Operator Notes / Read Me File

The COULTER® LH 500 Series

Revision 2A

File Date: September 2004

The purpose of this document is to provide you with the most up to date information to help you
implement and operate the system as smoothly as possible. The document describes changes in
operating instructions that were implemented in software after the HELP topics were completed. We
recommend review of these topics in order to assess the impact to your laboratory procedures.

Please read the contents entirely and carefully. Ensure that all operators of the LH 500 System are made
aware of these changes.

APPLICATION DESCRIPTION

Set Up
In System Setup [General], the operator has the option to display extra digits.
For Software version 2A the following selections are available:
• All Data – CBC (excluding MCV) and Retic # parameters results display an
extra digit
• Retic – Retic # parameter results only display an extra digit
• CBC Data – CBC (excluding MCV) parameter results only display an extra
digit

Daily Shutdown
After a Shutdown has been performed, the compressor will automatically shut off
after 1 hour of instrument inactivity.

Patient
If a 16-digit Sample ID is used with sample printout Format B and the ID has been
edited, then the last digit will overlap the “E” and may be unreadable. This “E”
indicates that the ID has been edited.

When more Decision Rules are triggered than can be printed in the space
available, [>>>>] appears at the end of the comments. The operator must go to the
Patient Test / Results and Graphics / Demographics tab to view the rest of the
Comments. If there are enough Comments to fill the display box, then the operator
must scroll down. If the operator scrolls back up, the comments will be unreadable.
The operator will need to exit the tab and re-enter it to read the comments
correctly.

PN 629475C
Patient (cont.) When editing patient information, sample request information sent from the host to
the workstation is not displayed. Upon completion and exit of the edit function a
refresh of the screen will display the patient information sent from the host.

In certain instances, WBC voteouts, when displayed on the Research Screen, will
display 0.0 for each individual count period. Results displayed in this manner
indicate that a potential for an aperture clog may have occurred during the count
cycle.

Performance
Specifications
Reportable Range for the MCV parameter on the LH 500 is from 50 to 150 fL.
Online help labeling lists the reportable range from 0.0 to 150 fL. MCV values
below 50 fL and above 150 fL are flagged as well as the indices that use MCV in
the calculation.

The Bar Code Specifications in Help incorrectly indicates that a bar code with 16
data digits can be read using the NW7 symbology. The handheld scanner is
capable of reading 16 data digits using the NW7 symbology. The Autoloader
scanner is capable of reading only 11 data digits with NW7 symbology.
Calibration
The “Enter Calibration Factor Option” located under Diagnostics > Operator
Options within the Instrument software is not password protected. Manual entries
or changes are not noted in the calibration or events logs.

Calibrator values, Lot number and expiration dating for LH diluent / Lyse S® III diff
Lytic Reagent are included on the Table of Expected Results. This same
information can be loaded to the calibration file from the blue diskette included in
the COULTER® S-Cal® Calibrator Kit.

Calibrator values, Lot number and expiration dating for Isoton® 4 / Lyse S® 4 Lytic
Reagent are included on the Table of Expected Results. This same information
can be loaded to the calibration file from the green diskette included in the
COULTER® S-Cal® Calibrator Kit.

Quality Assurance
When setting up a Retic control file, a value must be entered in the “RBC” field. If it
is left blank, the result for the “Retic #” will be calculated as a negative number and
it will be flagged.

XB Batch auto printouts on systems configured with the 16 digit sample ID will
have the last digit of the sample ID infringe on the first number in the date of
analysis column.

Control values, Lot number and expiration dating for LH diluent / Lyse S® III diff
Lytic Reagent are included on the Table of Expected Results. This same
information can be loaded to the calibration file from the blue diskette included in
the COULTER® 5C® Cell Control Kit.

Control values, Lot number and expiration dating for Isoton® 4 / Lyse S® 4 Lytic
Reagent are included on the Table of Expected Results. This same information
can be loaded to the control file from the green diskette included in the
COULTER® 5C® Cell Control Kit.

PN 629475C