A25
User Manual
English
USER MANUAL
English
TEUS00015-00-ING
January-2005
User Manual
2
Dear Customer,
Thank you for purchasing our A25 automatic analyser. We are sure that its specifications will make it a valuable instrument
in your laboratory. Although its operation and use is logical and straightforward, using a programme that runs under
Windows, please read this manual carefully. It will help you with both installation and correct programming, use and
maintenance of the instrument, enabling you to get maximum performance from its multiple possibilities.
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User Manual
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TABLE OF CONTENTS
Introduction .............................................................................6
1. Description of the instrument ............................................7
1.1. Components ............................................................................................................... 7
1.1.1. Operating arm ............................................................................................................................. 7
1.1.2. Dispensing system ...................................................................................................................... 7
1.1.3. Reactions rotor and reading ..................................................................................................... 8
1.2. Working theory ........................................................................................................... 9
1.3. Start-up ....................................................................................................................... 9
1.4. Functional specifications .......................................................................................... 9
2. General operation method................................................ 12
2.1 Program Installation .................................................................................................. 12
2.2. Operation procedure ................................................................................................ 12
2.2.1. Introduction ...............................................................................................................................
2.2.2. Start-up procedure, operation and shutdown. ......................................................................
2.2.3. Monitor ......................................................................................................................................
2.2.4. Programming ............................................................................................................................
2.2.5. Save/load test file .....................................................................................................................
2.2.6. Preparation of the work session .............................................................................................
2.2.7 Memorising sessions ..............................................................................................................
2.2.8. Current results...........................................................................................................................
2.2.9. Current and past alarms ..........................................................................................................
2.2.10. Past results ..............................................................................................................................
2.2.11. Patient data .............................................................................................................................
2.2.12. Configuration ..........................................................................................................................
2.2.13. About ........................................................................................................................................
2.2.14. Utilities .....................................................................................................................................
2.2.15. Internal quality control ..........................................................................................................
12
13
14
16
21
21
25
25
26
26
27
28
30
30
32
3. Calculation and measurement procedures ..................... 35
3.1. End point................................................................................................................... 36
3.1.1. Absorbance ............................................................................................................................... 36
3.1.2. Concentration ........................................................................................................................... 36
3.1.3. Replicates .................................................................................................................................. 36
3.2. Bireagent differential ................................................................................................ 37
3.2.1. Absorbance ............................................................................................................................... 37
3.2.2. Concentration ........................................................................................................................... 37
3.2.3. Replicates .................................................................................................................................. 37
3.3. Fixed time .................................................................................................................. 37
3.3.1. Absorbance ............................................................................................................................... 37
3.3.2. Concentration ........................................................................................................................... 38
3.3.3. Replicates .................................................................................................................................. 38
3.4. Kinetics ..................................................................................................................... 38
3.4.1. Variation of the absorbance per unit of time ......................................................................... 38
3.4.2. Concentration ........................................................................................................................... 39
3.4.3. Replicates .................................................................................................................................. 39
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User Manual
Introduction
The A25 analyser is an automatic analyser for random
access In Vitro Diagnosis specially designed for performing
biochemical and turbidimetric clinical analyses.The
instrument is controlled on-line in real time from an external
dedicated PC. The analyser performs patient-by-patient
analyses and enables the continual introduction of samples.
The results are shown immediately after each measurement.
The high-speed preparation of the reactions makes it ideal
for medium-capacity automated laboratories. The flexibility
of the samples and reagents racks system enables the
perfect adjustment of the capacity of the analyser to the
specific needs of each laboratory.
diluted. The analyser automatically orders the tests of each
patient to avoid incompatibilities between reagents and to
optimise performance. From the Monitor screen, which is
particularly graphic, the analyser keeps the user informed
about its functioning status and the result-obtaining process.
All these characteristics, together with the variety of possible
analysis modes (final monoreagent or bireagent point
(monochromatic or bichromatic), bireagent differential, fixed
monoreagent or bireagent time and monoreagent or
bireagent kinetic), make the A25 analyser an instrument
that is highly versatile and effective for clinical analysis
laboratories.
In each of the elements of the A25 analyser, BioSystems
has used leading edge technology to obtain optimum
analytical performance, as well as taking into account
economy, robustness, easy use and maintenance. A threeaxis Cartesian operating arm prepares the reactions.
Dispensing is performed by means of a pump with a ceramic
piston via a detachable thermostatised needle with Fuzzy
Logic control. A washing station guarantees that the needle
is kept perfectly clean throughout the process. The
reactions take place in a thermostatised rotor in which
absorbance readings are taken directly by means of an
integrated optical system.
The elaborate computer programme enables the easy control of the extensive functionality of the analyser. The user
interface is flexible, simple and very graphic, clearly
separating the daily routine tasks from the less frequent
tasks. All the data and results are stored securely, with
the possibility for exportation. Various initialisation,
functioning and shutdown options can be configured for the
analyser. The user can programme an indefinite number of
measurement procedures (techniques), technique profiles
and reagent racks, depending merely on the computer’s
hard disk capacity. The analyser works with 5 sample types:
serum, urine, plasma, cerebrospinal and supernatant liquid.
Each measurement procedure can be adapted to each one.
During a work session, the user can continually introduce
normal or urgent samples in the analyser without interrupting
the measurements in progress. The samples may be pre6
1. Description of the instrument
The A25 analyser prepares the reactions by means of a
three-axis Cartesian operating arm. This arm supports and
displaces a dispensing needle which pre-thermostatises
the preparations at 37º. The dispensing is carried out by
means of a low-maintenance ceramic piston pump. The
analyser can carry out one preparation every 15 seconds.
The preparations are dispensed in a reactions rotor
thermostatised at 37ºC. The optical absorbance readings
are taken directly on this rotor.
of the instrument. If the user wishes to manually move the
arm to its resting position, he or she must ensure that the
needle is at its highest position. For this, it must be raised
completely by pressing the vertical chain of the operating
arm upwards as shown in the photograph. The return system
prevents the needle from descending and the user can then
move the arm with no danger of damaging the needle or
injuring him or herself on it. The operating arm only makes
the preparations if the general cover of the analyser is closed.
If the cover is raised while it is functioning, the arm
automatically aborts the task in progress and returns to its
parked position to avoid injury to the user.
1.1. Components
The A25 analyser is made up of three basic elements: the
operating arm, the dispensing system and the reading and
reactions rotor.
1.1.1. Operating arm
This is a three-axis XYZ Cartesian mechanism. The X and
Y axes move the dispensing needle over the analyser
horizontally and the Z axis moves it vertically. It is operated
by three step-by-step motors. In each 15-second
preparation cycle, the operating arm performs the following
actions: first of all, it sucks in the reagent from the
corresponding bottle. Next, the needle is washed externally
in the washing station and sucks in the sample from the
corresponding tube. It is washed externally again and dispenses the sample and the reagent into the reactions rotor.
Finally, it is exhaustively washed internally and externally
before proceeding with the next preparation. The arm has a
system for controlling vertical movement to detect whether
or not the needle has collided into anything on descending.
If a collision occurs, as may be the case if, for example, a
lid has been left on a bottle of reagent, the arm automatically
restarts, verifies the straightness of the needle and continues
working issuing the corresponding alert to the user. A return
system on the vertical axis automatically raises the needle
in the case of a power failure, preventing it from descending
and colliding with an object at the bottom or with the housing
1.1.2. Dispensing system
This system consists of a thermostatised needle, supported
and displaced by an operating arm and connected to a
dispensing pump. The needle is detachable to enable
cleaning and replacement. The analyser has capacity level
detection to control the level of the bottles and tubes and
prevent the needle from penetrating too far into the
corresponding liquids, thus minimising contamination. An
automatic adjustment system informs the user if the needle
is not mounted or if it is too bent. The needle has a
sophisticated Peltier thermostatisation system, with Fuzzy
Logic control, capable of thermostatising the preparations
at approximately 37º in less than 6 seconds. Dispensing
is carried out by means of a low maintenance ceramic
piston pump driven by a step-by-step motor. It is capable
of dispensing between 3 and 1250 µL. The dispensing
system of the analyser uses system liquid which the user
must prepare by adding 6 ml of concentrated system liquid
supplied with the analyser to the corresponding container
filled to the top with distilled water (approx. 2700 ml).
Analyses must never be made using distilled water only in
the dispensing system, since the analytical performance
and the lifetime of the system may notably be lowered.
The exterior of the needle is kept constantly clean by means
of a washing station, which consists of a font specially
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User manual
take the optical reading is 200 µl. The wells have a maximum
useful capacity of 800 µl. When the reactions rotor is
completely full, the user must change it for one that is
empty, clean and dry. The reactions rotors may be reused
if they are appropriately cleaned immediately after use.
The Cleaning the semi-disposable reactions rotor section
in the Installation and maintenance manual describes how
to clean the rotors. The rotors must be rejected if they are
noticeably deteriorated. The user has a test in the computer
programme, which he or she may use to check the
condition of the rotor. The rotor is driven by a step-by-step
motor with a transmission. A Peltier system with PID control thermostatises the rotor at 37ºC.
designed to clean and dry the needle, integrated in the
racks tray. A system of membrane pumps supplies the
font with system liquid and transports the waste to its container.
The A25 analyser has a tray with 6 free positions for racks
of reagents or samples, plus three fixed positions for bottles
opposite the washing station. Each reagents rack can carry up to 10 reagents in 20 ml or 50 ml bottles. Each samples
rack can contain up to 24 tubes of samples. The samples
can be patients, calibrators or controls. The analyser can
be configured to work with 13 mm or 15 mm diameter tubes
of samples with a length of up to 100 mm or with paediatric
wells. Any possible configuration of racks can be mounted
An optical system integrated in the rotor takes the readings
directly on the reaction wells. The light source is a 20 W
halogen lamp. The detector is a silicon photodiode. The
wavelength is selected by a drum with 9 positions available
for optic filters. The filters are easily changed by the user
from the exterior of the analyser, without the need for
disassembling the filter drum. A step-by-step motor
positions the drum. The optical system is capable of taking
5 readings per second, with or without a filter change in
between. The light beam of the lamp passes through a
compensated interferential filter to select the desired
wavelength and through focalisation lenses. It then passes
through the rotor well and finally reaches the photodiode,
where the light signal is turned into an electric signal. A
sophisticated analogical digital integrator-converter system
converts the electric signal into a digital value with which
the analyser obtains the absorbance values. The optical
system continues to work when the general cover of the
analyser is open, whereby the analyser can continue to
take readings while the user handles, for example, the
sample tubes or the reagent bottles. The rotor cover must
be in place for the optical system to work correctly. A detector tells the analyser of the presence of said cover. The
analyser aborts the readings if the user removes the rotor
cover while the optical system is taking photometric
measurements. If the rotor is not covered, the analyser
informs the user so that he or she places the rotor cover
when it sends samples to be analysed. The analyser also
issues an alert if there is no reactions rotor in it.
from 1 rack of reagents (10 reagents) and 5 racks of samples
(120 samples) to 5 racks of reagents (50 reagents) and 1
rack of samples (24 samples). Any reagent may be placed
in the fixed positions, but it is recommendable to use them
for the bottles of distilled water, saline solution for the
automatic pre-dilutions and washing solution. The rack tray
detects and identifies the type of racks. In this way, if the
physical disposition of the racks does not coincide with
that programmed on the computer, the analyser alerts the
user.
On the left of the analyser are system liquid containers
(marked in blue) and waste containers (marked in red).
The analyser constantly controls the level of these
containers and issues the appropriate alerts if the system
liquid is nearly empty or if the waste container is full.
1.1.3. Reactions rotor and reading
The preparations are dispensed in an optical quality
methacrylate reactions rotor thermostatised at 37ºC. The
optical absorbance readings are taken directly on this rotor.
Each reaction can be read for 15 minutes. The readings
are taken as they are programmed in each measurement
procedure. The reaction wells have been designed to enable
the mixture of the sample and the reagent during the
dispensing. Each rotor has 120 reaction wells. The length
of the light path is 6 mm. The minimum volume required to
8
1.2. Working theory
section for routine start-up. The analyser must be in standby
mode, i.e. plugged into the mains and with the switch in
the (I) position. The computer must be started up and the
programme launched. From the Monitor screen of the
programme, click on the Warm up button to start
initialisation. The analyser automatically carries out all
the checks required for correct functioning and continually
informs of its status through this screen. No manual
adjustment is necessary. If, for any reason, user intervention
is necessary, the analyser issues the corresponding alert
through the computer. Once warm-up has finished, the
analyser is in standby mode, ready for work.
The A25 analyser is an automatic random access analyser
specially designed for performing biochemical clinical
analyses. The analyser performs patient-by-patient
analyses and enables the continual introduction of samples.
The analyser is controlled from a dedicated PC that is
permanently communicated to the instrument. The
programme, installed on the computer, keeps the user
constantly informed of the status of the analyser and the
progress of the analyses. As results are obtained, the
computer shows them to the user immediately.
When a Work Session is begun, the analyser proposes
performing the blanks, calibrators and controls programmed
for the measurement procedures it is to carry out. The user
may choose between performing the blanks and the
calibrators or not. If they are not performed, the analyser
uses the last available memorised data. The controls can
also be activated or not. During a session, while the analyser
is working, the user can introduce new normal or urgent
samples to be analysed. Each time a new sample is added,
the analyser automatically proposes the possible new
blanks, calibrators or controls to be performed. A work
session can remain open for one or more days. When a
session is closed and another new session is opened
(Reset Session), the analyser again proposes performing
the blanks, calibrators and controls. It is recommended
that the session is reset each working day.
1.4. Functional specifications
All the functions of the analyser are controlled from the
programme installed on the computer. This programme has
a flexible, simple and highly graphic interface, with a clear
separation between routine and less frequent tasks. Its
flexibility makes routine use of the analyser extremely simple. It is also possible to access numerous functions to
fully customise the functioning of the analyser. All the data
and results are stored securely, with the possibility for
exportation. The configuration and programming data can
be easily updated or stored.
The analyser determines the concentrations of the analytes
based on optical absorbance measurements. To measure
the concentration of a certain analyte in a sample, the
analyser uses a pipette to take a specific volume of the
sample and the corresponding reagent, quickly
thermostatises them in the needle itself and dispenses them
into the reactions rotor. The very dispensing speed together
with the geometry of the reaction well causes the mixture
to be shaken and the chemical reaction begins. In the
bireagent modes, the reaction begins when the analyser
later dispenses a second reagent in the same reaction well.
The reactions can be biochemical or turbidimetric. In both
cases, the reaction or the chain of reactions produced
generate substances that attenuate certain wavelengths,
either by absorption or by dispersion. Comparing the light
intensity of a certain wavelength that crosses a well when
there is a reaction and when there is not a reaction can
determine the concentration of the corresponding analyte.
This comparison is quantified with the physical magnitude
called absorbance. In some cases, the concentration is a
direct function of the absorbance, and in other cases, it is
a function of the variation of the absorbance over time,
depending on the analysis mode.
Power off
Sleeping
Shutdown
Stand by
Running
Sampling Stop
1.3. Start-up
Once the analyser has been installed, it can be started up.
The steps to be followed for the first start-up are the same
as those indicated in the Start-up and shutdown procedure
Alarm
Mode
9
Warming up
User manual
- Several calibrators (Multipoint calibrator). This can be
specific (for a certain test) or multiple (common for several
tests). Up to 8 points and up to 3 replicated points for
each one. Calculation of the Calibration Curve (spline,
linear regression, quadratic or polygonal regression, with
linear or logarithmic axes).
STATUSES OF THE ANALYSER
- Sleeping Mode: The analyser is connected to the mains
with the switch in (l) position, but it is not working. The
analyser can be left in this status indefinitely. Power
consumption is minimal
- Warm-up: Transitory status during which the analyser
initialises all its elements and performs the checks
required to be able to begin analyses. Once warm-up
has finished, the analyser is in standby mode, ready for
performing analyses.
PROGRAMMING
- Tests: unlimited number, depending on the hard disk
capacity of the computer. Programmable for 5 sample
types: serum, urine, plasma, cerebrospinal and
supernatant liquid.
- Shutdown: Transitory status during which the analyser
appropriately switches off all its elements to maintain
them in optimum condition for future analysis work. Once
finalised, the analyser is in standby mode.
- Test profiles: unlimited number, with an unlimited number
of tests.
- Standby mode: The analyser is in communication with
the PC. If the initialisation process has taken place, the
analyser is ready to perform analyses.
- Multiple calibrators: up to 10.
- Multiple controls: up to 20.
- Running Mode: The analyser is performing analyses
(preparations and readings or readings only if there is no
preparation pending).
- Contaminations: unlimited number.
- Reagent racks: unlimited number.
- Sampling stop: The analyser can be taking readings, but
the operating arm is parked and the pending reactions
are not prepared. In this status, the user can handle the
bottles and containers of the analyser with no risk, in
order to, for example, add a new sample.
OPERATION
MONITOR SCREEN
- Warm-up and shutdown process of the analyser .
- Cancellation of the preparations and readings in process
(Abort)
- Alarm Mode: If during any of the operations, an anomaly
occurs requiring the intervention of the user and whose
correction is essential for the process to continue, the
analyser enters alarm mode and issues the corresponding
alert through the PC.
- Real-time monitoring of the status of the analyser and
development of the work session. Display of the tasks
sent to the analyser and the advance of their execution.
- Mains disconnection: Switch (0) (Power Off): The switch
is in the (0) position. The analyser is completely off. It
can then be disconnected from the mains.
- Access to the results of the measurements, with the
possibility of automatic printing.
- Alerts and alarms. Access to detailed explanations.
ANALYSIS MODES
- Access to introduction of new samples at all times.
- Final point. Monoreagent or bireagent. Monochromatic
or bichromatic.
- Interruption and renewal of the preparation of reactions
(Sampling stop / Continue).
- Bireagent differential.
- Fixed time. Monoreagent or bireagent.
PREPARATION OF THE WORK SESSION
- Kinetic. Monoreagent or bireagent. Readings every 15 s,
up to 15 min Linear regression analysis, with linearity
evaluation. Automatically extracted kinetic blank.
- Sample types: Normal patient, urgent patient, blank,
calibrator and control.
- One patient can have up to 5 different types of samples.
- Easy allocation of the tests and profiles to be performed
on one or several samples.
CALIBRATION TYPES
- Factor
- Up to 50 replicates for patient samples. Up to 3 replicates
for blanks, calibrators and controls.
- Single calibrator (Single-point calibrator). This can be
specific (for a certain test) or multiple (common for several
tests).
10
CONFIGURATION
- Automatic allocation of blanks and calibrators. Possibility
of storing the results of blanks and calibrators.
- Partial or total sending of work to the analyser.
- Options of the user programme (languages, printing,
reports).
- Possibility of introducing patient data while the analyser
is performing the analyses.
- Options for the functioning of the analyser (washing,
sample tubes, filter drum, cover detection, rack detection).
- Automatic selection of the reagents required and
indication of the minimum required volumes.
UTILITIES
- Analyser test, preparation and maintenance utilities
(needle disassembly, supply, washing, rotor verification,
lamp change, PC-analyser communications,
demonstration).
- Graphic, automatic or manual allocation of sample and
reagent positions in the racks.
- Printable summary of positions to enable the positioning
of the samples and the reagents in the racks.
- Verification of the correspondence of the programmed
racks with the racks of the analyser.
QUALITY CONTROL
- Analytical limitations control for each test: blank, linearity,
detection, factor.
- Automatic reordering of the tests of each sample to
optimise work and avoid contamination between
programmed tests.
- Internal quality control with up to 2 control materials per
test. Manual or statistical calculation. Levey-Jennings
graphics and Westgard algorithm.
- Automatic verification of the resources available on the
analyser to be able to proceed with the required analyses.
Issuing of alerts with instructions for the user if his or her
intervention is required.
PROCESSING OF RESULTS
- Current or historical reports, by patients or test, with
possibility of repetition to confirm results.
- Current or past reports, by patients or by tests.
- Patient database.
- Internal quality control reports.
- Alarm and alert records.
- Exportation of results.
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User manual
2. General operation method
This chapter gives the basic instructions for using the
instrument. Although the operation of the analyser is very
simple and intuitive, it is recommended you read this chapter
carefully to make the most of its features effortlessly and
as quickly as possible.
corresponding blanks, calibrators and controls. The user
can choose to perform them or reuse the data from the
previous session. Until the work session is restarted, the
analyser will not propose the repetition of the blanks,
calibrators and controls that have already been carried out,
even if the analyser is switched off, maintaining all the
information of the session in progress. To obtain maximum
quality of the analytical results, it is recommended that
you perform all the corresponding blanks, calibrators and
controls in each working day. This implies restarting the
work session daily and always choosing to perform new
blanks, calibrators and controls.
2.1 Program Installation
For the program installation, you must carry out the following
steps:
a) Initiate the computer
b) Uninstall the old version with the Windows option Add
and Remove programs
c) Insert the D-ROM with the new version.
d) Press Start, select Execute and write: name of the CDROM unit:\setup (for example: D:\Setup).
Once the samples have been introduced, the user must
allocate positions to the samples and to the required
reagents and physically place them in the analyser. The
Positions screen distributes the samples and the reagents
in the different racks of the analyser tray. This distribution
can be made automatically or manually.
From version 2.5.0, the program keeps a copy from all the
data files of the previously installed version, in the
subdirectory \previous of the application directory (generally
c:\program files\A25).
Should there be an error during installation, the user can
install the previous version again and recover the old data.
Follow the steps to recover a previous version:
As soon as the required elements have been distributed,
the work session can be started. The Monitor screen is
automatically displayed, containing a summary of the main
information received from the analyser and showing the
progress of the work session. From this screen, it is possible
to access other screens that offer more detailed information
about results and alarms. The user can cancel the work
session if he or she detects that the results are incorrect.
a) Uninstall the version of the problem. Do not erase the
created subdirectories or the files generated by the
application.
b) Install the previous version
c) Execute it. When initiating the application, it will restore
the old data files. This process will solely be made from
version 2.5.0 on.
At any moment, the user can introduce urgent samples or
add new normal samples to the work session in progress
from the Introduction of new samples screen without losing
the information of the samples that have been sent
previously. If the sample is normal, it is added at the end of
the list. If it is urgent, and there are no other urgent samples
in progress, the current sample is interrupted and the urgent
one is introduced in first place. If there are already other
urgent samples, it is added to the end of the group of urgent
samples. If a new sample is added, with a test that has not
yet been performed in the current session, the analyser
will propose new corresponding blanks, calibrators and
controls. The user again has the possibility of choosing
whether to perform them or not.
2.2. Operation procedure
2.2.1. Introduction
The operation of the analyser is flexible and simple using
the user programme from the dedicated PC. This programme
is subdivided into different screens that provide specific
functionality. They are described in more detail in the
following sections.
The system can automatically block samples or tests in
accord with the information received from the analyser. This
can happen, for example, when a sample or a reagent has
run out. When the user corrects the problem and notifies
the analyser from the Positions screen, the blocked
samples or tests are automatically unblocked and the
affected samples are turned into pending samples, and are
analysed later.
Firstly, the user must switch on the analyser and launch
the user programme, and warm up the analyser from the
Monitor screen. To start a work session, the samples that
are to be analysed must be introduced through the
Introduction of New Samples screen, indicating the
measurement procedures desired. Each measurement
procedure or test is defined by a set of parameters that
can be programmed by the user from the Tests programming
screen.
The user can access the results as they are obtained and
print the results of the patients whose tests have already
finalised.
In accord with the tests to be carried out, the analyser
automatically proposes the performance of the
The basic screens of the user programme are as follows:
12
- Monitor screen: Main screen that appears when the user
programme is launched. It displays the status of the
analyser and the work session in progress. It lets the
user intervene in the progress of the work session. It
contains the main buttons for controlling the analyser.
issues the corresponding alert through the computer. Once
warm-up has finished, the analyser is in standby mode,
ready for work.
Once the work session has been prepared from the
corresponding screens and warm-up has finalised, click
the Start button on the vertical bar for the analyser to start
performing the analyses. On beginning the analyses, the
analyser enters running mode. If during the running mode
you wish to physically introduce a sample or a reagent in
the analyser, click on the Sampling Stop button on the
vertical bar menu and the analyser enters running mode
with readings only, without the preparation of samples
(Sampling stop). The user can then raise the cover and
place the sample or reagent in safety. Closing the cover
and clicking on the Continue button on the same bar, the
analyser returns to running mode. When the analyser ends
the analyses, it automatically returns to standby mode. If
you wish to abort the preparation of new reactions as well
as the readings in progress, click on the Abort button
located on the same bar. In this case, the analyser requests
confirmation and, if the response is affirmative, it aborts
the preparations and readings in progress, and returns to
standby mode.
- Programming screens: These enable the programming
of tests, profiles, multiple calibrators, multiple controls,
contaminations and reagent racks.
- Work session preparation screens: These enable the
preparation of the work session and the storage of data
that may be used in later sessions. Basically, the user
can introduce new samples to be analysed and position
the corresponding samples and reagents in the analyser.
- Results screens: These make it possible to view the results
and see and print the reports with the results obtained in
the current or previous sessions. The reports can be
organised by patients or by tests. It also allows managing
sample repetitions
- Alarms screens: These give detailed information about
the alarms and alerts occurring in the current session or
in previous sessions and enable the printing out of reports.
- Patient data screen: This enables the introduction and
modification of the patient data sent to the analyser.
To switch off the analyser, click on the Shutdown button on
the vertical menu bar from standby mode. The programme
asks for confirmation and if the response is affirmative, it
performs the shutdown sequence and returns to sleeping
mode. The analyser can be left in this status indefinitely.
Power consumption is minimal. The user programme can
be closed and the computer switched off. If you wish to
switch off the analyser completely, for example to carry
out a maintenance operation or repair a breakdown, the
switch must be put in the (0) position (Power off) and the
mains cable unplugged.
- Configuration screens: These make it possible to configure the working mode of the user programme and the
analyser.
- Utility screens: These let the user access the different
test, preparation and maintenance utilities of the analyser.
- Quality control screens: These enable access to the
internal quality control results of the analyser.
The following sections describe these screens and their
functionality in more detail. You can access any of them
easily from the main menu and specific buttons.
If during any of the operations, an anomaly occurs requiring
the intervention of the user and whose correction is essential
for the process to continue, the analyser enters alarm mode
and issues the corresponding alert through the PC. Once
the user has solved the problem and has indicated this to
2.2.2. Start-up procedure, operation and shutdown.
Before starting up the analyser, the user must check that
the waste container is empty, that the system liquid container is full and that a reactions rotor is correctly installed.
To start up the analyser, the analyser must be in sleeping
mode, i.e. plugged into the mains and with the switch in
the (I) position. Reboot the computer and launch the user
programme. The computer automatically communicates
with the analyser, which changes to standby mode. The
screen that appears when the programme is launched is
the Monitor screen. The programme shows horizontal and
vertical button bars. The horizontal bar enables access to
the main functions of the application, whereas the vertical
bar enables the control and functioning of the analyser.
Click on the Warm up button on the vertical bar menu to
begin Warming up. The analyser automatically performs
all the checks required for its correct functioning and the
programme continually informs the user of the status of
the analyser. No manual adjustment is necessary. If, for
any reason, user intervention is necessary, the analyser
13
Statuses of the analyser
LED
Sleeping Mode
Orange
Warm-up
Green
Shutdown
Green
Standby mode
Green
Running Mode
Green
Running mode with readings only
(Sampling Stop)
Red
Alarm Mode
Flashing red
Mains disconnection:
Switch (0) (Power Off):
Off
User manual
the analyser, the analyser checks that it has indeed been
solved and returns to the previous mode.
new rotor is placed in position, which enables the
cancellation of the standby.
The three-colour LED indicator (green, orange and red)
located on the front right of the analyser indicates the current
status of the analyser.
- The status of the cover of the analyser (open or closed)
and the rotor cover (in position or not in position). The
analyser also issues an alert if there is no rotor placed in
the analyser.
- Control of the useful lifetime of the lamp.
2.2.3. Monitor
- The status of the thermostatisation systems of the needle
and the rotor.
This is the main screen that appears when the user
programme is launched. This lets the user supervise and
intervene in the progress of the work session or any other
task sent to the analyser. It displays the status of the
analyser and the work session in progress, providing
graphic information about any alarm produced. The content
of this screen is as follows:
- The levels of the waste and system liquid containers
- The status of the racks tray. The analyser alerts the user
if the configuration of the racks in the analyser does not
coincide with the programmed configuration or if some of
the reagents or samples have run out.
- Other alarms.
- Status of the analyser and the work session.
- The list of samples in the current work session. This
list presents all the samples to be performed in the
current work session, in accord with the order of
execution. To indicate the status of each sample, a
colour code and icons are used:
- Vertical button bar which enables the control of the
functioning of the analyser.
- Horizontal button bar which provides access to the main
function of the application.
- Pending (yellow): Samples that have not yet been
analysed.
- In progress (red): Samples that are being analysed.
- Finished (green): Samples that have been completely
analysed without incidences in any of the tests
performed. The results of these samples are accepted
automatically.
- Finished with incidences (green + attention icon):
Samples with which not all the analyses programmed
have been performed due to an incidence of some kind.
- Blocked (Blocking icon): Samples to which no analysis
has been possible due to an incidence of some kind
(lack of sample, lack of reagent, error in the performance of the blank or calibrator…).
2.2.3.2. Blocking pending samples
2.2.3.1. Status of the analyser and the work session.
From the monitor screen, you can block samples pending
to be analyzed. When pressing the button details, the
monitor screen opens and each patient with all his
programmed test visualizes. If you double-click on any test,
an icon of a hand will appear showing that this test is
blocked. The whole patient can also be blocked by double
clicking on the patient code. Blanks, calibrators and controls
can not be blocked. By double clicking on the same sample
a second time, you can unblock it.
Real-time monitoring of the status of the analyser and
development of the work session.
- The total time of the programmed work session and the
number of rotors necessary for it to be carried out.
- The status of the analyser at any given moment: Sleeping,
Warm-up, Shutdown, Standby, Running, Sampling Stop
or Alarm. The transitions between the statuses in some
cases are automatic and in others they are requested by
the user.
2.2.3.3. Vertical button bar for the control of the
analyser
- The warm-up time control, which enables the cancellation
and control of the performance of the photometric base
lines.
This bar contains the main buttons for the control of the
functioning of the analyser, which enable the user to change
its status and perform different actions. This bar can also
be accessed directly from the positioning screen of the
- The status of the reactions rotor: number of wells used,
number of free wells and graphic bar of the percentage of
wells used. The thermostatisation time control when a
14
reagents and samples in the racks. The buttons are as
follows:
Configuration A25: This enables access to the analyser
configuration screen.
Connection: This re-establishes the connection between
the computer and the analyser if the analyser has been
accidentally switched off or the computer has been
disconnected (it changes from Sleeping to Standby). If
the analyser is in sleeping mode and the computer
programme is launched, the connection is made
automatically.
Test programming: This enables access to the test
programming screen.
New sample: This enables access to the introduction of
new samples screen.
Warm Up: This initialises the analyser (performs Warming
up and leaves the analyser on standby ready for work).
Position: This enables access to the screen for the
positioning of reagents and samples in the rack tray.
Start: The analyser begins to perform the programmed
analyses (changes from standby to running).
Monitor: This enables a return to the monitor screen from
any other screen.
Continue: This continues the preparations if they have been
stopped by the analyser or by the user. (It changes
from Sampling Stop to Running). It also continues when
new samples are added to a finished session. (It changes
from Standby to Running).
Current results: This enables access to the current results
screen. These can be displayed in order of patients or
tests in real time during the execution of the analyses.
It also allows managing sample repetitions
Profile programming: This enables access to the profile
(group of tests) programming screen.
Current alarms: This enables access to the current alarms
screen which offers more detailed information about the
alerts and alarms that have appeared on the Monitor
screen during the current session.
Sampling Stop: This enables the interruption of the
preparations without interrupting the readings of the
samples in progress and the reception of results from
the analyser (it changes from Running to Sampling
Stop).
Utilities: This enables access to the utilities screen.
Reset Session: This restarts the work session.
Abort: This aborts the work session, both readings and
preparations, i.e. it cancels the execution of the analyses
in progresses (it changes from Running, Sampling Stop
or Standby by Rotor End to Standby and considers the
session as finished).
2.2.3.5. Special buttons in monitor screen
New Rotor: This button indicates to the analyser that a
new empty rotor has been installed. This is active only
when the analyser is on standby. The analyser controls
the time required for the thermostatisation of the new
rotor, which is approximately 5 minutes. The user can
cancel this waiting time if a previously thermostatised
to 37ºC rotor is introduced.
Printing final reports: This button allows printing each
patient’s results which are finished before ending the
whole list. It will only print those finished patients with a
printer symbol in the printing column.
Preparation table per well: Button to open a window that
shows in each rotor well which sample, test and replicate
have been prepared.
Legend of icons and monitor colours: This button opens an
extra window that explains what each colour and symbol
means.
New System Liquid Container: This button tells the analyser
that the system liquid container has been refilled. The
analyser then automatically supplied the dispensing
system to prevent the accumulation of air, which is
detrimental to the execution of the analyses. It is active
when the analyser is on standby, running or sampling
stop mode, but the supply is carried out on standby or
running only.
Details: This button allows opening the monitor screen and
visualizing the programmed tests for each patient. By
pressing again the same button, you can recover the
previous screen.
Shutdown: It performs the shutdown process of the analyser
(it changes from standby to sleeping and performs
shutdown).
2.2.3.4. Horizontal button bar
This button bar provides access to the main functions of
the application and is accessible from all the programme
screens, not only from the monitor screen. These functions
and others whose use is not as frequent can also be
accessed through the dropdown text menu at the top of
the screens. The buttons are as follows:
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User manual
2.2.4. Programming
Save: Clicking this button after modifications have been
made provisionally stores the new parameters.
Various screens enable the programming of the parameters
of tests, profiles, multiple calibrators, multiple controls,
contaminations and reagent racks. These parameters are
usually constant over long periods of time once the analyser
has been adapted to the needs of the laboratory where it is
being used. Programming requires knowledge of the
analyser and the analysis process. It is not possible to
modify any of the programmed parameters while they are
being used in a work session.
OK: Clicking this button definitively stores all the changes
made in the tests file.
Cancel: This enables the recovery of the initial tests file,
without taking into consideration the changes made
since the tests programming screen was opened.
Programmable parameters
The parameters programmable for each test are as follows:
2.2.4.1. Test programming
General
This screen enables the programming of new tests, the
querying or modification of parameters of tests that have
already been programmed and the elimination of tests that
are no longer used. It also enables the ordering of the list of
tests and the printing of their parameters. The default tests
are those pre-programmed by BioSystems to use the line
of reagents adapted to the analyser. The total number of
programmable tests is unlimited and depends only on the
capacity of the computer. The screen is divided into two
parts:
- Test name: Test name with up to 16 characters.
- List of tests.
- Units: Units that are used to express all the concentrations
associated with the test. One of the memorised units
can be selected or a new one introduced.
- Analysis Mode Final monoreagent point, Final bireagent
point, Bireagent differential, Monoreagent fixed time,
Bireagent fixed time, Monoreagent kinetics, Bireagent
kinetics.
- Sample type: Each test may contain specific parameters
for five different sample types: Serum (SUE), Urine (ORI),
Plasma (PLM), Cerebrospinal (LCR) or Supernatant (SBN)
liquid. The Delete Type button can delete all the data
related to a certain sample type of a test.
- Information about parameters, grouped together in five
folders: General, Procedure, Calibration, Controls,
Options.
- Turbidimetry test: It shows the program that the
programmed test is a special one. The analyzer makes
a different cycle with turbidimetry tests.
The parameters of a test can be queried by selecting it on
the list with a click. If you wish to modify the parameters of
a test, select it with a double-click or pressing Enter. None
of the programmed parameters of a test can be modified if
it has been programmed in a work session. The list of tests
can be ordered by dragging a test to the new position in
the list or alphabetically by clicking on the list header.
- Reaction type: Increasing or decreasing.
- Decimals: Number of decimals to be used to express
the concentration in the reports.
- Replicates: Number of times each preparation is carried
out for the patient samples (from 1 to 50). The final result
obtained is the average of the replicates performed and
accepted.
If a test parameter is modified, the results stored for the
blank and calibrator are automatically reset and must be
redone.
- Name of the Associated Constituent. Optionally, it is
possible to introduce the name of the constituent
measured with the test. If introduced, it will appear in the
reports.
Buttons
Various buttons let the user perform the following actions:
New: This enables the creation of a new test and the
introduction of its parameters in the corresponding
folders. The programme introduces some parameters
by default to speed up this process and checks that
the data introduced is within the expected margins. If
this is not so, it sends the user alerts (the alerts appear
on the status bar and do not allow further introduction of
data until the incorrect data has been put right).In order
to identify the created test as a user test different from
the original tests, the colour of the test icon changes to
orange. The original tests are blue.
Print: This prints out the parameters of the selected tests.
Delete: This deletes the selected tests.
16
- Calibration curve: For Multipoint Calibrator (Multiple or
Specific). It can be polygonal, linear regression, spline or
regression parabola. The x and y axes can be normal or
logarithmic.
Procedure
- Reading type: Monochromatic or Bichromatic (for End
Point only)
- Volumes of Sample and Reagents: Sample volume
(between 3 µl and 40 µl), Reagent 1 volume (between 10
µl and 440 µl), Reagent 2 volume (between 10 µl and 200
µl). The Reagent 2 volume will be active or not depending
on the analysis mode used. The programme controls that
the total volume of the reaction is between 200 µl and
800 µl.
- Calibrator replicates: number of times the calibrator is
measured (1, 2 or 3). The final result obtained is the average of the replicates performed and accepted.
- Blank replicates: number of times the blank is measured
(1, 2 or 3). The final result obtained is the average of the
replicates performed and accepted.
- Alternative calibrator: Option that enables the analysis
of a certain type of sample using the results of the
calibration of another different sample type. For example,
it enables the use of calibration for serum to analyse a
urine sample.
- Washing Volume: Internal washing volume of the needle
which the analyser performs automatically after the
preparation of the test (1200 µl, 1000 µl or 800 µl).
- Pre-dilution Factor: Pre-dilution factor of the sample. Predilution can be carried out automatically or by the analyser
or manually by the user.
Controls
- Automatic repetition: It shows the program to repeat that
test automatically if the result is out of the limits.
- Number of controls: Number of controls the analyser
proposes for each work session (0, 1 or 2).
- Postdilution Factor: It is the factor of sample postdilution
when it makes an automatic repetition.
- Rejection criteria: Criteria for rejecting an analytical series (between 0.1 and 4 standard deviations).
- Filters: One or two filters to be chosen in accord with the
reading type. Only filters that are physically in the filter
drum can be chosen (they can be revised from the
Configuration screen of the A25).
- Replicates: number of times the control is measured (1,
2 or 3). The final result obtained is the average of the
replicates performed and accepted.
- Control type: Multiple or Specific. If the control is specific,
- Times: Depending on the analysis type, the
corresponding boxes are activated to programme the
different reading or dispensing times of the second
reagent. The times can be introduced in seconds or in
cycles. Each cycle is equal to 15 s.
Calibration
- Calibration type: Factor, Multiple Calibrator or Specific
Calibrator. If factor is used, its value must be introduced
in the corresponding field. If the calibrator is specific, the
fields appear to introduce the concentration values,
depending on the number of calibrators. For multiple
calibrators, this data is introduced on the multiple
calibrators programming screen, which is accessed
directly from this screen.
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User manual
the fields appear for introducing Name, Batch, Maximum
Concentration and Minimum Concentration for each of
the controls. For multiple controls, this data is introduced
on the multiple controls programming screen, which is
accessed directly from this screen.
unlimited and depends only on the capacity of the computer.
The screen contains:
- List of profiles
- List of programmed tests
- List of tests in the selected profile
- Calculation Mode: This indicates the method used for
deciding if a series of results is accepted or rejected. It
can be manual or statistical. In statistical mode, the user
must introduce the number of series. The Internal Quality
Control section gives a detailed explanation of its
functioning.
The parameters of a profile can be queried by selecting it
on the list with a click. If you wish to modify the parameters
of a profile, select it with a double-click or pressing Enter. It
is not possible to modify any of the programmed parameters
of a profile while they are being used in a work session.
The list of profiles can be ordered by dragging a profile to
the new position in the list or alphabetically by clicking on
the list header.
Options
- Blank absorbance limit. In kinetic or fixed time tests,
this limit refers to the initial reading of the programmed
absorbance.
- Kinetic blank limit.
Buttons
- Linearity limit.
Various buttons let the user perform the following actions:
- Detection limit.
New: Enables the creation of a new profile.
- Factor limits.
Add tests (Arrow >) and remove tests (Arrow <): It is possible
to add or remove tests to or from a profile that is being
edited by selecting the desired tests from the test or
profile lists and clicking on the corresponding button.
- Reference interval.
- Limits of repetition
- Perform blank without distilled water: When this option
is activated, the analyser performs the blanks without
using distilled water as a sample, i.e. it dispenses reagent
only.
Print: Prints the content of one or more profiles.
Delete: This deletes the selected profiles.
Save: Clicking this button after modifications have been
made provisionally stores the new parameters.
- Contaminations: This button enables access to the
contaminations programming screen.
OK: Clicking this button definitively stores all the changes
made in the profiles file.
2.2.4.2. Profile programming:
Cancel: This enables the recovery of the initial profiles file,
without taking into consideration the changes made
since the profiles programming screen was opened.
This screen enables the programming of test profiles. A
test profile is a set of tests identified by a name. Using
programmed test profiles simplifies the preparation of the
work session. On allocating a profile to a sample, all the
tests contained in said profile are automatically allocated
to it. Each profile has one single sample type associated
to it. If you wish to create the same profile for different
sample types, a profile must be programmed for each
different type. The total number of programmable tests is
2.2.4.3. Programming of Multiple Calibrators
A multiple calibrator can be used to calibrate more than
one test. Up to 10 multiple calibrators can be programmed.
Each of these calibrators can be monopoint or multipoint,
i.e. a single calibrator or several calibrators may be used.
18
it with a click or using the cursor keys. To edit the calibration
parameters of a test, select it with a double click or by
pressing Enter.
Buttons
Various buttons let the user perform the following actions:
New: Enables the creation of a new calibrator. You must
introduce the name, batch and number of calibrators.
Print: Prints out the data of the selected calibrators.
Delete: Deletes the selected calibrators from the grid.
Save: Clicking this button after modifications have been
made provisionally stores the new parameters.
OK: Clicking this button definitively stores all the changes
made in the calibrators and tests file.
Cancel: This enables the recovery of the initial tests and
multiple calibrators files, without taking into
consideration the changes made since the multiple
calibrators programming screen was opened.
The multiple calibrators programming screen can be
accessed only from the tests programming screen, from
the Calibration tab. The screen contains:
- Calibrator grid:
- List of tests with multiple calibrator
2.2.4.4. Programming of Multiple Controls
- Information about parameters
A multiple control can be used to control more than one
test. Up to 20 multiple controls can be programmed. The
multiple controls programming screen can be accessed
only from the tests programming screen, from the Controls
tab.
The calibrator grid displays the name of the calibrator, the
batch and the number of calibrators. The number of
calibrators ranges from 1 (single calibrator) to a maximum
of 8. The list of tests with multiple calibrator shows the
tests programmed to be calibrated with a multiple calibrator.
The display shows the name of the test, the sample type,
the name of the allocated calibrator and its batch. To allocate
or change the calibrator of a test, click on the name or
batch of the calibrator and choose the desired calibrator
from the list that drops down on the row corresponding to
the test. If a calibrator that has already been allocated to
one or more tests is modified, the allocations are deleted.
Once a calibrator has been allocated to a certain test, the
user must programme the test calibration parameters:
The screen contains:
- Control grid
- List of tests with multiple control
- Information about parameters
The control grid displays the name of the control and the
batch. The list of tests with multiple control shows the
programmed tests to be controlled using a multiple control. The display shows the name of the test, the sample
type, the name of the allocated control and its batch. To
allocate or change the control of a test, click on the name
or batch of the control and choose the desired control from
the list that drops down on the row corresponding to the
- Concentration data: Assigned values of calibrator
(monopoint) or calibrators (multipoint) concentration for
the test, introduced from greater to smaller. The
corresponding factors are calculated automatically from
the concentrations introduced.
- Calibration Curve Data: For multipoint calibrators, the
curve type (polygonal, linear regression, spline or
regression parabola) and the type of x and y axes (normal or logarithmic) must be selected.
By selecting a calibrator with a click or with the cursor
keys, it is possible to query its data and the tests allocated
to it. The allocated tests appear selected on the tests list.
If you wish to modify the parameters of a calibrator, select
it with a double-click or pressing Enter. The data can be
modified on the grid itself. It is not possible to modify any
of the programmed data of a calibrator while it is being
used in a work session. The calibrator grid can be ordered
by dragging a calibrator to its new position in the grid. The
calibration parameters of a test can be queried by selecting
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User manual
test. If a test requires 2 controls (generally 2 levels: high
and low), each one must be allocated separately. If a control that has already been allocated to one or more tests is
modified, the allocations are deleted. Once a control has
been allocated to a certain test, the user must programme
the test control parameters:
- Concentration data: Allocated values of maximum and
minimum control concentration for the test.
By selecting a control with a click or with the cursor keys,
it is possible to query its data and the tests allocated to it.
The allocated tests appear selected on the tests list. If you
wish to modify the data of a control, select it with a doubleclick or pressing Enter. The data can be modified on the
grid itself. It is not possible to modify any of the programmed
data of a control while it is being used in a work session.
The control grid can be ordered by dragging a control to its
new position in the grid. The control parameters of a test
can be queried by selecting it with a click or using the
cursor keys. To edit the control parameters of a test, select
it with a double click or by pressing Enter.
- List or programmed reagent racks
- Information about parameters
The parameters interface contains a list with all the reagents
associated with the tests programmed in the analyser, the
name of the selected rack and an image of this rack showing
the real positions of the reagents, their names and volumes.
The bottles on the racks can be added, removed or reordered
by dragging them with the mouse. The bottle type (50 or 20
ml) may be changed using the corresponding button. Its
parameters may be queried by selecting a programmed
rack with a click or using the cursor keys. If you wish to
modify a programmed rack, select it with a double-click or
pressing Enter. A programmed rack cannot be modified while
it is being used in a work session. The list of programmed
racks can be ordered by dragging a rack to the new position
in the list or alphabetically by clicking on the list header.
Buttons
Various buttons let the user perform the following actions:
New: Enables the creation of a new control. You must introduce the name and batch.
Print: Prints out the data of the selected controls.
Delete: Deletes the selected controls from the grid.
Save: Clicking this button after modifications have been
made provisionally stores the new parameters.
OK: Clicking this button definitively stores all the changes
made in the controls and tests file.
Buttons
Cancel: This enables the recovery of the initial tests and
multiple controls files, without taking into consideration
the changes made since the multiple controls
programming screen was opened.
Various buttons let the user perform the following actions:
New: Enables the creation of a new programmed rack.
Print: Prints out the data of the selected programmed racks.
Delete: Deletes the programmed racks selected on the list.
2.2.4.5. Reagent Rack Programming
Save: Clicking this button after modifications have been
made provisionally stores the programmed rack.
Programming a reagent rack consists of saving a certain
configuration of reagent bottles of a rack, identified by a
name. When preparing a work session, to position the
reagents, you can load a programmed rack and the saved
reagent distribution is automatically allocated. If the user
frequently uses the same reagents, it is very practical to
use programmed racks to speed up the work. An unlimited
number of reagent racks can be programmed, depending
on the capacity of the computer only. The rack programming
screen can be accessed directly from the programming
menu of the main programme menu. From the positioning
screen, it is also possible to save sample racks with a
specific identifying name. It is not possible to access sample
racks from the reagent racks programming screen. It may
be useful, for example, to save a calibrator and control rack
that is used frequently. The reagent rack programming
screen contains:
OK: Clicking this button definitively stores all the changes
made in the programmed racks file.
Cancel: This enables the recovery of the initial programmed
racks file, without taking into consideration the changes
made since the racks programming screen was opened.
2.2.4.6. Contaminations programming
To obtain correct analytical results, it is recommendable to
not execute certain pairs of tests one after the other. This
is due to the fact that the reagent used in the first test may
affect the measurement procedure of the second test. Even
though the needle of the analyser is washed after each
preparation, a minimum residue from the reagent of the
first test may alter the analytical results of the second.
20
OK: Clicking this button definitively stores all the changes
made in the contaminations file.
Cancel: This enables the recovery of the initial
contaminations file, without taking into consideration
the changes made since the contaminations
programming screen was opened.
2.2.5. Save/load test file
The user can save the test programming in an external file,
he has only to execute the option Save Test File of the
programming menu. This option saves all the test data in a
compressed file. It is the program itself the one that
compresses and decompresses the file with no need of
the user’s intervention.
Each contamination consists of a pair of tests that should
or should not be performed in the order indicated. The
contaminating test (first test) and the contaminated test
(second test). The analyser automatically reorders the tests
to be performed on each sample in such a way that the
programmed contaminations are avoided. If, in any case,
this reordering is not possible, the analyser automatically
introduces a special exhaustive washing cycle between
the corresponding tests. If two tests mutually affect each
other, two contaminations must be programmed, one for
each execution order. The contaminations programming
screen can be accessed through the tests programming
screen, from the Options tab, or directly from the
programming menu on the main programme menu. A
contamination cannot be modified while one of the tests
involved is being used in a work session. The screen
contains:
In order to load a new test file, the user has to execute the
option Load Test File of the programming menu and then
all the tests of the application are automatically replaced.
This process is only active with the following options:
- When working without passwords or as Supervisor user.
- When the analyzer is in SLEEPING or STANDBY state
- When there is no working list. If you have a programmed
list, make a RESET.
2.2.6. Preparation of the work session
The Introduction of New Samples and Reagents and
Samples Positioning screens help the user to prepare the
work session conveniently, easily and quickly. Furthermore,
it enables the storage of data that can be used in later
sessions.
- List of Contaminations
- List of Contaminating Tests (first tests)
- List of Contaminated Tests (second tests)
2.2.6.1. Introduction of New Samples
Its data may be queried by selecting a contamination with
a click or using the cursor keys. All the tests contaminated
by the first contamination test appear selected on the
contaminated tests list. If you wish to modify a
contamination, select it with a double-click or pressing
Enter. A contamination cannot be modified while it is being
used in a work session. The list of contaminations can be
ordered by dragging a contamination to the new position in
the list or alphabetically by clicking on the list header.
This screen contains the interface for introducing the data
of each sample and the lists of New Samples and Sent
Samples.
Interface for introducing sample data
The user can select the sample class (normal patient, urgent
patient, blank, calibrator or control) and the sample type
(serum, urine, cerebrospinal liquid, plasma or supernatant).
A tree diagram shows all the tests and profiles programmed
in the analyser. The user can select or introduce the patient
code (alphanumeric). If the patient code introduced does
not exist in the current work session, the new patient is
added together with his or her sample. If the patient already
exists, the sample of the patient in question is selected
and, on the tests tree, the tests previously allocated are
selected for possible edition. If the user does not introduce
the patient code, the programme adds the patient sample
with a correlative numeric identifier. If several normal or urgent
samples are to be introduced with the same tests to be
carried out, the desired number must be introduced in the
Buttons
Various buttons let the user perform the following actions:
New: Enables the creation of a new contamination. You
must select the names of the tests, respectively, from
the lists of contaminating and contaminated tests.
Print: Prints out the data of the selected contaminations.
Delete: Deletes the contaminations selected on the list.
Save: Clicking this button after modifications have been
made provisionally stores the contamination.
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User manual
Number of Patient Samples field and the programme
automatically adds all the samples, allocating them a
correlative patient code. By default, the Number of Patient
Samples is 1. The maximum value is 120.If the user has
got a code bar reader, he can use such reader to insert the
patient code. Place the cursor in the box of the patient
code and read the code to be inserted with the reader.
Lists of samples
The list of New Samples shows all the samples introduced,
grouped together by classes, which the user can then send
to the analyser. The list of Sent Samples shows those the
user has sent to the analyser, also grouped together by
classes. To introduce a new sample into the list of new
samples, proceed as follows:
The grids of New Samples enable the modification of the
information they contain. The grids of blanks and calibrators
and controls are completed automatically as patients are
added. If the user wishes, he or she can also introduce
blanks, calibrators or controls manually. From the
corresponding grids, it is possible to activate or deactivate
the performance of blanks, calibrators and controls,
changing the value of the fields New or In Use, respectively
(as long as there are results stored from a previous session).
If the blanks and calibrators are deactivated, the analyser
will use the data of the last work session. If the user wishes
to send certain samples for positioning on the racks and
analysis, they must be selected and the Position button
pressed. It is also possible to send certain tests of a sample
only. The associated and activated blanks, calibrators and
controls are sent automatically. By clicking on the Position
button, with no previous selection, all the introduced and
activated samples of the corresponding grid are sent.
Clicking the Delete button deletes the samples or the tests
of a sample that have been selected.
The lists of New Samples and Sent Samples show the
information grouped together by sample class. Each one
contains a patient grid, one of blanks and calibrators and
one of controls. By default, the patient grid of the list of
new samples is displayed.
1. Select the sample class
2. Select the sample type
3. If desired, introduce the patient code.
4. Select the profiles and tests to be performed.
5. Add the sample to the list of samples by clicking on the
Add (Arrow >) button.
If you wish to introduce a certain number of samples n with
the same set of tests to be performed, proceed as follows:
1. Select the sample class
2. Select the sample type
3. Select the profiles and tests to be performed.
The Sent Samples grids enable the query of the samples
sent to the analyser and the tests to be performed on each
sample, but they do not allow modifications or the resending
of samples to the analyser.
4. Introduce the number of samples n
5. Add the sample to the list of samples by clicking on the
Add (Arrow >) button.
The code of a patient can be changed on the list itself by
clicking the right button of the mouse on the existing code.
Once you have made the desired changes, press Enter. It
is possible to add tests or profiles to a patient sample that
has already been introduced. Different sample types can
be introduced fro the same patient and the programme
groups them together automatically. It is also possible to
add, in one go, tests or profiles to several samples of the
same type for different patients.
The Reset Session button on the horizontal bar restarts
the work session and deletes all the sample lists.
When you reuse a Calibrator, you can modify the memorized
factor from the New Samples screen, within the Blanks
and Calibrators folder in order to recalculate the results
with the new inserted value.
- In order to edit the factor: double click its cell, insert a
new value and accept by pressing Enter. This action
recalculates all the affected Concentration results.
22
associated and activated blanks are also automatically
sent.
Patient data: This enables access to the screen for
introducing the data of each patient. This data is not
necessary for the performance of analyses and can be
introduced once the analyser is running.
2.2.6.2. Positioning of samples and reagents
This screen contains a tree diagram showing all the
elements to be positioned, an image of the analyser tray
indicating the current programmed distribution of the racks
and an enlarged image of the racks showing the details of
all the elements in the selected rack.
Tree diagram of elements to be positioned
- In order to recover the previous factor value: click any
crossed cell. This action recalculates all the affected
Concentration results.
This tree contains all the reagents and samples to be
positioned on the racks to execute the work session. For
each of the reagents, the tree shows the name, the volume
required and the minimum number of bottles required for
each type (20 or 50 ml). The samples are grouped together
by class: calibrators, controls and patients. For the
calibrators, the tree indicates the name, the number of
calibrators if it is multipoint and, if the test or tests allocated
have pre-dilutions programmed, the pre-dilution tubes
required, together with the corresponding factor of each
one. For the controls, the tree indicates the name and, if
the test or tests allocated have pre-dilutions programmed,
the pre-dilution tubes required, together with the
corresponding factor of each one. For the patients, normal
or urgent, it indicates the patient code, the sample type
and, if the test or tests allocated have pre-dilutions
programmed, the pre-dilution tubes required, together with
the corresponding factor of each one.
Buttons
Various buttons, some of which have already been
mentioned, let the user perform different actions. The
following is a brief description of the functionality of each
one.
Add sample (Arrow >): This dumps the information of the
interface to introduce sample data in the corresponding
new samples grid.
Edit patient (Arrow <): This enables the edition of a patient
sample or of several of the same type, of the new
samples grids. The edition enables the addition of tests
or profiles to the group of samples selected. It is also
possible to change the priority of the edited samples,
i.e. change from urgent to normal or vice versa. The
patient code of a sample is changed during the edition,
the programme adds a new patient, which is a copy of
the pervious one. If you wish to change the patient code
only without adding another new patient, make the
change directly on the samples grid with the right button
of the mouse.
The colour blue indicates which reagents and samples are
completely positioned in the racks tray. The colour black
indicates the reagents and/or samples that are not
positioned completely or whose volume has finished during
the work session.
Delete: This deletes the patient sample or control data
selected. It is possible to delete tests, test or sample
profiles of a patient or patients that have been completed.
This is active for the new samples grids only.
Position: This sends a selection or a complete list of
samples to be positioned in the analyser for later
analysis. This is active for all the new samples grids. It
enables:
- Sending of groups of patient samples. In this case,
the associated and activated blanks, calibrators and
controls are also automatically sent.
- Sending of control groups. In this case, the
associated and activated blanks and calibrators are also
automatically sent.
- Sending of groups of blanks and calibrators for
making lists for calibration only. In this case, the
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User manual
Rack tray and extended rack
Buttons
The image of the rack tray shows the current rack
distribution in the analyser. In each of the 6 rack positions,
there may be a reagent rack or a sample rack or the
position may be empty. In the reagent racks, the image
shows which positions are occupied by 20 and 50 ml
bottles. In the same way, in the sample racks the image
shows the positions occupied by sample tubes. The 3 central positions, preferably used for bottles of distilled water,
saline solution and washing solution, are also shown.
Various buttons, some of which have already been
mentioned, let the user perform different actions. The
following is a brief description of the functionality of each
one.
Position Reagents Automatically: The programme places
the reagents from the tree that are not yet positioned
(black colour) in the free positions on the reagent racks
on the tray. If required, it allocates new reagent racks
to the free positions on the tray and fills the positions. A
maximum of 5 reagent racks is permitted. If there are
elements on the racks that are not required for the current
work session, the programme alerts the user to remove
them. If there is no room for all the reagents, the user is
also alerted.
The user can choose the rack type at each position on the
tray. The limit configurations are 5 racks of reagents and 1
of samples (50 reagents / 24 samples) and 1 rack of reagents
and 5 of samples (10 reagents / 120 samples). In the
analyser options, the user can choose which type of
samples rack he or she wishes to use for all the samples
in the current session (13 mm diameter sample tube, 15
mm diameter sample tube or 13 mm diameter well). If he or
she wishes to use racks of samples of different types in
the same session, the user must deactivate the rack
detection on the analyser configuration screen. It must also
be taken into account that the analyser will not check that
the physical disposition of the racks on the tray is the same
as the programmed disposition. Besides empty racks, it is
also possible to position reagent racks programmed on
the rack programming screen or racks previously saved
from the positioning screen itself.
Position Samples Automatically: The programme places
the samples from the tree that are not yet positioned
(black colour) in the free positions on the samples racks
on the tray. If required, it allocates new samples racks
to the free positions on the tray and fills the positions. A
maximum of 5 samples racks is permitted. If there are
elements on the racks that are not required for the current
work session, the programme alerts the user to remove
them. If there is no room for all the samples, the user is
also alerted. If different types of sample racks are used
in one session, the user must manually reposition each
sample on the corresponding rack in accord with the
tube type used, since the analyser does not have
information about the tube type used for each sample.
The screen displays an enlarged view of the rack selected
on the tray, enabling easy manipulation of its content. The
selected elements can be unloaded from the rack or the
rack can be completely emptied. It is possible to change
the position of any element by dragging it to a free position
on the enlarged image of the rack. The volume of a bottle of
reagents can also be changed by double-clicking on it.
When any change is made, the programme checks if all
the required volume of said reagent is in position and alerts
the user if it is not.
Remove: This removes the selected elements from the
enlarged rack. If no selection has been made, all the
elements are removed from the rack. It is also possible
to remove the selected elements using the delete button.
Save Rack: This saves the enlarged rack (reagents or
samples) for later use.
Summary of positions: This enables easy verification of all
the allocated positions. The user accesses a screen
showing the current distribution of the racks tray in text
mode, indicating the content of each position rack by
rack. This information may be printed out.
The positioning of the reagents and the samples on the
racks can be carried out automatically or manually. Two
buttons make it possible to automatically position the
reagents or the samples, respectively. With automatic
positioning, the programme allocates the rack types that
are required. If the user wishes to position the elements
manually, he or she must choose the required rack types
and place the elements by dragging them with the mouse
from the tree to a free position in the corresponding enlarged
rack. It is possible to position individual bottles of reagent
or all the required reagent in one bottle. If a sample is
dragged and it has programmed pre-dilutions, the pre-dilution
tubes required are also dragged. If you wish to use different
sample rack types in one session, the user must manually
position each sample in the corresponding rack in accord
with the type of tube used.
OK: By clicking OK, the programme checks that all the
required elements are in position and requests
confirmation from the user to save the information as
definitive. When all the elements have not been
positioned, an auxiliary alerts screen opens. If the
analyser is ready for work, the Start button of the vertical buttons bar is enabled and the user can press it for
the analyser to start the analyses. The programme
automatically changes to the Monitor screen, from which
the execution of the work session can be supervised.
When the analyser is carrying out the analyses, the
user can press the Sampling Stop button on the vertical
button bar to introduce new elements into the analyser
physically. Once the positions have been programmed
on the Positions screen, by clicking OK, the programme
checks that all the new required elements are in position
Once all the elements have been positioned on the screen
and physically in the analyser, the user can begin the
analyses.
24
and requests confirmation from the user to save the
information as definitive. The Continue button on the
vertical bar is enabled and when the user presses it,
the programme changes to the Monitor screen and the
analyser continues the pending analyses and the new
ones that have been sent.
2.2.8.2. Repetitions
The User can make repetitions of blanks, calibrators,
controls and samples. Repetitions can be manual or
automatic.
Manual Repetitions: In order to make manual repetitions,
the own user has to select the samples that he wants
to repeat. Once the sample measurement is finished
and the result is in the Current results screen, select
the results to be repeated in the Rep column and then
press the Repeat Selected Samples button. The program
will automatically insert the sample to be repeated in
the working list. It will be added (rep) to the end of the
sample name to distinguish it from the initial sample. In
the Current results screen, the result of the repetition
will appear under the initial sample. So the user will be
able to choose, by means of the OK column, which of
both results will comprise the patients’ report and
become historical. The repetition result will be selected
by default. If repeating blanks and calibrators, all the
associated values will be recalculated.
Cancel: This exits the screen without updating any of the
changes made and keeps the previous distribution.
Alerts: This button appears when there are elements not
positioned in the prepared work session and it informs
the user of everything that cannot be analysed. When
nothing is in position, the Start button is not enabled.
2.2.7 Memorising sessions
When Memorizing a working session, the assigned
samples and tests are saved, but the positions are not. If
you wish to memorize the current session, you should save
it before starting its execution. When loading a memorized
session, the tests are loaded such as they are programmed
at that moment, and the tests that have been deleted from
the test file are eliminated.
Automatic repetitions: In the test programming, some limits
or intervals of reference can be programmed to carry
out automatic repetitions if the sample result is outside
these intervals. In order to carry out the repetitions
automatically, the automatic repetition tick must also
be selected in the test programming:
In order to Load a memorized session, it is necessary to
carry out a RESET one previously. Once it is loaded, the
session can be freely modified (modify identifiers, eliminate
tests, add samples or tests...)
- If the patient concentration is higher than the linearity
limit, the sample is repeated with the decreased
Factor of postdilution.
The memorized sessions can be also Eliminated.
2.2.8. Current results
- If the patient concentration is lower than the detection
limit, the sample is repeated with the increased Factor of postdilution.
The results can be consulted as they are obtained on the
Current results screen, grouped together by patients or by
tests. The results are updated automatically in real time
as information is received from the analyser. For each
analysis, the results of the replicates performed are
displayed together with the corresponding average. Once
the analyses have finalised, the user can discard the
replicates of samples (blanks, calibrators, patients or
controls) he considers aberrant and the programme
automatically recalculates and displays the new results.
The results can be printed in reports ordered by patients or
by tests.
- If the patient concentration is within the Rank of
repetition, the sample is repeated with the same
relation of sample-reagent.
- If the absorbances of the kinetic in blanks, calibrators,
controls and samples are not linear, it is repeated
with the same relation of sample-reagent volumes.
2.2.8.1. Calculated factor modification
The calculated Factor can be experimentally modified by
the user in the Current Results screen, once the present
session is finished.
- In order to edit the factor: double click its cell, insert a
new value and accept by pressing Enter. This action
recalculates all the affected Concentration results. It
also changes the test programming and becomes
programmed with factor
- In order to recover the factor experimental value: click any
cell crossed at the average or replicate level. This action
recalculates all the affected Concentration results.
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User manual
2.2.9. Current and past alarms
out reports with said results. The results can be organised
by patients or by tests. It is also possible to make reports
of patients per session or with all sessions. Reports by
tests can be made only by previous selection of a specific
session. The Delete button deletes all the data of the
selected work session.
The Monitor also displays information about the alarms or
alerts that may appear throughout the work session in the
shape of identifying icons, together with a brief informative
text. By clicking on the corresponding button, the user can
access the Current alarms screen, which offers more
detailed information about the problems and their possible
solution. The alarms and alerts occur when the certain
detectors or sensors are triggered in the analyser or when
the analyser detects anomalous functioning. When
necessary, the analyser acts to avoid continuing working
in unsafe conditions and notifies the computer. The alarms
screen displays a list with all the alarms and alerts
generated by the analyser in the current session. It is also
possible to access the Past alarms and alerts, which
contains a list with the alarms and alerts generated during
previous work sessions. For each alarm or alert, the following
can be displayed:
The screen contains:
- List of completed session dates
- List of elements: patients or tests
- Interface of patient or test data selected on the list
- Interface of patient or test results selected on the list
List of elements
This list contains all the elements of the selected sessions.
In the past results by patient, the list shows the patient
code and the patient names introduced, corresponding to
- Type of alarm or alert
- Date of alarm
- Brief definition of the alarm (name)
- Detailed description
- Proposed solution
- Observations (lets the user introduce information: applied
solution, date of solution, implicated personnel…)
the selected session or to all the sessions. In the past
results by test, the list contains the name of the tests
performed in the specific selected session. This list enables
the selection of elements for query, deletion or printing out
the associated data by means of the corresponding buttons.
The list can be ordered alphabetically by clicking on the
title. In the past results by patient, the Allocate button
enables the allocation to the selected patient previously
introduced patient data. The Delete button enables the
deletion of the elements selected on the list. The Print button
enables the printing or exportation to file of a report with
the data and results of the selected elements. The
programme always displays a preview of the report.
The lists are updated automatically in real time as information
is received from the analyser. The alarms pending correction
can be edited for text introduction indicating the
implemented solution, the date of the solution and the
personnel implicated. If so desired, the corrected alarms
can be eliminated. The lists can be ordered according to
the field type, date or name. Problem solution reports can
be printed with the selected alarms. The Alarms and alerts
section of this manual lists the main alarms and alerts the
analyser can display and which require user intervention.
Data Interface
In the past results by patient, the data interface contains
the following patient information: name of the selected
patient, sex, date of birth, person who has requested the
analysis and a field for comments. A button enables access
to the Patient Data screen, where the data can be
introduced or modified. In the past records by test, the
data interface contains the absorbance of the blank and
2.2.10. Past results
The Past results screen displays the results obtained in all
the work sessions prior to the current session and prints
26
the calibrator or calibrators used in the selected session,
the date the blanks and calibrators were performed and the
reference range of the test.
2.2.11. Patient data
This screen enables the introduction and modification of
the data of patients who are analysed frequently. This data
is not necessary for the performance of analyses and can
be introduced once the analyser is running. This screen
can be accessed directly from the Introduction of New
Samples or Past Results screen by patients using the
Patient Data button or from the Past results menu. It also
enables the allocation of previously introduced data to a
patient. This screen contains a list of patients and a patient
data interface.
Results Interface
This interface shows the results of the element selected
on the list, whether it is a patient or a test. Each grid record of results by patient contains: name of the test and
sample type on which it has been carried out, value of the
result, units, reference range programmed in the test
(optional), date and time of the result and observation about
the result obtained. Each grid record of results by test
contains: patient code, result value, units, date and time of
the result and observations. By clicking on the
corresponding column, the results can be ordered by
session date, by test or by patient name.
List of patients
This list contains the code and the name and surnames of
all the patients with allocated data. To query patient data,
the user must select it on the list. The list can be ordered
alphabetically by title. To edit the data of a patient, double
click on the patient on the list. The New button enables the
introduction of new patient data. The Delete button deletes
the data of the selected patient. The Print button prints out
the data of the selected patient.
General buttons
The past results screen contains two general buttons:
Delete: This deletes completed past sessions.
OK: This saves the changes made to patient data and to
the results and exits the screen.
Cancel: This exits the screen without saving the changes
made.
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User manual
Patient data interface
The data interface shows the code of the selected patient,
his or her name and surnames, sex, date of birth, the person
who has requested the analysis and a field for introducing
comments. The user can consult current data, modify them
or introduce new data.
General buttons
The patient data screen contains two general buttons:
Save: Saves all the changes made to the data.
Cancel: Recovers all previous data without saving any
change.
2.2.12. Configuration
shutdown process. For each one, you may select whether
it is performed with system liquid only or with washing
solution. In the case of the latter, besides using washing
solution, the analyser then performs a rinse with system
liquid. The wash consumption can also be chosen
(economical, normal or exhaustive). It is highly
recommendable to always use washing solution to keep
the fluid system in optimum condition, avoiding the
accumulation of both residues and air bubbles. In this case,
the user must place the washing solution container, supplied
with the analyser, marked in green, in the system liquid
container position when so requested by the analyser.
These screens enable the user to configure the running
mode of the analyser and the user programme. The different
parameters can be configures from four dedicated screens:
- A25 analyser
- Languages
- Configuration of the serial port
- Header of results reports
2.2.12.1. A25 analyser
When the analyser cannot avoid contamination between
incompatible tests by reordering the tests of each patient,
it automatically performs and intermediary special washing
cycle. The user can choose to perform these special washes
with system liquid or with washing solution. If the second
option is chosen, a 50 ml bottle of washing solution must
be placed in the analyser.
Clicking on the A25 button on the horizontal button bar
directly accesses the analyser configuration screen. The
different options are separated in three tabs: Washes,
Session and Analyser
Washes
- Initial, final and special washes between incompatible
tests
Carrying out of repetitions
- Carrying out of automatic repetitions
This option allows to activate or to deactivate all the
automatic repetitions.
- Calibrators and blanks in paediatric racks
Separate Calibrators and Controls in Paediatric Racks
- Automatic printing of patient reports
In the A25 Configuration–Session screen, you can select
the option: “Calibrators and Controls with paediatric racks”.
Session
- Used sample tube
This option is intended for the Automatic positioning of
samples. When pressing the button Place Samples
Automatically of the “Positioning of Samples and Reagents”
screen, the samples of Calibrator and Control type are
placed in paediatric racks and the patient samples in the
type of rack selected in the A25- Configuration-Session
screen.
Analyser
- Container level control scales
- Rack detection
- Cover detection
- Configuration of the filter drum
Automatic printing of patient information
Initial, final and special washes between
incompatible tests
This option allows activating and deactivating the automatic
printing by patient during a current session without waiting
for the list to finish.
In this tab, it is possible to configure the initial washing of
the fluid system, which is performed by the analyser during
warm-up and the final washing that is performed during the
28
alarms appears: lack of reagent, lack of sample, waste
bottles full, system liquid bottles empty, etc., together with
the corresponding icon. Said acoustic signal sounds until
the user stops it by pressing the end alarm button or any of
the star, sampling&stop, continue, new rotor buttons.
Configuration of the filter wheel
This screen enables the modification of the analyser filter
wheel. To access this screen, the work session must be
restarted. The wheel has 10 positions. Position 0 must
always contain a covered filter so that the analyser can
perform the darkness adjustment. Positions 1 to 9 can be
used for optical filters. All the positions of the wheel must
be occupied for it to work correctly. The positions that do
not contain an optical filter must be occupied by a covered
filter. The analyser includes as standard 8 optical filters in
positions 1 to 8 and two covered filters in positions 0 to 9.
If one of the filters is to be changed, select the desired
position of the wheel and press the Change Filter button.
The analyser automatically positions the wheel filter
appropriately so that the user can change the filter through
the window of the optical system. Next, if it is different,
introduce the wavelength of the new filter that has been
installed. If the filter is covered, the value 0 must be
introduced. The programme requests confirmation to know
if the filter in the analyser has been physically changed. If
it has, the programme resets certain reference values used
to issue alerts and alarms from the optical system.
Used sample tube
This enables the selection from a dropdown list of the type
of sample tube to be used in the work session. To access
this list, the work session must be restarted. The possible
types are: 15 mm diameter tube with a maximum height of
100 mm, 13 mm diameter tube with a maximum height of
100 mm and a 13 mm diameter well. If he or she wishes to
use racks of samples of different types in the same session,
the user must deactivate rack detection. It must also be
taken into account that the analyser will not check that the
physical disposition of the racks on the tray is the same
as the programmed disposition.
Container level control scales
An alert is issued to the user if any of the tests has
programmed filters that do not physically exist in the wheel.
It enables the deactivation of the functioning of the scales
the analyser uses to control the level of the waste and
system liquid containers. In this way, the user can continue
working with the analyser in case of breakdown of any of
the scales, until the technical assistance service arrives to
repair it. In this case, the user must ensure that the system
liquid does not run out and that the waste container does
not fill while the analyser is running.
2.2.12.2. Languages
The user can change the language of the user programme on
a dropdown list that offers all the languages available. When
the language has been selected and OK clicked, the
programme updates all the texts to the selected language.
Rack detection
2.2.12.3. Serial port
This enables the deactivation of the rack tray that identifies
the rack in each position. In this way, the user can continue
working with the analyser in case of breakdown of any of
the detectors, until the technical assistance service arrives
to repair it. If he or she wishes to use racks of samples of
different types in the same session, the user must
deactivate rack detection. It must also be taken into account
that the analyser will not check that the physical disposition
of the racks on the tray is the same as the programmed
disposition.
This screen enables the configuration of the computer serial port used by the programme. The user can choose for
the configuration to be performed automatically or manually.
If manual, he or she can choose the computer serial port
and the transmission speed of the communications.
2.2.12.4. Header of results reports
From this screen, the user can customise the header of
the results reports. It is possible to introduce the name of
the laboratory, the address, telephone number and a bitmap
(.bmp) image. The format of the texts introduced can be
varied.
Configuring the acoustic alarm.
This option configures the enabling or disabling of the
acoustic alarm. If this option is enabled, an acoustic alarm
sounds when the analyser is running and one of the following
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User manual
All the utilities require the analyser to change to specific
mode, called Test mode, and for this reason it is not possible
to access this screen when a work session is not being
prepared or performed. When running test utilities, the rest
of the programme’s functionality is blocked until the test
ends and the utilities screen is closed.
2.2.13. About
This screen displays information about the User Programme
version being executed. The Firmware version also appears
(program executed directly by the analyser) and the serial
number of the analyser. In order to see the Firmware and
serial number, the program must be connected to the
analyser.
2.2.14.1. PC-Analyser communications channel test
On pressing the test button, the computer attempts to
establish communication with the analyser. The programme
tells the user if communication with the analyser has been
possible or not.
2.2.14.2. Reactions rotor check
The user can use this test to check the optical status of a
reactions rotor. he or she can choose the optical filter with
which the test is to be performed. The rotor must be placed
in the analyser, the rotor cover replaced and the analyser
cover closed, then press the Test button. The analyser fills
the 120 wells of the rotor with system liquid and then
performs a base line in each well with the selected filter.
The analyser presents a graph of the absorbances relative
to the average of the light intensity of the wells together
with the standard deviation of said standards. In accord
with these results, the user can decide whether or not the
rotor can be reused or if it should be replaced by a new
one. It is important to point out that the test checks the
optical quality of the wells but not the status of chemical
cleansing. Depending on the analysis made with the rotor,
the chemical residues that may be left in the wells can
have a noticeable effect on the following analyses performed
with the rotor. In case of doubt, or when very sensitive tests
are to be performed, it is always recommendable to use a
new rotor. After the test, the user must remove the rotor of
the analyser, empty it and dry it completely before using it
for analyses.
2.2.14. Utilities
Clicking on the utilities button on the horizontal button bar
directly accesses the main utilities screen. This screen
lets the user access the different test, preparation and
maintenance utilities of the analyser, by clicking the
corresponding button. For some of the utilities, the
programme displays a corresponding screen. The available
utilities are:
- PC-Analyser communications channel test
- Reactions rotor check
- Disassembly of the dispensing needle
- Fluid system supply
- Cleaning of the dispensing system
- Changing the lamp
30
2.2.14.3. Disassembly of the dispensing needle
analyser, marked in green, in the system liquid position.
Once the wash has been performed, the analyser asks
him or her to replace the system liquid container and
performs a rinse with the system liquid.
On clicking on the Disassemble Needle button, the
operating arm positions itself over the rack tray. The
programme alerts the user to remove any object positioned
under the arm. On clicking OK, the needle descends and
the user can remove it to work with it or change it. To remove
the needle, unscrew it by holding the top fitting. If, while
handling the needle, the carriage rises due to the pressure
made by the user, press the Lower Needle button for the
needle to descend once again. Once the needle has been
reassembled on the analyser, press the OK button for the
needle to rise. It performs the self-centring test and the
arm finally returns to its parked position. These operations
must be done with utmost care since they are carried out
with the analyser cover open and the needle may be
contaminated. Laboratory gloves must always be used.
2.2.14.6. Changing the lamp
When the user fits a new lamp, this utility must be used to
notify the analyser that the lamp has been changed and
optimise the luminosity of the photometric system. The
programme requests confirmation to know whether or not
the lamp of the analyser has been physically changed. If it
has, the programme resets certain reference values used
to issue alerts and alarms from the optical system.
To access this utility, the work session must be restarted.
The lamp must be changed with the analyser in sleeping
mode. If the analyser is on standby mode, the programme
shuts it down automatically. The lamp must never be
touched with fingers. Once the new lamp has been installed
and the covers of the optics and the rotor have been closed,
the instructions given by the programme must be followed.
The programme starts up the analyser, checks the light
intensity of the optical system, shuts down the analyser
and then requests the user to remove the lamp holder again
and replace it again turning it 180º on the axis of the lamp.
The programme forces waiting periods to prevent the lamp
holder from getting too hot. If the temperature of the lamp
holder is still high, handle it with pincers. The programme
starts up the analyser again, measures the light intensity
of the optical system again, compares the light intensity in
both possible positions and chooses the greatest luminosity.
If it is the current position, it tells the user that the test is
complete. If the best position were the previous one, the
programme shuts down the analyser and asks the user to
remove the lamp holder and replace it, turning it 180º on
the axis of the lamp, returning the lamp to its initial position.
2.2.14.4. Fluid system supply
On clicking the Supply button, with the main cover closed,
the analyser fills the fluid system conduits with system
liquid. It is possible to supply the dispensing system, the
washing system or both at the same time. To supply the
dispensing system, the operating arm moves to the washing
station. It is possible to choose the number of supply cycles
to be performed. When the system liquid container is filled
during a work session, the fluid system can be supplied by
clicking directly on the New System Liquid Container button
on the vertical button bar.
2.2.14.5. Cleaning of the dispensing system
By clicking on the Wash button, with the main cover closed,
the analyser washes the dispensing system internally and
externally. To perform this operation, the operating arm is
moved to the washing station. The user can choose to
perform the wash with system liquid or with washing solution.
In the case of the latter, the analyser asks the user to
position the washing solution container, supplied with the
31
User manual
2.2.15. Internal quality control
(Cmin) and Maximum (Cmax) Concentration, respectively.
These values are programmed by the user on the test
programming screen, for the specific controls, or on the
multiple controls programming, for multiple controls. The
average value and the standard deviation are calculated,
respectively, as Xm = (Cmin+Cmax) / 2 and s = (Cmax-Cmin) /
(2k).
Internal quality control enables the verification of the correct
functioning of each measurement procedure and the
validation or rejection of the analytical series. An analytical
series is an interval of time or results in which it is
reasonable to suppose that the metrological characteristics
of the measurement procedure are maintained stable. Each
laboratory must establish its own internal quality control
programme and the correction procedures to be followed if
the controls do not meet acceptable tolerances. The basic
idea of internal quality control is very simple: one or more
control materials, the controls, are placed between the
patient samples and they are measured together. The result
from the control material is compared with an expected
value. In this way, it is possible to detect the occasional
existence of anomalies in the measurement procedure. The
use of controls is programmed independently for each
measurement procedure from the Test Programming
screen. The analyser automatically proposes the carrying
out of controls whenever the work session is reset, in accord
with the tests programmed, and the user simply has to
activate them. The user can also launch additional controls
manually. The use of BioSystems valuated control materials
and calibrators is recommended.
The Quality Control screen of the user programme enables
access to the quality control results of the analyser. The
programme memorises all the control results for each test
and for each sample type. The user can select a test and a
sample type and the screen indicates, for each control,
the name, batch, average value (Xm), standard deviation
(s), variation quotient CV = 100 s / Xm, and the rejection
limits programmed. Whenever a new batch is introduced
for one of the controls, the programme automatically creates
a new data sheet and the statistical calculations are reset
for this new sheet. All the sheets created can be accessed
through a dropdown list. A grid displays, for each series
performed, the date, concentration, absolute error and
relative error, for each control, and an alert for the rejected
series. Absolute error is defined as Eabs = C - Xm, where C
is the measured control concentration, and the relative error
as Erel = Eabs / s. The programme displays the alert for
rejecting a series when the result of one of the controls is
out of the programmed rejection limits.
From the test programming screen, the user can programme
the number of controls (0, 1 or 2), the rejection criteria
(between 0.1 and 3 standard deviations), the number of
replicates (1, 2 or 3), the control type (multiple or specific)
and the calculation mode (manual or statistical). The
calculation mode indicates the method used for deciding if
a series of results is accepted or rejected.
With the memorised data, the programme displays the
corresponding Levey-Jennings graphs. When any of the
controls of a series exceeds the interval limits Xm ± 2s, the
programme automatically executes the Westgard algorithm
and shows the results on the Levey-Jennings graph. This
algorithm is a set of control rules that are examined
sequentially. The result of this algorithm is not used by the
programme to accept or reject a series. It is presented as
graphic information only and the user is who must decide
to accept or reject the series. The programme only displays
the rejection alert based on the rejection interval chosen
by the user. The Westgard rules examined are:
· In statistical mode, the user must introduce the number
of series. This parameter is the number of data used to
perform the statistical analysis, i.e. to calculate the
measurement (Xm) and the standard deviation (s). It is
recommended that it is not above 20. A series of results
is accepted if the values of the controls are within the
interval Xm ± ks, where k is the rejection criteria.
· 13s: The result obtained on one of the controls exceeds
the limits of the interval Xm ± 3s.
· In manual mode, the series of results is accepted if the
results of the controls are between the values of Minimum
32
· 22s: The results obtained on two controls exceed, in the
same way, the limits of the interval Xm ± 2s. This can be
the two controls of one series or one single control on
two consecutive series.
with the alarms and alerts generated during previous work
sessions.
The following is a description of the main alarms and alerts
issued by the analyser, requiring user intervention, together
with their possible cause and solution. The alarms that
require contact with the technical Assistance Service are
indicated. If any of the alarms persists, it is also necessary
to contact the TAS (Technical Assistance Service).
· R4s: The difference between the results of two controls of
one series or of one control on two consecutive series is
higher than 4s.
· 41s: Four consecutive results have been obtained,
exceeding, in the same way, the limits of the interval
Xm ± 1s. This may occur with two controls on two
consecutive series or with one single control on four
consecutive series.
Machine alarms and alerts
General
· 10Xm: Ten consecutive results have been obtained, all
greater or all less than the average. This may occur with
two controls on five consecutive series or with one single
control on ten consecutive series.
- Incorrect rack type. Check the configuration of the rack
tray. If the error persists once the racks have been
correctly positioned, deactivate the sensor of the rack
tray from the corresponding configuration screen and
contact the TAS.
Buttons
- Analyser cover open. Close the analyser cover. If the
error persists, deactivate the cover sensors from the
corresponding configuration screen and contact the
TAS. Danger: the main cover of the analyser must
always be closed when it is running.
The Quality Control screen has different buttons that let
the user perform different actions:
Graphs: This enables the display of the Levey-Jennings
graphs of the test selected for each control. The squares
represent the values obtained in the accepted series. When
a Westgard algorithm rule is activated, the values involved
are represented in circles. In the rejected series, the values
are represented by a triangle. The axis of ordinates indicates
the concentration, at standard deviation s. The horizontal
line indicates the number of the series. The horizontal lines
indicate the multiples of the standard deviation and the
continual lines the programmed rejection limits.
- Electronics start-up fail. Shut down the analyser and
start it up again. If the problem persists, contact the
TAS.
- Error in the Firmware version. Contact the TAS.
Operating arm
- The operating arm cannot be started. Check that the
arm is not blocked and that there is no object obstructing
its movement.
Delete: Deletes the series selected on the grid.
- Loss of steps during the functioning of the Z axis. The
arm has collided vertically or is broken. Check that there
is no object obstructing the movement of the arm.
Delete Sheet: Deletes the selected results sheet.
Print: Prints a Quality Control report with the data of the
selected test and sample type. It is also possible to
print out the Levey-Jennings graph.
- Self-elevation safety device broken. Contact the TAS.
Dispensing system
Edit: Modifies the rejection criteria and the calculation mode.
The changes affect the selected sheet only.
• Needle
Introduce Series: Enables manual introduction of series
up to a maximum of 30 series per sheet.
- No needle detected. Check that the needle is correctly
installed.
New sheet: Enables the creation of a new sheet when the
30 series of the current sheet are exceeded. If a new
sheet is not created, the following series overwrite the
oldest series. A new sheet is automatically created when
a test parameter is changed.
- Needle is too bent. The needle has been detected to
be outside its safety margins. Check the straightness
of the needle. If necessary, replace it with a new needle.
- Needle level detection error. Contact the TAS.
• Needle thermostatisation system
- Needle thermostatisation error. Contact the TAS. The
alarm gives supplementary information to be used by
the TAS to diagnose the breakdown.
2.2. Alarms and alerts
By clicking on the corresponding button on the horizontal
bar menu, the user can access the Current alarms screen,
which displays the alarms and alerts generated during the
current session. Through the main menu, it is also possible
to access the Past alarms and alerts, which contains a list
• Dispensing pump
- The dispensing pump cannot be started. Contact the
TAS.
33
User manual
• Containers
Results
- There is no system liquid container. Place the container correctly.
- Absorbance > 2.5 A. reading with absorbance above
2.5 A. Repeat the analysis with the sample pre-dilution.
- There is no waste container. Place the container
correctly.
- Absorbance OUT. It has not been possible to measure
the absorbance. Repeat the analysis.
- Waste container full. Empty the waste container.
- Blank absorbance limit exceeded. Reagent in bad
condition. Replace it with a new one.
- System liquid container empty. Fill the system liquid
container.
- Kinetic blank absorbance limit exceeded. Reagent in
bad condition. Replace it with a new one.
- Error in the container level control system. Deactivate
the level control scales from the corresponding
configuration screen and contact the TAS.
- Test linearity limit exceeded. Repeat the analysis with
sample pre-dilution.
- Test detection limit exceeded. As a check, the analysis
can be repeated. If the alert persists, we may consider
the concentration sample null and void.
Reactions rotor and readings
- The rotor cannot be started. Check that the reactions
rotor is not blocked.
- Test reference values exceeded. The patient has
pathological results. As a check, the analysis can be
repeated.
- No rotor. Place a rotor in the analyser.
- End of rotor. 120 wells of the current rotor have been
used. Place a new empty rotor in the analyser.
- Lack of linearity in kinetic reaction. Check the status
of the reagent. Repeat the analysis. If the alert persists,
the sample concentration probably exceeds the linearity
limit of the kinetic test.
- No rotor cover. Position the cover correctly. If the error
persists, deactivate the cover sensors from the
corresponding configuration screen and contact the
TAS. Danger: the main cover of the analyser must
always be closed when it is running.
- Calibrator sensitivity error (factor limits exceeded).
Check the status of the calibrator and the reagent.
Repeat the analysis.
• Rotor thermostatisation system
- Calibration curve error. Check the status of the
multipoint calibrator and the reagent. Repeat calibration.
- Rotor thermostatisation error. Contact the TAS. The
alarm gives supplementary information to be used by
the TAS to diagnose the breakdown.
- Internal quality control alert. Access the Quality Control screen.
Optical system
- Base line error: reduced light intensity. Place a new
rotor. If the alert persists, replace the lamp.
- Lamp’s life. Information referring to the insufficient
luminosity of the lamp. This message will appear during
the Warming up or during the change of rotor. Replace
the lamp.
- Reduced light intensity in x filter. Replace x filter
recommended / necessary. Replace corresponding filter.
- Filter drum cannot be started. Contact the TAS.
- Error in photometric system. Contact the TAS.
- Lamp lifetime exceeded. Replace the lamp.
Work session alarms and alerts
Preparations
- Sample volume run out. Add more sample and indicate
it to the analyser from the Positions screen for it to
perform the analyses. Check the sample tube is
correctly in position.
- Reagent volume run out. Add more reagent and indicate
it to the analyser from the Positions screen for it to
perform the analyses. Check the reagent bottle is
correctly in position.
34
3. Calculation and measurement procedures
This chapter describes the different analysis modes of the
analyser and the calculations made to obtain the analytical
results, i.e. the concentration values of the different analytes
of the samples. In each case, the different formulas used
are indicated. The analysis modes are the same for blanks,
calibrators, controls and samples of patients. The controls
are treated in the same way as the patient samples in all
the calculations.
Symbols used in the formulas
Asample
Sample absorbance (patient or control)
Acalibrator
Calibrator absorbance
Ablank
Blank absorbance
[...]
λmain
Absorbance value at main wavelength
[...]λreference
Absorbance value at reference wavelength
TR
Factor that depends on the type of reaction programmed. Its value is +1 for increasing reactions
and -1 for decreasing reactions.
F
Calibration factor
Csample
Sample concentration (patient or control)
Ccalibrator
Programmed calibrator concentration
Func[...]
Calibration curve or function (with multipoint calibrators)
nsample
Number of sample replicates (patient or control)
ncalibrator
Number of calibrator replicates
nblank
Number of blank replicates
i
Replicate index
[...]R1
Absorbance value with the first reagent in a bireagent differential method.
[...]
Absorbance value after adding the second reagent in a bireagent differential method.
R1+R2
[...]T1
Absorbance value in the first reading in a fixed time method.
[...]
∆A
∆t
Absorbance value in the second reading in a fixed time method.
T2
Variation of absorbance of a sample per unit of time (patient or control)
sample
∆A
∆t
Variation of absorbance of a calibrator per unit of time
calibrator
∆A
∆t
Variation of absorbance of a blank per unit of time
blank
35
User manual
3.1. End point
Csample=
3.1.1. Absorbance
The absorbance of the reaction is measured once only on
a base line of distilled water. In this procedure, one or two
reagents may be used and the absorbance may be
measured at one or two wavelengths. The calibration can
be based on the use of multiple or specific calibrators (one
or several), or on a programmed factor. For each test, a
blank is prepared using distilled water instead of the sample
or with reagent only. The absorbance of the blank is also
measured on the base line of distilled water.
Asample-Ablank
Ccalibrator
Acalibrator-Ablank
Considering that TR2=1, this formula is equivalent to the
previous one with a factor
F=TR·
Ccalibrator
Acalibrator-Ablank
3.1.2.3. Several calibrators
If a multipoint calibrator is used, the concentration is
calculated using a calibration function or curve. This curve
is obtained from the programmed concentration values of
the calibrators and the absorbance values measured for
each one with regard to the base line Acalibrator, using an
interpolation method (polygonal or spline) or a regression
method (linear or quadratic) and linear or logarithmic axes,
in accord with how it is programmed fro each test. With
this curve, the analyser calculates the concentration of the
sample in accord with its absorbance with regard to the
base line
3.1.1.1. Monoreagent / Bireagent
The procedure is different for the tests using one or two
reagents. For the monoreagents, the analyser dispenses
the reagent and the sample in cycle 1 and measures the
absorbance of the reaction during a later cycle, in accord
with how it is programmed in the test. For bireagents, the
analyser dispenses reagent 1 and the sample in cycle 1.
In a later cycle, it dispenses reagent 2 in the same well
and then measures the absorbance of the reaction in another
later cycle, in accord with how it is programmed in the
test.
Csample=Func[Asample]
3.1.1.2. Monochromatic / Bichromatic
3.1.3. Replicates
The absorbance can be measures at one or two
wavelengths. In the case of bichromatic readings, the
difference between the absorbance at the main wavelength
and the absorbance at the reference wavelength is taken
as the absorbance value.
Up to 50 replicates can be programmed for each sample
and up to 3 for each blank, calibrator or control.
3.1.3.1. Blank
The average of the absorbance values measured is taken
as the absorbance of the blank.
Amuestra=[Asample]λmain-[Asample]λrefefence
Acalibrator=[Acalibrator]λmain-[Acalibrator]λreference
Ablank=
Ablank=[Ablank]λmain-[Ablank]λreference
1
nblank
nblank
ΣA
i
blank
i=1
3.1.2. Concentration
3.1.3.2. Calibrator
Based on the absorbance value obtained, the analytical
concentration in the sample can be calculated.
The average of the absorbance values measured is taken
as the absorbance of the calibrator.
3.1.2.1. Factor
Acalibrator=
The concentration is calculated using a programmed factor with the formula
1
ncalibrador
ncalibrator
ΣA
i
calibrator
i=1
3.1.3.3. Sample
Csample=TR·F·(Asample-Ablank)
The average values calculated for the absorbance of the
blank and the calibrator or calibrators are used in the
calculations set forth in the previous section to obtain the
concentration of each replicate of the sample. The average
value of the calculated concentrations is taken as the
concentration of the sample.
3.1.2.2. Single calibrator
If a single point calibrator is used, the concentration is
calculated with the formula
36
Csample=
3.2.2.3. Several calibrators
n sample
Σ
1
nsample
Cisample
If a multipoint calibrator is used, the concentration is
calculated using a calibration function or curve. This curve
is obtained from the programmed concentration values of
the calibrators and the absorbance values measured for
each one with regard to the base line Acalibrator, using an
interpolation method (polygonal or spline) or a regression
method (linear or quadratic) and linear or logarithmic axes,
in accord with how it is programmed fro each test. With
this curve, the analyser calculates the concentration of the
sample in accord with its absorbance with regard to the
base line
i=1
3.2. Bireagent differential
3.2.1. Absorbance
The analyser dispenses reagent 1 and the sample in cycle
1. In a later cycle, it measures the absorbance of the
mixture on a base line of distilled water. later, it dispenses
reagent 2 in the same well and then measures the
absorbance of the reaction in a later cycle, in accord with
how it is programmed in the test. The absorbances are
measured at one single wavelength. For each test, a blank
is prepared using distilled water instead of the sample or
with reagents only. The absorbances of said blank, with
the first reagent and with both reagents, are also measured
on the base line of distilled water. The calibration can be
based on the use of multiple or specific calibrators (one or
several), or on a programmed factor. The difference between
the absorbance measured with the two reagents and the
absorbance measured with the first reagent only is taken
as the absorbance value.
Csample=Func[Asample]
3.2.3. Replicates
Up to 50 replicates can be programmed for each sample
and up to 3 for each blank, calibrator or control.
3.2.3.1. Blank
The average of the absorbance values measured is taken
as the absorbance of the blank.
Asample=[Asample]R1+R2-[Asample]R1
Acalibrator=[Acalibrator]
R1+R2
Ablank=[Ablank]
R1+R2
-[Acalibrator]
Ablank=
R1
1
nblank
3.2.3.2. Calibrator
-[Ablank]
R1
n blank
ΣA
i
blank
i=1
The average of the absorbance values measured is taken
as the absorbance of the calibrator.
3.2.2. Concentration
Based on the absorbance value obtained, the analytical
concentration in the sample can be calculated.
Acalibrator=
1
ncalibrator
ncalibrator
ΣA
i
calibrator
i=1
3.2.2.1. Factor
3.2.3.3. Sample
The concentration is calculated using a programmed factor with the formula
The average values calculated for the absorbance of the
blank and the calibrator or calibrators are used in the
calculations set forth in the previous section to obtain the
concentration of each replicate of the sample. The average
value of the calculated concentrations is taken as the
concentration of the sample.
Csample=TR·F·(Asample-Ablank)
3.2.2.2. Single calibrator
If a single point calibrator is used, the concentration is
calculated with the formula
Csample=
Asample-Ablank
Acalibrator-Ablank
Csample=
Ccalibrator
nsample
nsample
ΣC
i
sample
i=1
3.3. Fixed time
Considering that TR2=1, this formula is equivalent to the
previous one with a factor
F=TR·
1
3.3.1. Absorbance
The absorbance of the reaction is read at two particular
times with regard to a base line of distilled water at one
single wavelength. The calibration can be based on the
Ccalibrator
Acalibrator-Ablank
37
User manual
is obtained from the programmed concentration values of
the calibrators and the absorbance values measured for
each one with regard to the base line Acalibrator, using an
interpolation method (polygonal or spline) or a regression
method (linear or quadratic) and linear or logarithmic axes,
in accord with how it is programmed fro each test. With
this curve, the analyser calculates the concentration of the
sample in accord with its absorbance with regard to the
base line
use of multiple or specific calibrators (one or several), or on
a programmed factor. For each test, a blank is prepared
using distilled water instead of the sample or with reagent
only. The absorbances of this blank at the two specific
times are also measured on the base line of distilled water.
3.3.1.1. Monoreagent / Bireagent
The procedure is different for the tests using one or two
reagents. For the monoreagents, the analyser dispenses
the reagent and the sample in cycle 1 and measures the
absorbance of the reaction in two later cycles, at the
moments in time T1 and T2, in accord with how it is
programmed in the test. For bireagents, the analyser dispenses reagent 1 and the sample in cycle 1. In a later
cycle, it dispenses reagent 2 in the same well and then
measures the absorbances of the reaction at the moments
in time T1 and T2, in accord with how it is programmed in
the test. The difference between the absorbance measured
at time T1 and the absorbance measured at time T2 is
taken as the absorbance value.
Asample=[Asample] -[Asample]
T2
3.3.3. Replicates
Csample=Func[Asample]
Up to 50 replicates can be programmed for each sample
and up to 3 for each blank, calibrator or control.
3.3.3.1. Blank
The average of the absorbance values measured is taken
as the absorbance of the blank.
Ablank=
T1
Acalibrator=[Acalibrator]T2-[Acalibrator]T1
1
nblank
n blank
ΣA
i
blank
i=1
3.3.3.2. Calibrator
Ablank=[Ablank]T2-[Ablank]T1
The average of the absorbance values measured is taken
as the absorbance of the calibrator.
3.3.2. Concentration
Based on the absorbance value obtained, the analytical
concentration in the sample can be calculated.
Acalibrator=
1
ncalibrator
ncalibrator
ΣA
i
calibrator
i=1
3.3.2.1. Factor
3.3.3.3. Sample
The concentration is calculated using a programmed factor with the formula
The average values calculated for the absorbance of the
blank and the calibrator or calibrators are used in the
calculations set forth in the previous section to obtain the
concentration of each replicate of the sample. The average
value of the calculated concentrations is taken as the
concentration of the sample.
Csample=TR·F·(Asample-Ablank)
3.3.2.2. Single calibrator
If a single point calibrator is used, the concentration is
calculated with the formula
Csample=
Asample-Ablank
Acalibrator-Ablank
Csample=
Ccalibrator
nsample
nsample
ΣC
i
sample
i=1
3.4. Kinetics
Considering that TR2=1, this formula is equivalent to the
previous one with a factor
F=TR·
1
3.4.1. Variation of the absorbance per unit of time
Ccalibrator
The kinetic mode is used to measure the catalytic activity
of an enzyme. The absorbance of the reaction on a base
line of distilled water is measured periodically during several
cycles, between the times Ti and Tf programmed in the
test. The readings are taken at one single wavelength.
Based on these absorbance measurements, the analyser
calculates the variation of the absorbance of the reaction
per unit of time. The calibration can be based on the use of
Acalibrator-Ablank
3.3.2.3. Several calibrators
If a multipoint calibrator is used, the concentration is
calculated using a calibration function or curve. This curve
38
Considering that , this formula is equivalent to the previous
one with a factor
Ccalibrator
Csample=TR
multiple or specific calibrators (one or several), or on a
programmed factor. For each test, a blank is prepared using
distilled water instead of the sample or with reagent only.
The absorbances of this blank are also measured on the
base line of distilled water.
∆A
∆t
3.4.1.1. Monoreagent / Bireagent
calibrator
blank
3.4.2.3. Several calibrators
The procedure is different for the tests using one or two
reagents. For the monoreagents, the analyser dispenses
the reagent and the sample in cycle 1 and measures the
absorbance of the reaction in several later cycles, between
the times Ti (start) and Tf (end), in accord with how it is
programmed in the test. For bireagents, the analyser dispenses reagent 1 and the sample in cycle 1. In a later
cycle, it dispenses reagent 2 in the same well and then
measures the absorbances of the reaction at the moments
in several later cycles, between the times Ti and Tf, in
accord with how it is programmed in the test.
If a multipoint calibrator is used, the concentration is
calculated using a calibration function or curve. This curve
is obtained from the programmed concentration values of
the calibrators and the absorbance gradient values measured
for each one with regard to the base line ,
∆A
∆t
using an interpolation method (polygonal or
spline) or a regression method (linear or
calibrator
quadratic) and linear or logarithmic axes, in
accord with how it is programmed fro each test. With this
curve, the analyser calculates the concentration of the
sample in accord with the absorbance gradient with regard
to the base line
∆A
Csample=Func
∆t
3.4.1.2. Checking linearity
Catalytic activity is measured by the speed of the reaction,
which is proportional to the gradient of the absorbancetime curve. This ∆A/∆t gradient is calculated using the linear method over the set of absorbances measured between
the times Ti and Tf. The most common units for measuring
the gradient are ∆A/min. Depending on the test, the period
of measurements can be different. In general, for the more
common tests, around 13 readings are taken at regular 15second intervals. The analyser automatically calculates the
best line of regression by the squared minimums method
and checks the linearity of the measurements base don
the correlation quotient. If the linearity is low, the analyser
issues the corresponding alert together with the result of
the test.
[
]
sample
3.4.3. Replicates
Up to 50 replicates can be programmed for each sample
and up to 3 for each blank, calibrator or control.
3.4.3.1. Blank
The average of the absorbance gradient values measured
is taken as the absorbance gradient of the blank.
∆A
∆t
3.4.2. Concentration
=
blank
Based on the absorbance gradient obtained, the analytical
concentration in the sample can be calculated.
1
nblank
n blank
Σ
i=1
∆A
∆t
blank
The average of the absorbance gradient values measured
is taken as the absorbance gradient of the calibrator.
The concentration is calculated using a programmed factor with the formula
(
∆A
∆t
∆A
∆t
sample
∆A
∆t
)
=
calibrator
blank
1
ncalibrator
ncalibrator
Σ
i=1
∆A
∆t
3.4.2.2. Single calibrator
∆A
∆t
∆A
∆t
blank
Ccalibrator
∆A
∆t
calibrator
calibrator
The average values calculated for the absorbance gradient
of the blank and the calibrator or calibrators are used in the
calculations set forth in the previous section to obtain the
concentration of each replicate of the sample. The average
value of the calculated concentrations is taken as the
concentration of the sample.
∆A
∆t
sample
i
3.4.3.3. Sample
If a single point calibrator is used, the concentration is
calculated with the formula
Csample=
i
3.4.3.2. Calibrator
3.4.2.1. Factor
Csample=TR·F
∆A
∆t
Csample=
blank
39
1
nsample
nsample
ΣC
i=1
i
sample