User Guide: AU400 Clinical Chemistry System
User Guide: AU400 Clinical Chemistry System
User Guide: AU400 Clinical Chemistry System
AU400®
Clinical Chemistry System
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.
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
3 System Outline
Introduction.........................................................................................21
4 Configuring Tests
Introduction.........................................................................................51
6 Performing Analysis
Introduction.......................................................................................123
Starting Analysis...............................................................................124
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
7 Additional Tasks
Introduction.......................................................................................161
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
8 Maintenance
Introduction.......................................................................................187
9 Error Flags
Introduction.......................................................................................241
10 Error Messages
Introduction.......................................................................................263
11 Troubleshooting
Introduction.......................................................................................279
12 Menu Trees
Routine Menu ...................................................................................313
Parameter Menu...............................................................................315
13 Reorder List
U.K/IRL Reorder List ........................................................................319
AU400 Acronyms..............................................................................327
Index.................................................................................................329
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:
• Added “Using a Floppy Disk” on pages 10, 15, 146, and 186.
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.
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:
AU2700 Users
Users who have advanced knowledge of the Beckman Coulter AU2700
system should read the following sections of this guide before operating
the AU400:
AU5400 Users
Users who have advanced knowledge of the Beckman Coulter AU5400
system should read the following sections of this guide before operating
the AU400:
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:
• 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.
• 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.
• 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.
These are the note and warning symbols used throughout this guide.
Please read Chapter 2, “Primary Safety Precautions” on page 9.
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.
Introduction
You must understand how to use the AU400 safely before you begin
using the system. This chapter provides instructions on:
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.
• Do not open the upper and rear lids, the reagent refrigerator lid,
cuvette wheel lid, large STAT table lid or ISE lid during analysis.
Preventing Infection
To avoid infection, adhere to the following guidelines:
Handling Specimens
To handle specimens safely, adhere to the following guidelines:
• 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.
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.
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.
Minimum 500
Breaker
Minimum 1760
Data processor
700
(DPR)
760
AU400
Analyser (ANL)
Minimum 500
F Minimum 220
R
O
N
T
EM. GND
ON OFF RESET
STOP Terminal
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.
Cuvette wheel
Mixing
Washing and drying
Reagent transfer
Grating
Photometer sensor
Light
source Auto repeat run
Sample transfer
Sample pot
Optional
Report printer
Electrode
Hard
Record and data storage disk
Keyboard
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.
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.
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.
Calculating Results
The system can calculate analysis results in several ways:
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.
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
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)}
Reaction OD value = Colour Reaction Test OD (ODc) - Serum Blank Test OD (ODB)
Color reaction channel
OD
ODC
R1 S R2 27
Rate Assay
There are two types of rate assay:
OD
TIP
OD
ΔOD(2)/min.
ΔOD(1)/min.
R1 S R2 27
[ΔOD(2)-ΔOD(1)]/min.
OD
R1 S R2 A B 27
• Na electrode
• K electrode
• Cl electrode
Sample pot
Electrode
System Switches
The location of the system switches is shown in Figure 3-10.
This section describes the following switches:
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.
a a
F
R
O
N
T A maximum of 8 racks can be set at one time.
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
Mixing unit
Mixing bar
Mixing-bar
wash well
T
ON
FR
Knob
Joint tube
Tube mounting joints
Wash nozzles
Wash nozzle
station FR
Aspiration nozzle ON
T
Drying nozzle
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
Syringe case
FR
ON
T
Piston fixing screw
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
Incubator
T
ON
FR
Cuvette
Lamp cover
Knobs
Photometer
lamp
T
ON
FR Lamp cords
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)
Rear view
DPR (PC) breaker
Reagent refrigerator and
incubator breaker
Analyser breaker
Fuse Heater breaker
FUSE
Pilot lamp 250V 2A
TYPE-F
DPR (PC)
service outlets OP.1 SIGNAL OP.2 SIGNAL
K electrode
Pinch valve Na electrode
Thermistor Cl electrode
Mixing unit
T
ON
FR
Mixture aspiration rolling pump
MID solution dispense rolling pump Sample pot
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
To Serum: 600 µl
To Urine: 750 µl
Power Switch
This is located behind the right front door.
Syringe case
• Buffer Solution
• Reference Solution
FR
ON
T
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
1
2
3
Figure 3-28: Example GUI Window
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.
System
Feeder Stop key
Status key
Pause key
Menu Help key Print Screen
Function key key
ESC key Number Lock key
Start key
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
: Template
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.
Introduction
This chapter describes how to add a new test to the AU400 and
configure the system.
• Adding the New Test to the List Format for Printing. See page 84.
TIP
If a test is
missing in a
round, the
system
does not
run this test.
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 .
Sample Pre-dilution Rate Sample Quantity (µl) Sample Dilution (Water, µl) Total
5 48 192 240
10 24 216 240
50 5 245 250
5 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.
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.
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.
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
5 Click E x i t ( F 2 ) to return to the main window.
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.
OD
ACAL OD2
ACAL OD1
CONC
Concentration Concentration
value 1 value 2
ACAL AB
This is measured as shown in Figure 4-16.
OD
ACAL OD
CONC
Concentration value
OD
OD 7
OD 6
OD 5
OD 4
OD 3
OD 2
OD 1
OD 0 CONC
Concentration value 1
Concentration value 2
Concentration value 3
Concentration value 4
Concentration value 5
Concentration value 6
Concentration value 7
Figure 4-17: ACAL 2 to 7AB
OD
CONC
• 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.
OD
OD 7
OD 6
OD 5
OD 4
OD 3
OD 2
OD 1
CONC
Concentration value 1
Concentration value 2
Concentration value 3
Concentration value 4
Concentration value 5
Concentration value 6
Concentration value 7
Example 1
ODn’=ODn x OD2
OD
OD2’
OD3’
OD3
OD2’
OD2
OD1’
OD1
CONC
0 CONC1 CONC2 CONC3
OD
OD4’
OD4
OD3’
OD3
OD2’
OD2
OD1’
OD1
CONC
0 CONC2 CONC3 CONC4
a= OD3’ - OD1
OD3 - OD1
b=OD1
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.
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.
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.
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.
TIP
• 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:
1 Select Parameter>Specific Test 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
TIP
A C A L is
Automatic
Calibration.
M C A L is Manual
Calibration.
Manual Calibration
This is measured as shown in Figure 4-30.
Potential
difference (mV) Calibration
EH-EM’
EL-EM’’
Concentration
CL CH value
(logarithm)
mmol/L
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.
b
b’
X (known concentration of a specimen subject to A-CAL)
C
Introduction
This chapter details the tasks needed to prepare the AU400 for use:
Performing Daily
Maintenance
There are a number of procedures to perform before you enter analysis
requisitions and prepare your samples:
Master detergent
tank A
(factory optional) Master detergent
tank B
O NT
FR
Mixing unit
Mixing bar
Mixing-bar
wash well
T
ON
FR
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.
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:
Check All Positions: Reads all reagent barcodes and volume checks
all reagents.
Positioning pin
T
ON
FR
• 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.
Case head
Syringe case
ISE
ON FR
ON
T
F
OF ISE power switch
Aspiration tube
MID solution Cap
tank
Buffer solution
tank
FR
ON
T
REF solution tank
Ready/Busy/Stop/No Connection
Indicates the operation mode of the ISE
Electrode
Electrode indicates whether the latest slope value falls within the range of
normal values.
Reagent
Indicates the quantities of the buffer, Mid Standard Solution and REF
solutions
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.
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.
7 Click E x i t ( F 2 ) to return to the main window.
Performing QC Requisition
To perform a QC analysis requisition:
1 Select Routine>Test Requisition>QC.
2 Select the sample type from the T y p e drop-down list.
3 Click S t a r t E n t r y ( F 4 ) .
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.
9 Click E x i t ( F 2 ) to return to the main window.
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.
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.
• 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
Orange: Repeat-run
analysis
Red: Emergency
analysis
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.
Rack side
φ16.0mm or less
Sample cup (outside diameter including
the barcode label)
Rack top
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
Rack
Adapter
1 2 3 4 5 6 7 8 9 10
Rack
Slit
Adapter lock
Rack window
Push up lightly
with a finger
Sample Order
• Orange Rack: Must correspond with the repeat run work list
(except when barcode mode is used).
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
F
R
O
N
T A maximum of 8 racks can be set at one time.
Rack
Window for reading rack ID
Sample protection
cover
LED
T
ON
Feed side rack feeder FR
Introduction
This chapter details tasks to be performed during analysis:
• Turning On and Off the Sample Barcode Reader. See page 159.
Monitoring Analysis
You can monitor general system status with the System Status window.
In addition, you can also examine the following
TIP
B lu e
No Error
Yellow
Red
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
• All Data: Data appears only when all tests for that sample are
completed.
• ISE Data: Data appears as soon as all ISE data for that sample
is complete.
TIP
The
operator
can unmask
a sample by
deselecting
the masked test. When a
new index is created all
masked tests are
automatically unmasked.
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:
PAGE 1
INDEX DATE 04/05/1999 17 : 59 ROUND NO.1 ROUND - 01 OPERATOR
PRINT TIME [ 04/05/1999 18 : 19 ]
Calibration Checks
You can perform the following checks:
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:
• Reagents Deterioration
• Stained Cuvettes
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
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 .
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 ).
3 Select the index from the I n d e x drop-down list.
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.
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.
TIP
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.
CAUTION
Do not select
the following
flags:
R, #, ?, U, u, Y,
y, % as they
command an operator
action
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.
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
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.
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:
Introduction
This chapter describes tasks that can be performed as needed:
Additional Programming
Tasks
You can set the following configuration parameters as needed:
TIP
0.9% Saline
solution
should be
used as R1
in a fixed
position
when you are performing the
LIH test.
5 Click S e t ( F 4 ).
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.
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
9 Click E x i t ( F 2 ) to save these settings and E x i t ( F 2 ) again
each test. This must match
host computer settings.
to return to the main window.
Setting Up Printers
You can configure printers in the following ways:
Setting General
Parameters
This section describes how to set some general AU400 parameters:
• Sequential
• Barcode Mode
See “Sample Identification” on page 23 for more details on these
modes.
To set system parameters:
1 Select Parameters>System>System.
2 Click S e t ( F 4 ).
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.
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.
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:
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.
Introduction
It is vital to perform planned preventative maintenance on the AU400 to
ensure optimal performance. The maintenance tasks are as follows:
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.
• Ensure the reagent has not expired by checking the label on it.
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.
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.
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.
R1/R2
W1
W2
U-L
CLEAN
Neat W2 Detergent
U-H
S-L
STAT table
S-H
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.
Nozzles
Tubes
Liquid-level sensors
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.
Sample pot
Connector
FR
ON
T
Sample pot
T connector
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.
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.
Monthly Maintenance
Perform the following tasks every month:
• 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.
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
Tube
Tube mounting
joint
Knob
Wash nozzle
Wash nozzle FR
ON
station T
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.
10 Select Maintenance>ANL Maintenance>F/Prime Wash-lines.
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.
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
• Roller tube
To replace the roller tubing:
1 Check that the system is in Warm-up mode or Standby mode.
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.
Nos.
T
ON Nos.
FR
As Required Maintenance
Perform the following tasks when necessary:
• Cleaning the Deionised Water Filter and the Sample Probe Filter.
See page 216.
• Cleaning the Cuvettes and the Cuvette Wheel. See page 225.
Positioning pins on
the cuvette wheel
Green positioning
mark
O NT Positioning pin on the
FR cuvette wheel cover
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
• Sample Probe
T
ON
FR
Sample probe
T
ON Sample probe wash well
FR
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.
• Reagent Probe
Probe connector
Reagent probe
• Mixing bar
Mixing bar
Mixing unit
T
ON
FR
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.
• Sample Syringe—Size S
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.
Fixing nut
Fixing screw
FR
ON
T
Case head
Syringe case
Piston fixing screw
• Removing the Old Wash Nozzle Joint Tubes. See page 214.
• Fitting the New Wash Nozzle Joint Tubes. See page 215.
• Priming the New Wash Nozzle Joint Tubes. See page 216.
Material Needed:
Tube mounting
joints
Knob
Wash nozzle
Wash nozzle FR
ON
station T
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.
• Basin
Connector
Fixture
Button
Deionised water
Filter case drain hose
Joint
T
ON
FR
Vessel
Filter case
Vessel
Joint
Connecting hose
Button Fixture
Filter case
Button
NT Joint
FRO Vessel
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.
• Basin
Deionised-water tank
Fixture
Joint
T
ON Vessel
FR
• Basin
Filter case
Vessel
• Basin
Joint
Connecting hose
Button Fixture
Filter case
Button
NT Joint
FRO Vessel
O-ring
Filter case
T
ON
FR
Knobs
Lamp holder
T
ON
FR Lamp cords
Lamp holder
Photometer lamp
T
ON
FR
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.
Lamp receptacle
Guide key
Collar notch
Cuvette wheel
Cuvette
L wrench
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.
K electrode
Na electrode
Cl electrode
Cord
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
Lock lever
K electrode
Na electrode
Cl electrode
Tube
Blue cord
Yellow cord
Red cord
• Inserting the New Tubing in the Pinch Valve. See page 232.
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
TIP
Pinch valve
4
T
ON
FR
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.
Connector
REF electrode
Packing insertion hole
Set screw
REF electrode Block
T
ON
FR
Electrode bar
REF electrode
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.
Aspiration tube
MID solution Cap
tank
Buffer solution
tank
FR
ON
T
REF solution tank
Calibrate ISEs-Serum: ~ 4
ISE and Analyser
Calibrate ISE
Perform Wash 1
Daily
Overdue Weekly/Monthly/As-
required maintenance
Perform a W2
Perform a Photocal
bottle
Back up parameters
tubing
Replace cuvettes
cuvette wheel
Perform W1
As required Maintenance
Signed________________ Date__________
Introduction
This chapter explains any error flags that can occur:
Flag Cause
d QC data has been excluded from calculation
e Edited data
R Reagent Empty
a Reagent expired
b Calibration expired
c Corrected Data
i Data correction is not performed on ISE results which are diluted manually
Action:
• None required.
e - Edited Data
Cause:
Action:
• None required.
Cause:
Action:
Action:
Action:
• Add more sample to the sample cup and run the test
again.
Action:
Action:
Cause:
• Reagent expiry.
Action:
Cause:
• Reagent expiry.
• Reagent contamination.
Action:
Cause:
• Reagent expiry.
• Reagent contamination.
Action:
Cause:
• Reagent expiry.
• Reagent contamination.
Action:
• Check syringes.
• Check probes.
Cause:
Action:
• Check syringes.
• Check probes.
Cause:
Action:
Cause:
*
Linearity Error in Rate Methods
Cause:
• Contaminated reagent.
• Defective cuvettes.
• Electrical noise.
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.
Action:
Z - Prozone Error
Cause:
Action:
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.
Cause:
Action:
a - Reagent Expired
Cause:
b - Calibration Expired
Cause:
Action:
Action:
• Check syringes.
• Check probes.
Action:
• Check probes.
Action:
Action:
• None required.
Action:
• None required.
Action:
Action:
Action:
Action:
Action:
Action:
Cause:
Action:
Action:
Action:
Action:
Action:
Cause:
Action:
• None required.
Action:
• None required.
c - Corrected Data
Cause:
Action:
• None required.
Cause:
Action:
• Checking the Sample Probe and Reagent Probe. See page 260.
• 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.
• Examine the syringe tubing for leaks or crimps. Ensure the metal
tubing connectors are on correctly.
• Ensure the probes are fitted on the system correctly and are
not bent.
Introduction
This chapter details the AU400 error messages.
ACAL INCOMPLETE
Cause:
• This can also occur if the most recent calibration curve is not
available for that round.
Action:
Cal. expired
Cause:
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.
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.
Cause:
The calibration result for the test which prompted the error is not
calculated.
Action:
See above.
CHANGE INDEX
Cause:
The index has reached its limit. 8000 samples can be stored in
one index
Action:
Cause:
Action:
Expired
Cause:
Action:
Action:
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.
Action:
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.
Action:
Cause:
Action:
• RB data does not exist for any of the bottles to be used during
analysis.
No Cal. Data
Cause:
• Calibration data does not exist for any of the bottles to be used
during analysis.
Action:
Cause:
Action:
Cause:
Analysis is not performed for the sample that prompted the error.
Action:
Cause:
STAT-CAL is not performed for the test that prompted the error.
Action:
Cause:
Cause:
• R1/R2 are not both ID (R1/R2 are not both set to read ID or both
set as fixed reagents).
Action:
Cause:
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.
Cause:
Action:
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:
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:
Action:
Check that all QC samples are correctly positioned in the QC rack/s and
perform the necessary QC analysis again.
Action:
Ensure that the W2 bottles (position 77) are full and then restart the W2
process.
Cause:
Action:
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:
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:
Cause:
Action:
Action:
Action:
Cause:
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.
Cause:
A reagent blank has failed (exceeded Reagent OD limits) or has not yet
been performed.
Action:
Action:
Action:
Action:
Cause:
Action:
Cause:
Action:
Cause:
A lot number other than that which has been calibrated is placed in the
system.
Action:
Cause:
Action:
Action:
Cause:
Action:
Action:
Action:
Action:
Action:
Cause:
The STAT table cover is not on the table or is not positioned properly.
Cause:
Cause:
Cause:
Cause:
Action:
Cause:
Action:
Introduction
This chapter discusses how to tackle any problems that can occur with
the AU400:
Troubleshooting the
System—Data Problems
This section helped locate the source of problems with result data:
• Have you interpreted the data print out correctly? See “Checking
Results” on page 130.
Troubleshooting Software
Troubleshoot abnormal data by checking the following:
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.
• 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).
• Ensure the material has not been exposed to the air for an
extended period of time.
Syringe Problems
Check for:
Probe Problems
Check whether:
• The mixing bars not properly installed: Ensure that the mixing
bars are fully seated. See “Replacing Mixing Bars” on page 211.
Check for:
• Tap water below 5°C used: Always ensure that the water supply
to the deioniser is above 5°C. For detailed information, contact
your Beckman Coulter Representative.
Rack Problems
General Rack Troubleshooting::
• The rack was loaded correctly (see “Placing the Sample Cups
into the Rack” on page 117).
Troubleshooting the
System—System
Problems
The following system problems can occur:
• Liquid Spilling from the Reagent Probe Tip. See page 293.
• Reagent Probe Not Aligned over the Cuvette. See page 293.
REAGENT COMPARTMENT
TEMPERATURE HIGH alarm for the
cooling unit
Check for:
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.
• Ensure that samples are run from the correct tube or cup for the
rack type being used.
• 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.
Troubleshooting the
System—Data Processor
Problems
The following DPR problems can occur:
• Number Key Pad on Keyboard Does Not Work. See page 296.
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.
• 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.
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.
Checking Reagents
1 Select System Status>Reagent Status.
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:
Indications of an Overflow
Check whether:
Troubleshooting the
ISE Unit
Problems can occur in the ISE unit under the following headings:
ISE Checklist
Before you begin troubleshooting the ISE unit, read through the
following checklist.
Data Problems
Check for:
• Sample Probe and ISE Reagent Buffer Syringe. See page 303.
• 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
FR
ON
T
O-Rings
Check for:
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.
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.
Priming
Calibration Selectivity
Perform a calibration from diagnostics, using the following functions:
Reset
• 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.
Introduction
This chapter provides a reference to the menu options available in the
AU400:
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.
(R)Reaction Monitor
Displays information
about reaction
processes during
analysis.
(P)Photocal Monitor
Displays the photocal
measurement result.
See page 193.
(I)Specific Test
Parameters
Used to set detailed
parameters for
individual test
items.See page 56.
(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
analysis. See page 64.
(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.
(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.
(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.
(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.
(B)Standby Set Moves from the warm-up mode to the standby mode.
See page 301.
(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.
(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
63093 60 ml Bottle 20
63094 30 ml Bottle 20
63165 15 ml Bottle 20
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 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.
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').
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.
• 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.
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.
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.
Rate Assay
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 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.
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.
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
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
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
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
N
second printer 170
setting up printers 168, 169
this guide 5
probes
Na electrode 31
dead volume 117
position 117
problems 287
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
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
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
correlation chart 180
masking 130 zero adjustment
repeat tests See reagents
See repeat tests
time setting 176
two point assay
See end point assay
typographical conventions 6