APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

APPENDIX A.
THEORY OF CALCULATIONS
DATA PROCESSING AND CONVERSION
REACTION PROCESS AND MEASUREMENT POINTS
Measurements are taken at 9 second intervals over a 10 minute period. This results in
a maximum throughput of 400 photometric tests per hour. The F560 analyser has a 9
second cycle. During each cycle the system either adds sample, adds reagent, mixes
or takes a measurement. Measurements may be taken at one or two wavelengths,
depending on the assay specific chemistry parameters.
F560 Timeline
Measurement point
Time (seconds)

Measurement range 1

Measurement range 2

WATER BLANK
A water blank is performed on each cell during the washing process prior to R1
addition. This data is used to correct for cuvette variation and also to monitor the
degree of staining of the cuvettes.

ABSORBANCE DATA
Measurement details for each sample are defined on the Chemistry Parameters
menu (Parameter F6, Normal). Measurement conditions for each method are
different therefore samples should be corrected with a water blank.

W1: Water blank with primary wavelength

S1: Absorbance of sample with primary wavelength
W2: Water blank with secondary wavelength
S2: Absorbance of sample with secondary wavelength

Page 409

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

Absorbance of sample shows ABS1-68 for measurement points 1 to 68. The formula
for absorbance is as follows:
Primary wavelength: ABS1-68 = (S1-W1) 1-68
Secondary wavelength: ABS1-68 = (S2-W2) 1-68
Total wavelength: ABS1-68 = (S1-W1) 1-68 - (S2-W2) 1-68

MEASUREMENT PRINCIPLES
The system measures the standard sample, calculates absorbance differences
(ABS) from the reaction process (time course data), constructs the calibration curve
and converts to a concentration value based on the calibration curve data. Two assay
types are available, one is an end-point based method (END), the other is a ratebased method (RATE).

END-POINT METHOD (END)

The median value is calculated from the measurement range 1 and 2. The
absorbance value in the measurement points is shown as X.

If the number of values of n is odd:

X = X n +1
2

If the number of values of n is even:

X =

1
Xn + Xn
+1
2 2
2

The formula for ABS using an end-point method is as follows:

ABS = Median value of measurement points 2 - Median value of measurement point
1 (mABS)

Page 410

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

RATE METHOD
The variation of the reaction in a measurement point is approximated by primary
regression. Calculate the variation of the reaction between the measurement point 1
and measurement point 2.

The formula of the primary regression is as follows:

Y = a + bX
(Y: Absorbance X: Time a : Intercept b : Slope)
The formula of slope b if the number of data points is n is as follows:
n
n n
n xi yi xi yi
i =1 i =1
b = i =1
2
n
n
2
n xi xi
i =1
i =1

The formula of ABS for a rate-method is as follows:

ABS = The slope of measurement point 2 - The slope of measurement point 1
(the units are mABS/minute).

REAGENT BLANK CORRECTION

The reagent may have an inherent absorbance that may interfere with the calculation
of concentration from the absorbance values, this may vary slightly over time, or with
different reagent lots. Therefore a reagent blank measurement should be performed
on the first round of each day or after exchanging reagent bottles.

There are 3 methods for reagent blank measurement.

1. Reagent blank measurement without sample added

2. Reagent blank measurement with system water as sample
3. Reagent blank measurement with saline solution as a sample on the ASP tray

Page 411

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

For methods 1 and 2 above, time-course data for the reagent blank and cuvette blank
is saved for each method. These values will be used to offset the absorbance during
measurement of test samples.
Method 3 is used when a one point offset is performed using saline as S1.

ABSS1 - ABSS68= Time course of sample absorbance value

ABSSW

= Cuvette blank absorbance value during sample measurement

ABSR1 - ABSR68= Absorbance value of reagent blank time course

ABSRW

= Cuvette blank absorbance value during reagent blank measurement

Using the above definitions, the time course calculation used to obtain the change in
absorbance (ABS) will be as follows:

When a reagent blank is not used.

Time course absorbance value = (ABSS1 - ABSSW) - (ABSS68 - ABSSW)

When a reagent blank is used.

Time course absorbance value = ((ABSS1 -ABSSW) - (ABSR1- ABSRW)) - ((ABSS68ABSSW)-(ABSR68-ABSRW))

When method 3 is used (Reagent blank measurement with saline solution as a

sample on the ASP tray).
Time course absorbance value = (ABSS1- ABSSW) - (ABSS68 - ABSSW)

Page 412

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

EXAMPLES OF ENDPOINT ASSAY METHODS

END1: 1 POINT END METHOD

ABS = The median of the measurement range

For a single-shot, single reagent R1 assay:

ABS

measurement range

Time

For a two shot, 2 step R2 assay:

measurement range

ABS

dispensing of R2 Reagent
Time

Page 413

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

END2: 2 POINT END METHOD

ABS = The median value of measurement range 2 The median value of
measurement range 1
For a single shot, single reagent R1 assay:

ABS

measurement range 2
measurement range 1

without R2 reagent

Time
ABS = The median value of measurement range 2 The median value of
measurement range 1
* (S+R1/S+R1+R2)
S: Sample volume
R1: R1 volume
R2: R2 volume
For a two shot, 2 step R2 assay.

measurement range 2

ABS
measurement range 1

dispensing of R2 Reagent

Time

Page 414

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

EXAMPLES OF RATE BASED METHODS

RATE1: 1 POINT RATE-METHOD

ABS = The slope of the measurement range
For an R2, 2 shot assay method

ABS
measurement range
dispensing
of R2 Reagent

Time
For a single step one shot assay method.

ABS

measurement range

Time

RATE2: 2 POINT RATE METHOD

ABS = The slope of the measurement range 2 The slope of the measurement
range 1

ABS
measurement range 1
measurement range 2
Dispensing
of R2 reagent
Time

Page 415

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

MEASUREMENT RESULT CHECK

Before the conversion of absorbance values and calculation of the concentration, it is
possible to perform the following checks:

Linearity Check

Absorbance Limit Check

Prozone Check

Duplicate Limit Check

Sensitivity Limit Check

These limit checks can be set on the Parameter, Normal 2 screen.

LINEARITY CHECK
The linearity of kinetic assays (RATE method) is calculated by measuring the
deviation of the reaction curve from linear behaviour. If the specified value is
exceeded, the system will show a LIN flag attached to the result indicating that the
sample has failed the linearity check.

When the measurement range is set as 1 point, measurement range 2 will be

checked. When the measurement range is set as 2 point, measurement range 2 will
also be checked- Measurement range 1 will be ignored.

Range of measuring range 2 (measurement point number) = n (n is 4 or greater).

Absorbance of starting point of measurement range 2 = ABS1 (Reagent blank is
subtracted).
Absorbance of the last point of measurement range 2 = ABSn (Reagent blank is
subtracted).

Page 416

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

ABS1 + ABS2
Movingaverage1 = ---------------------------------------2

ABS2 + ABS3
Movingaverage2 = ---------------------------------------2

ABS ( n 1 ) + ABS ( n )
Movingaverage ( n 1 ) = ---------------------------------------------------------2

The slope of the moving average for points 1 to 3 will be calculated by regression
analysis.
This will be ABSfirst.
The slope of the moving average for the last 3 points (n-3) to (n-1) will be calculated
by regression analysis.
This will be ABSlast.
The slope of the moving average over the measurement range, 1 to (n-1) will be
calculated by regression analysis.
This will be ABSslope.
ABSlast- 100 %
LinearityLimit = ABSfirst
-------------------------------------------------------ABSslope

ABSslope
ABSlast
ABSfirst

1 1 2 3 4 5 6 7 8 9 10 11 12 13
34 14 15 16 17 18 19 20 21 22 23 24 25 26
68
Measurement range 1

Measurement range 2
Moving average

Page 417

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

A Linearity check will not be performed if:

a. The Linearity Limit has not been set on the Parameter Normal2 screen
b. The Rate method has not been selected.
c. The ABSslope check threshold (mABS/min).
d. The ABSfirst -ABSlast check threshold (mABS/min).
e. The number of measurement points for the measurement range 2 is less than 4
points.
f. A higher priority error than LIN has occurred.

ABSORBANCE LIMIT CHECK

If samples of high concentration or high activity are measured, it may cause
erroneous test results due to substrate depletion. In order to establish the validity of
results, the reaction limit at the primary wavelength is defined. Samples with
measured ABS values that exceed this limit will be output with an ABS flag.

FOR A DECREASING REACTION:

Reaction

Select decrease for a reaction with decreasing absorbance.

Limit

3500 mAbs/10

(Absorbance values which are less than

the limit value are not used)

ABS

Abs limit
Water blank value

Measuring range

Page 418

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

FOR AN INCREASING REACTION:

Reaction

Select increase for a reaction with increasing absorbance.

Limit

25000mAbs/10 (Absorbance values which are greater than

the limit value are not used)

ABS
Abs limit

Water blank value

Measuring Range

ABSORBANCE OF LIMIT CHECK FLAGS

Table: Absorbance Limit Check Flags

Number

Explanation

Flag

Result output

All the points in measuring

range of primary wavelength
are within the limit.

N/A

All points in
measuring range will
be used for
absorbance
calculation.
All points in
measuring range will
be used for
absorbance
calculation.
Points which are
within the limit will be
used for absorbance
calculation.

More than 8 points in

measuring range of primary
wavelength are within the limit.

N/A

Only 2 points in measuring

range of primary wavelength
are within the limit

AB2

Only 1 point in measuring

range of primary wavelength is
within the limit.

AB1

No result.

All the points in measuring

range are outside the limit.

AB1

No result.

Page 419

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

Set limit value

Water Blank
Measurement range

The reaction progress of normal and out of range reactions (labels 1-5: see
preceeding table).

PROZONE CHECK FOR RATE ASSAYS

The prozone check is used to detect a high dose Hook effect occurring in
turbidimetric immunoassays with excess antigen levels.
This has the effect that very high activity samples produce absorbance values
equivalent to low samples and therefore an incorrect result may be reported for rate
assays.

The formula for the prozone check value P:

( ABS SL 2 F ABS SL 2 S ) ( t SL 2 F t SL 2 S )
P = ---------------------------------------------------------------------------------------------------------------------( ABS SL 1 F ABS SL 1 S ) ( t SL 1 F t SL 1 S )

SL1-S

Slope range 1 Start

1 - 26

1st measuring point of slope

range 1

SL1-F

Slope range 1 End

1 - 26 (SL1-F > SL1-S)

Last measuring point of slope

range 1

SL2-S

Slope range 2 Start

1 - 26

1st measuring point of slope

range 2

SL2-F

Slope range 2 End

1 - 26 (SL2-F > SL2-S)

Last measuring point of slope

range 2

Page 420

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

If the specified value is exceeded, the system will output these results with a PRO
flag attached.

A Prozone check is not performed for control samples or for samples with values
below the specified Sensitivity Limit.

S = ( ABS SL 1 F ABS SL 1 S ) ( t SL 1 F t SL 1 S )
ACTUAL MEASUREMENT VALUE
The absorbance of measurement points for the Prozone check range SL1 and SL2 is
represented by X.
The value X is the measurement value for SL1 and SL2 ( ABSSL1 and ABSSL2 ) for
the prozone limit check.

If n is odd i.e the mid-point within the range

X = Xn + 1
-----------2

If n is even i.e. the average of the 2 midpoints within the range

1
X = --- ( X n + X n
)
2 ----- + 1
2
2

PROZONE CHECK FORMULA

Actual measurement value P is defined if the ranges SL1 and SL2 are defined.
P =ABSSL1-ABSSL2
Actual measurement value P is defined if the range SL1 is defined.
P = ABSSL1 - ABSwaterblank ( ABSreagent blank is not subtracted)

If Upper is selected
Error if P > Prozone value (Prozone value is defined on the display menu)

If Lower is selected
Error if P < Prozone value

(Prozone value is defined on the display menu)

Page 421

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

SENS CHECK FORMULA

The actual measurement value for S (Sens) is defined by the following formula
whether SL1 or SL1 and SL2 ranges are defined.

S = ABSSL1 - ABSwaterblank (ABSreagent blank is not subtracted)

When "S < Sens value", Prozone Limit Check is not performed.
(Sens value is defined on the display menu)

CALIBRATION

MEASUREMENT PRINCIPLES OF CALIBRATION

By measuring a set of calibrators with known concentrations and calculating the
ABS values, a calibration factor can be defined:

ABS calibrator = f ( concentration calibrator )

The unknown concentration of a sample can be determined from the factor in the
above equation.

concentration sample = f inverse ( ABS sample )

CALIBRATION CHECK
Standards and Calibrators are measured in duplicate or triplicate. The following
checks are carried out if the functions are enabled on the Parameters Normal2 menu.

DUPLICATE LIMIT (ALLOWABLE VARIATION LIMIT)

If a Standard sample is set to be measured 2 or 3 times and the absorbance
difference between the measurements is larger than the threshold value a Duplicate
Limit error flag is generated (DUP).

Page 422

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

The absorbance difference is calculated as follows:

Threshold value = Absorbance of first measurement - absorbance of second

measurement

Threshold value = Absorbance of second measurement - absorbance of third

measurement

Threshold value = Absorbance of third measurement - absorbance of first

measurement

The threshold value can be set on the Parameters, Normal2 menu screen within the
range 1 to 99999. An invalid result (*1) will not be included in the calculation. In the
case of triplicate measurements, a duplicate error (DUP) will be generated on every
invalid measurement. *1 Results with no error flag or an STB flag are valid. Results
with flags other than STB will be invalid.

Standard sample absorbance is measured as follows:

When all three measurement values are valid (*), the median value of three values
will be used.

When two measurement values are valid (*), the average of two values will be
used.

When only one measurement value is valid, or one reagent blank value is used for
one point offset, that one value will be used.

When there is no valid measurement value, a SEN limit error will be generated.

The threshold value can be set on the Parameters Normal2 screen within the range 1
to 99999. * Results with no error flag or STB flag are valid. Results with flags other
than STB will be invalid.

Under the following conditions a duplicate limit error flag will not be generated.
a. If the duplicate limit error check is disabled.
b. When S1 is the reagent blank and measured only once.
c. When a higher priority error than duplicate limit error occurs.

Page 423

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

SENSITIVITY (ALLOWABLE SENSITIVITY LIMIT)

If the difference in absorbance, ABS, between the first and last calibrators in a full
calibration is smaller than the specified value the last calibration value will be used.

CALIBRATION TYPE

FACTOR
ABS
10000
ABS

sample

ABS s1

S1

concentration sample

concentration

The formula of the calibration curve is defined as:

concentrationsample =

K
(ABS sample ABSs1 )
10000

ABSS1 is the actual measured value of standard S1, and S1 is the known
concentration.
The concentration of the sample after calibration is defined as:

1
concentration sample = --- ABS
b
sample

Page 424

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

LINEAR
ABS
Sn
S2
ABS sample

S1

concentration

concentration sample

The formula of the calibration curve is defined as:

ABS = a + b concentration
where the intercept a and slope b are calculated according to the least squares
method with:

yi b xi
i=1
i=1
a = --------------------------------------n

y i
xi
n
xi yi

i=1
i=1
i = 1 b = ---------------------------------------------------------------------n
n

2
2
n
xi
x i

i=1
i=1

xi and yi are pairs of corresponding values, i.e. ABS and known concentration of
calibrators i.
n is the number of calibrators, i.e. the values from 3 to 7.

Page 425

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

Concentration of the sample after calibration is defined as:

1
concentration sample = --- ( ABS sample a )
b
A correction of intercept a for a single calibrator Sx, using a 1point recalibration with
slope b remaining constant can be performed. Intercept anew will be defined after
correction as follows:

a new = ABS Sx ( b concentration Sx )

SPLINE
A non-linear calibration curve may be obtained from the measurement of 3-7
calibrators by spline interpolation. A Spline function is determined as cubic spline
under the following conditions:
1. A cubic equation for a small section.
2. Adapt a specified function value for both end points on a small section of the
curve.
3. Apply the derivatives to each of the following sections of the curve.
= Calibrator Point

ABS
AS5
A S4
Asample
AS3 AS2
AS1
CS1

concentration
CS2
CS4
sample
C
S3
C

CS5

Page 426

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

The formula for the calibration curve on each small section is defined as:

ABS = A * concentration 3 + B * concentration 2 + C * concentration + D

The procedure to convert the measured ABS to a concentration value is as follows:
1. Locate the section of the curve that fits the measured ABS.
2. Substitute the ABS into the cubic equation for that section, and convert it into a
concentration using either Cardano's formula or the Newton-Raphson method.

POINT TO POINT
In a Point to Point calibration each calibrator value, or point, is connected to the next
one by a straight line. For example, if there are 5 standards as shown below, the
calibration curve is composed of four straight lines (k1 to k4) between the 5 points.

= Calibrator Point

ABS
AS5
A S4
Asample
AS3 AS2
AS1
CS1

concentration
CS4
CS2
sample
C
S3
C

CS5

The formula for the point to point calibration curve may be obtained from the following
equation:

ABS = a + b concentration
a is derived as follows:

ABS Sk + 1 ABS Sk
a = ABS Sk ------------------------------------------------------------------------------------------------- concentration Sk ]
concentration Sk + 1 concentration Sk

Page 427

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

b is derived as follows:

ABS Sk + 1 ABS Sk
b = ------------------------------------------------------------------------------------------------concentration Sk + 1 concentration Sk

Therefore, the formula for calculating the concentration of the samples after
calibration is defined as:

1
concentration sample = --- ( ABS sample a )
b
LOG-LOGIT
= Calibrator Point

ABS
AS5 1
A S4
Asample
AS3 AS2
AS1
CS1

concentration
CS2
CS4
sample
CS3 C

CS5

In the case of a log-logit calibration type, in which there are 5 calibrators, the formula
for the calibration curve is given as follows:

ABS = k /( r + exp(ax 3 bx 2 cx d ) + 1)

Page 428

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

EXPONENTIAL
= Calibrator Point

ABS
AS5
AS4
A sample
AS3

A S2
AS1
CS1

concentration
CS4
CS2
sample
CS3 C

CS5

In the case of an exponential calibration, with 5 calibrators, the formula of the

calibration curve is given by:
ABS = A * concentration 3 + B * concentration 2 + C * concentration + D

Page 429

Operator Manual

APPENDIX A THEORY OF CALCULATIONS

Version 1.1 Rev October 2006

Page 430

Operator Manual

Operator Manual

APPENDIX B MAINTENANCE LOG SHEET

F560 Maintenance Log Sheet

Version 1.1 Rev October 2006

Page 431

APPENDIX B MAINTENANCE LOG SHEET

Operator Manual

Version 1.1 Rev October 2006

Page 432

APPENDIX C SOFTWARE UPGRADE PROCEDURE

Version 1.1 Rev October 2006

APPENDIX C.
SOFTWARE UPGRADE PROCEDURE
The software upgrading procedure for the F560 Clinical Chemistry Analyser PC
(running Windows XP operating system) is detailed as follows:
Materials required
ITEM
New Software
CD

DESCRIPTIONS
Software No. 25503281XX where "XX" denotes
2-digit version number.

To upgrade the software, follow procedures A to G as shown below.

A. Preparation for Software Upgrade

1. Terminate all programs running on the PC.
2. Terminate the user-interface software as follows:
(a) Hold down the CTRL key and the [.] (full stop) key and the following options will
be displayed:
Sleep
Power Off
Cancel
(b) Click on the POWER OFF button, to return to the Windows XP desktop.
3. Proceed to point B.

B. Backup of System Parameters

1. Start the existing user-interface software.
(Start Program (P), -> ca400, -> main)
2. Click on SYSTEM (F9) in the job menu.
3. Click on BACKUP in the tab menu.

Page 433
Operator Manual

APPENDIX C SOFTWARE UPGRADE PROCEDURE

Version 1.1 Rev October 2006

4. With the "Backup Operation" screen displayed, click on the Save box beside
Save Data in the "Data backup (HD)"section of the backup operation screen and
the following message will appear:
"Warning! Any existing data will be over written. OK?
5. Click on the OK button and the message "Backup in process" will appear.
6. When backup complete proceed to point C.

C. Termination of User-interface Software

1. Terminate the user-interface software as follows:
a) Hold down the CTRL key and the [.] (full stop) key. The following options will be
displayed:
Sleep
Power Off
Cancel
(b) Click on the POWER OFF button to return to the Windows XP desktop.
2. Proceed to point D

Page 434
Operator Manual

APPENDIX C SOFTWARE UPGRADE PROCEDURE

Version 1.1 Rev October 2006

D. Removal of Old User-interface Software

Remove the old user interface software as follows:
1. Click on the START button and select SETTINGS.
2. Click on CONTROL PANEL.
3. Double-click on ADD/REMOVE PROGRAMS.
4. Click on CA400 in the selection box and then click on the ADD/REMOVE button.
The installer/uninstaller "Install Shield Wizard" will start up.
5. Click on the NEXT> button, and the PROGRAM MAINTENANCE screen will
appear.
6. Select REMOVE and then click on the NEXT> button again. The Remove the
Program screen will appear.
7. Click on the REMOVE button. A bar-graph showing the degree of progress will
appear and the message "Install Shield Wizard Completed" will be displayed.
8. Click on the FINISH button, to return to the Windows XP desktop.
9. Proceed to point E.

E. Installation of New User-interface Software

1. Insert a new user software CD into the drive, and the following message will
appear:
"Welcome to the Install Shield Wizard "
2. Click on the NEXT> button, and the "Customer Information" screen will appear.
3. In the customer information screen enter the following details:
User Name: F560
Organization: Menarini
4. Click on the NEXT> button, and "Destination Folder" will appear.
5. Click on the NEXT> button again, and the message "Ready to Install the Program"
will appear.
6. Click on the INSTALL button, and a bar-graph showing the degree of progress will
appear. The following message will be displayed:
"Wait until Install Shield Wizard Completed"

Page 435
Operator Manual

APPENDIX C SOFTWARE UPGRADE PROCEDURE

Version 1.1 Rev October 2006

7. Click on the FINISH button to return to the Windows XP desktop.

8. Proceed to point F.

F. Restoration of System Parameters

1. Start the newly-installed user-interface software.
(Start Program (P) -> ca400 -> main)
2. Click on SYSTEM (F9) in the job menu.
3. Click on BACKUP in the tab menu and the Backup Operation screen will be
displayed.
4. Click on LOAD in the "Data backup (HD)" section of the Backup Operation screen
and the following message will appear:
"Warning! Retrieving the data will over write existing data. OK?
Select OK to proceed or CANCEL to return to existing data.
5. Click on the YES button, and a bar-graph showing the degree of progress will be
displayed.
6. Terminate the user-interface software as follows:
(a) Hold down the CTRL key and press the [.] (full stop) key. The following
options are displayed:
Sleep
Power Off
Cancel
(b) Click on the POWER OFF button, to return to the Windows XP desktop.
7. Proceed to point G.

G. Confirmation of Successful Software Upgrade

1. Perform the power shutdown procedure on the PC.
2. Turn the Clinical Chemistry Analyzer on.
3. Turn the PC on again to start the Windows XP.
4. The new user-interface software will start automatically.
(If it is does not start automatically: Start-> Program (P) -> ca400 -> main)
5. Click on SYSTEM (F9) in the job menu.

Page 436
Operator Manual

APPENDIX C SOFTWARE UPGRADE PROCEDURE

Version 1.1 Rev October 2006

6. Click on VERSIONS in the tab menu.

7. Make sure that the new PC version number (printed on the CD label) is displayed
on the upper-right section of the screen as shown below:
PC program version number
Program Version
UI
UI
UI
UI

Main:
UC:
PRT:
LIS:

25503281XX
25503291XX
25503301XX
25503311XX

Unit Main: 25503021XX

Unit LIQ: 25503041XX
Unit DTR: 25503031XX

NOTE: 2-digit Number "xx" Indicates A Program Version Number.

8. Click on MAINTE (F10) in the job menu.
9. Click on SEQUENCE in the tab menu and the "Sequence" screen will appear.
10. Click on the INITIALIZATION button to check that the operation has been
performed correctly.

PLEASE NOTE: It is advisable to make a backup copy of the new software on

the C drive of the computer in case the sofware needs to be reloaded and the
CD is lost or damaged.

Page 437
Operator Manual

APPENDIX C SOFTWARE UPGRADE PROCEDURE

Version 1.1 Rev October 2006

Page 438
Operator Manual

APPENDIX D GLOSSARY

Version 1.1 Rev October 2006

Appendix D: GLOSSARY

Job Menu

Permanent menu options located along the top of the screen.

This menu includes: Run Monitor, Chemistry Parameters,
Calibration, Quality Control (QC), System Parameters and
Maintenance.

Tab Menu

Additional menu options accessed within each Job Menu. The

Tab Menu is located down the right hand side of the screen.

Global Menu

Permanent menu options located at the bottom of the screen.

These options Include: START, EMERGENCY STOP, STAT
sample addition and ALARM.

FD

Floppy Disc drive

SPT

Sample Pipette Unit

RPT

Reagent Pipette Unit (RPT 1 and RPT2)

ISE

Ion Selective Electrode

IRU

Incubation Reaction Unit containing cuvettes.

ASP

Auto Sampler Unit

RCU

Reagent Container Unit

WPP

Water Pump Unit

WU

Wash Unit

SWU

Supply Water Unit

MIX

Mixing-Stirrer Unit (MIX-1 and MIX-2)

DTR

Detector Unit

RPP

Reagent Pump Unit

SPP

Sample Pump Unit

PID

Patient Identification Number.

SID

Sample Identification Number.

Pos

Autosampler unit (ASP) sample position number.

STAT

Emergency samples requiring immediate or priority

measurement.

Page 439
Operator Manual

APPENDIX D GLOSSARY

Version 1.1 Rev October 2006

RCU Scan

Scan of reagent barcodes on board the RCU to enable

registration of reagents.

BCR

Barcode Reader (this enables the barcode reading function for

management of samples, reagents and controls).

Profile

User defined selection of tests to be associated and performed

on a sample.

Multi-standard

Standard or Calibration details used for a number of tests.

Calculated Test

Method by which results are calculated using data obtained from

one or more selected tests.

Normal Range

The expected range of values for an analyte in a defined normal/

healthy population group.

Result Flag

Indication on a results printout to alert the operator that the result

is outside the normal or technical range.

Error Flag

Indication on a results printout to alert the operator that an error

has ocurred during processing or measurement of the sample.

Alarm Code

Alarm or error code generated by the analyser to indicate that a

fault has occured. Alarm code details can be accessed from the
Alarm (F4) button on either the Global menu or keyboard.

Prime

Pumps are activated to fill the fluid system and remove air which
would otherwise affect analyser performance.

Initialisation

System procedure to return the mechanical units (RPT 1 and 2,

SPT pipettes and mixers 1 and 2) to their home (original) position.

C1

C1 decontamination solution (contains Sodium Hyphochlorite)

used for cleaning.

Cal A

Calibrator A solution (Cal A bag) used as a wash, prime and

calibration solution for the ISE module.

Cal B

Calibrator B solution, used for calibration of the ISE module. Cal

B solution is placed in a user defined position in the ASP prior to
use.

Jig

A customised tool used in servicing/maintenance of the analyser

(e.g. nozzle cleaning jig).

Mosaic Plates

Removable panels located on the top work surface of the

analyser.

Page 440
Operator Manual