Content of the accessory box

Accessory Description
Empty 60mL reagent bottles (3) for
additional solutions.

Empty 20mL reagent bottles (3) for

additional solutions.

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Accessory Description
Labels for identifying the empty bottles.

“Reaction Rotor” (10)

Sample rotor. Only 1 of the 2

rotor models is provided.

Reagent rotor

Sample wells (1000)

Bottle of concentrated washing solution

(500 mL)

Acid washing solution bottle (1)

Alkaline washing solution bottle (1)

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Accessory Description
Adapter for primary tubes (90)

Adapter for sample wells (45)

DVD with the user program and

user manual.

Mains connection cable, European pin

Mains connection cable, American pin

USB cable.

Fuses (2).

Connection tube with fast

connector fitting for the water
mains. (3 m).

Connection tube with fast

connector fitting for waste. Red
tube (3 m).

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Identification of the main components

The different component parts of the analyser are marked and numbered in
the following figures and their associated lists:

2
3

5 67 8910 11 1
2
Figure 1 Main components

1– General cover
8– ISE module access
2– R2 stirrer
cover 9 – Reagent 2
3– Reaction rotor
arm
4– Sample rotor
10 – Sample arm
5– Reagent rotor
11 – Wash
6– Reagent 1 arm
station
7– R1 stirrer
12 – Bottle access doors

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 1

6 7
Figure 2 Rear view components

1 – Rear cover
5– Adjustable leg
handle 2 –
6– Distilled water and waste connection
Ventilation outlet
7– Wheel
3 – RS-232 and USB connection
4 – Main voltage switch

1
2

456

Figure 3 Internal components

1– LED status lamp 4– Reagent kit for ISE module
2– ISE module 5– Cleaning solution bottle
3– Ceramic pump viewer 6– High contamination waste bottle

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Reagent rotor
The reagent rotor consists of a removable drum for positioning the reagents. All
the reagents are refrigerated. The rotor has a barcode reader for identifying the
reagent bottles. The barcode reader for reagents are permanently activated.
The disk has a circular structure with 2 concentric rings with positions for insert-
ing the reagent bottl

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 Figure 35 Reagent rotor

Positions There are 88 positions in all, laid out in two rings. The bottle barcodes can be
read in both rings.
Bottles 2 types of bottle can be inserted. The volumes of the bottles are as follows:
• 60 mL, only for positioning in the inner ring.
• 20 mL, for positioning in the inner and the outer ring.
Refrigeration The refrigeration system power supply is separated from that of the analyser,
which means the analyser can be switched off and the refrigeration system can
be left on.

Reaction rotor
The reaction rotor consists of a thermostatted channel containing an optical-quality
plastic rotor that permits the transmission of UV light.

Figure 36 Reaction rotor

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Positions There are 120 positions in all. The reagent and sample are dispensed into each
cuvette. While the mixture is reacting the optical reading is taken, to obtain the
absorbance.
Volume The reaction volume is between 180 μL and 600 μL.
Temperature The rotor is maintained at a stable temperature of 37° C by a Peltier-based ther-
mostatting system.
Dispensing cycles for each of the arms:
• Cycle 1: Dispensation Reagent 1
• Cycle 31: Dispensation sample
• Cycle 33: Stirring Reagent 1 and sample
• Cycle 34: Initiation of photometric readings
• Cycle 66: Dispensation Reagent 2 and stirring of Reagent 2
• Cycle 100: End of the reading processes
• Cycles 101 –111: Washing of cuvettes in the wash station

Description of the software

Identification of the program parts

Figure 40 shows the main areas of the program. These parts are common for the
whole program and are always visible.
1

1– Menu bar 4– Action buttons

2– Total estimated current work 5– Main window
session time. 6– Information bar
3– Fast access buttons

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 Figure 40 Screen format
 See Software installation in the chapter 4.12
Menu bar This gives access to the program menus.
Total time Show the total time of the current session.
Fast access buttons Buttons providing fast access to the different menus.
Action buttons Analyser operation action buttons.
Main window Main zone where the work area is shown.
Information bar Program zone that displays the informative and error messages. It also indicates
the analyser states: WARM-UP, STAND-BY, RUNNING, SAMPLE&STOP.

Icon Name Description

New Allows an element to be created: test, standard,
control, user, etc.
Edit Allows an already-created element to be edited.

Delete Eliminates an element.

Print Prints information about the element or elements

selected.
Copy Copies the selected element.

Save Saves the data.

Undo Undoes the latest changes and retrieves the previous

information on the element being edited.
Accept Accepts the changes and closes the window.

Close Cancels and closes the window.

Table 2 Description of the most frequently-used buttons

List of fast access buttons

The buttons on the horizontal bar are buttons that give direct access to the
main program menus. Table 3 contains a description of each of the buttons.

Icon Description of the icon

Access to the general setup.

Access to the test program.

Access to the profiles program.

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Access to creation of work sessions.

Access to the positioning of samples and reagents.

Access to the monitor screen.

Access to the results screen.

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 Icon Description of the icon
Access to the quality control screen

Access to the cumulative quality control screen

Access to the screen where information is generated for the technical

service.
Access to the information about additional functionality available in
certain screens.
Execution of the work session reset.

Indicates the total time at the start of the session and the time
remaining during the execution of the session.

Table 3 Description of fast access buttons

List of buttons related to LIS communication

Buttons which appear on the horizontal bar and indicate the main actions that can
be performed with a LIS application and the communications status with the LIS
 See chapter 17 for details about LIS communications operation.

Icon Name Description

LIS state LIS connection off.
LIS state LIS connection established and operating.

LIS state LIS connection established but the LIS

does not respond correctly to other actions.
To solve it: check the physical connection,
check that the low level LIS communication
protocol is correct, check the LIS operation
(response times, sending of messages in
correct format, correct message flow, etc)
LIS state LIS connection established and operating,
but the messages are delivered with delays
and the message queue may be saturated
(check LIS operation)
Query All Button for making a request to all
pending LIS computers.
Query by specimen Button that opens the auxiliary screen for
requesting orders by specimen (sample
tube position in sample rotor with barcode
identifier)
 See chapter 10.5.4

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Icon Name Description

Add orders Button that is activated when orders are
Download Orders received from the LIS which must be added
to the work session.

Table 4 Description of the LIS communication buttons

List of action buttons

List of buttons that execute actions in the analyser. Only the appropriate buttons
for the action being performed by the analyser are activated at any given time.

Icon Name Description

Connect Button for connecting the program with
the analyser.
Initialise analyser Button for initialising the analyser.

Shut down Button for stopping and shutting down

the analyser.
Confirmation of Button confirming the washing solution
change in bottle bottle has been changed or for cancelling
the high contamination waste bottle alarm.
Recover the analyser Button for recovering the analyser after an
accidental stoppage.
Cancel acoustic alarm Button for cancelling the acoustic alarm; that
button is activated when an alarm appears.
Start session Button for initiating the work session. It can
also be used to restart the work session after
a pause.
Pause session Button for executing a pause in the work
session. It only appears when the session
has been started. It appears in the same
position as the start session button
Abort session Button for aborting or stopping the work
session without being able to continue.
Recommended only when the user does not
wish to continue the session or if there are
problems that make it impossible to execute
it.

Table 5 Description of action buttons

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Working procedure

Starting up the program

To start up the program, double click on the icon located on the desktop.
On initiating the program a welcome screen will appear and then the user
iden- tification screen (enter your login and password)

Figure 41 Identification screen

The first time the program is started, the login and password to be entered are:

Parameter Value
User name Admin
Password BA400
Table 6 Initial login and password

Click on the icon to change the password. You can only change the user pass-
word that was entered in the home screen.
Figure 42 shows the screen for changing the password. Enter the different values
required to change the password.

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Figure 42 Screen for changing the password

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 Setup
Test parameters: quality control

Figure 61 Test parameters, quality control screen

Active quality control Check this option to activate the quality control for this test.
Control replicates Number of replicates for measuring the controls. The margin is between 1 and
3.
Rejection criterion Enter the rejection criterion for controlling the activation of alarms in quality
control management. This value is calculated in standard deviations (SD). The
margin is between 0.1 and 4.
Calculation mode The calculation mode may be manual or statistical. Indicate how to calculate the
ranges in order to draw the Levy-Jennings graph and activate the Westgard rules
alarms.

Calculation Description
mode
Manual Use the theoretical ranges of the serum control seating
values entered when registering a control. They remain
unaltered, unless new cumulative values are to be assigned.
 See chapter 10.7.4

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Calculation Description
mode
Statistical Use the ranges calculated from the mean and SD of the
above series.
The minimum number of series indicates the number
of controls measured by the analyser before starting to
calculate the mean and the SD. During these first series,
the manual mode is used internally. The minimum number
of series to be programmed is 5.
Different quality regulations in the laboratory make it
advisable to assign 20 minimum series when starting to use
a specific control batch.

Applicable rules Select which Westgard rules you want to apply to the quality controls for this
test.
It serves to register the controls with their batch and concentration values.
 See how to register a control in chapter 10.3.6.
Selection of controls This table shows the different controls registered for the test. In the box, activate
the controls to be used, as you may have created various controls. It can activate
up to 3 controls at one time.

Test parameters: options

Screen where the limit values are programmed for issuing warnings and alarms
to the user, depending on the results.

Figure 62 Test parameters, options screen

Blank absorbance limit Limit value established for comparing against the result of the blank absorb-
ance. It is used for checking the state of the reagent.

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Kinetic blank limit Enter the correct kinetic blank value limit. It is only applied to tests with the
kinetic calculation mode.
Linearity limit Enter the value for which the reagent is no longer linear. If the concentration
value is higher than this value, the program will issue a warning message and if
it is activated in the programme a repetition will automatically be launched.
Detection limit Enter the value for which the reagent does not detect a value. If the concentra-
tion value is higher than this value, the program will issue a warning message
and if it is activated in the program a repetition will automatically be launched.
Factor limits Upper and lower range for verifying that the calibration factor is correct.
Repetition range The analyser repeats the sample automatically if the concentration value is
within the range. This range serves to confirm the result automatically.
Prozone effect The prozone effect may occur in tests based on the principle of the formation
of antigen-antibody complexes (agglutination). This effect is usually detected in
samples with a high antigen content. Excess antigen inverts the reaction direc-
tion and may cause incorrect sample measurements. To detect that effect you
should activate the prozone effect option.
The program will calculate the absorbance increases in times 1 and 2, obtain the
increase quotient and compare the result against the ratio. If the quotient
does not exceed the ratio, an alarm is triggered indicating that the sample could
have the prozone effect, in which case the user must make a manual repetition
with a dilution factor, to finally determine the exact value of the sample.
In the event of doubt with respect to detecting the prozone, the user must
per- form a sample dilution to ensure the correct result.
CAUTION
Slope function Enter parameters a and b of the formula Y=aX+b. These parameters change
the value of the result concentration in a linear manner. This option is used to
match the results of different analysers. Where X will be replaced by the concen-
tration value and Y will be the changed concentration value.

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Figure 63 Test parameters, reference range screen

Substrate depletion A calculation algorithm is used to detect reactions in which the sample substrate
has been exhausted. This algorithm functions for the following calculation
modes and is different, depending on each type of reaction:
• Increasing end point.
• Decreasing kinetics.
• Decreasing fixed time.
The default values have already been entered in some tests.
If the substrate depletion alarm is triggered in a test replication result and if
the software and the test have been configured to perform the automatic
repetition, a reduced automatic repetition is submitted for this request (and all
the replicates are repeated).
Reference ranges Indicate the normal reference values for the population. If values are entered in
the fields, the results are shown on the screen along with the patient report and
the concentration result.

Reference range Description

Generic A series of common ranges for the whole population is
entered in these fields.
Detailed In this table the specified ranges are entered by gender
and/or by age.
Enter the gender, age group and normal values in each
row.

Panic ranges Enter the values for which a result is pathological. The values entered must meet
the following conditions:
Minimum panic < Minimum normality< Maximum normality< Maximum panic

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Calculated tests
Screen in which the calculated tests are programmed. The result of the calculated
tests is obtained by applying a formula with the concentrations of several
standard tests performed previously.

Figure 64 Screen for creating calculated tests

On the left-hand side of the screen is a list of calculated tests and on the right-
hand side are the parameters to be entered for each calculated test.
 See functioning of creation icons, edition, deletion and printing of the test screen in
chapter 10.3.1.
Name Name of the calculated test.
Short name Abbreviated name of the calculated test.
Sample type Indicates the type of sample to be used for selecting the standard tests.

Sample type Description

Single In this option the standard tests have only one type
of sample
Multiple In this option the standard tests may have different
sample types

Unit Unit in which the results of the calculated tests will be shown. This unit may
be different from that of the standard tests.
Decimal points Number of decimal points for displaying the calculated test concentration val-
ues. This number of decimal places may be different from that of the standard
tests.

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Print out experimental tests Check this option if the patient report also has to show the results of the
stand- ard tests in addition to the result of the calculated test.
Formula definition Formula relating the calculated test to the standard tests. To enter the formula,
select the standard tests, other calculated tests, numbers and operators. The pro-
gram verifies whether the formula entered is correct and indicates this through
one of the following icons:
This icon indicates that the formula has been correctly entered with no errors.
This icon indicates that there are errors in the formula. Change the formula
until the icon disappears.

Delete the last character entered.

Delete the whole formula entered.

Control
s
In this screen the controls to be used are registered. You can create new controls
and edit, and delete them.
You can also edit the minimum and maximum values of each test for each
control level.

Figure 71 Screen for programming the control serums

Control name Enter the control name.

Sample type Enter the type of sample that will use this control.
Level Enter the control level (1, 2 or 3). This is used to facilitate the selection of an
entire level in the sample request screen.
Batch number Enter the batch number of this control
Press this icon to change the batch for a specific control already registered.
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  See Figure 72.
Date activated The date on which the control is first used.

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Expiry date Enter the expiry date. The program issues a warning when a control whose
expiry date has been exceeded is used.
Tests Press this button to assign or eliminate the tests associated to a control level. An
auxiliary screen appears that contains only the tests for the same sample type,
with the quality control activated (when created, the tests normally have a deac-
tivated quality control).

Figure 72 Screen for changing the batch of a control

Patient
data
Screen for entering the patient data: patient code, name, gender, etc. After
entering the data, a report for each patient can be generated with the analyte
concentration results. Having the patient data entered makes it easier to organise
and search in the historical log. In this way the results for one patient obtained
during different periods can be grouped together.

Figure 73 Screen for programming the patient data

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 At the top of the screen is a list with all the patients entered.
 See the functioning of the creation, edition, deletion and print icons in chapter 10.3.1.
Patient identification Enter a patient identifier in order to associate the patient data to the results.
Name Enter the name of the patient.
Surname Enter the surname of the patient.
Gender Enter the gender of the patient: male or female
Date of birth Enter the date of birth of the patient. The age field is calculated automatically
after entering the date.
Analysis requested by Enter the name of the doctor
Remarks Field blank for entering the opportune text.
Press this icon to make a search for a specific patient in the patient list. When
the icon is pressed an auxiliary screen will appear for you to select the search
field.
 See Figure 74 for more information.
Press this icon to cancel the search options and view all the patients.

Figure 74 Screen for selecting the search options.

Complete one or more fields to enter the search criteria. For the date of birth and
age fields you must enter a range of dates and ages, respectively.

Press this icon to make a search after entering the criteria.

Press this icon to delete all the search criteria. It is activated when data is entered
in any field.
Result
s Option in the main menu for accessing the results screen for the current
session (completed or in progress).
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Figure 93 Results screen

On the left is a list of patients and tests performed in the session (separated
into two tabs). It allows you to see all the results for each patient or all the
results for each test. Select an element from the list to see the results in the tables
on the right
Button accessible from the Controls option in the Tests tab. It enables the calcu-
lation of the Westgard rules on the controls of the current session. The control
result line is shown in colour, depending on the severity of the Westgard rule
that was breached. The alarm results are shown in the observations field.
Ordering The list of patients can be ordered by different criteria:
• Ascending order
• Descending order
• Order requested in the sample request screen
Select the header of the patients list and a pop-up screen will appear where
you can select one of the three options described above.
 See Figure 94.

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 Figure 94 Ordering the patient results list

Button accessible from the Controls option in the Tests tab. It enables the calcu-
lation of the Westgard rules on the controls of the current session. The control
result line is shown in colour, depending on the severity of the Westgard rule
that was breached. The alarm results are shown in the observations field.

Results by patient
First select the patient tab and a list of all the patients with results will appear
below in the left-hand column.
Select a patient and all the information on the result of that patient will be
dis- played on the right.

Patient tab
Field Description
Buttons allowing you to show or hide the replicates
with a result.
If you press the header, icon all the patient tests will
be shown or hidden.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical file and to LIS. When
repetitions are executed the last results is always
accepted. If you like, you can accept various results.
This indicates whether it was sent to LIS
automatically or manually.

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Field Description
New This allows you to repeat a preparation.
This option is deactivated if the repetition option
has only been selected for LIS in the LIS setup
screen.
 See the different repetition options in chapter 10.6.4
Test Test name
Type Sample type
This allows you to access the kinetic reaction graph.
Number Indicates the replicate number, if there is more than
one replicate
Absorbance Absorbance value of the sample obtained.
Concentration Concentration value calculated in accordance with
the calculation method programmed in the test
Units This shows the units programmed in the test.
Reference ranges This shows the reference ranges programmed in
the test. If there are patient data and
demographic
ranges, then it automatically selects the ranges based
on the patient data.
Remarks This displays the alarms that could appear in the
results.
 See the possible alarms in chapter 13
Date Date on which the result was delivered
Repetition mode This shows the mode in which the sample was
repeated.

Press this icon to print out the final patient reports.

Press this icon to see a summary table of the results. A table appears with the
results for all the patients and all the tests of the session in progress.
Press this icon to print out a list of the patient results.
Press this icon to manually send the selected results to a LIS laboratory informa-
tion system.
Press this icon to enter the external test results. When the button is pressed, an
auxiliary screen appears for you to enter the external test values.
Press this icon to send the selected samples for repetition. (I.e., tests with the
New field activated)
This option is deactivated if the repetition option has only been selected for LIS
in the LIS setup screen.
 See the different repetition options in chapter 10.6.4

Results by test
Select the test tab to see the list of tests performed in the session.

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 Select a test from the list and four tabs will appear on the right with all the
results of that test. Select the screen, depending on the information you want
to see: blanks, standards, controls and patients.
All the replicates and the resulting mean are shown in the results table.
You can rule out the replicates by pressing on the row you want to eliminate.
This will show the replicate that was deleted and recalculate the resulting mean
without that replicate. You can reactivate it by pressing the replicate row again.
The blank results table contains the following information:

Blank tab Field Description

Buttons allowing you to show or hide the replicates
of a result.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical file and to LIS. When
repetitions are executed the last results is always
accepted.
New This allows you to repeat a preparation.
 See the different repetition options in chapter 10.6.4
Test Test name
This allows you to access the kinetic reaction graph.
Number Indicates the replicate number, if there is more than
one replicate
Absorbance Blank absorbance value that will intervene in
calculating the concentration.
Main filter absorbance This shows the main filter blank absorbance
value. Only shown in tests with bichromatic
programming.
Reagent absorbance This shows the reagent absorbance value. Only
shown in tests with differential programming.
Blank absorbance limit Blank limit value. This value is programmed in the
test. It is used to check that the reagent is in good
condition. If the reagent absorbance value exceeds
that limit, the program will issue a warning message
in remarks.
Remarks This displays the alarms that could appear in the
results.
 See the possible alarms in chapter 12
Date Date on which the result was delivered
Repetition mode This shows the mode in which the sample was
repeated.

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The standard results table contains the following information:

Standard tab Field Description

Buttons allowing you to show or hide the replicates
of a result.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical file and to LIS. When
repetitions are executed the last results is always
accepted.
New This allows you to repeat a preparation.
 See the different repetition options in chapter 10.6.4
Name Standard name
Batch Standard batch
Type Type of sample.
This allows you to view the kinetic reaction graph.
Number Indicates the replicate number, if there is more than
one replicate
Absorbance Standard absorbance value that will intervene in
calculating the factor.
Theoretic concentration Standard concentration value. This value comes
from the test programming.
Units This shows the units in which the test has been
programmed.
Factor Value calculated based on the standard absorbance
that will intervene in calculating the concentration.
Factor limits Factor limit entered in programming the test. If
the factor value is off limits, a warning message
will appear in the remarks field.
Remarks This displays the alarms that could appear in the
results.
 See the possible alarms in chapter 12
Date Date on which the result was delivered
Repetition mode This shows the mode in which the sample was
repeated.

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 The controls results table contains the following information:

Control tab Field Description

Buttons allowing you to show or hide the replicates
of a result.
When the header icon is pressed, all the different
controls of the test are shown or hidden.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical file and to LIS. When
repetitions are executed the last results is always
accepted.
Indicates whether it was sent to LIS automatically
or manually.
New This allows you to repeat the result.
 See the different repetition options in chapter 10.6.4
Name This shows the control name.
Batch This shows the control batch
Type This shows the type
This allows you to view the kinetic reaction graph.
Number Indicates the replicate number, if there is more than
one replicate
Absorbance Absorbance value of the control obtained.
Concentration Calculated concentration value of the control.
Units This shows the units programmed in the test.
Concentration limits This shows the maximum and minimum limits for
the controls entered in programmings the test.
Remarks This displays the alarms that could appear in the
results.
 See the possible alarms in chapter 12
Date Date on which the result was delivered
Repetition mode This shows the mode in which the sample was
repeated.

When the patient tab is selected the information viewed is detailed in chap-
ter 10.6.11
Allows you to view a report of the control results of the work session. It also
calculates the results of the Westgard rules on the current session controls.

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Blank and calibration standard results

Screen for saving the blank and calibration standard results from previous sessions.

Figure 98 Screen showing historical blank and calibration standard data

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 At the top of the screen there are several fields that permit the entry of selection
criteria for restricting the viewing of the results. More than one selection
criterion may be selected at one time.
After making the selection, press the icon to execute the search and view the
results at the bottom of the screen.
Date range Enter the start and end date for selecting the results by a date range.
Test name Enter the name of the test to make the selection.
The results will be shown in two tables, ordered by date. The first table shows
the results of the blanks and the second one shows the results of the calibration
standards. On pressing the date or test heading in the table, the results of
that column will be rearranged.
The blank and calibration standard fields displayed are the same as the fields
shown on the current session results screen, selected by test.
 See chapter 10.6.2 for a description of each field in the blank and calibration standard
screens.

Quality control results

Screen that allows you to review the current quality control results. It also allows
you to change the defined calculation criteria and view the results in graphic
format.
The quality control results of the active work session will not be available on the
screen until the reset function has been executed.
Up to 500 results can be stored and viewed for each control and test. When reset-
ting the active work session, this condition is verified for each control and test
with quality control results in the session and in the event that the maximum has
been exceeded, a screen appear saying that the current results (except those of
the work session) will be accumulated. The user can accept the warning and
accumulate the results automatically, or temporarily cancel the reset and
accumulate the results manually in the Accumulate daily quality control
results screen.
 See chapter 10.7.4.1

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Figure 99 Screen for displaying quality control results

On the left is a list of tests with quality control results. In selecting a test
from the list, the information about its programmed and active controls is
shown on the right of the screen, but only for those with at least one result.
There are three clearly defined zones in this list area: