you observe a higher rate of suspect
flags than usual call your Beckman Coulter Representative.
PN 624602A 5-9
DATA REVIEW
SUSPECT AND DEFINITIVE MESSAGES
Definitive Messages
Definitive messages appear for sample results based on action limits exceeded for age only.
The messages are set up as part of your flagging limits.
5-10 PN 624602A
DATA REVIEW
AUTO VALIDATION OVERVIEW 5
Macrocytosis (with High limit for MCV
gradient ranges)
Microcytosis (with Low limit for MCV
gradient ranges)
Monocytosis High limit for MO% or
MO#
Neutropenia Low limit for NE% or NE#
Neutrophilia High limit for NE% or
NE#
Pancytopenia Low limit for WBC, RBC This message can override messages
and Plt for Anemia, Leukopenia and
Thrombocytopenia, if it is enabled.
The system generates this message
automatically.
Reticulocytosis High limit for RET% or
RET#
Small Platelets Low limit for MPV
Thrombocytopenia Low limit for Plt Pancytopenia overrides this
message.
Thrombocytosis High limit for Plt
r Auto Validated, meaning that it has passed all criteria for validation
r Validated, meaning that although it failed at least one criteria, the sample has been
manually validated
r Not Validated, meaning that the sample failed at least one criteria and has not been
manually validated.
On the screen, samples which are Auto Validated will not appear in the Reflex, Delta, or
Review folders, and will not have the Validate button enabled. If the sample fails validation
for non-decision rule criteria, it would appear in the Review Folder. If the sample fails for
Decision Rule criteria, it could appear in either the Delta Check or Reflex folders (depending
which one was triggered), or in the Review folder, depending whether they have configured
Delta Check and Reflex failures to go to the Review folder. It is possible, if the sample fails
both decision rule-related and non-rule related criteria, for the sample to appear in both or all
three folders. If the user reviews and manually validates the sample, it would no longer
appear in any of these folders, and the validate button would be in a depressed state when
that single sample is selected.
PN 624602A 5-11
DATA REVIEW
AUTO VALIDATION OVERVIEW
For the print and host transmission, these messages are output as "Sample Auto Validated",
"Sample Not Validated", or "Sample Validated". In addition, individual codes will provide
validation information for predefined parameter sets, referred to as parameter blocks. If at
least one parameter from the parameter block is included in the reported results, the
appropriate validation code will be displayed. The codes may be disabled for host
transmission in the Host Communications Setup area.
The major difference between the screen and print is that the screen is not profile specific.
This means that on screen, all parameters, suspect/definitive messages, and rules triggered
will be displayed, and the validation status depends on the whole sample. For the print and
host transmission, only those parameters, suspect/definitive messages, and rule messages
which are part of the profile are output, and the validation codes and messages are based on
this output.
We first reduce the parameters to an active set. The set of active parameters starts with the set
of parameters which is enabled for the system in parameter setup. It is further reduced to
those parameters which were either run on the analyzer or edited into the sample. For
printing and transmission, the active set is further reduced to the parameters included in the
selected profile. If the status we are looking for is a validation code, the active set is further
reduced to the parameters applicable to that code.
For example, suppose that all parameters are enabled for the system except research. Now
suppose that a CD sample is run. We are now only looking at CD parameters, except the
research ones. Now if we are looking at the printout and the selected profile is CBC, we are
reduced to only the CBC parameters. To determine the status of the Validiation Message we
are looking for all the CBC parameters. To determine the status of the parameter codes, such
as the C Code (CBC parameter block), then we're still looking at all CBC parameters. If it is H
Code, we're looking at only Hgb and Hct parameters. The W code only looks at the WBC,
Hgb and Plt parameters If we're looking for the D code (Diff parameter block) or R code
(Reticulocyte block), we have no parameters, and the code would not be displayed.
Now that we know which parameters to include, we will look for anything which causes an
Auto Validation failure:
r Any active parameter which exceeds limits, where the limit has been configured as
autoverification criteria. This could also be based on a definitive message, where the
definitive set has been specified as autoverification criteria.
r H & H Check Failed is a separate check. Since it is not tied to any limit set, it can not be
configured as autoverification criteria. It will always trigger a failure when both HGB and
HCT are part of the active set.
r Any active parameter which has a nonnumeric value (+++++, :::::, ....., -----), a Review
flag, Partial Aspiration (P), exceeds linearity (+), or MCV exceeds threshold (*).
r Any suspect (non-research) flag, where the active parameter set includes at least one
parameter from the suspect message parameter group. Suspect messages are associated
with either CBC, Diff, or Retic parameters. If, for example, a CBC suspect message is
triggered and at least one CBC parameter is in the active set, we have an autovalidation
failure.
5-12 PN 624602A
DATA REVIEW
AUTO VALIDATION OVERVIEW 5
r Any reflex or delta rule, where ALL parameters included in the rule must be in the active
set.
IMPORTANT Several precautions have been taken to ensure integrity of Manual Validation. If new data is
collated to a sample, if the sample is edited in a way that would cause a reflag, or if the profile is changed,
manual validation for the sample is cleared.
Sample Setup:
r Run Type = CBC/Diff
r Patient Sample preassigned with a CBC and Retic Report Profile
Ret % %
Ret # /pL
PN 624602A 5-13
DATA REVIEW
AUTO VALIDATION OVERVIEW
Manual Validation:
Once the results are reviewed and manually validated at the workstation the report
appears as follows.
Comments:
WBC 4.8 103/L RBC 2.53 106/L Plt 80 aL 103/L
Hgb 6.3 g/dL MPV 10.3 fL
Hct 19.6 %
MCV 77.4 fL
MCH 24.9 pg
MCHC 32.1 g/dL
RDW 16.1 %
Ret % %
Ret # /pL
Sample Setup:
Run the sample in the Retic mode, sample results are as follows.
Ret % 0.14 %
Ret # .0035 /pL
5-14 PN 624602A
6SHUTDOWN 6
6.1 POWER ON/OFF OVERVIEW
The LH 500 Series Analyzer, Workstation Computer, Instrument Computer and Monitor are
connected to an Uninterrupted Power Supply (UPS). In the event of a power outage at your
facility, the components will continue to operate for a short time so you can shut down the
system. If your system has a printer, it should be connected directly to the facility power.
For troubleshooting purposes, you may be directed to power down selected pieces of the
system. The following sections provide information on the pieces of the system that you can
power on/off.
Analyzer
Every 24 Hours: Beckman Coulter recommends that you shut down the instrument for at
least 30 minutes every 24 hours. If you leave your instrument powered on in Shutdown and
the pneumatics are off, an automatic purge occurs every 24 hours to prevent flow cell and
sample line clogging.
Over 48 hours: Prolonged Shutdown. Perform a Shutdown for 30 minutes. Then perform a
Startup and turn the power off.
Over 7 Days: Extended Shutdown. All reagents are replaced with Distilled water. Turn the
power to the instrument off.
Over 45 Days: Long-Term Shutdown. Call your Beckman Coulter Representative who will
decide appropriate actions that will need to be taken. This could include complete removal of
reagents and release of the pinch valves.
Instrument Computer
See topic Optimizing the Instrument Computer Hard Disk.
Workstation Computer
You should only power down the Workstation after shutting it down. Powering down the
Workstation also powers down the monitor. See topic Shutting Down the Workstation.
Monitor
You can turn the Monitor off while the instrument cycles samples; however, a screen saver is
available to extend the life of the monitor. It is unnecessary to power off the monitor on a
regular basis.
PN 624602A 6-1
SHUTDOWN
PERFORMING EXTENDED SHUTDOWN
WARNING To prevent injury, turn the power OFF when performing any manual cleaning, replacement or
adjustment procedure if the instrument has been in Shut Down more than 22 hours. The Autopurge cycle
turns on the pneumatics power supply and performs a special Diluter cycle automatically 23 hours after a
Shut Down cycle has been initiated. This cycle repeats every 24 hours after that.
Beckman Coulter, Inc. recommends that you perform an extended Shutdown if the
instrument will be idle for more than 7 days. If you turn off the power at night and the
instrument is going to be idle for more than 48 hours, perform the Prolonged Shutdown
procedure.
6-2 PN 624602A
SHUTDOWN
RESETTING THE WORKSTATION 6
3. Select . The Workstation logs you off, saves all active data and closes all
applications. It can no longer receive information from your information system or the
Analyzer.
Several messages appear, such as the Shutdown in Progress window. When the
Workstation finishes closing all applications, the Shutdown Computer window
appears. This window indicates that it is all right to power off the machine. If the
Shutdown Computer window does not appear within 5 minutes, the Workstation has
encountered a software problem. You must power down the Workstation.
3. Select . The Workstation logs you off, saves all active data and closes all
applications. It can no longer receive information from your information system or the
Analyzer.
Several messages appear, such as the Shutdown in Progress window. When the
Workstation finishes closing all applications, the Shutdown Computer window
appears. This window indicates that it is all right to power off the machine. If the
Shutdown Computer window does not appear within 5 minutes, the Workstation has
encountered a software problem. You must power down the Workstation.
PN 624602A 6-3
SHUTDOWN
RESETTING THE WORKSTATION
4. Select . The Workstation logs you off, saves all active data and closes all
applications. Several messages appear, such as the Shutdown in Progress window. When
the Workstation finishes closing all applications, it restarts the Workstation.
6-4 PN 624602A
7OPERATION PRINCIPLES 7
7.1 GENERAL PRINCIPLES
CBC Analysis
The Coulter method accurately counts and sizes cells by detecting and measuring changes in
electrical resistance when a particle (such as a cell) in a conductive liquid passes through a
small aperture.
Each cell suspended in a conductive liquid (diluent) acts as an insulator. As each cell goes
through the aperture, it momentarily increases the resistance of the electrical path between
the submerged electrodes on either side of the aperture. This causes a measurable electronic
pulse. For counting, the vacuum used to pull the diluted suspension of cells through the
aperture must be at a regulated volume.
The number of pulses correlates to the number of particles. The height of the electrical pulse
is proportional to the cell volume.37, 38, 39, 40
Differential Analysis
As the sample, prepared for differential analysis, streams through the flow cell (Figure_2)
these three measurements occur simultaneously on each individual white cell to classify it:
PN 624602A 7-1
OPERATION PRINCIPLES
GENERAL PRINCIPLES
r Light from the laser bouncing off the individual WBC cells characterizes cellular surface,
shape, and reflectivity.
Effect of Reagents
The conductive diluent must affect cells minimally, if at all.
Both lytic reagents must destroy erythrocytes without significantly affecting leukocytes. They
must work rapidly to satisfy the speed with which the system works.
Retic Analysis
The Coulter Reticulocyte Method is a two-step sample preparation, followed by analysis in
the LH 500 Hematology Analyzer Retic Mode using volume conductivity and scatter (VCS)
technology. First, a supravital dye, New Methylene Blue, in a special solution (Reagent A), is
incubated with whole blood samples. The dye precipitates the basophilic RNA network found
in reticulocytes. Then, when added to the samples, a hypotonic clearing reagent (Reagent B)
clears hemoglobin and unbound stain from the cells. After the treatment, and if viewed in a
7-2 PN 624602A
OPERATION PRINCIPLES
SPECIMEN TRANSPORT 7
wet prep microscopically, mature erythrocytes appear as clear, slightly spherical cells.
Reticulocytes have the same characteristics but with darkly-stained reticulum.
Stained reticulocytes differ from mature erythrocytes (RBCs) and other cell populations by
light scatter, direct current measurements, and opacity characteristics.
r At the Workstation, instruct the instrument to run samples in the Automatic mode.
r The right lift platform beneath the stacked cassettes rises and the bottom cassette is
deposited on the rocker bed.
r The platform lowers the cassette to the level of the rocker bed where it is rocked back
and forth, mixing the samples.
r The cassette moves along the bed, while rocking, until the first tube reaches the piercing
station.
r The cassette stops moving forward but continues rocking.
t The bar-code scanner reads the Cassette/Position label and the tube label.
t The cassette continues rocking.
t The Autoloader stops if the Cassette/Position label is not read.
r If the labels are read, the bed is brought forward into the piercing position.
PN 624602A 7-3
OPERATION PRINCIPLES
SAMPLE FLOW
7-4 PN 624602A
OPERATION PRINCIPLES
SAMPLE FLOW 7
3. Figure_6 applies to steps d through h. The BSV rotates to segment three portions of the
sample:
r 1.6 µL for the RBC bath dilution
r 28 µL for the WBC bath dilution
r 28 µL for the WBC diff.
4. The air pump transfers the diff portion to the sample line.
5. Dispensers send diluent to the BSV to pick up and dilute the RBC and WBC portions.
6. The CBC lytic reagent pumps send the CBC lytic reagent (LYSE S III) to the WBC bath. It
lyses the RBCs and converts the hemoglobin into a stable compound.
7. Mixing bubbles enter both baths.
PN 624602A 7-5
OPERATION PRINCIPLES
SAMPLE FLOW
8. The BSV rotates back. The Erythrolyse II (PAK LYSE) reagent pumps send the diff lytic
reagent to pick up and deliver the diff portion to the mixing chamber, rupturing red cell
membranes and dissolving cell debris in the process.
The StabiLyse (PAK PRESERVE) reagent pump dispenses diff leukocyte preservative. It
enters the mixing chamber to stabilize the leukocyte subpopulations. See Figure_7.
7-6 PN 624602A
OPERATION PRINCIPLES
SAMPLE FLOW 7
9. The vacuum isolators supply vacuum to the baths to pull the sample through the
apertures for the cell counts. The unit counts and sizes RBCs and Plts at the RBC
aperture and WBCs at the WBC aperture.
It measures hemoglobin photometrically through the WBC bath. See Figure_8.
10. The unit does the WBC differential in the triple transducer module (TTM) at the flow
cell aperture.
Sample pressure to the mixing chamber pushes the sample through the flow cell for the
diff analysis. See Figure_9.
PN 624602A 7-7
OPERATION PRINCIPLES
COUNTING AND SIZING
CAUTION Using undiluted whole blood can clog multiple components of the instrument and might require
a service call to clean the components when the LH 500 Hematology Analyzer is in the Retic Mode.
Manually dilute the blood before introducing the sample to the instrument for aspiration when it is in the
Retic Mode.
Placing the instrument in the Retic Mode allows the sample to flow directly to the mixing
chamber and flow cell of the triple transducer module (TTM). When in this mode, the sample
MUST be manually diluted and prepared before being aspirated by the instrument.
Routine Counting
Each bath has one aperture. The regulated vacuum draws a precise volume of sample dilution
through each aperture. At each aperture, the system counts cells in three consecutive periods
of 4 seconds each. During each counting period, the analyzer gathers and amplifies the cell
pulses. It also checks that WBC and RBC data accumulations are above a predetermined low
cut-off value.
7-8 PN 624602A
OPERATION PRINCIPLES
COUNTING AND SIZING 7
Pulses from the RBC bath that represent cells as 36 fL or greater are classified as red cells.
Pulses from the WBC bath that represent cells as 35_fL or greater are classified as white cells.
Both counts then go to the computer for coincidence correction and voting.
Extended Counting
If accumulations are too low, the unit extends the sensing period. This ensures that the
size-distribution curves accurately reflect the true cell population.
Coincidence Correction
Occasionally, more than one cell goes through the aperture at the same time. When cells
coincide, however, the analyzer counts only one pulse. Because the frequency of coincidence
is proportional to the actual count, the system easily corrects results for coincidence.
Triplicate Counting/Voting
The LH 500 Hematology Analyzer uses triplicate counting, strict voting criteria, and
proprietary flagging algorithms to confirm parameter results prior to reporting. After
coincidence correction, the system compares the data from the three count periods then votes
and rejects any questionable data. Voting occurs for: WBC, RBC, Plt, MCV, RDW, and MPV. If
the system finds disagreement among all the count periods or some other internal criteria are
not met, the system displays and prints a total voteout code (– – – – –) instead of the
parameter result.
IMPORTANT In rare instances, especially for specimens where fibrin, cell fragments, or other debris are
likely to occur, such as pediatric and oncology specimens, a transient or partial aperture blockage may not
be detected by any of these methods. Therefore, verify flagged results for accuracy and review any result
which exceeds your laboratory action limits.
Beckman Coulter uses triplicate counting and voting to maximize the accuracy of the results.
Sweep Flow
The sweep flow is a steady stream of diluent that flows behind the RBC aperture during the
sensing periods (B). This keeps cells from swirling back into the sensing zone. Because these
swirling cells (A) would be peripherally sensed, their pulse height would be similar to Plt
pulse heights. See Figure_3.10.
PN 624602A 7-9
OPERATION PRINCIPLES
COUNTING AND SIZING
Pulse Editing
When cells pass through the aperture near the edge or at an angle rather than at the center,
they create atypical pulses. Pulse editing technology eliminates atypical pulses from the
analysis because they distort the true size of the cell. This prevents atypical pulses from
influencing size measurements.
7-10 PN 624602A
OPERATION PRINCIPLES
SCATTERPLOT DEVELOPMENT 7
The Algorithm verifies that each of the fitted curves:
Condition 5 above causes generation of a Plt no-fit condition where the Plt is flagged with a
Review (R) flag, and the 'Low Plt Interference' message is displayed on the Research screen.
Additionally, Plt results are Review (R) flagged when the 'High Plt Interference' flag occurs
(the text message is displayed on the Research screen).
Differential-Related
The scatterplot, Figure 11, shows lymphocyte {circle key 4}, monocyte {circle key 1},
neutrophil {circle key 2}, and eosinophil {circle key 3} populations. The basophil population
is behind the upper right quadrant of the lymphocyte {circle key 4} population.
PN 624602A 7-11
OPERATION PRINCIPLES
SCATTERPLOT DEVELOPMENT
Retic-Related
Figure 12, this graph shows the mature red blood cell population {circle key 1} and the
reticulocyte population {circle key 2}.
7-12 PN 624602A
OPERATION PRINCIPLES
SCATTERPLOT DEVELOPMENT 7
Retic Parameters
The system makes three measurements as each cell passes through the flow-cell aperture:
PN 624602A 7-13
OPERATION PRINCIPLES
SCATTERPLOT DEVELOPMENT
r Multiplies the number of RBCs in each channel by the size of the RBCs in that channel.
r Adds the products of each channel between 36 fL and 360 fL.
r Divides that sum by the total number of RBCs between 36 fL and 360 fL.
r Multiplies by a calibration constant and expresses MCV in femtoliters.
Hematocrit (Hct)
This is the relative volume of packed erythrocytes to whole blood, computed as:
7-14 PN 624602A
OPERATION PRINCIPLES
SCATTERPLOT DEVELOPMENT 7
Differential Counts
Percentages
The percentages of leukocytes from each category are derived from the scatterplot.
Absolute Numbers
The absolute numbers of leukocytes in each category are computed from the WBC count and
the differential percentage parameters.
PN 624602A 7-15
OPERATION PRINCIPLES
SCATTERPLOT DEVELOPMENT
On the LH 500 Series, you can enter the red cell count manually, via data base explorer, if you
want the absolute number result. For more information, see Cycling Retic Samples topic.
The MRV parameter is the average volume of all reticulocytes (or the mean volume of all retic
events). It is calculated from the RET% and reported in femoliters (fL).
The IRF parameter is an indication of new reticulocyte synthesis. It is calculated from the
RET% as the total number of reticulocyte events in the outermost light scattering region,
corresponding to immature reticulocytes, relative to the total number of reticulocytes and is
reported as this ratio.
7-16 PN 624602A
OPERATION PRINCIPLES
METHOD HISTORY 7
7.6 METHOD HISTORY
Development
The COULTER COUNTER® Model S analyzer was the first instrument that automated
simultaneous multiparameter measurements on blood. Brittin et_al., Gottmann, and
Hamilton and Davidson, reviewed the performance and clinical value of the Model S.6, 7, 8
Among the advantages offered by the Coulter method of counting and sizing was the ability
to derive an accurate Hct measurement by summing the electronic volume of erythrocytes.
England et al. speculated that electronic Hct measurements did not have the trapped plasma
error of centrifugal Hct measurements.11
Bull et al. described the use of a COULTER COUNTER analyzer for counting thrombocytes.12
This method, useful as it was, depended on preparing thrombocyte-rich plasma to avoid
counting erythrocytes as thrombocytes. Mundschenk et al. and Schulz and Thom discussed
the possibility of counting thrombocytes in the presence of erythrocytes and classifying them
by size.13, 14 Electronic refinements in the Model S-PLUS™ enhanced the accuracy of the
hydrodynamic method. Von Behrens and Paulus also cited the feasibility of counting
thrombocytes by the Coulter method.15, 16
Hemoglobinometry
The lytic reagent used for the complete blood count (CBC) parameters prepares the blood so
the system can count leukocytes and sense the amount of hemoglobin. The lytic reagent
rapidly and simultaneously destroys the erythrocytes and converts a substantial proportion of
the hemoglobin to a stable pigment while it leaves leukocyte nuclei intact. The absorbance of
the pigment is directly proportional to the hemoglobin concentration of the sample.
The accuracy of this method equals that of the hemiglobincyanide method, the reference
method of choice for hemoglobinometry recommended by the International Committee for
Standardization in Hematology (ICSH).17
PN 624602A 7-17
OPERATION PRINCIPLES
METHOD HISTORY
Differential Measurement
The COULTER VCS established WBC differential technology using three measurements:
individual cell volume, high-frequency conductivity, and laser-light scatter.
Volume Analysis
Electronic leukocyte volume analysis, using low-frequency current, has been used since
1967.18 It has been evaluated as a possible adjunct to the differential white cell
count.19,_20,_21,_22
Conductivity Analysis
Cell walls act as conductors to high-frequency current. As the current passes through the cell
walls and through each cell interior, it detects differences in the insulating properties of cell
components. The current characterizes the nuclear and granular constituents and the
chemical composition of the cell interior.23, 24, 25
The most common means of measuring reticulocytes is to use supravital dyes, such as New
Methylene Blue or Brilliant Cresyl Blue. These dyes precipitate and aggregate the basophilic
substances within the reticulocyte, resulting in a granular, staining pattern easily seen with
light microscopy.32
XB Analysis
Dennis B. Dorsey, MD, proposed in 1963 that the relatively constant blood cell indices could
be used to follow the performance of hematology instrumentation.33 Brian Bull, MD,
improved the technique and named it Analysis.34
Analysis uses a "weighted moving average" of patient sample results because Koepke said
that QC materials "ideally should be similar in structure and in reactivity to the patient
constituent being measured, [and] therefore freshly drawn patient blood samples seem to be
the most appropriate [QC material]."35 Bull explains, "The analyser [sic] is considered to be
‘in control’ when the MCV, MCH, and MCHC determined on a batch of 20 patients by use of
the algorithm are within 3% of the expected mean indices of the population."36
7-18 PN 624602A
8SETUP 8
8.1 SYSTEM SETUP OVERVIEW
Your COULTER LH 500 Series provides a lot of flexibility in setup. You can tailor the way
your system appears and runs to suit your laboratory's needs. Select a button on the System
Setup window to access different setup options you can set to control the processing on your
Some buttons on the System Setup window may appear gray and inactive depending on the
security level of the user name currently logged on. If you need to access an inactive function,
contact your laboratory administrator.
Select To Set Up
General settings, such as display labels, parameters, reporting units
and reports.
PN 624602A 8-1
SETUP
CHANGING REAGENT INFORMATION
Your password.
4. Note: Press to reuse the lot number.The Workstation automatically fills the Date
Opened and the Use Before fields with the appropriate dates.
5. Type the shelf life expiration for the reagent.
6. Verify the open expiration date.
7. If your laboratory has not set up open expiration times, type the Beckman Coulter or the
other manufacturer expiration time.
8. Select:
8-2 PN 624602A
SETUP
SETTING UP CONTROLS 8
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. The Workstation also
updates the Reagents history log.
Another tab To change additional Quality Assurance Setup information. The
Workstation asks you if you want to save the changes you made to the
8. Select to specify the reference values and ranges for the control. The window you
see varies depending on the source and type of control you selected.
9. Perform one of the following depending on the source and type of control:
PN 624602A 8-3
SETUP
SETTING UP CONTROLS
Note: A reference RBC is used to calculate the reticulocyte absolute number for Retic
only samples.
11. Select
12. If you want to stop the processing of samples automatically based on Controls, specify
the AutoStop details.
1. Specify whether or not you want results automatically transmitted to your information
system.
8-4 PN 624602A
SETUP
SETTING UP CONTROLS 8
6. Verify the information you want to delete and select . The Workstation deletes all
the control setup information, including lab limits.
7. Select
PN 624602A 8-5
SETUP
SETTING UP CONTROLS
Lab limits
7. Select to save the reference values and return to the list of existing controls set up
for your laboratory.
8. Select:
8-6 PN 624602A
SETUP
SETTING UP CONTROLS 8
To save the lab limits and return to the existing controls list.
PN 624602A 8-7
SETUP
SETTING UP XB ANALYSIS
6. Type the target and limit values for each parameter. Use to move between
fields.
7. Select:
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. The changes to XB Analysis
take effect with the next batch you process.
Another tab To change additional Quality Assurance Setup information. The
Workstation asks you if you want to save the changes you made to the
8-8 PN 624602A
SETUP
SETTING UP DISPLAY LABELS FOR REPORTING 8
5. Type the start times for each shift. The Workstation automatically changes the end times
for you.
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. When you review workload
reports, the information now appears based on the shifts you specified.
Another tab To change additional Quality Assurance Setup information. The
Workstation asks you if you want to save the changes you made to the
3. Select to display the Display Labels that currently appear on reports and
Workstation windows.
4. Verify that the appropriate positive identifier for your laboratory appears selected.
5. For each identifier, type the label you would like to appear, next to the data associated
with the field, when it appears on your Workstation or on a report.
6. Select:
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. The Workstation windows
update immediately. The next report that prints contains the new
labels you provided.
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
PN 624602A 8-9
SETUP
SETTING UP A POSITIVE IDENTIFIER
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. The next sample cycled will
use the positive identifier you specified.
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
8-10 PN 624602A
SETUP
SPECIFYING THE PARAMETERS YOU WANT TO REPORT 8
6. Select to save the sequence starting numbers. The next time the Workstation
requires a sequence number, it uses the numbers you saved.
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. The Workstation windows,
such as the Results & Graphics window, update immediately. The next
report that prints contains the parameters you specified.
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
1. After selecting , the Workstation displays a User Agreement Notice. Read the
notice.
PN 624602A 8-11
SETUP
SETTING UP REPORTING UNITS
To save the changes. The Workstation stores the changes and updates
the date last modified and the user name. The Workstation updates the
reporting units immediately.
8-12 PN 624602A
SETUP
SETTING UP FLAGGING LIMITS 8
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
IMPORTANT Flagging is evaluated when the sample is analyzed. Flagging is reevaluated for a sample when
the results are manually edited, or when new results are received for a pending sample. Flagging is not
reevaluated upon a change of flagging limits for results already in the database. Delta check and Reflex
Decision Rules are not reevaluated.
Beckman Coulter suggests using all available flagging options to optimize the sensitivity of instrument
results. All flagging options include reference ranges (H/L), action and critical limits, definitive flags,
suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter
recommends avoiding the use of single messages or outputs to summarize specimen results or patient
conditions.
3. Select to display the list of flagging limits set up for your laboratory.
8. Select on the Setup New Limit Set window to save the limit name, location and
age range.
9. Select the limit name that you want to set the flagging limits for.
10. Select and display the Laboratory Flagging Limits Setup window.
11. Specify whether you want to Auto Validate the results that match this limit.
PN 624602A 8-13
SETUP
SETTING UP FLAGGING LIMITS
12. Type the lower and upper limits for each parameter of the default Male category. Use
Female To define low and high limits for samples originating from a
female and whether you want to AutoVerify the results that match
this list.
Action Limits To define low and high limits for samples that require action by
your laboratory and whether you want to AutoVerify the results
that match this list.
Critical Limits To define low and high limits for samples that are critical and
require immediate action by your laboratory and whether you
want to AutoVerify the results that match this list.
Definitive Limits To identify the definitive messages you want to appear and
whether you want to AutoVerify the results that match this list.
14. Repeat steps 9 through 12 for each category you want to use for this limit name.
15. Select . The Workstation saves the limit information with the limit name and
returns you to the Flagging Limits tab on the Patient Setup window. The Workstation
flags future sample results based on the attributes you specified. If you review existing
results in the database, they appear with the OLD attributes.
16. Select:
To close the Patient Setup window and return to the System Setup
window.
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
8-14 PN 624602A
SETUP
SETTING UP RULES FOR FLAGGING SAMPLE RESULTS 8
3. Select to display the list of flagging limits already set up for your
laboratory.
4. Select the limit name you want to edit.
5. Select:
6. Modify as appropriate:
r Auto Validation Criteria
r Lower
r Upper
r Limits that you want to force the display of definitive messages.
7. Select to save the attributes with the limit name and return the list of existing
flagging limits. The Workstation flags future sample results based on the attributes you
specified. If you review existing results in the database, they appear with the OLD
attributes.
8. Select:
To close the Patient Setup window and return to the System Setup
window.
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
PN 624602A 8-15
SETUP
SETTING UP RULES FOR FLAGGING SAMPLE RESULTS
IMPORTANT Flagging is evaluated when the sample is analyzed. Flagging is reevaluated for a sample when
the results are manually edited, or when new results are received for a pending sample. Flagging is not
reevaluated upon a change of flagging limits for results already in the database. Delta check and Reflex
Decision Rules are not reevaluated.
Beckman Coulter suggests using all available flagging options to optimize the sensitivity of instrument
results. All flagging options include reference ranges (H/L), action and critical limits, definitive flags,
suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter
recommends avoiding the use of single messages or outputs to summarize specimen results or patient
conditions.
IMPORTANT REVIEW YOUR DECISION RULES THAT CONTAIN MULTIPLE PARAMETERS. If you create a
rule that has more than one parameter or contains more than one item that is related to a parameter, all of
the parameters included in the rule (even if an OR condition is used) must also be included in the
parameters reported in your report profile. Refer to Example A.
10. Select to return to the Patient Setup Decision Rules & Criteria tab.
8-16 PN 624602A
SETUP
SETTING UP RULES FOR FLAGGING SAMPLE RESULTS 8
To close the Patient Setup window and return to
the System Setup window. The Workstation tests
for the rule you defined the next time it receives a
sample result.
Another tab To change additional Patient Setup information.
The Workstation asks you if you want to save the
changes you made to the current information.
Select to proceed.
Note: If decision rules are to be used for sample flagging, the decision rules must be
enabled on the Decision Rules & Criteria screen and Decision Criteria must be
enabled on the Run Configuration screen
IMPORTANT REVIEW YOUR DECISION RULES THAT CONTAIN MULTIPLE PARAMETERS. If you create a
rule that has more than one parameter or contains more than one item that is related to a parameter, all of
the parameters included in the rule (even if an OR condition is used) must also be included in the
parameters reported in your report profile. Refer to Example A.
PN 624602A 8-17
SETUP
SETTING UP REPORTS
6. Select to save the criterion with the criterion name you specified.
When you select on the Decision Rules & Criteria Setup window, you can set up
characteristics for the Reflex Manager and for delta checking.
Reflex Manager
1. Type a message you want used as a rule action.
Delta Check
1. Specify the time limit for delta checking.
2. Specify the unique patient identifier to use for delta checking.
3. Specify where you want sample results that match the delta checking criteria to appear.
After setting up the Reflex Manager and Delta Check characteristics, select to save the
changes and return to the Decision Rules & Criteria Setup window.
8-18 PN 624602A
SETUP
SETTING UP INSTITUTION DETAILS 8
3. Select to display the content for each report defined for your
Workstation.
4. For each report number (tabs 1 through 7):
a. Specify report format you want used.
b. If necessary, specify whether you want a chartable or laboratory report.
c. Specify the printout options.
5. For each report number (tabs 8 through 10):
a. Select the parameters you want included for printing and transmission.
b. Specify report format you want used.
c. If necessary, specify whether you want a chartable or laboratory report.
d. Specify the printout options.
6. Select:
To close the Patient Setup window and return to the System Setup
window. The next report the Workstation prints uses the items you
selected.
Another tab To change additional Patient Setup information. The Workstation asks
you if you want to save the changes you made to the current
7. If you want your institution’s information, such as name and address, to appear on the
report, verify the Institution Details Setup.
PN 624602A 8-19
SETUP
SETTING UP LIS / HIS COMMUNICATIONS
14. Select: to close the Institution window and return to the System Setup window.
The next time you print a report, the institution details you specified appear in the
header of the report.
Consult with your information system administrator to ensure you have the correct
information to perform this procedure. Also ensure your information system administrator
has the latest Host Transmission manual, PN 4277303.
3. Select to display the communications settings for transmitting data from your
instrument to your information system.
4. Select whether to transmit validation codes to your information system.
5. Select whether to Replace DLE E with DLE C in the standard data set transmitted to your
information system.
6. Select whether to enable Replace V and v Flags with R in the standard data set
transmitted to your information system.
7. Select the time out interval you want used.
8. Select the baud rate your information system can receive.
9. Select the type of parity you want used for communications with your information
system.
10. Select the stop bits for your information system.
11. Select the data bits you want used for transmission to your information system.
12. Select the block size for transmissions to your information system.
13. Select the data format for compatibility.
14. If a handshake with your information system is necessary, verify that Handshake is
turned on.
8-20 PN 624602A
SETUP
SETTING UP LIS / HIS COMMUNICATIONS 8
15. Select Collate ToDo List to enable the ability to request additional tests for the same
patient.
16. If you specified the LH 500 Series compatibility format, specify the graphics data you
want to transmit to your information system.
17. Select:
1. Enable the Auto Validation codes on the Communications screen if you want the
validation codes to be transmitted to your information system.
2. Enable Auto Validation Criteria on the Flagging Limits Setup screen.
3. Setup Decision rules for your laboratory. If Decision Rules are enabled and a decision
rule is met for a sample, this will cause an Auto Validation failure.
IMPORTANT REVIEW DECISION RULES THAT CONTAIN MULTIPLE PARAMETERS. If you create a rule
that has more than one parameter or contains more than one item that is related to a parameter, all of the
parameters included in the rule (even if an OR condition is used) must also be included in the parameters
reported in your report profile. Refer to Example A.
Example A:
Rule Setup: Reflex rule is defined as "If WBC is < 2.0 OR Hgb is < 6.0 then
Repeat sample and call results".
Sample Setup: Run Type = CBC
Preassigned Sample: includes only Hgb and Hct (Report Name)
Sample Results: (As printed and transmitted to LIS.)
Hct 17.8 %
PN 624602A 8-21
SETUP
SETTING UP LIS / HIS COMMUNICATIONS
Note: The decision rule will not be applied to this sample even though the Hgb value is
below 6.0. This is because the WBC parameter is not reported. In order for the Decision
Rule to be applied to the sample, all parameters in the rule have to be reported. Therefore
this sample would not result in an Auto Validation failure since the decision rule was not
applied.
IMPORTANT If the Validation Codes are going to be used on either the printout or in the LIS, all parameters
specified in a rule must be included in a parameter block in order for all of the Validation codes to be
CORRECT. Refer to Example B.
Example B:
Rule Setup: Reflex rule is defined as "If Hgb < 6.5 OR Hct < 19.5 then Rerun
Sample and Phone Results”.
Sample Setup: Run Type = CBC
Preassigned Sample: Report all CBC parameters (Report Name),
Sample Results: (As printed and transmitted to LIS.)
Hct 19.6 %
MCV 77.4 fL
MCH 24.9 pg
RDW 16.1 %
Plt 80 103/L
MPV 10.3 fL
The parameter blocks that will be evaluated against the Decision Rule are the H and C
blocks, because both Hgb and Hct are included in these blocks. The Decision Rule is not
applied to the W block because Hct is not included in this block. Therefore, the Auto
Validation message/codes will print and transmit "Sample Not Validated, C NV, H NV, W
AV”. In order for the Decision Rule to be applied to the W block, you must create a
Decision rule for Hgb and then a Decision rule for Hct, in order to get "Sample Not
Validated, C NV, H NV, W NV”.
8-22 PN 624602A
SETUP
CHANGING AN INSTRUMENT NAME 8
Enable Auto Validation Codes
Enable the Auto Validation codes on the Communications screen if you want the validation
codes to be transmitted to your information system. These codes will always print on the
patient reports, even if disabled on this screen. To enable transmission of the validation codes:
PN 624602A 8-23
SETUP
REVIEWING WORKSTATION SETTINGS
4. Type a user name to identify the person you want to grant access and press .
5. Type a password for the user name you want to grant access and press .
6. Type the same password you just typed for verification.
8-24 PN 624602A
SETUP
SETTING UP USER ACCESS LEVELS 8
7. Select Select to save the current user name and clear the fields so you can add
another user name.
5. Select .
PN 624602A 8-25
SETUP
SETTING UP USER ACCESS LEVELS
r Step 4, type your new password then use the backspace key to erase the password
and press
r Step 5, type your new password a second time then use the backspace key to erase
the password.
After you select to save the new password and close the window, you will be able to
log on without using a password.
Resetting a Password
To reset a password, an administrator must delete the user name and then create a new user
name with the same name.
10. Select to save the current user name and clear the fields so you can add another
user name.
8-26 PN 624602A
SETUP
CHANGE PHYSICIAN LIST 8
8.19 CHANGE PHYSICIAN LIST
Select to edit the Physician List. You can add, delete, or edit names that appear in the
Physician List.
When you change the Physician List, the changes are available to all operators that use the
Workstation.
Select to edit the Location List. You can add, delete, or edit names that appear in the
Location List.
When you change the Location List, the changes are available to all operators that use the
Workstation.
PN 624602A 8-27
SETUP
SETTING UP DATABASE STORAGE LIMITS
Setting Up Colors
Note: To perform this task, you must log on with a user name that was set up as an Advanced
Operator or Lab Administrator. If you need to access this function, contact your laboratory
administrator.
8-28 PN 624602A
SETUP
SETTING UP DATABASE STORAGE LIMITS 8
Network Printer
Note: To perform this task, you must log on with a user name that was set up as an Advanced
Operator or Lab Administrator. If you need to access this function, contact your laboratory
administrator.
3. Double click on and follow the instructions in the Add Printer Wizard
4. Select File Properties and verify the printer properties, paper size, and print
orientation.
PN 624602A 8-29
SETUP
RUN CONFIGURATION WINDOW
5. Select to save the changes. The Workstation prints the next item to the
printer you just selected.
Local Printer
Note: To perform this task, you must log on with a user name that was set up as a Lab
Administrator. If you need to access this function, contact your laboratory administrator.
2. Double click on and follow the instructions in the Add Printer Wizard.
3. Select File Properties and verify the printer properties, paper size, and print
orientation.
4. Select to save the changes. The Workstation prints the next item to the
printer you just selected.
Changes to this window take effect the next time the Workstation receives a sample. The
changes remain in effect until you or another user change the options again.
8-30 PN 624602A
SETUP
RUN CONFIGURATION WINDOW 8
Research flags are included in ‘Any Flags’, but are not included in ‘Suspect’. If you wish to
implement a function based on all Suspect flags, including the Research flags, select Specific
Flags, then select all the pertinent checkboxes.
Note: Once the default lot number has been selected, close the Run Configuration window by
3. Select to save the changes. The next item that prints from the Workstation prints
using the report you selected.
6. Select to display the reported parameters and print options for each
report defined for your Workstation.
7. Select the report number used as the default.
8. Specify a different report layout.
PN 624602A 8-31
SETUP
RUN CONFIGURATION WINDOW
9. Select to save the changes. The next item that prints from the Workstation prints
using the report you selected.
5. Select to save the changes. The next item prints based on the flags you selected.
1. Check that your controls and XB analysis are set up with the AutoStop options you want.
8-32 PN 624602A
SETUP
RUN CONFIGURATION WINDOW 8
4. Select to save the changes. The Workstation stops processing samples the next
time it encounters the conditions you selected.
Note: AutoStop does not function when you log off the Workstation.
3. Select to save the changes. The Workstation uses the customer rules based on the
selection you made. You must reset this option on this window to change the customer
rules option back to its original state.
PN 624602A 8-33
SETUP
RUN CONFIGURATION WINDOW
3. Select to save the changes. The Workstation includes the next results in quality
assurance analysis based on the selections you made. You must reset this option on this
window to change quality assurance analysis back to its original state.
4. Select to save the changes. The Workstation prints the next item to the
printer you just selected.
8-34 PN 624602A
9TROUBLESHOOTING 9
9.1 HAZARDS
Laser Safety Precautions
The LH 500 Hematology Analyzer uses two lasers:
WARNING The laser in the diff module (TTM) can damage both the instrument and your eyes if you do not
use it safely. Follow the instructions and procedures in this manual to safely use the instrument and prevent
damage.
In its design and manufacture of the LH 500 Hematology Analyzer, Beckman Coulter has
complied with the requirements governing the use and application of a laser as stipulated in
regulatory documents issued by the:
WARNING Use of controls or adjustments, or performance of procedures other than those specified herein
may result in hazardous radiation exposure.
Do not attempt to remove the laser or to open it. If removal is required, it must be done only
by your Beckman Coulter Representative.
To ensure your safety, LH 500 Hematology Analyzer lasers are covered with protective shields
held in place by tamper-proof screws. Do not attempt to remove these shields.
This instrument contains components dangerous to the operator. If any attempt has been
made to defeat a safety feature, or if this instrument fails to perform as listed in this manual,
disconnect power and call your Beckman Coulter Representative.
Warning Labels
CDRH-approved labels are placed near or on those covers that, when removed, might expose
one to laser radiation.
Note: As installed in the Triple Transducer Module (TTM) safety fixture, the laser presents no
radiation hazard to users and complies with 21 CFR 1040.
PN 624602A 9-1
TROUBLESHOOTING
HAZARDS
9-2 PN 624602A
TROUBLESHOOTING
HAZARDS 9
Figure 9.2 Safety Labels on the TTM
Figure 9.3 Laser Safety Labels for Bar-Code Reader on the LH 500 Hematology Analyzer
PN 624602A 9-3
TROUBLESHOOTING
DRAINAGE AND WASTE DISPOSAL
CAUTION Incomplete drainage and overflow into the vacuum system can occur if the waste line is longer
than the recommended length. Contact your Beckman Coulter Representative if you need to increase the
length of the waste line supplied with the system.
WARNING Risk of personal injury if the waste line is twisted, kinked, or knotted. Ensure that waste can
flow freely through the line to prevent a biohazardous condition from waste backup.
9-4 PN 624602A
TROUBLESHOOTING
CALIBRATION OVERVIEW 9
WARNING Biohazardous contamination can occur from contact with the waste container and its
associated tubing if not handled with care. Avoid skin contact. Clean up spills immediately. Dispose of the
contents of the waste container in accordance with local environmental regulations and with acceptable
laboratory procedures.
The waste line supplied with the instrument can be connected to either:
Your laboratory is responsible for the final calibration of the CBC parameters and for
recording the calibration factors. Beckman Coulter recommends S-CAL® calibrator, or an
exact equivalent, as an acceptable alternative to whole-blood 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 for
an individual sample.
For best performance, calibrate all the CBC parameters. The WBC differential and Retic
parameters are calibrated at the factory; they do not require calibration in the laboratory.
When to Calibrate
You should calibrate your instrument:
r At installation
r After the replacement of any component that involves dilution characteristics (such as
the BSV) or the primary measurements (such as the apertures)
r When advised to do so by your Beckman Coulter Representative.
You should verify the calibration of your instrument:
PN 624602A 9-5
TROUBLESHOOTING
TROUBLESHOOTING OVERVIEW
subtle reagent or pneumatic problems. In that case, you can use the questionable parameter
result as a clue to the location of the malfunction.
Specimen-Related Problems
An instrument problem is differentiated from a specimen-related problem by running a
control. If the control results are acceptable, the problem is probably specimen-related.
Instrument Problems
If the control results show similar problems, it indicates an instrument problem. The next
step is to determine the subsystem (electronic, pneumatic/hydraulic, or reagent) causing the
problem. Because it is easiest to detect a problem in the electronic subsystem and hardest to
detect a problem in the reagent subsystem, the subsystems are usually checked in the
following order: electronic, pneumatic/hydraulic, reagent.
Workstation Troubleshooting
If the Workstation encounters a problem, it tries to display a message. The message describes
the problem and provides information about how to avoid or fix the problem. For best results,
follow the instructions with the messages.
Some messages appear from the Windows® 2000 operating system and other software
packages that are included on your Workstation. Because these messages may not be logged
by the Workstation and may not have online help available for them, it is important that you
write these down and call your Beckman Coulter Representative.
Note: During the course of testing the Workstation, specific intermittent problems have been
reported and corrective actions have been determined. You may want to review the Problem
List periodically to help avoid these problems.
Electronic Troubleshooting
Detecting a problem in the electronic subsystem--or eliminating the electronic subsystem as
the source of the problem--is simplified by indicators and electronic tests.
Indicators
An indicator may inform you that a problem exists; it may also pinpoint the source of a
problem. For example, a voltage message may indicate a problem with a fuse.
Pneumatic/Hydraulic Troubleshooting
Most pneumatic/hydraulic problems are detected by observing the Diluter section in
operation. When you identify a symptom of a malfunction, try to isolate the malfunction to
9-6 PN 624602A
TROUBLESHOOTING
TROUBLESHOOTING OVERVIEW 9
the specific part of the cycle, for example, during preparation, counting, or cleanup. Then, try
to isolate the malfunction to the specific components and tubing. Next, look for one of four
possible problems--pinched tubing, plugs, leaks, or defective components.
Pinched Tubing
When tubing is pinched, flow is either restricted or stopped. Tubing most often pinches
where it passes through, between, or around something, or where it attaches to a fitting.
Examples: tubing passing through a pinch valve, around a panel, or between two hard
objects.
Plug
A plug, like a pinch, restricts or stops a flow. A plug can be composed of liquid, salt, or debris.
This type of problem may be hard to find because it often occurs inside other components. A
plug can occur in tubing, in a fitting, at an aperture, or in a choke.
Plugs are most common in vacuum lines and waste paths that involve the use of fluids and
air.
Leak
A leak allows fluid to escape before reaching its destination. If there is a leak in a pneumatic
line, the pneumatic signal may fail to operate a component, such as a pinch valve, pump, or
diluent dispenser. A leak generally occurs where one component attaches to another, such as
where tubing attaches to a fitting, a housing, a pilot actuator, a pump, or the Blood Sampling
Valve. Leaks can also be the result of cracks in components, such as pumps or glassware.
Defective Components
The interrelationship of components performing a pneumatic/hydraulic process can make it
difficult to determine which component, if any, is defective. For example, if a pinch valve
does not open, it is possible the pinch valve is defective. But it is also possible that the
solenoid responsible for activating the pinch valve is defective.
Reagent Troubleshooting
A reagent problem can be as obvious as precipitate in the reagent tubing. In the less obvious
cases, the most effective way of detecting a problem is by keeping a log of the lot numbers
with the opening and expiration dates of the reagents in use, and knowing how each reagent
affects the data. Refer to the labeling information with your reagents for details.
PN 624602A 9-7
TROUBLESHOOTING
CLEAR FLOW CELL CLOG
Error Messages:
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:
Note: This procedure requires that the Instrument interface is displayed.
b. Press .
9-8 PN 624602A
TROUBLESHOOTING
CLEAR FLOW CELL CLOG 9
c. Aspirate the solution at the manual aspiration probe by pushing the sample bar.
Remove solution container when the System Status Box displays DILUTING and the
beep sounds.
d. Aspirate distilled water in the same manner.
e. Perform Disinfect procedure.
4. On the Command Center, select AUTOANALYSIS as the process type.
5. Cycle a normal whole blood sample in the Automatic mode. If the error message recurs,
call your Beckman Coulter Representative.
PN 624602A 9-9
TROUBLESHOOTING
CLEAR FLOW CELL CLOG
9-10 PN 624602A
TROUBLESHOOTING
9
PN 624602A 9-11
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
3 CONSECUTIVE VOTEOUTS ERROR CHECK / CLEAN Yes Data is available 3 CONSECUTIVE Data for affected Stopped. Three consecutive total 1. Zap the apertures. Refer to the Online Help topic:
THE APERTURES VOTEOUTS parameters is voteouts of a particular Zap Apertures.
incomplete; dashes parameter occurred. 2. If error recurs, check the mixing bubbles.
(----) appear in affected
3. If error recurs, bleach the apertures. Refer to the
parameter fields..
Online Help topic: Bleach Apertures and Flow
Cell/Disinfect.
4. To resume operation access the appropriate
screen, reselect the mode of operation and rerun
the specimens. Continue processing.
30 PSI OUT OF RANGE ERROR CHECK / ADJUST Yes If error occurred before 30 PSI OUT OF RANGE Data is invalid; dots (....) Stopped. Pressure out of 1. Perform a System Test to confirm the pressure
[XX.XX] 30 PSI aspiration was [XX.XX] appear in all parameter established operating reading. Refer to the Online Help topic: System
Note: XX.XX = actual completed, data is not Note: XX.XX = actual fields. range. Range is +26.0 to Test.
reading available. reading +34.0 psi. 2. If the pressure is still out of range, adjust the
If error occurred after 30-psi pressure (RG2). Refer to the Online Help
aspiration was topic: Adjust Pressure and Low Vacuum.
completed, data is
invalid.
PN 624602A 9-13
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
ANALYZER POWER ERROR INSTRUMENT PC One N/A N/A N/A - No message is Stopped Instrument detected Note: Any process running on the Instrument
INTERRUPTION WILL RESET Long No message displayed or displayed. Analyzer power failure. Computer ends and the computer resets. The system
logged. Generated if the input resynchronizes and returns to a Ready state.
power drops below To resume operation, reselect the desired function.
88 Vac.
BAD DOWNLOAD MSG ERROR RESET THE Yes N/A BAD DOWNLOAD MSG N/A Stopped Instrument Computer Reset the instrument by turning the Standby/Reset
RCVD - 196 CODE SYSTEM RCVD - 196 CODE received bad download switch off and then on.
message while
downloading sample
handler code. System
locked up.
BAD PORT IN USE TO SEND ERROR RESET THE Yes N/A BAD PORT IN USE TO N/A Stopped Data sent to wrong port. Reset the instrument by turning the Standby/Reset
DATA SYSTEM SEND DATA System locked up. switch off and then on.
BARCODE READER DID NOT ERROR RESET THE Yes Data is not available. BARCODE READER DID No data displayed for Stopped Barcode scanner not Reset the instrument by turning the Standby/Reset
RESPOND SYSTEM NOT RESPOND the specimen. Data for active. Cass/pos and tube switch off and then on.
previous specimen is labels not read System
still displayed. locked up.
BLOOD COMPARISON OUT ERROR REMIX AND Yes Data is available. BLOOD COMPARISON No data displayed for Stopped Instrument unable to 1. Rerun the specimen.
OF LIMITS REPEAT THE OUT OF LIMITS the specimen. Data for detect the presence of 2. If the error recurs, perform a System Test. Refer
SAMPLE previous specimen is blood. to the Online Help topic: System Test.
still displayed.
3. If the System Test is OK, run the specimen again.
4. If the error recurs, run in Manual mode.
CANNOT ROCK BED ERROR CHECK BED Yes If error occurred before CANNOT ROCK BED Data is displayed if Stopped. Bed does not rock, 1. Manually unload the bed.
MECHANISM aspiration was available.. indexing mechanism 2. Perform the Rock the Bed test:
completed, data is not jammed or rocking motor
a. Set the Computer Switch to position 1.
available. faulty.
b. From the Main menu, select Diagnostics tt
If error occurred after
Operator Options tt Autoloader Tests tt Rock
aspiration was
the Bed and visually check for obvious
completed, data is
obstructions.
available.
3. If the test fails, call your Beckman Coulter
Representative.
CASSETTE LABEL NO READ ERROR RESTART Yes Data is not available. CASSETTE LABEL NO No data displayed for Stopped. Single NO READ of 1. Try running specimens in an alternate cassette.
POSITION WILL READ the specimen. Data for Cass/pos number 2. If the alternate cassette works, try cleaning the
BE SKIPPED previous specimen is occurred, or cassette not bar-code label on the first cassette and rerunning
still displayed advanced. that cassette.
3. If problem persists, call your Beckman Coulter
Representative.
PN 624602A 9-15
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
PN 624602A 9-17
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
DOWNLOAD NOT ERROR CHECK ERROR Yes N/A DOWNLOAD NOT N/A Stopped Errors occurred during 1. Check the error log to determine why the
SUCCESSFUL LOG SUCCESSFUL download of software to download was unsuccessful.
the instrument from 2. Reset the instrument by turning the
Instrument Computer. Standby/Reset switch off and then on.
3. If problem recurs, call your Beckman Coulter
Representative.
ERROR READING ERROR RESET THE Yes If error occurred before ERROR READING Data is displayed if Stopped SYSTEM.CFG file could Reset the instrument by turning the Standby/Reset
SYSTEM.CFG FILE SYSTEM data acquisition, data is SYSTEM.CFG FILE available. not be read. The system switch off and then on.
not available. locked up.
If error occurred after
data acquisition, data is
available.
ERROR UPDATING ERROR RESET THE Yes N/A ERROR UPDATING Data is displayed if Stopped SYSTEM.CFG file could Reset the instrument by turning the Standby/Reset
SYSTEM.CFG FILE SYSTEM SYSTEM.CFG FILE available. not be updated. The switch off and then on.
system locked up.
FILE I/O ERROR ERROR RESET THE Yes N/A FILE I/O ERROR N/A Stopped File input/output error Reset the instrument by turning the Standby/Reset
SYSTEM occurred. The system switch off and then on.
locked up.
HGB OUT OF RANGE ERROR PERFORM Yes Data is not available. HGB OUT OF RANGE No data displayed for Stopped Hemoglobin lamp voltage 1. Perform a System Test to confirm the reading.
SYSTEM TEST the specimen. Data for is not within established Refer to the Online Help topic: System Test.
previous specimen is operating range. 2. If the HGB is still out of range:
still displayed. Range is a. Ensure the WBC bath contains diluent.
6.65 to 7.35 V.
b. Adjust the HGB lamp.
c. Check the HGB lamp and replace it if necessary.
PN 624602A 9-19
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
PN 624602A 9-21
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
RED A/I/V OUT OF RANGE ERROR PERFORM Yes If error occurred before RED A/I/V OUT OF RANGE Data is invalid, dots (....) Stopped Red aperture current 1. Perform a System Test to confirm the reading.
SYSTEM TEST data acquisition, data is appear in all parameters. voltage (A/I/V) out of Refer to the Online Help topic: System Test.
not available. established range. Range 2. If problem recurs, call your Beckman Coulter
If error occurred after is 141.5 to 169.1 V. Representative.
data acquisitionwas
completed, data is
invalid.
RETIC VOLTAGE ERROR ERROR PERFORM Yes Data is not available. RETIC VOLTAGE ERROR No data displayed for Stopped Retic voltage out of 1. Perform a System Test to confirm the reading.
[XX.XX] SYSTEM TEST [XX.XX] the specimen. Data for established range. Range Refer to the Online Help topic: System Test.
Note: XX.XX = actual Note: XX.XX = actual previous specimen is is 0.20 to 1.20V. 2. If voltage is out of range, disinfect the Analytical
reading reading still displayed. Station. Refer to the Online Help topic: Bleach
Apertures and Flow Cell/Disinfect.
3. If error recurs, call your Beckman Coulter
Representative.
RETRIES EXCEEDED IN ERROR RESET THE Yes N/A RETRIES EXCEEDED IN N/A Stopped Three attemptss to Reset the instrument by turning the Standby/Reset
DILUTER DWNLD SYSTEM DILUTER DWNLD download diluter table switch off and then on.
from Instrument
Computer to instrument
failed. The system locked
up.
RETRIES FAILED 196CODE ERROR RESET THE Yes Data is not available. RETRIES FAILED 196CODE No data displayed for Stopped Three attempts to 1. Ensure the needle shield is installed properly.
DWNLD TO 376 SYSTEM DWNLD to 376 the specimen. Data for download sample handler 2. Ensure the Stop switch is not stuck.
previous specimen is code from Instrument
3. Reset the instrument by turning the
still displayed. Computer to instrument
Standby/Reset switch off and then on.
failed. The system locked
up.
PN 624602A 9-23
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
SAMPLE HANDLER ERROR RESET THE Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Analyzer lost Reset the instrument by turning the Standby/Reset
COMMUNICATION ERROR SYSTEM COMMUNICATION ERROR the specimen. Data for communication with switch off and then on.
previous specimen is sample handler. The
still displayed. system locked up.
SAMPLE HANDLER NOT ERROR RESET THE Yes N/A SAMPLE HANDLER NOT N/A Stopped Instrument detected Reset the instrument by turning the Standby/Reset
OPERATIONAL SYSTEM OPERATIONAL severe sample handler switch off and then on.
error.
SAMPLE HANDLER ERROR CHECK NEEDLE Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative.
SENSOR 16 ERROR ALIGNMENT SENSOR 16 ERROR the specimen. Data for handler sensor 16. Needle
previous specimen is not aligned
still displayed.
SAMPLE HANDLER ERROR CLEAN BED Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample 1. Clean the bed-position sensors.
SENSOR 17 ERROR POSITION SENSOR 17 ERROR the specimen. Data for handler sensor 17. Bed 2. To resume operation, access the appropriate
SENSOR previous specimen is position sensor should be screen, reselect mode of operation and rerun the
still displayed. cleaned or its faulty. sample.
COMMUNICATION ERROR ERROR CHECK Yes Available. N/A N/A N/A N/A Available Stopped Failure in communications 1. Check serial communication connections between
COMMUNICATIO to Workstation Computer the Analytical Station and the Workstation.
NS on a message with data 2. If OK, reset the system (Workstation Computer
associated. and then Instrument Computer).
3. If message persists, call your Beckman Coulter
Representative.
4. The Instrument Computer:
a. Queues original message and sends it
whenever communications are re-established.
b. Inhibits sample analysis until communication is
established.
SEND TO INSTRUMENT ERROR RESET THE Yes N/A SEND TO INSTRUMENT N/A Stopped Transmission of sampler 1. Ensure the needle shield is installed properly.
FAILED 196CODE SYSTEM FAILED 196CODE handler code from 2. Ensure the Stop switch is not stuck.
Instrument Computer to
3. Reset the instrument by turning the
instrument failed. The
Standby/Reset switch off and then on.
system locked up.
SHEATH PRESSURE OUT OF ERROR CHECK / ADJUST Yes If error occurred before SHEATH PRESSURE OUT Data is invalid, dots (....) Stopped Sheath pressure out of 1. Perform a System Test to confirm the reading.
RANGE SHEATH data acquisition, data is OF RANGE appear in all parameters. established operating Refer to the Online Help topic: System Test.
PRESSURE not available. range. 2. If the sheath pressure is still out of range, adjust
If error occurred after Range is 5.80 to 6.20 psi. the sheath pressure (RG3). Refer to the Online
data acquisition was Help topic: Adjust Pressure and Low Vacuum.
completed, data is
invalid.
STOP SWITCH ACTIVATED ERROR RESELECT Yes If error occurred before STOP SWITCH ACTIVATED Data is displayed if Stopped Stop switch activated 1. Access the appropriate screen and reselect the
FUNCTION aspiration was available when Autoloader module desired function.
completed, data is not was not in the Stop mode. 2. Ensure the Stop switch is not stuck or
available. disconnected.
If error occurred after
aspiration was
completed, data is
available.
SYSTEM BACKGROUND ERROR CHECK Yes If error occurred before SYSTEM BACKGROUND Data is displayed if Stopped Instrument did not Call your Beckman Coulter Representative.
TIMEOUT DIGIBOARD transmission, data is TIMEOUT available. respond to background
not available. test in specified time.
If error occurred after
transmission, data is
available.
PN 624602A 9-25
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
PN 624602A 9-27
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
INVALID ERROR CODE ERROR RESET THE Yes N/A INVALID ERROR CODE N/A Stopped An invalid error code was Reset the instrument by turning the Standby/Reset
SYSTEM received by the switch off and then on.
Instrument Computer.
SYSTEM BACKGROUND ERROR RESET THE Yes N/A SYSTEM BACKGROUND N/A Stopped System background res 1 Reset the instrument by turning the Standby/Reset
RES 1 SYSTEM RES 1 switch off and then on.
SYSTEM BACKGROUND ERROR RESET THE Yes N/A SYSTEM BACKGROUND N/A Stopped System background res 2 Reset the instrument by turning the Standby/Reset
RES 2 SYSTEM RES 2 switch off and then on.
SYSTEM BACKGROUND ERROR RESET THE Yes N/A SYSTEM BACKGROUND N/A Stopped System background res 3 Reset the instrument by turning the Standby/Reset
RES 3 SYSTEM RES 3 switch off and then on.
MEMORY ERROR ERROR RESET THE Yes Data is not available. MEMORY ERROR No data displayed for Stopped Instrument Computer Reset the instrument by turning the Standby/Reset
SYSTEM the specimen. Data memory error detected. switch off and then on.
displayed for the The system locked up.
previous specimen is
still displayed.
RAW DATA TRANSMISSION ERROR RESET THE Yes Data is not available. RAW DATA Data is displayed. Stopped The system detected an Reset the instrument by turning the Standby/Reset
ERROR SYSTEM TRANSMISSION ERROR error during raw data switch off and then on.
transmission. The system
locked up.
RBC AND WBC BATH ERROR CHECK VACUUM Yes If error occurred before RBC AND WBC BATH Data is invalid, dots (....) Stopped RBC and WBC baths 1. Verify the vacuum trap is empty and the float is
OVERFLOW TRAP data acquisition, data is OVERFLOW appear in all parameters. overflowed. not stuck in the up position.
not available. 2. If you corrected the overflow problem, but are still
If error occurred after getting the error, the sensor may be wet. Call your
data acquisitionwas Beckman Coulter Representative.
completed, data is
invalid.
PN 624602A 9-29
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
SAMPLE HANDLER ERROR CLEAN Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative.
SENSOR 2 ERROR CASSETTE SENSOR 2 ERROR the specimen. Data for handler.
DETECTION previous specimen is
SENSORS still displayed.
SAMPLE HANDLER ERROR CLEAN Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative.
SENSOR 3 ERROR CASSETTE SENSOR 3 ERROR the specimen. Data for handler.
DETECTION previous specimen is
SENSORS still displayed.
SAMPLE HANDLER ERROR CLEAN Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative.
SENSOR 13 ERROR CASSETTE SENSOR 13 ERROR the specimen. Data for handler.
DETECTION previous specimen is
SENSORS still displayed.
SAMPLE HANDLER ERROR CHECK LOAD Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative..
SENSOR 8 ERROR ELEVATOR SENSOR 8 ERROR the specimen. Data for handler.
previous specimen is
still displayed.
SAMPLE HANDLER ERROR FREE CASSETTE Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative..
SENSOR 6 ERROR STACKS SENSOR 6 ERROR the specimen. Data for handler.
previous specimen is
still displayed.
SAMPLE HANDLER ERROR FREE CASSETTE Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample Call your Beckman Coulter Representative..
SENSOR 11 ERROR STACKS SENSOR 11 ERROR the specimen. Data for handler.
previous specimen is
still displayed.
NEEDLE SHIELD SENSOR ERROR CHECK NEEDLE Yes If error occurred before NEEDLE SHIELD SENSOR Data dispalyed if Stopped Error detected by needle 1. Ensure the needle shield is properly installed and
ERROR SHIELD SENSOR aspiration was ERROR available. shield sensor. The sensor reselect the desired function.
completed, data is not may be faulty. 2. If the problem persists, call your Beckman Coulter
available. Representative if the test fails.
If error occurred after
aspiration was
completed, data is
available.
SAMPLE HANDLER ERROR CHECK THE BED Yes Data is not available. SAMPLE HANDLER No data displayed for Stopped Error detected by sample 1. If a cassette is jammed on the bed, remove it.
SENSOR 9 ERROR MECHANISM SENSOR 9 ERROR the specimen. Data for handler sensor 11. Bed 2. Perform the Autoloader Test Routine:
previous specimen is mechanism sensor may
a. Place a cassette in the loading bay.
still displayed. be faulty.
b. Set the Computer Switch to position 1.
c. From the Main menu, select Diagnostics tt
Operator Options tt Autoloader Tests tt
Autoloader Test Routine.
3. If the test fails, call your Beckman Coulter
Representative.
INSTRUMENT DRIVE C ERROR None Yes Data is not available. INSTRUMENT DRIVE C No data displayed for Stopped Instrument Computer Call your Beckman Coulter Representative.
< 1MB < 1MB the specimen. Data Drive C has <1 MB of
displayed for the space
previous specimen is
still displayed.
LOAD STACK NOT EMPTY ERROR EMPTY THE Yes N/A LOAD STACK NOT EMPTY N/A Stopped Loading bay not empty. 1. Ensure the load stack empty switch (S15) is not
LOAD STACK This prevents load (right) stuck or pushed inside the Autoloader housing.
elevator from functioning 2. Empty the loading bay.
properly.
3. Test the performance of the loading elevator by
reselecting desired function.
PN 624602A 9-31
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
BACKWASH NOT SYSTEM PERFORM RINSE Yes If error occurred before BACKWASH NOT Data is displayed if Stopped Rinse block not in proper 1. Set the Computer Switch to position 1
PERFORMED HALT data acquisition, data is PERFORMED available. position for backwash. 2. Do a Rinse function (Diluter Functions tt Rinse)
not available. and monitor the movement of the rinse block to
If error occurred after ensure the block moves the full length of the
data acquisition, data is aspirator tip.
available. 3. Remove any obstructions.
CLEANER OUT SYSTEM REPLACE Yes Data is available. CLEANER OUT Data is displayed Stopped Out of cleaner signal 1. Check the level of cleaning agent.
HALT CLEANER detected from reagent 2. If reagent container is empty:
UPDATE FILE, sensor, insufficient
a. Replace the cleaning agent. Refer to the Online
PRIME cleaner to perform
topic: Replace Reagent Containers.
another cycle.
b. Update the reagent file.
c. Prime the cleaner and perform startup.
3. If reagent container is not empty, verify reagent
input tubing is connected properly at both ends.
INCONSISTENT SAMPLE SYSTEM CHECK Yes N/A INCONSISTANT SAMPLE N/A Stopped Instrument detected that 1. Verify the Stop switch is not stuck.
HANDLER HARDWARE HALT HARDWARE HANDLER HARDWARE downloaded software is 2. Reset the instrument by turning the
REINSTALL incompatible with sample Standby/Reset switch off and then on.
SOFTWARE handler hardware. The
3. If problem recurs, call your Beckman Coulter
system locked up.
Representative.
LYSE OUT SYSTEM REPLACE LYSE, Yes Data is available. LYSE OUT Data is displayed. Stopped Out-of-Lyse signal 1. Check the level of lytic reagent.
HALT UPDATE FILE, detected from reagent 2. If reagent container is empty:
PRIME sensor, insufficient lytic
a. Replace the lytic reagent. Refer to the Online
reagent to perform
topic: Replace Reagent Containers.
another cycle.
b. Update the reagent file.
c. Prime the Lyse.
3. If reagent container is not empty, call your
Beckman Coulter Representative.
PN 624602A 9-33
TROUBLESHOOTING
INSTRUMENT ERROR MESSAGES
WASTE CONTAINER FULL SYSTEM EMPTY WASTE Yes Data is not available. WASTE CONTAINER FULL No data displayed for Stopped Waste container is full.
HALT CONTAINER the specimen. Data for WARNING Risk of contamination. Biohazardous
previous specimen is contamination can occur from contact with the
still displayed. waste container 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 in
accordance with the local regulations and
acceptable laboratory procedures.
Log Message and Icon on Command Center Appliable Log Sample Results System Status Probable Cause Corrective Actions
Communication to LH 500 Instrument Instrument N/A Stop Failure in communications to analyzer. 1. Check serial communication connections between the Analytical
Workstation failed on operation “< Operation Station and the Workstation.
name >” 2. If OK, reset the system (this re-starts the Instrument Computer).
Where “< Operation name >” can be one of the 3. Log On/Off Workstation Computer.
following:
4. If message persists, call your Beckman Coulter Representative.
r Clear Alarm
5. The Instrument Computer:
r Stop Instrument
a. Queues original message and sends it whenever communications
r Send Manual Barcode are re-established.
r Change Instrument Run Configuration b. Inhibit sample analysis until communication is established.
r Send Calibration Factors
r Perform Startup
r Perform Shutdown
Calibration factors with sample data do not Instrument Not available Stop 1. The transmission was invalid. 1. Ensure the calibration factors are set to the same values on both the
match those stored on Workstation. Sample 2. Communications between the Instrument Computer and Workstation.
(<Tube ID>, <Cass/Pos>) discarded. Instrument Computer and the 2. If message persists, all your Beckman Coulter Representative.
Workstation failed.
3. Calibration factors were
corrupted.
An archive files with control samples was Control N/A Ready The operator archived control results Status Only: No action necessary.
created. via the QA menu functions.
PN 624602A 9-35
TROUBLESHOOTING
WORKSTATION PC ERRORS
You can change the size of the three areas of this window by dragging the divider bars that
separate the three areas. You can change the size of columns by dragging the border of the
column heading. Each time you shut down and restart your Workstation, the sizes return to
the system-defined size.
Double-click the heading of a column to sort the samples or sample requests by that column.
For example, double-click to sort by patient ID. * appears next to the
heading.
Selecting
Select This To
Expand the list of test groups.
PN 624602A 10-1
DATABASE AND TODO LIST
COMMON FUNCTIONS (OVERVIEW)
button. For example, select a group of sample results and then select to print the
sample results.
Some of the buttons require you to perform actions on one sample result or pending sample
at a time.
Other Actions
Select sample results in the list on the right side of the window that show slides requested but
no slides made.
Select to increment the Slides Made column and remove the sample from the ToDo slide
list. The Slides Made field in the Completed list will be incremented from 0 to 1.
You can set up default settings for most of the common functions to ensure the Workstation
handles your data in the same way each time you use the functions. Of course, the flexibility
exists to change the settings for the function. For example, you can quickly change the
printer to which you print items.
Transmitting Results
You can transmit results automatically or manually to your information system.
10-2 PN 624602A
DATABASE AND TODO LIST
COMMON FUNCTIONS (OVERVIEW) 1
Printing Reports
Printing is an important part of working with sample results and controls. Your system
automates a lot of printing you do by enabling you to specify which results you want
automatically printed.
Archiving Data
If you need to be able to retrieve sample results for samples run several months ago, use the
archive function.
Archiving data allows you to copy important sample result data (patient demographics,
results, and flags) to a diskette in a spreadsheet format. After copying the data to your
diskette, the Workstation deletes the data from the DataBase. This frees up valuable space on
your Workstation for additional sample results.
You can later retrieve the data using a spreadsheet application on another (non-LH 500 Series
Workstation) computer.
Deleting Data
When you no longer need to maintain results information, you can delete it. This saves room
on the Workstation, and it may enable you to find results in the DataBase faster.
3. Select to delete the data. A message that asks you to confirm your request
appears.
4. Select to delete the data. The Workstation deletes the selected data. The data
cannot be retrieved.
PN 624602A 10-3
DATABASE AND TODO LIST
COMMON FUNCTIONS (OVERVIEW)
2. If you are working with the DataBase & ToDo window, ensure the sample is selected.
Otherwise, proceed to step 3.
3. If the sample is marked as saved, select to unmark it. The button changes to
7. Select to confirm your deletion. The Workstation deletes the sample information
and returns to the previous window.
Printing
1. Select the items you want to print.
r If you are currently viewing the Results & Graphics window, only the current
results can be printed.
r If you are currently viewing the DataBase & ToDo window, you can select several
items that appear in the list and print them as a batch.
4. Select to print the items. The Workstation sends the selected items to the default
printer based on the settings your verified.
To print a popup Help window, use your right mouse button to click inside the popup
window, and then select Print Topic.
Note: Reference Information, Cleaning Procedure, and Replacing Procedure Help Topics that
display full screen should be printed using Landscape Orientation.
10-4 PN 624602A
DATABASE AND TODO LIST
COMMON FUNCTIONS (OVERVIEW) 1
What Prints When You Select
Patient Application
Setup Application
Status Application
Prints the information on the Status window.
PN 624602A 10-5
DATABASE AND TODO LIST
COMMON FUNCTIONS (OVERVIEW)
Color Printouts
Color printouts may not exactly match Workstation screen colors. This a function of how
Windows® 2000 supports peripherals such as printers. If the 'normal' colors printed make
interpretation difficult, you may be able to perform Halftone Color Adjustment for your
printer. You can determine if your printer supports halftone color adjustment by following
these steps:
Archiving
Select the items you want to archive.
3. Select to specify the name of the archive file and the location where you want it
created. The Save As window appears.
4. Check the filename for the archived items.
5. Specify the drive where you want to archive the information.
6. Select to archive the selected items. The Workstation copies the items to the
archive location and marks the items in the database as archived. The archived items
remain in the database until deleted.
The file can be retrieved into any spreadsheet application. Use your spreadsheet program’s
instructions to transpose the information if it is not in a readable format.
10-6 PN 624602A
DATABASE AND TODO LIST
SAVING SAMPLE RESULTS 1
Understanding the Information
The archived information appears in a tabular format. Each column contains a label, but some
columns may appear condensed. This may make it difficult to read the labels. To view the
label, you must widen the columns. Refer to the product information for the spreadsheet
program for details about widening the columns.
The archived information appears with the same flags and codes that appear on the LH 500
Series Workstation.
Transmitting
1. Select the items you want to transmit to your information system. If you are currently
viewing the Results & Graphics window, only the current results can be transmitted. If
you are currently viewing the DataBase & ToDo window, you can select several items
that appear in the list and transmit them as a batch.
4. Select to transmit the items. The Workstation sends the selected items to your
information system. The items are sent based on the options set up for communicating
with your information system.
3. Select to transmit the items. The Workstation sends the selected items to your
information system. The items are sent based on the options set up for communicating
with your information system.
4. Menu Access: File Transmit Result(s)
PN 624602A 10-7
DATABASE AND TODO LIST
ADDING A SAMPLE REQUEST TO THE TODO LIST
4. Select to mark the sample results so they are saved in the database. As the
Workstation processes new samples, the new samples will not overwrite the saved
samples. The button changes to to indicate that the sample results will be saved.
The sample results are saved until you unmark them. To unmark the sample results, you
b. Provide the sample identification information for the tests. Use to move
between fields.
c. Specify the demographic information.
NOTE: Duplicate Sample IDs or Cass/Pos are allowed for the same Patient ID only if
the Test Type is different. If the same test type is specified for a Sample ID, the
following message will display:
Duplicate Sample ID entry. Sample IDs must be unique within the ToDo list. Original
value will be restored.
Blank Patient IDs are considered to be the same Patient ID.
IMPORTANT Risk of incorrect identification. Before saving identification information, check that you typed
the information properly.
4. Select:
To save the test information and clear the fields on the window so
you can add another test.
10-8 PN 624602A
DATABASE AND TODO LIST
DATABASE OVERVIEW 1
Adding a Test to an Existing Set of Sample Results
3. Select from the specific (right side) toolbar. The Edit Sample window appears.
4. Select the specific test identifiers you want to add or remove.
5. Provide the sample identification information for the tests. Use the tab key to navigate
between fields.
NOTE: Duplicate Sample IDs or Cass/Pos are allowed for the same Patient ID only if the
Test Type is different. If the same test type is specified for a Sample ID, the following
message will display:
Duplicate Sample ID entry. Sample IDs must be unique within the ToDo list. Original value
will be restored.
Blank Patient IDs are considered to be the same Patient ID.
IMPORTANT Risk of incorrect identification. Before saving identification information, check that you typed
the information properly.
The LH 500 Series stores data in a DataBase on the Workstation. This data includes all the
numeric and graphic information from:
The Workstation has no practical storage limit for control runs. However, the Workstation
will perform better if you delete unused control folders.
PN 624602A 10-9
DATABASE AND TODO LIST
TODO LIST OVERVIEW
different types of sample data that the DataBase stores (up to 20,000). For example, your lab
administrator could reduce the graphic data storage.
When the Workstation receives sample results, the Workstation stores the results as graphic,
numeric and list mode data. When the Workstation reaches its list mode limit, it deletes the
oldest list mode data. When the Workstation reaches its graphic limit, it deletes the oldest
graphic data. When the Workstation reaches its numeric limit, it deletes the oldest numeric
data.
This effect of deleting the oldest data is known as “wrap-around.” Wrap-around on list mode
data is on a per run basis. Wrap-around on graphic and numeric are per sample basis.
Collated results remain in the DataBase based on the time the last sample results were collated
(not the time the DataBase received the first results).
r You download information from your information system and the instrument has not yet
processed them.
r You generate the list manually because you have no information system and you want to
store identification data for your samples in the ToDo list.
r You add a test to an existing sample result. This comes in handy if a physician orders a
second test or if you forget to add a test.
To add a sample to the ToDo list, the sample must include:
10-10 PN 624602A
DATABASE AND TODO LIST
TODO LIST OVERVIEW 1
You can also provide further identification information, such as the patient's name, birth date
and gender. You can even provide information defined by your laboratory, such as special
identification codes and comments. If the Workstation recognizes the patient ID, it
automatically fills in all known identification information.
To reduce the amount of typing when you add to the ToDo list, the Workstation provides
AutoSequencing for several fields. You can set up which fields you want automatically
sequenced and provide default values for them. You can also change these values individually.
r If a sample request is sent from the host that matches an existing pending order on all
three IDs (patient, cass/pos, sample) and is a superset of that order's test types, the orders
will be combined. For example, if a C was previously ordered and a CD order is
received, the orders will be combined into a single CD. If there is nothing to add (e.g., a
second C order is received), a separate order will be created.
Note: Matching includes NULL fields, such as two orders with empty Patient IDs.
The Automatic To Do List Deletion function allows you to determine how long entries remain
on the ToDo list. The user-specified timeframe deletes ToDo list entries older than 'x' hours
(range = 00 to 99 hours).
Setting Up AutoSequencing
6. Select to save the sequence starting numbers. The next time the Workstation
requires a sequence number, it uses the numbers you saved.
PN 624602A 10-11
DATABASE AND TODO LIST
COLLATION OVERVIEW
The Workstation can collate results automatically. When you turn on the AutoCollation
option on the Run Configuration window, the Workstation automatically collates results
when it finds a match of the sample ID within the AutoCollation time interval you specify.
If you add sample information on the Add window that includes more than one positive
identifier and more than one test, the Workstation recognizes that you want the results
collated. If you do not want to collate the information, you must add each positive identifier
and test on a new Add window.
The Workstation produces separate test results (not collated), if any of the following
conditions occur while analyzing samples:
r Partial Aspiration
r NO Read
r NO Match
r Subsequent test is run after the AutoCollation time interval on the Run Configuration
window has expired
r Diff or Retic % is invalid
r Flow cell is clogged (:::::)
If the Workstation collates two or more sets of results, parameter calculations are performed
based on the appropriate run type (examples: RET# is calculated from RET% of Retic
analysis; RBC is derived from the CBC analysis).
The Workstation searches for all samples that match the combination of characters.
Example: If you type 0002*, the Workstation finds all sample IDs that begin with 0002.
10-12 PN 624602A
DATABASE AND TODO LIST
FINDING SAMPLE RESULTS USING THE DATABASE EXPLORER BUTTON 1
If a field is unimportant in searching
Leave the field blank or type *. The Workstation ignores the field when searching.
Results of a Search
Select on the DataBase & ToDo window to display the sample identification
information the Workstation found the last time you used the DataBase Explorer window.
The Workstation keeps this information to make it easy for you to access information you
need on a recurring basis.
Search Criteria
If you need to search for particular types of results on an ongoing basis, save a Search Criteria.
A Search Criteria is a group of attributes you specify on the DataBase Explorer window. The
attributes indicate what you want the Workstation to use when searching for results. For
example, if you want to find all the results with Critical limits, you would select Specific Flags
and Critical limits. Specific Flags and Critical limits are attributes of the Search Criteria.
You can save the Search Criteria and retrieve it later. This keeps you from having to set up
search criteria each time you want to look for sample results. It also reduces the chance for
error in specifying your search criteria. You can now quickly and easily devise complex
searches of the DataBase.
PN 624602A 10-13
DATABASE AND TODO LIST
FINDING SAMPLE RESULTS USING THE DATABASE EXPLORER BUTTON
2. Select next to the Load Saved Criteria field to see a list of available search criteria
names.
3. Select the search criteria name you want.
3. Select .
10-14 PN 624602A
DATABASE AND TODO LIST
VIEWING DATABASE COUNT INFORMATION 1
4. Type the search criteria name you want to use.
PN 624602A 10-15
DATABASE AND TODO LIST
VIEWING DATABASE COUNT INFORMATION
10-16 PN 624602A
AAPPENDIX A A
A.1 TUBE LIST
Beckman Coulter does not recommend the use of one tube in preference to another nor
guarantee the acceptability of the sample tube to produce quality results. If you need
information on a tube not listed here, contact your Beckman Coulter Representative.
CAUTION Possible system damage could occur if adapters for the Beckman Coulter® JT2 and JT3
analyzers are used for the LH 500 Series. Do not use these adapters on the LH 500 Series.
o.d. x Length
No. Volume (mm) Cassette
367662 5.0 mL 13.0 x 75 Regular
o.d. x Length
No. Volume (mm) Cassette
367841 2.0 mL 13.0 x 75 Regular
367842 2.0 mL 13.0 x 75 Regular
367856 3.0 mL 13.0 x 75 Regular
367859 3.0 mL 13.0 x 75 Regular
367861 4.0 mL 13.0 x 75 Regular
367862 4.0 mL 13.0 x 75 Regular
COULTER Tubes
o.d. x Length
Type (mm) Cassette
5C Series cell control tubes 13.0 x 62 13 mm
Retic-C control tubes 13.0 x 31 None
S-CAL® calibrator tubes 13.0 x 62 13 mm
PN 624602A A-1
APPENDIX A
TUBE LIST
o.d. x Length
No. Volume (mm) Cassette
454087 2.0 mL 13.0 x 75 Regular
454086 3.0 mL 13.0 x 75 Regular
454036 4.0 mL 13.0 x 75 Regular
KABE
o.d. x Length
No. Volume (mm) Cassette
35241S140 3.0 mL 12.0 x 81 Regular
35271S159 5.0 mL 12.0 x 81 Regular
o.d. x Length
Type Volume (mm) Cassette
Plastic purple 4.0 mL 13.0 x 75 Regular
LDM
o.d. x Length
No. Volume (mm) Cassette
940712 5.0 mL 12.0 x 75 Regular
940713 5.0 mL 12.0 x 75 Regular
LIP
.d. x Length
No. Volume (mm) Cassette
A-2 PN 624602A
APPENDIX A
TUBE LIST A
38917 3KE4/GL 4.0 mL 12.0 x 81 Regular
SARSTEDT
o.d. x Length
No. Volume (mm) Cassette
05.1167.600 2.7 mL 11.5 x 66 13mm
SHERWOOD MEDICAL
TERUMO TUBES
o.d. x Length
No. Volume (mm) Cassette
T-206SQS 5.0 mL 13.0 x 75 13 mm
T-202SQS 7.0 mL 16.0 x 75 16 mm
T-325SQS 2.5 mL 13.0 x 75 13 mm
PN 624602A A-3
APPENDIX A
TUBE LIST
o.d. x Length
No. Volume (mm) Cassette
P-206SQK 5.0 mL 13.0 x 75 13 mm
P-225SQK 2.5 mL 13.0 x 75 13 mm
A-4 PN 624602A
BAPPENDIX B B
B.1 BAR-CODE READER
Description
The HmX Hematology Analyzer uses a visible laser-type reader containing a Class II laser,
operating at a wavelength of 670 nm, with a maximum power output of 1 mW.
Character Set
This refers to the range of data characters that can be encoded for a specific symbology. There
are essentially three types:
PN 624602A B-1
APPENDIX B
BAR-CODES AND THE LH 700 Series
Symbology Type
There are essentially two types:
r Discrete—Each character is separated from the next by an intercharacter gap. This allows
each character to be decoded independently. Every character has a bar on each end.
r Continuous—Has no intercharacter gaps. Every character begins with a bar and ends
with a space.
Self-Checking
A self-checking symbology has the ability to prevent character transposition due to a single
printing defect.
The following information is intended as a guide to help you in your selection process.
B-2 PN 624602A
APPENDIX B
BAR-CODES AND THE LH 700 Series B
IMPORTANT Risk of misidentification. Use of poor quality, dirty, improperly placed or damaged bar-code
labels could keep the instrument from reading the bar-code labels. Ensure the bar-code labels are
undamaged. Ensure the bar-code labels conform to the specifications provided in the Bar-Code Label
Specifications section of this manual.
Checksum Algorithm
Beckman Coulter strongly recommends the use of bar-code checksums to provide automatic
checks for read accuracy.
IMPORTANT Use of bar-codes is an extremely accurate and effective method of positive patient
identification. Certain features, such as checksum digits, maximize accuracy in reading Codabar, Code 39
and Interleaved 2-of-5 labels. In one study, the use of checksum digits detected 97% of misread errors. Use
checksums to provide protection against occasional misread errors caused by problems such as damaged
or misapplied labels. If you must use bar-codes without checksums, Beckman Coulter recommends that
you verify each bar-code reading to assure correct patient identification.
Interleaved 2-of-5
Interleaved 2-of-5 is a high density, continuous numeric symbology. It is self-checking. Every
character in the symbology encodes two digits, one in the bars and one in the spaces.
This symbology is susceptible to an incorrect read due to a partial scan (a scanning path that
does not include both leading and trailing quiet zones). The most common incorrect read is a
shorter, but valid decoding of the information. The presence of a checksum does not
eliminate this risk. It is recommended that any Interleaved 2-of-5 label contain Bearer Bars.
Alternatively, this label should be used with a fixed length only, with the scanning devices set
to recognize labels of a specific length (for example 12 digits).
Codabar
Codabar has a character set of 16 characters. It is a discrete, self-checking symbology and is
most commonly used in libraries and blood banks.
NW-7
NW-7 is very similar to Codabar. It uses the same character set. The difference is in the
checksum calculation.
PN 624602A B-3
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
Code 128 is character dependent. See AIM® Uniform Symbol Specification (USS) Rev. 1986
for additional required dimensional tolerances.
You must use and print a checksum character, and it must conform to the AIM USS 128
checksum generation procedure.
IMPORTANT If a laboratory uses Code 128 bar-code format, it must have checksum enabled. If the
checksum is disabled, the LH software produces a bar-code that does not comply with the Code 128
standard and cannot be read by bar-code scanners.
Bar-code Tips
No bar-code symbology is perfect. You will occasionally get a read error. Below are some tips
to help you get the best performance from the symbology you choose:
General
A bar-code consists of black lines (bars) and white lines (spaces), which are called elements.
There are narrow elements (NE) and wide elements (WE); their arrangement is determined
by the code.
IMPORTANT Possible misidentified results. For accurate reading by the scanner, it is important that
bar-code labels for specimen tubes adhere strictly to the specifications given in this section. Labels that
meet these specifications are available from Beckman Coulter.
B-4 PN 624602A
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS B
r No spots or voids; no ink smearing.
r Edge roughness is included in the bar and space tolerances.
Measurement method is according to American National Standards Institute's
MH10-8M-1983.
PCS = Rw -- Rb X 100%
Rw
Printing Method
Photographic, thermal transfer, dot matrix, and laser printer.
Label Thickness
Maximum label thickness must be such that:
r The tube's outer diameter including the label is not greater than 13.3 mm.
r The label including adhesive = 0.006 ±0.003 in.
NE/WE Ratio
Must remain constant over code length.
PN 624602A B-5
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
0.045 +0.045"
0.055"
630-370
0.005"
0.300"
MIN.
LABEL
WIDTH
(SEE SPEC. 9)
PLACEMENT
INDICATOR
(SEE SPEC. 8)
*
0.100 +0.030"
0.250"
0.250" MIN.
MIN.
LEADING QUIET TRAILING QUIET
ZONE (SEE SPEC. 7) ZONE (SEE SPEC. 4)
LABEL LENGTH
(SEE SPEC. 5)
B-6 PN 624602A
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS B
Acceptable Bar-codes
Within the given specifications, the scanner automatically distinguishes the following
bar-codes.
Interleaved 2-of-5
Code 39
Codabar* or NW7*
Code 128/USS 128
*Only one of these types (Codabar or NW7) can be active at the same time. The NW7
Code used on the instrument is the same as the Codabar symbology with a check digit.
The following table summarizes the code-related specifications.
IMPORTANT If a laboratory uses Code 128 bar-code format, it must have checksum enabled. If the checksum is
disabled, the LH software produces a bar-code that does not comply with the Code 128 standard and cannot be read by
bar-code scanners.
PN 624602A B-7
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
Checksum Algorithm
Beckman Coulter strongly recommends the use of bar-code checksums to provide automatic
checks for read accuracy.
IMPORTANT Use of bar-codes is an extremely accurate and effective method of positive patient
identification. Certain features, such as checksum digits, maximize accuracy in reading Codabar, Code 39
and Interleaved 2-of-5 labels. In one study, the use of checksum digits detected 97% of misread errors.
Use checksums to provide protection against occasional misread errors caused by problems such as
damaged or misapplied labels. If you must use bar-codes without checksums, Beckman Coulter
recommends that you verify each bar-code reading to assure correct patient identification.
The algorithm for determining the checksum for each code is given below.
Interleaved 2-of-5
This code requires 2 to 16 data digits plus a checksum.
1. Identify even- and odd-positioned characters in the message with the right-hand message
character always defined as an even-positioned character.
2. Sum the numeric values of the odd-positioned characters.
3. Sum the numeric values of the even-positioned characters and multiply the total by 3.
Sum the odd and even totals from steps 2 and 3.
4. Determine the smallest number which, when added to the sum in step 4, results in a
multiple of 10.
This number is the value of the checksum character.
5. Determine whether total number of characters (message plus checksum) is odd or even.
If odd, add a leading nonsignificant zero to the message to produce an even number of
characters as required by the symbology.
Example:
MESSAGE 1 2 5 6 7 8
PARITY 0 E 0 E 0 E
STEP 2: 1+5+7=13
STEP 3: (2+6+8)x3=48
STEP 4: 13+48=61
STEP 5: 61+9=70
Therefore, the checksum is 9, and the final decoded message is 01256789.
The value assigned to each of the characters is presented in the following table.
B-8 PN 624602A
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS B
CHARACTER VALUE CHARACTER VALUE
0 0 - 10
1 1 $ 11
2 2 : 12
3 3 / 13
4 4 . 14
5 5 + 15
6 6 A 16
7 7 B 17
8 8 C 18
9 9 D 19
r The character value of a message is obtained from the above table and added together.
r This sum is divided by 16, and the remainder corresponds to the value of the checksum
character.
Examples:
1.
MESSAGE 2 3 4 7 1 3
VALUE 2 3 4 7 1 3
2+3+4+7+1+3 = 20
20 ÷ 16 = 1, REMAINDER 4
The value 4 corresponds to character 4; therefore, the checksum is 4 and the final
decoded message is 2347134.
2.
MESSAGE $ $ / / + + + +
VALUE 11 11 13 13 15 15 15 15
11+11+13+13+15+15+15+15 = 108
108 ÷ 16 = 6, REMAINDER 12
The value 12 corresponds to character :, therefore, checksum is :, and the final decoded
message is: $$//++++:
CHARACTER VALUE
0 0
PN 624602A B-9
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
1 1
2 2
3 3
4 4
5 5
6 6
7 7
8 8
9 9
r The data digit value that is the difference between 11 and the Mod 11 sum of the
weighted values of the data digits is used as the check digit. The start and stop digits are
not used as part of the checksum calculation.
r NW7 is made up of 1 start digit, 9 data digits and 1 stop digit.
r The checksum digit immediately precedes the stop digit.
WEIGHTED MODULUS 11:
DIGIT POSITION
(Right Justified) 12 11 10 9 8 7 6 5 4 3 2 1
WEIGHT (1) 6 3 5 9 10 7 8 4 5 3 6 2
WEIGHT (2) 5 8 6 2 10 4 3 7 6 8 5 9
The first 9 digits from the right are used for the calculation of the check digit.
B-10 PN 624602A
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS B
Examples:
1. MESSAGE 011529007
USE WEIGHT (1): 6 3 5 9 10 7 8 4 5 3 6 2
DIGIT POSITION
(Right Justified) 0 0 0 0 1 1 5 2 9 0 0 7
WEIGHT (1) 6 3 5 9 10 7 8 4 5 3 6 2
Result 0 0 0 0 10 7 40 8 45 0 0 14
0 + 10 + 7 + 40 + 8 + 45 + 0 + 0 + 14 = 124
124 ÷ 11 = 11, REMAINDER 3
When the REMAINDER IS 0, 0 is the check digit.
11 - 3 = 8
The value 8 corresponds to character 8, therefore the checksum is 8 and the final
decoded message is 0115290078
2. MESSAGE 023229006
USE WEIGHT (1): 6 3 5 9 10 7 8 4 5 3 6 2
DIGIT POSITION
(Right Justified) 0 0 0 0 2 3 2 2 9 0 0 6
WEIGHT (1) 6 3 5 9 10 7 8 4 5 3 6 2
Result 0 0 0 0 20 21 16 8 45 0 0 12
0 + 20 + 21 + 16 + 8 + 45 + 0 + 0 + 12 = 122
122 ÷ 11 = 11, REMAINDER 1
When the REMAINDER is 1, the calculation must be repeated using weight (2): 5 8 6 2
10 4 3 7 6 8 5 9
DIGIT POSITION 0 0 0 0 2 3 2 2 9 0 0 6
(Right Justified)
WEIGHT (2) 5 8 6 2 10 4 3 7 6 8 5 9
Result 0 0 0 0 20 21 6 14 54 0 0 54
0 + 20 + 12 + 6 + 14 + 54 + 0 + 0 + 54 = 160
160 ÷ 11 = 14, REMAINDER 6
When the REMAINDER is 0, 0 is the check digit.
11 - 6 = 5
The value 5 corresponds to character 5, therefore the checksum is 5 and the final
decoded message is 0232290065.
PN 624602A B-11
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
r The character values of the message are obtained from the above table and added together.
r This sum is divided by 43, and the remainder corresponds to the value of the checksum
character.
Example:
CHARACTER S T U V W X Y F
VALUE 28 29 30 31 32 33 34 15
28+29+30+31+32+33+34+15 = 232
232 ÷ 43 = 5, REMAINDER 17; 17 = H = CHECKCHARACTER
The value 17 corresponds to character H; therefore, checksum is H, and the final
decoded message is: STUVWXYFH.
Code 128
This code uses 3 to 16 data digits.
The checksum character immediately precedes the stop character. The checksum character
used with Code 128 must conform to the AIM USS 128 checksum generation procedure. Do
not use these values:
B-12 PN 624602A
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS B
The checksum value (see the following table) is equal to the modula 103 sum of the value of
the start character and the weighted values of the data/special characters. The weights are one
for the first data/special character and continuing with two, three, four and so forth for the
following data/special characters.
For example, a label contains a START character (Code C), Data (25), a Check character and a
STOP character. The value of the Start character C is 105, and the data character for 25 is 25.
The weight of the first data character is one, so the check character value is calculated as follows:
For additional information on this procedure, refer to AIM USS-128 Rev. 1986, published by
AIM, Inc., 1326 Freeport Road, Pittsburgh, PA 15238.
PN 624602A B-13
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
22 6 6 22
23 7 7 23
24 8 8 24
25 9 9 25
26 : : 26
27 ; ; 27
28 < < 28
29 = = 29
30 > > 30
31 ? ? 31
32 @ @ 32
33 A A 33
34 B B 34
35 C C 35
36 D D 36
37 E E 37
38 F F 38
39 G G 39
40 H H 40
41 I I 41
42 J J 42
43 K K 43
44 L L 44
45 M M 45
46 N N 46
47 O O 47
48 P P 48
49 Q Q 49
50 R R 50
51 S S 51
52 T T 52
53 U U 53
54 V V 54
55 W W 55
56 X X 56
57 Y Y 57
58 Z Z 58
59 [ [ 59
B-14 PN 624602A
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS B
60 \ \ 60
61 ] ] 61
62 62
63 ___ ___ 63
64 NUL ` 64
65 SOH a 65
66 STX b 66
67 ETX c 67
68 EOT d 68
69 ENQ e 69
70 ACK f 70
71 BEL g 71
72 BS h 72
73 HT i 73
74 LF j 74
75 VT k 75
76 FF l 76
77 CR m 77
78 SO n 78
79 SI o 79
80 DLE p 80
81 DC1 q 81
82 DC2 r 82
83 DC3 s 83
84 DC4 t 84
85 NAK u 85
86 SYN v 86
87 ETB w 87
88 CAN x 88
89 EM y 89
90 SUB z 90
91 ESC { 91
92 FS | 92
93 GS } 93
94 RS ~ 94
95 US DEL 95
96 FNC 3 FNC 3 96
97 FNC 2 FNC 2 97
PN 624602A B-15
APPENDIX B
BAR-CODE LABEL SPECIFICATIONS
98 SHIFT SHIFT 98
99 CODE C CODE C 99
100 CODE B FNC 4 CODE B
101 FNC 4 CODE A CODE A
102 FNC 1 FNC 1 FNC 1
103 START (CODE
A)
104 START (CODE
B)
105 START (CODE
C)
B-16 PN 624602A
REFERENCES
1. Coulter WH. High speed automatic blood cell counter and cell size analyzer. Paper
presented at National Electronics Conference, Chicago, IL, 1956; October 3.
2. Brecher G, Schneiderman M and Williams GZ. Evaluation of electronic red blood cell
counter. Am J Clin Path, 1956; 26:1439-1449.
3. Brittin GM, Brecher G and Johnson CA. Evaluation of the COULTER COUNTER Model
S. Am J Clin Path, 1969; 52(6):679-689.
4. Gottman AW. Multiple hematologic analyses by means of a COULTER COUNTER Model
S. Paper presented at International Symposium of Standardization of Hematological
Methods, Fondazione, Carlo Erba, Milan, Italy, November 9 and 10, 1970. Symposium
proceedings published in Haematologica Latina, 1969.
5. Hamilton PJ and Davidson RL. The interrelationships and stability of Coulter
S-determined blood indices. J Clin Path, 1973; 26:700-705.
6. Bessman JD and Johnson RK. Erythrocyte volume distribution in normal and abnormal
subjects. Blood, 1975; 46(3):369-379.
7. Price-Jones C. The diameters of red cells in pernicious anaemia and in anaemia following
haemorrhage. J Path Bact, 1922; 25:487-504.
8. England JM, Walford DM and Waters DAW. Re-assessment of the reliability of the
haematocrit. Brit J Haemat, 1972; 23:247-256.
9. Bull BS, Schneiderman MA and Brecher G. Platelet counts with the COULTER
COUNTER. Am J Clin Path, 1965; 44(6):678-688.
10. Mundschenk DD, Connelly DP, White JG and Brunning RD. An improved technique for
the electronic measurement of platelet size and shape. J Lab Clin Med, 1976;
88(2):301-315.
11. Schultz J and Thom R. Electrical sizing and counting of platelets in whole blood. Med
Biol Engr, 1973; 73:447-454.
12. Von Behrens WE. Mediterranean macrothrombocytopenia. Blood, 1975; 46(2):199-208.
13. Paulus JM. Platelet size in man. Blood, 1975; 46(3):321-336.
14. International Committee for Standardization in Haematology. Recommendations for
reference method for haemoglobinometry in human blood (ICSH Standard EP 6/2: 1977)
and specifications for international haemiglobincyanide reference preparation (ICSH
Standard EP 6/3: 1977). J Clin Path, 1978; 31(2):139-143.
15. Gauthier J, Harel P, Belanger C and Fraysse J. Human leukocytes: their size distribution
and mean corpuscular volume. Can Med Assoc J, 1967; 97:793-796.
16. Hughes-Jones NC, England JM, Norley I and Young JMS. Differential leucocyte counts by
volume distribution analysis. Brit J Haemat, 1974; 28(1):148.
17. England JM, Bashford CC, Hewer MG, Hughes-Jines NC and Down MC. A
semi-automatic instrument for estimating the differential leucocyte count. Biomed Engr,
1975; 10(8):303-304.
18. Wycherley PA and O'Shea MJ. Abridged differential leucocyte counts provided by a
Coulter Channelyzer in a routine haematology laboratory. J Clin Path, 1978;
31(3):271-274.
19. Oberjat TE, Zucker RM and Cassen B. Rapid and reliable differential counts on dilute
leukocyte suspensions. J Lab Clin Med, 1970; 76(3):518-522.
PN 624602A REFERENCES-1
REFERENCES
20. Hoffman RA and Britt WB. Flow-system measurement of cell impedance properties. J
Histochem Cytochem, 1979; 27(1):234-240.
21. Leif RC, Scwartz S, Rodriguez CM, Peel-Fernandez L, Groves M, Leif SB, Cayer M and
Crews H. Two-dimensional impedance studies of BSA buoyant density separated human
erythrocytes. Cytometry, 1985; 6(1):13-21.
22. Coulter WH et al. Signal modulated apparatus for generating and detecting resistive and
reactive changes in a modulated current path for particle classification and analysis. US
Patent 3,502,974, March 24, 1970.
23. Fulwyler MJ. Electronic separation of biological cells by volume. Science, 1965;
150:910-911.
24. Loken MR, Sweet RG and Herzenberg LA. Cell discrimination by multiangle light
scattering. J Histochem Cytochem, 1976; 24(1):284-291.
25. Jovin TM, Morris SJ, Striker G, Schultens HA, Digweed M and Arndt-Jovin DJ.
Automatic sizing and separation of particles by ratios of light scattering intensities. J
Histochem Cytochem, 1976; 24(1):269-283.
26. Miale JB. Laboratory Medicine: Hematology. CV Mosby Company, St. Louis, MO, 4th ed.,
1972; 22.
27. Corash L, Rheinschmidt M, Lieu S, Meers P and Brew E. Fluorescence-activated flow
cytometry in the hematology clinical laboratory. Cytometry, 1988; Supplement 3:60-64.
28. Friedman EW. Reticulocyte counts: How to use them, what they mean. Diagnostic
Medicine, 1984; 7(6):29-33.
29. Williams WJ, Beutler E, Erslev AJ, and Lichtman MA. Hematology. McGraw-Hill, Inc,
New York, NY, 4th ed., 1990; 416.
30. Brecher G. New methylene blue as a reticulocyte stain. Am J Clin Path, 1949;
19:895-896.
31. Dorsey DB. What can quality control do for hematology? Am J Med Tech, 1965;
Mar-Apr:150-153.
32. Bull BS. A statistical approach to quality control. Quality Control in Hematology,
Symposium of the International Committee for Standardization in Haematology. Lewis
SM and Coster JF, eds, Academic Press, London, England, 1975.
33. Koepke JA and Protextor TJ. Quality assurance for multichannel hematology
instruments. Am J Clin Path, 1981; 75(1):28-33.
34. Bull BS. A statistical approach to quality control. Quality Control in Hematology,
Symposium of the International Committee for Standardization in Haematology. Lewis
SM and Coster JF, eds, Academic Press, London, England, 1975.
35. Eckhoff RF. An experimental indication of the volume proportional response of the
Coulter Counter for irregularly shaped particles. J Sci Inst, 1967; 44:648-649.
36. Grover NB, Naaman J, Ben-asson S and Dojanski F. Electrical sizing of particles in
suspension III. Rigid spheroids and red blood cells. Biophys J, 1972; 12:1099-1116.
37. Waterman CS, Atkinson EE, Wilkins B, Fischer CL and Kimsey SL. Improved
measurement of erythrocyte volume distribution by aperture-counter signal analysis.
Clin Chem, 1975; 21:1201-1211.
REFERENCES-2 PN 624602A
REFERENCES
Specimen Collection
1. Corash L. Platelet Sizing: Techniques, Biological Significance, and Clinical Applications.
Current Topics in Hematology. New York, New York: Alan R. Lise, Inc. 1983
2. Threatte GA, Andrados C, Ebbe S and Brecher G. Mean Platelet Volume: The Need for a
Reference Method. AJCP, 1984; 81:769-772.
3. Thompson CB, Diaz DD, Quinn PG, Lapins M, Kurtz SR and Valeri CR. The Role of
Anticoagulant in the Measurement of Platelet Volumes. AJCP, 1983; 80: 327-332.
PN 624602A REFERENCES-3
REFERENCES
4. NCCLS document H4-A3. Procedures for the collection of diagnostic blood specimens
by skin puncture. National Committee for Clinical Laboratory Standards. Villanova, PA,
1991.
5. NCCLS document H3-A3. Procedures for the collection of diagnostic blood specimens
by venipuncture. National Committee for Clinical Laboratory Standards. Villanova, PA,
1991.
6. NCCLS document H18-A. Procedures for the handling and processing of blood
specimens. National Committee for Clinical Laboratory Standards. Villanova, PA, 1990.
7. NCCLS document H15-A. Reference procedure for the quantitative determination of
hemoglobin in blood. National Committee for Clinical Laboratory Standards. Villanova,
PA, 1984.
8. NCCLS document H7-A. Procedure for determining packed cell volume by the
microhematocrit method. National Committee for Clinical Laboratory Standards.
Villanova, PA, 1985.
9. NCCLS document H20-A. Approved Standard for the Evaluation of the Differential Cell
Count. National Committee for Clinical Laboratory Standards. Villanova, PA, 1992.
10. NCCLS document H44-A. Approved Guideline for Methods for Reticulocyte Counting
(Flow Cytometry and Supravital Dyes). National Committee for Clinical Laboratory
Standards. Villanova, PA, 1997.
11. Brunson D., Smith D., Bak A., Przyk E., Sheridan B., Muncer D.L., Comparing
Hematology Anticoagulants: K2EDTA vs. K3EDTA, Lab. Hematol. 1:12-119, 1995.
12. Phillips J., Coiner J., Smith E., Becker D., Leong J., Performance of K2EDTA vs. K3EDTA
-- Collected Blood Specimens on Various Hematology Analzyers, Lab. Hematol. 4:17-20,
1998.
13. Moser K., Seelenbinder F., McFadden S., Adkins C., Goshay M., Davis F., Selecting a New
Analyzer for the Hematology Laboratory: The Experience at OhioHealth Hospitals, Lab.
Hematol 7:245-254, 2001.
REFERENCES-4 PN 624602A
INDEX
PN 624602A INDEX-1
INDEX
INDEX-2 PN 624602A
INDEX
Changing Your Default Report Layout, 8-31 Workstation failed on operation “<
Changing Your Password, 8-25 Operation name>” [LH 500
changing,password, 8-25 analyzer], 9-36
characteristics, B-4 communications, 8-20
performance, B-4 components, B-4
check, 2-2 components,dimensions, B-4
check,background, 2-2 COMPRESSOR DID NOT BLEED [XX.XX]
check,daily, 2-2 [LH 500 analyzer], 9-16
check,Hgb voltage, 2-2 COMPRESSOR PRESSURE ERROR [XX.XX]
check,startup, 2-2 [LH 500 analyzer], 9-32
Checking Background Test Results, 2-2 computer, 8-32
Checking Daily Test Results, 2-2 control, 3-1, 3-6, 3-7, 3-9, 3-10, 3-11, 3-12,
Checking Hgb Voltage Test Results, 2-2 3-14, 8-3, 8-4, 8-5, 8-6, 8-7, 8-8, 8-32
checksum algorithm, B-4 control run (automatic mode), 3-6
Codabar, B-4 control,adjust target limits, 3-11
Code 128, B-4 control,auto-stop, 8-32
Code 39, B-4 control,codes, 3-7
Interleaved 2-of-5, B-4 control,comments, 3-7, 3-11
Japan Red Cross NW7 Decoding, B-4 control,control window, 3-10
NW7, B-4 control,cycling in automatic mode, 3-6
cL, 5-5 control,delete, 3-10, 8-4
clean, 1-14, 4-5 control,edit, 8-5
clean,cassette, 1-14, 4-5 control,edit limits, 8-5
CLEANER OUT [LH 500 analyzer], 9-33 control,outside limits, 3-9
clip, 1-14, 4-4, 4-5, A-1 control,quality, 3-14
closed-vial mode, 4-6 control,review results, 3-7
Codabar bar code, B-4 control,saving IQAP, 3-12
Code 128 bar code, B-4 control,setup, 8-3
Code 39 bar code, B-4 control,setup latex ranges, 8-4
codes, 3-7, 5-1, 5-5 control,setup limits, 8-6
codes,for controls, 3-7 control,setup shifts, 8-8
codes,for results, 5-5 control,XB/XM setup, 8-7
codes,reviewing results, 5-1 COULTER Tubes, A-1
collation, 10-12 CRC ERROR ON READ SYSTEM .CFG.FILE
Collation Overview, 10-12 [LH 500 analyzer], 9-17
collation,overview, 10-12 criteria, 10-14
collecting, 4-1 critical limits, 8-12, 8-14
Collecting specimens, 4-1 customize flags, 5-3
color, 8-28 cycling, 3-6, 4-5, 4-6, 4-7
Command Center buttons, 1-10 Cycling Controls in Automatic Aspiration
COMMAND COMPLETE NOT SUCCESSFUL Mode, 3-6
[LH 500 analyzer], 9-16 Cycling Samples in Automatic Aspiration
COMMAND TO DIGIBOARD NOT Mode, 4-6
ACCEPTED [LH 500 analyzer], 9-16 Cycling Samples in Manual Aspiration
comments, 3-7, 3-11 Mode, 4-7
common, 10-2 cycling,automatic mode, 3-6, 4-6
Common Functions (Overview), 10-2 cycling,manual mode, 4-7
COMMUNICATION ERROR [LH 500
analyzer], 9-23, 9-25
Communication to LH 500 Instrument
PN 624602A INDEX-3
INDEX
D analyzer], 9-18
data, 3-10, 10-3, 10-4, 10-6 dimensions, B-4
data,archive, 10-6 disabling, 1-14, 4-9
data,delete control, 3-10 diskette drive, 1-9
data,print, 10-4 display, 8-9, 8-11
DataBase, 8-27, 10-1, 10-9, 10-14 distribution curve, 5-1
DataBase & ToDo Window, 10-1 DMS, 1-8
database explorer, 10-13 drive, 1-9
DataBase Overview, 10-9
database storage limits, 10-9 E
database wrap-around (overwriting), 10-9 E, 5-5
DataBase,overview, 10-9 edit, 5-2, 8-5, 8-14
DataBase,search, 10-14 edit,control setup information, 8-5
DataBase,storage limits, 8-27 edit,flagging limits, 8-14
DataBase,window, 10-1 edit,lab limits, 8-5
date, 8-28 edit,sample results, 5-2
decision criteria, 8-33 Editing Control Setup Information, 8-5
default lot numbers, 8-34 Editing Existing Flagging Limits, 8-14
default report, 8-31 Editing Sample Results, 5-2
definitive, 5-3, 8-12 EDTA, 4-1
definitive messages, 5-8 enabling, 1-14, 4-9
delete, 3-10, 8-4, 8-7, 10-2, 10-3 error, 3-7, 3-9, 9-5
delete,control data, 3-10 ERROR READING SYSTEM.CFG FILE
delete,control setup information, 8-4 [LH 500 analyzer], 9-18
delete,lab limits, 8-7 ERROR UPDATING SYSTEM.CFG FILE
delete,sample information, 10-3 [LH 500 analyzer], 9-18
Deleting Control Data, 3-10 expected range, 3-9
Deleting Control Setup Information, 8-4 expire, 8-2
Deleting Lab Limits, 8-7 extra digit, 8-12
Deleting Sample Information, 10-3
delta check, 5-3, 8-15, 8-33
delta check,ON/OFF, 8-33 F
delta check,review patient history, 5-3 fault isolation, 5-5
delta check,setup, 8-15 figure, 1-8, 1-9, 1-10, 1-15
details, 8-19, 8-23, 8-24 FILE I/O ERROR [LH 500 analyzer], 9-18
detector, 1-14, 4-9 files, 8-3, 8-4
Diff, 3-1 files,delete control, 8-4
DIFF DATA ACQUISITION FAILURE files,setup control, 8-3
[LH 500 analyzer], 9-17 find, 10-1, 10-13, 10-14
DIFF PRESSURE OUT OF RANGE [LH 500 Finding Sample Results Using the Database
analyzer], 9-17 Explorer Button, 10-13
digits, 8-12 flag, 3-7, 5-1, 5-3, 5-5, 8-12, 8-14, 8-15
digits,setup extra, 8-12 flag,edit limits, 8-14
DILUENT COMPARISON OUT OF LIMITS flag,for controls, 3-7
[LH 500 analyzer], 9-17 flag,for results, 5-5
DILUENT OUT [LH 500 analyzer], 9-17 flag,priority, 5-3
Diluter Function, 3-1 flag,processing overview, 5-3
Diluter Function,F57, 3-1 flag,setup limits, 8-12
DILUTER TABLE ERROR [LH 500 flag,setup rules, 8-15
INDEX-4 PN 624602A
INDEX
PN 624602A INDEX-5
INDEX
K analyzer], 9-31
KABE Tubes, A-2 loading, 4-5
keyboard, 1-9 Loading the Cassette, 4-5
loading,how to put tubes into a cassette, 4-5
local, 8-29
L locate, 10-13
L, 5-5 Logging OFF/ON, 2-1
lab limits, 8-7 logoff, 2-1
LABCO Exetainer Tubes, A-2 logon, 2-1
label, 4-3, 4-4, 8-9, B-1, B-2 lot number, 8-34
bar codes overview, B-1, B-2 LOW VACUUM OUT OF RANGE [LH 500
label,bar-code, 4-3 analyzer], 9-21
label,requirements, 4-4 LYSE OUT [LH 500 analyzer], 9-33
label,setup for display, 8-9
Labeling Requirements--Tubes without
Adapters or Clips, 4-4
M
labels, B-4 manual, 4-7, 10-4
bar-code, dimensions, B-4 manual,mode cycling, 4-7
bar-code, specifications, B-4 manual,print, 10-4
Labo Express Service (LES) Tubes, A-2 MEMORY ERROR [LH 500 analyzer], 9-29
laboratory, 8-6, 8-7, 8-19, 8-20, 8-32 message, 3-7, 3-9, 5-3, 5-8
laser, 9-1 microsample collection, 4-1
Laser Safety, 9-1 minimum sample volume, 4-1
Laser Warning Labels, 9-1 mode, 4-9
latex, 3-1, 8-4 modify, 5-2, 8-5, 8-14
LATRON, 3-1, 8-4 modify,control, 8-5
layout, 8-18 modify,flagging limits, 8-14
LDM Tubes, A-2 MULTI INTER. WHILE RECEIVING DATA
limit, 3-9, 8-5, 8-6, 8-12, 8-14, 8-15, 8-27, 1 [LH 500 analyzer], 9-22
0-9
limit,controls outside, 3-9 N
limit,database storage, 8-27, 10-9 name, 8-23, 10-14
limit,delta check, 8-15 NEEDLE FORWARD SENSOR ERROR
limit,edit lab limits, 8-5 [LH 500 analyzer], 9-22
limit,flagging, 8-12, 8-14 NEEDLE HOME SENSOR ERROR [LH 500
limit,laboratory, 8-6 analyzer], 9-22
limits for database storage, 10-9 NEEDLE SHIELD SENSOR ERROR [LH 500
linearity range, 5-5 analyzer], 9-31
link results (collate), 10-12 network, 8-29
LIP Tubes, A-2 NO Match, 5-3
LIS, 8-20 No Match processing, 4-2
list, 3-7, 5-5, 5-8, A-1 No Read, 5-3
list,control codes, 3-7 NW7 bar code, B-4
list,definitive messages, 5-8
list,flags and codes, 5-5
list,tube, A-1 O
LOAD ELEVATOR FAILURE [LH 500 OFF/ON, 8-33
analyzer], 9-21 open-vial mode, 4-7
LOAD STACK NOT EMPTY [LH 500 operation, 4-9
INDEX-6 PN 624602A
INDEX
PN 624602A INDEX-7
INDEX
Q reset,Workstation, 6-3
QA, 3-1 Resetting A Password, 8-26
QC, 3-1 Resetting the Workstation, 6-3
quality, 3-1, 3-7, 8-3, 8-7 results, 2-2, 3-12, 3-14, 5-1, 5-2, 5-3, 5-5, 8-
Quality Control Overview, 3-1 32, 10-3, 10-7, 10-12, 10-13, 10-14
quality,QC overview, 3-1 results,check background, 2-2
quality,reviewing control results, 3-7 results,check Hgb voltage, 2-2
quality,setting up controls, 8-3 results,collate, 10-12
quality,setting up XB/XM analysis, 8-7 results,link, 10-12
quick change, 8-30 results,processing, 5-3
results,reviewing samples, 5-1
results,XB, 3-14
R Retic, 3-1, 3-6
R, 5-5 RETIC VOLTAGE ERROR [XX.XX] [LH 500
ramp, 2-2 analyzer], 9-23
range, 3-9 Retic,cycling Retic-C automatic, 3-6
RAW DATA TRANSMISSION ERROR [LH 500 Retic,running latex Diff and Retic, 3-1
analyzer], 9-29 RETRIES EXCEEDED IN DILUTER DWNLD
RAW FILE TOO LARGE [LH 500 [LH 500 analyzer], 9-23
analyzer], 9-23 RETRIES FAILED 196CODE DWNLD TO 378
RBC AND WBC BATH OVERFLOW [LH 500 [LH 500 analyzer], 9-23
analyzer], 9-29 review, 3-7, 3-14, 5-1, 5-3, 5-5
RBC BATH OVERFLOW [LH 500 review,control results, 3-7
analyzer], 9-30 review,flags and codes, 5-5
reagent, 8-2 review,histograms, 5-1
RED A/I/W OUT OF RANGE [LH 500 review,patient history, 5-3
analyzer], 9-23 review,research data, 5-1
reference, 8-4, 8-12, 8-14 review,sample results, 5-1
reference,editing existing flagging review,XB results, 3-14
limits, 8-14 Reviewing Control Results, 3-7
reference,latex ranges, 8-4 Reviewing Histograms, 5-1
reference,setting up flagging limits Reviewing Patient History, 5-3
setup, 8-12 Reviewing Sample Results, 5-1
References, REFERENCES-1, REFERENCES Reviewing Workstation Settings, 8-24
-3 Reviewing XB/XM Results, 3-14
reflex manager, 5-3, 8-18, 8-33 RF VOLTAGE LOW [LH 500 analyzer], 9-24
reflex manager,setup rule environment, 8-18 RINSE BLOCK ERROR [LH 500
reflex manager,turning ON/OFF, 8-33 analyzer], 9-34
report, 8-8, 8-9, 8-11, 8-12, 8-18, 8-31 ROCKER BED NOT EMPTY [LH 500
report,layout, 8-31 analyzer], 9-24
report,parameters to report, 8-11 Rule Type Field, 1-13
report,setup display labels, 8-9 rules, 5-3, 8-18
report,setup layout, 8-18 rules,setup environment, 8-18
report,setup positive ID, 8-9 run, 3-6, 4-6, 4-7, 8-30, 8-31, 8-32, 8-33
report,setup profiles, 8-18 Run Configuration Window, 8-30
report,setup shifts, 8-8 run controls (automatic mode), 3-6
report,units, 8-12 run samples (automatic mode), 4-6
reset, 6-3, 8-26 run samples (manual mode), 4-7
reset,password, 8-26 run,configuration
INDEX-8 PN 624602A
INDEX
PN 624602A INDEX-9
INDEX
INDEX-10 PN 624602A
INDEX
PN 624602A INDEX-11
INDEX
INDEX-12 PN 624602A
TRADEMARKS
5C, Beckman Coulter, Coulter, Coulter Clenz, Coulter Counter, Lin-C, Lyse S, S-Cal,
Z Series, Zap-Oglobin are trademarks of Beckman Coulter, Inc.
All other trademarks, service marks, products, or services are trademarks or registered
trademarks of their respective holders.
PN 624602A
COULTER LH 500 SERIES SYSTEM HARD-COPY DOCUMENTATION
The Getting Started booklet and the Host Transmission manual come with your LH 500 Series System.
s Getting Started Overview of system hardware and software
PN 624601
s Host Transmission Specifications for transmitting to a host computer
PN 4277303
s Reference Use and Function • Installation • Operation Principles • Specifications/Characteristics •
PN 624604 Precautions/Hazards • References • Glossary • Index
Available in hard copy by request.
s Instructions for Use Controls and Indicators • Startup • QC • Sample Analysis • Data Analysis • Shutdown •
PN 624602 Analyzer CRT Functions • Workstation • Run Samples Display • To Do List • Database •
Controls • Setup • Appendices
Available in hard copy by request.
s Special Procedures Calibration • Cleaning Procedures • Replace/Adjust Procedures
PN 624603 Available in hard copy by request.
s Master Index Combined index for Reference, Instructions For Use, and Special Procedures manuals.
PN 624605 Comes with hard copy of Instructions For Use and Special Procedures.
The information in the Reference manual, Instructions for Use, and Special Procedures manual comes from the Online
Help System.