User Guide: AU400 Clinical Chemistry System

User Guide
AU400®
Clinical Chemistry System
For In Vitro Diagnostic Use
O9100106AC
June 2013
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
AU400® Clinical Chemistry System
User Guide
PN O9100106AC (June 2013)
Copyright © 2013 Beckman Coulter, Inc.
Find us on the World Wide Web at:

www.beckmancoulter.com
Beckman Coulter Ireland Inc.

Lismeehan
O'Callaghans Mills
Co Clare Ireland
Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda

Estr dos Romeiros, 220 - Galpao G3 - Km 38.5
06501-001 - Sao Paulo - SP - Brasil
CNPJ: 42.160.812/0001-44
製造販売業者 : ベックマン･コールター株式会社
東京都江東区有明三丁目 5 番 7 号
TOC 有明ウエストタワー
Beckman Coulter KK
贝克曼库尔特株式会社
东京都江东区有明三丁目 5 番 7 号
邮编：135-0063
Revision History
Document Change Notification
Date Version Page Description

Added U.S.A. to the corporate address.
Added “Biohazard” label in the “Safe Use of the System”
section.
Updated the “Preventing Eye Injury” section.
Updated the “Use of Consumables” section.
Added cuvette part number and CAUTION to the
"Replacing Cuvettes" section.
Added the “Using a Floppy Disk” section.
Updated warning labels in compliance with IEC61010-1
second edition.
Title Page, Copyright page, Added a red arrow to indicate the barcode reader laser
v, vii, viii, 1, 2, 10, 11, 14, 15, direction and barcode reader specification in compliance
19, 34, 35, 40, 43, 53, 85, with IEC61010-1 second edition.
June 2013 AC
87, 88, 96, 97, 106, 146,
186, 189, 197, 206, 227, Added CAUTION on changing test names.
242, 251, 252, and 254. Added the "Inspect the Stability of the Upper Cover"
procedure.
Updated the “Precautions in Filling a Reagent Bottle”
section.
Added CAUTION on using a floppy disk.
Updated the “!” error flag.
Added two action items in the "G" error flag.
Removed CAUTION from the “Requesting Advanced
Calibrations” section.
Updated the wording in the "Replacing the Na, K or Cl
Electrode" section.
Contents
1 Before You Start

Beckman Coulter Introduction ..............................................................1
What’s New in this Release..................................................................1
Using this User Guide...........................................................................2

Where to Start .............................................................................................................................................................. 2
Using the Online Help................................................................................................................................................... 4
Printing this User Guide on a Simple Desk Jet............................................................................................................. 5
Typographical Conventions Used in this User Guide ................................................................................................... 6
2 Primary Safety Precautions

Introduction...........................................................................................9
Safe Use of the System........................................................................9

Preventing Fire and Damage...................................................................................................................................... 10
Preventing Electric Shocks......................................................................................................................................... 10
Preventing Minor and Serious Injury .......................................................................................................................... 10
Preventing Eye Injury ................................................................................................................................................. 11
Ensuring Optimal Analytical Performance .................................................................................................................. 11
Treating Waste Liquids............................................................................................................................................... 11
Preventing Infection.................................................................................................................................................... 11
Correct Handling of Reagents, Calibrators and Control Sera..................................................................................... 12
Preventing Damage to other Equipment and Facilities .............................................................................................. 12
Handling Specimens................................................................................................................................................... 12
Water Supply and Drain Hoses .................................................................................................................................. 13
Electromagnetic Wave and Noise Precautions .......................................................................................................... 13
Handling the Keyboard, Monitor and Mouse .............................................................................................................. 13
Replacing Parts .......................................................................................................................................................... 14
Use of Consumables .................................................................................................................................................. 14
Setting Analysis Parameters ...................................................................................................................................... 14
Planned Maintenance Routines.................................................................................................................................. 14
Performing Important Checks at Analysis .................................................................................................................. 15
Using a Floppy Disk.................................................................................................................................................... 15
Installation Environment Precautions .................................................16

Installation Environment ............................................................................................................................................. 16
Installation Space Requirements................................................................................................................................ 17
Approximate Daily Consumption ................................................................................................................................ 17
System Labels and Displays ..............................................................17

Displays ...................................................................................................................................................................... 18
Background Colours of Pictograms ............................................................................................................................ 18
AU400 User Guide Version AC Contents v

Beckman Coulter Guarantee ..............................................................20
3 System Outline
Introduction.........................................................................................21
How the AU400 Analyses Samples....................................................21

Summary of the Process ............................................................................................................................................ 22
Computer Automation................................................................................................................................................. 23
Sample Identification .................................................................................................................................................. 23
Sample Transfer ......................................................................................................................................................... 24
Reagent Transfer ....................................................................................................................................................... 24
Sample Mixing ............................................................................................................................................................ 25
Measurement by Photometry ..................................................................................................................................... 25
Washing and Drying ................................................................................................................................................... 25
Calculating Results..................................................................................................................................................... 25
ISE Unit Testing (Optional Unit) ................................................................................................................................. 31
Understanding the System Hardware.................................................32

System Switches ........................................................................................................................................................ 32
Rack Feeder ............................................................................................................................................................... 34
Sample Probe Units.................................................................................................................................................... 36
Reagent Probe Units .................................................................................................................................................. 36
The Mixing Unit........................................................................................................................................................... 37
Washing and Drying Unit............................................................................................................................................ 37
STAT Table ................................................................................................................................................................ 39
Sample and Reagent Syringes................................................................................................................................... 41
The Incubator ............................................................................................................................................................. 41
Photometer Unit ......................................................................................................................................................... 42
Refrigeration Unit........................................................................................................................................................ 42
Tank Storage .............................................................................................................................................................. 43
Breakers and Fuses ................................................................................................................................................... 44
ISE Unit ...................................................................................................................................................................... 45
ISE Buffer Syringe ...................................................................................................................................................... 46
ISE Reagent Containers............................................................................................................................................. 46
Sample Cups .............................................................................................................................................................. 47
Understanding the Computer Software ..............................................48

Graphical User Interface (GUI)................................................................................................................................... 49
Customised Keyboard ................................................................................................................................................ 49
System Security.......................................................................................................................................................... 50
4 Configuring Tests
Introduction.........................................................................................51
Entering Test Name Parameters ........................................................52

Entering a Test Name................................................................................................................................................. 53
Entering a Long Name ............................................................................................................................................... 53
Entering a Reagent ID ................................................................................................................................................ 54
Programming Calculated Tests .................................................................................................................................. 54
vi Contents AU400 User Guide Version AC

Selecting a Multi-Reagent Item .................................................................................................................................. 54
Entering Alarm Shots.................................................................................................................................................. 54
Adding the New Test to the Round.....................................................55
Entering Specific Test Parameters .....................................................56

Entering General Test Parameters............................................................................................................................. 56
Entering ISE Specific Parameters .............................................................................................................................. 58
Entering LIH Specific Parameters .............................................................................................................................. 58
Setting Normal Ranges .............................................................................................................................................. 59
Setting Decimal Places............................................................................................................................................... 60
Creating a New Profile........................................................................60
Entering Quality Control (QC) Parameters .........................................61

Entering QC Common Parameters............................................................................................................................. 62
Entering QC Specific Parameters............................................................................................................................... 63
Entering Calibration Parameters ........................................................64

Adding a New Calibrator............................................................................................................................................. 65
Adding Calibrator Specific Parameters....................................................................................................................... 66
Generating a Summary of Calibration Types ............................................................................................................. 68
Setting Advanced Calibrations ................................................................................................................................... 73
Entering Contamination Parameters ..................................................74
Entering Data Check Parameters.......................................................76
Programming Repeat Tests................................................................77

Manual Repeats ......................................................................................................................................................... 77
Automatic Repeats ..................................................................................................................................................... 79
Reflex Testing ............................................................................................................................................................ 80
Entering Settings for ISE ....................................................................81

Entering ISE Specific Test Parameters ...................................................................................................................... 81
Calibration Curve Adjustment for Sample Matrix........................................................................................................ 82
Calibration Process on the ISE................................................................................................................................... 82
Adding the New Test to the List Format for Printing...........................84
5 Preparing for Analysis

Introduction.........................................................................................85
Performing Daily Maintenance ...........................................................85

Launching the System ................................................................................................................................................ 86
Logging in to the System ............................................................................................................................................ 86
Creating a New Index ................................................................................................................................................. 87
Inspect the Stability of the Upper Cover ..................................................................................................................... 87
Inspecting the System ................................................................................................................................................ 88
Replacing Sample Probe Detergent (W1) .................................................................................................................. 90
AU400 User Guide Version AC Contents vii

Checking Reagents .................................................................................................................................................... 90
Summary of Reagent Check Boxes ........................................................................................................................... 95
Replacing Reagents ................................................................................................................................................... 96
Precautions in Filling a Reagent Bottle....................................................................................................................... 96
Checking the Printer and Printer Paper...................................................................................................................... 97
Preparing the ISE Unit................................................................................................................................................ 97
ISE Status Messages ............................................................................................................................................... 102
Performing Calibrations ............................................................................................................................................ 103
Requesting Advanced Calibrations .......................................................................................................................... 106
Performing Auto-Calibration from the STAT Table................................................................................................... 107
Preparing for QC Analysis ........................................................................................................................................ 109
Entering Analysis Requisitions .........................................................112

Entering Manual Requisitions................................................................................................................................... 113
Entering Batch ID Requisitions................................................................................................................................. 114
Downloading Requisitions from a Host Computer.................................................................................................... 114
One-Touch Mode ..................................................................................................................................................... 115
Preparing Samples for Analysis .......................................................115

Attaching Barcode Labels to Sample Racks ............................................................................................................ 116
Applying the Barcode Labels to the Sample Cups ................................................................................................... 116
Placing Samples in Sample Cups ............................................................................................................................ 117
Placing the Sample Cups into the Rack ................................................................................................................... 117
Placing Racks on the Feeder ................................................................................................................................... 120
6 Performing Analysis
Introduction.......................................................................................123
Starting Analysis...............................................................................124
Monitoring Analysis ..........................................................................124

Checking Analyser Status ........................................................................................................................................ 125
Monitoring Cuvette Status ........................................................................................................................................ 126
Monitoring Result Data ............................................................................................................................................. 128
Monitoring the Alarm List.......................................................................................................................................... 128
Monitoring Data Processor Status............................................................................................................................ 129
Masking a Test .................................................................................130
Checking Results..............................................................................130
Checking for Error Flags and Alarms ....................................................................................................................... 131
Using the Reaction Monitor ...................................................................................................................................... 131
Calibration Checks ................................................................................................................................................... 132
Checking QC ............................................................................................................................................................ 134
Viewing and Editing QC Analysis Results ................................................................................................................ 139
Excluding QC data ................................................................................................................................................... 140
Editing Analysis Results ...................................................................140

Editing Results by Sample Number.......................................................................................................................... 141
Editing Results by Test Number ............................................................................................................................... 142
Correcting Analysis Results...................................................................................................................................... 143
Recalculating Analysis Results................................................................................................................................. 143
viii Contents AU400 User Guide Version AC

Printing Analysis Result Data ...........................................................144
Printing Reports........................................................................................................................................................ 144
Printing Data Lists .................................................................................................................................................... 145
Resending Data to a Host ................................................................146
Saving Information to a Floppy Disk.................................................146

Initialising a Floppy Disk ........................................................................................................................................... 146
Saving Parameters to a Floppy Disk (3.5" Diskette) ................................................................................................ 147
Loading Parameters onto the System from a Floppy Disk ....................................................................................... 148
Saving Test Result Data to a Floppy Disk ................................................................................................................ 148
Performing a Manual Sample Dilution ..............................................149
Performing a Repeat Run.................................................................149

Performing an Auto-Repeat Run .............................................................................................................................. 150
Performing a Manual Repeat Run ............................................................................................................................ 152
Processing Emergency Samples......................................................153

Using the STAT Table for Processing Emergency Samples .................................................................................... 153
Using the Red Rack for Emergency Sample Analysis.............................................................................................. 155
Pausing Analysis ..............................................................................156
Stopping the Rack Feeder................................................................156
Stopping the System ........................................................................156
Shutting Down the System ...............................................................157
Performing an Emergency Stop .......................................................158
Restarting the System ......................................................................158

Recovering Data after an Emergency Stop .............................................................................................................. 158
Bypassing Warm-up Mode ....................................................................................................................................... 159
Turning On and Off the Sample Barcode Reader ............................159
7 Additional Tasks
Introduction.......................................................................................161
Additional Programming Tasks........................................................161

Setting an LIH Test (serum quality index for estimation of lipemia, icterus and hemolysis)..................................... 162
Setting a Test Channel as a Calculated Test Channel............................................................................................. 163
Programming Calculated Tests ................................................................................................................................ 164
Checked Tests ......................................................................................................................................................... 165
Entering Sample Blank Parameters ......................................................................................................................... 166
Entering Online Settings........................................................................................................................................... 167
AU400 User Guide Version AC Contents ix

Setting Up Printers ...........................................................................168
Entering Printer Parameters ..................................................................................................................................... 169
Printing Batch Reports.............................................................................................................................................. 169
Adding a Second Printer to the System.................................................................................................................... 170
Entering Login Names and Allocating Levels of Access ..................170

Adding a Login Name ............................................................................................................................................... 170
Editing a Login Name ............................................................................................................................................... 171
Deleting a Login Name ............................................................................................................................................. 171
Changing a Password. ............................................................................................................................................. 171
Creating a User Menu .............................................................................................................................................. 171
Setting General Parameters .............................................................173

Setting System Parameters...................................................................................................................................... 174
Creating Comments in Comment Masters ............................................................................................................... 175
Entering Auto Power-On Parameters ....................................................................................................................... 176
Setting Date and Time.............................................................................................................................................. 176
Viewing the Program Version ................................................................................................................................... 177
Calibration Verification.............................................................................................................................................. 178
Viewing Statistics..............................................................................179
Data Statistics .......................................................................................................................................................... 180
Creating a Correlation Chart..................................................................................................................................... 180
Selecting Histogram Data......................................................................................................................................... 181
Viewing Reagent Consumption Volumes ................................................................................................................. 183
Tracking Consumable Supply................................................................................................................................... 184
Reagent Inventory .................................................................................................................................................... 185
Offline Output ...................................................................................186
8 Maintenance
Introduction.......................................................................................187
Using the Routine Maintenance Schedule .......................................187
Periodic Maintenance .......................................................................188

Adding a Maintenance Task ..................................................................................................................................... 188
Updating the Maintenance Register ......................................................................................................................... 188
Viewing Maintenance History ................................................................................................................................... 188
Daily Maintenance ............................................................................189

Performing a Wash 1................................................................................................................................................ 189
Daily ISE Maintenance .....................................................................190
Weekly Maintenance ........................................................................190

Performing a Wash 2................................................................................................................................................ 190
Performing a Photocal .............................................................................................................................................. 193
Washing the Pre-Dilution Bottle................................................................................................................................ 194
Shutting Down and Rebooting the System............................................................................................................... 194
x Contents AU400 User Guide Version AC

Weekly ISE Maintenance .................................................................195
Performing a Selectivity Check for the Na/K Electrodes .......................................................................................... 195
Washing the Mixing Bar, Liquid Level Sensors, Sample Pot Tubing and Sample Pot ............................................. 196
Bleach Cleaning Electrodes and Bypass Tubing...................................................................................................... 199
Monthly Maintenance .......................................................................200

Cleaning Wash Wells ............................................................................................................................................... 200
Cleaning the Wash Nozzle ....................................................................................................................................... 201
Backing up Parameters ............................................................................................................................................ 203
Cleaning Air Filters ................................................................................................................................................... 203
Replacing the Detergent Roller Tubing .................................................................................................................... 204
Monthly ISE Maintenance.................................................................204

Replacing the Mixture and Mid Standard Pump Roller Tubing................................................................................. 204
As Required Maintenance ................................................................205

Performing a Photometer Check .............................................................................................................................. 206
Replacing Cuvettes .................................................................................................................................................. 206
Replacing the Sample Probe.................................................................................................................................... 208
Replacing the Reagent Probe .................................................................................................................................. 209
Replacing Mixing Bars.............................................................................................................................................. 211
Replacing Sample, Reagent and ISE Buffer Syringes ............................................................................................. 212
Replacing the Wash Nozzle Joint Tubes.................................................................................................................. 214
Cleaning the Deionised Water Filter and the Sample Probe Filter ........................................................................... 216
Cleaning the Deionised Water Tank......................................................................................................................... 219
Replacing the Deionised Water Filter ....................................................................................................................... 220
Replacing the Sample Probe Filter........................................................................................................................... 222
Replacing the Photometer Lamp .............................................................................................................................. 223
Cleaning the Cuvettes and the Cuvette Wheel......................................................................................................... 225
As Required ISE Maintenance .........................................................227

Replacing the Na, K or Cl Electrode......................................................................................................................... 227
Replacing the Valve Tubing...................................................................................................................................... 230
Adding Reference Electrode Solution....................................................................................................................... 233
Replacing the Reference Electrode.......................................................................................................................... 233
Replacing the ISE Buffer Syringe ............................................................................................................................. 235
Replacing ISE Reagents .......................................................................................................................................... 235
Running Remote Maintenance .........................................................237
Routine Maintenance Schedule AU400 with ISE .............................238
9 Error Flags
Introduction.......................................................................................241
Tabular Summary of Error Flags ......................................................241
Error Flag Details..............................................................................243
Troubleshooting for Data Flags ?,@,$,D,F,G,! .................................259

Checking Syringes.................................................................................................................................................... 259
Checking the Sample Probe and Reagent Probe..................................................................................................... 260
AU400 User Guide Version AC Contents xi

Verifying the Calibrator Material ............................................................................................................................... 260
Verifying the Reagent Integrity ................................................................................................................................. 260
Verifying the QC Material ......................................................................................................................................... 261
10 Error Messages
Introduction.......................................................................................263
11 Troubleshooting
Introduction.......................................................................................279
Troubleshooting and Maintenance ...................................................280
Troubleshooting the System—Data Problems .................................280

Data Problem Checklist ............................................................................................................................................ 280
Checking Abnormal Data.......................................................................................................................................... 280
Troubleshooting Software......................................................................................................................................... 281
Troubleshooting the System—Reagents and Samples....................282

Sample Problems Causing Abnormal Data .............................................................................................................. 283
Reagent Problems Causing Abnormal Data............................................................................................................. 284
QC and Calibrator Problems Causing Abnormal Data ............................................................................................. 285
Abnormal Data Caused by Detergent or Wash Solution .......................................................................................... 285
Other Causes of Abnormal Data .............................................................................................................................. 285
Troubleshooting the System—Mechanical Problems.......................286

Syringe Problems ..................................................................................................................................................... 286
Probe Problems........................................................................................................................................................ 287
Mixing Bar Problems ................................................................................................................................................ 288
Cuvette Wheel or Wash Nozzle Problems ............................................................................................................... 288
Photometer Lamp or Photometer Unit Problems...................................................................................................... 289
Deionised Water Tank Problems.............................................................................................................................. 289
Deionised Water or Dirty Filter Problems ................................................................................................................. 289
Incubation Temperature Problems ........................................................................................................................... 290
Reagent Refrigerator Problems................................................................................................................................ 290
STAT Table Problems .............................................................................................................................................. 290
Rack Problems ......................................................................................................................................................... 290
Troubleshooting the System—System Problems .............................290

REAGENT COMPARTMENT TEMPERATURE HIGH alarm for the cooling unit .................................................... 291
Abnormal Sound from Inside the System ................................................................................................................. 291
Barcode Errors ......................................................................................................................................................... 292
Leaks from the Bottom of the System ...................................................................................................................... 292
No Wash Solution Supplied to the Mixing Bars ........................................................................................................ 292
Reagent Alarm when Sufficient Reagent Remains in Bottles................................................................................... 292
Sample Insufficient Alarm when Sufficient Sample Remains ................................................................................... 293
No Sample Cup Alarm when Sample Cup is Present .............................................................................................. 293
Printer Not Printing/Printer Light Not On .................................................................................................................. 293
Liquid Spilling from the Reagent Probe Tip .............................................................................................................. 293
Reagent Probe Not Aligned over the Cuvette .......................................................................................................... 293
Clogged Sample Probe Alarm .................................................................................................................................. 294
xii Contents AU400 User Guide Version AC

Abnormal Data Flag # (Sample Level Detection Error) Displayed in the Second Half of the Sample Dispense Operation
294
Cuvette Wash Overflow............................................................................................................................................ 294
Sample Rack Jammed ............................................................................................................................................. 294
Printer Problems (Alarm—Some Data Not Printed) ................................................................................................. 295
Troubleshooting the System—Data Processor Problems ................295

Menu Cannot Be Selected ....................................................................................................................................... 296
Number Key Pad on Keyboard Does Not Work ....................................................................................................... 296
Keyboard Not Responding ....................................................................................................................................... 296
Inaccessible Floppy Disk .......................................................................................................................................... 296
Analysis Results Do Not Print Automatically ............................................................................................................ 297
Online Auto-Output to Host Computer Not Executed ............................................................................................... 297
No Data Stored Despite Space on Disk ................................................................................................................... 297
Unsuccessful Transfer of Data between the System and the Host Computer ......................................................... 298
Recovering from an Emergency Stop or Power Loss.......................298

Performing an Emergency Stop ............................................................................................................................... 298
Resetting the System after a Power Failure or an Emergency Stop ........................................................................ 298
Recovering from a Cuvette Wheel Overflow ....................................299

Causes of Overflow .................................................................................................................................................. 300
Indications of an Overflow ........................................................................................................................................ 300
Recovering from an Overflow ................................................................................................................................... 300
Preparing to Continue Analysis ................................................................................................................................ 301
Troubleshooting the ISE Unit............................................................301

ISE Checklist ............................................................................................................................................................ 301
ISE Sample Requirements ....................................................................................................................................... 302
ISE Dispensing System ....................................................................303

Sample Probe and ISE Reagent Buffer Syringe....................................................................................................... 303
Mixture Pump Tubing ............................................................................................................................................... 303
Mixing Bar ................................................................................................................................................................ 304
Sample Pot ............................................................................................................................................................... 304
Pinch Valve Tubing .................................................................................................................................................. 305
ISE Measuring Components.............................................................306

O-Rings .................................................................................................................................................................... 306
Electrodes ................................................................................................................................................................ 306
Flowcell Blocks ......................................................................................................................................................... 307
ISE Calibration Errors.......................................................................307
ISE Selectivity Check .......................................................................308
AU400 User Guide Version AC Contents xiii

ISE Sequential Sample Measure......................................................308
Other ISE Diagnostics Functions.............................................................................................................................. 309
Shifts and Trends ..................................................................................................................................................... 310
Checking Reagent Integrity ...................................................................................................................................... 312
12 Menu Trees
Routine Menu ...................................................................................313
Parameter Menu...............................................................................315
Auxiliary Menu ..................................................................................317
Maintenance Menu ...........................................................................318
13 Reorder List
U.K/IRL Reorder List ........................................................................319
AU400 Glossary ...............................................................................321
AU400 Acronyms..............................................................................327
Useful References ............................................................................328
Index.................................................................................................329
xiv Contents AU400 User Guide Version AC

Before You
Start
Beckman Coulter
Introduction
Thank you for choosing the Beckman Coulter AU400 automated
chemistry system. The intended use of this automated system is the
photometric and potentiometric determination of analytes in samples,
in combination with appropriate reagents, calibrators, quality control
materials and other accessories. This system is for in-vitro diagnostic
use only. To ensure optimal performance and prevent system failure,
you should always operate the system in accordance with the
procedures outlined.
This chapter provides information on:
• What’s New in this Release. See page 1.
• Using this User Guide. See page 2.
What’s New in this

Release
This release of the user guide contains the following new material:
• Added U.S.A to the corporate address
• Added “Biohazard” label on page 10.
• Added “Using a Floppy Disk” on pages 10, 15, 146, and 186.
• Added “Preventing Eye Injury” caution from a laser beam on page

11.
• Updated “Use of Consumables” on page 14.
• Added “New cuvette ZM0634 (cuvette case color: blue)” on page

206.
• Updated warning labels in compliance with IEC61010-1 second

edition on page 19.
• Added a red arrow to indicate the barcode reader laser direction

and barcode reader specification in compliance with IEC61010-1
second edition on pages 34, 35, 40 and 43.
AU400 User Guide Version AC Before You Start 1

• Added “CAUTION” on changing test names on page 53.
• Added "Inspect the Stability of the Upper Cover" procedure on

pages 85, 87, 88, and 189.
• Updated “Precautions in Filling a Reagent Bottle" on pages 85,

96, and 97.
• Removed CAUTION from the “Requesting Advanced

Calibrations” section on page 106.
• Updated step 4 of "Cleaning the ISE Mixing Units and Liquid

Level Sensors" on pages 197.
• Updated “! - Unable to calculate concentration” on pages 242,

251, and 252.
• Added two action items in “G - Results Lower than Dynamic

Range” on page 254.
• Updated the wording in the "Replacing the Na, K or Cl Electrode"

section on page 227.
Using this User Guide

This user guide explains in a step-by-step way how to understand and
use the system effectively. It is also a maintenance and troubleshooting
guide and is intended as the primary source of reference for all AU400
users. This includes all medical laboratory personnel who might have to
use any part of the system or might have to prepare samples to be
processed by the system. It is assumed that the user has a knowledge
of analytical chemistry processes and specialist knowledge of sample
analysis. This guide also assumes users have basic PC operating skills
and knowledge of a Windows operating system. Users who have never
used a PC or a PC operating system should receive basic PC skills
training before using the system.
This section provides information on:
• Where to Start. See page 2.
• Using the Online Help. See page 4.
• Printing this User Guide on a Simple Desk Jet. See page 5.
• Typographical Conventions Used in this User Guide.

See page 6.
Where to Start
Before operating this system, you should receive training either directly
from Beckman Coulter or from someone who has already attended an
Beckman Coulter-approved training course. While this user guide deals
with each system procedure in a step-by-step manner, it does not aim
to be a substitute for training.
2 Before You Start AU400 User Guide Version AC

This section provides information on:
• Users New to Automated Analysers. See page 3.
• AU640 Users. See page 3.
• Installation Engineers. See page 4.
• System Administrators. See page 4.

If you are looking for information related to a specific concept, use the
search function in the PDF version of this guide. See “Using the Online
Help” on page 4.
If you are looking for information on a specific topic, use the index at the
back of this guide. This lists every topic in alphabetical order followed
by the page number.
If you are looking for a specific chapter, you can either use the fast find
tabs or the table of contents at the beginning of the guide.
Users New to Automated Analysers

If you have never used an automated chemistry system before or you
are only slightly familiar with one of the other Beckman Coulter models,
it is recommended that you read this user guide thoroughly before
operating the system, even if you have completed an Beckman Coulter-
approved instructor-led training course.
AU640 Users
Users who have advanced knowledge of the Beckman Coulter AU640
system should read the following sections of this guide before operating
the AU400:
• Chapter 3, “System Outline” on page 21
• Chapter 5, “Preparing for Analysis” on page 85
• Chapter 6, “Performing Analysis” on page 123
AU2700 Users
the AU400:
AU5400 Users
the AU400:
• Chapter 6, “Performing Analysis” on page 123

Installation Engineers
While this guide contains information related to the system environment
and hardware, it is not an installation guide. Installation of the AU400
should be performed by Beckman Coulter-approved engineers only.
There is therefore no installation information supplied with this system.
If you wish to change any aspect of the installation, please contact your
Beckman Coulter Representative or seek the help of an Beckman
Coulter-approved installation engineer.
System Administrators
Ensure you read chapters one and two closely and follow the
procedures outlined. The computer hardware and software parameters
should be part of an internal maintenance routine and all data produced
by the software should be backed up regularly. One copy of data should
be stored on-site and one off-site.
Read “Creating a User Menu” on page 171. This allows you to:
• Create a secure operating environment where unauthorised

users cannot interfere with the system while it is in operation.
• Track the actions of each user. When each user logs out, details
of the time spent working on the system are added to the Alarm
Log list file. This file should be backed up regularly for security
reasons.
Using the Online Help

This system is shipped with a PDF copy of this user guide. To access
this you should click the H e l p icon on the main button bar. You can
also access the online help by pressing F 1 and C o n t r o l on the
keyboard.
Alarm-specific help is also available and can be accessed by clicking
the A l a r m H e l p button to the left of the main help button. This
provides users with more details of alarms and possible remedies. See
Chapter 11, “Troubleshooting” on page 279.
Online Help button
Alarm Help button
Figure 1-1: Online Help and Alarm Help Buttons

This PDF file is viewed using Adobe Acrobat Reader. The most
important features you need to know are:
• Zoom in and out: You can either use the plus and minus buttons
to the left and right of the percentage reading or you can click the
magnifier and then click the page. If you want to decrease the TIP
size of the page, select the minus magnifier from the drop-down
list. If you are
unsure
• Maximise and minimise: You can minimise the reader window which
(i.e., make it smaller) by clicking the minimise button on the top button is
right hand corner of the window. When the window is minimised, which, then
put the cursor on the edge of the window and when it changes to hover the
a double-ended arrow, drag and drop the borders of the window mouse over the button to see
a pop-up message of what
to the size you want. As you do this, the size of the document
the button does.
automatically zooms so you can still read as much text. The next
time you minimise, the document automatically becomes the size
you have selected.
• Browse from one page to another: Use forward and backward

buttons.
• Search for information by entering a keyword: Click the

binoculars symbol. Enter the keywords and click search.
• View double-sided pages: To the left of the key icon on the

bottom of the Acrobat window, you find the double-sided icon.
Click this to view left and right pages.
• Close the Acrobat Reader: To close the PDF file when you have
finished using it, click the X button on the top right hand corner of
the reader window. If the X button is hidden underneath the
system icons, press C t r l + S p a c e and select C l o s e .
TIP
Printing this User Guide on a Simple Desk Jet
The text in
It is recommended that this guide be printed on double-sided A4 paper this guide
of not less than 110 g/m2. It can be printed either in black and white, cannot be
blue and black or full colour. edited or
copied. If
To print the guide on left and right pages: you click the
Text icon, you can make a
1 Click the printer icon on the top tool bar of the Adobe Acrobat
selection but the Copy option
viewer.
is greyed out.
2 Select the correct printer from the P r i n t e r drop-down list.
3 Click printer P r o p e r t i e s and select a high print quality.
4 Print all pages and check Print E v e n P a g e s O n l y .
5 When all even pages are printed, take them out and turn them
printed side up. Then re-insert the pages so that the header enters
TIP
the feeder first.
When right
6 Print all pages and check Print O d d P a g e s O n l y .
side pages
7 When pages are printed, remove them and check that each odd have
page has printed on the back of an even page. Check every page. printed,
leave them
for a while
to dry off before re-inserting
them. This prevents smears.

Typographical Conventions Used in this
User Guide
This section describes the conventions used in this guide:
• Tips, Cautions and Warnings. See page 6.
• Software Paths. See page 6.
• Software Buttons. See page 7.
Tips, Cautions and Warnings
These are the note and warning symbols used throughout this guide.
Please read Chapter 2, “Primary Safety Precautions” on page 9.
This book symbol indicates a note. Notes contain

important supplementary information that users
should take into account when performing
procedures or understanding concepts.
This symbol indicates a caution. Cautions indicate

that appropriate care or action must be taken. Failure
to do so may result in minor injury, sub-optimal
system performance or damage, which may
generate hazards. You should also read “Primary
Safety Precautions” on page 9.
This symbol indicates a warning. Warnings indicate

that great care must be exercised. Failure to do so
may result in serious injury or death, serious
degradation of instrument function or the potential to
generate incorrect sample data. You should also
TIP read “Primary Safety Precautions” on page 9.
See
Chapter 12,
“Menu Software Paths
Trees” on A software path is a sequence of options that should be selected in the
page 313 software interface in the order indicated.
for details of
Software paths in this guide are expressed as follows:
all software menu items.
“Select Routine>Test Requisition>Calibration.”
Following this path, a user should first click the Routine menu, then on
Test Requisition from that menu and finally click Calibration from the
resulting sub-menu. Software buttons, such as S y s t e m S t a t u s
that are part of such a sequence also use this blue italic font.

Software Buttons
All buttons that appear on the software interface and are part of a single TIP
procedural step appear in large highlighted blue font. When the Start When
Entry button is to be clicked for example, it appears as follows: “click”
appears in a
procedure,
1 Click S t a r t E n t r y ( F 4 ) .
users
should click
Each software button has a corresponding function key that can be once over the software
pressed on the keyboard instead of using the mouse. This appears in button with the left click
brackets after each button in every procedure. mouse button.

Primary Safety
Precautions
Introduction
You must understand how to use the AU400 safely before you begin
using the system. This chapter provides instructions on:
• Safe Use of the System. See page 9.
• Installation Environment Precautions. See page 16.
• System Labels and Displays. See page 17.
• Beckman Coulter Guarantee. See page 20.
Safe Use of the System

You should read the following safety precautions carefully before using
the system. If the system is not operated according to the following
precautions, the manufacturer or provider cannot be liable for any
damage or injury that might result.
Read all the following safety precautions:
• Preventing Electric Shocks. See page 10.
• Preventing Minor and Serious Injury. See page 10.
• Preventing Eye Injury. See page 11.
• Ensuring Optimal Analytical Performance. See page 11.
• Treating Waste Liquids. See page 11.
• Preventing Infection. See page 11.
• Correct Handling of Reagents, Calibrators and Control Sera.

See page 12.
• Preventing Damage to other Equipment and Facilities.

See page 12.
• Handling Specimens. See page 12.
• Water Supply and Drain Hoses. See page 13.
• Electromagnetic Wave and Noise Precautions. See page 13.
• Handling the Keyboard, Monitor and Mouse. See page 13.
AU400 User Guide Version 2.11 Primary Safety Precautions 9

• Replacing Parts. See page 14.
• Use of Consumables. See page 14.
CAUTION • Setting Analysis Parameters. See page 14.

Observe the • Planned Maintenance Routines. See page 14.
following
warning labels • Performing Important Checks at Analysis. See page 15.
that appear on
parts of the • Using a Floppy Disk. See page 15.
system where caution must
be exercised.
Do not cover up or remove
these labels. If they peel off Preventing Fire and Damage
or become illegible, please
inform the Beckman To prevent fire and damage:
Coulter Service
Department. Orange labels • This system should only be installed by Beckman Coulter-
warn of the risk of Serious authorised personnel.
Injury. Yellow labels warn
of the risk of Personal • Please contact the Beckman Coulter Sales or Service
Injury, Fire or Damage. Department if wish to alter your installation.
Preventing Electric Shocks

To prevent electric shocks:
• Never remove surfaces secured by screws, including the rear

and side covers.
Caution, risk of
electric shock • If liquid spills or leaks within the system, contact the Beckman
Coulter Service Department immediately. Careless handling of
liquids around the system might result in an electric shock.
Personal
Injury
Preventing Minor and Serious Injury

Warning, hot Minor Injury is considered any injury that does not require
surface hospitalisation or long term medical care. Serious injury is considered
any injury that leaves permanent effects and requires long-term medical
care or hospitalisation.
Warning, • Always operate the system with the main lid down.
laser beam
• Do not touch any moving parts of the system while it is
in operation.
Biohazard • Do not put your fingers or hands into any holes or openings.
• When replacing the photometer lamp, turn off the power switch
and allow at least five minutes for the lamp to cool down.
Touching the lamp before it is cool might result in burning.
• Observe the precautions on the system labels and in this

user guide.
• See the PC and printer operation manuals for information

on operating those devices safely.
10 Primary Safety Precautions AU400 User Guide Version AC

Preventing Eye Injury
Do not look directly into the photometer lamp or any of the barcode
readers while the system is powered on. Light entering your eyes
directly from the photometer lamp or the beam of light from the barcode
reader might result in eye damage. Follow all instructions and
procedures without modification in this AU400 User Guide to prevent
hazardous radiation exposure.
Ensuring Optimal Analytical Performance

To ensure optimal analytical performance:
• Do not open the upper and rear lids, the reagent refrigerator lid,
cuvette wheel lid, large STAT table lid or ISE lid during analysis.
• Perform system maintenance, parts replacement and inspection

routines, as outlined in this user guide (see Chapter 8,
“Maintenance” on page 187).
• Refer to the instructions for use supplied with reagents,

calibrators, controls or accessories to be used on the system
and follow them carefully. Ensure all settings are programmed
correctly and any supplementary information is followed.
• Ensure appropriate quantities of reagents and wash solutions

are present prior to daily operation.
Treating Waste Liquids

The waste liquids and mixtures might require special treatment before
being discarded. This system is designed to discard the concentrated
waste liquids (mixtures) and washing waste liquids (washing water and
detergents) separately.
For proper waste disposal, refer to relevant local authority guidelines.
Preventing Infection
To avoid infection, adhere to the following guidelines:
• To avoid infection, always wear personal protective clothing

when handling samples, performing maintenance and coming
in contact with waste.
• If infectious substances come in contact with your skin, flush

the area and seek medical advice.
• Wipe off any spilled contaminant immediately from the system.
• If any of the reagents or samples are accidentally swallowed,

seek medical advice.
AU400 User Guide Version AC Primary Safety Precautions 11

Correct Handling of Reagents, Calibrators and
Control Sera
To handle reagents, calibrators and control sera safely, adhere to the
following guidelines:
• Strictly follow any safety instructions supplied with reagents,

calibrators and control sera. Refer to the reagent manufacturer
for any questions concerning the safe handling of any material
to be used on this system.
• Prepare reagents in accordance with the manufacturer’s

instructions for use, paying particular attention to any
reconstitution, mixing and pre-treatment instructions.
• Store reagents correctly, prior to placing them on-board the

system. Refer to the manufacturer’s instructions. Pay particular
attention to the temperature requirements and light protection,
where appropriate.
• If reagents are removed from the system for later use,

particular care should be taken to ensure they are protected
from contamination. A clean cap should be applied and careful
inspection should be undertaken prior to re-use.
Preventing Damage to other Equipment

and Facilities
This system should have an independent power connection so that
it cannot interfere with other important electrical laboratory devices.
Handling Specimens
To handle specimens safely, adhere to the following guidelines:
• The quality of the sample placed on the Beckman Coulter system

is of paramount importance and all efforts should be made to
ensure it is of the highest quality. Numerous pre-analytical
variables exist and these should be accounted for before
interpretation of the final result.
• Typical samples used on the Beckman Coulter system include

serum, plasma, urine and cerebrospinal fluid (CSF). Other fluids
might not be suitable for analysis and care should be taken
before analysis.
• All samples should be handled as if potentially infectious and

protective clothing should be worn at all times.
• Serum and plasma samples should be separated from blood

cells as soon as possible to reduce the risk of adulteration.
Prior to analysis, samples should be free from suspended matter
such as fibrin. Any abnormal optical characteristics such as
lipemia, icterus or hemolysis should be noted. Results from
such samples should be interpreted after consultation with the
applicable reagents instructions for use.

• Care should be taken to ensure that any anticoagulants or
collection devices that employ a barrier are compatible with
the test reagent being employed.
• Urine samples should be collected into appropriate preservatives

and any suspended matter removed by centrifugation prior to
analysis (NCCLS GP16-A2).
• All samples should be protected from evaporation, contamination

and, where applicable, light (i.e. for bilirubin determination) prior
to analysis.
Water Supply and Drain Hoses

To prevent disconnection and leaks, ensure water supply and drainage
hoses are fitted by authorised personnel only and in accordance with
local authority guidelines.
Electromagnetic Wave and Noise Precautions

To safeguard the system from electromagnetic waves and noise,
adhere to the following guidelines:
• Do not locate this system near equipment that generates extreme

levels of noise.
• Do not use mobile or cordless telephones and transceivers in

the room where the system is installed.
• Never use, in the immediate vicinity, medical equipment that

might malfunction due to the effect of the electromagnetic waves
produced by the monitor and data processing unit (DPR).
Handling the Keyboard, Monitor and Mouse

To handle the keyboard, monitor and mouse safely, adhere to the
following guidelines:
• Do not operate the keyboard and mouse while wearing gloves

used to handle samples or reagent bottles.
• Ensure that your hands are clean and dry while using these
pieces of equipment and that you do not spill any liquid or
chemicals on them. If this occurs, contact the Beckman Coulter
Service Department immediately.

Replacing Parts
To replace parts safely, adhere to the following guidelines:
• Calibration of system reagents is required after replacement

of key parts such as syringes or probes. Refer to the reagent
manufacturer’s instructions for use.
• Only use detergents (Wash Solution, Cleaning Solution etc.)

of the type specified in this guide to ensure optimum system
performance.
Use of Consumables
Only use consumables that are approved by Beckman Coulter to
ensure optimum system performance. When replacing a consumable
part, always verify that the part name and part number from the part
label are correct to ensure the correct part is replaced on the system.
For some consumable parts such as syringes, probes, and cuvettes, it
is difficult to identify the correct part by appearance. The correct part
must be replaced on the system to avoid generating incorrect data.
Setting Analysis Parameters

Before using the system for the first time, you must set parameters such
as the reagent and sample quantity. Enter these parameters from the
Settings Sheet provided with reagents, to ensure optimum system
performance (see Chapter 4, “Configuring Tests” on page 51).
Planned Maintenance Routines

To maintain the system safely, adhere to the following guidelines:
• Have a planned maintenance routine for this system and follow

the guidelines contained in Chapter 8, “Maintenance” on
page 187. If this system is not maintained in accordance with
these instructions, then optimum system performance and safe
operation cannot be guaranteed.
• Have a maintenance routine for the computer software and

hardware. This must include frequently backing up data that
contains analysis parameters and results history.
• Back-up disks should not be stored on-site. Ideally, keep

one copy on-site for reference and one copy at another site.
• The computer hardware should be dedicated to running the

system software only and should never be connected to the
internet, to isolate it from harmful software viruses.

Performing Important Checks at Analysis
To ensure the validity of analytical data, operators should pay particular
attention to the following:
• Ensure system maintenance is performed adequately and repeat CAUTION

it if necessary.
The Alarm List
• Check the quality of purified water and check all flags. and all flags
should be
• Check the calibration for abnormality. cleared before
making these
• Check the appropriateness of Polygonal Calibration, as it might checks.
not be flagged. For diagnostic purposes,
the results of any analysis
• Check the quality control data. should be assessed in
conjunction with other
• Check the individual analysis results for flags. Review, using the available information, such
reaction monitor as required. as patients’ medical history,
clinical status and results of
• Check the syringes and tubing for leaks. other tests.
• Check the samples for contaminants (dust, fibrin, etc.).
• Check the quantity of each sample and that no bubbles

are present.
Using a Floppy Disk

To save and load data or parameters using a floppy disk, follow these
precautions:
• Use a formatted floppy disk to save data or parameters from the

analyzer computer to the floppy disk.
• When loading data or parameters to the analyzer’s computer

from a floppy disk1, run a virus check on the disk and verify that
no virus is detected. Set the write-protect tab to the LOCK
position before inserting it into the computer.
1 When you format a floppy disk or run a virus check on a floppy disk
intended to be inserted into the analyzer's computer using another
computer, the computer must be installed with anti-virus software
and its virus pattern files2 must be current.
2 ”Virus pattern files” are information files necessary for virus
detection. You must update your anti-virus software on a regular
basis to keep it current. You can obtain current files from the anti-
virus manufacturer. Contact the anti-virus manufacturer if
necessary.

Installation Environment
Precautions
Although this is not an installation guide, it is still important to be aware
of installation requirements. This section describes:
• Installation Environment. See page 16.
• Installation Space Requirements. See page 17.
• Approximate Daily Consumption. See page 17.
Installation Environment
To enable this system to operate safely and accurately, ensure that the
installation room:
CAUTION • Is located Indoors and never more than 2000 m above sea level.
If using an air • Is not exposed to direct sunlight.
conditioning
system to • Is clean and clear of dust.
regulate the
installation • Has a flat floor (gradient: less than 1/200) that can support
room temperature, locate approximately 485 kg and is free of vibration.
the system as far away as
possible from the air flow. • Has good ventilation. This system produces heat while operating.
• Has a temperature of between 18 and 32°C. This temperature

should not fluctuate by more than 2°C during analysis.
Air conditioning should be used if these conditions do not
exist naturally, to ensure optimum system performance.
CAUTION The calorific output is approximately 6500 KJ/H (1.8 Kilowatts).
This system
generates
• Has a humidity of between 40 and 80% RH, with no
condensation.
heat. Ensure
that it has the
minimum
space around it needed
to circulate cool air.

Installation Space Requirements
The AU400 requires the space demonstrated in Figure 2-1.
Minimum 500
Breaker
Minimum 1760
Data processor
700
(DPR)
760
AU400
Analyser (ANL)
700 Minimum 500
Minimum 500
F Minimum 220
R
O
N
T
Minimum 500 1450
Minimum 3370 Unit: mm
Figure 2-1: Installation Space
Approximate Daily Consumption

Name Approx. Daily Consumption
Wash Solution 1 l (8,000 tests)
(For washing cuvettes and mixing bars)
ISE Buffer Solution 180 ml (200 serum samples)
ISE Mid Standard Solution 260 ml (200 serum samples)
ISE Reference Solution 35 ml (200 serum samples)
ISE Cleaning Solution 2 ml
System Labels and

Displays
The following are displayed on the system:
• Displays. See page 18.
• Background Colours of Pictograms. See page 18.

Displays
The following kinds of pictograms are used to represent the switches
and the breaker unit.
EM. GND
ON OFF RESET
STOP Terminal
Figure 2-2: Pictograms
• Strip labels: Orange strips are present on the surface of the

system to indicate the movement areas of the mechanisms.
Users should take great care to avoid these areas during
operation.
• Instruction labels: In order to assist the operator to use the

system properly, “Instruction” labels are stuck on the relevant
parts of the system, in addition to the “Warning” labels.
Background Colours of Pictograms

• Orange - Warning: Warnings indicate that great care must be
exercised. Failure to do so may result in serious injury or death,
serious degradation of instrument function or the potential to
generate incorrect sample data.
• Yellow - Caution: Cautions indicate that appropriate care or

action must be taken. Failure to do so may result in minor injury,
sub-optimal system performance or damage, which may
generate hazards.
The AU400 warning labels are as shown in Figure 2-3.

Figure 2-3: Warning Labels

Beckman Coulter
Guarantee
Beckman Coulter guarantees this automated chemistry system to be
free from defects in materials or workmanship under normal use for a
period of one year commencing on the day of purchase. In the event
that the system should be rendered defective within the guarantee
period, it is repaired on-site free of charge. The Beckman Coulter
guarantee does not include the following:
• Defect or damage caused by natural disasters such as fires

or floods.
• Defect or damage caused by carelessness or abuse.
• Defect or damage resulting from maintenance performed by

personnel not approved by the Beckman Coulter Service
Department.
• Defect or damage caused by the use of consumables or fitting

replacement parts not recommended by Beckman Coulter.
• Malfunction caused by unauthorised disassembly.
• Corrosion of the electrical system caused by exposure to a

system environment other than that stated in this guide.
• Deterioration of the Optical measurement system resulting from

exposure to a system environment other than that stated in this
guide, such as exposure to extremely strong corrosive gases like
salt or sulphur.
• Loss of stored data caused by inadequate or incorrect system

maintenance.
Beckman Coulter shall not be liable for any consequential damages
such as loss of profit or business that might arise from the misuse of this
system.
Beckman Coulter offer a maintenance and repair service after the
guarantee period has expired. For details, please contact the Beckman
Coulter Sales or Service Department.

System
Outline
Introduction
This chapter aims to provide you with a general understanding of how
the system works. It also gives an introductory outline to key processes,
each of which are dealt with in detail in Chapter 6, “Performing Analysis”
on page 123.
It also provides you with a system hardware profile that enables you to
better understand the technical composition of the entire system.
• How the AU400 Analyses Samples. See page 21.
• Understanding the System Hardware. See page 32.
• Understanding the Computer Software. See page 48.
How the AU400 Analyses

Samples
This system carries out automated analysis of serum, plasma, urine,
cerebrospinal fluid (CSF) samples and other body fluids. It measures
sample components and automatically generates results. This section
describes the key processes:
• Summary of the Process. See page 22.
• Computer Automation. See page 23.
• Sample Identification. See page 23.
• Sample Transfer. See page 24.
• Reagent Transfer. See page 24.
• Sample Mixing. See page 25.
• Measurement by Photometry. See page 25.
• Washing and Drying. See page 25.
• Calculating Results. See page 25.
• ISE Unit Testing (Optional Unit). See page 31.
AU400 User Guide Version 2.11 System Outline 21

Summary of the Process
1 The AU400 performs analysis as follows:
2 The user places samples in racks. These enter the system as
shown in Figure 3-1.
3 The system reads a barcode on each rack as it moves along
the feeder conveyer. This tells the system what type (serum, urine
or other) the sample is, and how they should be tested.
4 A robotic syringe dispenses Reagent 1 into a cuvette on a rotating
cuvette wheel. A quantity of deionised water is added to dilute it.
These two liquids are mixed.
5 A small volume of the sample is then similarly taken out of the
sample cup and transferred into the cuvette.
Cuvette wheel
Mixing
Washing and drying
Reagent transfer
Grating
Photometer sensor
Light
source Auto repeat run
Sample transfer
Reagent refrigeration unit

STAT table
Rack feeder
ISE unit (optional)

Sample transfer
Mixing bar
Colour CRT Standard
Report CPU
monitor printer
Sample pot
Optional
Report printer
Electrode
Hard
Record and data storage disk
Keyboard
Figure 3-1: AU400 Process
6 Another syringe adds Reagent 2 to the cuvette and mixes it again.

7 The mixture passes the photometer. White light shines through the
mixture in order to measure its optical density (OD).
22 System Outline AU400 User Guide Version AC

8 A reaction occurs between reagent and the analyte contained
within the sample. This reaction generates a change in OD which
is measured by the analyser.
9 The reaction mixture is aspirated from the cuvette and the
TIP
cuvette is washed and dried before it returns again to the
sample transfer position. The system
computer
10 Every part of the system, such as the probes and mixing units, are
can also be
also automatically washed each time they are used.
connected
to the
Beckman
Coulter service network. This
Computer Automation allows Beckman Coulter
personnel to access the
The whole analysis process is controlled by a computer system linked system data from a remote
directly to the system and located beside it as an integral part of the location, enabling faster and
system. The computer system used is a PC which runs a Windows more effective troubleshooting
graphical user interface. While this computer can drive the analysis to be performed.
process completely independently, systems are often connected to
a network. This allows information to be received from a host computer
and be used as test rules in what are known as test requisitions.
The computer uses this information to drive the AU400 and make the
calculations that produce test results.
The test parameter data must be entered before the system can be
used for the first time. It can also be loaded from a floppy disk. This
information can be accessed from the P a r a m e t e r menu on the
main window.
The computer system allows you to:
• Edit Test Parameters. CAUTION
• Enter Test Requisitions (program each sample test). Only System

Administrators
• Monitor the analysis process closely. should be able
to edit test
• Measure the progress of analysis. parameters.
See “System Security” on
• Analyse and edit analysis results. page 50.
• Print analysis results.
• Track which users use the system and at which times.
• Enforce security by limiting the possible tasks certain users

can perform using the system.
Sample Identification
A test requisition is a specific programme or set of instructions entered
by users and used by the system to specify exactly what parameters to
use when testing each sample. It is important, therefore, that the system
correctly identifies which test requisitions to use for which sample.
The system can use barcodes to link test requisition information to each
sample to be tested. Every sample rack must always have a barcode,
as it is this information that the system uses to identify the most basic
information about the samples on a rack, i.e. whether they contain
serum, urine or other fluids.
AU400 User Guide Version AC System Outline 23

There are three modes of recognising samples on racks:
CAUTION
• Sequential mode: The sample barcode is not required in
Running the sequential mode. The system analyses the first sample on the
system in first rack, using the information in the first test requisition. It uses
Sequential the second test requisition for the second sample on the rack and
mode (i.e. so on. Samples, therefore, should be placed on the racks in strict
without reading numerical order.
sample barcode ID) is not
recommended due to the • Rack No. mode: The sample barcode is usually not read in rack
possibility of sample/result mode either, but the sample number of the test requisitions
mismatch. If you must run
indicates to the system where exactly the samples are positioned
without sample barcode ID,
on the rack. Samples, therefore, should be placed on the racks
please ensure that you are
aware of the pitfalls. in the order that matches those entered in the test requisitions.
Contact your Beckman Sample numbers 1 to 10, for instance, would be on rack 0001
Coulter Technical and sample numbers 11 to 20 would be on rack 0002. Sample
Representative. number 14 would be found on Rack 2, position 4 and sample
number 57 would be found in Rack 0006, position 7. In Rack ID
mode, racks can be in any order on the feeder.
CAUTION
To produce • Barcode (Sample ID) mode: The system reads the sample
correct sample barcode on each sample cup and then links this information to
results, there a corresponding requisition, to perform analysis. Samples can
must be no therefore be in any order and there can be vacant spaces on
vacant spaces each rack. Critical to test results is that sample barcodes match
in racks used in Sequential sample requisitions.
analysis.
Never have different
sample types on one rack.
Sample Transfer
A fixed volume of the sample is aspirated from each sample cup
and dispensed into a cuvette on the cuvette wheel. The system
uses information entered in the system parameters to determine
how much of a sample to dispense and how deep to reach into the
sample cup. The sample probes are washed internally with deionised
water and externally in a wash well between the dispensing of each
individual sample.
Reagent Transfer
A fixed volume of Reagent is aspirated from a specific reagent container
and dispensed into an empty cuvette on the cuvette wheel before the
sample is added. The system uses information entered in the system
parameters to determine how much reagent to use and how deep to
reach into the reagent container. The reagent probe is washed
internally with deionised water and externally in a washing well between
the dispensing of each individual reagent. Reagents are highly
concentrated liquids and, therefore, deionised water can be added
by the reagent probe.

Sample Mixing
The mixing unit dips into the cuvette containing the sample, reagent and
deionised water and mixes the contents. Each mixing bar is washed
with Wash Solution and rinsed with deionised water after each use.
Mixing can occur three times:
1 Mixing of reagent 1 with deionised water
2 Mixing of reagent 1 and sample
3 Mixing of reagent 1, sample and reagent 2
Measurement by Photometry
When a reagent is added to a sample, the resulting reaction causes the
mixture to undergo optical change. Measuring the change in optical
density of this mixture allows a result to be calculated. Concentration
of the analyte being measured is proportional to the optical change.
Optical density is measured by passing a beam of white light through
the mixture and measuring the amount of absorbance. This value is
then used in the calculation of the result.
Washing and Drying

After a sample is analysed, the cuvette used moves to the washing and
drying unit. This unit adds detergent to the cuvette, rinses it with cold
water and then hot water. This liquid is aspirated between dispenses
after which the cuvette is dried.
Calculating Results
The system can calculate analysis results in several ways:
• Reagent Blank (Zero Adjustment). See page 26.
• End Point Assay. See page 27.
• Rate Assay. See page 29.
• Fixed Point Assay. See page 30.

Reagent Blank (Zero Adjustment)
Because reagents have some intrinsic optical characteristics, the
Optical Density of the reagent used must always be calculated, as
shown in Figure 3-2, before being used for analysis and this data stored
by the system. This is achieved by using the reagent to test a sample
with no analyte, i.e. deionised water. The resulting reagent optical
density is termed reagent blank. The reagent blank is used by the
system to compensate for any optical contribution made by the reagent
to the final optical density of the reaction.
To perform a reagent blank:
1 Prepare a sample cup containing deionised water.
2 Using a blue rack, place the cups in the following positions:
1 for Serum, 10 for Urine and 4 for other fluids.
3 The system takes water from the cups and measures the reagent
blank optical density value by averaging:
• 2 of the replicate measurements, excluding the maximum and

minimum data if replicates are set equal to 4.
• The system can also be set to 1, 2, 3 or 4. If 1 is selected,

then only one is used.
• If 2 is selected, two values are averaged.
• If 3 is selected, the two closest values are averaged.
OD Reagent Blank (Compared with water blank ; example of 2 step analysis)
Reagent OD value at the

Reagent OD value at the first point (first data)
last point
(second data)
Deionised water blank (photocal data)

Photometric point
P0 P1 P10 P11 P27
R1 Sample R2
R1 : First Reagent
R2 : Second Reagent
Figure 3-2: Reagent Blank

End Point Assay
There are three types of End Point Assay. TIP
One Point assay is a general end point assay, as shown in Figure 3-3, End 1,
that determines the optical density of the reaction mixture from the Rate 1 and
optical density measured at a specified photometric measuring point. Fixed 1 do
not use the
The diagram below illustrates the case for one reagent only,
reagent
with reagent volume equal to or greater than 150 µl. In this case, blank to
the measuring point is 27. Points 1-27 can be used. calculate results.
Reaction OD value=OD (at specified measuring point) - OD0

(at measuring point 0)
OD
R1 0 S 1 2 3 4 5 6 7 8 27
Reaction OD value = Px - (K1 x P0) when positive reaction
Reaction OD value = -{Px - (K1 x P0)} when negative reaction
where K1 = R1.V / (R1.V + S.V)
P0: OD value at point 0

Px: OD value at end point
R1.V: First reagent dispense volume
S.V: Sample dispense volume
Figure 3-3: One Point Assay

• Two Point (Self-blank method) assay provides sample blank
adjustment, as shown in Figure 3-4. The optical density values
before dispensing reagent 2 are eliminated as the sample blank.
The optical density values in this blank channel should then be
subtracted from those calculated after dispensing the second
reagent. Any contribution to the final reaction OD from the
sample (turbidity, icterus etc.) is removed to improve
measurement reliability. The final OD value in this assay is as
shown in Figure 3-4 on page 28.
Reaction OD value = (Px - K2 x P0) - (K3 x Pz - K2 x P0)
OD
TIP
27 is the last
read point.
There are
no OD
R1 0 S 1 2 .... 9 10 R2 11 .... 27
values or
variables R1.V S.V Pz R2.V Px
after this point.
K2 = {R1.V / (R1.V + S.V + R2.V)}
K3 = {(R1.V + S.V) / (R1.V + S.V + R2.V)}
P0 : OD value at the first point

Pz : OD value before dispensing the second reagent. Can be P1 - P10.
Px : OD value after dispensing the second reagent. Can be P11 - P27.
R1.V : First reagent dispense volume
R2.V : Second reagent dispense volume
S.V : Sample dispense volume
Figure 3-4: Two Point Assay

• End Assay (two test: blank/colour method, OD of the serum
using the blank channel) measures the blank channel and then TIP
subtracts this from the measured optical density to calculate the To link
actual optical density of the reaction, as shown in Figure 3-5. the colour
While the use of an additional blank is required, this method reaction test
ensures greater measurement accuracy than two point assays. and serum
blank test,
select:
Parameters>Inter-related
Tests>Sample Blank.
Select tests from the pull-
down menu.
Reaction OD value = Colour Reaction Test OD (ODc) - Serum Blank Test OD (ODB)
Color reaction channel
OD
ODC
Serum blank channel

ODB
R1 S R2 27
Figure 3-5: End Assay
Rate Assay
There are two types of rate assay:
• Normal rate assay measures the variation in the rate of

absorbance per minute by calculating the average change in
absorbance between two photometric points, using the least
squares method, as shown in Figure 3-6. At least three
consecutive OD values must be within the OD range limit. If no
lag time is defined as yes, then values before the defined first
read point can be used for fast reactions.
OD
TIP
OD/min. The Y axis

OD limit is the
reaction OD
and the
X axis
R1 S R2 27
represents
the total reaction time in
Reaction OD value = ΔOD/min when positive reaction photometric read points.
Reaction OD value = -{ ΔOD/min} when negative reaction
Figure 3-6: Normal Rate Assay

• Double rate assay determines the rate of absorbance variation
per minute by calculating the average of the absorbance
variations between two measuring points, using the least squares
method, as shown in Figure 3-7. The system then gets the optical
density rate of the objective substance from the calculation
expression.
OD
ΔOD(2)/min.
ΔOD(1)/min.
R1 S R2 27
[ΔOD(2)-ΔOD(1)]/min.
Reaction OD value = ΔOD(2)/min - (K1 x ΔOD(1)/min) when positive reaction

Reaction OD value = -{ΔOD(2)/min - (K1 x ΔOD(1)/min)} when negative reaction
where K1 = (R1.V + S.V) / (R1.V + S.V + R2.V)
Figure 3-7: Double Rate Assay
Fixed Point Assay

This method, shown in Figure 3-8, determines the difference between
the optical densities at two specific positions where a reaction is
taking place.
OD
R1 S R2 A B 27
Reaction OD value = Px - Py when positive reaction

Reaction OD value = -{Px - Py} when negative reaction
Px: OD value at the last point

Py: OD value at the first point
Figure 3-8: Fixed Point Assay

ISE Unit Testing (Optional Unit)
ISE testing is optional. It is performed potentiometrically in a built-in but
independent test unit, as shown in Figure 3-9. This unit measures the
potential difference between the ion-selective electrode and a reference
electrode. This potential is generated by ions in the sample passing
through an ion-selective membrane. The purpose of the test is to TIP
calculate the concentration of individual ions in the sample and Mid
Beckman
standard solution. The concentration of ions is adjusted for drift by
Coulter
measuring the Mid Standard solution and calculating the difference systems
between the measured value and the expected value of the Mid use what is
Standard Solution. The Mid Standard Solution is measured after every termed as
sample. “Indirect”
The sample probe is used to dispense a small volume of the sample into ISE analysis. This means
that each sample is mixed
the ISE unit sample pot. An exact volume of buffer solution is added
with high ionic strength
to the sample and the ISE unit uses its own mixing bar to mix the diluent (ISE buffer). This
sample and buffer solution. The mixture is then passed into the enables smaller sample
ion-selective electrode unit and after measurement is pumped to waste. volumes to be used for
The Mid Standard Solution is then dispensed, measured and pumped analysis.
to waste. The direct method measures
neat samples
The following 3 ion-selective electrodes are available:
• Na electrode
• K electrode
• Cl electrode
ISE unit (optional)

Sample transfer
Mixing bar
Sample pot
Electrode
Figure 3-9: ISE Unit Process

Understanding the
System Hardware
This section describes the hardware components of the AU400:
• System Switches. See page 32.
• Rack Feeder. See page 34.
• Sample Probe Units. See page 36.
• Reagent Probe Units. See page 36.
• The Mixing Unit. See page 37.
• Washing and Drying Unit. See page 37.
• STAT Table. See page 39.
• Sample and Reagent Syringes. See page 41.
• The Incubator. See page 41.
• Photometer Unit. See page 42.
• Refrigeration Unit. See page 42.
• Breakers and Fuses. See page 44.
• ISE Unit. See page 45.
• ISE Buffer Syringe. See page 46.
• ISE Reagent Containers. See page 46.
• Sample Cups. See page 47.
System Switches
The location of the system switches is shown in Figure 3-10.
This section describes the following switches:
• Power-On Switch (Sub-Power). See page 33.
• EM STOP (Emergency stop) Switch. See page 33.
• Reset Switch. See page 33.
• STAT Led (Set LED, End LED). See page 33.
• STAT Test Switch. See page 33.
• STAT Rotation/DIAG (ISE Prime) Switch. See page 33.
• ISE Power Switch. See page 33.
• The DIAG Switch. See page 34.

Power-On Switch (Sub-Power)
This switch turns the system power on. Power to the reagent
refrigerators and the STAT table refrigerator is constantly supplied
by the main power switch.
EM STOP (Emergency stop)

Switch
When this switch is pressed, power
supply to the entire system is
immediately cut off. The system TIP
stops operating immediately. This
switch should only be used if there is You
health and safety emergency. should
always
During an emergency stop analysis data might be lost and perform a
the computer’s hard disk might be damaged. Wash 1
following
Reset Switch an emergency stop. See
This switch restores the main power supply following an emergency Chapter 8, “Maintenance”
on page 187.
stop. The incubator and reagent refrigerators rely on power from the
main switch and are reconnected, using Reset. This switch also resets
the power failure detection circuit. The power failure detection circuit
alerts users to any power failure that happens during normal analysis.
STAT Led (Set LED, End LED)

The Set LED indicates whether or not you can place sample cups onto
the STAT table. When the light is on, aspiration is complete, samples
are dispensed and you can place new samples on the STAT table.
When the light is off, this indicates that the STAT table is working and
you should not open it. The light always flashes a few times before it
turns on fully.
STAT Test Switch

This switch is used to start
analysis using the STAT table.
It is also used to prompt the
Set LED light to turn on so that
samples can be placed on
the STAT table.
STAT Rotation/DIAG (ISE Prime) Switch

This rotates the STAT table. The STAT table rotates 1/5 of a rotation
each time the switch is pressed. The STAT table can only be rotated
when the set LED light for STAT is on. This switch also acts as a trigger
for diagnostic functions when such functions are selected within the
software.
ISE Power Switch

This switch turns the ISE power on and off. When the system power
is on the ISE power is also automatically turned on.

The DIAG Switch
This switch is used to activate diagnostic or maintenance functions.
STAT testtest
STAT STAT LED
STAT (END
LED (ENDLED)
LED)
switch
switch STAT LED
STAT (SET
LED LED)
(SET LED)
S
T
S
A
T
T
A
T
STAT
STAT ROTATION/DIAG
ROTATION/DIAG
switch
switch
Power-ON switch
Power-ON (Sub-power
switch switch)
(Sub-power switch)
EMEM
STOP switch
STOP switch Main
Mainbreaker
breaker
RESET
RESETswitch
switch (main
(mainpower
power
supply)
supply)
CAUTION
Figure 3-10: Location of Switches
Never place
a rack on the
feeder while
the Rack load Rack Feeder
inhibition light
(labelled 'LED' in Keep the sample protection cover closed at all times to prevent dirt and
Figure 3-13) is on as this dust getting into the sample cups on the rack feeder, as shown in
indicates that the rack Figure 3-11 on page 34, and to prevent samples from evaporating.
feeder is in operation. Always ensure racks are placed on the feeder with the rack barcode
Placing a rack on the
facing the barcode reader on the inside of the feeder, as shown in
feeder while it is in
Figure 3-12 on page 35.
operation might cause the
sample to be spilled.
Figure 3-11: Rack Feeder

CAUTION
Do not look
directly into the
lens of the
Sample ID
barcode reader
due to the eye damaging
effects of the laser beam.

The following table summarizes the specifications for the barcode
readers.
Barcode Reader Specifications

Wave length: 650±10 nm
M a xi m u m ou t p u t : 6.2 mW
Pulse width: 0.18 µs
Frequency: 2.5 MHz
Class: 2
Scan rate: 100±20 Hz
Top view of rack feeder

Window for reading rack ID
Surface where the rack
ID label is applied
a a
F
R
O
N
T A maximum of 8 racks can be set at one time.
Figure 3-12: Direction of Rack Flow

Sample Probe Units
The system has one sample probe, as shown in Figure 3-13 on
page 36. A track on the cuvette wheel cover and on the casing of the
system indicates the path taken by the probe arm when the system is
in operation.
Probe arm
Sample probe cover
Reagent probe
Relay tube
Probe connector
Sample probe
Reagent probe
wash well
Sample probe
wash well
T
ON
FR
Probe arm
Figure 3-13: Sample Probe
Reagent Probe Units

The system has one reagent probe, which supplies the cuvette wheel.
The reagent probe has a dedicated wash well.

The Mixing Unit
This is a unit containing six spiral-shaped mixing bars revolving on its
own axis, as shown in Figure 3-14. Rotating the mixing unit means that
while one set of bars are mixing, the next ones are being washed and
rinsed in the mixing unit wash wells.
Mixing unit
Mixing bar
Mixing-bar
wash well
T
ON
FR
Figure 3-14: Mixing Unit
Washing and Drying Unit

Each nozzle is made up of three smaller nozzles of different lengths,
as shown in Figure 3-15. The longest one aspirates the mixture from
the cuvette. The next longest dispenses the detergent or water.
The shortest nozzle aspirates any excess detergent and water to
prevent spillage.
Tube mounting joints
Knob
Joint tube
Tube mounting joints
Wash nozzles
Wash nozzle
station FR
Aspiration nozzle ON
T
Drying nozzle
Figure 3-15: Washing and Drying Unit

The dispense sequence of the wash nozzles, as shown in Figure 3-16,
is as follows:
• Nozzles 1 and 2 - Diluted Wash Solution
• Nozzles 3 and 6 - Warm water
• Nozzle 7 (not shown) - aspiration
• Nozzle 8 (not shown) - drying.

Wash nozzles
1 2 3 4 5 6
Figure 3-16: Washing Nozzles

STAT Table
The STAT Table is shown in Figure 3-17. Contact your Beckman
Coulter Representative for information on setting up and performing
Calibration and QC from the STAT table. This section describes the
following parts of the STAT table:
• Outer Positions. See page 39.
• Inner Positions. See page 39.
• W1 hole. See page 39.
• W2 hole. See page 39.
• STAT Table Clean hole. See page 39.
• STAT table S-H and S-L holes. See page 39.
• STAT table U-H and U-L holes. See page 40.
Outer Positions CAUTION

Emergency, quality control, calibration samples and deionised water for The STAT
measuring reagent blank should always be placed in the outer table can only
positions. read barcodes
on samples (if
Inner Positions set up) that are
The cleaning solutions and reagents used for ISE calibration must placed on the outer
positions of the table.
always be placed in the assigned inner positions.
Always keep the cover
on the table to keep the
W1 hole temperature of the table
During normal analysis, detergent for Wash 1 is placed in a sample cup, down and to prevent dust
which is then placed in the W1 hole. from entering the samples.
Whilst the STAT table is
refrigerated, you should
W2 hole never store samples on it.
Detergent to wash the sample probe during Wash 2 is placed in
a sample cup, which is then placed in this hole.
STAT Table Clean hole

This holds the Cleaning Solution to wash the ISE sample pot and
electrode line.
STAT table S-H and S-L holes

These hold the sample cups containing the standard solutions for
serum calibration for the ISE unit. The High Serum Standard is placed
in the S-H hole. The Low Serum Standard is placed in the S-L hole.

STAT table U-H and U-L holes
CAUTION
The High Urine Standard Solution is placed in the U-H hole.
Do not look The Low Urine Standard Solution is placed in the U-L hole.
directly into the
lens of the
Sample cups containing the solution used to check the selectivity of the
Sample ID Na and K ISE electrodes are also placed in these positions. The
barcode reader standard solution for the Na selectivity check is placed in the S-H hole,
due to the eye damaging and the standard solution for the K selectivity check is placed in the
effects of the laser beam. S-L hole.
Figure 3-17: STAT Table

readers.
B a r c o d e R e a d e r S p e c i fi c a ti o n s
Wave length: 650±10 nm
M a xi m u m o u t p u t : 6.2 mW
Pulse width: 0.18 µs
Frequency: 2.5 MHz
Class: 2
S c a n ra t e : 100±20 Hz

Sample and Reagent Syringes CAUTION
The AU400 has 3 syringes, as shown in Figure 3-18. Reagent
syringes
• 1 for Reagent should be
checked daily
• 1 for Sample for leaks.
Always check for any drops
• 1 for ISE Buffer Solution around the syringe case
head.
ISE reagent dispenser

Sample dispenser Fixing nut
Reagent dispenser Syringe head
Relay tube
Syringe case
FR
ON
T
Piston fixing screw
Figure 3-18: Syringes
The Incubator
The purpose of the incubator, shown in Figure 3-19, is to keep the
reaction temperature at 37°C. 88 cuvettes are contained on the cuvette
wheel. A cuvette is a small container made from quartz glass. The light
path of a cuvette is 6 mm, and the capacity is 750 µl.
Minimum Reaction Volume: 150 µl
Maximum Reaction Volume: 550 µl
Cuvette wheel cover
Cuvette wheel
Incubator
T
ON
FR
Cuvette
Figure 3-19: Incubator

CAUTION Photometer Unit
Never touch The photometer unit consists of a lamp that provides the white light
the photometer source, as shown in Figure 3-20 on page 42. Output is about 12V/20W.
lamp while it is
hot and never
allow the light
from it to enter your eyes
directly.
Lamp cover
Knobs
Photometer
lamp
T
ON
FR Lamp cords
Figure 3-20: Photometer Source
CAUTION Refrigeration Unit

Always ensure The reagent refrigerator, shown in Figure 3-21 on page 43, contains
reagent bottles first and second reagents, maintaining their temperature between 4 and
are placed on 12°C even when the system is shut down using the E n d P r o c e s s
the unit with
key. There are 76 reagent spaces on the unit. 15, 30 and 60 ml bottles
the barcode
can be placed on the unit, using the adapters provided.
side of the bottle to the
outer surface.
Be sure the caps are
removed from all bottles
placed in the unit.

Figure 3-21: Refrigerator

readers. CAUTION
Barcode Reader Specifications Do not look

directly into the
Wave length: 650±10 nm lens of the
M a xi m u m ou t p u t : 6.2 mW Reagent ID
barcode reader
Pulse width: 0.18 µs due to the eye damaging
effects of the laser beam.
Frequency: 2.5 MHz
Class: 2
Scan rate: 100±20 Hz
Tank Storage CAUTION

The system contains the following tanks, as shown in Figure 3-22. Older AU400
analysers may
• Deionised Water Tank. See page 43. have two
Concentrated
• Concentrated Wash Solution Tank. See page 43. Wash Solution
Tanks (A & B) and two
• Diluted Wash Solution Tank. See page 44. Diluted Wash Solution
Tanks (A & B). A & B can
Deionised Water Tank be considered identical
This holds 10 litres. Deionised water provided from an external water in content and function.
purifier via an automatic valve.
Concentrated Wash Solution Tank

This holds two litres of Wash Solution.

Diluted Wash Solution Tank
This holds two litres of automatically diluted Wash Solution.
Front
Front view
view
Deionised
Deionised water
water tank
tank
Diluted
Diluted detergent
detergent tank
tank AA
(factory
(factory optional)
optional)
Diluted
Diluted detergent
detergent tank
tank BB
Master
Master detergent
detergent tank
tank AA Master
Master detergent
detergent tank
tank BB
(factory
(factory optional)
optional)
Figure 3-22: Tank Storage

CAUTION
If the main
system
breaker switch
Breakers and Fuses
is on and the
This is the main system fuse board, as shown in Figure 3-23, that allows
pilot lamp is
out, you might have to
you to isolate power from specific areas of the system. The System
change the fuse. Main breaker is the main trip switch and automatically shuts down all the
breaker switches.
Rear view
DPR (PC) breaker
Reagent refrigerator and
incubator breaker
Analyser breaker
Fuse Heater breaker
FUSE
Pilot lamp 250V 2A
TYPE-F
P.L. 7.5A 15A 15A 15A

PC REF/ISE ANL HEATER
COM.
DPR (PC)
service outlets OP.1 SIGNAL OP.2 SIGNAL
OP.1 POWER OP.2 POWER OPD

System main breaker AC100V
7.5A
Figure 3-23: Main Fuse Board

ISE Unit
The ISE unit, as shown in Figure 3-24, contains the following:
• Sample Pot. See page 45.
• Mixing Unit (for ISE). See page 45.
• Pinch Valve (for ISE). See page 45.
• Rolling Pumps. See page 46.
• Rolling Pump Tubes. See page 46.
• Power Switch. See page 46.
K electrode
Pinch valve Na electrode
Thermistor Cl electrode
Rolling tubes REF

electrode
Mixing unit
T
ON
FR
Mixture aspiration rolling pump
MID solution dispense rolling pump Sample pot
Figure 3-24: ISE Unit
Sample Pot
The volume of each sample dispensed into the sample pot is fixed
as follows:
Serum: 20 µl
Urine: 25 µl
Extrusion Water:
To Serum: 8 µl
To Urine: 10 µl
The volume of buffer solution added to each sample is fixed as follows:
To Serum: 600 µl
To Urine: 750 µl
Mixing Unit (for ISE)

This is equipped with two liquid-level sensors to detect overflow of the
sample pot due to a blockage.
Pinch Valve (for ISE)

This is used to switch from the bypass tubing to the electrode flow path
to remove contamination from the previous sample.

Rolling Pumps
One of the pumps aspirates the mixture and the Mid Standard Solution
through the electrodes and bypass tubing and one dispenses the
Mid Standard Solution.
Rolling Pump Tubes

These are rubber tubes that are wrapped around the rolling pump.
As the rolling pumps rotates, the tubes are squeezed by the pump’s
roller to either dispense or discharge solution.
Power Switch
This is located behind the right front door.
ISE Buffer Syringe

The ISE buffer syringe, as shown in Figure 3-25, dispenses ISE buffer
solution into the ISE sample pot to dilute the samples before
measurement. The syringe should be checked daily for leaks.
ISE reagent dispenser Fixing nut

Sample dispenser
Case head
Reagent dispenser
Relay tube
Syringe case
Piston fixing screw

FR
ON
T
Figure 3-25: ISE Buffer Syringe
ISE Reagent Containers

There are two containers, as shown in Figure 3-26, with a 2 litre
capacity and one (Reference Solution) with a 1 litre capacity:
• Buffer Solution
• Mid Standard Solution
• Reference Solution

Buffer solution tank
MID solution tank
REF solution tank
FR
ON
T
Figure 3-26: ISE Reagent Containers
Sample Cups
Sample cups, as shown in Figure 3-27 on page 47, contain samples in
the sample racks:
Outside diameter: 11.5 mm to 16 mm
Inside diameter: 9 mm to 15 mm
Length: 55 mm to 102 mm
• Sample cups used in the conventional rack (no slits in side)

Outside diameter: ø12 mm or more
Length: 10 mm or more from top of rack
Figure 3-27: Sample Cups

CAUTION Understanding the
Do not operate
this system if
Computer Software
you are This system is controlled using a Windows software application. It is
unfamiliar with therefore easy to navigate for anyone who has basic PC skills and
a PC operating experience with Windows. You can use the mouse to access every
system and Windows button you see on the window. The system also has a customised
applications. keyboard which is an alternative option to using the mouse. This section
It is recommended that
describes:
users who have only used a
Unix, Linux, Mac or legacy
operating system take an
• Graphical User Interface (GUI). See page 49.
approved MS Windows and • Customised Keyboard. See page 49.
basic PC skills training
course before using this • System Security. See page 50.
system to perform analysis.

Graphical User Interface (GUI)
Figure 3-28 shows an example GUI window:
1
2
3
Figure 3-28: Example GUI Window
This interface is composed of a main window display area

surrounded by three other important features
1 Main Button Bar: This contains the control buttons that start,
stop and pause the analysis process.
2 Menu Bar: This allows you access all other system functions.
For a complete list of the functions available here, see the
Software Options sheet, and Chapter 12, “Menu Trees” on
page 313.
3 Message Areas: Two types of message are displayed while
the system is in operation. One displays function specific user
assistance information and the other displays warning
messages when there is a process problem.
Customised Keyboard TIP

This system is supplied with a computer keyboard, as shown in The exact
Figure 3-29, designed specially to provide users with quick access design and
to software commands on the window. Using the keys is an alternative layout of
to using the mouse. The system does not need to be set in either keyboard
keyboard or mouse mode so you can also use a combination of the two. may vary
This guide lists the function key and mouse button for every procedure from that
described. illustrated but all function
keys described will be
available. Some keyboards
incorporate a touchpad and
this is provided in place of a
mouse.

Num Lock lamp
Alarm Clear key
System
Feeder Stop key
Status key
Pause key
Menu Help key Print Screen
Function key key
ESC key Number Lock key
Start key
FEEDER STOP/ SCREEN SYSTEM ALARM

START PAUSE
STOP STANDBY COPY STATUS CLEAR
Print Scroll Num Caps Scroll

Esc F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12 Pause
Screen Lock Lock Lock Lock
BECKMAN
COULTER MU8108 HELP
~ ! @ # $ % ^ & * ( ) _ + | Back
Insert Home
Page Num / * -
` Space Up
1 2 3 4 5 6 7 8 9 0 - = \ Lock
Q W E R T Y U I O P { } Page 7 8 9
Tab Enter Delete End
[ ] Down Home ↑ 9
END
+
Caps Lock A S D F G H J K L : " PROCESS 4 5 6
; ' ← →
Z X C V B N M < > ? ↑ 1 2 3
Shift Shift
, . / End ↓ Pg Dn
Enter
← ↓ → 0 .
Ctrl Alt Alt Ctrl
Ins Del
Alarm Help key Numeric

Stop/Stand-by key ↑ ,↓ ,← ,→ key pad
End Process key key
: Template
Figure 3-29: Customised Keyboard
System Security
This system allows users to enter a user name and password each time
they login to the system. The system administrator should ensure that
each user is assigned a unique user name and password. This user
should also be assigned a level of access. Only administrators should
be given access to the test parameters menu. For more information, see
“Entering Login Names and Allocating Levels of Access” on page 170.

Configuring
Tests
Introduction
This chapter describes how to add a new test to the AU400 and
configure the system.
Adding a new test involves the following procedures: TIP

• Entering Test Name Parameters. See page 52. Some tests
might
• Adding the New Test to the Round. See page 55. require
contamin-
• Entering Specific Test Parameters. See page 56. ation
parameters
• Creating a New Profile. See page 60.
and data check parameters
• Entering Quality Control (QC) Parameters. See page 61. to be set in the S p e c i a l
menu. Check Settings
• Entering Calibration Parameters. See page 64. Sheets and current technical
information to determine if
• Entering Contamination Parameters. See page 74. required.
• Entering Data Check Parameters. See page 76.
• Programming Repeat Tests. See page 77.
• Entering Settings for ISE. See page 81.
• Adding the New Test to the List Format for Printing. See page 84.
AU400 User Guide Version 2.11 Configuring Tests 51

Entering Test Name
Parameters
To enter test name parameters, perform the following procedures:
1 Click each tab to enter parameters. Each tab is detailed below:
• Entering a Test Name. See page 53.
• Entering a Long Name. See page 53.
• Entering a Reagent ID. See page 54.
• Programming Calculated Tests. See page 54.
• Selecting a Multi-Reagent Item. See page 54.
• Entering Alarm Shots. See page 54.

Select Parameter>Common Test Parameters>Test Name, as shown in
Figure 4-1.
2 Click each tab to enter parameters. Each tab is detailed below.
3 When parameters are entered, click E x i t ( F 2 ) to close the
Test Name window and save your settings and E x i t ( F 2 )
again to return to the main window.
Figure 4-1: Test Name Window
52 Configuring Tests AU400 User Guide Version AC

Entering a Test Name CAUTION
Click the T e s t N a m e tab. Changing the test name

will affect all results with
4 Click S e t ( F 4 ) , then click an available test number. that test number
5 Click E d i t ( F 5 ) and enter the test name of maximum retrospectively. Any
five characters, as shown in Figure 4-2. previously reported
results (with the old name) will be
assigned the new test name and thus
extreme caution must be applied
when making any changes to the test
name.
DO NOT CHANGE THE TEST NAME

WITHOUT NOTING THE TIME AND
DATE THE CHANGE OCCURRED.
ENSURE THAT ANY RESULTS
PRINTED OUT PRIOR TO THIS
TIME AND DATE ARE REVIEWED
AND CORRECTLY IDENTIFIED.
Figure 4-2: Entering a Test Name
6 Click C l o s e to save this.
Entering a Long Name

Enter the longer name that is printed on reports.
1 Click the L o n g N a m e tab.
2 Click E d i t ( F 5 ) and enter the long test name of maximum
20 characters.
AU400 User Guide Version AC Configuring Tests 53

Entering a Reagent ID
CAUTION
1 Click the R e a g e n t I D tab.
If reagents IDs
(barcodes on 2 Click the new test.
reagent bottles)
are missing, the 3 Click E d i t ( F 5 ) and enter the first three digits of the reagent ID
system cannot under T e st C o d e , as shown in Figure 4-3. The Reagent ID
recognise the reagent. can be found either on the Settings Sheet or on the reagent bottle.
Figure 4-3: Entering a Reagent ID
Programming Calculated Tests

TIP See “Setting a Test Channel as a Calculated Test Channel” on
If you do not
page 163
use the
Multi
Reagent
function, Selecting a Multi-Reagent Item
new R1
is used with old R2 or vice If you have multiple bottles of a reagent on-board and want to
versa, depending on which automatically and simultaneously change over to a new R1 and R2,
bottle is empty first. you should enable the multi-reagent switch.
1 Click the M u l t i - R e a g e n t S w i t c h tab.
2 Select the test by clicking it. It should turn blue when selected.
Entering Alarm Shots

The Alarm Shots function enables you to set the number of remaining
reagent shots that, when reached, prompts a system alarm.
1 Click the A l a r m S h o t s tab.
2 Double click a test to edit the number of reagent shots.
3 Click C l o s e to save change

Adding the New Test to
the Round
You can set up to three rounds (51 tests including three ISE tests,
99 parameters are possible). Each round allows a different configuration
of tests to be set on the system. Rounds allow quick access to the three
different sets of tests. Tests not in the round are inactive and any errors TIP
related to these tests do not appear. The system does not generate an
error, for example, if reagents for the inactive test are not on-board.
To do this:
1 Select Parameter>Common Test Parameters>Round.
2 Click S e t ( F 4 ) . LIH
3 Click R o u n d N o . ( F 8 ) and select the round to which the M e a s u r e can be set to
a ll or s e l e c t , using the
new test is added.
drop-down list. This feature
4 Click O k . applies when using an
5 Select the new test from the Te s t N o . field or click E d i t existing on-board reagent for
LIH screening. When set to
( F 5 ) and click the test to be included in the Round. Selected
a ll , LIH analysis is
tests are highlighted in blue, as shown in Figure 4-4. performed on all samples.
6 Click C l o s e to save changes. When set to s e l e c t ,
LIH is only performed
7 Click E x i t ( F 2 ) to return to the main window.
on those samples with a
requisition for LIH.
TIP
If a test is
missing in a
round, the
system
does not
run this test.
Figure 4-4: Adding a Test to a Round

Entering Specific Test
Parameters
When you have added a new test, you can perform the following
procedures:
• Entering General Test Parameters. See page 56.
• Entering ISE Specific Parameters. See page 58.
• Entering LIH Specific Parameters. See page 58.
• Setting Normal Ranges. See page 59.
• Setting Decimal Places. See page 60.
Entering General Test Parameters

1 Select Parameter>Specific Test Parameters.
2 Ensure the G e n e r a l tab is selected.
3 Click T e st N o. ( F 8 ), enter the test name and click O k
(or select it from the T e st N a m e B o x drop-down list).
4 Select the sample type from the T yp e drop-down list.
5 Click S e t ( F 4 ) and begin entering necessary parameters,
as shown in Figure 4-5. Use the tabs to get to other pages on the
CAUTION window.
Always follow
• Operation: Select Y e s to perform the currently selected test
for each sample type and N o if testing is not required.
the instructions
on the Settings • Sample Volume and Diluent: Enter both volumes. Sample
Sheet provided volume range is 2 to 50 µl or 2 to 25 µl for diluted dispensing.
with the Diluent volume range is 0 or 10 µl.
reagent. Always ensure that • Reagents R1 Volume and Diluent: Enter both volumes.
settings are entered Reagent volume range is 25 to 300 µl. Diluent volume range
correctly. is 0 or 10 µl to 250 µl.
• Reagents R2 Volume and Diluent: Enter both volumes.
Reagent volume is 25 to 300 µl. Diluent volume range is 0 or
10 µl to 250 µl. If the R2 volume is set to 0, diluent cannot be set.
• Wavelength Pri.: Select the value from the drop-down list.
• Wavelength Sec.: Select the value from the drop-down list. This
wavelength eliminates interference.
• Method: Set to either E N D , R A T E, F IX E D , E N D 1 ,
R A T E 1 or F I X ED 1 . See “Calculating Results” on
page 25.
• Reaction Slope: Select + or - from the drop-down list.
• Measuring Point 1: Enter the first (0 to 26) and last (1 to 27)
photometric points.
• Measuring Point 2: Enter the first (0 to 26) and last (1 to 27)
photometric points.
• Linearity Limit: Enter the limit of linearity in the reaction curve
(range 0 to 100). This can only be set if M e t h o d is set to
R A T E or R A T E 1 .

• No Lag-Time: This can only be set if Me th od is set to
R A T E or R A T E 1 .
• Pre-dilution Rate: Enter the sample pre-dilution rate (1 or 5
to 100). Use the following for reference.
Sample Pre-dilution Rate Sample Quantity (µl) Sample Dilution (Water, µl) Total
5 48 192 240
10 24 216 240
50 5 245 250
100 3 297 300
Figure 4-5: Entering Specific Test Parameters

• Min. OD: Enter the lower limit of the photometric range (-2.0 to
2.5). This cannot be set if M e t h o d is set to E N D or E N D 1 .
• Max. OD: Enter the upper limit of the photometric range (min OD
to 2.5). This cannot be set if M e t h o d is set to E N D or
END1.
• Reagent OD Limit (First L and First H): Enter the reagent OD
limit for the first and last read points. First L range is -2.0 to 2.5.
First H range is first L to 2.5. If no setting is required, enter a
space. Values read that fall outside of these ranges generates
an alarm.
• Last L and Last H: Enter the reagent OD limit. Last L range is -
2.0 to 2.5. Last H range is last L to 2.5. If no setting is required,
enter a space.
• Dynamic Range: Enter the upper and lower dynamic range
limit. Use a maximum of 7 characters. The upper dynamic range
must be greater than the lower range.
• Correlation Factor: Enter Correlation Factor A and B, where
A is the slope and B is the intercept. Use a maximum of
7 characters. Correlation factor is used to correlate with
that on other systems for example.
• On-Board Stability Period (Reagent Stability period): Enter
the number of days between 1 and 999. If no setting is required,
enter a space.
6 When parameters are entered, click Ex i t (F 2) to return to the
main window.
Entering ISE Specific Parameters

See “Entering ISE Specific Test Parameters” on page 81.
Entering LIH Specific Parameters

See “Setting an LIH Test (serum quality index for estimation of lipemia,
icterus and hemolysis)” on page 162.

Setting Normal Ranges
To enter ranges:
1 Select Parameters>Specific Test Parameters.
2 Click the Range tab, as shown in Figure 4-6.
3 Select the test name from the T e s t N a m e drop-down list.
4 Select the sample type from the T y p e drop-down list.
5 Click S e t ( F 4 ) and set the following parameters:
Figure 4-6: Entering a Value Range
• Value/Flag: Select F l a g from the drop-down list in order

to generate a positive P or Negative N when result values fall
outside set levels. If V a l u e is selected, ranges are not
available to select or define at this prompt. See Chapter 8,
Error Flags.
• Normal Range, check boxes 1-6: Check the check box to the
left of the number to activate the other fields. Set the levels that
generate a H (Result higher than normal range) or L flag (Result
is lower than normal range) when ranges are affected by Sex
(gender) or Age or both.
• Non-specific: None of the boxes 1 to 6 are checked (and so not
filled in). A single reference range for low and high results should
therefore be entered.
• Out of Range: Normal Range boxes 1-6 are defined for Sex and
Age. If there is a requisition for sex or age that does not fall in
any of the box 1-6 limits, Out of Range limits are used to
generate H or L flags.
• Sex (relating to a range of normal values): Check the check
box. Select the sex from the drop-down list. If N o is chosen, the
lower and upper limit of age and month are left blank.
• Age (Year, Month): Set a lower age limit (year) of between
0 and 150 and the lower age limit (month) of between 0 and 11.
• L, H: Set the lower limit and upper limit of the reference value.
Use a maximum of seven characters.
• Unit: Set the unit, using a maximum of eight characters.
• Decimal Places: See Setting Decimal Places.

Setting Decimal Places
1 Select Parameters>Specific Test Parameters.
2 Click the R a n g e tab.
3 Click S e t ( F 4 ) and then click D e ci m a l P l a c e s ( F 7 ).
4 Enter the number of decimal places from 0 to 4, as shown in
Figure 4-7.
Figure 4-7: Setting Decimal Places
5 Click O k.
Creating a New Profile

A profile is a test or set of tests to which a number is assigned. Profiles
are most useful in a working environment where tests are programmed
by a small number of operators and used by a larger number. Profile 99
CAUTION is used by the One-Touch mode to perform analysis on emergency
samples using the STAT table. Profile 0 is the default profile. This is
Before you automatically used when:
save the new
profile, double- • There is a barcode read error.
check that the
tests selected • There is no requisition found for a sample in sequential mode.
appear on the window with
the correct profile number. • There are online errors.
To create a profile:
1 Select Parameter>Common Test Paramters>Profile.
2 Click S e t ( F 4 ).
3 Enter the new profile number (0 to 99).
4 Enter the profile name in the P r o f i l e N a m e field and
click O k.
TIP 5 Click E d i t ( F 5 ) and select the tests that should be in the new
profile, as shown in Figure 4-8 on page 61.
Click
Print 6 Click C l o s e to save these settings.
( F 3 ) to 7 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
print out the to return to the main window.
Profile
Number
and all the tests contained
in it.

Figure 4-8: Creating a New Profile
TIP
Single flags
QC as out-
of-range
Entering Quality Control from 1 to 4
SD. This
(QC) Parameters 1 to 4 SD
setting can be changed on
Use Quality Control (QC) to ensure the accuracy of analysis. You can the QC Common window in
set QC in the following areas: Single Check Level.
• Entering QC Common Parameters. See page 62. Multi Check is similar to

Westgard rules. Multi is
• Entering QC Specific Parameters. See page 63. enabled by selecting Yes on
the Multi Check Level and
Trend Check fields on the
QC Common window.
Refer to the manufacturer’s
Settings Sheet for more
information on determining
SD ranges for the QC
material used.

Entering QC Common Parameters
QC common sets the overall conditions for on-board QC data
management.
To set common QC Parameters:
1 Select Parameters>QC Control>QC Common.
2 Click S e t ( F 4 ), as shown in Figure 4-9.
Figure 4-9: Setting QC Common
3 Set the barcode QC operation to enable use of barcoded QCs

(if required).
4 Select Single check level or Multi check level (see tip).
5 Select the QC Mode. A mode is the calculation method used
to obtain a reference value. The options are:
• P r e - s e t : A pre-defined value is used as the reference value.
If a QC from the green rack is analysed and the values are
beyond the range of the pre-set values, the result is flagged
with 1 .
• C u m u l a t i v e : Average daily value is used as the
reference value.
6 Click the C o n t r o l tab to edit the QC numbers from 1 to 60.

7 Click Set (F4) and than E d i t ( F 5 ) and enter the control name, TIP
ID., expiry and lot number, as shown in Figure 4-10 on page 63.
Set
8 Click Ex i t (F2 ) to save these settings and E x i t ( F 2 ) again Multi
to return to the main window. r u l e for
two levels
of QC to
enable the
Twin Plot function.
TIP
Use the
Twin Plot
function to
plot a Twin
Figure 4-10: Editing QC Common Plot chart.
This chart
displays the QC points, using
their standard deviation from
Entering QC Specific Parameters the mean as the axis units.
For details on the Twin Plot
1 Select Parameters>QC Control>QC Specific. function, see “Checking QC
2 Click S e t ( F 4 ) and then E d i t ( F 5 ) , as shown in Results Using Twin Plot”
on page 139
Figure 4-11.

Figure 4-11: Setting QC Specific
TIP
3 For each control level, select the control number, multi or single
When QC is rule, mean, SD range and control Range.
edited using
4 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
QC
Monitor> to return to the main window.
Data Edit,
this does Displaying Stack Values of QC Samples
not show up in the The C u m u l a t i v e tab allows you to view the QC data used to check
cumulative value. When the all the Multi-rule check levels set.
edited data is in the same
index, then the edited 1 Select Parameters>QC Control>QC Specific.
contents are included in the 2 Click the C u m u l a t i v e tab.
cumulative value.
3 Click Q C S t a c k R e v i e w ( F 5 ) to access the stored list
of individual values for QC samples.
4 Click C l o s e to close the Q C S p e c if i c window.
TIP
Up to 200
different
calibrator
materials
can be Entering Calibration
added to
the system. Parameters
Calibration sample names Calibration parameters allow the system to measure samples.
can have up to 26 This section describes:
characters.
• Adding a New Calibrator. See page 65.
Expiry date should be in
DDMMYYYY format. • Adding Calibrator Specific Parameters. See page 66.
Lot No. should have no more

• Generating a Summary of Calibration Types. See page 68.
than 15 characters.
• Setting Advanced Calibrations. See page 73.

Adding a New Calibrator
To add a new calibrator:
1 Select Parameter>Calibration>Calibrator.
2 Click S e t ( F 4 ) .
3 Click the C a l i b r a t o r B a rc o d e option to use barcoded
calibrators if required.
4 Double click the next available calibrator number or select the
calibrator number and click E d i t ( F 5 ) to add a calibrator name,
calibrator ID, expiry and lot number, as shown in Figure 4-12 on
page 65. The calibrator number chosen is the position the
calibrator has on the yellow rack.
5 Click C l o s e to save these settings.
6 Click E x i t ( F 2 ) to close the calibrator window and click E x i t
( F 2 ) to return to the main window.
Figure 4-12: Adding a New Calibrator

Adding Calibrator Specific Parameters
Calibration parameters are provided on Settings Sheets provided with
the test reagent. Concentrations should be set according to the Settings
Sheets provided with the calibrator.
• Entering AB Calibration Type (Set Points). See page 67.
• Entering MB Calibration Type (Factor). See page 68.

To enter Calibration Specific Parameters:
1 Select Parameter>Calibration>Calibration Specific.
2 Select the test name, using the arrow buttons or from the drop-
down list.
3 Select the sample type from the drop-down list.
4 Click S e t ( F 4 ) and enter calibration parameters:
• Formula: Set a formula according to the calibration type, using
the drop-down list.
• OD: Set the calibrator OD value within the range of -2.0 to 2.5 at
each point. See the Settings Sheet.
• Counts: Set the number of replicate calibration and reagent
blank analyses to be measured. Depending on the number, the
following values are used:
Set to 2 - An average of two values
Set to 3 - An average of the two closest values
Set to 4 - An average of two values, excluding maximum

and minimum values.
• Process: Set the method to be used if any update of the
calibration fails. Set to:
• C o n c. to output results as a concentration using the
existing factors.
• O D if a concentration conversion is not initially
performed. Results will be saved as the measured OD
value, and conversion to concentration units can be
performed after a successful calibration has been
achieved. This can be set only if the calibration type is set
to ACAL (AB, AA, 2AB-7AB).
• Factor/OD-L: This can be set only if the calibration type is set to
ACAL (AB, AA, 2AB - 7AB). Set a factor range if the formula
approximation is for a line. Set an absorbance range if the
formula approximation is for a curve.
TIP • Factor/OD-H: This can be set only if calibration type is set to
1- ACAL (AB, AA, 2AB - 6AB).
point • 1-point cal. point: This can be set only if the calibration type is
c a l. set to 2AB - 7AB. Set a cal. no. up to the maximum point that is
point specified according to the calibration type. This determines
defines a which calibrator is used for single point calibration.
single • With Conc-0: If there is a standard solution with a concentration
calibrator that can be used to
value of 0, calibration can be performed at concentration value 0
make an adjustment to a
and at a second point.
multi-point calibration curve.

• Slope Check: This can be set only if the calibration type is set
to Multi-Point Calibration (2AB - 7AB, 2MB - 7MB).
• None: Not using the check
• + : If the curve is increasing
• - : If the curve is decreasing
• MB Type factor: This can be set only if the calibration type is set
to MB. See the Settings Sheet. See “Entering MB Calibration
Type (Factor)” on page 68.
• Advanced Calibration: Use this pull-down menu to program
advanced calibration. (see “Setting Advanced Calibrations” on TIP
page 73).
• Calibration Stability period: Enter the number of days, You can
between 1 and 999. To leave this field blank, enter a space. use the
This is not needed for MB type assays. Calibration
Specific
5 Click Ex i t (F2 ) to save these settings and E x i t ( F 2 ) again
window to
to return to the main window. program the
system so that urine tests
Entering AB Calibration Type (Set Points) use serum calibrations.
Select urine from the
1 Select Parameter>Calibration>Calibration Specific. T y p e drop-down list and
2 Click S e t ( F 4 ) and enter the calibration type and formula from check the U s e S e r u m
the Settings Sheet, as shown in Figure 4-13 on page 67. C a l . box.
3 Enter the C a l N o . This should match the position number on
the yellow rack entered on the Calibrator window.
4 Enter the C o n c . v a l u e from the Settings sheet of the
calibrator. TIP
5 Enter the F a c t o r O D - L a n d F a c t o r O D - H range Calibration
from the Settings Sheet. fails when
results are
6 Enter the C a l i b . S t a b i l i t y P e r i o d from the outside of
Settings Sheet. the OD-L
7 Click Ex i t (F2 ) to save these settings and E x i t ( F 2 ) again and OD-H ranges.
to return to the main window.
Figure 4-13: Entering AB Calibration

Entering MB Calibration Type (Factor)
TIP
For
2 Click S e t ( F 4 ) and enter the calibration type, formula
information
on how to
(always Y=AX+B for MB factor) and MB type factor that you
calculate have calculated, as shown in Figure 4-14.
the MB 3 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
factor, to return to the main window.
see the settings sheet for
enzymes.
Figure 4-14: Entering MB Calibration
Generating a Summary of Calibration Types

You can generate up to 15 types of calibrations depending on the
analysis test. Six of the 15 principal types of calibration plus 1-point
calibration correction are described here:
• ACAL AA. See page 69.
• ACAL AB. See page 69.
• ACAL 2 to 7AB. See page 70.
• MCAL MB. See page 71.
• MCAL 2 to 7MB. See page 71.
• 1-point cal. correction. See page 72.

ACAL AA
This is measured as shown in Figure 4-15.
OD
ACAL OD2
ACAL OD1
CONC
Concentration Concentration
value 1 value 2
Figure 4-15: ACAL AA
• Enter two kinds of standard liquid with a different concentration

or calibrator value.
• This can be applied to analysis items like Phenytoin, for instance,

where the calibration chart is a straight line but does not pass
through the origin (reagent blank).
ACAL AB
OD
ACAL OD
CONC
Concentration value
Figure 4-16: ACAL AB
• Enter the value of only one calibrator or standard solution.
• This can be applied to general calibrations which are straight

lines and pass through the origin (reagent blank).

ACAL 2 to 7AB
OD
OD 7
OD 6
OD 5
OD 4
OD 3
OD 2
OD 1
OD 0 CONC
Concentration value 1
Figure 4-17: ACAL 2 to 7AB
• Create a calibration chart in the Calibration Specific window,

as shown in Figure 4-18 on page 70, by using two to seven
kinds of standard solutions or calibrators and enter the
concentration values.
• This is used for immunoassays and immunoturbidimetric items.
Figure 4-18: Setting 5AB

MCAL MB
OD
CONC
Figure 4-19: MCAL MB
• Set the calibration coefficient with the K factor. For factor details,
see the Settings Sheet provided.
• This is typically used for enzyme items through the rate assay
method.
MCAL 2 to 7MB
This is measured as shown in Figure 4-20 on page 71.
• Create a calibration chart, using a maximum of 7 points of OD

values and their corresponding concentration values.
• This is applied to analysis items whose calibration is not a line

but where each of the sections has a constant slope. This is very
occasionally used for immunoassays and immunoturbimetric
items.
OD
OD 7
OD 6
OD 5
OD 4
OD 3
OD 2
OD 1
CONC
Figure 4-20: MCAL 2 to 7MB

1-point cal. correction
The following examples illustrate this type of calibration:
• Example 1—If no multiple standard solution has a

concentration of 0: If the single-point correction is performed for
the CONC2 standard solution, execute the following calculation:
a Perform this single-point correction.
Example 1
ODn’=ODn x OD2
OD
OD2’
OD3’
OD3
OD2’
OD2
OD1’
OD1
CONC
0 CONC1 CONC2 CONC3
Figure 4-21: Example 1
b Recalculate for the calibration chart

• Example 2—If any standard solution has a concentration
of 0: If correction is performed with two points of CONC1 and
another (CONC3), execute the following calculation:
a Use the reaction OD values of CONC1 and CONC3 (OD1’
and OD3’) as they are.
b Correct each point as shown in Figure 4-22 on page 73.

Example 2
OD
OD4’
OD4
OD3’
OD3
OD2’
OD2
OD1’
OD1
CONC
0 CONC2 CONC3 CONC4
ODn : previous OD value ODn’ : OD value after correction
ODn’ = a x (ODn - OD1) + b
a= OD3’ - OD1
OD3 - OD1
b=OD1
Figure 4-22: Example 2
TIP
Setting Advanced Calibrations
If advanced
Advanced Calibration Analysis enables you to perform calibration calibration
analysis for all sequenced reagent bottles that are in the system and and auto
calibration
produce a calibration curve and a factor for each one. See “Requesting
(from the
Advanced Calibrations” on page 106.
STAT table)
are programmed for the
Advanced Calibration Features same test. the following error
message indicates if this is
• Calibrate new bottles or new lot numbers before patient testing. the case:
Advanced Calibration (Auto)
• Calibrate up to five bottles of one reagent at a time. Mismatch.
Advanced Calibration is used
• Five calibration results can exist for particular tests. with calibration racks.
• The system automatically requisitions calibrations for new
bottles, new reagent lot numbers and expired calibrations.
• All calibrations required for run volume are performed and

checked before patient testing begins.

To set advanced calibrations:
TIP
Advanced
calibration 2 Click S e t ( F 4 ).
is used to 3 Select L o t , L o t + B o t t l e or N o n e from the Advanced
perform
Calibration drop-down list, as shown in Figure 4-23.
additional
calibrations • Selecting L o t advance-calibrates new lot numbers.
(or controls) during a run. • Selecting L o t + B o t t l e advance-calibrates new bottle
Care should be exercised numbers including new Lot numbers.
when using Advanced • Selecting N o n e disables advanced calibration.
Calibration for tests with only
one day calibration stability
4 Check that the other information on the window is correct (see
(e.g. creatinine and total “Adding Calibrator Specific Parameters” on page 66).
protein).' 5 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
to return to the main window. See “Requesting Advanced
Calibrations” on page 106.
Figure 4-23: Setting Advanced Calibrations
Entering Contamination
Parameters
You can enter parameters that allows a proper corrective course
of action to be taken if reagent cross-contamination occurs or is
suspected. You can do this by entering the order of tests you think
might cause this and then entering parameters for action. Contact your
Beckman Coulter Representative for the AU400 Contamination
Parameters List.
To create a contamination table:
TIP
1 Select Parameters>Special>Contamination Parameters
Selecting
cross- 2 Click S e t ( F 4 ) and then click the line number to begin with.
contamin- 3 Click E d i t ( F 5 ) and then select the test that causes
ation contamination from the P r e c e d i n g T e s t N a m e drop-
parameters down list, as shown in Figure 4-24 on page 75.
might cause
the system to work more 4 Select the test that is affected by contamination from the
slowly. F ol l o w i n g T e s t N a m e drop-down list.

5 Select the solution for cleaning the reagent probes from the
C l e a n e r K i n d drop-down list. This cleaner must be placed
on the reagent trays.
6 Enter the W a s h C o u n t N o . to set the number of times the
probe should be washed.
7 Beckman Coulter strongly recommend against checking
C a n c e l because special wash procedures do NOT occur if the
system goes to measure 2 Stop, Pause or Standby and restarts
testing sensitive tests.
8 Select M ix e r if you do not want to use the same mixing bar for
the two tests specified. Select the C u v e t t e option if you do not
want to use the same cuvette for the two tests specified.
Figure 4-24: Entering Contamination Parameters

Entering Data Check
Parameters
By entering data check parameters, you can set up checks and decision
limits to detect one to four different abnormal reaction types for prozone
effects in an increasing turbidimetric assay. For more detailed
information on this, please contact your Beckman Coulter
Representative.
To enter data check parameters:
1 Select Parameter>Special>Data Check Parameters.
2 Select the test from the T e s t N a m e drop-down list, as shown
in Figure 4-25.
3 Select the sample T y p e from the drop-down list.
5 Enter parameters according to the Settings Sheet provided with
the test reagent.
Figure 4-25: Setting Data Check Parameters

Programming Repeat
Tests
There are four types of Repeat Test:
• Manual Repeats. See page 77.
• Automatic Repeats. See page 79.
• Reflex Testing. See page 80.
Manual Repeats
TIP
For manual repeat tests, the, the system generates a repeat-run work
When
list and you place the repeat sample in an orange rack in order to be
program-
recognised as a repeat by the system. ming
You must enter the error flags used to trigger a repeat-run list. manual
repeats,
To program repeat tests: ensure that
1 Select Parameter>Repeat Parameters>Repeat Common. correct dilution and
condense factors are
2 Click S e t ( F 4 ) . entered in Parameters>
3 Click A u t o R e p e a t . Check the box to enable the repeat-run Repeat Parameters>
Repeat Specific.
work list to be automatically generated.
4 Select R e p e a t D a t a O v e r w r i t e if you want the original
data to be overwritten by the repeat data. If this option is
unselected, you can choose the test data that should be
overwritten.

5 Select error flags that should generate a repeat request by clicking
CAUTION on them, as shown in Figure 4-26. For detailed information on
Do not select error flags, see Chapter 9, “Error Flags” on page 241.
the following
flags: R, #, ?, U,
u, Y, y, % as
they command
an action.
Figure 4-26: Setting Error Flags

About A N D and O R flags

For each of the repeat run samples and diluted repeat run samples requiring
a repeat run, you must set either A N D or O R error flags.
OR Mode
Samples appended with any of the selected error flags are extracted as
repeat run samples.
AND Mode
Only samples that are appended with all of the selected abnormal data
symbols are extracted as repeat run samples.
Entering Repeat-Run Parameters

1 Select Parameter>Repeat Parameters>Repeat Specific.
2 Select the test from the T e s t N a m e drop-down list (or a test
number by clicking T e s t N o . ).
5 Set the P r e - d i l u t i o n and/or reduced sample volume (diluted
repeat) and Pre-dilution and/or increased sample volume
(condensed repeat) as appropriate for the test..

6 Set the R e p e a t R a n g e to generate J and K flags which can
be used to generate repeat requisitions.
7 Set the A u t o m a t i c R e p e a t O v e r w r i t e .
TIP
Automatic Repeats When

program-
To run fully automatic repeats, you must set the system to return racks ming
automatically with samples requiring repeats to the rack feeder. automatic
repeats,
To enable this option: ensure that
1 Select Parameter>System>System. correct dilution and
condense factors are
2 Select A u t o from the R e p e a t s drop-down list, as shown in entered in Parameters>
Figure 4-27 on page 79. Repeat Parameters>
Repeat Specific
Figure 4-27: Setting Automatic Repeats

TIP Reflex Testing
When Reflex testing allows a test to be run by linking it to a repeat flag
program- generated by another test. If the TBIL falls outside of the dynamic
ming reflex range for example, you might want to repeat DBIL even if DBIL did
tests, not generate a flag, or was not requested in the original run. Up to
ensure that ten sets of tests can be programmed as reflex tests.
correct pre-
dilution and condensed To enter reflex testing parameters:
factors for each test are 1 Select Parameters>Repeat Parameters>Repeat Common.
entered in Parameter>
Repeat Parameters> 2 Click the G ro u p tab.
Repeat Specific
4 Select the D e c id i n g T e s t and R e l a t e d T e s t, as shown
in Figure 4-28 on page 80. When deciding tests generate a flag,
the related tests and the deciding test are repeated.
5 Enter the repeat decision values by going to Parameters>Repeat
Parameters>Repeat Specific and select the J and K flags by
TIP going to Parameter>Repeat Parameters>Repeat Common.
You can 6 Click C l o s e to save this.
re-run
samples on 7 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
the STAT to return to the main window.
table. See
“Using the
STAT Table for Processing
Emergency Samples” on
page 153 or contact
Beckman Coulter Support for
more information.
Figure 4-28: Setting Reflex Tests

Entering Settings for ISE TIP
This section describes how to set up the ISE: Test
numbers 97,
• Entering ISE Specific Test Parameters. See page 81. 98 and 99
are used for
• Calibration Curve Adjustment for Sample Matrix. See page 82. ISE tests.
• Calibration Process on the ISE. See page 82. You cannot edit sample
volume, sample diluent
volume, Mid Standard
Solution concentration and
Entering ISE Specific Test Parameters high and low standard
solution concentration.
To enter parameters:
2 Click the I S E tab. TIP
3 Select the test name from the T e s t N a m e drop-down list. ISE dynamic
ranges
4 Select the sample type from the T y p e drop-down list, as shown
would be as
in Figure 4-29 on page 81. follows:
5 Select Y e s from the Operation drop-down list if the currently
selected test is to be performed on the selected sample type.
Item Serum
6 Click S e t ( F 4 ) .
7 Set dynamic range (lower and upper). The upper dynamic range Na 50 to 200
should be greater than the value used for the lower dynamic range K 1.0 to 10.0
and each range should be no more than seven characters. Cl 50 to 200
8 Enter correlation factors A and B in no more than seven Item Urine

characters.
Na 10 to 400
K 2.0 to 200
Cl 15 to 400
TIP
A C A L is
Automatic
Calibration.
M C A L is Manual
Calibration.
Figure 4-29: Entering ISE Parameters

Calibration Curve Adjustment for
Sample Matrix
To adjust the ISE calibration of each ISE test (Na, K, Cl) for sample
matrix, perform the following, using a test number set between 97
and 99 in the Calibration Specific window.
To enter these parameters:
2 Click the I S E tab.
3 Select the test name from the T e st N a m e drop-down list.
6 Set analysis parameters for each analysis test to ACAL or MCAL
for cal. types, A/B factors or calibrator. MCAL is the default. Counts
1 to 4 for ACAL only. Factor A: slope or multiplier, B: offset or
constant, cal no., conc. factor range: for ACAL.
Calibration Process on the ISE

Mid, High and Low Standard Solutions, which have a known
concentration, are measured during ISE calibration. The relationship
between the electrode potential and ion concentration at that time is
obtained, and the Na, K, and Cl calibration coefficient S (slope) is
calculated.
• Manual Calibration. See page 82.
• Correction by M-CAL. See page 83.
• Correction by ACAL. See page 83.
Manual Calibration
Potential
difference (mV) Calibration
EH-EM’
EL-EM’’
Concentration
CL CH value
(logarithm)
mmol/L
Figure 4-30: Manual Calibration

• CH: A known concentration of High Standard Solution is used for
calibration.
• CL: A known concentration of Low Standard Solution is used for

calibration.
• EH-EM’: A potential difference between High Standard Solution

and Mid Standard Solution.
• EL-EM”: A potential difference between Low Standard Solution

and Mid Standard Solution.
• Set a calibration chart, using the potential difference between the

two points of known concentration.
Correction by M-CAL
MCAL for the ISE corrects results using this formula; Y=AX + B.
Coefficients A and B are obtained in the following way. The system
performs a regression analysis between measurement values from
this system without an M-CAL data correction and a conventional
or basic method:
Y=aX + b.
Where Y=measurements from this system, and
X=reference values using the conventional method or basic
method.
X=(1/a)Y - (b/a). Thus, A=1/a, B=-b/a
Correction by ACAL
To use ACAL, assay a calibrator with known concentration C. The result
obtained for this sample by ACAL after an MCAL correction is C’.
To correct the concentration of samples run for ACAL, the system
calculates the difference between C and C’, as shown in Figure 4-31.
This ACAL correction is applied to values in addition to any MCAL
correction coefficients B.
Y (measured value) Corrected value: c’ - c

Y=aX+b
c’ b’=b-(c’-c)
Y=aX+b’
c a = factor
b = offset
b
b’
X (known concentration of a specimen subject to A-CAL)
C
Figure 4-31: Correction by ACAL

Adding the New Test to the
List Format for Printing
To do this:
TIP 1 Select Parameter>Format>List Format.
As many as 2 Click L i s t N o . ( F 8 ) and enter the list number to format and
ten different click O k.
types of list
format can 3 Click S e t ( F 4 ) and give a name to the list number you are
be entered. formatting from the L i s t N a m e field.
4 Select the list type from the A t t r i b u t e drop-down list.
5 Select the C o m m o n F o r m a t, T i t l e I n f o r m a t i o n
F or m a t and S a m p l e I n f o r m a t i o n F o r m a t by
clicking them.
6 Go to the Test Tab and select the T e s t A r r a n g e m e n t
from the drop-down list.
7 Select the tests you want to add to the list. Only selected tests are
printed.

Preparing for
Analysis
Introduction
This chapter details the tasks needed to prepare the AU400 for use:
• Performing Daily Maintenance. See page 85.
• Entering Analysis Requisitions. See page 112.
• Preparing Samples for Analysis. See page 115.
Performing Daily
Maintenance
There are a number of procedures to perform before you enter analysis
requisitions and prepare your samples:
• Launching the System. See page 86.
• Logging in to the System. See page 86.
• Creating a New Index. See page 87.
• Inspect the Stability of the Upper Cover. See page 87.
• Replacing Sample Probe Detergent (W1). See page 90.
• Checking Reagents. See page 90.
• Replacing Reagents. See page 96.
• Precautions in Filling a Reagent Bottle. See page 96.
• Checking the Printer and Printer Paper. See page 97.
• Preparing the ISE Unit. See page 97.
• Performing Calibrations. See page 103.
• Requesting Advanced Calibrations. See page 106.
• Performing Auto-Calibration from the STAT Table.

See page 107.
• Preparing for QC Analysis. See page 109.
AU400 User Guide Version 2.11 Preparing for Analysis 85

In addition to these, you should perform any weekly, monthly or
CAUTION quarterly maintenance routines that are due. For the proper
maintenance of this system, it is recommended that you have planned
When you
maintenance routines and that you use a system, whether computer
approach this
system first,
automated or otherwise, to plan maintenance effectively. See
installation Chapter 8, “Maintenance” on page 187 for recommended maintenance
should be routines.
fully completed. This
means that:
1. The system is removed Launching the System

from its crate and
assembled for operation by There are two power switches on this system:
an Beckman Coulter-
approved service engineer. • The main power switch is a single entry point for current to the
2. The power source and whole system. This is located on the right side of the system.
earth wires are connected. Before you use the system for the first time, turn this on and then
3. Water supply and leave it on permanently while the system is in use. This switch
drainage pipes are controls the reagent refrigerator and STAT table incubator
connected. temperatures.
• The sub-power switch is located on the front of the system. This

is turned on each time you perform analysis. This switch controls
TIP
power to the computer system and main system functions.
The sub-
To launch the system.
power
switch is the 1 Turn on the deionised water supply by opening any valves.
green
button on
2 Switch on the sub-power on the front of the system. Initialisation
the front of the system. might take up to 20 minutes.
3 The Start-up window appears asking the user to enter the data
index, select the R o u n d N u m b e r , enter the O p e r a t o r
N a m e, S e r u m S a m p l e S t a r t N u m b e r, U r in e
S a m p l e S t a r t N u m b e r, and O t h e r S a m p l e
S t a r t N u m b e r if required.
Logging in to the System

TIP Before logging in, be sure that you get a user name and password from
the system administrator. Keep your password secret. Menus that you
If the login do not have access to are greyed out. When the system is started,
function is the login box appears automatically.
disabled,
you can To login:
skip 1 Enter your L o g i n
login and N a m e that is
go to the main window by registered and press
pressing F2.
R e t u r n.
2 Enter your
P a s s w o r d.
3 Click O k to access
the main window and menu bar.
86 Preparing for Analysis AU400 User Guide Version AC

Creating a New Index
The system generates a certain volume of data for each analysis. Each
set of test data is termed a run. A run might occur over a period of hours
to days, depending on the number of samples involved. This is saved
on the computer as an official record of the analysis and the results
generated. In order to archive this information effectively and therefore
retrieve it more quickly, each set of test data is labelled with the current
date and time. This label is known as the index.
Each index usually relates to a one day period. You should create a new
index as part of the daily start-up procedure.
To create a new index:
1 Select Routine>Start Condition.
2 Click S e t on the S t a r t C o n d i t i o n window.
3 Select C u r r e n t T i m e from the D a t a I n d e x drop-down
list, as shown in Figure 5-1.
4 Press E x i t once to save the new index and once again to close
the Start Condition window.
Figure 5-1: Creating a New Index
Inspect the Stability of the Upper Cover

Before starting daily analysis, check the stability of the upper cover of
the analyzer to verify that it is stable and remains in the upright position
when raised. If the upper cover starts to descend when opened, have
the cover supports inspected and replaced by Beckman Coulter
Technical Services.
AU400 User Guide Version AC Preparing for Analysis 87

Inspecting the System
Inspecting the system involves a number of procedures:
• Checking for Leaks. See page 88.
• Checking the Concentrated Wash Solution Level. See page 88.
• Inspecting and Cleaning the Sample Probe and Reagent Probe.

See page 89.
• Inspecting and Cleaning the Mixing Bars. See page 90.
Checking for Leaks

TIP 1 Open the left door on the front of the system, as shown in
To remove Figure 5-2.
air bubbles 2 Check each syringe case for condensation.
from inside
the sample 3 Touch the bottom of each syringe case, the joint of each case head
and reagent and syringe case, and around the fixing screws to see if it is wet.
syringes, go 4 If wet, dry it with a clean cloth and tighten the syringe and the
to the software window, screws holding it a little.
select Maintenance>ANL
Maintenance and then 5 If the wetness reappears in five minutes, then replace the syringe
select the correct reagent or (see Chapter 8, “Maintenance” on page 187).
sample syringe.
Use the white DIAG button
Sample dispenser Fixing screw
near the STAT table to
Reagent dispenser
activate prime.
CAUTION Case head
Leaks from the Syringe case

Syringe Case,
FR
Syringe Head or ON
T
near the fixing
screws will affect
the volume of liquid
dispensed. This in turn : Possible leakage locations
produces inaccurate analysis
results.
Wash you hands thoroughly Figure 5-2: Checking For Leaks
with soap and water after this
check. Checking the Concentrated Wash Solution Level
1 Open the left door on the front of the system, as shown in Figure 5-3.
Master detergent
tank A
(factory optional) Master detergent
tank B
O NT
FR
Figure 5-3: Checking the Wash Solution

2 If the level of liquid is low, replace the Wash Solution bottle with a
full one. It is recommended that you always make sure it is full
before you start working.
3 The minimum volume is enough for approximately 8000 tests.
If the level becomes too low during analysis, you see an alarm
and the system shifts into Pause mode.
4 Tighten the lid afterwards.
Inspecting and Cleaning the Sample Probe and Reagent Probe

1 Check the probes for any signs of clogging.
2 Check for any stains or crystallisation.
3 Wipe the probes with an alcohol swab or a new cloth dipped
in ethanol. Always wipe downwards towards the tip of the probe
to prevent blockages. CAUTION
4 Select Maintenance>ANL Maintenance>Prime Wash-lines and If Wash
click E n t e r . Solution comes
5 Press the STAT ROTATION/DIAG switch, to flush water from in contact with
skin or clothing,
each system component.
wash
6 Examine each probe closely. If the detergent is sprayed or is not immediately.
ejected in a straight gush from the sample or reagent probe tip, If Wash Solution is
the probe must be cleaned (see Chapter 8, “Maintenance” on accidentally swallowed or
page 187). If the problem persists after washing the probe, the comes in contact with your
probe might be bent or otherwise damaged and should be eyes, rinse thoroughly and
seek immediate medical
replaced.
attention.
7 Send the system into initialisation mode in order to check that each Mixing acid and alkaline
probe enters the washing wells properly. Do this by pressing solutions might result in
S t o p / S t a n d b y on the keyboard. toxic gases. If any Wash
Solution spills, clean the
8 If there is any irregular function, contact your Beckman Coulter area thoroughly to avoid
Representative immediately. corrosion.

Inspecting and Cleaning the Mixing Bars
1 Check for any stains or crystallisation on all mixing bars, as shown
in Figure 5-4.
2 Wipe all mixing bars with an alcohol swab or a new cloth dipped
in ethanol.
Mixing unit
Mixing bar
Mixing-bar
wash well
T
ON
FR
CAUTION Figure 5-4: Mixing Bars
Wipe the
probes gently 3 Check all mixing bars for chips on the teflon coating.
and be careful
4 If the teflon is even scratched, the mixing bar should be replaced.
not to bend
them. 5 See “Replacing Mixing Bars” on page 211 for details on how to
Ensure that the teflon change the mixing bars.
surfaces on the mixing bars
are not chipped.
Replacing Sample Probe Detergent (W1)

1 Check the Sample Probe Detergent cup in the W1 position of the
STAT table. Top up if necessary (2% Wash Solution).
Checking Reagents
You must make sure that the right reagents are in the right places on
the refrigerator and that each one has enough reagent in it for the run
you are about to perform. Each time you prepare for analysis. See the
following sections relating to performance of these checks:
• Checking and Allocating Fixed Positions. See page 91.
• Checking All Positions. See page 92.
• View Number of Tests Remaining in Bottles. See page 94.
• Checking Specified Positions. See page 94.

Checking and Allocating Fixed Positions
The system recognises reagent bottles with no barcodes if they are
placed in fixed positions on the reagent refrigerator. You must set these
positions before analysis or if already set, then verified. It is critical to
have these bottles in the correct positions.
To set fixed positions:
1 Select System Status>Reagent Status.
Figure 5-5: Checking Fixed Reagent Positions

2 Select the position on the reagent wheel diagram, as shown in
3 Click E d i t ( F 6 ) .
4 Select the test to be fixed from the T e st drop-down list.
5 Click F ix e d R e a g e n t.
6 Enter the L o t N o . in the Edit space.
7 Select bottle size 15 ml, 30 ml or 60 ml from the drop-down list.
Default size is 60 ml.
8 Click C l o s e to return to the Reagent Status window.
Checking All Positions

When you use the C h e c k A ll P o s it io n s function, the system
reads barcoded reagent bottles, checks their lot numbers, bottle
numbers, expiry date and checks the remaining volume in each one.
To check all reagent positions:
TIP 1 Select System Status>Reagent Status.
Before 2 Click S t a r t C h e c k and then C h e c k a l l P o s it io n s .
starting to
check the 3 Click Y e s to begin the reagent check. When the Status changes
reagent, from C h e c k i n g to C h e c k e d , then the process is
open the successfully completed.
upper cover of the system 4 Click D is p la y b y T e s t for a list of tests and the number
and check that the reagent
of shots available, as shown in Figure 5-6 on page 93.
refrigerator cover is
completely closed. After 5 Click D e t a il to check R1 and R2 for the setting status of reagent
checking the refrigerator bottles and the remainder in each. Error information such as N o
cover, close the upper cover. r e a g e n t or N o b o t t l e s is highlighted in yellow in the
If there is not enough Comment Column.
reagent, replace the reagent
bottles or place a second set 6 Click C l o s e to close the Detail dialogue box.
of reagents on-board. 7 Click C l o s e again to return to the System Status window.
8 Click E x i t ( F 2 ) again to return to the main window.

Figure 5-6: Checking All Reagent Positions

View Number of Tests Remaining in Bottles
To quickly assess the number of tests remaining in each bottle you can
perform a Display by Test.
To perform a Display by Test:
2 Click Display by Test (F7).
3 The bottle size, position and the number of remaining shots in
each one are displayed in a list, as shown in Figure 5-7.
Figure 5-7: Test Display
Checking Specified Positions

When the fixed reagent is already in place, you should perform
a volume check. To do this:
1 Select Reagent Status>Start Check.
2 Click C h e c k S p e c if i e d P o s it io n.
3 Select the reagents that you want to check by clicking them with
the mouse, as shown in Figure 5-8 on page 95. When you have
selected all necessary positions, click S t a r t.

Figure 5-8: Checking Specified Reagent Positions
Summary of Reagent Check Boxes CAUTION

Never add fresh
Reset Only: Resets the system to C h e c k e d without actually
reagent to old
performing a check.
reagent.
Check Specified Position: Volume checks one or more specific
reagent positions.
Check Specific Position (With ID): Reads reagent barcode and

volume checks one or more specific reagent positions.
Check Changed Positions (With ID): Reads all reagent barcodes

and volume checks new or moved reagents.
Check All Positions: Reads all reagent barcodes and volume checks
all reagents.

CAUTION Replacing Reagents
Ensure that To replace reagent bottles:
there are no
1 Lift the main lid on the system.
bubbles or froth
in the reagent 2 Remove the refrigerator lid, as shown in Figure 5-9 on page 96.
bottles before
3 Remove the bottle lid and gently place the new reagent bottle in
loading them onto the
system. a compartment so that it is sitting firmly in position and neither
end is sticking up, as shown in Figure 5-10 on page 96.
4 Check Specified Position (With ID) to update the reagent
information.
Reagent refrigerator cover
Positioning pin
T
ON
FR
CAUTION Figure 5-9: Reagent Refrigerator

The reagent
refrigerator lid
should only be
Top view of the reagent refrigerator
opened when
the system is in Reagent bottle (60 mL)
Standby or Stop mode. Reagent bottle (30 mL)
Reagent bottle (30 mL)
Reagent bottle (15 mL)
When you replace the Reagent bottle (15 mL)
refrigerator lid, ensure the Reagent tray
positioning pin is inserted in
the insertion point (hole). Partition Positioning pin
Partition
Figure 5-10: Placing Bottles in the Refrigerator
Precautions in Filling a Reagent Bottle

Observe the following precautions when handling reagent bottles:
• If a reagent bottle is filled over the maximum liquid level limit for
the bottle size, bubbles can occur and cause a level detection
error.
• Verify that no bubbles exist in the bottles.

• Do not fill over the maximum liquid level limit for the 15 mL,
30 mL, or 60 mL reagent bottles. WARNING
• Condensation
can form on the
walls of the
reagent
compartment, in
the bottle neck, or on the
barcode label on the bottle.
If the bottle neck has
condensation, a level
detection error may occur.
If the bottle surface with the
barcode label has
condensation, detection of
the bottle may fail. If
condensation is present,
Figure 5-11: Maximum Liquid Level for the 15 mL, 30 mL, remove the condensation
and 60 mL Bottles using a dry paper towel.
• When using 15 mL
bottles, verify they are
placed on the reagent tray
Checking the Printer and Printer Paper with the barcode facing out.
Setting the bottles
Before you begin each day, ensure the printer has enough paper and is incorrectly may damage the
turned on. See the Printer Manual for instructions on changing paper. bottle and reagent probe.
• If bubbles are present in
the bottles, correct analysis
may not occur. Check the
Preparing the ISE Unit bottles for bubbles, and
remove any bubbles before
The ISE unit is an optional part of the system. If you have an ISE unit, placing bottles in the R1
ensure that the ISE power switch button (when you open the right door and R2 refrigerators.
of the system) is on. Prepare it in the following way:
• Checking the Buffer Syringe for Leaks. See page 97.
• Checking the ISE Reagent Level. See page 98.

TIP
• Priming the ISE Unit (Only if Reagent is Replaced). See page 99.
If the printer
• Performing an Auto-Clean of the Sample Pot. See page 100. is off or is
out of
• ISE Calibration. See page 100. paper,
an error
In addition to these, you should perform any weekly, monthly message is displayed.
or quarterly maintenance routines that are due. Create planned
maintenance routines to maintain the ISE unit effectively
(see Chapter 8, “Maintenance” on page 187). TIP
An
Checking the Buffer Syringe for Leaks
insufficient
The ISE Buffer syringe dispenses buffer to the sample pot. Buffer is liquid alarm
used to dilute the ISE sample. If liquid leaks from the syringes, incorrect is displayed
volumes of buffer are dispensed and the analysis result calculation are when the
affected. ISE reagent
level drops below minimum.
To inspect the buffer syringe:
After the alarm, about 180
1 Have a clean, dry cloth prepared. MID Standard Solution
samples can be dispensed,
2 Open the right front door on the system.
about 600 Reference
3 Check the bottom of the syringe case, the case housing and the Solution and about 240
case head for signs of leakage, as shown in Figure 5-12. Also Buffer Solution samples.

check around the screws and tubing. Make sure none of the tubes
CAUTION
are twisted in such a way that might prevent liquid flowing through
Do not allow them freely. If any surfaces are wet, dry with the cloth.
the buffer 4 Check that the two screws on the case head are not loose. If so,
solution to
tighten them gently.
come in direct
contact with 5 If the wetness reappears in five minutes, then replace the syringe.
your skin. Should this See “Replacing the ISE Buffer Syringe” on page 235.
happen, wash immediately
with soap and water.

Fixing screws
Case head
Syringe case
ISE
ON FR
ON
T
F
OF ISE power switch
: Possible leakage locations

TIP
Figure 5-12: Checking the Buffer Syringe
Checking the ISE Reagent Level

Reference To check the reagent level:
Solution: Top up once only.
On-board stability; 2 months.
1 Open the left door on the front of the system, as shown in
Buffer: Top up once only. 2 If the liquid level in any tank is below the minimum level line 3 cm
On-board stability; 2 months. from the bottom, reagent should be added.
Mid Standard Solution: Do 3 Replace reagent by pulling out the tank, opening the cap and
not top up or consolidate 3 or pulling out the aspiration tube. Either add more solution or replace
4 part used bottles. When the tank. Replace the tube and tighten the cap properly and push
this runs low discard the the tank all the way back in.
remainder. On-board
stability; 1 month. 4 Close the system door again.
Aspiration tube
MID solution Cap
tank
Buffer solution
tank
FR
ON
T
REF solution tank
Figure 5-13: Checking ISE Reagent

Priming the ISE Unit (Only if Reagent is Replaced)
Perform this procedure only if the reagent is replaced.
The ISE Unit is primed to eliminate all air bubbles from the aspiration TIP
tubes that carry ISE reagents from the reagent tank to the syringes as
well as from the syringes themselves. Air presence would alter the If priming is
volume of reagent dispensed and therefore also alter the analysis necessary,
results. To prime the ISE unit: it should
always be
1 Select System Status>ISE Status>Prime (F6). done prior to
calibration.
2 From the P r i m e O p e r a t i o n window, select B u ff e r
P r i m e or M I D / R E F P r i m e , depending on the liquids you Buffer is pushed through by
have added. If the system (or ISE unit) has not been used for more a syringe. MID Standard
than 24 hours, select T o t a l P r i m e even if no solutions are Solution and reference
replaced or topped up, as shown in Figure 5-14 on page 99. solution are pulled through
3 Press the S T A T R O T A T I O N / D I A G switch. the unit by a rolling pump
(peristaltic pump).
4 The ISE Unit should be primed at least three times.
5 Close the door again on the system.
Figure 5-14: Priming the ISE Unit

Performing an Auto-Clean of the Sample Pot
To auto-clean the sample pot:
1 Prepare the Cleaning Solution (used neat - i.e. 5% effective
chlorine).
2 Ensure the ISE unit is on and the system is in Warm-up or
Standby mode.
3 Place 1ml of the Cleaning Solution in a sample cup and place this
in the Clean position on the STAT table.
4 Select System Status>ISE Status>ISE Unit Start (F5).
5 Select E / C l e a n i n g from the ISE single operations window, as
6 Click Y e s to start the process. The process takes about
five minutes.
7 When auto-washing is complete, click E x i t ( F 2 ) to return to
the main window.
Figure 5-15: Auto-Cleaning the Sample Pot
CAUTION ISE Calibration

During calibration analysis, each standard solution is measured
Before ISE four times for slope check.
Calibration,
ensure the top To perform ISE Calibration:
lid and ISE lid 1 Place ISE standard solutions on the STAT table by removing the
are closed. lid and rotating the table so that the positions of “S-H”, “S-L”, “U-H”,
If analysis has started and and “U-L” can be accessed by pressing the S T A T
the display mode reads
R O T A T I O N / D I A G switch.
BUSY, do not add the
standard solutions. 2 Pour the ISE standard solutions for serum and urine into the
sample cups provided and place them in the inner STAT table
holders. For blood serum, high serum standard should be placed
in holder “S-H” and low serum standard should be placed in holder
“S-L”. High urine standard should be placed in holder “U-H”, and
low urine standard should be placed in holder “U-L”.
3 Click System Status->ISE Status.
4 Replace the STAT table lid.
5 Click I S E u n i t s t a r t ( F 5 ).

6 Select the type of calibration; A / C A L. is for serum only,
TIP
B / C A L is for urine and C / C a l i b r a t i o n s e r u m +
u r i n e is for both, as shown in Figure 5-16 on page 101. Time taken
7 Click Y e s on the Start Operation dialogue to begin to update
calibration
ISE Calibration.
data:
8 The calibration results are listed when the process has ended.
Compare these results to the normal values below. Results
highlighted in yellow are abnormal and indicate that calibration Serum only: approx. 4 mins.
should be repeated. Serum and urine: approx.
6 mins.
9 Click E x i t ( F 2 ) to close the window.
Use Type Change

to change from
serum to urine.
When something happens during ISE

measurement you can stop the ISE
immediately by pressing this button.
Figure 5-16: ISE Calibration

Normal Slope Value Range
Na,K 38 to 68
Cl -38 to -68
Normal MID standard correction factor range
Na 0.80 to 1.20
K 0.75 to 1.25
Cl 0.75 to 1.25
ISE Status Messages
Ready/Busy/Stop/No Connection
Indicates the operation mode of the ISE
Message Meaning Change in colour
READY Ready to start analysis Blue
BUSY Analysis in Progress Red
STOP ISE in stop mode Yellow
Unconnect ISE is disconnected from Yellow

system (Communication error
or power failure)
Electrode
Electrode indicates whether the latest slope value falls within the range of
normal values.
Electrode Slope values in range Blue
Electrode Slope out-of-range or an End Yellow

Process performed and a new
calibration not done
Reagent
Indicates the quantities of the buffer, Mid Standard Solution and REF
solutions
Reagent Reagent sufficient Blue
Reagent Reagent empty Yellow

Performing Calibrations
TIP
After performing the calibration requisition operation, start analysis.
If a number
If S e l e c t A l l T e st s is set for the calibration conditions during the
of bottles of
requisition operation, it enables the reagent blank to also be measured. the same
reagent are
• Performing Calibration Requisition. See page 103.
placed
on-board, the system
• Performing the Reagent Blank Measurement Requisition.
assigns a number in
See page 105.
sequence to each bottle.
This enables individual
Performing Calibration Requisition requisition of the calibration
You must calibrate before measuring samples. analysis for each bottle of
reagent when advanced CAL
To perform calibration: is enabled for that test.
1 Select Routine>Test Requisition>Calibration. See “Requesting Advanced
Calibrations” on page 106.
2 Select a sample type.
4 Select A n a l ys e r R e q u i s i t i on (if Advanced Calibration is
configured). This carries out automatic requisition for bottles that
have either no calibration values or expired calibration stability.
5 Select any additional tests requiring calibration, as shown in
Figure 5-17.
6 Click E n t r y ( F 4 ) to save those settings.
7 Click D is p la y C a l to view rack numbers and positions TIP
required. Calibrators should be placed in the racks accordingly.
Remember
8 Click D e t a i l I n f to view calibrator names corresponding that the blue
to rack positions, as shown in Figure 5-18 on page 105. rack
(reagent
blanks)
must also
be loaded immediately prior
to the yellow racks and
should include fresh
deionised water in positions
1 (serum), 10 (urine) and
4 (other).'
TIP
You can
also
perform
Calib-
rations from
the STAT
table without using racks.
Contact your Beckman
Coulter Representative for
more information on pre-
programming the STAT
table.

Figure 5-17: Performing Calibration

TIP
Those
calibrators
required
for the
requested
calibrations
are labelled with black text.
Those labelled with red text
are not required for the
currently-requested
calibrations.
Figure 5-18: Calibrator Names By Position
Performing the Reagent Blank Measurement Requisition

To measure the reagent blank only or to use the calibration curve
factors, you should:
1 Select Routine>Test Requisition>Calibration.
2 Select the sample type and cuvette ring.
3 Click S t a r t E n t r y ( F 4 ).
4 Click the tests to be measured for reagent blank, as shown in
Figure 5-19.
Figure 5-19: Reagent Blank Measurement
5 Select each test by clicking it. Each selected test should change to
blue. If not Click C h a n g e O p t i o n ( F 6 ).
6 Click E n t r y ( F 4 ) to save those settings.

Requesting Advanced Calibrations
You can perform Advanced Calibration Analysis on all reagent bottles
to which a sequence number is assigned. Reagent bottles are
sequenced when a number of bottles containing the same reagent are
present on the reagent wheel. This might be necessary when a change
over is required from an empty reagent bottle.
When this occurs, you must always create a new calibration curve and
evaluate it before analysis continues. Advanced Calibration Analysis
enables the operator to perform calibration analysis for all sequenced
reagent bottles that are in the system and produces a calibration curve
and a factor for each one.
To perform advanced calibration analysis:
1 Verify calibration-specific parameters by selecting Parameters>
Calibration>Calibration Specific. Ensure the A d v a n c e d C a l
is set to Lo t or L o t & B o t t l e .
TIP 2 Change any parameters as necessary and click S e t ( F 4 ) to
save these settings, as shown in Figure 5-20.
If no
calibration 3 Click E x i t ( F 2 ) to return to the main window.
curve
appears to
4 Perform a reagent check by selecting System Status>Reagent
have been Status>Start Check (F5). Advanced Calibration requests can not
created for any particular test be generated if R e a g e n t S t a t u s is unchecked.
item, then perform the 5 Select the T y p e o f c h e ck and then click S t a r t.
advanced calibration
procedure again for that test 6 Perform a requisition. You can only use a rack to perform
item. advanced calibration.
Figure 5-20: Requesting Advanced Calibrations
7 Select Routine>Test Requisition>Calibration to automatically

display the system request for tests. Calibration should now be
performed. If you click S t a r t E n t r y , you can add further tests
individually.

8 Click I n d i v i d u a l R e q u i s i t i o n s to select any sequenced
reagent bottles. If more than one is placed on-board, you should
calibrate.
9 Click C l o s e and then E n t r y to save you selection. Click E x i t
10 To assess the resulting calibration curve, select Routine>
Calibration Monitor. Use the Me a su re d D a t a drop-down list
to view the calibration curve for each sequenced reagent, as shown
in Figure 5-21.
Figure 5-21: Viewing the Calibration Curve TIP

The Multi
Reagent
Performing Auto-Calibration from the Switch tab
should be
STAT Table selected in
Parameter>Common
To use the STAT table for auto-calibration, you must preprogram the Test Parameters>Test
positions for the calibrator, reagent blank and controls. These positions Name window to assure
are then blocked and cannot be run for emergency samples. proper reagent calibration.
Use this to select reagents
To allocate the calibrator to the STAT table, you must set up the that automatically calibrate
calibrator as for the yellow rack first, then: new R1 and R2
1 Select Parameter>Calibration>STAT Table Calibration. simultaneously. If the option
is not used, new R1 is
2 Click S e t ( F 4 ) . calibrated with old R2, or old
3 Select the round name from the drop-down list. The round R1 is calibrated with new R2.
(depending on which bottle is
is always the same as for the normal run under the start
empty first).
conditions selected.

4 Select the A u t o operation from the drop-down list.
5 Select the calibrator to use for auto calibration.
6 Click T e st .
7 Select the C a l i b r a t i o n mode: either full calibration (A ll) or
Reagent blank (R B ) only, as shown in Figure 5-22.
Figure 5-22: Auto-Calibration from the STAT Table

8 Select the E x e c u t i o n T y p e from C h a n g e B o t t l e
N o . or C h a n g e L o t . N o . as shown in Figure 5-22. When
Change Bottle No.is selected, the system calibrates each new
Bottle of the test detected on the reagent tray.
9 Select Execution on Measuring Start if you wish for the system to
perform calibration at each transfer from Standby to Start.
Preparing for QC Analysis

QC samples are samples with a known composition. While the system
TIP
normally tests samples, the QC samples test the system and more
importantly ensure that calibration is still valid. By selecting
Individual
Each laboratory should establish its own control frequency. Good
Requisition,
laboratory practice however suggests controls be tested each time
the system
patient samples are tested and each time calibration is performed. can perform
If any trends or sudden shifts in values are detected, review all control
operating parameters. analysis for each of the
Each laboratory should also establish guidelines to enable corrective reagent bottles to be
action to be taken if controls do not recover within the specified limits. calibrated. It is recommended
that you perform QC analysis
You can prepare for QC in the following ways: on all test items as advanced
calibration.
• Performing QC Requisition. See page 109.
• QC Analysis with Barcodes. See page 110.
• STAT Table QC. See page 110.
Performing QC Requisition
To perform a QC analysis requisition:
1 Select Routine>Test Requisition>QC.
4 By default all tests are selected and therefore appear in blue.
Click the tests you do not want to QC. Each deselected test
appears white. You can click D e s e le ct A l l ( F 8 ) to deselect
all items.
5 Click E n t r y ( F 4 ) to save your selection.
6 Click D is p la y Q C to view the rack numbers and QC positions
required.
7 Click D e t a i l I n f to view control serum names corresponding
to rack positions. Place QC’s in the green racks according to the
on-window diagram.
8 Click C l o s e to close this window.

QC Analysis with Barcodes
QC analysis using barcodes can also be performed, using a green rack.
To perform QC analysis this way:
1 Select Parameter>QC Control>QC Common.
TIP
2 Check the B a r co d e Q C O p e r a t io n check box.
If STAT
table QC is 3 Select the Control tab and enter the Control ID for each control
set to "Auto" sample.
and sample
4 It is now possible to place the barcoded QC sample cups on a
blank tests
(e.g. Direct
green rack in any order.
Bilirubin) are requisitioned,
set the cyclic type for the STAT Table QC
blank and coloured test to You can use the STAT table for QC by preprogramming QC positions.
"Sample". If it is set to "Test", These Position are blocked and cannot be used for emergency
optimal results are not Samples. Please contact your Beckman Coulter Representative for
obtained.
information on preprogramming.
To use controls from the STAT table, QC must first be defined for the
green rack.
1 Select Parameters>QC Control>Stat Table QC.
2 Click S e t ( F 4 ). The system shows the configuration for the
selected round, as shown in Figure 5-23.
3 Select the quality controls you want to run from the STAT table.
Figure 5-23: STAT Table QC
4 Click the T e s t tab.

5 Select the round name from the drop-down list.
7 Select the test.
9 Select the C y c l i c T y p e , as shown in Figure 5-24.

10 Enter the C o u n t , between 0 and 999. This determines the
CAUTION
number of analyses performed before executing STAT table QC.
11 Check the Execution Mode check-boxes as appropriate: You should
specify how long
• Execution on Measuring Start: runs QC from the STAT Table samples are to
each time the system is started. be kept on the
STAT table after
• Execution after Calibration: runs QC from the STAT table after checking the necessary
the reagent blank analysis or calibration analysis (ACAL) is accuracy. The STAT table is
cool, but samples should not
performed.
be kept there for long periods.
Do not open and close the
STAT table cover more than
necessary, or its temperature
can increase.
Figure 5-24: Selecting the Cyclic Type
12 Click C l o s e to save this and E x i t ( F 2 ) .

13 Select System Status>STAT Table Status.

14 Click S t a r t C h e c k , and click Y e s , as shown in Figure 5-25.
Figure 5-25: Check Start for STAT Table
TIP
Entering Analysis
Manual
Requisitions
Requisition Each time you perform an analysis you must enter specific information
is about the patient samples and process you are about to start. This
unnecessary
information is termed “Requisitions”.
if performing
real-time online analysis. There are a number of ways of entering requisitions:
If an online error occurs, the
analysis items of profile • Entering Manual Requisitions. See page 113.
number 0 are automatically
assigned to the sample for • Entering Batch ID Requisitions. See page 114.
analysis.
• Downloading Requisitions from a Host Computer. See page 114.
• One-Touch Mode. See page 115.

Entering Manual Requisitions
Requisition is performed using this method if the tests are different for
each individual sample. Settings for the sample type, patient
information and tests are repeated for each of the samples to be
analysed.
1 Select Routine>Test Requisition>Normal.
2 On the N o r m a l A n a l y s i s window, enter the sample TIP
number. Click E if you are entering a requisition for emergency
If
samples on the red rack and P for emergency samples on the
performing
STAT table. manual
3 Select the sample type and click S t a r t E n t r y ( F 4 ) . barcode
analysis,
4 Enter the sample ID, sex, age (years and months), as shown in enter the barcode ID as the
Figure 5-26 on page 113. sample ID here. If the
5 Select the tests you want by clicking them or choose a profile, barcode type is “ISBT128” in
the S y s t e m menu, the
if profiles are set up.
inputted barcode ID is
6 Click E n t r y ( F 4 ) to save your selection and move on to the checked to determine
next sample number. Repeat the procedure for each sample. whether it conforms to the
“ISO 7064 Mod 37, 2”
7 To register additional patient information, click the standard.
D e m o g r a p h i c s tab.
8 Enter patient information and click E n t r y ( F 2 ) to save it.
9 Click E x i t ( F 2 ) to close this window and once again to return
to the main window.
Figure 5-26: Entering Manual Requisitions

TIP Entering Batch ID Requisitions
If batch ID This method is used when performing the same test/s on a number of
requisition samples. Patient information is entered for one sample and then reused
is for every other sample in the batch.
performed
using To enter batch ID requisitions:
Last 1 Select Routine>Test Requisition>Normal.
N o . , tests for the samples
starting from the currently 2 Enter normal requisition details for the first patient in the group,
displayed sample number to as described in “Entering Manual Requisitions” on page 113.
the last are registered as a
3 Click X n - E n t e r ( F 3 ).
group.
If group requisition is 4 Enter the last sample number or the number of samples, as shown
performed using in Figure 5-27 on page 114.
S a m p l e s , the tests for
the number of samples 5 Click E x e c u t e.
entered is registered as a 6 Click Ex i t (F 2) to close this window and once again to return
group, starting from the to the main window.
currently displayed sample
number.
Figure 5-27: Entering Batch ID Requisitions
TIP
Downloading Requisitions from a
Host Computer
A message
is displayed You can download requisitions if barcode analysis is done
to indicate through batch online analysis instead of real-time online analysis.
that the
To download requisitions from a host computer:
requisition
data is 1 Select Routine>Test Requisition>Normal.
downloading successfully
2 Click O n li n e ( F 7 ) .
from the host system.
3 Select the sample from the drop-down list in the sample type
dialogue.
4 Enter the sample number of the sample for which requisition is
to be performed.
5 Click E x e c u t e.
6 The sample request information is then downloaded from the
host system.
7 Click Ex i t (F 2) to close this window and once again to return
to the main window when the system has finished downloading
requisition data from the host system.

One-Touch Mode
One-Touch mode allows you to place a sample on the STAT table and
press a switch to process that sample. It is designed for operators who
are not completely familiar with the system and therefore would not
know how or perhaps would not have the time to perform a requisition
for an emergency sample.
To process an emergency sample in One-Touch mode:
1 Create a profile by selecting Parameter>Common Test
Parameters>Profile. Profiles are frequently used requisitions that
are stored on the system and given a profile number. Profile 99,
for instance, is used by the One-Touch mode to perform One-
Touch analysis using the STAT table.
2 Choose an analysis test for a profile.
3 Click E n t r y ( F 4 ).
5 To switch the system to One-Touch Mode, select System Status
and then O n e T o u c h ( F 8 ).
6 Click E x i t ( F 2 ) .
7 Remove the STAT table lid and place the emergency sample in
position No.1 on the STAT table.
8 Replace the lid and press the S T A T T e s t switch to start
analysis.
Preparing Samples for

TIP
Analysis Racks are
Before starting analysis, samples must be placed in the sample cups or colour-
or tubes and the cups placed on the correct racks. The method of coded
preparing samples and racks differs in each hospital or reference according
laboratory and depends on the facilities available. This guide therefore to the
purpose of analysis.
only deals with the following key procedures:
• Attaching Barcode Labels to Sample Racks. See page 116. White: Normal Patient
analysis
• Applying the Barcode Labels to the Sample Cups.
See page 116. Blue: Reagent Blank
analysis
• Placing Samples in Sample Cups. See page 117.
Yellow: Calibration
• Placing the Sample Cups into the Rack. See page 117. analysis
• Placing Racks on the Feeder. See page 120. Green: QC Analysis
Orange: Repeat-run
analysis
Red: Emergency
analysis

Attaching Barcode Labels to Sample Racks
1 Attach rack ID labels to the white, red, yellow, green, and orange
racks. The system does not process a rack without an ID.
2 Attach the rack ID label to the front of the rack so that it is perfectly
perpendicular, as shown in Figure 5-28 on page 116.
Rack front
The label should not stick out 1–1
from the rack.
Rack ID label The label should not stick out from the rack.
(Stick the label on the rack in
parallel with the side face.)
1234
+1
0 0 The label cannot be placed on
the protruding part of the rack.
Orient the label so the numbers are located to

the left if viewed from the front .
Rack side
Protruding part of the rack
Figure 5-28: Labelling Sample Cups

CAUTION
Barcode labels
must not Applying the Barcode Labels to the
protrude from
the top of a
Sample Cups
sample cup.
The label must be
To perform analysis using a barcode as the sample ID, barcode labels
positioned perfectly must be attached to the outside of the sample.
perpendicular. The angle To apply barcode labels:
can vary to a maximum
of 5°. 1 Stick the barcode labels onto the outside of the sample cup so
Barcode labels that are too the end of each label is at least 7 mm from the bottom of the cup,
long or too short might not as shown in Figure 5-29.
be identified by the barcode
2 Rub the label gently with your finger to make sure that it is well
reader.
stuck on and will not peel off.
Barcode label Top view
φ16.0mm or less
Sample cup (outside diameter including
the barcode label)
NE rack Barcode label
Rack top
Figure 5-29: Rack ID Labels

Placing Samples in Sample Cups
Ensure the dead volume position is in the highest position possible
so the sample probe does not break the sample cup. When using an
adapter to place varied sizes of sample cups in a single sample rack,
remember you can only set one dead volume position for each rack
type (colour).
The minimum dead volume required for reliable sample detection is
4 mm below the sample surface in the sample cup. If a centrifuged
sample is analysed, ensure there is sufficient sample for analysis in
addition to minimum dead volume.
To avoid blood cells under the serum or plasma being aspirated and
causing abnormal analysis results, transfer the serum or plasma into
a smaller sample cup if the serum or plasma level is below the 4mm
minimum.
Placing the Sample Cups into the Rack CAUTION
Placing sample cups on racks involves the following steps: Ensure sample
cups suit racks
• Setting Sample Cups on the Rack. See page 117. used. Ensure
also that
• Using Adapters on Sample Racks. See page 118. barcodes suit
racks used. Benoject-II type
• Sample Order. See page 119. sample cups must not be
used because the caps of
Setting Sample Cups on the Rack adjacent sample cups
interfere with each other.
The prepared sample cups are set into the rack as follows. Only cups with an outside
1 Place each sample in the correct rack. Racks are colour coded. diameter of ø16mm or less
Each colour indicates a type of analysis. can be used in the rack.
Do not twist the sample
2 Look at each opening in the rack and make sure the barcode is cups around inside the
aligned in the centre, as shown in Figure 5-30. 2 mm is the most racks as this might damage
each barcode should deviate from the centre. If a barcode label is the barcode. If you want to
not aligned with the opening in the rack, lift it out and place in back reposition a sample cup, lift
in correctly. it out and place it back in
properly.
3 Fit a rack adapter if required, as shown in Figure 5-30.
4 If using an adapter on the rack, ensure the openings that allow
barcodes to be scanned are aligned.
The rack ID label is
applied to this surface.
Barcode
Sample container
The rack ID label is The barcode label is

applied to this surface. applied to this surface.
Rack
Direction that rack moves
Figure 5-30: Placing Sample Cups in Racks

5 Place all of the sample cups registered during normal analysis
requisition on the rack.
6 Do not have serum or plasma and urine samples on the
same rack.
7 When performing sequential analysis, do not leave any gaps on
the rack. This confuses analysis results. Barcode and Rack ID
modes permit spaces.
Using Adapters on Sample Racks

Adapters are used to hold thin sample cups (approximately 11.5
to 13.5 mm) firmly in place on the racks. Thicker sample cups
(approximately 13.6 to 16 mm) do not need an adapter. If you are
in doubt, place the samples in a slot on the rack and see how much
play it has.
To insert an adapter:
1 Align the adapter opening and the rack opening.
2 Insert the adapter guide, as shown in Figure 5-31, into the guide
groove of the rack.
3 Push the adapter into the rack until you hear a click.
4 Ensure the adapter has engaged the rack.
Adapter lock
Guide
Slit
Adapter
Push in Rack window

Guide groove
1 2 3 4 5 6 7 8 9 10
Rack
Slit
Figure 5-31: Using Rack Adapters

To remove an adapter:
1 Push the adapter lock lightly with a finger from the outside of the
rack window to disengage the lock.
2 When the upper edge of the adapter comes out from the rack, pull
it out the rest of the way, as shown in Figure 5-32 on page 119.
Adapter lock
Rack window
Push up lightly
with a finger
Figure 5-32: Removing Adapters
Sample Order
• Blue Rack: Serum position 1, Urine position 10, Other position 4.
• Yellow Rack: Must correspond with calibrator number order set

in parameters.
• White Rack: Sample type is set using rack barcode number.

This can be set in Parameters>System>System. See “Sample
Identification” on page 23 for more information on placing
samples in the white rack.
• Green Rack: Must correspond with control number order set in

parameters (if not using a barcode).
• Orange Rack: Must correspond with the repeat run work list
(except when barcode mode is used).
• Red Rack: Sample numbers are automatically assigned to

emergency samples in the order they are placed. Some
laboratories use the red rack as a paediatric or small sample rack
rather than as an emergency rack. This allows an appropriate
sample dead volume position to be set for a particular type of
sample cup used for analysing very small samples. This can
reduce dead volumes and eliminates the risk of damaging the
sample probes.

CAUTION Placing Racks on the Feeder
Only eight 1 Open the protector cover for the samples on the rack supply unit,
racks can be as shown in Figure 5-35 on page 121.
placed on the
2 Set the prepared racks on the rack feeder on the feed side of the
feeder at any
one time. system, as shown in Figure 5-34 on page 121.
3 Arrange the racks in colour order, as shown in Figure 5-33 on
page 120.
Red rack
1 10
Set in any order.
White rack
1 10
White rack
1 10
Set in order of smallest
control No.
Green rack
1 10
Set in order of smallest
calibrator No.
Yellow rack
1 10
Set the sample cup with
distilled water at the front.
Blue rack
1 10
Direction that racks move
Figure 5-33: Rack Order

Top view of rack feeder CAUTION
Do not place
Surface where the rack racks on the
ID label is applied
feeder while the
LED light is
flashing. This
indicates that the rack feed
plate is operating.
Never look directly into the
barcode readers as this may
seriously damage your
a
eyes.
a
F
R
O
N
T A maximum of 8 racks can be set at one time.
Figure 5-34: Rack Feeder, Top View
Surface where the rack ID label is applied
Rack
Sample protection
cover
LED
T
ON
Feed side rack feeder FR
Figure 5-35: Rack Feeder

Performing
Analysis
Introduction
This chapter details tasks to be performed during analysis:
• Starting Analysis. See page 124.
• Monitoring Analysis. See page 124.
• Masking a Test. See page 130.
• Checking Results. See page 130.
• Editing Analysis Results. See page 140.
• Printing Analysis Result Data. See page 144.
• Resending Data to a Host. See page 146.
• Saving Information to a Floppy Disk. See page 146.
• Performing a Manual Sample Dilution. See page 149.
• Performing a Repeat Run. See page 149.
• Processing Emergency Samples. See page 153.
• Pausing Analysis. See page 156.
• Stopping the Rack Feeder. See page 156.
• Stopping the System. See page 156.
• Shutting Down the System. See page 157.
• Performing an Emergency Stop. See page 158.
• Restarting the System. See page 158.
• Turning On and Off the Sample Barcode Reader. See page 159.
AU400 User Guide Version 2.11 Performing Analysis 123

CAUTION Starting Analysis
Before starting When analysis is started, S T A N D B Y = > M E A S . 1 can be
analysis, be seen in mode display. It takes about 12 minutes for the first results to be
sure to perform calculated after analysis has begun. Analysis results can be arranged
all the steps on a report template that you can print out when the process is
outlined in complete. You can however also program the system to print results as
Chapter 5, “Preparing for they are produced or in batches afterwards. If you have no printer,
Analysis” on page 85.
you can simply view results as they are produced.
To start analysis:
1 If you haven’t logged in, do so by entering your L o g i n N a m e
TIP and P a s s w o r d and press O K to access the main window.
2 Select Routine>Start Condition.
If the login
function is 3 Ensure all data on the S t a r t C o n d i t i o n window is correct.
disabled,
then you can
skip login 5 Click S t a r t.
and go to the
main window by pressing F2.
6 Ensure all data on the starting window
is correct.
7 Ensure there are no outstanding error messages for which action
has not been taken.
8 Click C h a n g e S e l e c t to change settings such as S t a r t
R ou t in e S N o .
9 Click Y e s to start analysis.
Monitoring Analysis
You can monitor general system status with the System Status window.
In addition, you can also examine the following
• Checking Analyser Status. See page 125.
• Monitoring Cuvette Status. See page 126.
• Monitoring Result Data. See page 128.
• Monitoring the Alarm List. See page 128.
• Monitoring Data Processor Status. See page 129.
124 Performing Analysis AU400 User Guide Version AC

To access System Status:
1 Click the S y s t e m S t a t u s button on the main window.
2 When you have finished viewing the window, shown in Figure 6-1
on page 125, click E x i t ( F 2 ) to return to the main window.
TIP
B lu e
No Error
Yellow
Error has occurred but

analysis can continue
Figure 6-1: System Status
Red
Checking Analyser Status Error has occurred

and analysis cannot
To monitor system status: continue
1 Select System Status>Analyser Status.
2 When you have finished viewing system status, click Ex i t ( F 2 )
Analyser Status allows you monitor the following:
• Vacuum Tank Status: This stores liquid waste and turns

red if full.
• Reagent Refrigerator Temperature Status: Yellow if the

temperature range goes outside of 4°C to 12°C.
• Refrigerator Lid Status: Red if it is not closed properly.
• Reagent Position Status: The circles you see on the R1 and R2

refrigerators each indicate a reagent position.
• An empty position is grey.
• An occupied position is blue.
• A yellow position indicates a warning (i.e. calibration
expired).
• A blue ring around a blue or yellow position indicates
a fixed position.
• A green ring around a blue or yellow position indicates
a cleaner position.
• Cuvette Wheel Temperature Status: Yellow when out-of-

range; 36.5°C to 37.5°C.
AU400 User Guide Version AC Performing Analysis 125

• Cuvette Status: Blue indicates that photocal data is acceptable.
Yellow indicates that at least one cuvette exceeded the range,
was abnormal or photocal was not performed.
• Sample Status: Sample numbers at the sample aspiration

position, Reagent 1 position and Reagent 2 position are
displayed here.
• Rack Feeder Status: Red if there is a rack feeder jam.
• Deionised Water Tank: Yellow if there is an overflow and red

when empty.
• Condensed/Diluted Waste Tank: Red when the tank is full.
• Wash Solution Tank: Red when the tank is empty.

TIP • ISE Electrode Status: Yellow if the slope value is greater than
Mid
65 or less than 38 (where Na and K are positive and Cl is
Standard negative).
factors
would be as
• ISE Operation Status: Displayed Messages are as follows:
follows:
Na 0.80 to 1.20 Message Meaning Change in Colour
K 0.75 to 1.25 READY Analysis can start Blue
Cl 0.75 to 1.25 COVER ISE cover is open Red
with Mid standard BUSY Analysis in progress Red

concentrations as follows: STOP ISE unit Yellow
disconnected
Na 140
N o C o n n e c t i o n ISE unit Yellow
K 4.0 disconnected
Cl 100
TIP
Monitoring Cuvette Status
Remember Cuvette Status allows you to monitor the cuvette check for each unit,
to perform following photocal. You can also view the date and time of photocal
Check measurement and W2. Recommended mean check range is ±0.03 and
S t a rt on absolute check range is ±0.1. The cuvette status window uses colour
the cuvette coding to indicate photocal status. See “Performing a Photocal” on
wheel and page 193.
to save it with S a v e .
White: Cuvettes passed the photocal
Green: Failed the cuvette check
Red: Failed the mean check
Blue: Failed the absolute check
TIP Most Common Reasons for Failure

Green: Scratch, hair, or fingerprint on cuvette surface.
If all Red: Washing and drying unit overflow (laundry overflow).
cuvettes
Blue: Lamp changed since last photocal.
are blue,
click
Save,
and run another check. Blue
numbers should then
disappear.

To monitor cuvette status:
1 Select System Status>Cuvette Status.
2 When you have finished viewing cuvette status, as shown in
Figure 6-2 on page 127, click E x i t ( F 2 ) to return to the
main window.
Figure 6-2: Viewing Cuvette Status
Cuvette Status allows you to monitor the following:
• Parameters for Photocal: The internal cuvette check range is

hard coded in the system as ±0.01 and cannot be changed.
Photocal measurement of one specific cuvette should not vary
more than ±0.03 from the average of all other cuvette photocal
measurements (Mean Check).
• Maintenance Status: If maintenance is overdue, the time

display of the most recent photocal and W2 procedure turns
yellow. See “Performing a Wash 2” on page 190.
• Error Cuvette Number List: Up to 88 defective cuvette numbers

can be displayed here. To print this list, click P r i n t ( F 3 ) on
the Cuvette Status window and then click O k .

Monitoring Result Data
If your printer is not functional or perhaps out of paper, you can still view
analysis results as they are produced, by using the Data Display
window. The Data Display has three tabs:
• All Data: Data appears only when all tests for that sample are
completed.
• STAT Data: Data appears as each test for that sample is

complete.
• ISE Data: Data appears as soon as all ISE data for that sample
is complete.
• Measured Data: The analysed and outputted sample list that

includes a maximum of 1000 lines of data from the most recent
back to the past displayed.
To access the Data Display window:
1 Select System Status>Data Display.
2 When you have finished viewing data, click Ex i t (F 2) to return
to the main window.
Data Display allows you monitor:
• Sample Data: Sample results are displayed as numerical values

with a maximum of nine digits including decimal points.
• Error Flags: If the results being produced are abnormal, an error

flag appears on the right of the sample data.
Monitoring the Alarm List

You can monitor the alarms that occur during analysis, using the Alarm
List. This can display up to 2000 alarms, starting from the most recent.
To view the alarm list:
1 Select System Status>Alarm List.
2 Use the arrow buttons if you want to view the alarms for a period
and date other than the present.
3 To get more detailed information on any particular alarm, highlight
it by clicking it and then click D i s p l a y H e l p , as shown in
4 Print an alarm by highlighting it, and clicking P r i n t ( F 3 ), then
select D i s p l a y e d D a t e or A l l D a t e and click O k.

Figure 6-3: Alarm List
Monitoring Data Processor Status

TIP
Processor Status allows you to see with which sample number analysis
If the printer
has started (and ended) as well as the total number of samples
is set as a
analysed. It also allows you view which samples were processed using real-time
data transferred from a host computer and you can also use it to check printer: in
the status of the printer. case of
To view data processor status: Paper
E n d or P a p e r O u t ,
1 Select System Status>DPR Status. please select System
2 When you are finished viewing DPR Status, click E x i t ( F 2 ) to Status>DPR Status>
Printer Control (F4) to
return to the main window.
resume or cancel printing.

Masking a Test
You can select tests to be left out of an analysis run or “masked” at any
time during analysis. You might have to mask samples if calibration or
QC fails or QC has failed but samples are already on the feeder and the
system is running. By masking the test, you can save time and save
reagent volume, as calibration or QC must be performed again for these
samples anyway. When masked, these samples are not analysed even
if manual requisition is performed from the normal requisition menu.
To mask a test:
1 Select Routine>Start Condition>Masking(F7) to display a list of
TIP
test items that can be masked.
You can
2 Select the samples you want to mask by clicking them, as shown
temporarily
in Figure 6-4.
prevent a
test from 3 Click O k to save these settings.
being
performed by selecting 4 Click E x i t ( F 2 ) to return to the main window.
Routine>Start Condition
selecting M a s ki n g and
then clicking the test.
TIP
The
operator
can unmask
a sample by
deselecting
the masked test. When a
new index is created all
masked tests are
automatically unmasked.
When tests are masked, Figure 6-4: Masking a Test

a message indicating that
M a sk e d It em s
E x i s t appears when you
click S t a r t .
Checking Results
When analysis has finished, the printer automatically begins to print
a list of results. If the printer is set up in real-time, it prints each set
of results as they are produced. You can check results in the
following ways:
• Checking for Error Flags and Alarms. See page 131.
• Using the Reaction Monitor. See page 131.
• Calibration Checks. See page 132.
• Checking QC. See page 134.
• Viewing and Editing QC Analysis Results. See page 139.
• Excluding QC data. See page 140.

Checking for Error Flags and Alarms
TIP
When results are printed, look for any error flags or alarms. See
The first
Chapter 9, “Error Flags” on page 241 for detailed information on each click an
flag. All flags should be investigated and the appropriate action taken. alarm stops
Alarms are displayed in red at the bottom of the window. Use A l a r m the alarm
H e l p (yellow triangle with an exclamation mark) to get details on each sound. The
alarm. Each Alarm issue should be resolved completely. Click A l a r m second click clears the
C l e a r each time you resolve an alarm. alarm.
To view alarms (when cleared):
1 Select System Status>Alarm List.
2 Click A l a r m H e l p to get more information on any alarm,
as shown in Figure 6-5.
PAGE 1
INDEX DATE 04/05/1999 17 : 59 ROUND NO.1 ROUND - 01 OPERATOR
PRINT TIME [ 04/05/1999 18 : 19 ]
R001 IN MANUAL -04 SERUM

TP-1 0.5593 ALB-1 0.5531 BUN-1 0.5567
GGT-1 0.5606 TP-W-1 -0.5538 TCHO-1 0.5577
Reagent blank
value
R001 OUT MANUAL -04 SERUM
TP-1 0.5486 ALB-1 0.5469 BUN-1 0.5434
GGT-1 0.5496 TP-W-1 0.5474 TCHO-1 0.5440
A001 IN MANUAL -05 CAL. NO. 1 S. ID SERUM CAL. NAME

TP-1 -0.0011 TP-2 -0.0004 TP-3 -0.0004 TP-4 -0.0005
A001 OUT MANUAL -05 CAL. NO. 1 S. ID SERUM CAL. NAME
TP-1 -0.0005 TP-2 -0.0001 TP-3 -0.0001 TP-4 -0.0001
A001 IN MANUAL -06 CAL. NO. 2 S. ID SERUM CAL. NAME Calibration value
ALB-1 -0.0003 ALB-2 -0.0002 ALB-3 -0.0002 ALB-4 -0.0001
ALB-1 0.0000 ALB-2 -0.0002 ALB-3 -0.0002 ALB-4 0.0000
A001 IN MANUAL -07 CAL. NO. 3 S. ID SERUM CAL. NAME
BUN-1 -0.0005 BUN-2 -0.0002 BUN-3 0.0000 BUN-4 -0.0005
BUN-1 -0.0003 BUN-2 0.0000 BUN-3 -0.0002 BUN-4 0.0000
Q001 IN MANUAL -14 QC NO, 1 S. ID SERUM QC NAME
TP-1 -38.358
Q001 OUT MANUAL -14 QC NO, 1 S. ID SERUM QC NAME QC value
TP-1 -198.177
Q001 IN MANUAL -15 QC NO, 2 S. ID SERUM QC NAME
ALB-1 -2.627
Q001 OUT MANUAL -15 QC NO, 2 S. ID SERUM QC NAME
ALB-1 -13.972
0001 0005-01 S. ID AGE MONTH SEX TYPE SERUM
TP 6.3 ALB 4.0 BUN 17.7 TCHO- 146.2 LD 160 ALT 44
GGT 49 Na 141.5 K 4.58 Cl 103.1 TP-W 5.9
0002 0005-02 S. ID AGE MONTH SEX TYPE SERUM Analysis results

TP 6.2 ALB 4.0 BUN 17.2 TCHO- 147.7 LD 156 ALT 44
GGT 50 Na 141.6 K 4.58 Cl 102.8 TP-W 5.9

TP 6.1 ALB 4.0 BUN 18.1 # TCHO- 151.3 LD 157 ALT 45
GGT 52 # Na 141.8 K 4.59 Cl 103.2 TP-W 5.9

TP Sample
6.2 No.
ALB Rack No.
4.0 BUN 19.3 TCHO- 145.6 LD 162 ALT 44
GGT 51 Na 141.2
position K 4.57 Cl Abnormal
102.8data flag
TP-W 6.1

TP 6.2 ALB 4.0 BUN 18.1 TCHO- Test name
143.6 and
LD 162 ALT 43
GGT 51 Na 141.8 K 4.59 Cl
Analysis103.5
resultTP-W 5.9
0006 0005-06 S ID AGE MONTH SEX TYPE SERUM
Figure 6-5: Abnormal Data Flags
Using the Reaction Monitor

The reaction monitor can be used to compare a suspect reaction with
that of a successful reaction to identify abnormalities. The reaction
monitor plots absorbance data against photometric measuring points
for each test. The reaction process can be viewed either as a graph or
on a data sheet. You can use this data to investigate the causes for the
abnormality and take appropriate action.

To run the reaction monitor:
1 Select Routine>Reaction Monitor.
2 Select the T e s t N a m e and I n d e x from the drop-down lists.
3 Select the type of sample by checking one of the check boxes
on the left and then enter either the S a m p l e N o . or
S a m p l e I D.
4 Click S e a r ch D a t a, as shown in Figure 6-6 on page 132.
5 Click D a t a D i s p l a y when the sample data is retrieved for the
Optical Density (OD) at each photometric reading.
Figure 6-6: Reaction Monitor
Calibration Checks
You can perform the following checks:
• Checking Alarms and Flags. See page 133.
• Checking Calibration Curves. See page 133.
• Checking Urine/Serum Calibrations. See page 133.
• Checking Multi-Point Calibration Curves. See page 133.
• Checking Reagent Blank Results. See page 133.
• Checking Calibration Trace. See page 134.

Checking Alarms and Flags
When calibration is complete, check the calibration data printout for any TIP
flags. If the calibration has failed, an alarm is generated on the bottom Following
of your window. Use Alarm Help to interpret alarms and to find the any multi-
cause of calibration failures. See Chapter 9, “Error Flags” on page 241 point
for more detailed information. You should clear each flagged issue calibration,
before performing calibration again. QC procedures should be the resulting
undertaken immediately following calibration, in accordance with good curve should be visually
laboratory practice. reviewed, on the Beckman
Coulter system, for
acceptability using the
Checking Calibration Curves software options - Routine,
In addition to alarms and flags, the following should also be checked to Calibration Monitor,
ensure the validity of each calibration. Calibration Curve.
To ensure calibration date is updated, select Routine>Calibration
QC procedures should be
Monitor>Calibration Curve. If not, check that the calibration requisition
undertaken immediately
is made and that calibrator(s) are in the correct rack position before following calibration in
restarting calibration. accordance with good
laboratory practice.
Checking Urine/Serum Calibrations
Ensure both urine and serum calibrations are updated. To change your
view from urine to serum, for example, select S e r u m from the
T yp e drop-down list.
Checking Multi-Point Calibration Curves

Following calibration, the resulting curve should be visually reviewed for
acceptability.
Checking Reagent Blank Results

Check the reagent blank monitor to ensure reagent blank values are TIP
updated. You should check both urine and serum reagent blanks. You
MB Factor
can switch between urine and serum views, using the T y p e drop-
calibrated
down list.
tests use
reagent
blank only
when
changing lots. Ensure these
tests have a valid reagent
blank. Enzymes commonly
factor calibrated are ALP,
AST, GGT and LDH for
example. For further
information, see the
manufacturer’s instructions
for use.

Checking Calibration Trace
Ensure new calibrations are consistent with previous calibrations by
viewing Calibration Trace (or History).
To view Calibration Trace:
1 Select Routine>Calibration Monitor>Calibration Trace. Tests
names are displayed above the current calibration factor value,
Figure 6-7: Calibration Trace
2 Click individual tests to display the Calibration Trace. A vertical

dotted line on the graph indicates a change in reagent lot number.
3 If new calibration optical densities show significant variation,
investigate the reasons for this change and take action.
Checking QC
When the QC sample is analysed, look for any flags that might be on
the results printout and take corrective action. See Chapter 9, “Error
Flags” on page 241 for more detailed information.
You can check all four kinds of QC Chart:
• Checking the Daily Variation Chart. See page 135.
• Checking QC Using the QC Monitor. See page 137.
• Checking the Day-to-Day Variation Chart. See page 138.
• Checking QC Results Using Twin Plot. See page 139.

If the QC results are outside the pre-set range, these results are flagged
with “1 ” and an alarm are generated. Use Alarm Help to find more
details on the cause and take corrective action. See “QC and Calibrator
Problems Causing Abnormal Data” on page 285.

Possible causes for abnormal results might be:
• Reagents Deterioration
• Stained Cuvettes
• Incorrect Reagent Settings
• Control Serum Deterioration

When all flags and alarms are clear, run QC analysis again. QC analysis
results are only valid when no flags or alarms are generated. The QC
Chart displays the results of the QC sample analysis.
Checking the Daily Variation Chart

The daily control menu compares QC sample analysis results by
plotting the individual QC points from one day of analysis or from
one index only on a variation chart. This should always be reviewed
following QC analysis.
To check the Daily Variation Chart:
1 Select Routine>QC Monitor>Daily Control.
2 Select the index from the I n d e x drop-down list.
3 Select the C o n t r o l N a m e and S a m p l e T y p e from the
drop-down lists.
4 Click C o n t r o l N o . ( F 8 ) and enter the control number of
the control sample and click O k .
5 Select the tests you want to view by clicking them and click V ie w
D a t a ( F 6 ) to access the Daily Variation chart, as shown in
Figure 6-8 on page 136. See Chapter 11, “Troubleshooting” on
page 279 if you notice anything abnormal here.
6 Click P r e v i o u s C o n t r o l / T e s t ( F 5 ) to view other
QC charts.
7 Click P r i n t ( F 3 ) to print any statistics, data, graphs,
or comments you see.
8 Click C o m m e n t ( F 4 ) if you want to enter and save
a comment.

9 Click E x i t ( F 2 ) to close this window and click E x i t ( F 2 ) to
Figure 6-8: Daily Variation Chart

Checking QC Using the QC Monitor
The QC Monitor gives a quick visual summary of a particular day’s
QC results.
To view results using the QC Monitor:
1 Select Routine>QC Monitor>Daily Control>QC Monitor.
2 The last five results of each test and level of QC material are
displayed as a function of standard deviations from the set mean
or target value, as shown in Figure 6-9.
Figure 6-9: QC Monitor
Where
* : QC is within the Mean and 1SD
1 : QC is within 1SD and 2SD
2 : QC is within 2SD and 3SD
3 : QC is outside 3SD
E : Error
To view the daily variation chart, as shown in Figure 6-10, double click
the test or select the tests you want to view and click V ie w D a t a.
+3SD
Upper control limit
(+2SD)
+1SD
Central value M
-1SD
Lower control limit
(-2SD)
-3SD
Figure 6-10: Daily Data

Checking the Day-to-Day Variation Chart
Day-to-Day compares QC sample analysis results by plotting a number
of days analyses or a combination of indexes on a chart that displays
the variation. You can select the indexes you want to use such as a
couple of days, weeks or months.
To check the Day-to-Day Variation Chart:
1 Select Routine>QC Monitor>Day-to-Day Control.
2 Select the indexes to be viewed from the I n d e x drop-down list
and select the sample type from the T y p e drop-down list.
3 Select the Control Name from the C o n t r o l N a m e drop-
down list or click C o n t r o l N o . ( F 8 ) , enter the control
number of the control sample and click O k .
4 Select the test you want to view and click V i e w D a t a ( F 6 )
to see the results on the Day-to-Day Variation Chart, as shown in
Figure 6-11. If you notice anything abnormal, see Chapter 11,
“Troubleshooting” on page 279.
5 Click P r e v i o u s C o n t r o l / T e s t ( F 5 ) or N e x t
C o n t r o l / T e s t ( F 6 ) to view other QC charts.
6 Click P r i n t ( F 3 ) to print any statistics, data, graphs,
or comments you see.
7 Click C o m m e n t ( F 4 ) if you want to enter and save
a comment.
8 Click E x i t ( F 2 ) to close this window and click E x i t ( F 2 ) to
Figure 6-11: Day-to-Day Variation

Checking QC Results Using Twin Plot
You can use Twin Plot, as shown in Figure 6-12 on page 139, to
determine whether QC variation is caused by the system or just a
random error. A normal and abnormal control are usually used in
QC analysis. Twin plot displays the first control on the x-axis of a
2-dimensional plot and the second control on the y-axis. All points
should fall within the 2SD range in the centre of the twin plot.
Abnormal
region sample
+2SD
TIP
MEAN
The number
of points are
-2SD
divided into
three equal
groups of
-2SD MEAN +2SD Normal region data. The
sample oldest data is plotted with a
plus + , the middle data with
Figure 6-12: QC Twin Plot a dot. and the newest data
an X .
To view the Twin Plot:

1 Select Routine>QC Monitor>Twin Plot.
2 Select the I n d e x e s to be viewed and T y p e from the
drop-down lists.
3 Select the tests you want to view by clicking them.
4 Click T w in P l o t D is p la y ( F 6 ).
TIP
5 When the chart is displayed, check it for any abnormal results.
To enable
6 Click P r e v i o u s T e s t ( F 5 ) or N e x t T e s t ( F 6 ) to view twin plot and
other QC graphs. perform two
levels of QC
7 Click V i e w D a t a ( F 7 ) and then r e f . co m m e n t ( F 4 )
for a test,
if you want to enter the comment. Click C l o s e to save the test
the comment. must be set up as M u lt i in
8 Click E x i t ( F 2 ) twice to close this window and E x i t ( F 2 ) Parameter>QC Control>
again to return to the main window. QC Specific.
Viewing and Editing QC Analysis Results

To view or edit QC analysis results:
1 Select Routine>QC Monitor>Data Edit.
2 Select the test you want to view or edit by entering them in QC.
3 Click V i e w D a t a ( F 5 ) .
4 To edit, highlight the test and click E d i t R e s u lt ( F 5 ) .
5 Edit the QC data and click C l o s e .
6 Click R e a g e n t I N F to display the reagent lot and bottle
numbers of the selected test. Click C l o s e to return to the
D a t a E d i t window.

7 Add a comment by clicking T e s t C o m m e n t ( F 7 ).
Enter the comment and click O k .
8 Click E x i t ( F 2 ) to save changes.
You can click D e l e t e ( F 8 )to append the abnormal data flag d
to data items.
Excluding QC data
QC data can be excluded from statistical calculation by editing flags
into results. These flags do not erase the data but exclude it from any
evaluation.
To exclude QC data:
1 Select Routine>QC Monitor>Data Edit.
2 Select V ie w D a t a ( F 5 ).
4 Select A ll or a specific test to exclude from the T e st N a m e
drop-down list.
5 Enter the QC sample number or * to exclude the entire range
displayed.
6 Click the test to be excluded and then click Ed it R e su l t ( F 5 ).
7 Check the F la g box and enter the d flag.
8 Click C l o s e and then E x i t ( F 2 ) twice to return to the main
window.
CAUTION
To prevent
Editing Analysis Results
misdiagnosis This system allows users to directly edit all analysis results produced,
due to in the following ways:
inappropriate
editing of • Editing Results by Sample Number. See page 141.
results, editing of data
should be performed only by • Editing Results by Test Number. See page 142.
an appropriately qualified
and authorized person. • Correcting Analysis Results. See page 143.
For this reason it is
recommended that the Data • Recalculating Analysis Results. See page 143.
Edit function is secured by
use of password protection.

Editing Results by Sample Number
To edit analysis results by sample number:
1 Select Routine>Data Management>Data Edit.
3 Select the sample type you want to edit by checking one of the
check boxes on the left of the D a t a E d i t window.
4 Enter the range of sample numbers or sample IDs you want
to retrieve.
5 Click V i e w D a t a ( F 5 ) .
6 Highlight a result and click E d i t R e s u l t ( F 5 ) .
7 Edit the result data, as shown in Figure 6-13 on page 141,
and click C l o s e .
8 Click E x i t ( F 2 ) to save the changes.
Figure 6-13: Editing Results

Editing Results by Test Number
To edit analysis results by test number:
1 Select Routine>Data Management>Data Edit.
3 Select the sample type you want to edit by checking one of the
check boxes on the left of the D a t a E d i t window.
4 Click T e st N o . ( F 8 ) or select the test name from the
T e s t N a m e drop-down list.
5 Click V ie w D a t a ( F 5 ) .
6 Highlight a result and click E d i t R e s u lt ( F 5 ) .
7 Edit the result data, as shown in Figure 6-14 on page 142, and
click C l o s e .
8 To view reagent lot and bottle numbers click R e a g e n t I N F
and click C l o s e when finished.
9 Click E x i t ( F 2 ) once to save the changes and again to return
to the main window.
Figure 6-14: Editing Results By Test Number

Correcting Analysis Results
To correct analysis results:
1 Select Routine>Data Management>Data Correction. TIP
2 Select the type of sample data you want to correct by checking one
You can
of the boxes on the left of the D a t a C o r r e c t i o n window.
correct
3 Enter the sample number range or the sample ID range of the data analysis
you want to correct. results
according to
4 Click T e s t N o . ( F 8 ) or select the test name from the T e s t a coefficient
N a m e drop-down list. included in the calibration
5 Click C o r r e c t D a t a ( F 5 ). formula. A "c" is appended to
the corrected value,
6 Enter the correction factors A and B and click Y E S to save the indicating an abnormal data
correction factors. Enter factors A and B for the following formula symbol.
(each number must be between -9999999 and +9999999):
• Y (data after correction)=AX (data before correction)+B TIP

7 Click O k to exit this window. You can
8 Click E x i t ( F 2 ) to return to the main window. modify the
data saved
as OD value
by
Recalculating Analysis Results performing
re-calculation.
You can recalculate concentration values based on the stored Any data already saved as a
concentration value cannot
absorbance values. The existing analysis data is overwritten by the data
be modified.
after recalculation.
The recalculation function allows test results to be recalculated, using
the most current calibration data, i.e. if test results are produced from a TIP
poor or incorrect calibration, the test can be recalibrated and the sample
Only results
results recalculated without the need for reanalysis. in the current
To recalculate analysis results: index can be
recalculated.
1 Select Routine>Data Management>Data Correction.
2 Select the type of sample data you want to recalculate by checking
one of the boxes on the left of the Data Correction window.
3 Enter the sample number range or the sample ID range of the data
you want to recalculate.
4 Click T e s t N o . ( F 8 ).
5 Enter the test number to be corrected on the S e l e c t T e s t
N o . window.
6 Click R e c a l D a t a ( F 5 ) . Results are recalculated based
on the current calibration for that test. The last sample number
recalculated is displayed when finished.
7 Click O k to exit this window.

Printing Analysis
Result Data
You can print results in two formats:
• Printing Reports. See page 144.
• Printing Data Lists. See page 145.
TIP
Printing Reports
A report
format must To print edited or corrected data as a report:
be selected
before 1 Select Routine>Data Report>Report.
results are 2 Select the index from the I n d e x drop-down list.
printed. A
report format can be created 3 Select the type of sample data you want to print by checking
by selecting Parameter> one of the check boxes on the left of the R e p o r t window.
Format>Report Format.
4 Enter the sample number or sample ID range that you want
to print.
5 Select the Printer Report format from the R e p o r t N o .
drop-down list at the bottom of the window.
6 Click P r i n t ( F 3 ).
7 Click O k to start printing.
8 When printing is finished, click E x i t ( F 2 ) to return to the
main window.

Printing Data Lists TIP
To print test result data as a data list: A data list
format must
1 Select Routine>Data Report>Data List.
be selected
2 Click the P a t i e n t or Q C / C a l tabs according to whether you before
would like to print a data list of Reagent Blank, Calibrator, QC or results are
Patient Data, as shown in Figure 6-15. printed.
A data list can be created by
selecting Parameters>
Format>List Format.
Figure 6-15: Printing Data Lists
3 Select the data index from the I n d e x drop-down list.

4 Select the type of data to be sent by checking the check boxes and
entering either the sample number or range of sample numbers or
the sample ID or range of IDs (barcodes).
5 Select the data list format from the D a t a Li st N o . drop-down
list at the bottom of the window.
6 Click P r i n t ( F 3 ) .
7 Click O k to start printing.
8 When printing is finished, click E x i t ( F 2 ) to return to the main
window.
Resuming Printing when Printer Errors Occur in Measure Mode

1 Select System Status>DPR Status.
2 Click P r i n t e r C o n t r o l ( F 4 ).
3 Read the error message and take corrective action.
4 Click R e s u m e P r i n t i n g on the dialogue that appears.

TIP Resending Data to a Host
The time To resend result data to another computer:
taken to
1 Select Routine>Data Report>Online.
send data
to another 2 Select the data index from the I n d e x drop-down list.
computer
depends on
3 Select the type of data to be sent by checking the check boxes
the volume of data to be and entering either the sample number or range of sample
transferred. Data transfer numbers or the sample ID or range of IDs (barcodes).
might therefore be time 4 Click D a t a T r a n s f e r .
consuming.
TIP Saving Information to

The floppy a Floppy Disk
disks also
termed You should back up parameters and data regularly, following the
3.5 inch following procedures:
diskettes
should be • Initialising a Floppy Disk. See page 146.
2HD or 2DD and with enough
space for the data you wish • Saving Parameters to a Floppy Disk (3.5" Diskette).
to store. See page 147.
• Loading Parameters onto the System from a Floppy Disk.

See page 148.
• Saving Test Result Data to a Floppy Disk. See page 148.
Initialising a Floppy Disk

CAUTION
If you are using a new disk, you must initialise it as either a parameters
For information
disk or a data disk before attempting to save parameters or data onto it.
about
precautions when To initialise a floppy disk:
using a floppy
disk, refer to 1 Select Maintenance>Data operation>FD Data Management>
Using a Floppy Disk in FD Data Initialize.
Chapter 2. 2 Select I n i t i a l i s e P a r a m e t e r F D for a parameters disk
and I n i t i a l i s e D a t a F D for a data disk.
3 Insert the Floppy disk into the floppy disk drive.

4 Click S t a r t In i t i a l i s e ( F 5 ) , as shown in Figure 6-16 on
page 147.
5 Select Y e s on the Insert Floppy Disk start dialogue.
Figure 6-16: Initialising a Floppy Disk
TIP
Saving Parameters to a Floppy Disk Remember

to keep
(3.5" Diskette) parameter
and data
1 Ensure the disk you are using is initialised (see “Initialising a disks in a
Floppy Disk” on page 146) and select Auxiliary>Parameters safe place
Management. and away from magnetic fields
2 Select S a v e f i l e s t o F l o p p y D i s k . (e.g. sample racks).
3 Highlight one or more of the files in the F i l e column.

4 Put the disk into the floppy disk drive.
5 Click E x e c u t e ( F 5 ), as shown in Figure 6-17 on page 148.
6 Select Y e s on the Insert Floppy Disk Start prompt.
7 When data is loaded click E x i t ( F 2 ) to return to the
main window.

Figure 6-17: Saving Parameters to Disk
CAUTION Loading Parameters onto the System from

a Floppy Disk
Copying files to
the computer’s To load parameters from a floppy disk:
hard drive from
a floppy disk 1 Select Auxiliary>Parameters Management.
overwrite
2 Select L o a d f i l e s f r o m F l o p p y D is k .
existing files of the same
name already stored on the 3 Highlight one or more of the files in the F ile column.
computer.
4 Put the disk into the floppy disk drive.
5 Click E x e c u t e ( F 5 ) .
6 Select Y e s on the Insert Floppy Disk Start prompt.
7 When data is loaded click E x i t ( F 2 ) to return to the
main window.
Saving Test Result Data to a Floppy Disk

A similar 3.5” diskette can be used to back up test data. This disk should
be initialised as a data disk.
TIP
To save test result data to a floppy disk:
If your floppy
disk is 1 Select Maintenance>Data Operation>FD Data Initialise.
already
2 Select I n i t i a l i s e D a t a F D .
initialised as
a data disk, 3 Put the floppy disk into the floppy disk drive.
steps 1 to 4
4 Click S t a r t I n i t i a l i s e ( F 5 ) .
can be omitted.
5 Select Maintenance>Data Operation>FD Data Management.

6 In the F D D a t a S a v e tab, select the I n d e x to be saved.
7 Select the sample type.
8 Enter the range of sample numbers to save, or save the entire
range by entering an asterisk * . The samples can also be
saved by entering a range of sample ID numbers from the
Sample ID field.
9 Click S a v e D a t a ( F 5 ).
10 Click E x i t ( F 2 ) to return to the main window when the data
is saved.
Performing a Manual
Sample Dilution
To conduct a fully manual repeat test, dilute the sample and re-request
it by entering the dilution factor in the test requisition window. The system
then calculates the result, using the dilution factor.
Performing a Repeat Run

You can perform a repeat run in two ways:
WARNING
• Performing an Auto-Repeat Run. See page 150.
When a sample
• Performing a Manual Repeat Run. See page 152. requires auto-
repeat, the rack
These can be summarised as follows: is re-fed into the
system. The
• Automatic: Analysis is repeated in line with parameters system only monitors the
automatically read from the repeat run data file and run rack ID and the samples
automatically from the white rack. position within that rack.
Do not use another rack
• Manual: Analysis is repeated manually by the user from a print- with the same ID.
out of the repeat run data file termed the Repeat Run Work List. Do not replace the sample
Samples can be re-run on an orange rack or from the STAT table (selected for repeat-run) in
in a designated re-run position. the original rack. Failure to
observe this instruction will
For more information, see “Programming Repeat Tests” on page 77. cause data transposition
The method used to perform Repeat Run analysis is set in parameters. and incorrect results.
To change this setting:
As an additional security
1 Select Parameter>System>System. measure, do not use the
2 Go to the A u t o / S t a n d a r d R e p e a t drop-down list. repeat data overwrite
option.
3 Select A u t o or S t a n d a r d , as shown in Figure 6-18 on
page 150.

4 Click E x i t ( F 2 ) to save the setting.
Figure 6-18: Setting a Repeat Run
Performing an Auto-Repeat Run

You can set the system to repeat a run with the following procedures:
• Setting the Repeat Data Overwrite. See page 150.
• Verifying Repeat Data. See page 151.
CAUTION Setting the Repeat Data Overwrite

Ensure that When a sample is automatically re-run, samples are sent back onto the
there is no rack feeder, re-analysed and then the original result is overwritten by
duplication of the new measurement if you have selected the overwrite setting.
rack IDs. The
You can, however, manually choose the sample data you want to
system cannot
distinguish a new rack on overwrite. This requires the Repeat Data Overwrite setting to be
the feeder from a repeat run unchecked.
rack if they have the same
rack ID.

To uncheck this setting:
1 Select Parameter>Repeat Parameters>Repeat Common.
2 Uncheck the R e p e a t D a t a O v e r w r i t e check box, as
With this setting unchecked, you must verify the sample data each time
you perform an automatic repeat run.
CAUTION
Do not select
the following
flags:
R, #, ?, U, u, Y,
y, % as they
command an operator
action
Figure 6-19: Setting Data to Over-write
Verifying Repeat Data

To verify repeat data:
1 Select Routine>Data Management>Repeat Data Verification.
TIP
2 Select the I n d e x and T e st N a m e from the drop-down lists.
Results
3 Select the S a m p l e T y p e by checking one of the boxes on
overwritten
the left. by repeat
4 Enter the Range of Sample No.s you want to run again. results are
flagged with
5 Click V i e w D a t a ( F 5 ) . an S flag.
6 Select the repeat sample(s) from the list that appears by clicking it.
7 Click E x e c u t e R e w r i t e ( F 5 ) .
8 Click E x i t ( F 2 ) to close this window and then click E x i t

TIP
Performing a Manual Repeat Run
Remember Performing a manual repeat run involves three procedures:
to use the
orange rack • Printing and Checking the Repeat Run Work List. See page 152.
for manual
Repeat
• Entering a Requisition for Repeat Run Analysis (Optional).
Runs. See page 152.
• Reloading Samples. See page 152.
Printing and Checking the Repeat Run Work List

1 Select Routine>Test Requisition>Repeat.
CAUTION
2 Click P r i n t ( F 3 ).
When using the
STAT table to 3 Select the sample type by checking one of the check boxes on
process repeat the left.
run samples, 4 Enter the range of sample numbers and sample IDs.
do not place
these in positions designed 5 Select the number from the R e p e a t W o r k L i s t N o .
for calibration or QC drop-down list.
samples.
6 Click O k to begin printing.
Contact Beckman Coulter
Support for assistance
preprogramming the STAT Entering a Requisition for Repeat Run Analysis (Optional)
table.
1 Select Routine>Test Requisition>Repeat.
2 Enter the S a m p l e N o . that must be tested again.
3 Select the S a m p l e T y p e by checking one of the check boxes
TIP on the left.
4 Click S t a r t E n t r y ( F 4 ).
If you do not
want the 5 Select the test or tests to be run again and click S t a r t E n t r y
original ( F 4 ) again. Repeat this procedure for each sample you want to
analysis test again.
data to be
overwritten, uncheck the 6 Click S TA T R e p e a t ( F 6 ), if the repeat run is to be done
Repeat Data using the STAT table.
O v e r w r it e box in 7 Click E x i t ( F 2 ) to return to the main window.
P a r a m e t e r s and
then verify the repeat data
each time you perform a Reloading Samples
repeat-run analysis. There are two ways of reloading samples:
• The Orange Rack: Load the samples indicated on the work list
onto the orange rack and place it in the feeder. Then start
analysis.
• The STAT table:
a Load the sample indicated on the work list onto the STAT
table in a designated rerun position.
TIP b If the samples are barcoded, they can be placed in any order
The order in these positions.
of samples c Press the S T A T button.
is only d When the End Led comes on, the STAT table can be rotated,
important using the R ot a t io n button.
if you are e Place the sample to be repeated in a rerun position.
operating in sequential
f Press the S T A T button again to start analysis.
mode. If you are operating
in barcode mode, order is not
necessary.

Processing Emergency
Samples
There are two methods of processing emergency samples:
CAUTION
• Using the STAT Table for Processing Emergency Samples.
Running the
See page 153.
STAT table in
Sequential
• Using the Red Rack for Emergency Sample Analysis.
mode (i.e.
See page 155.
without reading
sample barcode ID) is not
recommended due to the
possibility of sample/result
Using the STAT Table for Processing mismatch. If you must run
Emergency Samples without sample barcode ID,
please ensure that you are
This method is used to process one sample or a small number of aware of the pitfalls. Contact
samples, under different conditions: your Beckman Coulter
Technical Representative.
• If QC and Calibration Are Not Performed Using the STAT Table
and the System is in Standby Mode. See page 153.
• If the System is in Measure Mode. See page 154.
• If Auto-QC and Calibration are Performed Using the STAT Table.

See page 154.
• Processing a Barcoded Emergency Sample Using the STAT

Table. See page 155.
If QC and Calibration Are Not Performed Using the STAT Table and CAUTION
the System is in Standby Mode
To ensure that
1 Select Routine>Test Requisition>Normal. the STAT table
2 Enter the emergency sample number in p*** (offline mode only). maintains a low
temperature,
3 Click S t a r t E n t r y ( F 4 ) . only remove
4 Enter the sample ID, sex and age. the STAT table lid when
absolutely necessary and
5 Select the test from the list (or click P r o f i l e if it is replace it as quickly as
preprogrammed) and click E n t r y ( F 4 ) to save the settings for possible.
this sample. Repeat this procedure for all the emergency samples
you want to process.
6 Remove the STAT table lid and rotate the STAT table by pressing
TIP
the S T A T R O T A T I O N / D I A G switch to check for the
presence of possible tubes or cups. If so, remove them and place You can
the emergency sample cup or tube in an appropriate position on monitor the
the STAT table, as shown in Figure 6-20 on page 154. action by
selecting
7 Close the STAT table lid. System
8 Press the S T A T t e s t switch to start analysis. Status>STAT table.
White indicates that the cup
9 If the sample is successfully tested, the END LED turns on. This is is detected.
an indication that you can remove the sample and replace the Yellow indicates that
STAT table lid. dispensing is taking place.
Blue indicates that
dispensing is complete.
Red indicates that
dispensing has not taken
place.

STAT table
cover (small)
Sample cup
STAT table 22
1 2
3
END LED
4
21
U-H U-L
5
STAT test
20
S-L
K-
SE
6
L-
Na
19
7
S-H
switch
18
8
17
W1
9
CLEA
16
N
W2 10
15
11
14
13 12
S
T
A
T
E
N
S
D
T
A
T
S
E
T
IS
E
P
R
T
IM
E
ON STAT ROTATION/
FR DIAG switch SET LED
Figure 6-20: Placing an Emergency Sample on the STAT Table
If the System is in Measure Mode

TIP 1 Select Routine>Test Requisition>Normal.
It might take 2 Enter the emergency sample number in p*** (offline mode only).
up to 60
seconds for 3 Click S t a r t E n t r y ( F 4 ).
the SET 4 Enter the sample ID, sex and age.
LED light to
come on when you press the 5 Select the test from the list and click E n t r y ( F 4 ) to save the
STAT inspection switch. settings (or profile, if set up) for this sample. Repeat this procedure
for all the emergency samples you want to process.
6 Press the S T A T switch once.
7 Remove the STAT table lid, rotate the STAT table by pressing the
S T A T R O T A T I O N / D I A G switch to check the presence
of possible tubes or cups. If so, remove them. After that, place the
Emergency sample cup or tube on the STAT table in an
appropriate position.
8 Close the STAT table lid.
9 Press the S T A T t e s t switch to start analysis.
10 If the sample is successfully tested, the END LED turns on. This is
an indication that you can remove the sample and close the STAT
table lid.
CAUTION
If Auto-QC and Calibration are Performed Using the STAT Table
High humidity
If Auto-QC and calibration are performed using the STAT table, it is
and high
temperatures programmed to rotate automatically. You must change this setting
might give rise before using the STAT table to analyse emergency samples.
to To do this:
condensation on the sample
cups and on the STAT table. 1 Select Routine>Test Requisition>Normal.
This should always be 2 Enter the emergency sample number in p*** (offline mode only).
removed immediately, using
a dry paper towel. 3 Click S t a r t E n t r y ( F 4 ).
4 Enter the sample ID, sex and age.
5 Select the test (or profile, if set up) from the list and click E n t r y
( F 4 ) to save the settings for this sample. Repeat this procedure
for all the emergency samples you want to process.

6 Press the S T A T t e s t switch to prevent the STAT table from
rotating automatically. The S E T L E D light should flash for a few CAUTION
moments and then stay on. This is an indication that you can
Do not touch
remove the STAT table lid. the STAT table
7 Remove the STAT table lid, rotate the STAT table by pressing the while the SET
S T A T R O T A T IO N / D I A G switch to check the presence LED is still off
of possible tubes or cups. If so, remove them. After that, place the as this might
affects the aspiration of
Emergency sample cup or tube on the STAT table in an
samples already in process.
appropriate position. Remove samples immediately following
measurement.
8 Close the STAT table lid.
CAUTION
9 Press the S T A T t e s t switch to start analysis.
Do not place
10 If the sample is successfully tested, the E N D L E D lights. Press barcoded
the S T A T switch again to request access to the S T A T table. sample cups
11 When the S E T L E D is lit, use the S T A T R O T A T IO N / in the inner
D I A G button to rotate the sample to a position from which it can positions on the
STAT table. This might
be removed. Remove the sample and close the S T A T table lid.
cause read errors.
Processing a Barcoded Emergency Sample Using the STAT Table

When processing emergency samples, remember: TIP
• Place the sample cup in the outer positions. It is only

necessary to
• The barcodes must face out. use the red
rack for
• Barcodes should be well fixed to sample cups. The order in which emergency
samples are arranged when using barcode mode is not samples if running in
important. sequential mode (i.e. without
barcodes). Many users who
run samples barcoded
use the red rack for the
Using the Red Rack for Emergency Sample processing of small
(e.g. paediatric) samples as
Analysis sample dead volume can be
reduced. Contact Beckman
The red rack is used to process large quantities of emergency samples. Coulter for further
White sample racks placed ahead of emergency racks on the rack
feeder are however always processed first. If samples need to be
analysed immediately, therefore, the STAT table must be used. CAUTION
To process an emergency sample using the red rack: Be careful
1 Press F e e d e r S t o p . when pressing
Feeder Stop in
2 Click Y e s on the F e e d e r S t o p window and press R e t u r n. Auto Re-run
3 When the feeder has stopped, go to the main window and select mode. As the
Routine>Test Requisition>Normal. feeder is stopped, samples
that have to be rerun are not
4 Enter the emergency sample number in e * * * (in offline mode processed until Start is
only) and click S t a r t E n t r y. pressed again.
5 Enter the sample ID, sex and age.
6 Select the test (or a profile, if set up) and click E n t ry ( F 4 ) .
7 Repeat this procedure for each emergency sample.
8 Place the samples in a red rack in the correct order and place the
rack on the feeder.
9 Click S t a r t A n a l y s i s on the main window.

CAUTION Pausing Analysis
Do not leave Unlike Emergency stop which stops the system within a number of
the system in seconds, pausing tells the system to stop and standby after the current
Pause mode for test. This might be required to add reagent, for example.
a long period of To pause analysis:
time. The
nature of samples might be 1 Press P a u s e on the keyboard or on the
affected by the environment window.
if left standing for a longer
2 Select Y e s on the Pause window and then
period of time. This in turn
might affect the analysis R e t u r n. When the system is finished
results. analysing the sample it was processing when pause was selected,
Do not remove the sample the system pauses.
rack under analysis when
the system is paused or any
of the samples in that rack.
Stopping the Rack Feeder

To stop the rack feeder:
1 Press F e e d e r S t o p on the keyboard or on the window.
2 Select Y e s on the Feeder Stop window and press R e t u r n.
The rack feeder finishes feeding any racks being fed when Feeder
Stop was selected and then stops.
3 Restart analysis by clicking S t a rt on the
main window.
Stopping the System

WARNING
To stop the system:
If running in auto-
repeat mode, all 1 Press S t o p / S t a n d b y on the keyboard or click on the
racks/samples window.
removed must be 2 Select Y e s on the Stop window.
reloaded back
onto the system in order 3 When the display mode on the main window reads S t o p,
that any outstanding repeat remove the racks from the feeder.
requests are completed.
4 Press S t o p / S t a n d b y on the
keyboard again or click the on-window
S t o p button again.
5 Select Y e s on the S t a n d b y /
W a r m - u p window. The system takes a few moments to
initialise. The display mode should now read S t a n d b y .

Shutting Down the
System
The system can only be shut down by pressing End Process on the
keyboard if no software windows are open. CAUTION
To shut down the system:
The main
1 Press E n d P r o c e s s on your keyboard. power switch
(on the back of
2 Click S e t ( S ) and then A u t o O N if you want the system to
the system)
start again automatically at a specific time and date (if a time and
should not be
date are entered. See “Entering Auto Power-On Parameters” on turned off when analysis is
page 176). finished.
3 Enter the time and date.
4 Click Y e s w i t h A u t o P r e p a r a t i o n if you want to include
this in the auto start-up.
5 Click E n d ( E) to save the auto start-up settings.
6 Click P o w e r O ff Y e s to shut down the computer operating
system and the system sub-power, as shown in Figure 6-21.
TIP
To set
Auto
Prepar-
Figure 6-21: Power Off ation,
please
7 You can restart the system at any time by pressing the green contact your
P o w e r - O n switch on the right side of the front of the system. Beckman Coulter
Representative.

Performing an
CAUTION Emergency Stop
If an analysis Emergency Stop cuts off power and should only be used in extreme
process is emergencies such as spillage inside or on top of any part of the system.
interrupted by
an emergency To perform an emergency stop:
stop, you must 1 Press the E M S T O P button on the front of the system.
restart the analysis from
scratch. Do not use analysis 2 This shuts down the entire system
data produced up to the instantly.
point of an emergency stop.
3 You then have to reset the system to
continue analysis. See “Recovering Data
WARNING after an Emergency Stop” on page 158.
Emergency Stop
may cause
damage to the
hard disk and so
should be used
only in an emergency Restarting the System
situation.
There are two considerations when restarting:
• Recovering Data after an Emergency Stop. See page 158.

CAUTION
A Wash 1 should
• Bypassing Warm-up Mode. See page 159.
always be
performed
following an
emergency stop.
Recovering Data after an Emergency Stop
When the system resets you can recover the data produced up to the
time of emergency stop. It is recommended however that you start
analysis again and overwrite the original test data.
To recover data:
1 Press R e s e t . This is a white button on
the front of the system. See diagram.
2 Press P o w e r - O n. You hear the
system coming on.
3 When the system has re-initialised,
select Maintenance>Data Operation>Retrieve Database.
4 Select the index file to be rebuilt and click E x e c u t e ( F 5 ) .
5 Select Y e s on the rebuilding window and press R e t u r n to
recover the analysis data produced prior to emergency stop.

Bypassing Warm-up Mode
When restarting the system, the Standby Set option can be used to
override the Warm-up mode. If you go to Standby mode, before Warm-
up is complete, optimum system performance cannot be guaranteed
because the system temperature might not have reached the optimum.
To go to Standby mode from Warm-up.
1 Select Auxiliary>Standby Set.
2 Click Y e s to bypass Warm-up mode.
Turning On and Off the

Sample Barcode Reader
To turn off the sample barcode reader:
1 Select Parameter>System>System.
2 Click S e t ( F 4 ) .
3 To turn off the barcode reader, select S e q u e n t i a l or
R a c k N o . from the drop-down menu of the routine,
emergency, or STAT field.
4 To turn the barcode reader back on, select B a r c o d e from
the drop-down list.

Additional
Tasks
Introduction
This chapter describes tasks that can be performed as needed:
• Additional Programming Tasks. See page 161.
• Setting Up Printers. See page 168.
• Entering Login Names and Allocating Levels of Access.

See page 170.
• Setting General Parameters. See page 173.
• Viewing Statistics. See page 179.
• Offline Output. See page 186.
Additional Programming
Tasks
You can set the following configuration parameters as needed:
• Setting an LIH Test (serum quality index for estimation of lipemia,

icterus and hemolysis). See page 162.
• Setting a Test Channel as a Calculated Test Channel.

See page 163.
• Programming Calculated Tests. See page 164.
• Checked Tests. See page 165.
• Entering Sample Blank Parameters. See page 166.
• Entering Online Settings. See page 167.
AU400 User Guide Version 2.11 Additional Tasks 161

Setting an LIH Test (serum quality index for
estimation of lipemia, icterus and hemolysis)
Before the LIH level can be determined, you must enter the OD limits
for each level that generate flags. Select samples that represent the
five cut-off levels of each interferant; lipemia, icterus (bilirubin) and
hemolysis.
To set an LIH test:
1 Select Parameter>Common Test Parameters>Round.
2 Click LIH test 96 to include it in the round.
4 Click the L I H tab, as shown in Figure 7-1.
TIP
0.9% Saline
solution
should be
used as R1
in a fixed
position
when you are performing the
LIH test.
Figure 7-1: Setting LIH
6 If the LIH reagent test number is set to 96, enter the following
parameters on the window (this is only an example, do not use
these numbers. Contact your Beckman Coulter
Representative for more information).
• Sample Volume: 2 to 50 µl
• Sample diluent: 0 (do not use 10 µl)
• Reagent 1 volume: 25 to 300 µl
• Reagent 1 diluent: 0 or 10 to 250 µl
• on-board stability period: Number of days can be set from
1 to 999.
162 Additional Tasks AU400 User Guide Version AC

7 Define OD limits for each LIH flag level. +,++,+++,++++,+++++.
The OD limit for each subsequent level should be higher than the
previous limit. The range available is 0.0000 to 2.0000. The LIH
flag is the upper OD limit or maximum value that applies to that flag
level. The flag is applied to samples with reaction ODs greater than
the OD limit specified for the next lower level, but less than or
equal to the OD limit specified for the printed flag for lipemia,
icterus, or hemolysis. For example, if the values in Figure 7.1 were
used, a sample with a lipemia reaction OD of 0.0450 would be
flagged LIP++, an icterus reaction OD of 0.0100 would be flagged
ICT N and a hemolysis reaction OD of 0.0500 would be flagged
HEM N.
Setting a Test Channel as a Calculated

Test Channel
You must set a test channel as a calculated test channel before
a calculation can be programmed.
To do this:
1 Select Parameter>Common Test Parameters>Test Name>
Calculated Tests.
2 Click S e t ( F 4 ) .
Figure 7-2: Setting a Calculated Test Channel
AU400 User Guide Version AC Additional Tasks 163

3 Click the test number into which the calculated test is to be
programmed. The selected test should be in red, as shown in
Figure 7-2.
4 Click the T e s t N a m e tab.
5 Click the T e s t N u m b e r of the calculated test.
6 Click E d i t ( F 5 ) and name the calculated test, using no more
than 5 characters.
7 Click C l o s e and then E x i t twice to return to the main window.
Programming Calculated Tests

Calculated tests are used to enter test names and set up equations for
calculated tests.
To program calculated tests:
1 Select Parameter>Inter-related Tests>Calculated Tests.
2 Select the name from the C a l c u l a t e d T e s t N a m e
drop-down list.
5 Up to five tests can be assigned to the calculation. Select test
names from the drop-down lists, A to E, as shown in Figure 7-3.
6 Use the calculated test numbers “A” to “E” you have entered and
TIP the coefficients “a” to “d” to define a calculation formula. The
following symbols and alphanumeric characters can be used: +, -,
A *, /, (, ), A, B, C, D, E, a, b, c, d. “/” indicates division and “*”
calculation indicates multiplication. In the example on the window here, the
formula can calculated test is %HBA1c. A=HBA1c; B=THB; a=100; Calc.
use a formula=(A/B)*a.
maximum
of five tests. 7 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
Figure 7-3: Programming Calculated Tests

Checked Tests
If a calculation formula and its associated coefficients are set in
advance across multiple analysis items, it is possible to check whether
the results fall within a predetermined range. It is also possible to
append error flag T to those analysis result data used in the calculation
if the calculated result falls outside the predetermined range.
To enter these parameters:
1 Select Parameter>Inter-related tests>Checked Tests.
2 Select the name from the I n t e r - c h e ck T e s t N a m e
drop-down list. You can also select one using the arrow buttons.
3 Select the sample type from the T y p e drop-down list and click
Set (F4).
4 Enter the C h e c k N a m e by first checking the box, as shown
in Figure 7-4. Then enter the name, using not more than eight
characters.
5 Set analysis tests subject to calculation. Up to five tests can be
assigned to the checked analysis tests. Select test names from the
drop-down lists A to E. Test numbers of analysis tests that do not
have a test name cannot be entered.
Figure 7-4: Adding a Checked Test
6 Select the constants (coefficients) of a calculation formula for inter-

test calculation from the drop-down list. Four different constants
(coefficients) from “a” to “d” can be set, using a numerical value
between -9999999 and 9999999.

7 Use the calculated test numbers “A” to “E” you have entered
and the coefficients “a” to “d” to define a calculation formula.
The following symbols and alphanumeric characters can be used:
+, -, *, /, (, ), A, B, C, D, E, a, b, c, d. “/” indicates division and “*”
indicates multiplication. For example, specify a formula such as
AST/ALT using AST and ALT. A calculation formula can use a
maximum of four tests.
8 In the Check Range field, enter the upper limit and the lower limit
of the normal value range of the inter-test check. Specify a
numerical value between -9999999 and 9999999. Decimal points
can be used.
9 Enter the upper and lower limit of the range and click D e c i m a l
P l a c e s to set the number of decimal places allowed.
10 Click O K to save the change.
11 Click E x i t ( F 2 ) twice to return to the main window.
Entering Sample Blank Parameters

Sample blank correction is performed to remove noise from the
measurements. To calculate this correction, a colour test and a
blank test combination (measured in two separate cuvettes) is used.
A multiplier is then applied to the Optical Density value of Y (obtained
from the Y=X-B formula, where X is the OD value of the colour test and
TIP B is that of the blank test).
You can enter up to ten sample blank correction factors. To perform a
You cannot
select a
sample blank, the colour test items and the blank test items must be first
colour test selected here. The blank test is for Beckman Coulter Total Bilirubin/
or a blank Direct Bilirubin only (at time of print) and is used to compensate for the
test if none colour of the serum or plasma.
are entered
To enter sample blank parameters:
in P a r a m e t e r s .
The colour test and blank 1 Select Parameters>Inter-related Tests>Sample Blank.
test are programmed under
separate test numbers. See
reagent Settings Sheet for 3 Select the colour test from each C o l o u r T e s t drop-down list
more information. and select the blank test from each B l a n k T e s t drop-down
list, as shown in Figure 7-5.

Figure 7-5: Entering Sample Blank Parameters
Entering Online Settings

Online settings determine:
• The way information is transferred between a host computer and

the system’s computer. The options you can choose from are TIP
r e a l - t i m e, b a t c h or n o n e .
Contact
• The type of sample and the tests to be transferred. Beckman
Coulter
• OnlineWhether the transfer of analysis data is to be concurrent Support for
with system operation and online communication settings. further
information
To enter online parameters: when configuring online
communication.
1 Select Parameter>Online.
2 Click S e t ( F 4 ) .
3 Set T e st R e q u i s i t i o n I n f o r m a t i o n R e c e iv e
parameters by choosing one of the three methods of receiving
information from the host computer from each of the drop-down
lists, as shown in Figure 7-6. CAUTION
4 Set R e s u lt s T r a n s f e r parameters by similarly choosing
If the Auto-
one of the three methods of sending information to the host
Repeat function
computer from each of the drop-down lists. is used, the fields
Routine
Repeat,
Emergency Repeat and
STAT Repeat in the Test
Requisition Information
Receive section must be set
to N o n e . The same fields
in the Results Transfer
section do not have to be set
to N o n e .

Figure 7-6: Entering Online Settings
TIP 5 Click the P r o t o c o l tab.
The Online 6 Click S e t ( F 4 ) and select settings from the drop-down lists.
Test 7 Click the T e s t N o . tab.
Number is
the number 8 Select the test and click E d i t ( F 5 ). Then enter the online test
used in number and click C l o s e ( F 2 ). Repeat this procedure for each
online test number you wish to enter.
communications to identify
each test. This must match
host computer settings.
Setting Up Printers
You can configure printers in the following ways:
• Entering Printer Parameters. See page 169.
• Printing Batch Reports. See page 169.
• Adding a Second Printer to the System. See page 170.

Entering Printer Parameters TIP
To enter printer parameters: Report
Parameters
1 Select Parameters>Format>Printer.
can be set
2 Click S e t ( F 4 ) . by going to
Parameter>
3 To enable the printer, check the P r i n t e r U s e check box. You Format>
can only enter the other settings (except Real-time Report) on this Report Format.
page when this option is checked.
4 Decide which type of output you would like to be available by
checking the L i s t s or B a t ch R e p o r t boxes, or both. TIP
5 Select the R e a l - t i m e P r i n t option from the drop-down list. Check each

The options you can choose from are: box to print
the
• N o R e a l - t i m e p r i n t : Choosing this means that following in
analysis results are not printed as they are produced. real-time:
QC
• Real-time r e p o r t : This prints results in report format as Reagent Blank
they are produced. If you choose this option, you must then Calibration
choose a report format from the R e a l- t im e R e p o r t drop-
down list.
• D a t a L o g Li s t : This is real-time result printing. A data log
is printed as data is produced.
to return to the main window. TIP
Report
options must
Printing Batch Reports be set in
Parameter>
1 Select Parameter>Format>Printer. Format>
Report Format.
2 Ensure the B a t c h R e p or t check box is checked.
3 Ensure D a t a L o g Li st is selected from the Real-time
print field.
4 When analysis is complete, select Routine>Data Report>Report.
6 Enter the range of sample numbers or range of sample IDs
(barcodes) to print.
7 You can filter the data that appear on the report by clicking A d v .
S e a r c h ( F 5 ) and choosing a sex, age, range and report
operator. TIP
8 Ensure A l l T e s t s is selected from the Output Test drop-down You can click
list. Then click Y e s. List
9 Select the report format from the R e p o r t N o . drop-down list. Pending
( F 6 ) to
10 Click P r i n t ( F 3 ) and then click Ok to start printing. print a list of
samples that
are not yet printed on any
report.

Adding a Second Printer to the System
1 Select Parameters>System>Option.
3 Select Y e s from the S e c o n d P r i n t e r drop-down list.
4 Click E x i t ( F 2 ) twice to save this setting and close this
window.
TIP
5 Select Parameters>Format>Printer.
Ensure the 6 Click S e c o n d P r i n t e r ( F 5 ).
printer
power lead 7 Select the second printer.
is plugged 8 Click E x i t ( F 2 ) once to save this new setting and once again
in properly
and the
printer cable is connected to
the back of the computer.
Software printer drivers that
allow the computer to
interact with the printer
should be supplied with the
printer on a CD. These
Entering Login Names
should be also installed
before you add the printer to
and Allocating Levels of
the system. Contact
Beckman Coulter for further
Access
information. Only authorised users should be allowed to use this system. To prevent
unauthorised personnel from using the system, logging in should be
enabled and each authorised user assigned a login name and
password. You should also assign a level of access to each authorised
user. Only one user should have access to the parameters menus,
for example. Maximum security level is 1 and minimum is 10. A
maximum of 30 login names and levels of access can be added.
• Adding a Login Name. See page 170.
• Editing a Login Name. See page 171.
• Deleting a Login Name. See page 171.
• Changing a Password.. See page 171.
• Creating a User Menu. See page 171.
Adding a Login Name

TIP To add login names:
You cannot 1 Select Parameter>System>Login Name.
actually
2 Check the L o g i n F u n c t i o n check box. Logging in is
check the
login enabled following the next system shut-down and restart.
Function This means that each user must login before being able to use the
box until at system.
least one login name and 3 Click E d i t ( F 5 ) .
password is entered.
4 Enter the Login name (ten characters maximum).
5 Enter the password (ten characters maximum).

6 Enter that password again in the C o n f i r m field.
7 Enter the menu level between 1 and 10.
Editing a Login Name

To edit a login name:
1 Select Parameters>System>Login Name.
3 Make changes.
Deleting a Login Name

To delete a login name:
1 Select Parameter>System>Login Name.
2 Highlight a login name and click D e le t e ( F 6 ) .
3 Click O k to confirm deletion.
Changing a Password. TIP

You cannot
To change the password associated with a login name:
close the
1 Select Parameter>System>Password. Set
Login
2 Enter the old password.
Name
3 Enter the new password and then enter it again in C o n f i r m . dialogue
box if you do not type the
4 Click E x i t ( F 2 ) once to save this new setting and once again new password into
to return to the main window. C o n f i r m properly.
Creating a User Menu

The user menu function allows you to select up to 16 screens that
you most frequently use and create a short cut to them in one menu
called the User Menu. This should enable you to save time when using
the system. You can perform the following functions:
• Creating a User Menu. See page 172.
• Deleting a Shortcut from the User Menu. See page 173.
• Customising a Window Name Used by the User Menu.

See page 173.

Creating a User Menu
To create a user menu:
1 Select Parameter>System>User Menu.
2 Click N o . 1 if you are creating this menu from scratch. If you
have already added some menus, click the next free number.
3 Click E n t ry ( F 5 ).
4 On the window that appears, click the window that you wish to
add to the user menu, as shown in Figure 7-7 on page 172.
5 Click O k to add this window.
6 Repeat this procedure for each window you wish to add to the user
menu.
7 Click E x i t ( F 2 ) to save these settings and to return to the
main window.
8 Select U s e r menu from the main window. The drop-down list of
shortcuts that appear should now include the window(s) you have
just added.
Figure 7-7: Setting User Menu Access

Deleting a Shortcut from the User Menu
2 Click the item you want to delete.
3 Click D e l e t e ( F 7 ) .
4 Click O k to conform that this window is to be deleted. When one
item is deleted, all the items below it moves up one position.
Customising a Window Name Used by the User Menu

The system allows you to customise window names and the function
keys used to access them in order to be able to use more site-specific
terminology in the system’s user interface. This flexibility allows the
system to be more applied and user-friendly.
2 Click the item you want to change.
3 Click C h a n g e ( F 6 ) .
4 You can change both the function key associated with any window
you see here and the window label.
5 Change the window name by placing the cursor in the title field and
adding a new name of no more than 30 characters.
6 Click O k , then E x i t ( F 2 ) to save this setting and return to the
main window.
Setting General
Parameters
This section describes how to set some general AU400 parameters:
• Setting System Parameters. See page 174.
• Creating Comments in Comment Masters. See page 175.
• Entering Auto Power-On Parameters. See page 176.
• Setting Date and Time. See page 176.
• Viewing the Program Version. See page 177.
• Calibration Verification. See page 178.

Setting System Parameters
System Parameters determine the analysis mode used for routine,
emergency and STAT table samples. Analysis modes can be:
• Sequential
• Rack Mode (not available for STAT table)
• Barcode Mode
See “Sample Identification” on page 23 for more details on these
modes.
To set system parameters:
1 Select Parameters>System>System.
3 Select one of the three analysis modes from the Routine and
Emergency drop-down lists.
4 Select one of the two analyse modes from the STAT
drop-down list.
5 Select the type of barcode from the barcode T y p e drop-down
list, as shown in Figure 7-8 on page 175. If you select either
I S B T - 1 2 8 or M ix e d , the following restrictions apply:
• Mixed: If no digit number is set, only barcodes with readable
digits can be recognised for the 2 of 5 interleaved and 2 of 5
standard types. Even if the MSD or LSD for example, of a
barcode cannot be read due to incorrect positioning of the label,
the error is not deemed incorrect. Labels should always be
positioned on sample cups as directed (see Chapter 5,
“Preparing for Analysis” on page 85).
• ISBT-128: An I S B T - 1 2 8 barcode is handled as a
CODE - 128 barcode.
• N u m b e r o f d i g i t s should be set to 13.
• Y e s Mode should be selected.
6 Enter the number of digits in the D i g i t s field. This should be
no more than 26. Just enter a space to read any label between
1 and 26.
7 Choose a check mode from the C h e c k M o d e drop-down list.
8 Enter R a c k ID U p p e r L i m i t s . Set the upper limit of rack
numbers that identify samples by their type. If the upper limit for
routine serum sample racks is 25 for example, “26” is identified as
a urine sample rack. Enter upper limit values for routine and
emergency samples. Enter the value for repeat-run samples that
satisfies the Routine sample (urine), Routine sample (other),
Emergency sample (serum), Emergency sample (urine),
Emergency sample (other). To set designation, enter a space.
9 Select either A u t o or S t a n d a r d from the A u t o /
S t a n d a r d R e p e a t drop-down list. A u t o enables racks
with samples requiring repeats to be fed automatically back
around to the sampling position. S t a n d a r d disables this
function and enables samples flagged to be re-run on the
orange rack.

Figure 7-8: Setting System Parameters
Creating Comments in Comment Masters

You can register more than one different kind of comment in the
Comment Master file. If each menu item is executed, comments that are
registered in the Comment Master file are added to the target data.
To add a comment:
1 Select Parameters>Comment Masters. TIP
2 Click S e t ( F 4 ) . To select a
predefined
3 Enter the comment or edit an existing comment.
comment
4 Click E d i t ( F 5 ) . into a
comment
5 Click E x i t ( F 2 ) to save these comments. field simply
type * followed by the
comment number e,g, "*1"
for the first comment in the
Comment Masters list.

Entering Auto Power-On Parameters
To select the automatic power-on time see below. To perform a W1,
photocal, or both automatically when the system is powered on.
Contact your Beckman Coulter Representative for more information.
To set an auto start-up time:
1 Select Parameter>System>Auto Power On.
CAUTION
It takes about 3 Check the D a y o f t h e W e e k box.
30 minutes for
the photometer 4 Enter the auto-start time in each field, using military type format
lamp to warm i.e. HH:MM.
up after the
system is powered on.
Figure 7-9: Entering Auto Power-On Parameters
Setting Date and Time

To set the date and time:
1 Select Maintenance>Data Operation>Set Date &Time.
3 Enter the Y e a r from 0 to 99.
4 Enter the M o n t h from 1 to 12.
5 Enter the D a t e from 1 to 31.

6 Enter the H o u r from 0 to 23.
7 Enter the M i n u t e from 0 to 59.
8 The W e e k D a y should be automatically displayed, as shown
in Figure 7-10 on page 177.
Figure 7-10: Setting Auto-Power On
Viewing the Program Version

TIP
When troubleshooting or just performing maintenance, it is important to
be able to view the version of the system software that is running as well You can
as any revisions that are installed. view the
Program
To view the program version: Version
whether the
1 Select Maintenance>Maker Maintenance>Program Version.
system is in
2 You can view each program, its version number and the Stop or Standby mode.
appropriate version information on the Program Version window
that is displayed, as shown in Figure 7-11 on page 178.

Figure 7-11: Program Version
Calibration Verification
Calibration verification involves generating a calibration verification graph.
This graph displays the variance from true values calculated when
standard material is run on the system. Up to three replicates of each
test level can be plotted. You generate the graph in the following ways.
• Performing Calibration Verification. See page 178.
• Enter Material Parameters. See page 179.
• Display Chart. See page 179.
Performing Calibration Verification

To perform a calibration verification:
1 Select Auxiliary>Calibration Verification. The standard material
should already be run in routine racks.
3 Select the test name from the T e st N a m e drop-down list.
4 Select the sample type from T y p e drop-down list.

Enter Material Parameters
TIP
1 Click the M a t e r i a l P r m . tab.
2 Click S e t ( F 4 ) and then click the L e v e l check box. Enter the
expected value and tolerance (see the package insert for values
and tolerance).
3 Click M a t e r ia l E d i t ( F 5 ) . Enter the standard material
name, material ID, expiry date, and lot number. Change Mtr. No.
changes the replicate
4 Select C l o s e . number displayed. Up to
5 Click E x i t ( F 2 ) to save these settings. three replicates can be
displayed.
Display Chart A n a ly s t i n i t i a l
1 Click the S a m p l e tab. ( F 5 ) allows you enter your
name and initials on the
2 Enter the sample number or sample ID for the first level of graph.
samples. Repeat as many times as necessary.
3 Click D is p la y C h a rt ( F 5 ) to display a graph of the Note Edit (F6)
allows you to type a note on
observed versus the expected values. All specified levels are
the graph.
on this one graph. The symbols above the graph identify each
replicate result. The acceptable tolerance is indicated by a
vertical bar on the graph. Expected values, observed values,
and tolerance are displayed for the first replicate.
4 Display the second and third replicates, using the material number
button </>.
Viewing Statistics
Statistics help you monitor analysis and the AU400 over time.
The following statistics are available:
• Data Statistics. See page 180.
• Creating a Correlation Chart. See page 180.
• Selecting Histogram Data. See page 181.
• Viewing Reagent Consumption Volumes. See page 183.
• Tracking Consumable Supply. See page 184.
• Reagent Inventory. See page 185.

Data Statistics
To select samples to be used to generate sample statistics:
1 Select Auxiliary>Data Statistics.
2 Select the index range from the I n d e x drop-down lists.
3 Select the sample type for statistic calculation by checking one
of the check boxes on the left of the window.
4 Enter the range of sample numbers or the range of sample IDs
(barcodes). Enter an “*” to select all samples.
5 Click V ie w D a t a ( F 5 ). The following data is displayed:
• Index.
• Number of samples selected.
• Test Name
• Number of results, mean, standard deviation, coefficient of
variance (CV), range, maximum value and minimum value of
each test.
6 Click P r i n t and then O K to print the data statistics.
7 When you have finished viewing statistics, click E x i t ( F 2 ) once
and once again to return to the main window.
Creating a Correlation Chart

Statistical correlation allows you to select tests and the database to be
used to determine the statistical correlation between two tests.
• Creating the Chart. See page 180.
• Setting Display Conditions for a Correlation Chart.

See page 181.
• Deleting Correlation Chart Data Points. See page 181.
Creating the Chart

To create a correlation chart:
1 Select Auxiliary>Correlation Chart.
3 Select the test name for the X axis from the X - T e s t N a m e
drop-down list.
4 Select the test name for the Y axis from the Y - T e s t N a m e
drop-down list.
5 Select the sample type by checking one of the check boxes on the
left margin, i.e., either S e r u m, U r i n e or O t h e r s .
7 Click D is p la y c h a rt ( F 5 ) to view the chart.

Setting Display Conditions for a Correlation Chart
By setting the display parameters for the X and Y axes of a correlation
chart, you can change the chart display size.
To set display conditions:
1 Select Auxiliary>Correlation Chart and create a correlation chart.
2 Click C h a n g e A x i s ( F 6 ).
• If you select A u t o , the correlation diagram is displayed in

the largest possible size enabling you to view all data at the
same time.
• If you select M a n u a l , you must specify a lower limit and an

upper limit for both the X and Y axes. Only this part of the diagram
then becomes enlarged.
3 On the C h a n g e A x i s set-up window, set the display condition
to either A u t o or M a n u a l.
Deleting Correlation Chart Data Points

Specific data points can be deleted from the correlation calculation, but
the analysis data itself is not deleted.
To delete correlation chart data points:
1 Select Auxiliary>Correlation Chart and create a correlation chart.
2 Click V i e w D a t a .
3 On the list of sample numbers that appears, click the one you want
to delete.
4 Click D e l e t e ( F 2 ) , having selected the data points
to be deleted.
5 Click O K to begin deleting.
6 Click D is p la y c h a r t ( F 5 ) to view the new
correlation chart.
Selecting Histogram Data

Histograms are bar charts that display a history of the number of
samples, mean, SD, CV, range, as well as minimum or maximum
statistic calculations. You can view a histogram using the following
procedures:
• Selecting Histogram Data. See page 182.
• Displaying Histogram Information. See page 182.

Selecting Histogram Data
To select histogram data:
1 Select Auxiliary>Histogram.
2 Select the index from the I n d e x drop-down list and select the
test name from the T e st N a m e drop-down list.
3 Select the sample type by checking one of the check boxes on the
left margin, i.e either S e r u m , U r in e or O t h e r s.
5 Click D i s p l a y C h a r t ( F 5 ) to view the chart. Normal range
is displayed in blue and abnormal in yellow.
6 If you want to change the size of the axis, click C h a n g e
A x i s ( F 5 ).
• If you select M a n u a l condition, then you must decide the

number of class intervals to be displayed by selecting a number
between five and ten. The value you enter becomes the normal
range.
• If you select A u t o condition, number 7 is automatically

selected.
7 To print the histogram, click P r i n t ( F 3 ), then select
D is p la y T e s t (only prints the data you can see) or
A l l T e s t s and click O k .
Displaying Histogram Information

To display histogram information:
1 In the Histogram window, select V i e w D a t a ( F 6 ) to view the
following list of information.
• Upper and lower limit, number of samples and a percentage for
each class interval.
• Number of samples lower than the smallest class interval and
this as a percentage of the whole.
• Number of samples exceeding the largest class interval and this
as a percentage of the whole.
to the main window.

Viewing Reagent Consumption Volumes
Reagent consumption is used to view the total volume of reagent used
over a selected time interval (or indexes) by each test as well as the
purpose of consumption, such as QC, Calibrator, Repeat sample etc.
Volumes are expressed in µl. Total number of shots refers to the
consumption volume in terms of the total number of tests.
To view reagent consumption volumes:
1 Select Auxiliary>Reagent Consumption.
2 Select the index range from the I n d e x drop-down lists and
select the type from the T y p e drop-down list, as shown in
Figure 7-12.
3 Check Reagent 1 volume by clicking R e a g e n t
Volume (F5).
4 Check Reagent 2 volume by clicking R e a g e n t
V o l u m e ( F 5 ) and then R 2 .
5 Click E x i t ( F 2 ) to close this window.
Figure 7-12: Reagent Consumption
6 Click T e s t T o t a l ( F 6 ) to view the number of tests performed

in the currently selected indexes.
7 Click E x i t ( F 2 ) to close this view.
8 Click S h o t T o t a l ( F 7 ) to view the cumulative number
of tests and repeat runs performed using each reagent.
9 Click E x i t ( F 2 ) to close this view.
10 Click P r i n t ( F 3 ) to print the information on any window that
you see.

11 To save reagent consumption data to floppy disk, place a floppy
disk in the floppy drive and Click S a v e t o D is k ( F 4 )
(nothing appears to occur, but the data is immediately saved in the
correct format for a floppy disk).
12 Click E x i t ( F 2 ) to close any window still open and E x i t
( F 2 ) again to return to the main window.
Tracking Consumable Supply

Consumable management is designed to facilitate maintenance.
The feature allows you to view maintenance history, plan future
maintenance tasks and produce a re-order list. For the purposes of
TIP effective maintenance, the information contained here should be
Recent only
constantly kept up-to-date, using the following procedures:
displays the
last date a
• Editing the Consumable List. See page 184.
part was
changed.
• Adding a Part to the Consumable Management Table.
See page 184.
Editing the Consumable List

To edit the consumable list:
1 Select Maintenance>Consumable Management.
2 Click the part that is replaced. You might need to scroll down to
find it.
3 Click C h a n g e ( F 5 ) .
4 Click O k at the next prompt to update the current date and time.
5 You can click H is t o r y ( F 6 ) to view a list of change dates for
this particular part.
6 You can print data by first pressing P r i n t ( F 3 ) and then
selecting either R e c e n t or H is t o r y and then pressing
R e t u r n.
7 You can delete a part from the list by highlighting it and then
clicking D e l e t e .
to the main window.
Adding a Part to the Consumable Management Table

To add a part to the Consumable Management table, the function must
be enabled. Contact your Beckman Coulter Representative for
assistance.
To add a part
1 Select Maintenance>Consumable Management.
2 Click the next available number.
3 Click E n t ry ( F 7 ) .
4 Select the part number, using the arrow buttons.
to the main window.

Reagent Inventory
You can automatically calculate or predict the volume of reagent that
the system uses on the day of the week that the reagent inventory is
checked. You can also set the reagent or the reagent consumption for
each day of the week day of the week manually. You can perform the
following tasks: TIP
• Automatically Calculating Reagent Consumption. See page 185.
After setting
• Manually Entering Reagent Inventory. See page 186. up the
reagent
Automatically Calculating Reagent Consumption inventory
To auto-calculate reagent inventory: from the
A u x i l i a r y menu, you
1 Select Auxiliary>Reagent Inventory>Auto. can view the expected
number of shots or volume of
2 Select the index range by selecting a start index from the S t a r t
each reagent required for a
I n d e x drop-down list and an end index from the E n d I n d e x normal days workload for
drop-down list, as shown in Figure 7-13. In order for the resulting that particular day of the
inventory data to be meaningful, the index range selected must be week by selecting
representative of true workload. Routine>Start Condition>
3 Select either V o l u m e or S h o t s from the S h o t s / Reagent Inventory.
V o l u m e drop-down list.
4 To choose volume select either R 1 R e a g e n t or R 2
Reagent.
6 Click P r i n t ( F 4 ) to print the data.
7 Click E x i t ( F 2 ) to close this window and once again to return
to the main window.
Figure 7-13: Calculating Reagent Consumption

Manually Entering Reagent Inventory
To manually enter reagent inventory:
1 Select Auxiliary>Reagent Inventory>Manual.
2 Click the day and test for which you want to enter data.
3 Click E d i t ( F 4 ).
4 Enter the volume or number of shots you expect to be used.
5 Click C l o s e ( F 2 ) to save these values.
6 Repeat this for each day, test, and sample type for which you want
to enter data.
Offline Output
CAUTION
You can use the offline output function to save sample result data and
For information patient information on floppy disk for use on other computers. You can
about save data from normal, repeat or QC analyses.
precautions when
using a floppy
disk, refer to
To select data for offline output:
Using a Floppy Disk in
Chapter 2. 1 Select Maintenance>Data Operation>Offline Output.
2 Select an index from which you want to extract data.
3 Select a delimiter. This is a punctuation character that is used to
separate data in the output file.
4 Check the Routine or Sample boxes.
5 Enter a range of sample numbers or sample IDs or both. You can
enter an “*” to extract all samples or a space to select none. This
should also be done for Urine and Others.
6 Repeat this procedure for Repeat Run and QC.
7 When data parameters are entered, click Data Send (F5).
8 Select Yes on the output dialogue.
9 Set the write protect tab on the floppy disk to write-enabled, insert
the disk and click Yes.

Maintenance
Introduction
It is vital to perform planned preventative maintenance on the AU400 to
ensure optimal performance. The maintenance tasks are as follows:
• Using the Routine Maintenance Schedule. See page 187.
• Periodic Maintenance. See page 188.
• Daily Maintenance. See page 189.
• Daily ISE Maintenance. See page 190.
• Weekly Maintenance. See page 190.
• Weekly ISE Maintenance. See page 195.
• Monthly Maintenance. See page 200.
• Monthly ISE Maintenance. See page 204.
• As Required Maintenance. See page 205.
• As Required ISE Maintenance. See page 227.
• Running Remote Maintenance. See page 237.
• Routine Maintenance Schedule AU400 with ISE. See page 238.
Using the Routine

Maintenance Schedule CAUTION
To ensure optimal performance, planned preventative maintenance Failure to
should be performed on this system. It is highly recommended that perform user
you make copies of the maintenance schedule at the end of this chapter maintenance
and place a tick after each task when that task is complete. according the
instructions
within this User Guide may
adversely affect system
performance and may
invalidate a service contract.
AU400 User Guide Version AC Maintenance 187

Periodic Maintenance
The Periodic Maintenance function allows you to perform the following:
• Adding a Maintenance Task. See page 188.
• Updating the Maintenance Register. See page 188.
• Viewing Maintenance History. See page 188.
Adding a Maintenance Task

To add a maintenance task:
1 Click Maintenance>Periodic Maintenance.
2 Click E n t ry ( F 7 ) .
3 Select an unused position at the end of the list and enter
a description of the maintenance task.
4 Enter the period.
5 Select the period unit from the drop-down list.
6 Click C l o s e and then E x i t ( F 2 ) twice to return to the
main window.
Updating the Maintenance Register

After performing maintenance tasks, you must update the
TIP corresponding maintenance records.
As Photocal To do this:
and W2
processes
are activated 2 Select the maintenance item to update.
via the
3 Click E x e c u t e ( F 5 ) .
software,
the next due date for W2 and 4 Click O k to confirm the execution. This automatically enters the
Photocal measurement are current date on the maintenance task and sets the next due date.
automatically updated.
All other maintenance items 5 Click C l o s e and then E x i t ( F 2 ) twice to return to the main
must be manually updated. window.
Viewing Maintenance History

The system keeps track of the previous 10 dates of completed
maintenance tasks.
To view maintenance history for an item:
2 Click an item on the register and then click H i s t o r y ( F 6 ) .
3 The last ten maintenance dates and the next due date are
displayed.
188 Maintenance AU400 User Guide Version AC

Daily Maintenance
The following list of checks should be part of a daily maintenance
routine performed when preparing the system for analysis. For detailed
instructions on the following procedures, see “Performing Daily
Maintenance” on page 85.
• Inspect sample and reagent syringes.
• Inspect Wash Solution.
• Inspect, clean and prime sample and reagent probe.
• Inspect and clean mixing bars.
• Inspect the stability of the upper cover.
• Inspect printer and paper.
• Refill the pre-dilution bottle.
• Perform a Wash 1 following a routine. See page 189
• Perform any outstanding weekly, monthly or as-required

maintenance.
Performing a Wash 1
A Wash 1 cleans sample probe, cuvettes, reagent probe, mixing bars
and wash wells with a 2% Wash Solution. The procedure takes about CAUTION
9 minutes. Time remaining is displayed in the Display mode area of the
Always run a
window during the procedure. W1 after
You should perform a Wash 1: stopping
analysis in mid
• At the end of the working day, to prevent clogging in the run to clean out
sample probe. liquids remaining in the
cuvettes, which could
• When a power cut has occurred and power is not recovered adversely affect results.
immediately.
To perform a Wash 1:
1 Click S y s t e m S t a t u s .
2 Lift up the top lid of the system and place 2% Wash Solution in the
W1 position on the STAT table.
3 Click W 1 S t a r t ( F 1 ) .
4 When the process has ended, click E x i t ( F 2 ) to return to the
main window.

Daily ISE Maintenance
The following list of checks should be part of a daily maintenance
routine performed when preparing the ISE unit. For detailed instructions
on the following procedures, see “Preparing the ISE Unit” on page 97.
• Inspect the ISE buffer syringe.
• Check the ISE reagent levels.
• Ensure the reagent has not expired by checking the label on it.
• Prime the ISE unit (if you have replaced reagents).
• Perform an auto-clean of the sample pot.
• Perform ISE calibration.
• Place 2% washing solution in the W1 position on the STAT Table.

The Sample Probe is then cleaned between starts.
• Perform any outstanding weekly, monthly or as required

maintenance.
Weekly Maintenance
Perform the following tasks every week:
• Performing a Wash 2. See page 190.
• Performing a Photocal. See page 193.
• Washing the Pre-Dilution Bottle. See page 194.
• Shutting Down and Rebooting the System. See page 194.
Performing a Wash 2
If the sample probe, reagent probe, mixing bars or cuvettes become
contaminated, analysis results are adversely affected. Wash 2
thoroughly cleans cuvettes in preparation for photocal, when you follow
the following procedures:
• Precautions. See page 191.

A Wash 2 automatically washes:
• All Cuvettes
• The Mixing Bars
• The Sample or Reagent Probe
• The Waste Lines

A Wash 2 takes about 25 minutes. While the wash is running, you
TIP
can see how much time is remaining in the Mode Display area of the
system window. You can
It is recommended that you alternate between using prepared Cleaning select a
Solution (diluted 1 in 10, i.e. 0.5% effective Chlorine) one week and 1M photocal
when
HCl the next. In this User Guide, the generic term used to refer to these
selecting
solutions is "W2 solution" whether that is 1M HCl or a 10% dilution of a W2 wash
Cleaning Solution. Photocal measurement should always be performed so that the photocal runs
immediately after Wash 2. automatically afterwards.
The ISE cleaning can also
Precautions be selected there.
Before performing Wash 2, take the following precautions:
• When preparing the W2 solutions, do not allow acid and alkaline TIP
solutions to come in contact with each other.
For ISE
• Always have a label on each bottle to prevent acid and alkaline cleaning,
from getting mixed up. always use
neat
• Do not allow W2 solution to come in contact with your skin, your Cleaning
eyes or your clothes. If this occurs, wash immediately with warm Solution in
water. the clean position of the STAT
table.
• If any of the W2 solution is swallowed, seek medical attention
immediately.
• Do not allow the W2 solution to spill around the system. CAUTION
Materials Needed: To avoid the
production of
• 1 empty 60 ml W2 solution bottle toxic gases, do
not allow the
• 1 standard sample cup for washing Cleaning
Solution to mix with any
• 60 ml 1 mol HCl or 10% Cleaning Solution
other chemicals.
Performing a Wash 2
1 Fill one 60 ml W2 solution bottles. CAUTION
2 Lift off the top lid and remove the pre-dilution bottle from its Place the W2
position. solution bottle
into the pre-
3 Place the 60 ml bottle in the pre-dilution position.
dilution bottle
compartment
beside the cuvette wheel. It
should not stick out above the
surface of the system as this
could cause a probe to crash.
For a W2, cleaning W2
solution should be placed on
the W2 position on the STAT
Table.

4 Put a sample cup of ISE W2 Detergent in the Clean position on the
STAT table, as shown in Figure 8-1.
Weekly Maintenance
Pre Dilution
Pos.
Pre-Dilution Pos and W2 on Stat Table:
1. Week: 1 Mol Hydrochloric Acid
2. Week: 10% Cleaning Solution
NEVER use different Detergents on marked Pos.
Place neat Cleaning Solution in the Clean

position on the STAT table if an ISE Clean
is combined with Wash 2.
R1/R2
W1
W2
U-L
CLEAN
Neat W2 Detergent
U-H
S-L
STAT table
S-H
Figure 8-1: Performing a Wash 2
5 Select System
Status>W2 Start.
6 At the S t a r t W 2
prompt, click Yes and
then press R e t u r n .
Monitor the time by
watching the M o d e
D is p la y.
7 While Wash 2 is in
progress you can shut down automatically by pressing the
E n d P r o c e s s key. An Autostart with Autopreparation
(if preprogrammed by an Beckman Coulter Representative)
should be performed the following day.
See “Shutting Down the System” on page 157.
8 IMPORTANT - Place the pre-dilution bottle filled with fresh
deionised water back into the Position 77 before returning
to routine operation.
9 Close down the top lid.

Performing a Photocal
The purpose of photocal is to test the condition of the photometer, the
cuvettes and identify cuvettes that are scratched or dirty. Photocals take
about 20 minutes and, during the process, the time remaining can be
viewed in the Mode Display area of the window.
TIP
Do the following:
Use the
• Performing a Photocal. See page 193. photocal
monitor to
• Checking Photocal Results. See page 193. view the
OD
Performing the Photocal measured
To perform a photocal: for each cuvette during the
photocal.
1 Select System Status>Photocal Start. You can access this by
2 Click R e t u r n to start the process. selecting Routine>
Photocal Monitor.
Checking Photocal Results
To check photocal results:
1 Select System Status>Cuvette Status. CAUTION
2 Enter the range for mean check (0.03 is recommended). This sets Never perform
the limit which each cuvette reading at each of the wavelengths a Photocal
can be from the mean of all the cuvette readings at that before the
wavelength. system has
warmed up
3 Enter the range for absolute check (0.1 is recommended). This fully. i.e., not within 20
sets the limit which each cuvette reading can be from the reading minutes of switching on the
of that cuvette last time the photocal was performed and saved (at system.
each wavelength).
4 Click C h e c k S t a r t ( F 5 ). TIP
5 Enter the range for mean check (0.03 is recommended). If all
6 Enter the range for absolute check (0.1 is recommended). cuvettes
are blue,
7 Click C h e c k S t a r t ( F 5 ) . Cuvettes that fail the mean check click Save,
are listed in red in the E r r o r C u v e t t e N o . L i s t window. and run
Cuvettes that fail the internal cuvette check are listed in green. another check. Blue
Cuvettes that fail the absolute check are listed in blue. When all numbers should then
cuvettes pass, the window remains blank. disappear.
8 Click P r i n t ( F 3 ) to print a list of failed cuvettes.

TIP
9 Remove and clean all cuvettes on the failed list (see “Cleaning the
Cuvettes and the Cuvette Wheel” on page 225). When you
click
10 Perform a new Photocal after cleaning cuvettes and if an error still Check
occurs, then you must replace them and perform a final Photocal. S t a rt
11 Ensure that each item is selected and then click S a v e (F5),
H i s t o r y to save final Photocal Data History when you perform both the
the successful photocal. mean check and absolute
check are performed. Only
12 The photocal result should be saved each week. mean check data is used for
routine operation and never
absolute check data.

Washing the Pre-Dilution Bottle
The purpose of washing the pre-dilution bottle with bleach is to prevent
the growth of bacteria.
Materials Needed:
CAUTION
Ensure the
• Deionised water
bottle is fully re-
inserted in the
• Cleaning Solution, diluted 1 in 10
pre-dilution To wash the pre-dilution bottle:
position and is
not sticking up above the 1 Remove the pre-dilution bottle.
surface of the system. 2 Dispose of any liquid still inside.
3 Pour a small volume of Cleaning Solution into the bottle and shake
well inside.
4 Empty out the Cleaning Solution and rinse the bottle well, using
deionised water. Rinse twice.
5 Re-fill the bottle with deionised water and put it back into the pre-
dilution position on the system.
Shutting Down and Rebooting the System

If the system is in operation 24 hours a day, it should be shut down and
restarted at least once a week to allow the computer operating system
to clear out any temporary files and close multiple copies of the help file
that might still be open. This optimises the system processing speed
and helps prevent it from crashing during use.
Use the following procedures:
• Shutting Down and Restarting. See page 194.
• Bypassing Warm-up Mode. See page 195.
Shutting Down and Restarting

TIP To shut down the system:
End 1 Press E n d P r o c e s s on the keyboard (System End on some
Process keyboards).
can only be 2 Wait for the system to shut down.
selected
when all 3 When I t i s n o w s a f e t o t u r n o f f t h e c o m p u t e r
windows appears, no user action is required as the system turns
are closed. off automatically after a few seconds. Do not click the
R e s t a r t button.
4 To restart the system press the green P o w e r O N switch
(sub power) on the front of the system. The system starts up
and begin loading the software. This warm-up process takes
a few minutes.

Bypassing Warm-up Mode
Whenever the system is shut down it restarts in Warm-up mode.
It remains in Warm-up mode for at least 45 minutes, to ensure the
cuvette wheel and reagent and STAT wheels are at the correct
temperature. If the system is shut down and restarted immediately,
the Warm-up period can be bypassed.
To bypass Warm-up mode:
1 Select Auxiliary>Standby Set.
2 Click Yes>Yes to send the system into Standby mode.
Weekly ISE Maintenance

Perform the following tasks every week:
• Performing a Selectivity Check for the Na/K Electrodes. See

page 195.
• Washing the Mixing Bar, Liquid Level Sensors, Sample Pot

Tubing and Sample Pot. See page 196.
• Bleach Cleaning Electrodes and Bypass Tubing. See page 199.
Performing a Selectivity Check for the Na/K

Electrodes
Na and K are ion-selective electrodes. If the selectivity of electrodes
deteriorates, the ISE unit might become affected by ions other than
those to be measured and optimum analysis results might not be
obtained. To check the electrodes for deterioration, check the selectivity
of the Na and K electrodes every week. The process takes about
three minutes.
You can perform the following:
• Performing the Selectivity Check. See page 195.
• Performing a Mid/Ref Prime. See page 196.
Performing the Selectivity Check
This checks the electrodes for deterioration.

1 Prepare an Ion Selectivity Check Solution (Available on order from
your Beckman Coulter Representative).
2 Check that the system and the ISE Unit are on and the system
is in Warm-up or Standby.
3 Pour Na and K electrode check solution into two sample cups.
4 Place the sample cups filled with each check solution on the STAT
table. Place the Na cup in the S-H (Na-SEL) position. Place the
K cup in the S-L (K-SEL) position.
5 Select System Status>ISE Status>ISE unit start (F5).

6 Click C h e c k S e l e c t i v it y and click Y e s to start the
process.
7 Remove the sample cups from the STAT table and dispose of the
remaining solution from the sample cups.
8 Click the C h e c k R e s u l t tab when the process has ended.
9 Review the result data. Abnormal data is highlighted in yellow.
The system highlights a value of more than 160 for the
Na electrode and more than 6.0 for the K electrode as abnormal.
If any electrode value is highlighted as abnormal, see “ISE
Measuring Components” on page 306.
Performing a Mid/Ref Prime

1 Select System Status>ISE Status>Prime (F6)>MID/REF Prime.
2 Press the S T A T R O T A T I O N / D I A G switch to eliminate
the concentrated solution. You should press the S T A T
R O T A T I O N / D I A G switch three times to fully eliminate the
concentrated solutions.
Washing the Mixing Bar, Liquid Level Sensors,

Sample Pot Tubing and Sample Pot
TIP Each of these parts should be washed at least once a week. If they
become dirty, ISE results might be affected. The following procedures
If you are should be performed.
unable to
sonicate, • Cleaning the ISE Mixing Units and Liquid Level Sensors. See
then clean page 196.
the sample
pots, using • Removing and Cleaning the ISE Sample Pot and the Sample Pot
20-40% cleaning solution. Tubing. See page 197.
• Replacing the Sample Pot and Sample Pot Tubing. See

page 198.
Materials Needed:
• 20% Cleaning Solution (i.e. 1 in 5)
Cleaning the ISE Mixing Units and Liquid Level Sensors

1 Check that the system is in Warm-up mode or Standby mode.
2 Select S y s t e m S t a t u s > I S E S t a t u s > F 6
( p r i m e ) . Select one of the prime operation items, then press
the Enter key. The periodic washing of the ISE unit will be stopped.
3 Select Maintenance>Maker Maintenance>ISE Diag.>Drain
Electrode.

Mixing bar
Nozzles
Tubes
Liquid-level sensors
Mixing unit
Figure 8-2: Cleaning the Mixing Unit
4 Disconnect the liquid level sensor connector No. 143 and mixing
unit motor connector No. 142.
5 Loosen the knob securing the mixing unit and then lift it up.
6 Using a clean cloth dipped in alcohol, wipe the mixing bar and
liquid-level sensor.
7 Leave the mixing unit to one side.
Removing and Cleaning the ISE Sample Pot and the Sample Pot
Tubing
1 Loosen the sample pot fixing knob to remove the sample pot.
2 Unscrew the sample pot tube connected to the bottom of the
sample pot.

3 Remove the sample pot and Tubing as shown in Figure 8-3.
Sample pot
Connector Sample pot

fixing knob
Connector
Mixing unit on the

mount plate
FR
ON
T
Sample pot
T connector
Electrode unit Tubes
Figure 8-3: Removing the Sample Pot
4 Fill a beaker with 20% Cleaning Solution and place the sample pot
and Tubing into it, ensuring that it is fully submerged. Leave to
soak for 10 minutes.
5 Rinse the sample pot and tubing thoroughly with deionised water.
6 Dry the sample pot with a soft clean cloth or a paper towel.
Replacing the Sample Pot and Sample Pot Tubing

1 Screw the sample pot tube onto the sample pot. Replace the
sample pot. Engage the notch on one side of the sample pot with
the sample pot fixing knob, and align the hole on the opposite side
of the sample pot with the positioning pins.
2 Tighten the sample pot fixing knob to secure the sample pot.
3 Put the mixing unit back in its proper position and tighten the knob
to secure it in place.
4 Reconnect liquid-level sensor connector No.143 and mixing unit
motor connector No.142.

5 Switch on the ISE unit at the ISE power switch). Allow the ISE unit
to initialise and for ISE status to change to Ready.
6 Change the P r i m e option on the window to C / T o t a l
Prime.
7 Press the S T A T R O T A T IO N / D I A G switch so that the
rolling pumps activate and move the solution in each roller tube.
Press the S T A T R O T A T I O N / D I A G switch again until the
rolling pumps are activated intermittently two or three times. Have
a look at the tube at the bottom of the flow cell to see if there are
air bubbles in the solution passing through the electrodes. You
might have to press the S TA T R O T A T IO N / D I A G switch
a number of times to fully eliminate the air from the tubes.
8 Close the ISE lid and upper lid, click C l o s e , to get back to the
ISE Status.
9 Perform a calibration for the ISE (see “Calibration Process on the
ISE” on page 82). If the calibration is unsuccessful, check the
tubing on the ISE unit to make sure no air bubbles are present
when performing a Mid-Standard and Reference Prime. Ensure
also that fresh serum or urine standard solution is being used, then
recalibrate.
Bleach Cleaning Electrodes and

Bypass Tubing
Performing this procedure once a week.
Materials Needed:
• One Pasteur pipette (capacity—at least 1 ml)
• 2 ml neat Cleaning Solution (5% effective chlorine)

To bleach clean electrodes and bypass tubing:
1 Check that the system and the ISE Unit are on and the system is TIP
in Warm-up or Standby (go to Standby by pressing the S t o p /
S t a n d b y key. Click Y e s on the prompt that appears next).
2 Select ISE Status>Prime (F6).
If the
3 Open the upper cover of the system and then lift the ISE unit lid. ISE
4 Using the pipette, gently dispense 1 ml Cleaning Solution into D-POT
OVERFLOW
the bottom of the sample pot, taking care not splash the sides
SENSOR ERROR
of the pot. is generated during this
5 Click A / R e p la ce E le ct r o d e and activate the selection procedure, it is likely to be for
by pressing the white I S E P R I M E button on the system. one of two reasons:
6 After about five seconds the cycle is complete. Press the I S E • More than 1 ml was added
P R I M E button again. to the sample pot.
7 Using the pipette, again gently dispense 1 ml Cleaning Solution • The mixture aspiration
rolling pump tube (right
into the bottom of the sample pot, taking care not to splash the
hand pump) requires
sides of the pot. replacement.
8 Select F / P r im e b y p a s s t u b i n g and activate the
selection by pressing the I S E P R I M E button on the system. When corrective action is
taken and the error is fixed,
9 After about five seconds the cycle is complete. Press the perform the whole procedure
I S E P R I M E button again. as described.

10 Click C / T o t a l P r i m e on the I S E P R I M E window, and
activate, using the I S E P R I M E button on the system.
11 Repeat ISE Total Prime once when the first cycle is finished.
12 Clean and calibrate the ISE unit as in daily maintenance.
Monthly Maintenance
Perform the following tasks every month:
• Cleaning Wash Wells. See page 200.
• Cleaning the Wash Nozzle. See page 201.
• Backing up Parameters. See page 203.
• Cleaning Air Filters. See page 203.
• Replacing the Detergent Roller Tubing. See page 204.
Cleaning Wash Wells

The probe and mixing bar wash wells must be cleaned regularly to
prevent the formation of deposits that can cause contamination and
reduce the accuracy of analysis result data. Stained probes and mixing
bars might also contaminate samples. To prevent samples from being
contaminated, clean all wash wells at least once a month.
Materials Needed:
• Freshly prepared 10% Cleaning Solution (0.5% effective

chlorine).
• Cotton Swab
To clean the wash wells:
1 Lift up the top lid of the system, as shown in.
2 Ensure the system is in Warm-up mode or Standby mode.
3 Select Maintenance>ANL Maintenance>D/Cleaning Wash Wells.

4 Press the S T A T R O T A T IO N / D I A G switch to move the
sample and reagent probes to the cuvette wheel position. Turn the
mixing bar away from the wash wells.
Reagent probe
Reagent probe
wash well
Sample probe
T
ON
FR Sample probe wash well
Figure 8-4: Cleaning the Probes and Mixing Bar Wash Well
5 If Cleaning Solution is spilled, wash the affected area immediately.

6 Clean the inside of each wash well with a cotton swab and pour 1
or 2 mls Cleaning Solution into each one. Be careful not to damage
probe tips or mixing bars during cleaning.
7 Select Maintenance>ANL Maintenance>F/Prime Wash-lines.
8 Press the S T A T R O T A T IO N / D I A G switch to dispense
deionised water from the sample and reagent probes into the wash
wells. The mixing bars goes through one wash sequence. If the
deionised water is not properly drained from the drain hole or if a
stain still remains in the wells, repeat the procedure.
Cleaning the Wash Nozzle

Each nozzle comprises three smaller nozzles. The longest one
aspirates the reaction mixture, Wash Solution and water. The next
longest dispenses the wash water or Wash Solution. The shortest
nozzle aspirates any excess wash water or Wash Solution. If a nozzle
becomes clogged, the nozzle function is weakened. This can result in
cuvette overflow or problems with the analysis result data. To prevent CAUTION
this, the wash nozzles should be cleaned at least once a month.
When cleaning
Materials Needed: the wash
nozzle station
• Dry, clean cloth in a sonicator,
be careful not
• Sonicator filled with deionised water to scratch the wash nozzles.
Do not scratch or tear the
joints and tubes as this may
result in leakage.

To clean the wash nozzle:
1 Open the rear cover, as shown in Figure 8-5.
3 Select Maintenance>ANL Maintenance>E/Replacing Wash
Nozzle.
4 Press the S T A T R O T A T I O N / D I A G switch to drain the
liquid in the tubing on the wash nozzle.
5 Remove the four tube mounting joint manifolds from the system.
6 Clean the wash nozzle station (along the tubing) for 15 minutes,
using deionised water in a sonicator. No detergent is required.
7 Take out the wash nozzle station from the sonicator and wipe up
any drops of water, using a soft cloth.
Tube
Tube mounting
joint
Knob
Tube mounting Positioning screw

joint
Wash nozzle
Wash nozzle FR
ON
station T
Figure 8-5: Wash Nozzle
8 Make sure the tube joint manifolds are attached in the correct
places and firmly tightened. If a manifold is attached to an incorrect
position, normal analysis cannot be performed.
9 Align the two positioning holes on the wash nozzle station with the
positioning screws, then put on the station by tightening the knob.
11 Press the S T A T R O T A T I O N / D I A G switch to initiate a
prime cycle. When completed, press the S T A T
R O T A T I O N / D I A G switch again and then a third time. All
air in the dispense tubing lines should now be eliminated.
12 Check for leaks, then close the rear cover.

Backing up Parameters TIP
An up-to-date back-up copy of parameter files should be kept for every When
system in case of computer hard disk failure or permanent damage. saved,
To ensure the copy is up-to-date, parameters should be saved monthly be sure to
as part of your maintenance routines. keep the
parameter
A copy of parameter files should also be made immediately before
disk in a
making any changes to these files. This allows you restore the original safe place.
settings if the changes are not successful. If changes are successful a
back-up copy of the new parameters should then be made.
For more information on how to initialise a parameters disk, and how to
save parameters, see “Saving Information to a Floppy Disk” on
page 146.
CAUTION
Cleaning Air Filters If you wash the
air filters with
It is important to monitor the condition of the air filters on the back of the water, it is
system. If they become clogged with dust and dirt, you should clean essential that
them immediately with a vacuum cleaner. Otherwise, a reduced volume you thoroughly
of air enters the system, hindering the cooling system. dry them prior to refitting, or
water could enter the system
To clean the air filters: and lead to an electrical fault.
1 Remove the filters from the back of the system, as shown in
Figure 8-6.
2 Clean them, using a vacuum cleaner.
3 Put them back onto the system.
FR
ON
T
Air filter(S)
Air filter(L)
Air filter(S)
FR
ON
T
Figure 8-6: Location of Air Filters

Replacing the Detergent Roller Tubing
With time, the roller tubing eventually becomes flat or worn from the
repeated action of the roller pump and from vibration. It should therefore
be replaced at least every three months, depending on throughput. For
very high throughput systems this maintenance may be required on a
monthly basis.
Materials Needed:
• Roller tube
To replace the roller tubing:
2 Open the left front cover
3 Select Maintenance>ANL Maintenance>G/Replace Detergent
Tube and press the S T A T R O T A T I O N / D I A G switch.
The rolling pump is rotated reversely, the concentrated wash
solution in the tube is returned to the concentrated wash solution
tank.
4 After confirming that the wash solution in the tubes has been
exhausted, remove the rolling tube from the rolling pump.
5 Unscrew the roller tube connector to remove the roller tube.
Connect a new roller tube and tighten the connectors at each end
with your hand. Do not over tighten.
6 Place the roller tube on the rolling pump, then match the
connectors with the notches in the vicinity of the rolling pump.
7 Select S T A T R O T A T I O N / D I A G switch. The rolling
pump rotate in the normal direction, filling the tube with
concentrated wash solution.
Monthly ISE Maintenance

Perform this task every month:
• Replacing the Mixture and Mid Standard Pump Roller Tubing.
See below.
Replacing the Mixture and Mid Standard

Pump Roller Tubing
With time, the roller tubing becomes flat or worn from the repeated
action of the roller pump and from vibration. It should therefore be
TIP replaced at least every three months, depending on throughput.
Be careful Material Needed:
not to
switch the • Roller tube
numbers on To replace the roller tubing:
the roller
tubes 1 Check the system is in Warm-up mode or Standby mode.
as this can cause errors
to occur.

2 Select System Status>ISE Status>F6 (prime). Select one of the
prime operation items, then press the Enter key. The periodic
washing of the ISE unit will be stopped.
3 Lift the upper lid, as shown in Figure 8-7.
4 The MID standard and mixture roller tubes are stretched over the
rolling pump cylinders. Stretch and lift tubing up and away from
the rolling pump allowing it to rest on top of the cylinders.
Nos.
T
ON Nos.
FR
Figure 8-7: ISE Roller Tube Connectors
5 Unscrew each roller tube connector to remove the roller tube.

Connect a new roller tube and tighten the connectors at each
end with your hand. Do not over tighten.
6 Place the roller tubes on the correct rolling pumps, then match the
connectors with the notches in the vicinity of the rolling pump.
7 Select E / M I D / R E F P r i m e .
8 Press the S TA T R O T A T I O N / D I A G switch to turn on the
rolling pumps and move the solution along each roller tube. Keep
pressing the S T A T R O TA T I O N / D I A G switch until all the
air bubbles are eliminated from the tubing.
9 Close the ISE unit lid and the upper cover. Select C l o s e , to get
back to the ISE Status.
As Required Maintenance
Perform the following tasks when necessary:
• Performing a Photometer Check. See page 206.
• Replacing Cuvettes. See page 206.
• Replacing the Sample Probe. See page 208.
• Replacing the Reagent Probe. See page 209.
• Replacing Mixing Bars. See page 211.
• Replacing Sample, Reagent and ISE Buffer Syringes. See

page 212.

• Replacing the Wash Nozzle Joint Tubes. See page 214.
• Cleaning the Deionised Water Filter and the Sample Probe Filter.
See page 216.
• Cleaning the Deionised Water Tank. See page 219.
• Replacing the Deionised Water Filter. See page 220.
• Replacing the Sample Probe Filter. See page 222.
• Replacing the Photometer Lamp. See page 223.
• Cleaning the Cuvettes and the Cuvette Wheel. See page 225.
CAUTION Performing a Photometer Check

A Photometer The purpose of a photometer check is to test the photometer lamp.
Check should
only be To check the photometer lamp:
performed
1 Prepare a bottle of deionised water.
when the
system is in Stop mode. 2 If the system is not already in Stop mode, then switch it to Stop
The photometer check mode by pressing the S t o p / S t a n d b y key on the keyboard.
should not be performed
until the lamp is fully 3 Select Maintenance>Maker Maintenance>ANL DIAG.
warmed up. This takes at 4 Click the C o m b i n a t i o n tab at the top of the window and
least 20 minutes after select P h o t o m e t e r C h e c k A / O - 1 0 0 % .
system start-up.
5 Click P r i n t ( F 3 ) to print results.
6 Select the cuvette numbers you want to check (1 - 88).
7 Add about 500 µl of deionised water to the selected cuvette, using
a pipette. This water is removed during the next auto-wash.
8 Select Y e s to Start
Measure. Normal Photometer Range
0% = -5 to 25
9 The 0% and 100%
100% = 0.01 to 1.7
values are displayed
for all positions
selected on the
cuvette wheel. If the values you see are beyond the normal range,
you must replace the photometer lamp (see “Replacing the
Photometer Lamp” on page 223).
CAUTION Replacing Cuvettes

When replacing Materials Needed:
cuvettes, you
must use the • New cuvette ZM0634 (cuvette case color blue)
correct part
number • Cotton tipped applicators
ZM0634 to avoid generating
incorrect data.

To replace a cuvette:
CAUTION
When removing
2 Lift up the top lid of the system. the cuvette
3 Remove the cuvette wheel cover, as shown in Figure 8-8. wheel cover, be
sure not to hit
off any other
parts of the system.
Positioning pin on the cuvette

wheel cover
Positioning pins on
the cuvette wheel
Green positioning
mark
O NT Positioning pin on the
FR cuvette wheel cover
Figure 8-8: Cuvette Wheel Covers
4 You can remove the cuvette from the wedge by either unscrewing
the wedge and pushing the cuvette out of it, or you can pull it out,
using two cotton tipped applicators.
5 Insert the new cuvette without touching the photometric face, as
shown in Figure 8-9. Ensure it is inserted fully into the cuvette
wheel wedge.
Cuvette wheel
Cuvette
L wrench
Cuvette
Photometric
face
Frosted glass
face
Figure 8-9: Cuvette

6 Replace the cuvette wheel cover and close the top lid of the system.
7 Repeat this procedure for all cuvettes to be replaced and always
perform a photocal after fitting new cuvettes or after cleaning
existing cuvettes, as described in Performing a Photocal. See
page 193.
Replacing the Sample Probe

CAUTION
The sample probe should be replaced if it becomes bent or damaged in
Position the any way, using the following procedures
sample probe
over the wash • Removing the Old Sample Probe. See page 208.
wells when
replacing it to • Fitting the New Sample Probe. See page 209.
collect any drips.
• Priming the New Sample Probe. See page 209.
Material Needed:
• Sample Probe
Removing the Old Sample Probe

2 Select Maintenance>ANL Maintenance>A/Replaces S Probe
& Syringe.
3 Press the S T A T R O T A T I O N / D I A G switch to drain any
liquid remaining in the sample tubing.
4 Remove the sample probe cover by unlatching it on each side,
pulling out the sides and then lifting it up, as shown in Figure 8-10.
Sample probe cover
T
ON
FR
Figure 8-10: Removing the Sample Probe Cover
5 Disconnect the probe connector and undo the nut.

6 Hold the connector with one hand and lift out the sample probe,
as shown in Figure 8-11 on page 209.

Probe connector
Sample probe
T
ON Sample probe wash well
FR
Figure 8-11: Disconnecting and Fitting the Probe
Fitting the New Sample Probe

1 Fit the new sample probe by putting it down through the holder
until fully seated.
2 Connect the probe connector on the end of the tube and tighten it
firmly by hand. DO NOT USE ANY TOOLS TO TIGHTEN THE
CONNECTOR.
3 Put the sample probe cover back on. Just push it down until you
feel a click and each side is connected. Pull it slightly to check that
it is on properly and can’t move. If it shakes or moves at the touch
of a hand, the wedge might be broken and you might need to
replace the cover.
Priming the New Sample Probe

2 Press the S T A T R O T A T I O N / D I A G switch to dispense
deionised water through the probe tip. Ensure that the jet of water
is thin, direct and in a straight line.
3 Close the top lid of the system.
CAUTION
Replacing the Reagent Probe
Position the
The Reagent probe should be replaced if it is bent or damaged in any reagent probe
way, using the following procedures: over the wash
wells when
• Removing the Old Reagent Probe. See page 210. replacing it,
to collect any drips.
• Fitting the New Reagent Probe. See page 211.
• Priming the New Reagent Probe. See page 211.

Material Needed:
• Reagent Probe

Removing the Old Reagent Probe
2 Lift up the top lid of the system.
3 Select Maintenance>ANL Maintenance>B/Replace R Probe &
Syringe.
liquid remaining in the sample tubing.
5 Remove the reagent probe cover by unlatching it on each side,
pulling out the sides and then lifting it up, as shown in Figure 8-12.
Reagent probe cover
Reagent probe wash well

N T
FRO
Figure 8-12: Removing the Reagent Probe Cover
6 Disconnect the probe connector.

7 Hold the connector with one hand and lift out the reagent probe,
Probe connector
Reagent probe
Reagent probe wash well

T
ON
FR
Figure 8-13: Removing the Reagent Probe

Fitting the New Reagent Probe
1 Fit the new reagent probe by putting it down through the holder.
2 Connect the probe connector on the end of the tube and tighten
the nut that goes over it firmly.
3 Put the reagent probe cover back on. Just push it down until you
feel a click and each side is connected. Pull it slightly to check that
it is on properly and can’t move. If it shakes or moves at the touch
of a hand, the wedge might be broken and you might need to
replace the cover.
Priming the New Reagent Probe

2 Press the S T A T R O T A T IO N / D I A G switch to dispense
deionised water through the probe tip. Ensure that the jet of water
is thin, direct and in a straight line.
3 Close the top lid of the system.
Replacing Mixing Bars

Mixing bars should be replaced if any of their teflon coating is chipped
or if they are damaged in any other way. If you notice that any of the
mixing bars have stains that cannot be removed by the routine cleaning
procedure outlined in “Inspecting and Cleaning the Mixing Bars” on
page 90, then they should also be replaced as stains might affect
sample analysis result data.
Materials Needed:
• Mixing bar
Mixing bar
Mixing unit
T
ON
FR
Figure 8-14: Replacing a Mixing Bar
CAUTION
To replace a mixing bar:
Do not replace
1 Check that the system is in Warm-up mode or Standby mode. mixing bars
2 Lift up the top lid of the system. while the
system is in
3 Remove the mixing bar you want to replace, as shown in operation.
Figure 8-14.

4 Put a new mixing bar down through the hole taking care not to
scrape it.
5 Twist the mixing bar a little until you can feel it slipping into place
where it is gripped by the gear of the unit.
7 Press the S TA T R O T A T IO N / D I A G switch and examine
the action of the new bar to see that it is working properly.
8 Close the system lid.
9 Repeat this procedure for each mixing bar you have to replace.
Replacing Sample, Reagent and ISE Buffer

Syringes
Use the following procedures to replace a syringe:
• Removing the Old Syringe. See page 212.
• Fitting a New Syringe. See page 213.
• Priming the New Syringes. See page 214.

There are two different sizes of syringe:
• Sample Syringe—Size S
• Reagent and ISE Buffer Syringe—Size R

Each type of syringe is clearly labelled to indicate its type.
Replace syringes when:
• Movement of the syringe is either very stiff or very loose or just

not as smooth and resistant as it should be.
• Teflon tip is chipped, worn or damaged in any other way.
• Leaks are occurring, even following maintenance and correct

installation.
Materials Needed:
• New sample syringe
• New reagent syringe
• New buffer syringe
Removing the Old Syringe

3 Select Maintenance>ANL Maintenance>A/ Replace S Probe &
Syringe or B/ Replace R Probe & Syringe as appropriate.
4 Press the S T A T R O TA T I O N / D IA G switch to drain liquid
from the syringe tube you are about to replace.
5 Loosen the screws at the bottom and at the top of the syringe unit
you want to replace.

6 Remove the syringe unit carefully from the mounting grooves.
7 Remove the syringe from its case by turning it anticlockwise while
holding the case head, as shown in Figure 8-15 on page 213.
8 Be careful the O-ring doesn’t fall out of the head and gets lost. If it
remains in the syringe head, remove it carefully with a tweezers.
ISE reagent dispenser Fixing nut

Sample dispenser
Reagent dispenser Mounting groove
Fixing screws FFRRO

ONNT
Syringe case T
Mounting groove
Electromagnetic
valve
Piston fixing screw
CAUTION
Figure 8-15: Removing a Syringe
Do not use
pliers or any
Fitting a New Syringe other tools to
1 Ensure the new syringe and existing case head are thoroughly dry remove
syringes or to
before fitting the new syringe into the case head. Ensure the O-ring
tighten the screws that keep
is also in the case head.
them in place.
2 Fit the syringe case onto the syringe, as shown in Figure 8-16. Always tighten the top
screw first.

Sample dispenser
Reagent dispenser Mounting groove
Fixing nut
Fixing screw
FR
ON
T
Case head
Syringe case
Piston fixing screw
Figure 8-16: Fitting a New Syringe
3 Place the syringe back between the mounting grooves.

4 Tighten the top screw first by hand and then the bottom screw,
also only hand tight.

Priming the New Syringes
2 If you have replaced the ISE Buffer syringe, then select System
Status>ISE Status>Prime (F6)>D/Buffer Prime.
3 If you have replaced the Sample syringe, then select
Maintenance>ANL Maintenance>H/S Syringe Prime.
4 Press the S T A T R O T A T IO N / D I A G switch to prompt the
flow of liquid through the tubes and eliminate all air bubbles. You
might have to prime a number of times to eliminate all air bubbles.
5 Examine the tubing once more for signs of leaks and close the
two doors on the front of the system.
Replacing the Wash Nozzle Joint Tubes

Cracked washed nozzle tubes would allow liquid to drip from the
nozzles into the cuvettes and either cause an overflow in the cuvettes
or leave liquid in cuvettes, which might alter analysis result data.
Tubes should be replaced immediately, therefore, if they are damaged.
Use the following procedures:
• Removing the Old Wash Nozzle Joint Tubes. See page 214.
• Replacing an O-ring of the Wash Nozzle Tube Mounting Joint

Unit. See page 215.
• Fitting the New Wash Nozzle Joint Tubes. See page 215.
• Priming the New Wash Nozzle Joint Tubes. See page 216.
Material Needed:
• New Joint tube (three per set)
Removing the Old Wash Nozzle Joint Tubes

2 Left up the top lid of the system.
3 Select Maintenance>ANL Maintenance>E/Replacing
Wash Nozzle.
liquid remaining in the wash nozzle tubing.
5 Lift up the rear lid. Ensure the lid is opened right back and
therefore will not fall down during maintenance.
6 There are four tube mounting joint manifolds. Remove each one,

Tubing
Tube mounting
joints
Knob
Tube mounting Positioning screws

joints
Wash nozzle
Wash nozzle FR
ON
station T
Figure 8-17: Fitting Wash Nozzle Joint Tubes
7 Loosen the screw holding the wash nozzle station and remove
the unit and tubing leaving it to one side. Do not loosen the two
smaller screws.
8 Remove the old or damaged tubes.
Replacing an O-ring of the Wash Nozzle Tube Mounting Joint Unit

To check and replace O-rings: CAUTION
Materials Needed: If O-rings are
used without
• O-ring Type 1 cleaning for an
extended period
• O-ring Type 2
of time, or if the
1 Wipe off dust and dirt with a gauze dampened with water. If any cover on the joint unit is
dirt is not removed, detach the O-ring using tweezers, wash it closed without an O-ring in
with water, and then set it in place again. the groove, detergent crystals
are generated, or scratches
2 If any scratch or damage is found on an O-ring, replace it with made on the O-ring. Be sure
a new O-ring. to check the O-rings.
You should replace the
O-rings with new ones once
Fitting the New Wash Nozzle Joint Tubes
a year.
1 Place the new joint tube on the mounting joint and on the other end
of the wash nozzle.
2 Both ends of the tubing should be centred.
3 Allow about 1 mm between the ends of the tube and nozzle
(see Figure 8-17 on page 215).
4 Put the wash nozzle station back and tighten the screw.
5 Close down the rear lid.

Priming the New Wash Nozzle Joint Tubes
1 Select Maintenance>ANL Maintenance>F/Prime Washing-line.
2 Press the S T A T R O T A T IO N / D I A G switch to prompt the
flow of liquid through the tubes and eliminate all air bubbles. You
might have to prime a number of times to eliminate all air bubbles.
3 Examine the tubing once more for signs of leaks and close the rear
lid of the system.
Cleaning the Deionised Water Filter and the

CAUTION
Sample Probe Filter
It is important
that the system If dirt accumulates in the deionised water filter and sample probe filter,
is in Stop mode analysis results might be affected. These should be cleaned at least
before once a month, using the following procedures:
performing this
procedure. If it is not, the • Removing the Deionised Water Filter. See page 216.
float switch in the deionised
water tank is activated and • Cleaning and Mounting the Deionised Water Filter and the
water drains from the Sample Probe Filter. See page 218.
tubing.
• Priming the Wash-lines. See page 218.
Materials Needed:
• Dry, clean cloth
• Basin
• Sonicator filled with deionised water
Removing the Deionised Water Filter

TIP
1 Go to Stop mode by pressing the S t o p / S t a n d b y key.
Loosen the
deionised 2 Open the left front door of the system.
water filter 3 Put a basin on the floor at the door so that it reaches under the unit
case and
to collect any liquids that might spill.
the sample
probe filter
case over the basin. The
deionised water in the filter
cases drains. If the deionised
water spills onto the system,
wipe it off immediately with a
dry clean cloth.
Be careful not to lose the
O-ring when taking out the
sample probe filter.

4 While pressing the two buttons, at the top and the bottom of the
filter housing, disconnect the sample probe filter case and the
deionised water drain hose joint, as shown in Figure 8-18.
Connector
Fixture
Button
Deionised water
Filter case drain hose
Joint
T
ON
FR
Vessel
Figure 8-18: Disconnecting the Filter Case
5 Disconnect connector no. 240 at the left side of the deionised

water tank.
6 Pull out the deionised water tank gently, as shown in Figure 8-19.
Water supply tube
Filter case
Vessel
Deionised water filter

T
ON
FR Filter case cap
Figure 8-19: Pulling Out the Deionised Water Tank
7 Remove the water supply tube.

8 Remove the deionised water filter from the filter case.

9 Unscrew the sample probe filter from the filter case, as shown in
Figure 8-20.
Joint
Connecting hose
Button Fixture
Filter case
Button
NT Joint
FRO Vessel
Figure 8-20: Removing the Filter Case
Cleaning and Mounting the Deionised Water Filter and the Sample
Probe Filter
1 Clean the deionised water filter and the sample probe filter for
10 minutes in deionised water, using a sonicator. If you do not
have a sonicator, use a toothbrush and then rinse thoroughly with
deionised water.
2 Insert the deionised water filter back into the filter case. Ensure the
circular holder in the top of the casing is on correctly. One side of
the holder has a pin that should be facing outwards on top of the
casing.
3 Replace the filter case cap and tighten it firmly.
4 Insert the water supply tube back into the deionised water tank and
place the tank back into the system.
5 Insert the sample probe filter back into the sample probe filter
case, making sure to have the O-ring correctly in place. Tighten
the filter case firmly.
6 Connect the two joints on the sample probe filter case. Push them
together until you hear a click. Be sure the filter is right side up.
7 When everything is properly reconnected, take away the basin,
reconnect the joints to the deionised water tank and reconnect
connector no. 240.
8 Go to Standby mode by pressing the S t o p / S t a n d b y key.
Click Y e s to go to Standby mode.
Priming the Wash-lines

2 Press the S T A T R O T A T I O N / D I A G switch. The
deionised water flows through the tube eliminating air from the
tube. You might have to prime a few times to eliminate all the air.
3 Check for the last time that nothing is leaking.
4 Close the front door on the system.

Cleaning the Deionised Water Tank CAUTION
If deposits or bacteria accumulate in the deionised water tank, analysis It is important that
results might be affected. The deionised water tank should be cleaned the system is in
regularly, following the following procedures: Stop mode before
performing this
• Removing the Deionised Water Tank. See page 219. procedure. If it is
not, the float switch in the
• Replacing the Deionised Water Tank. See page 220. deionised water tank is
activated and water drains
• Priming the Deionised Water Tank. See page 220. from the tubing.
Materials Needed:
• Dry clean cloth
• Basin
• Freshly prepared 10% Cleaning Solution
Removing the Deionised Water Tank

1 Go to Stop mode by pressing the S t o p / S t a n d b y key.
3 Put a basin on the floor under the deionised water drain hose.
4 While pressing the button, disconnect the joint of the tube
connected to the deionised water tank. You might have to pull
the sample probe filter case forward to reach the deionised
joint button.
5 Disconnect liquid-level sensor No.240.
6 Pull out the deionised water tank, as shown in Figure 8-21 on
page 219.
Deionised-water tank
Connector Float switch
Fixture
Joint
Filter case Deionised-water

drain hose
T
ON Vessel
FR
Figure 8-21: Removing the Deionised Water Tank.
7 Loosen the cap and remove the float switch.

8 Remove the tubes inserted into the deionised water tank.

9 Pull out the deionised water tank.
10 Thoroughly rinse the inside of the tank and tubes with the 10%
Cleaning Solution and rinse thoroughly with deionised water.
Leave the tank to dry out naturally.
Replacing the Deionised Water Tank

1 Fill the deionised water tank with about 5 l of deionised water.
2 Insert the water tubes and the float back into the tank and
reconnect the joint on the tank by pushing it in until you hear
CAUTION a click.
The pumps 3 Tighten the cap and ensure the sample probe filter case is secure
might get in its clip.
damaged if the
4 Reconnect connector No. 240.
tank empties
and the pump 5 Go to Standby mode by pressing the S t o p / S t a n d b y key.
runs without water.
6 Click Y e s to go to Standby mode.
Priming the Deionised Water Tank

8 Press the S T A T R O T A T I O N / D I A G Switch. This makes
the deionised water flow through the tube and eliminate all the air
in the tubing. You might have to prime a number of times until all
air is eliminated from the tubing.
9 Close the right front door on the sampler unit.
Replacing the Deionised Water Filter

Use the following procedures to replace the deionised water filter:
• Removing the Old Deionised Water Filter. See page 220.
• Fitting the New Deionised Water Filter. See page 221.
• Priming the Deionised Water System. See page 221.

Materials Needed:
• Dry clean cloth
• Basin
• New deionised water filter
Removing the Old Deionised Water Filter

1 Go to Stop mode by pressing S t o p / S t a n d b y on the
keyboard.
2 Open the right front door on the sampler unit.
3 Put a basin in under the door to catch any liquid that might spill
during the procedure.
4 Remove the sample probe filter from the holder, as shown in
Figure 8-22.
5 While keeping the grey button pressed, disconnect the joint of the
deionised water drain hose and disconnect connector No. 240.

6 Slide the deionised water tank out gently and remove the water
supply tube from it.
7 Twist off the filter case and remove the deionised water filter
from inside.
Water supply tube
Filter case
Vessel
Deionised water filter

T
ON
FR Filter case cap
Figure 8-22: Removing the Deionised Water Filter
Fitting the New Deionised Water Filter

1 Fit the new deionised water filter into the filter case and replace the
cap tightening it firmly.
2 Re-insert the water supply tube and slide the tank back into place.
3 Reconnect the joint to the deionised water tank, reconnect
connector no. 240 and remove the basin, disposing of any water
collected.
Priming the Deionised Water System

1 Press the P o w e r O n button.
3 Press the S T A T R O T A T I O N / D I A G switch to prompt the
flow of deionised water through the tubes and eliminate all air
bubbles. You might have to prime a number of times to eliminate
all air bubbles.
right front door of the system.

Replacing the Sample Probe Filter
Follow the following procedures to remove the sample probe filter:
• Removing the Old Sample Probe Filter. See page 222.
• Fitting the New Sample Probe Filter. See page 223.
• Priming the New Sample Probe Filter. See page 223.

Materials Needed:
• Dry clean cloth
• Basin
• Sample Probe Filter
Removing the Old Sample Probe Filter

1 Go to Stop mode by pressing S t o p / S t a n d b y on the
keyboard.
2 Open the left front door on the sampler unit.
3 Put a basin under the door to catch any liquid that might spill during
the procedure.
4 Pull the filter case out gently removing it from its holder.
5 While keeping the top and bottom buttons pressed, disconnect the
sample probe filter case.
6 Unscrew the filter case, and remove the sample probe filter from it,
Joint
Connecting hose
Button Fixture
Filter case
Button
NT Joint
FRO Vessel
Figure 8-23: Removing the Sample Probe Filter

Fitting the New Sample Probe Filter
1 Fit the new sample probe filter into the filter case, tightening the
case firmly.
2 Connect the two joints on the sample probe filter by pushing them
together until you hear a click, as shown in Figure 8-24.
3 Place the filter back into the holder so that it is sitting securely.
4 Connect the joint to the deionised water tank and remove the basin
disposing of any liquid collected.
Sample probe filter
O-ring
Filter case
T
ON
FR
Figure 8-24: Fitting a New Sample Probe Filter
Priming the New Sample Probe Filter

1 Go to Standby mode by pressing the S t o p / S t a n d b y key.
Click Y e s to go to Standby mode.
3 Press the S T A T R O T A T I O N / D I A G switch to prompt the
flow of deionised water through the tubes and eliminate all air
bubbles. You might have to prime a number of times to eliminate
all air bubbles. CAUTION
Only replace
right door on the front of the system.
the photometer
lamp when the
system is
completely shut
Replacing the Photometer Lamp down and the main power
switch is off and has been
Photometer lamps are guaranteed for 1000 operating hours but so for at least 15 minutes.
frequently function for six months. Prior to total failure, they may Never touch the lamp with
become unstable and this is indicated by an increasing frequency your bare hands. The lamp
of "*" flags on enzyme results (non-linear reaction). can potentially be extremely
To replace the photometer lamp: hot and can cause serious
burns.
1 Shut down the system and turn off the main power.
2 Lift off the photometer unit cover on the top of the system next to
the cuvette wheel, as shown in Figure 8-25.

3 The lamp is connected to the power source by two wires, each of
which is attached to a terminal and kept in place by a screw. These
screws should loosen by hand and allow you to remove the two
wire connections.
Lamp unit cover
Knobs
Lamp holder
T
ON
FR Lamp cords
Figure 8-25: Photometer Lamp Unit Cover
4 Unscrew the lamp holder by twisting it anticlockwise. This allows

you to pull out the lamp, as shown in Figure 8-26.
Lamp holder
Photometer lamp
T
ON
FR
Figure 8-26: Removing the Photometer Lamp
5 Remove it from the collar and fit the new lamp into the collar and
then into the holder. Insert these into the lamp receptacle. The
notch on the lamp and the notch on the collar should be aligned
with the protrusion on the lamp receptacle as shown in
Figure 8-27.

Protrusion
Notch
Lamp receptacle
Guide key
Collar notch
Figure 8-27: Aligning the Photometer Lamp CAUTION

Never touch the
6 Twist the lamp holder tight. There should be no play or movement glass on the
lamp.
on the whole unit.
If it falls or hits
7 Slide the electric connectors on to the terminals and tighten the off something
knobs to keep them in place. you might need to test it
before fitting it. Similarly, do
8 Turn on the main power and start up the system. not allow it to hit off the
9 After allowing the photometer lamp to warm up for 15 to receptacle or any other
20 minutes, perform a photocal (see “Performing a Photocal” on fitting when you are putting
page 193) and a photometer check to make sure the installation it in.
is done correctly. Be sure to save photocal data.
Cleaning the Cuvettes and the Cuvette Wheel

Clean cuvettes if any visible cloudy residues form, and particularly
if cuvettes have overflowed due to wash nozzle blockage or
malfunction. Cuvettes should be cleaned at least every six months if
the analysis results produced by the system are to remain accurate.
Follow the following procedures:
• Removing Cuvettes. See page 226.
• Cleaning Cuvettes. See page 226. CAUTION

• Cleaning the Cuvette Wheel. See page 226. Do not touch
the photometric
Materials Needed:
face of a
cuvette.
• Cotton Tipped Applicators
Fingerprints
• 2% Wash Solution would stain the cuvette
glass and might adversely
affect photometric data.

Removing Cuvettes
1 Confirm that the sub-power of the system is off.
2 Open the rear door of the system. Open the door right back so that
CAUTION it stays open freely and that it does not fall down when you are
working with the unit.
Do not let the
cuvette wheel 3 Loosen the knob on the wash nozzle station, remove it and hang
hit off the it on the hook.
sample probe, 4 Open the upper cover and remove the mixing bars so that the
reagent probe cuvette wheel cover can be removed.
or mixing bars when
removing it. 5 Remove the cuvette wheel cover.
6 Remove each cuvette, as shown in Figure 8-28.
Cuvette wheel
Cuvette
L wrench
Figure 8-28: Removing Cuvettes
Cleaning Cuvettes
1 Sonicate the cuvettes in 2% Wash Solution for 15 minutes. If you
do not have a sonicator, leave the cuvettes submerged overnight
in 2% Wash Solution.
2 Rinse the cuvettes thoroughly in deionised water or sonicate them
in deionised water for at least 10 minutes.
3 Allow the cuvettes to either dry naturally or use a hair dryer.
You could also put them in an oven at 50°C.
4 When completely dry, replace all cuvettes, polishing each one with
a clean, dry, lint-free cloth as it is placed into its holder. Ensure that
the cuvette is pushed fully into the holder so that the top of the
cuvette is flush with the top surface of the holder.
Cleaning the Cuvette Wheel

1 Wash the cuvette wheel sufficiently with tap water and rinse it in
deionized water.
2 Allow the cuvette wheel to either dry naturally or under a
temperature of 50°C or less.

As Required ISE
Maintenance
Perform the following tasks when necessary:
• Replacing the Na, K or Cl Electrode. See page 227.
• Replacing the Valve Tubing. See page 230.
• Adding Reference Electrode Solution. See page 233.
• Replacing the Reference Electrode. See page 233.
• Replacing the ISE Buffer Syringe. See page 235.
• Replacing ISE Reagents. See page 235.
Replacing the Na, K or Cl Electrode

If the electrodes have deteriorated, appropriate analysis results will not
be obtained. Replace the electrode when calibration or Selectivity
Check results are out of range, and troubleshooting has been
performed. Electrode performance is under guarantee for 40,000
samples or 6 months, whichever comes first, on the condition that
calibration and Selectivity Check results are in range.
Replacing the electrode at the guarantee period ensures continuous,
reliable electrode performance without unexpected analyzer down-
time. Refer to the following procedures:
• Removing the Old Na, K or Cl Electrode. See page 228.
• Fitting the New Electrodes. See page 229.
• Priming the New Electrodes. See page 229.

Materials Needed:
CAUTION
• New Na Electrode
Ensure you do
• New K Electrode not lose the
O-rings that fit
• New Cl Electrode between the
electrodes.

Removing the Old Na, K or Cl Electrode
1 Check that the ISE unit is on and the system is in Warm-up mode
or Standby mode.
2 Open the top lid of the system and then the ISE lid, as shown in
Figure 8-29.
Lock lever (The electrodes

are locked in this state.)
K electrode
Na electrode
Cl electrode
Cord
STAT ROTATION/DIAG switch
S
T
A
T
E
N
S
D
T
A
T
S
E
T
IS
E
P
R
IM
E
Figure 8-29: ISE Electrodes
3 Click the S y s t e m S t a t u s button and the I S E S t a t u s

button.
4 Click P r i m e ( F 6 ) and then A / R e p l a c e E l e c t r o d e.
5 Press the S T A T R O T A T I O N / D I A G switch. The liquid
that remains in the region of electrodes will be drained.
6 Disconnect the electrical connection (red, yellow, or blue wire)
from the electrode and unlock the electrode by pulling the lock
lever forward.
7 Gently lift out the electrode taking care that the O-ring does not fall
out and get lost.

Fitting the New Electrodes
1 Fit the new electrodes in the following order:
• Cl
• Na
•K
2 Push the lock lever back into its original position and reconnect the
electrical connection (red, yellow, or blue wire) to the electrodes,
3 Press the S T A T R O T A T IO N / D I A G switch to resupply
MID standard solution to the electrodes.
Lock lever
K electrode
Na electrode
Cl electrode
Tube
Blue cord
Yellow cord
Red cord
REF electrode cord

T
ON
FR
Figure 8-30: Fitting New Electrodes
Priming the New Electrodes

1 Click the I S E S t a t u s button then Prime (F6) and then
E/MID/REF Prime.
Press the S T A T R O T A T IO N / D I A G switch until the
rolling pumps are activated intermittently four or five times. Have a
look at the tube at the bottom of the flow cell to see if there are air
bubbles in the solution passing through the electrodes. You might
have to press the S T A T R O T A T I O N / D I A G switch a
number of times to fully eliminate the air from the tubes. If bubbles
cannot be eliminated by priming, check that no O-rings are missing
and that the lock lever is fully down.
3 Wait about 5 minutes and then perform two consecutive ISE
calibrations (see “Calibration Process on the ISE” on page 82).

4 To perform ISE calibration, select System Status>ISE Status>ISE
Unit Start (F5). Perform a calibration for the ISE. If the calibration
is unsuccessful, check the tubing on the ISE unit to make sure
no air bubbles are present when performing a Mid-Standard and
Reference Prime. Ensure also that fresh serum or urine standard
solution is being used, then recalibrate.
5 If the difference between the calibrations is beyond the following
ranges, the new electrode might not be stable. To stabilise it,
you should prime again until you get satisfactory results.
Acceptable difference between 1st and 2nd replicates

of Mid Standard factors
Na 0.020
K 0.045
Cl 0.025
Replacing the Valve Tubing

From repeated use over a period of months, the tubing in the pinch
valves might become worn. The pinch valve tubing should therefore
be checked regularly and replaced if required. Follow the following
procedures:
• Disconnecting the Pinch Valve Tubing. See page 230.
• Fitting the New Pinch Valve Tubing. See page 232.
• Inserting the New Tubing in the Pinch Valve. See page 232.
• Priming the New Pinch Valve Tubing. See page 232.

Materials Needed:
CAUTION
• New Pinch Valve Tubing
Be sure you do
not put the tubing
Disconnecting the Pinch Valve Tubing
in the wrong
grooves on the 1 Check that the system is in Warm-up mode or Standby mode.
pinch valve as
this would disrupt the correct 2 Select System Status>ISE Status>F6 (prime). Select one of the
supply and draining of liquids. prime operation items, then press the Enter key. The periodic
washing of the ISE unit will be stopped.
3 Lift up the upper lid.
4 Lift up the ISE lid.

5 Disconnect tubing joints 4, 5, and 6 from the pinch valve tubing as
shown in Figure 8-31.
To position 5
To position 6
Groove
Pass the tube through 6
the middle of the
groove.
Pinch valve
4 Pinch valve
T
ON
FR
Figure 8-31: Pinch Valve Tubing
6 Following Figure 8-31, disconnect the pinch valve tubing

as follows.
a Pull the tube from the top pinch valve groove gently to the
left until it comes out of the slot.
b Press the green button on the top of the pinch valve and at
the same time pull the tubing gently out of the bottom slot
Pinch valve tubing
TIP
Pinch valve Follow the

diagram on
the inside of
T
ON the ISE Unit
FR
showing
how to put
Figure 8-32: Disconnecting the Pinch Valve Tubing the tubes correctly into the
pinch valves.

Fitting the New Pinch Valve Tubing
Following Figure 8-33, fit the new pinch valve tubing as follows.
1 Connect the single end of the tube at point 4.
2 Connect the other two ends to points 5 and 6.
Pinch valve tubing
Pinch valve
4
T
ON
FR
Figure 8-33: Positions 1, 5 and 6
Inserting the New Tubing in the Pinch Valve

Following Figure 8-33 on page 232, insert the new tubing into the pinch
valve as follows:
1 Press the green button on the pinch valve and, at the same time,
insert the lower tube (going to point 6) and release the button.
2 With the green button released, insert the upper tube (going to
point 5). Ensure that both tubes are fully inserted into the groove.
Priming the New Pinch Valve Tubing

1 System Status>ISE Status>Prime (F6)>E/MID/REF Prime.
2 Press the S TA T R O T A T IO N / D I A G switch to activate the
rolling pumps and move the solution through each roller tube.
Ensure liquid is completely aspirated from the sample pot to the
electrode unit. If any remains, check all the connection points in
the previous procedure.
3 Close the ISE lid and upper lid.
4 Click Close and twice E x i t ( F 2 ) to return to the main software
window.

Adding Reference Electrode Solution
If the solution in the reference electrode falls below the reference line,
you must add solution.
Material needed:
• Internal Reference Solution

TIP
If you are
having
difficulty
getting
REF electrode normal
calibration
results, change the solution
before you change the REF
electrode.
Reference line
REF electrode solution
Figure 8-34: Reference Electrode Solution Level
CAUTION
To replace reference electrode solution:
1 Remove the cap from the Reference Electrode, as shown The reference
in Figure 8-34. electrode is
made of glass.
2 Add Internal Reference Solution.
3 Put the cap back on.
Handle it carefully.
Replacing the Reference Electrode

Reference Electrodes should be replaced if:
• Results are abnormally high or low for each of the three

electrodes (Na, K and Cl).
• Calibration results are very unstable.

Follow the following procedures:
• Removing the Old Reference Electrode. See page 234.
• Fitting the New Reference Electrode. See page 234.
• Priming the New Reference Electrode. See page 235.

Materials Needed:
CAUTION
• Reference Electrode
The reference
• Reference Electrode Sealing Ring Adapter electrode might
break if you use
• Internal Reference Solution too much force
when replacing it.

Removing the Old Reference Electrode
1 Check that the ISE unit is on and the system is in Warm-up mode
or Standby mode.
2 Open the top lid of the system and then the ISE lid.
3 Click the S y s t e m S t a t u s button and the I S E S t a t u s
button.
4 Click P r i m e ( F 6 ) and then A / R e p l a c e E l e c t r o d e.
5 Press the S T A T R O T A T I O N / D I A G switch to drain the
remaining liquid from the area of the electrodes.
6 Disconnect the reference electrode cable and unlock the
electrodes by pulling the lock lever forward.
7 Gently lift out the reference electrode mounting block, as shown in
8 Loosen the set screw and gently remove the reference electrode
and the screw. Remove the packaging carefully with a pair of
blunt-tipped tweezers.
Connector
REF electrode
Packing insertion hole
Set screw
REF electrode Block
T
ON
FR
Cross-sectional View of REF Electrode
Electrode bar
REF electrode
Figure 8-35: Removing the Reference Electrode
Fitting the New Reference Electrode

TIP
1 Ensure there are no bubbles of air in the new reference electrode
Apply a very tip. Expel any air bubbles by lowering the electrode bar and
light coating tapping it with your finger.
of silicon
grease to 2 Replace the sealing ring in the block.
the stem 3 Place the new reference electrode fully into the block, tighten the
of the set screw by hand and remount the block.
reference electrode but do
not allow any on the tip. This 4 Push the lock lever back into it’s original position and reconnect
will ease insertion into the the reference electrode cable.
sealing ring and will ease 5 Press the S T A T R O T A T I O N / D I A G switch to resupply
future removal. MID standard solution to the electrodes.

Priming the New Reference Electrode
1 Click the I S E S t a t u s button then Prime (F6) and then E /
M I D / R E F P ri m e.
Repeat this process for four or five cycles. Have a look at the tube
at the bottom of the flow cell to see if there are air bubbles in the
solution passing through the electrodes. You might have to press
the S T A T R O T A T IO N / D I A G switch a number of times to
fully eliminate the air from the tubes.
3 Wait about five minutes and then perform two consecutive ISE
calibrations (see “Calibration Process on the ISE” on page 82).
4 To perform ISE calibration, select System Status>ISE Status>ISE
Unit Start (F5). Perform a calibration for the ISE. If the calibration
is unsuccessful, check the tubing on the ISE unit to make sure
no air bubbles are present when performing a Mid-Standard and
Reference Prime. Ensure also that fresh serum or urine standard
solution is being used, then recalibrate.
5 If the difference between the calibrations is beyond the following
ranges, the new REF electrode might not be stable. To stabilise it,
you should prime again until you get satisfactory results.
Acceptable difference between 1st and 2nd replicates

of Mid Standard factors
Na 0.020
K 0.045
Cl 0.025
Replacing the ISE Buffer Syringe

The ISE buffer syringe should be replaced when movement of the
syringe is either very stiff or very loose or if the teflon tip is damaged in
any way. For a detailed procedure on replacing the ISE buffer syringe,
see “Replacing Sample, Reagent and ISE Buffer Syringes” on
page 212.
CAUTION
Replacing ISE Reagents Take care to
open only one of
When ISE reagents are running low or become empty, the system the ISE reagent
generates an alarm advising you to replace reagents. Reagents should bottles at any
always be topped up before analysis and never during. Reagents one time as
should also not be used beyond their on-board stability date, as correct cross-contamination
analysis results cannot be guaranteed. See the reagent package insert (particularly by crystals
formed from highly
for this date.
concentrated reference
Materials Needed: solution) affects ISE results.
• New Buffer Solution Container
• New MID Standard Solution Container
• New Reference Solution Container

To replace ISE reagents:
TIP
1 Open the left door on the front of the system.
Reference
Solution:
2 Unscrew the lid and remove the aspiration tube from the container
Top up you want to replace, as shown in Figure 8-36 on page 236.
once only. 3 Dispose of this container carefully with other waste liquid.
On-board
stability; 2 months. 4 Put in a new container, insert the aspiration tube and tighten
the cap.
Buffer: Top up once only. 5 Slide the container right in so that it is in line with the others.
On-board
stability; 2 months. 6 Click the S y s t e m S t a t u s b u t t o n and then the I S E
S t a t u s button.
MID Standard Solution: Do
not top up or consolidate 3 or
7 Click P r i m e ( F 6 ) .
4 part used bottles. When 8 From the P r i m e O p e r a t io n window, select D / B u f f e r
this runs low discard the P r i m e or E / M I D / R E F P r i m e , depending on the liquids
remainder. On-board you have added.
stability; 1 month.
Aspiration tube
MID solution Cap
tank
Buffer solution
tank
FR
ON
T
REF solution tank
Figure 8-36: ISE Tanks
9 Press the S T A T R O TA T I O N / D IA G switch. The ISE Unit

should be primed at least three times.
10 Close the system door.

Running Remote
Maintenance
When the system is in Stop mode, you can make system information
such as data lists and analysis results remotely available to Beckman
Coulter personnel using the Modem function. This enables your Beck-
man Coulter representative to quickly assess data problems and pro-
vide quick troubleshooting solutions.
You can send information in two forms

• As output to a remote printer
• As a data file to be remotely viewed
To enable remote maintenance mode:

TIP
1 Select Maintenance>Data Operation>Modem.
2 Select the output format by selecting one of the radio buttons. In order to
use the
3 Click Connect (F5). remote
maintenance
4 Select Yes to enter remote maintenance mode.
functions,
To disable remote maintenance mode: the system must be
connected to a telephone
1 Click Stop (F6) on the Modem window. point configured to accept
2 Select Yes to exit remote maintenance mode. direct-dial incoming calls.

Routine Maintenance
Schedule AU400 with ISE
Maintenance Date (below)Month____________Year:______

Ref 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Inspect sample and reagent
syringes
Inspect ISE buffer syringe
Inspect ISE reagent levels
Inspect, clean and prime

sample and reagent probes
Inspect and clean mixing bars
Auto wash the ISE sample pot

and electrode lines
Inspect the master detergent

level (conc. wash solution)
Inspect printer and paper
Prepare and refill sample

probe detergent tube (W1)
Calibrate ISEs-Serum: ~ 4
ISE and Analyser
mins, Serum&Urine: ~7 mins
Calibrate ISE
Perform Wash 1
Daily
Overdue Weekly/Monthly/As-
required maintenance
Perform a W2
Perform a Photocal
Wash sample pre-dilution

Analyser
bottle
Shutdown and reboot the

system
Perform a Selectivity Check

for the Na/K Electrodes
Wash the mixing bar and

liquid level sensors
Wash sample pot and sample

pot tubing
Weekly
Bleach clean the electrodes

ISE
and bypass tubing

Clean the sample and reagent
probe wash wells
Clean the mixing bar and

wash wells
Clean the wash nozzle
Clean the air filters

Analyser
Back up parameters
Replace the detergent pump

Monthly
tubing
Replace the mixture and mid-

ISE
standard pump tubing
Replace cuvettes
Replace the sample and/or

reagent probes
Replace mixing bars
Replace sample and/or

reagent syringes
Replace the wash nozzle joint

tubes
Clean the deionised water

filter and sample probe filter
Clean the deionised water

tank
Replace the deionised water

filter
Replace the sample probe

filter
Replace the photometer

lamp*
Perform a photometer check
Clean the cuvettes and the

Analyser
cuvette wheel
Perform W1
As required Maintenance
Replace the Na, K or Cl

electrode
Replace valve tubing*
Replace the reference

electrode
Replace the ISE Buffer

syringe
ISE
Replace the ISE Reagents
Tick dates maintenance is performed and sign at the end of each

month.
Signed________________ Date__________

Error Flags
Introduction
This chapter explains any error flags that can occur:
• Tabular Summary of Error Flags. See page 241.
• Error Flag Details. See page 243.
• Troubleshooting for Data Flags ?,@,$,D,F,G,!. See page 259.
Tabular Summary of Error

Flags
Flag Cause
d QC data has been excluded from calculation
e Edited data
( Shortage of detergent for contamination parameters in user-defined detergent

bottles R1 and R2
R Reagent Empty
# Sample Level Detection Error
% Clot detected in sample
? Unable to Perform Calculations
U Reagent Blank absorbance at last photometric point is low
u Reagent Blank/Routine absorbance at first photometric point is low
Y Reagent blank absorbance at last photometric point is high
y Reagent blank/routine absorbance at first photometric point is high
@ Test Results are too high
$ Not enough data to determine linearity of reaction
D Absorbance of reaction is greater than maximum Optical Density range
B Absorbance of reaction is less than minimum Optical Density range
* Linearity error in rate methods
& Prozone test data is abnormal
AU400 User Guide Version 2.11 Error Flags 241

Z Prozone Error
! Unable to calculate concentration
) Cannot convert from Optical Density to concentration
a Reagent expired
b Calibration expired
F Results are higher than the dynamic range
G Results are lower than the dynamic range
p Results are outside of the panic value range
T Abnormality found in inter-chemistry check
P Positive: any value above flag level H
N Negative: any value below flag level L
H Result is higher than normal value range
L Result is lower than normal value range
J Result is higher than repeat run range
K Result is lower than repeat run range
X Data not registered
1 Data exceeds QC range
2 Data exceeds the 3SD control limit
3 Contiguous QC data exceeds the 2SD control limit
4 Data exceeds the R4S control limit
5 Data exceeds the 41S control range
6 Data under/over last 10 averages
7 Data trend detected
S Sample repeated and original results replaced with repeat results
/ Test Requisition entered but not performed
r Data transmitted to the host computer
c Corrected Data
i Data correction is not performed on ISE results which are diluted manually
242 Error Flags AU400 User Guide Version AC

Error Flag Details
d - QC Data Excluded from Calculation

Cause:
• QC data has been excluded from calculation. This flag is

applied in QC Monitor>Data Edit.
Action:
• None required.
e - Edited Data
Cause:
• Data has been edited on the D a t a E d i t window.
Action:
• None required.
(- Shortage of Detergent for Contamination

Parameters in User-Defined Detergent Bottles
R1 and R2
Cause:
• The detergent set for contamination parameters in the

reagent compartment is empty. Contamination
parameters are suspended for the related cleaning
solution. Carryover might have occurred on tests that
have this flag.
Action:
• Fill the cleaning solution bottle in the reagent

compartment.
• Run the flagged tests again.
• To check contamination parameters, go to

Parameters>Special>Contamination Parameters.
AU400 User Guide Version AC Error Flags 243

R - Reagent Empty
Cause:
• Level detectors cannot detect reagent.
Action:
• Add more reagent and repeat analysis (see “Performing

a Repeat Run” on page 149.
• There might be air bubbles in the reagent bottle. Remove

these with a transfer pipette.
• Dry the mouth of the bottle.
• Wipe the reagent probe (see “Inspecting and Cleaning

the Sample Probe and Reagent Probe” on page 89).
• Ensure the reagent probe is operating correctly.
# - Sample Level Detection Error

Cause:
The sample probe cannot detect liquid. This is caused by:
• Insufficient sample volume.
• Malfunction in the sample probe level detector itself.
Action:
• Add more sample to the sample cup and run the test
again.
• Wipe the probe with an alcohol swab and check the

probe is attached correctly.
• Replace the sample probe.
% - Clot Detected in Sample

Cause:
Sample liquid has clogged the probe tip.
Action:
• Clean the sample probe (see “Inspecting and Cleaning

the Sample Probe and Reagent Probe” on page 89).
• Replace the sample probe.

? - Unable to Perform Calculations
Cause:
The probe tip has become blocked or partially blocked during

sample aspiration.
• The absorbance of the sample is above 2.5 OD.
• In a rate reaction, fewer than three photometric readings

satisfy the assay criteria specified in the specific test
parameters.
• The system has had a technical malfunction or has

become isolated from the power supply. Samples that
were being tested during such a malfunction are flagged
with a ? .
Action:
• The sample might be severely lipemic, icteric, hemolytic

or might contain excessively large amounts of the
analyte being tested. Dilute the sample and run the test
again.
• Verify the reagent (see Chapter 11, “Troubleshooting” on

page 279).
• The system generates error codes or other alarms to

identify the malfunction. When the problem is solved,
test the samples again. See “Troubleshooting for Data
Flags ?,@,$,D,F,G,!” on page 259.
• Check the syringes.
• Check the probes.
• Verify the calibrator material. (see “Troubleshooting for

Data Flags ?,@,$,D,F,G,!” on page 259.
• Contact your Beckman Coulter Representative.
U - Reagent Blank absorbance at Last

Photometric Point Low
Cause:
The reagent blank absorbance at the last photometric point of the

assay is below the lower limit. This is caused by:
• Reagent expiry.
• Invalid reagent Optical Density parameters.

• Reagent contamination.
• Reagents have not been prepared properly.
Action:
• Check the Optical Density range parameters by

selecting Parameters>Specific Test Parameters.
• Check the reagent expiry date.
• Check reagent condition (see “Troubleshooting for Data

Flags ?,@,$,D,F,G,!” on page 259).
• Replace the reagent and run the test again.
u - Reagent Blank/Routine absorbance at

First Photometric Point Low
Cause:
The reagent blank absorbance at the first photometric point of the

assay is below the lower limit. This is normally caused by:
• Reagent expiry.
• Reagents not prepared properly.
Action:



Y - Reagent Blank absorbance at Last
Photometric Point High
Cause:
Reagent blank absorbance at the last photometric point is higher

than the high limit defined. This is normally caused by:
• Reagent expiry.
• Reagents not prepared properly.
Action:


y - Reagent Blank/Routine absorbance at

First Photometric Point High
Cause:
Reagent blank absorbance at the first photometric point is higher

than the high limit defined. This is normally caused by:
• Reagent expiry.
• Reagents have not been prepared properly.
Action:

• Check the reagent condition (see “Troubleshooting for

Data Flags ?,@,$,D,F,G,!” on page 259).

@ - Test Results are Too High
Cause:
CAUTION
In dual wavelength measurement, an error occurs if either of the
When you
replace the two wavelengths exceed 2.5 OD. This is caused by:
photometer
lamp, perform a • Sample quality.
photocal after
the lamp has burned for 15- • Faulty photometer lamp.
20 minutes and then repeat
the photometer check with Action:
the new lamp. Recalibrate
all tests then before • The sample might be severely lipemic, icteric, hemolytic
restarting analysis.
or might contain excessively large volumes of the
analyte being tested. Dilute the sample and run the
test again.
• Perform a photometer check to assess the condition of

the lamp. Replace the lamp if the results are out-of-range
(see “Replacing the Photometer Lamp” on page 223).
• Check syringes.
• Check probes.
• Verify calibrator material (see “Troubleshooting for Data

$ - Not Enough Data to Determine Linearity of

Reaction
Cause:
• Fewer than three read points of a rate reaction are within

the acceptable Optical Density range specified. In order
to calculate a rate reaction properly, at least three
readings must be taken before reaching maximum
or minimum Optical Density. If these Optical Density
limits are exceeded, the reaction might have gone into
substrate depletion due to a high concentration or a
problem with the condition of the reagent. Linearity
calculations are not made when this error occurs.
Action:

test again.
• Check syringes.
• Check probes.

• Verify calibrator material.
• Ensure the reagent has not expired.
D - Absorbance of Reaction Greater than

Maximum Optical Density Range
Cause:
• The Optical Density of the photometry point FST + 2

(first photometry point plus two) exceeds the maximum
Optical Density value range during a positive reaction
(more likely) or negative reaction rate method.
• The Optical Density of a specified read point (first

photometry point or last photometry point) has exceeded
the maximum Optical Density value range during a fixed
method.
Action:


test again.
• If this flag is generated for several assays, the lamp

might need to be replaced. Perform a photometer check
(see “Performing a Photometer Check” on page 206),
to assess the condition of the photometer lamp.
B - Absorbance of Reaction Less than

Minimum Optical Density Range
Cause:
• The Optical Density of the photometry point FST + 2

(first photometry point plus two) does not reach the
minimum Optical Density value range during a positive
reaction or negative (more likely) reaction rate method.
• The Optical Density of a specified read point (first

photometry point or last photometry point) does not
reach the minimum Optical Density value range during
a negative reaction fixed method.

Action:


test again.
• If this flag is generated for several assays, the lamp

might need to be replaced. Perform a photometer check
(see “Performing a Photometer Check” on page 206),
to assess the condition of the photometer lamp.
*
Linearity Error in Rate Methods
Cause:
This flag is generated when the rate of a reaction varies by

more than the defined % variance (as defines in specific test
parameters) and is therefore deemed non-linear. Possible
causes are:
• Contaminated reagent.
• Unusually high result.
• Defective cuvettes.
• Electrical noise.
• Dirty or defective mixing bars.
• Reagent dispense probe alignment problem.
• Sample probe misalignment.
• If several tests performed at 340 nm generate this flag,

check the condition of the photometer lamp.
• The acceptable linearity is defined in Parameters>

Specific Test Parameters>Linearity.
Action:
CAUTION
• Dilute the sample and run it again or perform a dilution
Contact your re-run.
Beckman
Coulter
Representative
• Replace reagent if contaminated or out-of-date.
if this error
occurs frequently.

• Clean all mixing bars and check them for damage.
Replace any that have scratches or chips to their
teflon coating.
• Run the photometer check to determine lamp condition.

If OK, check cuvette condition.
• Replace the photometer lamp and perform photo-

calibration
& - Prozone Test Data Abnormal

Cause:
• Optical density of the data check measuring points of the

prozone test data exceeds Optical Density 2.5.
Action:
• Dilute the sample and run the test again.
• Verify that the correct settings were programmed in

Parameter>Special>Data Check Parameters. See
“Entering Data Check Parameters” on page 76.
Z - Prozone Error
Cause:
• The data check equation for any one of logic checks 1, 2

or 3 is satisfied and the check for falsely low result is
passed. This is often caused by an abnormally high
concentration of analyte in a sample.
Action:
• Check parameters in Parameters>Special>Data Check

Parameters. See See “Entering Data Check
Parameters” on page 76.
• Dilute the sample and run the test again.
CAUTION
! - Unable to calculate concentration
When the ! flag
appears, the
Cause: result value you
can see is the
• The system has failed to calculate a result. optical density of
the sample only. This is NOT
a final result and should not
be used.

Action:
• If this is a single sample issue, repeat and dilute if

necessary.
• If multiple samples are affected, review all operating

parameters such as:
- Reagent quality
- Calibration
- Sample integrity
- General system issues
• Check the reaction data including those processed

immediately before and after the flagged result. In the
presence of any abnormality, check the cuvettes for a
possible overflow. If the issue persists, contact Beckman
Coulter Technical Services.
• If the flag is generated on Na, K, or Cl, repeat a sufficient

number of samples which preceded the appearance of
the "!" flag in order to verify that no incorrect results were
reported. It is possible that air in the flowcell affected
samples before the "!" flag was generated.
- Perform a MID/REF Prime and verify no bubbles are in

the tubing at the bottom of the flowcell to ensure there
are no obstructions in the flowcell path.
- Verify all tubing is properly connected.
) - Cannot Convert from Optical Density

to Concentration
Cause:
• Reagent lot number does not match the calibrated

reagent lot number.
Action:
• Calibrate the reagent used in the test that generated

the flag.
• Calculate the result manually by selecting Routine>

Data Management>Data Correction.
a - Reagent Expired
Cause:
• Reagent expiry date or on-board stability date is

reached.

Action:
• Replace reagent and then check reagent volume

(see “Checking Reagents” on page 90).
b - Calibration Expired
Cause:
• The calibration for the test in question has expired.
Action:
• Perform calibration again (see “Performing Calibrations”

on page 103).
F - Results Higher than Dynamic Range

Cause:
• The concentration of the sample is above the dynamic

range high limit.
Action:
• Dilute the sample and run again.
• Check the Dynamic range parameters by selecting

Parameters>SpecificTest Parameters. Then run the
sample test again.
• Check syringes.
• Check probes.
• Check calibrator material.
G - Results Lower than Dynamic Range

Cause:
• The concentration of the sample is below the dynamic

range low limit.
Action:
• Check the Dynamic range parameters by selecting

Parameters>SpecificTest Parameters. Then run the
sample test again if appropriate.

• Check syringes.
• Check probes.
• Check calibrator material.
• Check the reagent probes and bottles for correct

position.
• Check reagents for bubbles.
p - Results Outside Panic Value Range

Cause:
• The result is outside of the panic value range set in

Parameters>Specific Parameters>Ranges tab.
Action:
• Check the panic range corresponds with your

laboratory’s standard values.
T - Abnormality in Inter-Chemistry Check

TIP Cause:
Checked
Test
• Result values are outside of the high or low limits
specified for the check test parameters.
parameters
test the
different Action:
analyte results for the same
sample. Direct Bilirubin, for • Check that the inter-item range values contained in
instance, should be less than Parameters>Inter related test>Checked test match
total bilirubin. your laboratory’s standard values.
P - Positive: Any Value Above Flag Level H

Cause:
• The V a l u e / F l a g field is set to F la g and the result

exceeds the Level H setting in Parameters>Specific Test
Parameters>Range tab.
Action:
• None required.

N - Negative: Any Value Below Flag Level L
Cause:
• The V a l u e / F l a g field is set to F la g and the result

is lower than the Level H setting in Parameters>Specific
Test Parameters>Range tab.
Action:
• None required.
H - Result Higher than Normal Value Range

Cause:
• Result value is higher than value entered for level H in

Parameters>Specific Test Parameters>Range tab.
Action:
• Note these results.
L - Result Lower than Normal Value Range

Cause:
• Result value is lower than value entered for level L in

Parameters>Specific Test Parameters>Range tab.
Action:
• Note these results.
J - Result Higher than Repeat Run Range

Cause:
• Result value is higher than the range of values entered

for a repeat run in Parameters>Repeat Parameters>
Repeat Specific.
Action:
• Perform a repeat run on the sample flagged

(see “Performing a Repeat Run” on page 149).

K - Result Lower than Repeat Run Range
Cause:
• Result value is lower than the range of values entered

for a repeat run in Parameters>Repeat Parameters>
Repeat Specific.
Action:
• Perform a repeat run on the sample flagged

(see “Performing a Repeat Run” on page 149).
X - Data Not Registered

Cause:
• If one of the two pairs of data, in multi-rule QC, are

out-of-range, the other piece of data is flagged.
Action:
• Data is not registered in the stack. Follow standard

laboratory procedure for QC results that are out-
of-range.
1 - Data Exceeds QC Range

TIP Cause:
If you are • One point of QC data exceeds the limit defined in

working Parameters>QC Control>QC Common>Single
with multi- Check Level.
rule QC,
this flag Action:
does not appear.
• Follow standard laboratory procedure for out-of-range
QC results.
2 - Data Exceeds 3SD Control Limit

Cause:
• One point of QC data exceeds the +3SD limit defined in

Parameters>QC Control>QC Common.
Action:

QC results.

3 - Contiguous QC Data Exceeds the 2SD
Control Limit
Cause:
• Two contiguous QC data points exceed the control limit

of +2SD in the same direction.
Action:

QC results.
4 - Data Exceeds the R4S Control Limit

Cause:
• The difference between two controls exceeds 4SD.
Action:

QC results.
5 - Data Exceeds the 41S Control Range

Cause:
• Four consecutive results have exceeded the 1SD limit.
Action:

QC results.
6 - Data Under/Over Last 10 Averages

Cause:
• Data for ten data points falls either above or below

the mean.
Action:

QC results.

7 - Data Trend Detected
Cause:
• This flag is for user-defined numbers (5-10) of

consecutive data points trending either all increasing
or all decreasing.
Action:

QC results.
S - Sample Repeated and Original Results

Replaced with Repeat Results
Cause:
• A sample test has been repeated and this repeat result

has replaced the previous result to become the final
result.
Action:
• None required.
/ - Test Requisition Entered but Not Performed

Cause:
• The test was not done even though it was requested

(usually because of a shortage of reagent).
Action:
• Check that the reagent bottle is fitted properly inside the

system.
• Check the volume of reagent left in the bottle. If it is low,

top it up (see “Checking Reagents” on page 90).
r - Data Transmitted to the Host Computer

Cause:
• Data is transmitted to the host computer.

Action:
• None required.
c - Corrected Data
Cause:
• Data has been corrected on the D a t a

C o r r e c t i o n window.
Action:
• None required.
i - Data correction is not performed on ISE

results which are diluted manually
Cause:
• ISE Sample was diluted manually.
Action:
• Multiply the result by the dilution factor.
Troubleshooting for Data

Flags ?,@,$,D,F,G,!
Troubleshoot these flags by following the following procedures:
• Checking Syringes. See page 259.
• Checking the Sample Probe and Reagent Probe. See page 260.
• Verifying the Calibrator Material. See page 260.
• Verifying the Reagent Integrity. See page 260.
• Verifying the QC Material. See page 261.
Checking Syringes CAUTION
• Ensure the top and bottom screws are firmly tightened by hand. Never use tools
to tighten
• Ensure the bottom screw is tight and flush with the piston. syringe screws.
Always tighten
• Ensure the syringe provides a smooth resistant pull. by hand.

• Ensure the correct size syringe is in use (reagent or sample).
• Ensure one undamaged O-ring is used.
• Ensure the teflon tip is not flaking or worn.
• Examine the syringe tubing for leaks or crimps. Ensure the metal
tubing connectors are on correctly.
Checking the Sample Probe and

Reagent Probe
• Ensure the probes are straight with no occlusions or scratches.
• Ensure the probes are fitted on the system correctly and are
not bent.
• Ensure that all screw connectors are on tightly.
Verifying the Calibrator Material

• Check the lot number and expiry date. Check the stability and
storage conditions of the calibrator material (freezer, refrigerator,
open bottles).
• If using a lyophilised calibrator, check the reconstituted stability

and verify that it is calculated correctly. Use a volumetric pipette
to add the diluent.
• Ensure the calibrator material was not kept at room temperature

for an extended period of time. Avoid prolonged exposure to air
before processing, as evaporation would affect analyte
concentration.
• Ensure the calibrator materials are not contaminated at any point

before or after the run. Check for signs of instability like abnormal
colour, turbidity, or a precipitate. Use fresh material if necessary.
Always follow the calibrator package insert instructions.
• Ensure the calibrator material is in the correct rack position.

Position depends on calibrator number and barcode number.
The yellow rack with barcode No.0001 identifies calibrator
material numbers 1 to 10. The yellow rack with barcode number
0002 identifies calibrator material numbers 11 to 20 in rack
positions number 1 to 10. This system of identification can be
used for up to 200 calibrators. The correct position of a calibrator
( C a l . N o . ) on the yellow rack can always be verified by
selecting Parameters>Calibration>Calibrator.
Verifying the Reagent Integrity

• Check the lot number and expiry date. Check the stability and
storage conditions of the reagent. Follow the directions on the
package insert.

• Ensure the reagent is not contaminated at any point before or
during the run. Check for signs of instability like abnormal colour,
turbidity or a precipitate. Use fresh reagent if necessary. Always
follow the calibrator package insert instructions.
• Verify the reagent is properly placed in the compartment and the

correct parameters were entered (see “Checking Reagents” on
page 90).
Verifying the QC Material

1 Check the lot number and expiry date. Check the stability and
storage conditions for QC material. Always follow the package
insert instructions.
2 Use a volumetric pipette if reconstitution is necessary. Eliminate
possible errors by preparing fresh QC material.
3 Avoid prolonged exposure to air before processing as evaporation
affects analyte concentration.
4 Verify the QC material was not contaminated at any point before or
during the run. Check for signs of instability like abnormal colour,
turbidity, or a precipitate. Use fresh material if necessary. Always
follow the QC package insert instructions.
5 Verify the QC material is in the correct rack position.
a Place the control sample in the correct location on the green
rack. If the control sample is barcoded, you can use any
position on the green rack.
b Put the rack on the rack feeder unit.
c Start analysis.
d While the rack is being analysed, check that there are no
errors in the QC data.
e Look for any abnormal data in the daily variation chart and the
day-to-day variation chart by selecting Routine>QC Monitor.

Error
Messages
Introduction
This chapter details the AU400 error messages.
ACAL INCOMPLETE
Cause:
The set of calibrators required for the requested calibration/s is

incomplete, or a FEEDER STOP occurred during ACAL.
• A new reagent bottle has been added for advanced calibration

but calibration has not been performed.
• This can also occur if the most recent calibration curve is not
available for that round.
Action:
1 Check that all calibrators are correctly positioned in the

calibration rack/s.
2 Calibrate the un-calibrated test.
Cal. expired
Cause:
Calibration stability has expired.
Action:
TIP
1 Check the calibration stability date by selecting System Status>
Reagent Status. You can
2 Click Test Display (F7)>Details. check the
calibrators
3 Perform the reagent blank and calibrate the expired tests. to be used
by selecting
Routine>Test Requisition>
Calibration.
AU400 User Guide Version 2.11 Error Messages 263

CALIBRATION ERROR
Cause:
The calibration result for the test which prompted the error is not
calculated.
Action:
Confirm that the calibrator/s for the test which prompted the error is set
correctly to the rack, and again perform analysis for that test.
CALIBRATION FACTOR OVER/UNDER

RANGE
Cause:
The calibration result for the test which prompted the error is not
calculated.
Action:
1 Check the factor or OD range H / L setting for the respective item

by selecting Parameter>Calibration>Calibration Specific.
2 Confirm that the calibrator/s for the test which prompted the error
is set correctly to the rack. Perform analysis again for that test.
CALIBRATION OD OVER/UNDER RANGE
See above.
CHANGE INDEX
Cause:
The index has reached its limit. 8000 samples can be stored in
one index
Action:
Create a new index by selecting Routine->Start condition->Data Index.
264 Error Messages AU400 User Guide Version AC

Conc. Wash Solution A/B Short
Cause:
Concentrated Wash Solution is low.
Action:
Replace the empty Wash Solution bottle with a full one.
Expired
Cause:
Reagent stability (expiry date) has expired.
Action:

2 Click P o s it i on D is p l a y ( F 8 ) .
3 Identify expired reagents.
4 Replace expired reagents.
5 Perform a reagent volume and ID check to update the system.
ISE CLEANING SOLUTION SHORT
Action:
Refill the Cleaning solution on the STAT Table (CLEAN Position).
ISE D-POT OVERFLOW

Cause:
Liquid overflows the ISE dilution pot.
Action:
1 Check if the electrodes are properly fitted and that all O-rings are
present and undamaged.
2 Check if the tubing of the D-Pot are stained or blocked. If so,
perform the ISE bleach cleaning procedure. For further
information, see Chapter 8, “Maintenance” on page 187.
AU400 User Guide Version AC Error Messages 265

ISE LOW STANDARD SHORT
ISE HIGH STANDARD SHORT
Cause:
The low or high ISE standard solutions are insufficient.
Action:
Refill standard solutions on the STAT Table.
ISE MID STANDARD SHORT

ISE BUFFER SHORT
ISE REFERENCE SHORT
Action:
Check the levels of solution and replace with new containers,

if necessary.
ISE not connected

Cause:
• The main ISE Power Switch is off.

• The ISE is in S t o p mode.
Action:
1 Check that the ISE Power Switch is on and if not turn it on.
2 Select System Status>ISE Status.
3 If I S E R e a d y is displayed, press S e t ( F 4 ) .
4 Click Y e s at the T r a n s f e r I S E t o R e a d y M o d e
prompt.
ISE SELECTIVITY CHECK SOLN SHORT (Na)

ISE SELECTIVITY CHECK SOLN SHORT (K)
Cause:
The selectivity checking liquid (Na) (K) of the ISE is insufficient.
Action:
Refill selectivity check liquids on the STAT Table.

NO BLANK DATA
Cause:
The blank test was not analysed.
Action:
• RB data does not exist for any of the bottles to be used during
analysis.
• RB data exists but is not up-to-date for the round in question.
• Perform a new reagent blank for the tests.
No Cal. Data
Cause:
• Calibration data does not exist for any of the bottles to be used
during analysis.
• Calibration data exists but is not up-to-date for the round in

question.
Action:
• Perform a new calibration for the tests.
NO REQUEST EXISTS FOR SAMPLE
Cause:
Routine samples and emergency samples which have prompted this

error are not analysed.
Action:
1 In case of online sample reception, check if item selection has

been made at the external computer for the sample that prompted
the error.
2 To receive the requisition directly from the host, select
Routine>Test Requisition>Normal>Online (F7).
3 Reset the racks so that the rack with the sample that prompted the
error is the first rack.
4 When the item selection method for routine samples is
"Sequential", perform setting so that the start S . N o . set in
Routine>Start conditions matches the first routine sample of the
reset rack.
5 Perform analysis again.

NO SAMPLE CUP
Cause:
Analysis is not performed for the sample that prompted the error.
Action:
1 Check that the sample that prompted the error is placed in

the rack.
2 Check that you are using the right cups.
NO STAT CUP (CALIBRATOR NO.: aa)
Cause:
STAT-CAL is not performed for the test that prompted the error.
Action:
1 Check that the parameters (related to calibration) and the set

calibrator match. Match the set calibrator and the corresponding
parameters.
2 If step (1) is already correct, contact your Beckman Coulter
Representative.
NO STAT CUP (CONTROL NO.: aa)

STAT CAL./QC
See above.
NOT ALLOWED TO DELETE SAMPLE
Cause:
The sample that prompted the error is not deleted.

Samples already analysed cannot be deleted.

Not Assigned Seq. No
Cause:
• The bottle sequence number was not assigned after a reagent

check. The bottle cannot be sequenced because there is a
problem with the R1 or R2 of the R1/R2 set.
• Reagent lot numbers do not match.
• R1/R2 are not both ID (R1/R2 are not both set to read ID or both
set as fixed reagents).
• R1 or R2 are low or empty.
• R1 or R2 on-board stability has expired.
Action:
Check reagent bottles and positions. Go to System Status>Reagent

Status.
Part of data is not output yet
Cause:
Data can not be printed.
• Printer is not on.
• No Paper in the printer.
Action:
Confirm that the printer can print. Open the DPR status of the system
status, select the printer control of the function key F4, and select
processing of the unprinted analysis data.
PHOTOCAL DATA ERROR
Cause:
Analysis operation can be performed, but the analysis results are

not guaranteed.
Normal operation is possible for operations other than analysis
operation.

Action:
1 Check the cuvette data for R o u t i n e , P h o t o c a l

M o n it o r.
2 Exchange the cuvette if there is an OD value for any wavelength
which exceeds 2.0.
3 Perform photocalibration again.
4 If this error persists, contact your Beckman Coulter
Representative.
POWER FAILURE DETECTED
Action:
1 Press the E n d P r o c e s s key.

2 Wait for the complete shut down.
3 When the computer is off, wait for about 30 seconds.
4 Press the E M S T O P switch (Red) on the front of the system.
5 Press the R ES ET switch (White).
6 Press the O N switch (Green).
PRINTER NOT AVAILABLE
Printer output is not performed for the list that prompted the error.
Cause:
This error occurs for example when trying to print out a work list,
for example, while the real-time data log list is being printed during
analysis.
Action:
Wait until the printer is available.

QC DATA OVER/UNDER RANGE TIP
Cause: By
definition,
1 in 20 QC
QC data is outside of the defined check range.
results
would be
Action: expected to
fall outside of the +/- 2SD
1 When the reference value mode in Parameter>QC Control>QC range (assuming that the SD
Common is the pre-set mode, check that the m e a n v a l u e value is accurately defined).
and the S D (standard deviation) for the respective item are set
correctly in Parameter>QC Control>QC Specific.
2 Ensure that the control sample for the item that prompted the error
is set correctly to r a c k and perform analysis again for that rack.
QC INCOMPLETE
Cause:
The set of QC samples required for the requested QC profile is

incomplete.
Action:
Check that all QC samples are correctly positioned in the QC rack/s and
perform the necessary QC analysis again.
R** PROBE W2 SOLUTION SHORT
Action:
Ensure that the W2 bottles (position 77) are full and then restart the W2
process.
R1/R2 DIFFERENT LOT NO.
Cause:
Result data might be incorrect if the reagent lot number is different

even when the item is the same in the reagent compartment.
Action:
All bottles should be of the same lot number.

R1/R2 LOT NO. DIFFERENT FROM CAL
Cause:
Result data might be incorrect if the lot number of the reagent in the
reagent compartment is different from the lot number of the reagent
when calibration was performed.
Action:
Perform calibration again.
R1/R2 LOT NO. DIFFERENT FROM RB
Cause:
Result data might be incorrect if the lot number of the reagent in the
reagent compartment is different from the lot number of the reagent
when the reagent blank was run.
Action:
Run a reagent blank again.
R1/R2 Pair Mismatch
Cause:
• R1 and R2 lot numbers do not match.
• R1 or R2 is missing or has an error.
• There is no record stored in reagent history.
Action:
1 Replace reagent if necessary.

2 Perform a reagent volume and ID check to update the system.

R1 PROBE CLEANER SHORT
Action:
Refill the cleaner in the R1 or R2 fridge (CLN1, CLN2, or CLN 3 as

indicated)
RACK FEEDER ERROR CAUTION

RACK BUFFER ERROR If the system is
running with
RACK RECEIVER ERROR the Automatic
RACK RECEIVER UNIT ERROR Repeat option
active, all racks
RACK JAM other than those in the
BELT ERROR unloading area must be
reloaded directly onto the
RACK DETECTED ON RACK FEEDER system to ensure that all
RACK BUFFER JAM outstanding analyses are
correctly performed. Failure
RACK DETECTED ON RACK BUFFER to do so can cause
RACK RECEIVER FULL incorrect results to be
generated.
Action:
1 Remove the rack.

2 Perform a manual reset.
3 If no rack is present, contact your Beckman Coulter
Representative.
RACK CLASS ERROR
Cause:
The rack type cannot be read properly.
Action:
1 Check that the rack is correctly placed onto the system (i.e., with
barcoded end facing into the system).
2 Compare the configuration of magnets on the underside of the
rack with that of another rack of the same colour. The configuration
should be identical. If a magnet is missing do not use that rack until
it is replaced.

RB Error exists on test/s
Cause:
A reagent blank has failed (exceeded Reagent OD limits) or has not yet
been performed.
Action:
1 Check the test in Routine>Calibration Monitor>Reagent

Blank Monitor.
2 See Chapter 8, Error Flags, Troubleshooting for Data Flags.
REAGENT ID NOT DEFINED
Action:
Register the manufacturer code and the item code in Parameter>

Common Test Parameters>Test Name>Reagent ID.
REAGENT ID READ ERROR
Action:
1 Perform reagent check again. If an error reoccurs, switch the

sample that is causing the error to the fixed reagent position and
use it.
2 When R e a g e n t I D R e a d errors occur for several samples,
ensure that the reagent ID conforms to the standard.
3 If Reagent ID Read Errors relate to positions where no bottle is
present, clean the top of the reagent barcode reader window,
clean the square sensor window on the central pillar of the reagent
compartment and then try another reagent check. If the error
persists, contact your Beckman Coulter Technical Services.
REAGENT PROBE LEVEL DETECTOR

ERROR
Action:
Contact your Beckman Coulter Representative.

REAGENT PROBE UP/DOWN ERROR
Cause:
An error occurs when moving a probe up or down.
Action:
Set the system in Standby (Initialise) and start again.
REAGENT TRANSPOSITION DISABLED
Cause:
When executing RB/ACAL, there is not enough reagent in the reagent

bottle to analyse RB/ ACAL.
Action:
Replenish the reagent.
Reagent: Lot No. on-board requires Cal
Cause:
A lot number other than that which has been calibrated is placed in the
system.
Action:
Calibrate the test again for the lot number in question.
Reagents are unchecked
Cause:
• The reagent lid has been opened.
• The parameter menu has been accessed.
Action:
Select System Status>Reagent Status and perform a check.

SAMPLE EMPTY LEVEL DETECT
Action:
The S a m p l e L e v e l d e t e c t i o n S h o r t error has occurred.

If available, add more sample to the sample tube or cup and repeat the
analysis. If there is already plenty of sample in the cup, ensure that the
sample is run in an appropriate cup or tube for the rack type.
SAMPLE ID READ ERROR
Cause:
The ID ERRXXXX (XXXX is a serial number) is allocated to the sample

which has prompted the error. The samples specified by profile No. 0
are received automatically and analysis is performed on that basis.
Action:
1 Check the position of the barcode label, the angle it is at, if it is

quite dirty or stained, printing density, etc. on the sample that
prompted the error, and re-attach the label if necessary.
2 Reset the racks so that the rack with the sample causing the error
is in the first rack.
3 Perform analysis again.
SAMPLE PROBE DETERGENT SHORT /

EMPTY
Action:
Refill the sample probe detergent bottle/s tube (W1 position on

STAT table).
SAMPLE PROBE LEVEL DETECTOR

ERROR
Action:
Contact your Beckman Coulter Representative.

SAMPLE PROBE UP/DOWN ERROR
Action:
See Reagent Up/Down error. Contact your Beckman Coulter

Representative.
SAMPLE PROBE W2 DETERGENT SHORT
Action:
Refill the detergent in the W2 position on the STAT table.
STAT COVER OPEN
Cause:
The STAT table cover is not on the table or is not positioned properly.
STAT SET OVER TIME
Cause:
• An automatic/RB/ACAL/QC sample has occurred during

STAT set.
• The S T A T S e t switch has been pressed during STAT/

TIP
automatic RB/ACAL/QC analysis (before sample aspiration
completion). This error is
also
Action: displayed
when you
Press the S TA T S ET switch after STAT sample setting and restart remove the
analysis. priority
sample and do not insert a
new one (even if the STAT
Table is set for STAT Sample
only, with no Automatic RB/
STAT table unchecked ACAL/QC).
Cause:
• The large STAT table cover was removed.
• A STAT table check was not performed in the S T A T T a b l e

S t a t u s window.
• P a r a m e t e r windows have been accessed. This changes

the status of the STAT Table from C h e c k e d to
U n c h e ck e d.

Action:
Select System Status>STAT Table Status and perform a check.
System Status Icon (Red X)
Cause:
If a red X appears in the System Status icon, a fatal error exists in

System Status. This means that it is impossible to continue analysis
until the problem is solved.
System Status Icon (Yellow! mark)
Cause:
If a yellow exclamation mark appears in the System Status icon,

a nonfatal error exists in the System Status or in the Measure Start
Window.
THE SAMPLE ID IS ALREADY REQUESTED
The sample that has prompted the error is not analysed.

Cause:
The same sample ID is already registered for this sample type.
Action:
See Chapter 11, “Troubleshooting” on page 279.
Unset STAT table
Cause:
There is no container on the STAT table for auto/manual calibration

or QC.
Action:
1 Check System Status>STAT Table Status.

2 Set the sample container for calibration or QC analysis on the
STAT table.
3 Perform a STAT table check to update the system.

Troubleshooting
Introduction
This chapter discusses how to tackle any problems that can occur with
the AU400:
• Troubleshooting and Maintenance. See page 280.
• Troubleshooting the System—Data Problems. See page 280.
• Troubleshooting the System—Reagents and Samples.

See page 282.
• Troubleshooting the System—Mechanical Problems.

See page 286.
• Troubleshooting the System—System Problems. See page 290.
• Troubleshooting the System—Data Processor Problems.

See page 295.
• Recovering from an Emergency Stop or Power Loss.

See page 298.
• Recovering from a Cuvette Wheel Overflow. See page 299.
• Troubleshooting the ISE Unit. See page 301.
• ISE Dispensing System. See page 303.
• ISE Measuring Components. See page 306.
• ISE Calibration Errors. See page 307.
• ISE Selectivity Check. See page 308.
• ISE Sequential Sample Measure. See page 308.
AU400 User Guide Version 2.11 Troubleshooting 279

Troubleshooting and
Maintenance
Regular preventative maintenance is essential for optimum system
performance. A significant number of problems outlined in this chapter
are caused by not performing or not being particular enough about
regular preventative maintenance.
This chapter therefore goes hand in hand with Chapter 8,
“Maintenance” on page 187. For each aspect of troubleshooting, you
can find useful help by referring to the corresponding section of the
maintenance chapter.
Troubleshooting the
System—Data Problems
This section helped locate the source of problems with result data:
• Data Problem Checklist. See page 280.
• Checking Abnormal Data. See page 280.
• Troubleshooting Software. See page 281.
Data Problem Checklist

Before troubleshooting, answer the following questions:
• Have you interpreted the data print out correctly? See “Checking
Results” on page 130.
• Is the data flagged? See Chapter 9, “Error Flags” on page 241.
• Is the calibration out-of-range? See “Performing Calibrations” on

page 103.
• Is QC out-of-range? See See “Checking QC” on page 134.
• Is data inconsistent? This might be caused by maintenance tasks

that are overdue. See Chapter 8, “Maintenance” on page 187.
Checking Abnormal Data

Check the data on the following windows:
• QC Monitor: Compare the test with the normal QC data and

identify the differences. Check QC parameters by selecting
Parameter>QC Control>QC Specific.
• Error Flags: See “Checking for Error Flags and Alarms” on

page 131.
280 Troubleshooting AU400 User Guide Version AC

• Reaction Monitor: Use the reaction monitor window to compare
the difference between normal and abnormal Optical Density and
concentration readings. See “Using the Reaction Monitor” on
page 131.
• Calibration Monitor: Use the Calibration monitor to see the

differences in Optical Density and factor readings between the
normal and abnormal calibration data. Calibration Checks.
See page 132.
• Photocal Monitor: Check for abnormal cuvettes, using Photocal

Monitor. The photocal procedure tests the condition of the
cuvettes. Any cuvettes that fail are not in a suitable condition to
be used and should be cleaned or replaced. See “Performing a
Photocal” on page 193.
• Data Statistics: Check the mean SD, CV and ranges of the

results from the Data Statistics window. See “Data Statistics” on
page 180
• Histogram: Use the Histogram window to check the dispersion

of data. See “Selecting Histogram Data” on page 181.
Troubleshooting Software
Troubleshoot abnormal data by checking the following:
• Check Patient Data. See page 281.
• Check Patient Data Again. See page 281.
• Check the Calibration and Reagent Blank. See page 282.
• Check the Reaction. See page 282.
• Check Photocal Data. See page 282.
Check Patient Data

If abnormal data is recognised:
• In a single test: Check parameters.
• In some tests: Compare the parameters of the tests with the

abnormal data to identify (a) common parameter(s).
• In all tests: Check the Calibrator material for expiry date.
Check Patient Data Again

If the cause of abnormal data cannot be determined after checking
parameters, try to determine if the problem occurs at certain intervals
during testing.
• Does the problem occur after a specific reagent is used?

(Might indicate contamination of reagents).
• Do the patient samples have something in common?

Was a certain anticoagulant used?
AU400 User Guide Version AC Troubleshooting 281

Check the Calibration and Reagent Blank
Check whether the calibration or reagent blank could be causing the
abnormal data.
• If abnormal data is found in a single test: Compare normal

calibration data with abnormal calibration data to identify the
difference between them, using the Calibration Monitor window.
Check the reagent blank and calibration parameters also. For
information about the Calibration Monitor, see “Checking
Results” on page 130.
• If abnormal data is found in some tests: If all tests with

abnormal results are calibrated using the same calibrator, the
calibrator might be the cause of the abnormal data. See
“Verifying the Calibrator Material” on page 260.
• If abnormal data is found in all tests: There is a high possibility

that the calibration analysis itself might result in abnormal data.
Check the mixing bars, reagent probe or syringe, water,
calibration material and common hardware. See “Performing
Daily Maintenance” on page 85.
Check the Reaction

When a single test is performing erratically, identify where the error has
occurred in the data, using the Reaction Monitor window. See “Using
the Reaction Monitor” on page 131.
Check Photocal Data

Check the photocal data, to identify an abnormality with cuvettes, using
Routine>Photocal Monitor. For information on how to change the
photometer lamp, See “Replacing the Photometer Lamp” on page 223.
Troubleshooting the
System—Reagents and
Samples
Reagents or samples might cause abnormal data. The following list
details some reagent and sample problems that can affect results.
• Sample Problems Causing Abnormal Data. See page 283.
• Reagent Problems Causing Abnormal Data. See page 284.
• QC and Calibrator Problems Causing Abnormal Data.

See page 285.
• Abnormal Data Caused by Detergent or

Wash Solution. See page 285.
• Other Causes of Abnormal Data. See page 285.

Sample Problems Causing Abnormal Data
The following two items most commonly affect data:
• Sample Evaporation: High results might occur due to

evaporation of the sample. Store samples properly and keep
sample caps closed tightly if they need to be stored for a short
period before analysis.
• Not Following Package Insert Instructions.

Please take note of the following sample requirements:
• This system is designed to analyse serum, urine and

cerebrospinal fluid samples. If problems are encountered when
analysing a specific test or when using a specific reagent, refer
to the package insert or contact the reagent manufacturer or TIP
distributor. Refer to the
• Use serum that is sufficiently free of blood clots and urine that package
insert
is free of suspended matter to prevent the probe from becoming
provided by
clogged and adversely affecting analysis. the reagent
• Check that blood samples are sufficiently coagulated before manufacturer
for a list of acceptable
serum separation. Remove the suspended fibrin before placing
anticoagulants.
serum on the system.
• If there is any suspended matter present in urine to be tested,

perform centrifugal separation to precipitate the suspended
matter before testing the samples.
• If a sample requires pre-treatment depending on the analysis

test, contact the reagent manufacturer or distributor.
• A minimum quantity of sample is required for analysis. Set up an

appropriate quantity of sample for correct sampling in the system.
• To prevent sample evaporation, never leave samples unsealed

for an extended period of time. If samples evaporate, results are
biased.
• The serum is lipemic, icteric or hemolyzed (LIH). Check the

serum for the extent of LIH (see “Entering LIH Specific
Parameters” on page 58).
• Liquid-level sensor has not functioned properly due to bubbles on

the serum surface. Remove these bubbles and repeat analysis.
• The sample cups and racks might not be placed on the system
properly. Check that they are placed properly (see “Preparing
Samples for Analysis” on page 115).

Reagent Problems Causing Abnormal Data
Check for:
• The parameters for reagents and samples are not accurate:

Check Parameter settings (see “Entering Specific Test
Parameters” on page 56).
• Correct Reagent not used: To analyse serum, urine, or other

samples using this system, use the appropriate reagent. For
information on which products to use, consult the reagent
manufacturer, distributor or your Beckman Coulter
Representative.
• Reagent not stored properly: The correct methods of storing

reagents, reference materials, and control sera are provided in
each package insert. Follow these instructions. If reagents,
reference materials and control sera are not stored properly,
results are biased even if used within effective periods.
• Reagent expired: Consult the package insert, reagent

manufacturer or distributor for the stability of the opened product.
• Reagents not placed into the system correctly: To place

reagents in the system, follow the instructions in the package
insert and in “Replacing Reagents” on page 96. Unless the
reagents are placed into the system properly, accurate results
cannot be obtained and damage to the system might occur.
• Reagent interference between analysis tests: If a reagent has

become contaminated by another reagent during analysis,
results might be affected. The actual degree of interference
depends on the reagent. For detailed information, contact the
reagent manufacturer or distributor. For information on how to
check for contamination between tests, contact your Beckman
Coulter Representative.
• Reagent has not been prepared correctly: Replace the

reagent. Refer to the package insert for preparation instructions.
• Reagent has expired: Replace the reagent (see “Replacing

Reagents” on page 96).
CAUTION
• Liquid-level sensor has not functioned properly during
Never add reagent aspiration: This might be caused by bubbles in the
fresh reagent to reagent bottle. Remove bubbles in the reagent bottle.
old reagent
• Fresh reagent has been added to old reagent: Replace the
reagent.

QC and Calibrator Problems Causing
Abnormal Data
General QC and Calibrator Troubleshooting:
• Ensure the correct material is in the correct position in the rack.
• Ensure the material was prepared correctly.
• Check the open-bottle date and expiry date.
• Ensure the material has not been exposed to the air for an
extended period of time.
Abnormal Data Caused by Detergent or

Wash Solution
Recommended detergent or wash solution has not been used. Contact
your Beckman Coulter Representative.
Other Causes of Abnormal Data CAUTION

Never use
• Periodic maintenance has not been performed and some insecticides
maintenance tasks are overdue. Be sure to follow your near the
maintenance routines and perform regular preventative system.
maintenance (see Chapter 8, “Maintenance” on page 187).
• Insecticide was used in close proximity to the system.

Insecticides can affect the cholinesterase (CHE) levels.
If contamination is suspected:
a Replace the sample cups, reagents and reagent bottles.
b Wash the sample probe, reagent probe, mixing bars and
cuvettes. See “Cleaning the Cuvettes and the Cuvette Wheel”
on page 225, and “Inspecting and Cleaning the Mixing Bars”
on page 90.
• For recommendations relating to water purity, electrical

specifications and environmental conditions, contact your
Beckman Coulter Representative.

TIP Troubleshooting the
System—Mechanical
Problems
Abnormal data might also be caused by hardware malfunctions. See
Chapter 8, “Maintenance” on page 187 for further details on cleaning
Always use the and replacing system parts.
Analyser
Maintenance • Syringe Problems. See page 286.
functions when replacing a
probe, syringe, mixing bar,
• Probe Problems. See page 287.
wash nozzle or cuvette.
• Mixing Bar Problems. See page 288.
Analyser maintenance is • Cuvette Wheel or Wash Nozzle Problems. See page 288.
also used to drain and refill
liquid from the tubing and to • Photometer Lamp or Photometer Unit Problems. See page 289.
clean wash wells.
• Deionised Water Tank Problems. See page 289.
To use Analyser
Maintenance: • Deionised Water or Dirty Filter Problems. See page 289.
Select Maintenance>ANL
Maintenance. • Incubation Temperature Problems. See page 290.
Select the unit from the Unit
drop-down list. • Reagent Refrigerator Problems. See page 290.
Click a function.
Press the DIAG. switch to • STAT Table Problems. See page 290.
begin the process.
• Rack Problems. See page 290.
Syringe Problems
Check for:
• Water leaking from syringes: Tighten the syringe cases and

case heads of the sample and reagent syringes by hand.
• Bubbles in the syringe tubing: Select Maintenance>ANL

Maintenance. Select F / P r i m e W a s h i n g - l i n e. Press
the S T A T R O T A T I O N / D I A G switch then, to remove air
from the tubing.
• Syringe tubing clogged: Remove relay tubes. Clean the inside

of each tube with a stylet. Contact your Beckman Coulter
Representative if the tubing is then still clogged (see “Replacing
Sample, Reagent and ISE Buffer Syringes” on page 212).
• General Syringe Troubleshooting:

a Ensure the top and bottom screws are tightened by hand.
b Ensure probes are not clogged. Blockage will create back-
pressure in the tubing and can cause leakage at the
associated syringe.
c Ensure the bottom screw is tight up against the piston.
d Ensure there is a smooth resistant pull.
e Ensure the syringe used is the correct size (reagent or
sample).

f Ensure one O-ring is being used and that it is not damaged.
g Ensure the syringe is fitted to the system properly.
h Check the syringe tubing for scratches, folds or leaks.
i Check the teflon tip of the syringe for wear.
Probe Problems
Check whether:
• The sample and reagent probe is leaking from loose probe

connectors: Remove the covers on both probes. Tighten the
probe connectors. Check the tubing is firmly connected to the
dispense valves.
• The sample or reagent probe is clogged: Dispense deionised

water from the probe and ensure that it drains properly.
• The sample or reagent probe tip is bent or damaged: Replace

the probe. See “Replacing the Sample Probe” on page 208 and
“Replacing the Reagent Probe” on page 209.
• The sample aspiration position of the sample probe is

incorrect: If sample probe dead volume height is set incorrectly,
the probe might hit the bottom of the sample cup. Examine the
sample probe for abnormalities. If it is bent, replace it. If it is not
bent and the sample aspiration position is still not right, contact
• The reagent probe is not aligned over refrigerator: If the

reagent probe tip is hitting the reagent bottle or refrigerator cover:
Examine the reagent probe for abnormalities. If it is bent, replace
it. If it is not bent and the reagent aspiration position is still not
right, contact your Beckman Coulter Representative. See
“Replacing the Reagent Probe” on page 209
• The sample or reagent probe is not aligned over the cuvette:

If the sample or reagent probe tips are coming into contact with
the cuvettes: Examine the sample or reagent probe for
abnormalities. If a probe is bent, replace it. See “Replacing the
Sample Probe” on page 208 and “Replacing the Reagent Probe”
on page 209. If it is not bent but still not aligned properly, contact
• Abnormal sample or reagent probe wash position: If the

sample or reagent probe tip is hitting the wash wells: Examine the
sample or reagent probe for bends. If a probe is bent, replace it.
If it is not bent but the probe wash position is still abnormal,
contact your Beckman Coulter Representative.
• General sample and reagent probe troubleshooting:

a Ensure water is dispensed in a straight stream.
b Ensure the cap screws for the probe connections are tight.
c Verify that the probe tubing is free of air bubbles.

TIP Mixing Bar Problems
If the Check whether:
coating of a
mixing bar • The mixing bars are contaminated: Wash the mixing bars. See
is “Inspecting and Cleaning the Mixing Bars” on page 90.
scratched,
Iron (Fe) • The mixing bar coating is worn away: Replace the mixing bar.
levels rise above normal.
• There is abnormal noise while the mixing bars are operating:
If you hear rubbing, gear contact noise or other abnormal sounds
while the mixing bars are rotating.
• The wash water or detergent is not fully drained from the

wash well: Contact your Beckman Coulter Representative.
• The mixing bars not properly installed: Ensure that the mixing
bars are fully seated. See “Replacing Mixing Bars” on page 211.
Cuvette Wheel or Wash Nozzle Problems

Check whether:
• The cuvettes stained or dirty: Clean cuvettes. See “Cleaning

the Cuvettes and the Cuvette Wheel” on page 225
• Moisture detected outside the cuvette(s) and cuvette wheel:

Dry with a clean dry cloth and investigate the cause.
• Wash water or detergent spills on the inside or outside of a

cuvette: This might be caused by the wash nozzles not working
properly. Tighten the tube joints on the wash nozzles. Clean the
wash nozzles with a suitable gauge fishing line, to remove any
clogging. Ensure cuvettes are clean. See “Cleaning the Cuvettes
and the Cuvette Wheel” on page 225.
• Water remains in cuvettes after cleaning: Ensure the tube

joints on the wash nozzles are tight. Clean the wash nozzles with
a suitable gauge fishing line, to remove any clogging.
• Tube in the concentrated Wash Solution tank is not

aspirating: Straighten the tube and insert it towards the bottom
of the tank so it does not aspirate air.
• Concentrated or diluted Wash Solution tank float switch

malfunction: Check the float switch connector. Position the
tubing in the tank such that it does not come into contact with, or
interfere with, the float switch. If the float switch malfunction is not
corrected, the switch must be replaced. Contact your Beckman

Photometer Lamp or Photometer Unit
Problems
Check for:
• Photometer lamp deterioration: Replace the lamp when:

• Numerous rate assay results are flagged as non-linear (*).
• The photometer check falls outside of the acceptable
range.
• Reagent blank flags (U , u , Y , y ) are generated for
numerous assays.
TIP
• Data is inaccurate. Perform a photometer check and
analyse results. If the lamp
appears
• If the lamp is changed, a photocal must be performed and
dark, check
all tests must be calibrated. See “Replacing the
the lamp
Photometer Lamp” on page 223. and replace
it if
• Photometer lamp is unstable: Perform the photocal
necessary. Perform a
measurement twice to check the difference between two sets of photocalibration and
measurement data. If there is a significant difference between the recalibrate all tests
two sets, the photometer lamp might be defective. Replace the afterwards.
lamp and repeat the photocal.
Deionised Water Tank Problems

Check for:
• Deionised water tank dirty or stained: If there are water

deposits or particles on the inside of the tank, clean the tank fully.
See “Cleaning the Deionised Water Tank” on page 219
TIP
• Detergent remains after cleaning the deionised water tank:
Clean the tank again and rinse thoroughly with deionised water. Ensure
laboratory
deionised
water meets
Deionised Water or Dirty Filter Problems specifications.
Check for:
• If Ca, Mg and Fe are abnormal, the deionised water conductivity

might be greater than 2.0 mS/cm. Clean the deioniser. For
detailed information, contact your Beckman Coulter
Representative.
• Tap water below 5°C used: Always ensure that the water supply
to the deioniser is above 5°C. For detailed information, contact
• Filters stained, clogged or have microbial growth: Clean the

deionised water filter and the sample probe filter. Replace filters
if data continues to be abnormal after cleaning. See “Replacing
the Deionised Water Filter” on page 220.

Incubation Temperature Problems
After placing cuvettes back on the cuvette wheel, leave at least an hour
before starting analysis.
Reagent Refrigerator Problems

• Reagent refrigerator temperature out-of-range: Click
S y s t e m S t a t u s and check reagent refrigerator
temperature. Open the reagent refrigerator and ensure the
reagent bottles are cool.
STAT Table Problems

• STAT table temperature has increased: Check the STAT table
lid and ensure it is on correctly. Opening this frequently to add
and remove samples for analysis can increase the temperature
of the STAT table.
Rack Problems
General Rack Troubleshooting::
• The barcode is positioned correctly.
• The sample position is according to rack colour.
• The correct number of magnets are in the bottom of the rack.
• The rack was loaded correctly (see “Placing the Sample Cups
into the Rack” on page 117).
• The rack is generally clean and no surface is sticky.
Troubleshooting the
System—System
Problems
The following system problems can occur:
• REAGENT COMPARTMENT TEMPERATURE HIGH alarm for

the cooling unit. See page 291.
• Abnormal Sound from Inside the System. See page 291.
• Barcode Errors. See page 292.
• Leaks from the Bottom of the System. See page 292.
• No Wash Solution Supplied to the Mixing Bars. See page 292.

• Reagent Alarm when Sufficient Reagent Remains in
Bottles. See page 292.
• Sample Insufficient Alarm when Sufficient Sample Remains.

See page 293.
• No Sample Cup Alarm when Sample Cup is Present.

See page 293.
• Printer Not Printing/Printer Light Not On. See page 293.
• Liquid Spilling from the Reagent Probe Tip. See page 293.
• Reagent Probe Not Aligned over the Cuvette. See page 293.
• Clogged Sample Probe Alarm. See page 294.
• Abnormal Data Flag # (Sample Level Detection Error) Displayed

in the Second Half of the Sample Dispense Operation.
See page 294.
• Cuvette Wash Overflow. See page 294.
• Sample Rack Jammed. See page 294.
• Printer Problems (Alarm—Some Data Not Printed).

See page 295.
REAGENT COMPARTMENT
TEMPERATURE HIGH alarm for the
cooling unit
Check for:
• Problem in the reagent storage refrigerator unit: Check the

space between the system and the wall. Compare your
measurement against the recommended minimum space
requirements outlined in “Installation Environment Precautions”
on page 16. Ensure the room temperature too is between 18°C
and 32° C.
Abnormal Sound from Inside the System

Check for:
• Air bubbles trapped in tubing: Check the deionised water filter.

If it is damaged, replace it. For all other sources of noise such as
a faulty circulation pump, radiator fan, lamp cooling fan, air pump,
24V power supply fan or drying pump, contact your Beckman

• DI Water Empty alarm: Check that any valves from your
deioniser are open and that the deioniser is operating and
producing a sufficient volume of water to meet the specification.
Check that the inlet tubing is free of kinks and air-locks.The ion-
exchange capability of the deioniser may be insufficient. Replace
your deioniser if it is not up to standard. Check the deionised
water filters. If they are slimy to the touch, then you should clean
or replace them. See “Replacing the Deionised Water Filter” on
page 220.
Barcode Errors
TIP
Check for:
If a reagent
barcode is • Dirty barcode labels on sample cups or reagent bottles:
damaged, Wipe clean any stains or drops from barcode labels. Replace any
the reagent barcodes that are worn or damaged.
position can
be fixed so • Barcode labels are falling off or are not put on properly:
that the barcode does not See “Attaching Barcode Labels to Sample Racks” on page 116
have to be used. for information on how to put barcodes on properly.
• Dirty Barcode reader: Wipe the window, using an alcohol swab.
Leaks from the Bottom of the System

Check whether:
• Wash line obstructed: Check for obstructions in the wash wells

for sample and reagent probes. Clean them if you see any
clogging. See “Cleaning Wash Wells” on page 200.
• Waste line not installed properly: If your waste line is leaking

or kinked or if the tube itself is too long, contact your Beckman
No Wash Solution Supplied to the Mixing Bars

Check for:
• Deionised water filter clogged: Examine the deionised water

filter. If the filter surface is dirty, the filter might be clogged and
should therefore be cleaned. See “Cleaning the Deionised Water
Filter and the Sample Probe Filter” on page 216
Reagent Alarm when Sufficient Reagent

Remains in Bottles
The liquid-level sensor might be faulty. See the Alarm online help.

Sample Insufficient Alarm when Sufficient
Sample Remains
Check whether:
• The liquid-level sensor might be faulty or the sample may be in

an inappropriate cup or tube for the rack type used. See Alarm
online help also.
• Ensure that samples are run from the correct tube or cup for the
rack type being used.
No Sample Cup Alarm when Sample Cup is

Present
Unspecified cup used: Check that the sample cups meet specification.
Printer Not Printing/Printer Light Not On

See the printer manual for assistance with all printer troubleshooting.
• Printer is disconnected from the mains. Check the plug and

socket and connecting lead.
• Printer ribbon used and needs to be replaced.
• Ensure the online button is on.
• Ensure paper is loaded properly.
Liquid Spilling from the Reagent Probe Tip

Check for:
• Reagent Probe not properly installed: Select

Maintenance>ANL Maintenance. For reagent probe
replacement, select B / R e p l a c e R P r o b e & S y r i n g e .
Press the S TA T R O TA T I O N / D I A G switch to drain
water from reagent probe tip. If the deionised water does not
drain out normally, the reagent probe might not be properly
attached. Check the reagent probe installation.
• Reagent syringe case head fixing screw loose: Tighten

by hand.
Reagent Probe Not Aligned over the Cuvette

Check for:
• Reagent probe bent: Examine the probe and replace it if it is

bent. See “Replacing the Reagent Probe” on page 209.
• If the probe is not bent, contact your Beckman Coulter

Representative.

Clogged Sample Probe Alarm
Check whether:
• Sample probe contains excessive fibrin or protein: Clean the

sample probe. Check the sample for clots or fibrin. If cleaning the
probe does not remove the fibrin or protein, insert a stylus
through the probe tip to clear the blockage. “Inspecting and
Cleaning the Sample Probe and Reagent Probe” on page 89.
Abnormal Data Flag # (Sample Level

Detection Error) Displayed in the Second
Half of the Sample Dispense Operation
• Sample volume too low: An Hitachi cup should have 50 µl or
more. A conical cup should have 50 µl. These volumes include
dummy (5 µl) and remainder (5 µl) for each test item, in addition
to the sample volume necessary for analysis.
Cuvette Wash Overflow

• Aspiration nozzles clogged: Clean aspiration nozzle, using
a suitable gauge fishing line. Remove, clean, dry and polish
cuvettes, cuvette holders and cuvette wheel as necessary.
Perform a Photocal and check the resultant data. If the problem
persists, contact your Beckman Coulter Representative.
Sample Rack Jammed

Check for:
• Foreign matter on the rack: Check nothing has fallen onto the
rack and that the rack ID label, or sample ID labels have not
peeled off, causing the rack jam.
• Belts and belt area sticky: Clean surfaces with alcohol swab
and/or deionised water.
• Belts are slippery: Dust and slippery residues on the rubber

belts can be cleaned off, using alcohol swabs.

Printer Problems (Alarm—Some Data Not
Printed)
Check for:
• Analysis started while printer was offline.
• Printer turned off while analysis was in progress.
• Printer is out of paper.

a Turn on the printer and ensure it is online.
b Load paper if needed.
c Click System Status>DPR status.
d Click P r i n t e r C o n t ro l ( F 4 ) .
e Click Resume to begin printing data from analysis. When
printing is finished, the system moves to S t a n d b y mode.
Troubleshooting the
System—Data Processor
Problems
The following DPR problems can occur:
• Menu Cannot Be Selected. See page 296.
• Number Key Pad on Keyboard Does Not Work. See page 296.
• Keyboard Not Responding. See page 296.
• Inaccessible Floppy Disk. See page 296.
• Analysis Results Do Not Print Automatically. See page 297.
• Online Auto-Output to Host Computer Not Executed.

See page 297.
• No Data Stored Despite Space on Disk. See page 297.
• Unsuccessful Transfer of Data between the System and the Host

Computer. See page 298.

TIP Menu Cannot Be Selected
• You have no access to this function: Menu items to which you
do not have access appear greyed out. Contact your system
administrator to increase your level of access to the system.
• System software crashes: To reset the system:
Contact your Beckman a Ensure the hard drive LED light is off.
Coulter Representative if b Press C t r l + A l t + D e l e t e together.
crashes become frequent. c Select S h u t d o w n.
d At the R e st a r t prompt, press the E m e r g e n c y
S t o p button on the front of the system.
e Press the R e s e t button on the system.
• Contact your Beckman Coulter Representative if crashes
become frequent.
Number Key Pad on Keyboard Does Not Work

• Num Lock is released: Press the N u m L o c k key and then
check that the LED light over N u m on the keyboard comes on.
Keyboard Not Responding

Check:
• Keyboard cable: Check it is securely in the right socket in the

back of the computer (colour coded).
• System crash: See “Menu Cannot Be Selected” on page 296.
• System busy: The system might be saving data or performing a

series of tasks simultaneously. Wait for a few minutes until the
system is ready. If this happens frequently, contact your
Inaccessible Floppy Disk

Check whether:
• The floppy disk is formatted properly: Format the floppy disk

by selecting Maintenance>Data Operation>FD Data
Management. Select the way you want to initialise the diskette:
For parameters or data, click S t a r t I n i t i a l i s e ( F 5 ) .
See “Saving Information to a Floppy Disk” on page 146. Either of
the following two types of disk should be used:
a DOS formatted, 2HD 1.44MB
b DOS formatted, 2DD 720KB

• Floppy disk is write-protected: Slide the tab on the disk over.
If the diskette is punched, you must put in a new blank
unpunched diskette. Consult your internal systems department.
• Floppy disk is damaged: If writing is continuously unsuccessful,

your floppy disk is probably damaged. Use a new disk.
• Floppy disk drive is damaged: If the floppy disk is new and

properly formatted and you still cannot successfully save data,
then your floppy disk drive might be faulty. Contact your
Analysis Results Do Not Print Automatically

Check for:
• Real-time output is not set: Set the real-time output of reports

or data log lists from Parameters>Format>Printer.
• Out of Paper: Load more paper.
• Analysis was started when the printer was offline.
• Printer was turned off or taken offline during analysis: Turn on the
printer and ensure it is online (load paper if needed).
c Click System Status>DPR status.
d Click P r i n t e r C o n t r o l ( F 4 ).
e Click R e s u m e to begin printing data from analysis. When
printing is finished, the system moves to S t a n d b y mode.
Online Auto-Output to Host Computer

Not Executed
Check whether:
• I/F cable to the host computer is disconnected: Connect

the cable.
• Host I/O parameters are incorrectly modified: Set the

appropriate I/O parameters by selecting the Online window.
No Data Stored Despite Space on Disk

CAUTION
Check whether:
If the system
• An error might have occurred on the hard disk: Repair and does not start
rebuild the database(s) using the Retrieve Database function as up
follows: automatically
after executing
a Select Maintenance>Data Operation>Retrieve Database. Retrieve Database, the
b Select the data bases you want to rebuild by checking the hard disk might be seriously
check boxes. damaged and might require
c Select the database index from the I n d e x drop-down list. replacement.
Contact your Beckman
d Click E xe c u t e ( F 5 ) and then Y e s, when prompted, to
start rebuilding.

Unsuccessful Transfer of Data between the
System and the Host Computer
Check whether:
• The I/F cable to the host computer is disconnected: Connect

the cable correctly.
• The I/F cable is defective.
TIP
Recovering from an
In the event
of an Emergency Stop or
emergency
stop or Power Loss
power failure
during a In the event of power failure or an emergency stop, the main power
measure mode, it is not is immediately cut off. Power to the incubator and reagent refrigerator
possible to use the data
is also cut off.
generated. Perform analysis
again. • Performing an Emergency Stop. See page 298.
Prior to restarting analysis
after a power loss or • Resetting the System after a Power Failure or an Emergency
emergency stop, check Stop. See page 298.
reagent integrity if your
system is without power for
a lengthy period of time.
Performing an Emergency Stop
The optimal method of performing an emergency stop is to:
1 Press C t r l + A l t + D e l e t e to access the T a s k
Manager.
2 Click S h u t d o w n to close all running software.
3 At the “I t is n o w s a f e t o t u r n o f f y o u r
c o m p u t e r” prompt, press the EM S t o p button on the front
of the system to turn off all power to the system.
Resetting the System after a Power Failure or

CAUTION an Emergency Stop
If your system
is running Resetting the system involves the following procedures:
with an
Uninterruptable
• Resetting the System. See page 299.
Power Supply
(UPS), in the event of a
• Setting the Start Number. See page 299.
power failure please stop • Removing Reagents from the Cuvettes. See page 299.
analysis immediately and
power down the system in a • Checking Reagents. See page 299.
controlled manner before
the UPS batteries are
exhausted.

Resetting the System
1 Press the R e s e t button on
the front of the system.
2 Wait ten seconds and press
the O n button to load the
software. Wait 20 minutes until
the photometer lamp has
stabilised before starting
analysis.
3 P r o g r a m d o w n l o a d t o a n a l y s e r is displayed.
4 P o w e r F a i l u r e d e t e c t e d is then displayed as an alarm
(Click A la r m C l e a r to remove it).
Setting the Start Number

This is only necessary if running in Sequential mode:
1 Select Routine>Start Condition and select the index used when
the emergency stop was made.
2 Click S e t ( F 4 ) and click in the S t a r t N u m b e r field.
3 Set the S t a r t N u m b e r to the next sample number after any
completed data (last sample that appears on the printed results).
Removing Reagents from the Cuvettes

Perform a W1 to remove reagent left in the cuvettes.
Checking Reagents
2 Click C h e c k S t a r t ( F 5 ) and then R e s e t O n ly .
Verify reagent integrity if the system is without power for a long
period of time.
3 Press the S t a r t button.
4 I S E n o C a l appears as a warning. The ISE continues to use
the last ISE Cal. data generated, unless N o is selected at the start
prompt.
Recovering from a
Cuvette Wheel Overflow
Follow the following procedures to recover from an overflow:
• Causes of Overflow. See page 300.
• Indications of an Overflow. See page 300.
• Recovering from an Overflow. See page 300.
• Preparing to Continue Analysis. See page 301.

Causes of Overflow
Check whether:
TIP
• A wash nozzle has become clogged and liquid is not being fully
Use the aspirated from cuvettes. This might cause a gradual overflow.
A la r m
Log • A wash nozzle might be bent or damaged.
window to
view a list of • The reagent probe might be bent and liquid possibly dispensed
all alarms outside of the cuvette, causing instant overflow.
generated on a specific date
and for specific tests. • The sample probe might be bent and liquid possibly dispensed
To access the Alarm Log: outside of cuvette, causing instant overflow.
Select Maintenance>
Maker Maintenance> • Wash nozzle tubing might be disconnected from the nozzle.
Alarm Log.
Indications of an Overflow
Check whether:
• Tops of cuvettes appear dark or black when viewed on-board the

system (normal colour is frosty or white).
• Cuvettes wet when removed.
• QC on tests are out-of-range. QC alarms have occurred.
• Reagent blank flags and alarms have occurred on one or

more tests.
• The entire data printout is incorrect.
• The system is not performing as usual.
• Numerous failures occur after performing a photocal.
CAUTION Recovering from an Overflow

Immediate
attention If you require assistance for or advice about any of the following
should always procedures, please contact your Beckman Coulter Representative.
be given to an Perform the following checks:
overflow.
Never continue analysis • The wash nozzle station should be positioned and aligned
when an overflow occurs as precisely over the cuvettes.
overflows directly affect
analysis results. • Ensure wash nozzles are straight. Sonicate and clean the
nozzles with a suitable gauge fishing line to remove any debris.
CAUTION • Ensure reagent and sample probes are properly aligned.

Rotate the sample and reagent probes over the cuvette wheel
Probes should to check this.
always be
centred over • Check for chipped or cracked cuvettes. Replace any that
cuvettes. If you you find.
require any
assistance with this, please • Ensure the wash nozzle tubing connections are secure.
contact your Beckman

Preparing to Continue Analysis
1 Remove the cuvette wheel cover, making sure that the mixing bars
and wash nozzles are not in the way.
2 Remove all the wet cuvettes (appears darker), sonicate
(in deionised water) and dry them. Polish them with a clean,
soft, lint-free cloth.
3 Remove and dry the cuvette wheel wedges with a soft paper towel.
4 Remove the entire cuvette wheel, and dry it and the channel in
which it rotates, using soft paper towel. When dry, replace the
cuvette wheel.
5 Replace the cuvette wheel wedges and cuvettes.
6 Perform a photocal.
7 Run a new reagent blank, calibration and QC for all tests.
8 Continue processing samples.
Troubleshooting the
ISE Unit
Problems can occur in the ISE unit under the following headings:
• ISE Checklist. See page 301.
• ISE Sample Requirements. See page 302.
ISE Checklist
Before you begin troubleshooting the ISE unit, read through the
following checklist.
• Data Problems. See page 301.
• Alarms. See page 302.
• Other Operational Problems. See page 302.
Data Problems
Check for:
• Data Flags: See “Checking for Error Flags and Alarms” on

page 131 if there are any flags on the printout that you do not
understand.
• Calibration out-of-range: See “ISE Calibration” on page 100.
• QC out-of-range: See See “Checking QC” on page 134.
• Irregular data: Look at the maintenance schedule and see if

there are any maintenance tasks overdue.

Alarms
Check any alarms generated against alarm online help.
Other Operational Problems

Check for:
• Start-up procedure: Follow the guidelines in “Launching the

System” on page 86.
• Reagent Stability: Check Reagent expiry dates.
• Regent Level: An alarm is generated if the level of remaining

reagent is too low.
• Reagent or Calibrator or QC Material storage: See the

package insert for instructions on storage (see also
“Troubleshooting for Data Flags ?,@,$,D,F,G,!” on page 259).
• ISE Calibration: See “ISE Calibration” on page 100.
• Maintenance: Check the maintenance schedule to ensure that

no maintenance tasks are over due.
ISE Sample Requirements

ISE samples should meet the following requirements:
• The ISE is designed to analyse urine and serum samples.
• Use urine or serum that is free of suspended matter, to prevent

the probe from getting clogged and in turn affecting analysis.
• Exercise care when mixing with chemicals (anti-coagulant,

preservative etc.).
• If any suspended matter is recognised in the urine or serum to

be dispensed, perform centrifugal separation to precipitate the
suspended matter before testing the sample.
• A minimum quantity of sample is required for analysis. Set up an

appropriate quantity of sample for correct sampling in the system,
according to this manual.
• To protect samples from evaporation, never leave them unsealed

for an extended period of time. If samples evaporate, analysis
results is altered.
• Use the recommended control materials.
• Keep room temperature constant.
• Ensure all parameter settings are correct.
• Perform regular preventative maintenance on the unit. Keep a

maintenance schedule and perform any tasks that are overdue
before performing ISE analysis.

ISE Dispensing System
If the test results are biased, there could be a problem with the
dispensing system.
• Sample Probe and ISE Reagent Buffer Syringe. See page 303.
• Mixture Pump Tubing. See page 303.
• Mixing Bar. See page 304.
• Sample Pot. See page 304.
• Pinch Valve Tubing. See page 305.
Sample Probe and ISE Reagent Buffer

Syringe
Inaccuracy could be caused by the problems listed below.
• Worn ISE reagent (buffer) syringe or sample: Replace the

syringe.
• Water carryover caused by dirty probe: Clean the probe with

an alcohol swab.
• Obstruction in the sample probe: Sonicate the sample probe.
• Misalignment of the sample probe over the sample pot:

Check the pot is fitted into the right place. See if the probe tip
is bent. Contact your Beckman Coulter Representative.
General Syringe Troubleshooting
1 Ensure the top and bottom screws are tightened by hand.
2 Ensure the bottom screw is tight up against the piston.
3 Ensure there is a smooth resistant pull.
4 Ensure the syringe used is the correct size (buffer or sample).
5 Ensure one O-ring is being used and that it is not damaged.
6 Ensure the syringe is fitted to the system properly.
7 Check the syringe tubing for scratches, folds or leaks.
8 Check the teflon tip of the syringe for wear.
Mixture Pump Tubing

Check for:
• Worn, flattened or stretched aspiration tubing: Observe

sample pot, flowcell tubing and bypass tubing during a Mid/Ref
Prime cycle. There should be no air visible in the flowcell or the
outlet tubing. If leaks occur or the tubing is worn or flat in
appearance, replace the mixture pump tubing. This condition
could also generate a sample pot overflow error.

Mixing Bar
Figure 11-1: ISE Mixing Unit
• Mixing Bar not rotating: Check the connector no.142 to the left
of the mixing motor, as shown in Figure 11-1. Ensure the mixing
bar is not making contact with the side of the sample pot. If it is,
then check that the mixing unit is properly aligned. Ensure the
sample pot is fitted correctly. If it is on backwards, the mixing bar
cannot rotate. Contact your Beckman Coulter Representative.
Sample Pot
Sample pot
Connector Sample pot

fixing knob
Connector
Mixing unit on the

mount plate
FR
ON
T
Figure 11-2: Sample Pot

• Dirty sample pot causing calibration or QC errors: Perform
an auto-wash of the sample pot and electrode line, as shown in
Figure 11-2, daily. Perform the ISE bleach clean weekly (see
“Bleach Cleaning Electrodes and Bypass Tubing” on page 199),
and manually clean the sample pot as necessary.
Pinch Valve Tubing
Figure 11-3: Pinch Valve Tubing
• Calibration errors or sample pot overflow errors: Realign the

pinch valve tubing so that a different part of the tube is in the
valve. If the tube, as shown in Figure 11-3, shows any sign of
wear, replace the tube. Ensure the tubing is attached correctly
(refer to the diagram on the underside of the ISE unit lid).

ISE Measuring
Components
Problems can occur with the following ISE components:
• O-Rings. See page 306.
• Electrodes. See page 306.
• Flowcell Blocks. See page 307.
O-Rings
Check for:
• Missing O-ring: Ensure that there are a total of 4 O-rings, cell

inlet block, Cl electrode, Na electrode and K electrode.
• Defective O-ring: The O-rings should be positioned correctly.

Ensure they are not flat, bent or deformed. Replace them if
necessary.
• O-ring contaminated with KCl (from reference solution):

Remove the O-ring and wash it along with the groove in
deionised water to remove any residual KCl. KCl contaminates
electrodes and affects results.
Electrodes
Check for:
TIP • Old or obstructed Na,K,Cl or reference electrodes:
Electrode a Remove obstructions in the flowcell path. Repeat the daily
replacement cleaning procedure two or three times. Prime with mid-
should be standard.
performed if
b Perform a calibration.
the slope
values are c Perform a selectivity check to verify Na and K membrane
out-of-range, or if other selectivity.
troubleshooting measures do d Change electrodes only after appropriate troubleshooting.
not resolve the problem.
Remove the suspected • Bubble in the reference electrode: Check for a bubble in the
electrode, if possible, and reference electrode by removing and examining the electrode tip.
place it into another system. Gently tap the tip to dislodge the bubble and then replace the
Perform a calibration to verify electrode.
the performance of the
electrode. • Reference electrode not fitted properly: See “Replacing the
Reference Electrode” on page 233.
• Lead wires connected to the electrodes broken: Contact your

• Missing electrode bung and internal solution: Bung and

solution should be replaced.

Flowcell Blocks
• Obstruction in the flowcell inlet block
• Obstruction in the flowcell outlet block
• Defective port of flowcell inlet block

For all three:
a Replace defective flowcell inlet or outlet blocks. Prime the
flowcell with mid-standard and reference solution.
b Perform an ISE cleaning procedure. Contact your Beckman
Coulter Representative if the obstruction is not removed.
TIP
c Perform the ISE Bleach Clean procedure as described in
“Bleach Cleaning Electrodes and Bypass Tubing” on Typical life
page 199. of Na, K,
and Cl
electrodes
is 12 - 18
months.
ISE Calibration Errors

Calibrate the ISE daily and as needed. If the standards are in the STAT
table for more than one day, replace with fresh standards (see See
“Calibration Process on the ISE” on page 82).
• Verify Calibration results.
• Review calibration data against the ranges below. The day-to-

TIP
day slope values should be consistent for each electrode. Slopes
might decrease with time, but this does not indicate a faulty A
electrode. Always check for trends in slope values. calibration
failure will
occur if the
Range of slopes Mid-standard solution factor ranges buffer or
Na 38 - 65 Na 0.80 - 1.20 standard
solutions become
K 38 - 65 K 0.75 - 1.25 contaminated with the
reference solution. The
Cl -38 - -65 Cl 0.75 - 1.25 reference solution has a very
high concentration of KCl
• Verify the ISE reagent integrity. and even a small volume
affects ISE results.
• Check the dispensing system and measuring components.
• Perform a calibration in Diag mode (Maintenance>Maker

Maintenance>ISE DIAG) to obtain the electrical potential of the
low, mid and high standards.
• If the Na and K slopes are negative and the Cl slope is positive:

• High Standard vs. Low Standard: An inverted slope is
generated indicating that the standards are reversed on
the standard cup table. Pour the standards again, and
place them in the correct positions on the STAT table.
• If Na and Cl are out of range, a possible carryover from the K

selectivity solution has occurred. Perform a calibration 3 times
and verify results.

• If Na and K are out of range, the sample pot might be
contaminated.
• If Na or K and Cl have a shift in the opposite direction, check the

reference electrode.
• If Na or K and Cl have a shift in the same direction, verify the

integrity of the buffer reagent.
TIP
ISE Selectivity Check
A
successful The Na electrode and K electrode are ion-selective electrodes. If the
calibration selectivity of electrodes deteriorates, the ISE unit is affected by ions
must be other than those being measured and optimal analysis results is not
achieved generated. To check the electrodes for deterioration, check the
before selectivity of the Na and K electrodes once a week.
performing a selectivity
check.
ISE Sequential Sample

Measure
Sequential sample measure checks ISE precision. You can also
perform the following:
• Other ISE Diagnostics Functions. See page 309.
• Shifts and Trends. See page 310.
• Checking Reagent Integrity. See page 312.

To perform sequential sample measure:
1 Ensure the system is in S TO P mode.
2 Select Maintenance>Maker Maintenance>ISE Diagnostics.
3 Perform Sequence 1, 2 and 3:
• Sequence 1: Aspirates the sample 10 times from the same

sample cup (from either a rack or the STAT table), measures
each aliquot and then calculates precision statistics.
• Sequence 2: Passes Mid standard solution through the

electrodes 10 times, measures it each time, and then calculates
precision statistics.
• Sequence 3: Primes the flowcell with mid standard solution,

measures this stationary mid standard solution 10 times, and
then calculates precision statistics.

4 Interpretation of results:
• If only one of Na, K, Cl electrodes is displaying imprecision:

Change the offending electrode.
• If Sequence 1 precision is poor, but Sequence 2 and

Sequence 3 precision are good: The problem is in the sampling
system. Clean or replace the sample probe and check the ISE
Buffer syringe for leaks. Check the buffer dispense nozzle an the
ISE sample mixer.
• If Sequence 1 and Sequence 2 precision is poor, but

Sequence 3 precision is good: There is a problem with flow of
solutions through the ISE unit. Check for blockages or restrictions
and ensure that the pump tubing is good and that the pinch valve
tubing is correctly placed in the valve.
• If precision is poor even for Sequence 3: There is an electronic

fault. Check the electrical connections to all four electrodes.
Contact your Beckman Coulter Representative.'
5 Repeat the sequential sample measure until CVs come within the
acceptable range.
6 Out-of-range QC results are flagged with numbers on the printout.
See Chapter 9, “Error Flags” on page 241, for details on each of
these error flags. Ensure that the range for the QC lot number is
properly entered in QC parameters.
Other ISE Diagnostics Functions

The following ISE diagnostics are available:
• Priming. See page 309.
• D.Pot Electrode. See page 310.
• Calibration Selectivity. See page 310.
• Reset. See page 310.
Priming
• A/Total Prime: Primes all solutions.
• B:/Buffer Prime: A one cycle Buffer Solution prime.
• C/Mid/Ref Prime: A one cycle MID Standard and Reference

Solution prime.
• D/Drain Electrode: Liquid is drained from the sample pot

through the electrode to enable electrode replacement. Use this
when replacing electrodes.
• E/Drain-Bypass: Liquid is drained from the sample pot through

the bypass tubing. Use this when replacing the bypass tubing.

D.Pot Electrode
• F/Mix: Mix rod is moved for three seconds.
• G/Overflow Sensor: Checks the overflow sensor.
Calibration Selectivity
Perform a calibration from diagnostics, using the following functions:
• I/Calibration for Serum: Calibrates serum.
• J/Calibration for Urine: Calibrates urine.
• K/Calibration for Serum and Urine: Calibrates serum

and urine.
• L/Selectivity: Carries out a selectivity check.
Reset
• M/Reset: Aligns all ISE mechanical parts in their home positions.
Shifts and Trends

A S h i f t is more than 7-10 QC points in a row that fall either above or
below the mean.
• Correcting Shifts and Trends. See page 311.

A T r e n d is 5-10 QC points in a row that are steadily increasing or
decreasing.
• Each laboratory must determine the number of QC points that

define a shift or trend.
• Shifts or trends can be flagged by the system’s QC program.
• Check for shifts or trends by reviewing the Daily QC Chart Output

window.
• Pre-set or cumulative modes are available:

a Pre-set values are determined from the Settings Sheet.
b Cumulative values are calculated by indicating the start date
and end date of the QC files that the laboratory wants to
include in the calculation.

Correcting Shifts and Trends
• Verify the QC material:

a Check the lot number and expiry date.
b Check the stability for proper storage conditions for the QC
material (freezer, refrigerator, opened bottles).
c If using lyophilised QC, check the reconstituted stability and
verify that it was made correctly. Use a volumetric pipette to
add the diluent.
d Verify the QC material was not left at room temperature for an
extended time period. Avoid prolonged exposure to the air
before processing because evaporation affects analyte
concentration.
e Ensure QC material was not contaminated prior to or during
the run. Check for indication of instability such as abnormal
colour, turbidity or a precipitate. Use fresh material if
necessary. Refer to the QC package insert for detailed
information on deterioration.
f Ensure the QC material is well mixed.
• If using an external calibrator (ACAL) for the electrolytes, verify
the calibrator material, using the same criteria as above.
• Place the control samples in the green rack in the order of the
control numbers that were set as parameters. The control
numbers correspond with the sample positions in the green rack.
For example, 1 to 10 are the control numbers and sample
positions for the green rack of ID0001, and 11 to 20 are the
control numbers assigned to sample positions 1 to 10 of the
green rack of rack ID0002.
• Check the dispensing system (see “ISE Dispensing System” on

page 303).
• Verify all reagent integrity.
• If using an external calibrator (ACAL), verify that the correct

calibrator concentration is entered.
• Verify that the correct calibration number is being used.
• Select Parameters>Specific Test Parameters. Check the factor

and offset values. The factor should be 1.0 and the offset 0.0
unless results are being corrected.

Checking Reagent Integrity
To check reagent integrity:
1 Check the reagent lot number and expiry date. Check the stability
for storage conditions and always follow the directions on the
package insert.
2 Ensure reagent was not contaminated before or during the run.
3 Check for signs of instability such as abnormal colour, turbidity or
a precipitate. Use fresh material if necessary. Refer to the package
TIP insert for information on preparation and signs of deterioration.
Prime lines 4 Verify that the reagent is placed on-board properly.
with mid- 5 Do not mix old and fresh reagents. Mark the date on bottles before
standard placing them into the system.
and
reference 6 Prime lines with fresh reagent.
solution
about five times to fill the
lines completely.

Menu Trees
Introduction
This chapter provides a reference to the menu options available in the
AU400:
• Routine Menu. See page 313.
• Parameter Menu. See page 315.
• Auxiliary Menu. See page 317.
• Maintenance Menu. See page 318.
Routine Menu
Menu Submenu Option
(R) Routine (S) Start Condition
Used to set the index
date and time, start
sample number, etc.,
before starting
analysis. See page 87.
(T) Test Requisition (N)Normal

Used to set the sample numbers and analysis
items required for normal analysis. See
page 113.
(R)Repeat
Used to set the sample numbers and analysis
items required for repeat run analysis.
See page 152.
(Q)QC
Used to set the analysis items, etc., required
for quality control analysis. See page 109.
(C)Calibration
Used to set the analysis items etc. required
for calibration. See page 103.
(S)Retrieve Repeat Data
Batch-searches the samples that require repeat
run for analysis results. See page 113.
(R)Reaction Monitor
Displays information
about reaction
processes during
analysis.
AU400 User Guide Version 2.11 Menu Trees 313

Menu Submenu Option
(C)Calibration Monitor (S)Calibration Curve
Displays calibration results as a graph or data
list. See page 133.
(T)Calibration Trace
Displays the calibration results over a given
periods as graphs or data lists. See page 134.
(B)Reagent Blank Monitor
Displays the reagent blank data. See page 133.
(P)Photocal Monitor
Displays the photocal
measurement result.
See page 193.
(Q) QC Monitor (D)Daily Control

Displays the data variation within the same
index date.See page 135.
(S)Day-to-Day Control
Displays the data variation between index
dates.See page 138.
(T)Twin Plot
Displays the twin-plot chart. See page 139.
(E)Data Edit.
Used to edit the quality control data. See
page 139.
(D) Data Management (E) Data Edit

Used to search for and edit (if required) analysis
results. See page 141.
(C) Data Correction
Used to correct analysis results. See page 143.
(W)Repeat Data Verification
Updates the existing repeat run data with the
current data. See page 151.
(A) Data Report (R) Report

Prints out analysis results in a report format.
See page 144.
(D)Data List
Used to display and print results in a list format.
See page 144.
(N) Online
Outputs analysis data online to the host
computer. See page 146.
314 Menu Trees AU400 User Guide Version AC

Parameter Menu
Menu Submenu Option

(P) Parameter (Y) Common Test (A)Test Name
Parameters Used to select the names of test items. See page 52.
(B)Profile
Used to select specified test items for one profile.
Multiple profile setting is possible.See page 60.
(C)Round
Used to select the round name and test items for each
round. See page 55.
(I)Specific Test
Parameters
Used to set detailed
parameters for
individual test
items.See page 56.
(H)Inter Related (A)Calculated Tests

Tests Used to select the test items and calculation
expression for performing inter-item
calculation.See page 163.
(H)Checked Tests
Used to set the parameter to check the validity of
the test data between items. Also, test items, the
calculation expression, the check range, etc. are set.
See page 165.
(B)Sample Blank
Used to select the parameter of sample blank
correction. See page 166.
(R)Repeat (R)Repeat Common

Parameters Used to set the common parameters for a repeat run
(C)Repeat Specific
Used to set the sample type, sample dispense quantity,
etc., at repeat run analysis for individual test
items.See page 77.
(Q)QC Control (C)QC Common

Used to set the common parameters for a quality
control analysis. See page 62.
(I)QC Specific
Used to set the average value and standard deviation
of the control sample for quality control for individual
items. See page 63.
(S)STAT Table QC
Used to set the parameters of quality control analysis
using the STAT table. See page 110.
(B)Calibration (C)Calibrator
Used to set the common parameters for a calibration
(I)Calibration Specific
Used to set the calibration type, approximate
expression, etc., of a calibration sample for individual
items. See page 64.
(S)STAT Table Calibration
Used to set the parameters of calibration analysis
using the STAT table. See page 107.
AU400 User Guide Version AC Menu Trees 315

Menu Submenu Option
(O)Online
Used to set the
parameters for
online data
communication
between a host
computer and this
system. See
page 167.
(F)Format (P)Printer
Used to set the operating conditions of the printer.
See page 169.
(S)Requisition Format
Used to configure the sample requisition parameters.
(R)Report Format
Used to set the parameter of a desired report format.
See page 144.
(L)List Format
Used to set the common format parameter for printing
out the work list, master data file, repeat-run work list,
and pending sample list.See page 144.
(C)Special (C)Contamination Parameters

Used to set the conditions of contamination between
test items. See page 74.
(D)Data Check Parameters

Used to set the conditions of data check. For detailed
information, contact Beckman Coulter or the reagent
manufacturer. See page 76.
(S)System (O)Option
Used to select/deselect optional units, etc., integrated
in the system. See page 170.
(S)System
Used to set the system configuration parameters.
See page 174.
(P)Auto Power On
Used to set the time of auto power-on. See page 176.
(W)Password
Used to set the level of password. See page 171.
(L)Login Name
Used to set the login name and the menu level.
See page 170.
(U)User Menu)
Used to add menu items into a user defined menu.
See page 171.
(M)Comments
Master
Used to customise
the comments
appended to the
analysis results.
See page 175.

Auxiliary Menu
Menu Submenu Option
(A)Auxiliary (S)Data Statistics Used to calculate the average and standard deviation
of daily variations and day-to-day variations among the
analysis data over a given period. See page 180.
(C)Correlation Displays the correlation between two analysis items

Chart within the same index date and time, using the
correlation diagram and regression line. See page 180.
(H)Histogram Displays the frequency distribution of analysis data,

over a given period, as a histogram. See page 181.
(R)Reagent Displays the number of shots for each remaining

Consumption reagent. See page 183.
(I)Reagent Sets up the reference value for each day of the week to
Inventory perform daily checks as to whether there is insufficient
reagent. See page 184.
(P)Parameters Used to save parameters on the hard disk or a floppy

Management disk, and to load parameters that have been backed
up. See page 147.
(V)Calibration Verifies the calibration performance by putting a

Verification calibration specimen into the same analysis used for
the general samples. See page 178.
(B)Standby Set Moves from the warm-up mode to the standby mode.
See page 301.
AU400 User Guide Version AC Menu Trees 317

Maintenance Menu
Menu Submenu Option
(M) Maintenance (D)Data Operation (F)FD Data Management
Saves the analysis data on a floppy disk.
Initialises a floppy disk. See page 178.
(T)Set Date and Time

Used to set the system date and time of
the system. See page 176.
(D)Retrieve Data Base

Rebuilds the index file of the database in
the hard disk. See page 297.
(O)Offline Output
Saves the analysis data on a floppy disk to
transfer the data to an external computer.
(M)Modem
Enables remote diagnostics via modem.
(A)ANL Maintenance
Used to execute drainage if
replacing the probe, syringe,
mixing bar, etc., and also to prime
out from the tubes after
replacement. See page 187.
(C)Consumable Management
Used to manage information about
consumable supply and
replacement periods using the list.
See page 184.
(P)Periodic Maintenance
Used to manage the execution
condition of periodic maintenance
items using the list. See page 188.
(M)Maker Maintenance (V)Program Version

Displays version information about the
installed program. See page 177.
(A)ANL Diag
Used to perform independent operation
of each analyser mechanism.
(I)ISE Diag
Used to perform independent operation
of each ISE function (optional).
(L)Alarm Log
Chronologically lists the alarms that have
occurred.
(F)File Management
Used to save the parameters file on
the floppy disk and to load the file from
the disk

Reorder List
U.K/IRL Reorder List

The list below is an example only. An specific reorder list will be
produced by each Beckman Coulter organisation.
Part Number Part Quantity

66853 ISE/STAT Tubes 1000
55475 Sarstedt Tubes 1000
63093 60 ml Bottle 20
63094 30 ml Bottle 20
63165 15 ml Bottle 20
MU826200 Reagent Adapter 20
63167 15 ml Bottle Adapters 20
MU9599 Mixing Bar (packet of 3) 1
MU98880 Photometer Lamp 1
MU9623 ISE/Detergent Pump Tubes 2
ZM2970 ISE Pinch Valve Tubes 1
MU962800 ISE Mixing Unit 2
MU993400 Sample Probe 1
MU995800 Reagent Probe 2
ZM0111 Sample Syringe (S) 1
ZM0112 Reagent Syringe (R) 1 1
ZM0229 Syringe Casing for Reagent/Sample/ 1

Buffer Syringes
ZM0634 Cuvettes 10
63157 White Rack 10
63158 Blue Rack 1
63159 Green Rack 1
63160 Red Rack 1
63161 Yellow Rack 1
63162 Orange Rack 1
UKTRAY Sample Rack Holder 1
MU805100 Rack ID Labels 1-3 1
63104 Rack ID Labels 1-100 1
AU400 User Guide Version 2.11 Reorder List 319

63119 Rack ID Labels 1-20 1
63100 Sodium Electrode 1
63101 Chloride Electrode 1
63102 Reference Electrode 1
MU920900 Seal for the Reference Electrode 1
63103 Potassium Electrode 1
MU990000 O-ring for the ISE unit 5
66313 ISE Selectivity Check Solution 2 x 25ml
66314 ISE Internal Reference Solution 2 x 25ml
66318 ISE Reference Solution 4 x 1000ml
66319 ISE MID Standard Solution 4 x 2000ml
66320 ISE Buffer Solution 4 x 2000ml
66039 ISE Cleaning Solution 6 x 500ml
66316 ISE High Serum Standard 4 x 100ml
66317 ISE Low Serum Standard 4 x 100ml
66315 ISE Low/High Urine Standard 4 x 100ml
OSR0001 Detergent 4 x 2000ml
MU811900 Adapter for STAT table 22
320 Reorder List AU400 User Guide Version AC

AU400 Glossary
Advance Calibration
Advance Calibration Analysis enables the operator to perform
calibration analysis for all sequenced reagent bottles (up to five at a
time) that are in the system and simultaneously produce a calibration
curve and a factor for each one before the routine analysis is started.
Some analyses might require a high volume of one reagent and
therefore a number of bottles. These bottles are sequenced to enable
change over from one to the other. It is this change over that requires
a new calibration curve to be created and evaluated before analysis
can continue.
Alarm Shots
The Alarm Shots function enables you to set the number of remaining
reagent shots that when reached, prompts a system alarm.
Analysis Parameters
Before using the system for the first time, you must set parameters such
as the reagent and sample quantity. Enter these parameters from the
Settings Sheet provided with reagents, to ensure optimum system
performance.
Auto Calibration
Advance Calibration should be used with care for tests that have a
calibration stability of one day. Auto-calibration from the STAT table
may be more suitable for these tests.
Auto Preparation
Auto Preparation involves a Wash 1 and/or Photocal depending on how
it is programmed by the Beckman Coulter Representative. Auto
Preparation can be programmed to be performed following an Auto
Start, if required.
Auto Shut down

The system can be shut down by pressing E n d P r o c e s s on the
keyboard. This should only happen after performing a Wash 2. All other
software windows must also be closed. This cannot be preprogrammed.
When shutting down, you can turn on Auto Start and choose Auto
Preparation, if required.
Auto Start
Auto Start allows you to preprogram a time at which the system
automatically powers on and warms up. You can also program an
Auto Preparation to be performed following an Auto Start.
Calculated Tests
A Calculated Test is a one whose result is calculated according
to specific calculation formulas. These formulas must be entered
manually.
Calibration
Calibration is a control procedure whereby a calibrator with a specific
known concentration of an analyte is used to set the measured OD in
correlation to the determined concentration, to get a calibration curve.
AU400 User Guide Version AC

321
Calibration Trace
Calibration Trace is a graph that displays 0 in order to ensure that the
new calibration curve is consistent with the previous ones.
Consumable
A consumable is a term used to describe materials required by the
system, such as reagents and wash solutions.
Correlation Chart
A Correlation Chart allows users to plot the results of two tests on one
graph for the purposes of comparison.
Cuvette Status
Cuvette Status is a check used to assess the results of a Photocal.
A photocal is a process used to test the condition of the cuvette glass
and to set the baseline OD value for each cuvette (this is often referred
to as the 'cell blank').
Daily Variation Chart

A Daily Variation Chart is one of the four types of QC chart. It compares
QC sample analysis results by plotting the individual QC points from
one day of analysis or from one index only on a variation chart. This
should always be reviewed following QC analysis.
Electrode
There are 4 electrodes in the ISE Unit of the system; the three Ion-
Selective Electrodes (Na, K, Cl) and the Reference Electrode. The ISE
Unit works by measuring the potential difference between the Ion-
Selective Electrodes and the Reference Electrodes. This potential is
generated by ions in the sample passing through the Ion-Selective
Electrode. The electrode responds selectively to an ion in the presence
of other ions. The purpose of the test is to calculate the concentration of
individual ions in the sample and MID Standard solution.
End Point Assay

There are three types of End Point Assay:
• One Point assay is a general end point assay that determines the
optical density of the reaction mixture from the optical density
measured at a specified photometric measuring point.
• Two Point (Self-blank method) assay provides sample blank

adjustment. This optical density values before dispensing
reagent are eliminated as the sample blank. This optical density
is then subtracted from those calculated after dispensing the
second reagent. Any contribution to the final reaction OD from
the sample (turbidity, icterus etc.) is removed to improve
measurement reliability.
• Blanked End Assay measures the blank channel and then

subtracts this from the measured optical density to calculate
the actual optical density of the reaction. This requires an
additional blank.
322 AU400 User Guide Version AC

Flags
A Flag is a symbol that appears beside analysis results that indicates
that an error has occurred during analysis or that the result may require
review. See Chapter 9, “Error Flags” on page 241 for details on each
error flag.
Fixed Point Assay

Fixed Point Assay is a method of calculation that determines the
difference between the optical densities at two specific time points
within a reaction.
Histogram
Histograms are bar charts that display a history of the number of
samples, mean, SD, CV, range, as well as minimum and maximum
statistic calculations.
Ion-Selective Electrodes
The ISE Unit measures the potential difference between the Ion-
Selective Electrodes and the Reference Electrode. This potential is
generated when ions in the sample pass through the Ion-Selective
Electrodes Na, K and Cl.
ISE Status
ISE Status is a software window that allows you to prime, start and
stop the ISE Unit and perform calibration. It also enables you to view
ISE calibration result statistics or view the Slope Chart.
Maintenance History
Maintenance History is a list showing the last 10 dates when
maintenance was performed on each item on the Maintenance
Register.
Maintenance Register
The Maintenance Register is a list of planned preventative maintenance
tasks each flagged with a due date. When a maintenance task is
performed, users update the item record to show that maintenance
is performed on time.
Masking (a Test)
Masking a test excludes that test temporarily from the next run until
it is unmasked. Creating a new index unmasks tests.
Noise
Sample Blank correction is performed to remove noise from
measurements.
One Touch Mode

One Touch mode allows operators to process a sample by placing it on
the STAT table and pressing a switch. No requisition need be entered
for the sample. It can be used to process emergency samples.

323
Optical Density
The photometer sends a beam of white light through a cuvette and
measures light levels at the other side of the cuvette to determine how
much of the light (of various wavelengths) is transmitted through the
cuvette (and its contents). The Optical Density is the amount of light
absorbed (i.e., not transmitted) by the cuvette and its contents.
Optimal Analytical Performance

Optimal Analytical Performance is the ideal or most accurate
performance possible with the system and that which is intended by the
manufacturer and provider.
Photocal
A Photocal is a test to assess the condition of the cuvettes and to
determine the baseline optical density of each cuvette. This baseline
absorbance is often referred to a the 'cell blank'.
Photometry
Photometry is the process of measuring visible light in wavelengths and
calculating optical density. When a reagent is added to a sample, the
sample undergoes an optical change. Photometry is used to measure
this change and therefore calculate an analysis result.
QC Monitor
The QC Monitor gives an instant visual summary of a day’s QC analysis
results. See Chapter 5, Performing Analysis.
Quality Control (QC) Analysis

Quality Control (QC) analysis is the process of analysing samples with
known concentrations of analytes in order to test the quality of reagents,
calibrators, system and procedure.
Rate Assay
• Normal rate assay measures the variation in the rate of

absorbance per minute by calculating the average change in
absorbance between each two photometric points, using the
least squares method.
• Double rate assay determines the rate of absorbance variation

per minute by calculating the average of the absorbance
variations between each two measuring points, using the least
squares method. The rate of absorbance before dispensing
reagent 2 is subtracted from those calculated after dispensing
the second reagent.
Reaction Monitor
The Reaction Monitor can be used to compare a suspect reaction with
that of a successful reaction, to identify abnormalities. The reaction
monitor plots absorbance data against photometric measuring points
for each test. The reaction process can be viewed either as a graph or
on a data sheet.

Reagent
A reagent is a substance that when a sample is added, undergoes an
optical change. The optical change allows the analyte in each sample
to be measured.
Reagent Blank
Reagent Blank is the resulting optical density measured when a reagent
is used to test a sample with no analyte, i.e., deionised water. This is
then used when performing analysis calculations, to subtract the
reagents own intrinsic optical characteristics.
Reagent ID
A Reagent ID is a barcode attached to one end of each reagent bottle
that allows the system to identify the reagent.
Reagent Inventory
Reagent Inventory is a system software function that allows you to
automatically calculate/predict the volume of reagent that the system
uses on a selected day of the week. You can also use this function to
manually set the volume of reagent or the number of shots of reagent
that should be used in each test on a selected day.
Reflex Testing
Reflex testing enables a test to be run automatically by linking it to
a repeat flag generated by another test. Up to 10 sets of tests can be
programmed as Reflex tests.
Repeat Run
A repeat run is a process whereby samples are tested again, either
manually or automatically by the system.
Requisitions
A test requisition is information such as sample name, number and
test to be run, which is used by the system to specify exactly what
parameters should be used when testing each sample.
Sample Blank
Sample Blank is the optical density of a sample when measured before
a reagent is dispensed. The optical density values in this blank channel
should then be subtracted from those calculated after dispensing the
second reagent.
STAT Table
The Short Turn Around Time (STAT) table is a revolving feeder that
enables a sample requiring very urgent analysis to be tested quickly,
as well as performing certain types of calibration and QC.
System Status
System Status is a software window that gives operators a snapshot
of the status of the entire system. From System Status, you can access
all other core status windows such as Reagent Status, Analyser Status
and Cuvette Status.

325
Twin Plot
Twin Plot is used to determine whether a problematic variation in QC
is caused by the system or just a random error.
Warm-Up Mode
Whenever the system is shut down, it restarts in Warm-up mode.
The purpose of warm-up is to bring the cuvette wheel and reagent and
STAT wheels to the optimum temperature. It takes between 20 and
90 minutes.
Wash 1
A Wash 1 cleans:
• Sample probes
• Cuvette wheel
• Reagent probes
• Mixing bars
A Wash 1 uses a 2% Wash Solution and takes about 19 minutes.
Wash 2
A Wash 2 thoroughly cleans cuvettes, probes, mixing bars and waste
lines in preparation for photocal. A Wash 2 takes about 31 minutes.
Acid and alkaline solutions should be alternated each week.

AU400 Acronyms
ACAL
Automatic Calibration
CSF
Cerebrospinal Fluid
FD
Floppy Disk
ISE
Ion-Selective Electrode
HD
Hard Disk
LIH
Lipemia, Icterus and Hemolysis Test
MCAL
Manual Calibration
MID
MID Standard Solution
PDF
Portable Document Format
QC
Quality Control
STAT
Short Turn Around Time

327
Useful References
Refer to the following for more useful information:
• Beckman Coulter website: www.beckmancoulter.com.
• Burtis,C.A and Ashwood, E.R.eds.(1999). Tietz Textbook of

Clinical Chemistry, 3rd Edition. London, W.B. Saunders
Company. ISBN 0-7216-56192
• Marschall, W.J.(2000). Clinical Chemistry, 4th Edition. London,

Harcourt Publishers Ltd. ISBN 0-7234-3159-0
• Skoog, D.A, Holler,F.J. and Nieman,T.A.eds. (1998). Principles

of Instrument Analysis, 5th Edition. London, Saunders College
Publishing. ISBN 0-03-002078-6
• Ehret W, Heil W, Schmitt T, Topfer G Wisser H, Zawta B, et al.

Use of anticoagulant in diagnostic laboratory investigations and
stability of blood, plasma and serum samples. WHO/DIL/
LAB99.1 Rev.2:21pp.
• Young DS. Effects of drugs on clinical laboratory tests, 5th ed.

AACC Press, 2000.
• Young DS. Preanalytical variables on Clinical Laboratory Tests,

2nd ed. AACC Press, 2000.
Young DS. Effects of Disease on Clinical Laboratory Tests, 4th ed.
AACC Press, 2000.

Index advance 73
advance calibration 67
calibration curve 82, 97, 133
calibration trace 134
A
checking data 131
data problems 285
entering parameters 64
absorbance 25 ISE calibration 100
alarm display 131 MB type 68
alarm list 128 MCAL 2 to 7MB 71
alarm shots 54 MCAL MB 71
analysis performing 103
modes 174 performing calibrations 103
monitoring 124 recalculating results 143, 159
pausing 156 summary 68
starting 124 using STAT table 107
AU400 verification 178
automatic power-on 176 Cl electrode 31
pausing 156 cleaning solution 9, 191
software version 177 comment master 175
starting 85 consumption 183
starting analysis 124 consumable management 184
status 159 replacing reagents 94
training required 2 tests remaining 94
contamination 74
correlation chart 180
B
cuvette wheel
overflow 299
temperature 125
cuvettes
barcode reader 159 check range 125
barcodes
cleaning 127
attaching to racks 116
how used 24
checking positions 91
performing a photocal 126
emergency sample 155
problems 288
label problems 292
replacing 206
QC 110
status 125
setting barcode mode 174
when required 23
why used 23
batch report 169
bilirubin 162 D
daily variation chart
C
See QC
data
data check 76
histograms 181
calculated test channel 163 problem checklist 280
calibration
saving 147
1-point cal. correction 72
sending to another computer 146
AB type 67
statistics 180
ACAL 2 to 7AB 70
test run 87
ACAL AA 69
time index 87
ACAL AB 69
data lists 145
AU400 User Guide Version AC Index 329

data processor status 129
database
I
retrieval 158 icterus 162
date and time 176 incubator 41
day-to-day variation chart index (date and time) 87
See QC (Quality Control) infection 11
dead volume 117 installation, engineers required 4
detergent, use in washing unit 37 ion selective electrodes
DIAG switch 34 See ISE
downloading requisitions 114 ISE
buffer 97
calibration 79, 81, 100
E
calibration curve 82
checking reagent level 98
cleaning solution 9, 191
EM STOP 158 cleaning the sample pot 100
EM STOP (Emergency stop) switch 33 daily maintenance 190
emergency samples 153 described 31
emergency stop diagnostics 307
performing 158 electrode problems 306
recovering data 158 electrodes 31
resetting system 298 flowcell problems 307
end point assay, calculating 27 ISE prime switch 33
error flags 241 MID standard solution 31
error flags, checking 131 mixing bar problems 196
error messages 263 O-rings 306
power switch 33
preparing the ISE unit 97
priming 99
F replacing buffer syringe 235

replacing electrodes 227
replacing reagents 235
fixed point assay 30 replacing the reference electrode 233
floppy disk replacing valve tubing 230
initialising 146 sample problems 303
problems 296 syringe 41
saving data 147 unit testing 31
weekly maintenance 190
G
green rack
L
See racks leaks, checking for 88
LIH test 162
lipemia 162
H login
adding a user name 170
password 171
help, online 3 setting up 170
hemolysis 162 user menu 171
high serum standard 39 user name 86
high urine standard 40
330 Index AU400 User Guide Version AC

M saving 147
system parameters 24, 174
password
maintenance See login
as-required ISE maintenance 227 PDF, how to use 328
consumable management 184 personal injury 10
DIAG switch 33 photometer
history 188 checking 206
ISE daily 190 performing a photocal 126
maintenance register 188 photometry process 25
periodic maintenance 187, 191 problems 289
routine schedule 187 replacing lamp 206
weekly ISE 190 power-on switch 33
Manual 77 printing
MID standard solution adding new test 80
See ISE batch report 169
mixing bars, problems 288 parameters 168
mixing, cleaning mixing bars 90 printing results 144
problems 293
reports 144
N
second printer 170
setting up printers 168, 169
this guide 5
probes
Na electrode 31
dead volume 117
position 117
problems 287
O reagent probes described 36

replacing reagent probe 209
replacing sample probe 191
one point assay sample probe described 36
See end point assay when washed 24
one touch mode 115 profiles 60
online, data transfer 146
optical density 25
Q
P QC (Quality Control)
barcodes 110
parameters checking QC 134
calibration 64 daily variation chart 135
contamination parameters 74 data problems 285
data check 76 day-to-day variation chart 138
ISE 79, 81 editing results 139
LIH 162 entering parameters 61
loading 147 QC failure 130
performing repeat tests 152 QC monitor 137
printing 168 QC specific 63
problems 284 STAT table 110
QC 61 twin plot 139

R reflex 80
reset switch 33
results
rack mode 174 abnormal, causes 134
rack no. mode 23 batch report 169
racks calculated test 163
green rack 107, 110 calculating results 25
orange rack 77 checking results 130
problems 290 correcting results 143
rack adapters 118 editing QC 139
rack feeder 34 editing results 140
red rack 155 monitoring data 128
stopping the rack feeder 156 recalculating results 143, 159
yellow rack 107 sample blank correction 166
rate assay 29 rounds 55
reaction monitor 131 run, test data 87
reagents
amount remaining 94
S
checking bottles 96
checking reagents 90
contamination parameters 74
data problems 284 safety precautions 9
how transferred 24 sample I.D. mode 23
inventory calculation 184 sample pot
multi-reagent item 54 See ISE
reagent blank 26, 133 samples
reagent blank measurement 105 data problems 283
reagent ID 54, 78 emergency 153
replacing 94 histograms 181
sample probes 36 how recognised 23
saving reagents 130 how transferred 24
sequence numbers 97 ISE problems 302
syringes 41 placing barcodes 116
viewing consumption volumes 183 placing in cups 117
zero adjustment 26 reloading 152
reflex testing 80 replacing probe filter 222
refrigerator sample probe 36
problems 290 syringes 41
temperature 125 security
reorder list 319 password 171
repeat tests user menu 171
automatic 79 sequential mode 23, 174
data overwrite 150 serious injury 10
performing 149 software version 177
performing a manual repeat 152 start condition 124
programming 77 STAT rotation/DIAG switch 33

STAT table
and ISE solutions 102
auto-calibration 107
U
checking status. 111, 112 user menu 171
described 39 user name
emergency samples 153 See login
keeping samples 111
one touch mode 115
V
problems 290
QC 110
reloading samples 152
rotating 154
viewing reagent use 183
S-H and S-L holes 39
U-H and U-L holes 40
Wash 1 39
Wash 2 39
STAT test switch 33
statistics
W
correlation chart 180 warm-up mode, bypassing 159, 195
histograms 181 warning 6, 17
viewing data statistics 180 wash nozzle, problems 288
switches, location 32 washing
syringes checking wash solution 88
location 41 cleaning solution 9, 191
problems 286 cuvettes 27
replacing 212 performing wash 1 189
system administration 4 probes 24
system parameters, where used 24 replacing wash nozzle tubes 214
wash 2 190
washing unit described 37
T
temperature 125
test data
Y
See data yellow rack
test requisition 23 See racks
test rounds 55
tests
Z
adding manually 113
calculated test 163
masking 130 zero adjustment
repeat tests See reagents
See repeat tests
time setting 176
two point assay
See end point assay
typographical conventions 6


User Guide: AU400 Clinical Chemistry System

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

User Guide: AU400 Clinical Chemistry System

Uploaded by

Copyright:

Available Formats

User Guide

For In Vitro Diagnostic Use

Find us on the World Wide Web at:

Beckman Coulter Ireland Inc.

Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda

Document Change Notification

Date Version Page Description

1 Before You Start

What’s New in this Release..................................................................1

Using this User Guide...........................................................................2

2 Primary Safety Precautions

Safe Use of the System........................................................................9

Installation Environment Precautions .................................................16

System Labels and Displays ..............................................................17

AU400 User Guide Version AC Contents v

How the AU400 Analyses Samples....................................................21

Understanding the System Hardware.................................................32

Understanding the Computer Software ..............................................48

Entering Test Name Parameters ........................................................52

vi Contents AU400 User Guide Version AC

Adding the New Test to the Round.....................................................55

Entering Specific Test Parameters .....................................................56

Creating a New Profile........................................................................60

Entering Quality Control (QC) Parameters .........................................61

Entering Calibration Parameters ........................................................64

Entering Contamination Parameters ..................................................74

Entering Data Check Parameters.......................................................76

Programming Repeat Tests................................................................77

Entering Settings for ISE ....................................................................81

Adding the New Test to the List Format for Printing...........................84

5 Preparing for Analysis

Performing Daily Maintenance ...........................................................85

AU400 User Guide Version AC Contents vii

Entering Analysis Requisitions .........................................................112

Preparing Samples for Analysis .......................................................115

Monitoring Analysis ..........................................................................124

Masking a Test .................................................................................130

Editing Analysis Results ...................................................................140

viii Contents AU400 User Guide Version AC

Resending Data to a Host ................................................................146

Saving Information to a Floppy Disk.................................................146

Performing a Manual Sample Dilution ..............................................149

Performing a Repeat Run.................................................................149

Processing Emergency Samples......................................................153

Pausing Analysis ..............................................................................156

Stopping the Rack Feeder................................................................156

Stopping the System ........................................................................156

Shutting Down the System ...............................................................157

Performing an Emergency Stop .......................................................158

Restarting the System ......................................................................158

Turning On and Off the Sample Barcode Reader ............................159

Additional Programming Tasks........................................................161

AU400 User Guide Version AC Contents ix

Entering Login Names and Allocating Levels of Access ..................170

Setting General Parameters .............................................................173

Offline Output ...................................................................................186

Using the Routine Maintenance Schedule .......................................187

Periodic Maintenance .......................................................................188

Daily Maintenance ............................................................................189

Daily ISE Maintenance .....................................................................190

Weekly Maintenance ........................................................................190

x Contents AU400 User Guide Version AC

Monthly Maintenance .......................................................................200