USER MANUAL

English

TEUS00023-02-ING
August-2006
User Manual

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Dear Customer,

Thank you for purchasing our A15 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 ...................................................................................................................... 8
1.1.3. Reactions rotor and reading ..................................................................................................... 8
1.2. Working theory ........................................................................................................... 8
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 ............................................................................................................................... 12
2.2.2. Start-up procedure, operation and shutdown. ...................................................................... 13
2.2.3. Monitor ...................................................................................................................................... 14
2.2.4. Programming ............................................................................................................................ 16
2.2.5. Save/load test file ..................................................................................................................... 21
2.2.6. Preparation of the work session ............................................................................................. 21
2.2.7. Memorising sessions ............................................................................................................... 25
2.2.8. Current results........................................................................................................................... 25
2.2.9. Current and past alarms .......................................................................................................... 26
2.2.10. Past results .............................................................................................................................. 26
2.2.11. Patient data ............................................................................................................................. 27
2.2.12. Configuration .......................................................................................................................... 28
2.2.13. About ........................................................................................................................................ 29
2.2.14. Utilities ..................................................................................................................................... 30
2.2.15. Internal quality control .......................................................................................................... 31
Buttons ................................................................................................................................................. 32
2.3. Alarms and alerts ...................................................................................................... 33
Machine alarms and alerts ................................................................................................................ 33
Work session alarms and alerts ........................................................................................................ 34
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 A15 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.

In each of the elements of the A15 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 three-
axis Cartesian operating arm prepares the reactions.
Dispensing is performed by means of a pump with a ceramic
piston via a detachable thermostatised needle with PID
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 con-

trol 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 pre-
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 A15 analyser an instrument
that is highly versatile and effective for clinical analysis
laboratories.

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1. Description of the instrument
The A15 analyser prepares the reactions by means of a arm to its resting position, he or she must ensure that the
three-axis Cartesian operating arm. This arm supports and needle is at its highest position. For this, it must be raised
displaces a dispensing needle which pre-thermostatises completely by pressing the vertical chain of the operating
the preparations at 37º. The dispensing is carried out by arm upwards as shown in the photograph. The return system
means of a low-maintenance ceramic piston pump. The prevents the needle from descending and the user can then
analyser can carry out one preparation every 24 seconds. move the arm with no danger of damaging the needle or
The preparations are dispensed in a reactions rotor injuring him or herself on it. The operating arm only makes
thermostatised at 37ºC. The optical absorbance readings the preparations if the general cover of the analyser is closed.
are taken directly on this rotor. 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 A15 analyser is made up of three basic elements: the 1.1.2. Dispensing system
operating arm, the dispensing system and the reading and
reactions rotor. 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
1.1.1. Operating arm cleaning and replacement. The analyser has capacity level
detection to control the level of the bottles and tubes and
This is a three-axis XYZ Cartesian mechanism. The X and prevent the needle from penetrating too far into the
Y axes move the dispensing needle over the analyser corresponding liquids, thus minimising contamination. An
horizontally and the Z axis moves it vertically. It is operated automatic adjustment system informs the user if the needle
by three step-by-step motors. In each 24-second is not mounted or if it is too bent. The needle has a
preparation cycle, the operating arm performs the following thermostatisation system, with PID control, capable of
actions: first of all, it sucks in the reagent from the thermostatising the preparations at approximately 37º in
corresponding bottle. Next, the needle is washed externally less than 15 seconds. Dispensing is carried out by means
in the washing station and sucks in the sample from the of a low maintenance ceramic piston pump driven by a
corresponding tube. It is washed externally again and dis- step-by-step motor. It is capable of dispensing between 3
penses the sample and the reagent into the reactions rotor. and 1250 µL. The dispensing system of the analyser uses
Finally, it is exhaustively washed internally and externally system liquid which the user must prepare by adding 6 ml
before proceeding with the next preparation. The arm has a of concentrated system liquid supplied with the analyser
system for controlling vertical movement to detect whether to the corresponding container filled to the top with distilled
or not the needle has collided into anything on descending. water (approx. 3000 ml). Analyses must never be made
If a collision occurs, as may be the case if, for example, a using distilled water only in the dispensing system, since
lid has been left on a bottle of reagent, the arm automatically the analytical performance and the lifetime of the system
restarts, verifies the straightness of the needle and continues may notably be lowered. The exterior of the needle is kept
working issuing the corresponding alert to the user. A return constantly clean by means of a washing station, which
system on the vertical axis automatically raises the needle consists of a font specially designed to clean and dry the
in the case of a power failure, preventing it from descending needle, integrated in the racks tray. A system of membrane
and colliding with an object at the bottom or with the housing pumps supplies the font with system liquid and transports
of the instrument. If the user wishes to manually move the the waste to its container.

The A15 analyser has a tray with 4 free positions for racks
of reagents or samples. 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
from 1 rack of reagents (10 reagents) and 3 racks of samples
(72samples) to 3 racks of reagents (30 reagents) and 1
rack of samples (24 samples). Bottles of distilled water,
saline solution for the automatic pre-dilutions and washing
solution must be possitioned in a reagent rack.

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User manual

On the left of the analyser are system liquid containers compensated interferential filter to select the desired
(marked in blue) and waste containers (marked in red). wavelength and through focalisation lenses. It then passes
The analyser constantly controls the level of these through the rotor well and finally reaches the photodiode,
containers and issues the appropriate alerts if the system where the light signal is turned into an electric signal. A
liquid is nearly empty or if the waste container is full. sophisticated analogical digital integrator-converter system
converts the electric signal into a digital value with which
the analyser obtains the absorbance values. The optical
1.1.3. Reactions rotor and reading system continues to work when the general cover of the
The preparations are dispensed in an optical quality analyser is open, whereby the analyser can continue to
methacrylate reactions rotor thermostatised at 37ºC. The take readings while the user handles, for example, the
optical absorbance readings are taken directly on this rotor. sample tubes or the reagent bottles. The rotor cover must
Each reaction can be read for 10 minutes. The readings be in place for the optical system to work correctly. A de-
are taken as they are programmed in each measurement tector tells the analyser of the presence of said cover. The
procedure. The reaction wells have been designed to enable analyser aborts the readings if the user removes the rotor
the mixture of the sample and the reagent during the cover while the optical system is taking photometric
dispensing. Each rotor has 120 reaction wells. The length measurements. If the rotor is not covered, the analyser
of the light path is 6 mm. The minimum volume required to informs the user so that he or she places the rotor cover
take the optical reading is 200 µl. The wells have a maximum when it sends samples to be analysed. The analyser also
useful capacity of 800 µl. When the reactions rotor is issues an alert if there is no reactions rotor in it.
completely full, the user must change it for one that is 1.2. Working theory
empty, clean and dry. The reactions rotors may be reused
The A15 analyser is an automatic random access analyser
if they are appropriately cleaned immediately after use. The
specially designed for performing biochemical clinical
Cleaning the semi-disposable reactions rotor section in the
analyses. The analyser performs patient-by-patient
Installation and maintenance manual describes how to
analyses and enables the continual introduction of samples.
clean the rotors. The rotors must be rejected if they are
The analyser is controlled from a dedicated PC that is
noticeably deteriorated. The user has a test in the computer
permanently communicated to the instrument. The
programme, which he or she may use to check the
programme, installed on the computer, keeps the user
condition of the rotor. The rotor is driven by a step-by-step
constantly informed of the status of the analyser and the
motor with a transmission. A Peltier system with PID con-
progress of the analyses. As results are obtained, the
trol thermostatises the rotor at 37ºC.
computer shows them to the user immediately.
An optical system integrated in the rotor takes the readings
When a Work Session is begun, the analyser proposes
directly on the reaction wells. The light source is a 10 W
performing the blanks, calibrators and controls programmed
halogen lamp. The detector is a silicon photodiode. The
for the measurement procedures it is to carry out. The user
wavelength is selected by a drum with 9 positions available
may choose between performing the blanks and the
for optic filters. The filters are easily changed by the user
calibrators or not. If they are not performed, the analyser
from the exterior of the analyser, without the need for
uses the last available memorised data. The controls can
disassembling the filter drum. A step-by-step motor
also be activated or not. During a session, while the
positions the drum. The optical system is capable of taking
analyser is working, the user can introduce new normal or
1 readings per second, with or without a filter change in
urgent samples to be analysed. Each time a new sample
between. The light beam of the lamp passes through a
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.

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

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well. The reactions can be biochemical or turbidimetric. In performing analyses.
both cases, the reaction or the chain of reactions produced
generate substances that attenuate certain wavelengths, - Shutdown: Transitory status during which the analyser
either by absorption or by dispersion. Comparing the light appropriately switches off all its elements to maintain
intensity of a certain wavelength that crosses a well when them in optimum condition for future analysis work. Once
there is a reaction and when there is not a reaction can finalised, the analyser is in standby mode.
determine the concentration of the corresponding analyte. - Standby mode: The analyser is in communication with
This comparison is quantified with the physical magnitude the PC. If the initialisation process has taken place, the
called absorbance. In some cases, the concentration is a analyser is ready to perform analyses.
direct function of the absorbance, and in other cases, it is
a function of the variation of the absorbance over time, - Running Mode: The analyser is performing analyses
depending on the analysis mode. (preparations and readings or readings only if there is no
preparation pending).

1.3. Start-up - Sampling stop: The analyser can be taking readings, but
the operating arm is parked and the pending reactions
Once the analyser has been installed, it can be started up. are not prepared. In this status, the user can handle the
The steps to be followed for the first start-up are the same bottles and containers of the analyser with no risk, in
as those indicated in the Start-up and shutdown procedure order to, for example, add a new sample.
section for routine start-up. The analyser must be in standby
mode, i.e. plugged into the mains and with the switch in - Alarm Mode: If during any of the operations, an anomaly
the (I) position. The computer must be started up and the occurs requiring the intervention of the user and whose
programme launched. From the Monitor screen of the correction is essential for the process to continue, the
programme, click on the Warm up button to start analyser enters alarm mode and issues the corresponding
initialisation. The analyser automatically carries out all alert through the PC.
the checks required for correct functioning and continually
informs of its status through this screen. No manual - Mains disconnection: Switch (0) (Power Off): The switch
adjustment is necessary. If, for any reason, user intervention is in the (0) position. The analyser is completely off. It
is necessary, the analyser issues the corresponding alert can then be disconnected from the mains.
through the computer. Once warm-up has finished, the ANALYSIS MODES
analyser is in standby mode, ready for work.

1.4. Functional specifications

All the functions of the analyser are controlled from the
programme installed on the computer. This programme has Power off
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 sim-
ple. It is also possible to access numerous functions to
Sleeping
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 Shutdown
be easily updated or stored.
Stand by Warming up

STATUSES OF THE ANALYSER Running

- 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 Sampling Stop

- 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 Alarm
Mode

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User manual

- Final point. Monoreagent or bireagent. Monochromatic - Access to introduction of new samples at all times.
or bichromatic.
- Interruption and renewal of the preparation of reactions
- Bireagent differential. (Sampling stop / Continue).

- Fixed time. Monoreagent or bireagent.

- Kinetic. Monoreagent or bireagent. Readings every 24 s, PREPARATION OF THE WORK SESSION

up to 10 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.

CALIBRATION TYPES
- Easy allocation of the tests and profiles to be performed
- Factor on one or several samples.

- Single calibrator (Single-point calibrator). This can be - Up to 50 replicates for patient samples. Up to 3 replicates
specific (for a certain test) or multiple (common for several for blanks, calibrators and controls.
tests).
- Automatic allocation of blanks and calibrators. Possibility
- Several calibrators (Multipoint calibrator). This can be of storing the results of blanks and calibrators.
specific (for a certain test) or multiple (common for several
tests). Up to 8 points and up to 3 replicated points for - Partial or total sending of work to the analyser.
each one. Calculation of the Calibration Curve (spline,
- Possibility of introducing patient data while the analyser
linear regression, quadratic or polygonal regression, with
is performing the analyses.
linear or logarithmic axes).
- Automatic selection of the reagents required and
indication of the minimum required volumes.
PROGRAMMING
- Graphic, automatic or manual allocation of sample and
- Tests: unlimited number, depending on the hard disk reagent positions in the racks.
capacity of the computer. Programmable for 5 sample
- Printable summary of positions to enable the positioning
types: serum, urine, plasma, whole blood.
of the samples and the reagents in the racks.
- Test profiles: unlimited number, with an unlimited number
- Automatic reordering of the tests of each sample to
of tests.
optimise work and avoid contamination between
- Multiple calibrators: up to 10. programmed tests.

- Multiple controls: up to 20. - Automatic verification of the resources available on the

analyser to be able to proceed with the required analyses.
- Contaminations: unlimited number. Issuing of alerts with instructions for the user if his or her
intervention is required.
- Reagent racks: unlimited number.
PROCESSING OF RESULTS
OPERATION
- Current or historical reports, by patients or test, with
MONITOR SCREEN possibility of repetition to confirm results.
- Warm-up and shutdown process of the analyser . - Current or past reports, by patients or by tests.
- Cancellation of the preparations and readings in process - Patient database.
(Abort)
- Internal quality control reports.
- Real-time monitoring of the status of the analyser and
development of the work session. Display of the tasks - Alarm and alert records.
sent to the analyser and the advance of their execution.
- Exportation of results.
- Access to the results of the measurements, with the
possibility of automatic printing.

- Alerts and alarms. Access to detailed explanations. CONFIGURATION

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- Options of the user programme (languages, printing,
reports).

- Options for the functioning of the analyser (washing,

sample tubes, filter drum, cover detection, rack detection).

UTILITIES

- Analyser test, preparation and maintenance utilities

(needle disassembly, supply, washing, rotor verification,
lamp change, PC-analyser communications,
demonstration).

QUALITY CONTROL

- Analytical limitations control for each test: blank, linearity,

detection, factor.

- Internal quality control with up to 2 control materials per

test. Manual or statistical calculation. Levey-Jennings
graphics and Westgard algorithm.

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User manual

2. General operation method

This chapter gives the basic instructions for using the calibrators and controls that have already been carried out,
instrument. Although the operation of the analyser is very even if the analyser is switched off, maintaining all the
simple and intuitive, it is recommended you read this chapter information of the session in progress. To obtain maximum
carefully to make the most of its features effortlessly and quality of the analytical results, it is recommended that
as quickly as possible. 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
2.1 Program Installation blanks, calibrators and controls.
For the program installation, you must carry out the following
steps: Once the samples have been introduced, the user must
allocate positions to the samples and to the required
a) Initiate the computer reagents and physically place them in the analyser. The
b) Uninstall the old version with the Windows option Add Positions screen distributes the samples and the reagents
and Remove programs in the different racks of the analyser tray. This distribution
c) Insert the D-ROM with the new version. can be made automatically or manually.
d) Press Start, select Execute and write: name of the CD-
As soon as the required elements have been distributed,
ROM unit:\setup (for example: D:\Setup).
the work session can be started. The Monitor screen is
automatically displayed, containing a summary of the main
Should there be an error during installation, the user can
information received from the analyser and showing the
install the previous version again and recover the old data.
progress of the work session. From this screen, it is possible
Follow the steps to recover a previous version:
to access other screens that offer more detailed information
about results and alarms. The user can cancel the work
a) Uninstall the version of the problem. Do not erase the
session if he or she detects that the results are incorrect.
created subdirectories or the files generated by the
application. At any moment, the user can introduce urgent samples or
b) Install the previous version add new normal samples to the work session in progress
c) Execute it. When initiating the application, it will restore from the Introduction of new samples screen without losing
the old data files. This process will solely be made from the information of the samples that have been sent
version 2.5.0 on. 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
2.2. Operation procedure one is introduced in first place. If there are already other
urgent samples, it is added to the end of the group of urgent
2.2.1. Introduction samples. If a new sample is added, with a test that has not
The operation of the analyser is flexible and simple using yet been performed in the current session, the analyser
the user programme from the dedicated PC. This programme will propose new corresponding blanks, calibrators and
is subdivided into different screens that provide specific controls. The user again has the possibility of choosing
functionality. They are described in more detail in the whether to perform them or not.
following sections. The system can automatically block samples or tests in
Firstly, the user must switch on the analyser and launch accord with the information received from the analyser. This
the user programme, and warm up the analyser from the can happen, for example, when a sample or a reagent has
Monitor screen. To start a work session, the samples that run out. When the user corrects the problem and notifies
are to be analysed must be introduced through the the analyser from the Positions screen, the blocked
Introduction of New Samples screen, indicating the samples or tests are automatically unblocked and the
measurement procedures desired. Each measurement affected samples are turned into pending samples, and are
procedure or test is defined by a set of parameters that analysed later.
can be programmed by the user from the Tests programming The user can access the results as they are obtained and
screen. print the results of the patients whose tests have already
In accord with the tests to be carried out, the analyser finalised.
automatically proposes the performance of the The basic screens of the user programme are as follows:
corresponding blanks, calibrators and controls. The user
can choose to perform them or reuse the data from the - Monitor screen: Main screen that appears when the user
previous session. Until the work session is restarted, the programme is launched. It displays the status of the
analyser will not propose the repetition of the blanks, analyser and the work session in progress. It lets the

12
 user intervene in the progress of the work session. It Once the work session has been prepared from the
contains the main buttons for controlling the analyser. corresponding screens and warm-up has finalised, click
- Programming screens: These enable the programming the Start button on the vertical bar for the analyser to start
of tests, profiles, multiple calibrators, multiple controls, performing the analyses. On beginning the analyses, the
contaminations and reagent racks. analyser enters running mode. If during the running mode
you wish to physically introduce a sample or a reagent in
- Work session preparation screens: These enable the the analyser, click on the Sampling Stop button on the
preparation of the work session and the storage of data vertical bar menu and the analyser enters running mode
that may be used in later sessions. Basically, the user with readings only, without the preparation of samples
can introduce new samples to be analysed and position (Sampling stop). The user can then raise the cover and
the corresponding samples and reagents in the analyser. place the sample or reagent in safety. Closing the cover
- Results screens: These make it possible to view the results and clicking on the Continue button on the same bar, the
and see and print the reports with the results obtained in analyser returns to running mode. When the analyser ends
the current or previous sessions. The reports can be the analyses, it automatically returns to standby mode. If
organised by patients or by tests. It also allows managing you wish to abort the preparation of new reactions as well
sample repetitions as the readings in progress, click on the Abort button
located on the same bar. In this case, the analyser requests
- Alarms screens: These give detailed information about confirmation and, if the response is affirmative, it aborts
the alarms and alerts occurring in the current session or the preparations and readings in progress, and returns to
in previous sessions and enable the printing out of reports. standby mode.
- 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
- Configuration screens: These make it possible to confi- asks for confirmation and if the response is affirmative, it
gure the working mode of the user programme and the performs the shutdown sequence and returns to sleeping
analyser. mode. The analyser can be left in this status indefinitely.
- Utility screens: These let the user access the different Power consumption is minimal. The user programme can
test, preparation and maintenance utilities of the analyser. be closed and the computer switched off. If you wish to
switch off the analyser completely, for example to carry
- Quality control screens: These enable access to the
out a maintenance operation or repair a breakdown, the
internal quality control results of the analyser.
switch must be put in the (0) position (Power off) and the
The following sections describe these screens and their mains cable unplugged.
functionality in more detail. You can access any of them
If during any of the operations, an anomaly occurs requiring
easily from the main menu and specific buttons.
the intervention of the user and whose correction is essential
for the process to continue, the analyser enters alarm mode
2.2.2. Start-up procedure, operation and shutdown. and issues the corresponding alert through the PC. Once
the user has solved the problem and has indicated this to
Before starting up the analyser, the user must check that the analyser, the analyser checks that it has indeed been
the waste container is empty, that the system liquid con- solved and returns to the previous mode.
tainer 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 Statuses of the analyser LED
programme. The computer automatically communicates
with the analyser, which changes to standby mode. The Sleeping Mode Orange
screen that appears when the programme is launched is
the Monitor screen. The programme shows horizontal and Warm-up Green
vertical button bars. The horizontal bar enables access to Shutdown Green
the main functions of the application, whereas the vertical
bar enables the control and functioning of the analyser. Standby mode Green
Click on the Warm up button on the vertical bar menu to
begin Warming up. The analyser automatically performs Running Mode Green
all the checks required for its correct functioning and the
Running mode with readings only
programme continually informs the user of the status of
(Sampling Stop) Red
the analyser. No manual adjustment is necessary. If, for
any reason, user intervention is necessary, the analyser Alarm Mode Flashing red
issues the corresponding alert through the computer. Once
warm-up has finished, the analyser is in standby mode, Mains disconnection:
ready for work. Switch (0) (Power Off): Off

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User manual

The three-colour LED indicator (green, orange and red) - The status of the cover of the analyser (open or closed)
located on the front right of the analyser indicates the current and the rotor cover (in position or not in position). The
status of the analyser. analyser also issues an alert if there is no rotor placed in
the analyser.

2.2.3. Monitor - Control of the useful lifetime of the lamp.

- The status of the thermostatisation systems of the needle
This is the main screen that appears when the user and the rotor.
programme is launched. This lets the user supervise and
intervene in the progress of the work session or any other - The levels of the waste and system liquid containers
task sent to the analyser. It displays the status of the - Other alarms.
analyser and the work session in progress, providing - The list of samples in the current work session. This
graphic information about any alarm produced. The content list presents all the samples to be performed in the
of this screen is as follows: current work session, in accord with the order of
- Status of the analyser and the work session. execution. To indicate the status of each sample, a
- Vertical button bar which enables the control of the colour code and icons are used:
functioning of the analyser. - Pending (yellow): Samples that have not yet been
- Horizontal button bar which provides access to the main analysed.
function of the application. - In progress (red): Samples that are being analysed.
- Finished (green): Samples that have been completely
2.2.3.1. Status of the analyser and the work session. analysed without incidences in any of the tests
performed. The results of these samples are accepted
Real-time monitoring of the status of the analyser and automatically.
development of the work session. - Finished with incidences (green + attention icon):
- The total time of the programmed work session and the Samples with which not all the analyses programmed
number of rotors necessary for it to be carried out. 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 performan-
ce of the blank or calibrator…).

2.2.3.2. Blocking pending samples

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.

- The status of the analyser at any given moment: Sleeping,

Warm-up, Shutdown, Standby, Running, Sampling Stop 2.2.3.3. Vertical button bar for the control of the
or Alarm. The transitions between the statuses in some analyser
cases are automatic and in others they are requested by
This bar contains the main buttons for the control of the
the user.
functioning of the analyser, which enable the user to change
- The warm-up time control, which enables the cancellation its status and perform different actions. This bar can also
and control of the performance of the photometric base be accessed directly from the positioning screen of the
lines. reagents and samples in the racks. The buttons are as
- The status of the reactions rotor: number of wells used, follows:
number of free wells and graphic bar of the percentage of
wells used. The thermostatisation time control when a
new rotor is placed in position, which enables the
cancellation of the standby.

14
Connection: This re-establishes the connection between Test programming: This enables access to the test
the computer and the analyser if the analyser has been programming screen.
accidentally switched off or the computer has been Profile programming: This enables access to the profile
disconnected (it changes from Sleeping to Standby). If (group of tests) programming screen.
the analyser is in sleeping mode and the computer
programme is launched, the connection is made New sample: This enables access to the introduction of
automatically. new samples screen.
Warm Up: This initialises the analyser (performs Warming Position: This enables access to the screen for the
up and leaves the analyser on standby ready for work). positioning of reagents and samples in the rack tray.
Start: The analyser begins to perform the programmed Monitor: This enables a return to the monitor screen from
analyses (changes from standby to running). any other screen.
Continue: This continues the preparations if they have been Current results: This enables access to the current results
stopped by the analyser or by the user. (It changes screen. These can be displayed in order of patients or
from Sampling Stop to Running). It also continues when tests in real time during the execution of the analyses.
new samples are added to a finished session. (It changes It also allows managing sample repetitions
from Standby to Running). Current alarms: This enables access to the current alarms
Sampling Stop: This enables the interruption of the screen which offers more detailed information about the
preparations without interrupting the readings of the alerts and alarms that have appeared on the Monitor
samples in progress and the reception of results from screen during the current session.
the analyser (it changes from Running to Sampling Utilities: This enables access to the utilities screen.
Stop).
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 2.2.3.5. Special buttons in monitor screen
or Standby by Rotor End to Standby and considers the
session as finished). Preparation table per well: Button to open a window that
New Rotor: This button indicates to the analyser that a shows in each rotor well which sample, test and replicate
new empty rotor has been installed. This is active only have been prepared.
when the analyser is on standby. The analyser controls Printing final reports: This button allows printing each
the time required for the thermostatisation of the new patient’s results which are finished before ending the
rotor, which is approximately 5 minutes. The user can whole list. It will only print those finished patients with a
cancel this waiting time if a previously thermostatised printer symbol in the printing column.
to 37ºC rotor is introduced.
Legend of icons and monitor colours: This button opens an
New System Liquid Container: This button tells the analyser extra window that explains what each colour and symbol
that the system liquid container has been refilled. The means.
analyser then automatically supply the dispensing
Details: This button allows opening the monitor screen and
system to prevent the accumulation of air, which is
visualizing the programmed tests for each patient. By
detrimental to the execution of the analyses. It is active
pressing again the same button, you can recover the
when the analyser is on standby, running or sampling
previous screen.
stop mode, but the supply is carried out on standby or
running only.
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:
Configuration A15: This enables access to the analyser
configuration screen.

15
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, OK: Clicking this button definitively stores all the changes
contaminations and reagent racks. These parameters are made in the tests file.
usually constant over long periods of time once the analyser Cancel: This enables the recovery of the initial tests file,
has been adapted to the needs of the laboratory where it is without taking into consideration the changes made
being used. Programming requires knowledge of the since the tests programming screen was opened.
analyser and the analysis process. It is not possible to
modify any of the programmed parameters while they are Programmable parameters
being used in a work session.
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 - Test name: Test name with up to 16 characters.
querying or modification of parameters of tests that have - Analysis Mode Final monoreagent point, Final bireagent
already been programmed and the elimination of tests that point, Bireagent differential, Monoreagent fixed time,
are no longer used. It also enables the ordering of the list of Bireagent fixed time, Monoreagent kinetics, Bireagent
tests and the printing of their parameters. The default tests kinetics.
are those pre-programmed by BioSystems to use the line
- Sample type: Each test may contain specific parameters
of reagents adapted to the analyser. The total number of
for five different sample types: Serum (SER), Urine (URI),
programmable tests is unlimited and depends only on the
Cerebrospinal (CSF), Whole blood (WBL) or Plasma
capacity of the computer. The screen is divided into two
(PLM) liquid. The Delete Type button can delete all the
parts:
data related to a certain sample type of a test.
- List of tests. - Units: Units that are used to express all the concentrations
- Information about parameters, grouped together in five associated with the test. One of the memorised units
folders: General, Procedure, Calibration, Controls, can be selected or a new one introduced.
Options.
- Turbidimetry test: It shows the program that the
The parameters of a test can be queried by selecting it on programmed test is a special one. The analyzer makes
the list with a click. If you wish to modify the parameters of a different cycle with turbidimetry tests.
a test, select it with a double-click or pressing Enter. None - Reaction type: Increasing or decreasing.
of the programmed parameters of a test can be modified if
it has been programmed in a work session. The list of tests - Decimals: Number of decimals to be used to express
can be ordered by dragging a test to the new position in the concentration in the reports.
the list or alphabetically by clicking on the list header.

If a test parameter is modified, the results stored for the

blank and calibrator are automatically reset and must be
redone.

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 - Replicates: Number of times each preparation is carried
to identify the created test as a user test different from out for the patient samples (from 1 to 50). The final result
the original tests, the colour of the test icon changes to obtained is the average of the replicates performed and
orange. The original tests are blue. accepted.
- Name of the Associated Constituent. Optionally, it is
Print: This prints out the parameters of the selected tests. possible to introduce the name of the constituent
Delete: This deletes the selected tests. measured with the test. If introduced, it will appear in the
reports.
16
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.
- 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. Pre-
dilution can be carried out automatically or by the analyser
- Calibration curve: For Multipoint Calibrator (Multiple or
or manually by the user.
Specific). It can be polygonal, linear regression, spline or
- Automatic repetition: It shows the program to repeat that regression parabola. The x and y axes can be normal or
test automatically if the result is out of the limits. logarithmic.
- Postdilution Factor: It is the factor of sample postdilution - The calibration curve may be programmed to increase or
when it makes an automatic repetition. decrease.
- Filters: One or two filters to be chosen in accord with the - Calibrator replicates: number of times the calibrator is
reading type. Only filters that are physically in the filter measured (1, 2 or 3). The final result obtained is the ave-
drum can be chosen (they can be revised from the rage of the replicates performed and accepted.
Configuration screen of the A15).
- Blank replicates: number of times the blank is measured
- Times: Depending on the analysis type, the (1, 2 or 3). The final result obtained is the average of the
corresponding boxes are activated to programme the replicates performed and accepted.
different reading or dispensing times of the second
- Alternative calibrator: Option that enables the analysis
reagent. The times can be introduced in seconds or in
of a certain type of sample using the results of the
cycles. Each cycle is equal to 24 s.
calibration of another different sample type. For example,
it enables the use of calibration for serum to analyse a
urine sample.

Controls
- Number of controls: Number of controls the analyser
proposes for each work session (0, 1 or 2).
- Rejection criteria: Criteria for rejecting an analytical se-
ries (between 0.1 and 4 standard deviations).
- 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,
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
Calibration accessed directly from this screen.
- Calibration type: Factor, Multiple Calibrator or Specific - Calculation Mode: This indicates the method used for
Calibrator. If factor is used, its value must be introduced deciding if a series of results is accepted or rejected. It
in the corresponding field. If the calibrator is specific, the can be manual or statistical. In statistical mode, the user
fields appear to introduce the concentration values, must introduce the number of series. The Internal Quality
depending on the number of calibrators. For multiple Control section gives a detailed explanation of its
calibrators, this data is introduced on the multiple functioning.
calibrators programming screen, which is accessed
directly from this screen.

17
User manual

Options to it. If you wish to create the same profile for different
- Blank absorbance limit. In kinetic or fixed time tests, sample types, a profile must be programmed for each
this limit refers to the initial reading of the programmed different type. The total number of programmable tests is
absorbance. unlimited and depends only on the capacity of the computer.
The screen contains:
- Kinetic blank limit.
- List of profiles
- Linearity limit.
- List of programmed tests
- Detection limit.
- List of tests in the selected profile
- Factor limits.
- Reference interval. The parameters of a profile can be queried by selecting it
on the list with a click. If you wish to modify the parameters
- Limits of repetition of a profile, select it with a double-click or pressing Enter. It
- White with reagent only is not possible to modify any of the programmed parameters
of a profile while they are being used in a work session.
- White with saline solution
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.

Buttons

Various buttons let the user perform the following actions:

New: Enables the creation of a new profile.
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.
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.
2.2.4.2. Profile programming: OK: Clicking this button definitively stores all the changes
made in the profiles file.
This screen enables the programming of test profiles. A
test profile is a set of tests identified by a name. Using Cancel: This enables the recovery of the initial profiles file,
programmed test profiles simplifies the preparation of the without taking into consideration the changes made
work session. On allocating a profile to a sample, all the since the profiles programming screen was opened.
tests contained in said profile are automatically allocated
to it. Each profile has one single sample type associated

18
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.
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
- Information about parameters

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. Buttons
The display shows the name of the test, the sample type,
Various buttons let the user perform the following actions:
the name of the allocated calibrator and its batch. To allocate
or change the calibrator of a test, click on the name or New: Enables the creation of a new calibrator. You must
batch of the calibrator and choose the desired calibrator introduce the name, batch and number of calibrators.
from the list that drops down on the row corresponding to Print: Prints out the data of the selected calibrators.
the test. If a calibrator that has already been allocated to
one or more tests is modified, the allocations are deleted. Delete: Deletes the selected calibrators from the grid.
Once a calibrator has been allocated to a certain test, the Save: Clicking this button after modifications have been
user must programme the test calibration parameters: made provisionally stores the new parameters.
- Concentration data: Assigned values of calibrator OK: Clicking this button definitively stores all the changes
(monopoint) or calibrators (multipoint) concentration for made in the calibrators and tests file.
the test, introduced from greater to smaller. The Cancel: This enables the recovery of the initial tests and
corresponding factors are calculated automatically from multiple calibrators files, without taking into
the concentrations introduced. consideration the changes made since the multiple
- Calibration Curve Data: For multipoint calibrators, the calibrators programming screen was opened.
curve type (polygonal, linear regression, spline or
regression parabola) and the type of x and y axes (nor-
mal or logarithmic) must be selected. 2.2.4.4. Programming of Multiple Controls

By selecting a calibrator with a click or with the cursor A multiple control can be used to control more than one
keys, it is possible to query its data and the tests allocated test. Up to 20 multiple controls can be programmed. The
to it. The allocated tests appear selected on the tests list. multiple controls programming screen can be accessed
If you wish to modify the parameters of a calibrator, select only from the tests programming screen, from the Controls
it with a double-click or pressing Enter. The data can be tab.
modified on the grid itself. It is not possible to modify any
The screen contains:
of the programmed data of a calibrator while it is being
used in a work session. The calibrator grid can be ordered - Control grid
by dragging a calibrator to its new position in the grid. The - List of tests with multiple control
calibration parameters of a test can be queried by selecting
- Information about parameters
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 The control grid displays the name of the control and the
pressing Enter. batch. The list of tests with multiple control shows the
programmed tests to be controlled using a multiple con-
trol. 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
test. If a test requires 2 controls (generally 2 levels: high
and low), each one must be allocated separately. If a con-

19
User manual

trol that has already been allocated to one or more tests is 2.2.4.5 calculated tests
modified, the allocations are deleted. Once a control has
been allocated to a certain test, the user must programme This screen displays the calculated tests that can be
the test control parameters: performed by the analyser, along with their parameters.
- Concentration data: Allocated values of maximum and In order to obtain a calculated test result, the calculations
minimum control concentration for the test. are made using the values for the concentrations of the
associated tests.
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. When running a calculated test, the analyser first determi-
The allocated tests appear selected on the tests list. If you nes the associated test concentrations, then calculates
wish to modify the data of a control, select it with a double- the result of the operation.
click or pressing Enter. The data can be modified on the
grid itself. It is not possible to modify any of the programmed This screen displays the following information for each
data of a control while it is being used in a work session. calculated test:
The control grid can be ordered by dragging a control to its •The tests used in the operation and the formula applied.
new position in the grid. The control parameters of a test
can be queried by selecting it with a click or using the • The normal reference ranges
cursor keys. To edit the control parameters of a test, select • The units for the calculated test
it with a double click or by pressing Enter.
• Whether the partial values for the experimental tests are
Buttons to be printed in the final report for each patient.

Various buttons let the user perform the following actions:

New: Enables the creation of a new control. You must in-
troduce the name and batch.

When a calculated test is allocated to a sample, all the

associated tests are automatically allocated in the
calculation, exactly as for a profile.

2.2.4.6. Reagent Rack Programming

Print: Prints out the data of the selected controls. Programming a reagent rack consists of saving a certain
Delete: Deletes the selected controls from the grid. configuration of reagent bottles of a rack, identified by a
Save: Clicking this button after modifications have been name. When preparing a work session, to position the
made provisionally stores the new parameters. reagents, you can load a programmed rack and the saved
reagent distribution is automatically allocated. If the user
OK: Clicking this button definitively stores all the changes frequently uses the same reagents, it is very practical to
made in the controls and tests file. use programmed racks to speed up the work. An unlimited
Cancel: This enables the recovery of the initial tests and number of reagent racks can be programmed, depending
multiple controls files, without taking into consideration on the capacity of the computer only. The rack programming
the changes made since the multiple controls screen can be accessed directly from the programming
programming screen was opened. 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

20
that is used frequently. The reagent rack programming compressed file. It is the program itself the one that
screen contains: compresses and decompresses the file with no need of
- List or programmed reagent racks the user’s intervention.

- Information about parameters In order to load a new test file, the user has to execute the
option Load Test File of the programming menu and then
The parameters interface contains a list with all the reagents all the tests of the application are automatically replaced.
associated with the tests programmed in the analyser, the
name of the selected rack and an image of this rack showing This process is only active with the following options:
the real positions of the reagents, their names and volumes.
The bottles on the racks can be added, removed or reordered - When working without passwords or as Supervisor user.
by dragging them with the mouse. The bottle type (50 or 20
- When the analyzer is in SLEEPING or STANDBY state
ml) may be changed using the corresponding button. Its
parameters may be queried by selecting a programmed - When there is no working list. If you have a programmed
rack with a click or using the cursor keys. If you wish to list, make a RESET.
modify a programmed rack, select it with a double-click or
pressing Enter. A programmed rack cannot be modified while
2.2.6. Preparation of the work session
it is being used in a work session. The list of programmed
racks can be ordered by dragging a rack to the new position The Introduction of New Samples and Reagents and
in the list or alphabetically by clicking on the list header. 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.

2.2.6.1. Introduction of New Samples

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, whole blood or plas-
ma). A tree diagram shows all the tests, calculated tests
and profiles programmed in the analyser. The user can select
or introduce the patient code (alphanumeric). If the patient
Buttons code introduced does not exist in the current work session,
Various buttons let the user perform the following actions: the new patient is added together with his or her sample. If
the patient already exists, the sample of the patient in
New: Enables the creation of a new programmed rack. question is selected and, on the tests tree, the tests
Print: Prints out the data of the selected programmed racks. previously allocated are selected for possible edition. If the
user does not introduce the patient code, the programme
Delete: Deletes the programmed racks selected on the list.
adds the patient sample with a correlative numeric identifier.
Save: Clicking this button after modifications have been If several normal or urgent samples are to be introduced
made provisionally stores the programmed rack. with the same tests to be carried out, the desired number
OK: Clicking this button definitively stores all the changes must be introduced in the Number of Patient Samples field
made in the programmed racks file. and the programme automatically adds all the samples,
allocating them a correlative patient code. By default, the
Cancel: This enables the recovery of the initial programmed
Number of Patient Samples is 1. The maximum value is
racks file, without taking into consideration the changes
120. If the user has got a code bar reader, he can use such
made since the racks programming screen was opened.
reader to insert the patient code. Place the cursor in the
box of the patient code and read the code to be inserted
2.2.5. Save/load test file with the reader.

The user can save the test programming in an external file, The list of New Samples shows all the samples introduced,
he has only to execute the option Save Test File of the grouped together by classes, which the user can then send
programming menu. This option saves all the test data in a to the analyser. The list of Sent Samples shows those the
user has sent to the analyser, also grouped together by
21
User manual

classes. To introduce a new sample into the list of new only. The associated and activated blanks, calibrators and
samples, proceed as follows: controls are sent automatically. By clicking on the Position
1. Select the sample class button, with no previous selection, all the introduced and
activated samples of the corresponding grid are sent.
2. Select the sample type Clicking the Delete button deletes the samples or the tests
3. If desired, introduce the patient code. of a sample that have been selected.
4. Select the profiles, tests and calculated tests to be The Sent Samples grids enable the query of the samples
performed. sent to the analyser and the tests to be performed on each
5. Add the sample to the list of samples by clicking on the sample, but they do not allow modifications or the resending
Add (Arrow >) button. of samples to the analyser.

If you wish to introduce a certain number of samples n with The Reset Session button on the horizontal bar restarts
the same set of tests to be performed, proceed as follows: the work session and deletes all the sample lists.
1. Select the sample class
2. Select the sample type
3. Select the profiles and tests to be performed.
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 from the same patient and the programme
groups them together automatically. It is also possible to
add, in one go, tests, calculated tests or profiles to several
samples of the same type for different patients.

Lists of samples

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.

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 Buttons
to send certain samples for positioning on the racks and
analysis, they must be selected and the Position button Various buttons, some of which have already been
pressed. It is also possible to send certain tests of a sample mentioned, let the user perform different actions. The

22
following is a brief description of the functionality of each 2.2.6.2. Positioning of samples and reagents
one.
This screen contains a tree diagram showing all the
Add sample (Arrow >): This dumps the information of the elements to be positioned, an image of the analyser tray
interface to introduce sample data in the corresponding indicating the current programmed distribution of the racks
new samples grid. and an enlarged image of the racks showing the details of
Edit patient (Arrow <): This enables the edition of a patient all the elements in the selected rack.
sample or of several of the same type, of the new
Tree diagram of elements to be positioned

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
samples grids. The edition enables the addition of tests and, if the test or tests allocated have pre-dilutions
or profiles to the group of samples selected. It is also programmed, the pre-dilution tubes required, together with
possible to change the priority of the edited samples, the corresponding factor of each one.
i.e. change from urgent to normal or vice versa. The The colour blue indicates which reagents and samples are
patient code of a sample is changed during the edition, completely positioned in the racks tray. The colour black
the programme adds a new patient, which is a copy of indicates the reagents and/or samples that are not
the previous one. If you wish to change the patient code positioned completely or whose volume has finished during
only without adding another new patient, make the the work session.
change directly on the samples grid with the right button
of the mouse. Rack tray
Delete: This deletes the patient sample or control data
selected. It is possible to delete tests, test or sample The image of the rack tray shows the current rack
profiles of a patient or complete patients. This is active distribution in the analyser. In each of the 4 rack positions,
for the new samples grids only. there may be a reagent rack or a sample rack or the
position may be empty. In the reagent racks, the image
Position: This sends a selection or a complete list of shows which positions are occupied by 20 and 50 ml
samples to be positioned in the analyser for later bottles. In the same way, in the sample racks the image
analysis. This is active for all the new samples grids. It shows the positions occupied by sample tubes.
enables:
- Sending of groups of patient samples. In this case, The user can choose the rack type at each position on the
the associated and activated blanks, calibrators and tray. The limit configurations are 3 racks of reagents and 1
controls are also automatically sent. of samples (30 reagents / 24 samples) and 1 rack of reagents
and 3 of samples (10 reagents / 72 samples). In the analyser
- Sending of control groups. In this case, the
options, the user can choose which type of samples rack
associated and activated blanks and calibrators are also
he or she wishes to use for all the samples in the current
automatically sent.
session (13 mm diameter sample tube, 15 mm diameter
- Sending of groups of blanks and calibrators for sample tube or 13 mm diameter well). If he or she wishes
making lists for calibration only. In this case, the to use racks of samples of different types in the same
associated and activated blanks are also automatically session, the user must deactivate the rack detection on
sent. the analyser configuration screen. It must also be taken
Patient data: This enables access to the screen for into account that the analyser will not check that the
introducing the data of each patient. This data is not physical disposition of the racks on the tray is the same
necessary for the performance of analyses and can be as the programmed disposition. Besides empty racks, it is
introduced once the analyser is running. also possible to position reagent racks programmed on

23
User manual

the rack programming screen or racks previously saved Position Reagents Automatically: The programme places
from the positioning screen itself. the reagents from the tree that are not yet positioned
(black colour) in the free positions on the reagent racks
The screen displays an enlarged view of the rack selected on the tray. If required, it allocates new reagent racks
on the tray, enabling easy manipulation of its content. The to the free positions on the tray and fills the positions. A
selected elements can be unloaded from the rack or the maximum of 3 reagent racks is permitted. If there are
rack can be completely emptied. It is possible to change elements on the racks that are not required for the current
the position of any element by dragging it to a free position work session, the programme alerts the user to remove
on the enlarged image of the rack. The volume of a bottle of them. If there is no room for all the reagents, the user is
reagents can also be changed by double-clicking on it. also alerted.
When any change is made, the programme checks if all
the required volume of said reagent is in position and alerts Position Samples Automatically: The programme places
the user if it is not. the samples from the tree that are not yet positioned
(black colour) in the free positions on the samples racks
The positioning of the reagents and the samples on the on the tray. If required, it allocates new samples racks
racks can be carried out automatically or manually. Two to the free positions on the tray and fills the positions. A
buttons make it possible to automatically position the maximum of 3 samples racks is permitted. If there are
reagents or the samples, respectively. With automatic elements on the racks that are not required for the current
positioning, the programme allocates the rack types that work session, the programme alerts the user to remove
are required. If the user wishes to position the elements them. If there is no room for all the samples, the user is
manually, he or she must choose the required rack types also alerted. If different types of sample racks are used
and place the elements by dragging them with the mouse in one session, the user must manually reposition each
from the tree to a free position in the corresponding enlarged 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.
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.
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
rack. It is possible to position individual bottles of reagent positioned, an auxiliary alerts screen opens. If the
or all the required reagent in one bottle. If a sample is analyser is ready for work, the Start button of the verti-
dragged and it has programmed pre-dilutions, the pre-dilution cal buttons bar is enabled and the user can press it for
tubes required are also dragged. If you wish to use different the analyser to start the analyses. The programme
sample rack types in one session, the user must manually automatically changes to the Monitor screen, from which
position each sample in the corresponding rack in accord the execution of the work session can be supervised.
with the type of tube used.
When the analyser is carrying out the analyses, the
Once all the elements have been positioned on the screen user can press the Sampling Stop button on the vertical
and physically in the analyser, the user can begin the button bar to introduce new elements into the analyser
analyses. physically. Once the positions have been programmed
on the Positions screen, by clicking OK, the programme
Buttons checks that all the new required elements are in position
and requests confirmation from the user to save the
Various buttons, some of which have already been information as definitive. The Continue button on the
mentioned, let the user perform different actions. The vertical bar is enabled and when the user presses it,
following is a brief description of the functionality of each the programme changes to the Monitor screen and the
one. analyser continues the pending analyses and the new
ones that have been sent.

24
Cancel: This exits the screen without updating any of the - In order to edit the factor: double click its cell, insert a
changes made and keeps the previous distribution. new value and accept by pressing Enter. This action
Alerts: This button appears when there are elements not recalculates all the affected Concentration results. It
positioned in the prepared work session and it informs also changes the test programming and becomes
the user of everything that cannot be analysed. When programmed with factor
nothing is in position, the Start button is not enabled. - In order to recover the factor experimental value: click any
cell crossed at the average or replicate level. This action
2.2.7 Memorising sessions recalculates all the affected Concentration results.

When Memorizing a working session, the assigned 2.2.8.2. Repetitions

samples and tests are saved, but the positions are not. If
you wish to memorize the current session, you should save The User can make repetitions of blanks, calibrators,
it before starting its execution. When loading a memorized controls and samples. Repetitions can be manual or
session, the tests are loaded such as they are programmed automatic.
at that moment, and the tests that have been deleted from Manual Repetitions: In order to make manual repetitions,
the test file are eliminated. the own user has to select the samples that he wants
In order to Load a memorized session, it is necessary to to repeat. Once the sample measurement is finished
carry out a RESET one previously. Once it is loaded, the and the result is in the Current results screen, select
session can be freely modified (modify identifiers, eliminate the results to be repeated in the Rep column and then
tests, add samples or tests...). The memorized sessions press the Repeat Selected Samples button. The program
can be also Eliminated. will automatically insert the sample to be repeated in
the working list. It will be added (rep) to the end of the
2.2.8. Current results sample name to distinguish it from the initial sample. In
the Current results screen, the result of the repetition
The results can be consulted as they are obtained on the will appear under the initial sample. So the user will be
Current results screen, grouped together by patients or by able to choose, by means of the OK column, which of
tests. The results are updated automatically in real time both results will comprise the patients’ report and
as information is received from the analyser. For each become historical. The repetition result will be selected
analysis, the results of the replicates performed are by default. If repeating blanks and calibrators, all the
associated values will be recalculated.
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:
- If the patient concentration is higher than the linearity
limit, the sample is repeated with the decreased
Factor of postdilution.

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,
by tests or by calculated test.

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.

25
User manual

- If the patient concentration is lower than the detection implemented solution, the date of the solution and the
limit, the sample is repeated with the increased Fac- personnel implicated. If so desired, the corrected alarms
tor of postdilution. can be eliminated. The lists can be ordered according to
- If the patient concentration is within the Rank of the field type, date or name. Problem solution reports can
repetition, the sample is repeated with the same be printed with the selected alarms. The Alarms and alerts
relation of sample-reagent. section of this manual lists the main alarms and alerts the
analyser can display and which require user intervention.
- If the absorbances of the kinetic in blanks, calibrators,
controls and samples are not linear, it is repeated 2.2.10. Past results
with the same relation of sample-reagent volumes.
The Past results screen displays the results obtained in all
2.2.9. Current and past alarms the work sessions prior to the current session and prints
out reports with said results. The results can be organised
The Monitor also displays information about the alarms or by patients or by tests. It is also possible to make reports
alerts that may appear throughout the work session in the of patients per session or with all sessions. Reports by
shape of identifying icons, together with a brief informative tests can be made only by previous selection of a specific
text. By clicking on the corresponding button, the user can session. The Delete button deletes all the data of the
access the Current alarms screen, which offers more selected work session.
detailed information about the problems and their possible
solution. The alarms and alerts occur when certain detectors The screen contains:
or sensors are triggered in the analyser or when the analyser - List of completed session dates
detects anomalous functioning. When necessary, the - List of elements: patients or tests
analyser acts to avoid continuing working in unsafe
conditions and notifies the computer. The alarms screen - Interface of patient or test data selected on the list
displays a list with all the alarms and alerts generated by - Interface of patient or test results selected on the list
the analyser in the current session. It is also possible to
access the Past alarms and alerts, which contains a list
List of elements
with the alarms and alerts generated during previous work
sessions. For each alarm or alert, the following can be This list contains all the elements of the selected sessions.
displayed: In the past results by patient, the list shows the patient
- Type of alarm or alert code and the patient names introduced, corresponding to
the selected session or to all the sessions. In the past
- Date of alarm results by test, the list contains the name of the tests
- Brief definition of the alarm (name) performed in the specific selected session. This list enables
- Detailed description the selection of elements for query, deletion or printing out
the associated data by means of the corresponding buttons.
- Proposed solution The list can be ordered alphabetically by clicking on the
- Observations (lets the user introduce information: applied title. In the past results by patient, the Allocate button
solution, date of solution, implicated personnel…) enables the allocation to the selected patient previously

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

introduced patient data. The Delete button enables the

deletion of the elements selected on the list. The Print button

26
enables the printing or exportation to file of a report with contains: patient code, result value, units, date and time of
the data and results of the selected elements. The the result and observations. By clicking on the
programme always displays a preview of the report. corresponding column, the results can be ordered by
session date, by test or by patient name.
Data Interface
General buttons
In the past results by patient, the data interface contains
the following patient information: name of the selected The past results screen contains two general buttons:
patient, sex, date of birth, person who has requested the Delete: This deletes completed past sessions.
analysis and a field for comments. A button enables access
to the Patient Data screen, where the data can be OK: This saves the changes made to patient data and to
introduced or modified. In the past records by test, the the results and exits the screen.
data interface contains the absorbance of the blank and Cancel: This exits the screen without saving the changes
the calibrator or calibrators used in the selected session, made.
the date the blanks and calibrators were performed and the
reference range of the test. 2.2.11. Patient data
Results Interface This screen enables the introduction and modification of
the data of patients who are analysed frequently. This data
This interface shows the results of the element selected
is not necessary for the performance of analyses and can
on the list, whether it is a patient or a test. Each grid re-
be introduced once the analyser is running. This screen
cord of results by patient contains: name of the test and
can be accessed directly from the Introduction of New
sample type on which it has been carried out, value of the
Samples or Past Results screen by patients using the
result, units, reference range programmed in the test
Patient Data button or from the Past results menu. It also
(optional), date and time of the result and observation about
enables the allocation of previously introduced data to a
the result obtained. Each grid record of results by test
patient. This screen contains a list of patients and a patient
data interface.

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.

27
User manual

Patient data interface The user must replace the system liquid container with the
washing solution container (supplied with the analyser,
The data interface shows the code of the selected patient, bottle with the green dot), when required to do so by the
his or her name and surnames, sex, date of birth, the person analyser, during warm-up (initial wash) or during shut-down
who has requested the analysis and a field for introducing (final wash). Once the wash has been performed, the
comments. The user can consult current data, modify them analyser asks the user to replace the container with system
or introduce new data. liquid (only in the initial wash) and automatically performs
a wash and rinse of the dispensing system with system
General buttons liquid. With the initial wash, the system is ready for working
in optimum conditions during the entire working day, offering
The patient data screen contains two general buttons: maximum performance. In the final wash, the dispensing
circuit is left full of washing solution until the next warm-up
Save: Saves all the changes made to the data.
is performed, in order to condition the dispensing circuit
Cancel: Recovers all previous data without saving any during the rest period of the analyser.
change.
When the analyser cannot avoid contamination between
2.2.12. Configuration incompatible tests by reordering the tests of each patient,
it automatically performs and intermediary special washing
These screens enable the user to configure the running cycle. The user can choose to perform these special washes
mode of the analyser and the user programme. The different with system liquid or with washing solution. If the second
parameters can be configured from four dedicated screens: option is chosen, a 50 ml bottle of washing solution must
- A15 analyser be placed in the analyser.
- Languages
- Configuration of the serial port
- Header of results reports

2.2.12.1. A15 analyser

Clicking on the A15 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

Session
- Carrying out of automatic repetitions Carrying out of repetitions
- Calibrators and blanks in paediatric racks This option allows to activate or to deactivate all the
- Automatic printing of patient reports automatic repetitions.
- Export session when reset is selected Separate Calibrators and Controls in Paediatric Racks
- Used sample tube
In the A15 Configuration–Session screen, you can select
Analyser the option: “Calibrators and Controls with paediatric racks”.
- Container level control scales This option is intended for the Automatic positioning of
- Cover detection samples. When pressing the button Place Samples
Automatically of the “Positioning of Samples and Reagents”
- Configuration of the filter drum
screen, the samples of Calibrator and Control type are
placed in paediatric racks and the patient samples in the
Initial, final and special washes between type of rack selected in the A15- Configuration-Session
incompatible tests screen.
The analyser automatically performs a wash with washing
solution during the warm-up and during the shut-down.

28
Automatic printing of patient information alarms appears: lack of reagent, lack of sample, waste
bottles full, system liquid bottles empty, etc., together with
This option allows activating and deactivating the automatic the corresponding icon. Said acoustic signal sounds until
printing by patient during a current session without waiting the user stops it by pressing the end alarm button or any of
for the list to finish. the star, sampling&stop, continue, new rotor buttons.
Export session when reset is selected

This operation permits automatic activation or deactivation Configuration of the filter wheel
of results export file generation when reset is selected. This screen enables the modification of the analyser filter
wheel. To access this screen, the work session must be
Used sample tube restarted. The wheel has 10 positions. Position 0 must
always contain a covered filter so that the analyser can
This enables the selection from a dropdown list of the type
perform the darkness adjustment. Positions 1 to 9 can be
of sample tube to be used in the work session. To access
used for optical filters. All the positions of the wheel must
this list, the work session must be restarted. The possible
be occupied for it to work correctly. The positions that do
types are: 15 mm diameter tube with a maximum height of
not contain an optical filter must be occupied by a covered
100 mm, 13 mm diameter tube with a maximum height of
filter. The analyser includes as standard 8 optical filters in
100 mm and a 13 mm diameter well.
positions 1 to 8 and two covered filters in positions 0 and
9. If one of the filters is to be changed, select the desired
Container level control scales
position of the wheel and press the Change Filter button.
It enables the deactivation of the functioning of the scales The analyser automatically positions the wheel filter
the analyser uses to control the level of the waste and 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.

An alert is issued to the user if any of the tests has

programmed filters that do not physically exist in the wheel.

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.
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 2.2.12.3. Serial port
repair it. In this case, the user must ensure that the system
This screen enables the configuration of the computer se-
liquid does not run out and that the waste container does
rial port used by the programme. The user can choose for
not fill while the analyser is running.
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.

Configuring the acoustic alarm.

2.2.12.4. Header of results reports
This option configures the enabling or disabling of the
acoustic alarm. If this option is enabled, an acoustic alarm From this screen, the user can customise the header of
sounds when the analyser is running and one of the following 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.

29
User manual

- Cleaning of the dispensing system

- Changing the lamp
- Reset of the base line log

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.

2.2.14.1. 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
2.2.13. About possible or not.
This screen displays information about the User Programme
version being executed. The Firmware version also appears 2.2.14.2. Reactions rotor check
(program executed directly by the analyser) and the serial
number of the analyser. In order to see the Firmware and The user can use this test to check the optical status of a
serial number, the program must be connected to the reactions rotor. He or she can choose the optical filter with
analyser. 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

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 rotor can be reused or if it should be replaced by a new
programme displays a corresponding screen. The available one. It is important to point out that the test checks the
utilities are: optical quality of the wells but not the status of chemical
cleansing. Depending on the analysis made with the rotor,
- PC-Analyser communications channel test
the chemical residues that may be left in the wells can
- Reactions rotor check have a noticeable effect on the following analyses performed
- Disassembly of the dispensing needle with the rotor. In case of doubt, or when very sensitive tests
are to be performed, it is always recommendable to use a
- Fluid system supply new rotor. After the test, the user must remove the rotor of

30
the analyser, empty it and dry it completely before using it liquid. It is possible to supply the dispensing system, the
for analyses. 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
2.2.14.3. Disassembly of the dispensing needle to be performed. When the system liquid container is filled
On clicking on the Disassemble Needle button, the during a work session, the fluid system can be supplied by
operating arm positions itself over the rack tray. The clicking directly on the New System Liquid Container button
programme alerts the user to remove any object positioned on the vertical button bar.
under the arm. On clicking OK, the needle descends and
the user can remove it to work with it or change it. To remove 2.2.14.6. Cleaning of the dispensing system
the needle, unscrew it by holding the top fitting. If, while
handling the needle, the carriage rises due to the pressure 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
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.

2.2.14.7. 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

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.

2.2.14.4.Reset of the base line log

By pressing the base lines log reset button, an internal

initialisation of the log in the analyser will occur. The said
log serves to decide whether a base line is correct or
incorrect. In the event of many base line failure alarms
occurring, reset the base line log by pressing the said button has, the programme resets certain reference values used
in order for it to generate a new log. to issue alerts and alarms from the optical system.

Bear in mind that the next time you produce a base line, a To access this utility, the work session must be restarted.
log will be generated; to do this it will produce 3 consecutive The lamp must be changed with the analyser in sleeping
base lines. It will take a few minutes longer than normal to mode. If the analyser is on standby mode, the programme
produce these 3 base lines. 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,
2.2.14.5. Fluid system supply the instructions given by the programme must be followed.
The programme starts up the analyser, checks the light
On clicking the Supply button, with the main cover closed,
the analyser fills the fluid system conduits with system
31
User manual

intensity of the optical system, shuts down the analyser multiple controls programming, for multiple controls. The
and then requests the user to remove the lamp holder again average value and the standard deviation are calculated,
and replace it again turning it 180º on the axis of the lamp. respectively, as Xm = (Cmin+Cmax) / 2 and s = (Cmax-Cmin) /
The programme forces waiting periods to prevent the lamp (2k).
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.
2.2.15. Internal quality control

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 The Quality Control screen of the user programme enables
programme and the correction procedures to be followed if access to the quality control results of the analyser. The
the controls do not meet acceptable tolerances. The basic programme memorises all the control results for each test
idea of internal quality control is very simple: one or more and for each sample type. The user can select a test and a
control materials, the controls, are placed between the sample type and the screen indicates, for each control,
patient samples and they are measured together. The result the name, batch, average value (Xm), standard deviation
from the control material is compared with an expected (s), variation quotient CV = 100 s / Xm, and the rejection
value. In this way, it is possible to detect the occasional limits programmed. Whenever a new batch is introduced
existence of anomalies in the measurement procedure. The for one of the controls, the programme automatically creates
use of controls is programmed independently for each a new data sheet and the statistical calculations are reset
measurement procedure from the Test Programming for this new sheet. All the sheets created can be accessed
screen. The analyser automatically proposes the carrying through a dropdown list. A grid displays, for each series
out of controls whenever the work session is reset, in accord performed, the date, concentration, absolute error and
with the tests programmed, and the user simply has to relative error, for each control, and an alert for the rejected
activate them. The user can also launch additional controls series. Absolute error is defined as Eabs = C - Xm, where C
manually. The use of BioSystems valuated control materials is the measured control concentration, and the relative error
and calibrators is recommended. as Erel = Eabs / s. The programme displays the alert for
rejecting a series when the result of one of the controls is
From the test programming screen, the user can programme out of the programmed rejection limits.
the number of controls (0, 1 or 2), the rejection criteria
(between 0.1 and 3 standard deviations), the number of With the memorised data, the programme displays the
replicates (1, 2 or 3), the control type (multiple or specific) corresponding Levey-Jennings graphs. When any of the
and the calculation mode (manual or statistical). The controls of a series exceeds the interval limits Xm ± 2s, the
calculation mode indicates the method used for deciding if programme automatically executes the Westgard algorithm
a series of results is accepted or rejected. and shows the results on the Levey-Jennings graph. This
· In statistical mode, the user must introduce the number algorithm is a set of control rules that are examined
of series. This parameter is the number of data used to sequentially. The result of this algorithm is not used by the
perform the statistical analysis, i.e. to calculate the programme to accept or reject a series. It is presented as
measurement (Xm) and the standard deviation (s). It is graphic information only and the user is who must decide
recommended that it is not above 20. A series of results to accept or reject the series. The programme only displays
is accepted if the values of the controls are within the the rejection alert based on the rejection interval chosen
interval Xm ± ks, where k is the rejection criteria. by the user. The Westgard rules examined are:

· In manual mode, the series of results is accepted if the · 13s: The result obtained on one of the controls exceeds
results of the controls are between the values of Minimum the limits of the interval Xm ± 3s.
(Cmin) and Maximum (Cmax) Concentration, respectively. · 22s: The results obtained on two controls exceed, in the
These values are programmed by the user on the test same way, the limits of the interval Xm ± 2s. This can be
programming screen, for the specific controls, or on the the two controls of one series or one single control on

32
 two consecutive series. New sheet: Enables the creation of a new sheet when the
· R4s: The difference between the results of two controls of 30 series of the current sheet are exceeded. If a new
one series or of one control on two consecutive series is sheet is not created, the following series overwrite the
oldest series. A new sheet is automatically created when
a test parameter is changed.

2.3. 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
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
higher than 4s. with their possible cause and solution. The alarms that
· 41s: Four consecutive results have been obtained, require contact with the technical Assistance Service are
exceeding, in the same way, the limits of the interval indicated. If any of the alarms persists, it is also necessary
Xm ± 1s. This may occur with two controls on two to contact the TAS (Technical Assistance Service).
consecutive series or with one single control on four
consecutive series.
· 10Xm: Ten consecutive results have been obtained, all
greater or all less than the average. This may occur with Machine alarms and alerts
two controls on five consecutive series or with one single General
control on ten consecutive series.
- Analyser cover open. Close the analyser cover. If the
error persists, deactivate the cover sensors from the
Buttons corresponding configuration screen and contact the
TAS. Danger: the main cover of the analyser must
The Quality Control screen has different buttons that let always be closed when it is running.
the user perform different actions:
- Electronics start-up fail. Shut down the analyser and
Graphs: This enables the display of the Levey-Jennings start it up again. If the problem persists, contact the
graphs of the test selected for each control. The squares TAS.
represent the values obtained in the accepted series. When - Error in the Firmware version. Contact the TAS.
a Westgard algorithm rule is activated, the values involved
are represented in circles. In the rejected series, the values Operating arm
are represented by a triangle. The axis of ordinates indicates - The operating arm cannot be started. Check that the
the concentration, at standard deviation s. The horizontal arm is not blocked and that there is no object obstructing
line indicates the number of the series. The horizontal lines its movement.
indicate the multiples of the standard deviation and the
continual lines the programmed rejection limits. - Loss of steps during the functioning of the Z axis. The
arm has collided vertically or is broken. Check that there
Delete: Deletes the series selected on the grid. is no object obstructing the movement of the arm.
Delete Sheet: Deletes the selected results sheet. - Self-elevation safety device broken. Contact the TAS.
Print: Prints a Quality Control report with the data of the
selected test and sample type. It is also possible to Dispensing system
print out the Levey-Jennings graph. • Needle
Edit: Modifies the rejection criteria and the calculation mode. - No needle detected. Check that the needle is correctly
The changes affect the selected sheet only. installed.
Introduce Series: Enables manual introduction of series
up to a maximum of 30 series per sheet.

33
User manual

- Needle is too bent. The needle has been detected to

be outside its safety margins. Check the straightness Work session alarms and alerts
of the needle. If necessary, replace it with a new needle.
Preparations
- Needle level detection error. Contact the TAS.
- Sample volume run out. Add more sample and indicate
• Needle thermostatisation system it to the analyser from the Positions screen for it to
- Needle thermostatisation error. Contact the TAS. The perform the analyses. Check the sample tube is
alarm gives supplementary information to be used by correctly in position.
the TAS to diagnose the breakdown. - Reagent volume run out. Add more reagent and indicate
• Dispensing pump it to the analyser from the Positions screen for it to
perform the analyses. Check the reagent bottle is
- The dispensing pump cannot be started. Contact the correctly in position.
TAS.
Results
• Containers
- Absorbance > 2.5 A. reading with absorbance above
- There is no system liquid container. Place the contai- 2.5 A. Repeat the analysis with the sample pre-dilution.
ner correctly.
- Absorbance OUT. It has not been possible to measure
- There is no waste container. Place the container the absorbance. Repeat the analysis.
correctly.
- Blank absorbance limit exceeded. Reagent in bad
- Waste container full. Empty the waste container. condition. Replace it with a new one.
- System liquid container empty. Fill the system liquid - Kinetic blank absorbance limit exceeded. Reagent in
container. bad condition. Replace it with a new one.
- Error in the container level control system. Deactivate - Test linearity limit exceeded. Repeat the analysis with
the level control scales from the corresponding sample pre-dilution.
configuration screen and contact the TAS.
- Test detection limit exceeded. As a check, the analysis
Reactions rotor and readings can be repeated. If the alert persists, we may consider
- The rotor cannot be started. Check that the reactions the concentration sample null and void.
rotor is not blocked. - Test reference values exceeded. The patient has
- No rotor. Place a rotor in the analyser. pathological results. As a check, the analysis can be
repeated.
- 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,
- No rotor cover. Position the cover correctly. If the error the sample concentration probably exceeds the linearity
persists, deactivate the cover sensors from the limit of the kinetic test.
corresponding configuration screen and contact the
TAS. Danger: the main cover of the analyser must - Calibrator sensitivity error (factor limits exceeded).
always be closed when it is running. Check the status of the calibrator and the reagent.
Repeat the analysis.
• Rotor thermostatisation system
- Calibration curve error. Check the status of the
- Rotor thermostatisation error. Contact the TAS. The multipoint calibrator and the reagent. Repeat calibration.
alarm gives supplementary information to be used by
- Internal quality control alert. Access the Quality Con-
the TAS to diagnose the breakdown.
trol 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.

34
3. Calculation and measurement procedures
This chapter describes the different analysis modes of the are indicated. The analysis modes are the same for blanks,
analyser and the calculations made to obtain the analytical calibrators, controls and samples of patients. The controls
results, i.e. the concentration values of the different analytes are treated in the same way as the patient samples in all
of the samples. In each case, the different formulas used 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.
R1+R2
[...] Absorbance value after adding the second reagent in a bireagent differential method.
[...]T1 Absorbance value in the first reading in a fixed time method.
T2
[...] Absorbance value in the second reading in a fixed time method.
∆A Variation of absorbance of a sample per unit of time (patient or control)
∆t
sample

∆A Variation of absorbance of a calibrator per unit of time

∆t
calibrator

∆A Variation of absorbance of a blank per unit of time

∆t
blank

35
User manual

3.1. End point Asample-Ablank

Csample= Ccalibrator
Acalibrator-Ablank
3.1.1. Absorbance

The absorbance of the reaction is measured once only on

Considering that TR2=1, this formula is equivalent to the
a base line of distilled water. In this procedure, one or two
previous one with a factor
reagents may be used and the absorbance may be
measured at one or two wavelengths. The calibration can
Ccalibrator
be based on the use of multiple or specific calibrators (one F=TR·
or several), or on a programmed factor. For each test, a Acalibrator-Ablank
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. 3.1.2.3. Several calibrators

If a multipoint calibrator is used, the concentration is

3.1.1.1. Monoreagent / Bireagent calculated using a calibration function or curve. This curve
is obtained from the programmed concentration values of
The procedure is different for the tests using one or two the calibrators and the absorbance values measured for
reagents. For the monoreagents, the analyser dispenses each one with regard to the base line Acalibrator, using an
the reagent and the sample in cycle 1 and measures the interpolation method (polygonal or spline) or a regression
absorbance of the reaction during a later cycle, in accord method (linear or quadratic) and linear or logarithmic axes,
with how it is programmed in the test. For bireagents, the in accord with how it is programmed fro each test. With
analyser dispenses reagent 1 and the sample in cycle 1. this curve, the analyser calculates the concentration of the
In a later cycle, it dispenses reagent 2 in the same well sample in accord with its absorbance with regard to the
and then measures the absorbance of the reaction in another base line
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 measured at one or two Up to 50 replicates can be programmed for each sample
wavelengths. In the case of bichromatic readings, the and up to 3 for each blank, calibrator or control.
difference between the absorbance at the main wavelength
and the absorbance at the reference wavelength is taken 3.1.3.1. Blank
as the absorbance value.
The average of the absorbance values measured is taken
Amuestra=[Asample]λmain-[Asample]λrefefence as the absorbance of the blank.
Acalibrator=[Acalibrator]λmain-[Acalibrator]λreference nblank

ΣA
1 i
Ablank=
Ablank=[Ablank]λmain-[Ablank]λreference nblank
blank

i=1

3.1.2. Concentration 3.1.3.2. Calibrator

Based on the absorbance value obtained, the analytical The average of the absorbance values measured is taken
concentration in the sample can be calculated. as the absorbance of the calibrator.
ncalibrator

ΣA
3.1.2.1. Factor 1 i
Acalibrator= calibrator
The concentration is calculated using a programmed fac- ncalibrador
i=1
tor with the formula
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
3.1.2.2. Single calibrator calculations set forth in the previous section to obtain the
If a single point calibrator is used, the concentration is concentration of each replicate of the sample. The average
calculated with the formula value of the calculated concentrations is taken as the
concentration of the sample.

36
 n sample 3.2.2.3. Several calibrators

Σ
1
Csample= Cisample
nsample If a multipoint calibrator is used, the concentration is
i=1 calculated using a calibration function or curve. This curve
is obtained from the programmed concentration values of
3.2. Bireagent differential 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
3.2.1. Absorbance method (linear or quadratic) and linear or logarithmic axes,
The analyser dispenses reagent 1 and the sample in cycle in accord with how it is programmed fro each test. With
1. In a later cycle, it measures the absorbance of the this curve, the analyser calculates the concentration of the
mixture on a base line of distilled water. later, it dispenses sample in accord with its absorbance with regard to the
reagent 2 in the same well and then measures the base line
absorbance of the reaction in a later cycle, in accord with
how it is programmed in the test. The absorbances are Csample=Func[Asample]
measured at one single wavelength. For each test, a blank
is prepared using distilled water instead of the sample or 3.2.3. Replicates
with reagents only. The absorbances of said blank, with
the first reagent and with both reagents, are also measured Up to 50 replicates can be programmed for each sample
on the base line of distilled water. The calibration can be and up to 3 for each blank, calibrator or control.
based on the use of multiple or specific calibrators (one or
several), or on a programmed factor. The difference between
3.2.3.1. Blank
the absorbance measured with the two reagents and the
absorbance measured with the first reagent only is taken The average of the absorbance values measured is taken
as the absorbance value. as the absorbance of the blank.
n blank

ΣA
Asample=[Asample]R1+R2-[Asample]R1 1 i
Ablank= blank
Acalibrator=[Acalibrator] R1+R2
-[Acalibrator] R1 nblank
i=1
3.2.3.2. Calibrator
R1+R2 R1
Ablank=[Ablank] -[Ablank]
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 ncalibrator

ΣA
concentration in the sample can be calculated. 1 i
Acalibrator= calibrator
ncalibrator
i=1
3.2.2.1. Factor 3.2.3.3. Sample
The concentration is calculated using a programmed fac- The average values calculated for the absorbance of the
tor with the formula blank and the calibrator or calibrators are used in the
calculations set forth in the previous section to obtain the
Csample=TR·F·(Asample-Ablank) concentration of each replicate of the sample. The average
value of the calculated concentrations is taken as the
3.2.2.2. Single calibrator concentration of the sample.
nsample

ΣC
If a single point calibrator is used, the concentration is 1 i
calculated with the formula Csample= sample
nsample
i=1
Asample-Ablank
Csample= Ccalibrator
Acalibrator-Ablank 3.3. Fixed time
Considering that TR2=1, this formula is equivalent to the
previous one with a factor 3.3.1. Absorbance

The absorbance of the reaction is read at two particular

Ccalibrator times with regard to a base line of distilled water at one
F=TR· single wavelength. The calibration can be based on the
Acalibrator-Ablank

37
User manual

use of multiple or specific calibrators (one or several), or on is obtained from the programmed concentration values of
a programmed factor. For each test, a blank is prepared the calibrators and the absorbance values measured for
using distilled water instead of the sample or with reagent each one with regard to the base line Acalibrator, using an
only. The absorbances of this blank at the two specific interpolation method (polygonal or spline) or a regression
times are also measured on the base line of distilled water. 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
3.3.1.1. Monoreagent / Bireagent sample in accord with its absorbance with regard to the
The procedure is different for the tests using one or two base line
reagents. For the monoreagents, the analyser dispenses Csample=Func[Asample]
the reagent and the sample in cycle 1 and measures the 3.3.3. Replicates
absorbance of the reaction in two later cycles, at the
moments in time T1 and T2, in accord with how it is Up to 50 replicates can be programmed for each sample
programmed in the test. For bireagents, the analyser dis- and up to 3 for each blank, calibrator or control.
penses 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 3.3.3.1. Blank
in time T1 and T2, in accord with how it is programmed in
The average of the absorbance values measured is taken
the test. The difference between the absorbance measured
as the absorbance of the blank.
at time T1 and the absorbance measured at time T2 is
taken as the absorbance value. n blank

ΣA
1 i
Ablank= blank
T2
Asample=[Asample] -[Asample] T1 nblank
i=1

Acalibrator=[Acalibrator]T2-[Acalibrator]T1
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
ncalibrator

ΣA
Based on the absorbance value obtained, the analytical 1 i
concentration in the sample can be calculated. Acalibrator= calibrator
ncalibrator
i=1

3.3.2.1. Factor 3.3.3.3. Sample

The concentration is calculated using a programmed fac- The average values calculated for the absorbance of the
tor with the formula blank and the calibrator or calibrators are used in the
Csample=TR·F·(Asample-Ablank) 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
3.3.2.2. Single calibrator concentration of the sample.
nsample

ΣC
If a single point calibrator is used, the concentration is 1 i
calculated with the formula Csample= sample
nsample
i=1
Asample-Ablank
Csample= Ccalibrator
Acalibrator-Ablank 3.4. Kinetics
Considering that TR2=1, this formula is equivalent to the
previous one with a factor 3.4.1. Variation of the absorbance per unit of time
Ccalibrator The kinetic mode is used to measure the catalytic activity
F=TR· of an enzyme. The absorbance of the reaction on a base
Acalibrator-Ablank
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.
3.3.2.3. Several calibrators
Based on these absorbance measurements, the analyser
If a multipoint calibrator is used, the concentration is calculates the variation of the absorbance of the reaction
calculated using a calibration function or curve. This curve per unit of time. The calibration can be based on the use of

38
multiple or specific calibrators (one or several), or on a Considering that , this formula is equivalent to the previous
programmed factor. For each test, a blank is prepared using one with a factor
distilled water instead of the sample or with reagent only. Ccalibrator
The absorbances of this blank are also measured on the Csample=TR
base line of distilled water. ∆A ∆A
3.4.1.1. Monoreagent / Bireagent ∆t ∆t
calibrator blank

The procedure is different for the tests using one or two 3.4.2.3. Several calibrators
reagents. For the monoreagents, the analyser dispenses
If a multipoint calibrator is used, the concentration is
the reagent and the sample in cycle 1 and measures the
calculated using a calibration function or curve. This curve
absorbance of the reaction in several later cycles, between
is obtained from the programmed concentration values of
the times Ti (start) and Tf (end), in accord with how it is
the calibrators and the absorbance gradient values measured
programmed in the test. For bireagents, the analyser dis-
for each one with regard to the base line ,
penses reagent 1 and the sample in cycle 1. In a later
cycle, it dispenses reagent 2 in the same well and then ∆A using an interpolation method (polygonal or
measures the absorbances of the reaction at the moments ∆t spline) or a regression method (linear or
calibrator
in several later cycles, between the times Ti and Tf, in quadratic) and linear or logarithmic axes, in
accord with how it is programmed in the test. accord with how it is programmed fro each test. With this
curve, the analyser calculates the concentration of the
3.4.1.2. Checking linearity
sample in accord with the absorbance gradient with regard
Catalytic activity is measured by the speed of the reaction, to the base line
which is proportional to the gradient of the absorbance- ∆A
time curve. This ∆A/∆t gradient is calculated using the li-
Csample=Func [ ∆t ]
sample
near method over the set of absorbances measured between
the times Ti and Tf. The most common units for measuring 3.4.3. Replicates
the gradient are ∆A/min. Depending on the test, the period
of measurements can be different. In general, for the more Up to 50 replicates can be programmed for each sample
common tests, around 13 readings are taken at regular 15- and up to 3 for each blank, calibrator or control.
second intervals. The analyser automatically calculates the
best line of regression by the squared minimums method
3.4.3.1. Blank
and checks the linearity of the measurements base don
the correlation quotient. If the linearity is low, the analyser The average of the absorbance gradient values measured
issues the corresponding alert together with the result of is taken as the absorbance gradient of the blank.
the test.
n blank

Σ
∆A 1 i
3.4.2. Concentration = ∆A
∆t nblank ∆t
blank i=1
Based on the absorbance gradient obtained, the analytical blank

concentration in the sample can be calculated.

3.4.3.2. Calibrator
3.4.2.1. Factor
The average of the absorbance gradient values measured
The concentration is calculated using a programmed fac- is taken as the absorbance gradient of the calibrator.
tor with the formula
ncalibrator
∆A
Σ
∆A i
∆A 1
∆A
Csample=TR·F ( ∆t ∆t
) ∆t =
ncalibrator ∆t
sample blank calibrator i=1 calibrator
3.4.2.2. Single calibrator
3.4.3.3. Sample
If a single point calibrator is used, the concentration is
calculated with the formula The average values calculated for the absorbance gradient
of the blank and the calibrator or calibrators are used in the
∆A ∆A calculations set forth in the previous section to obtain the
∆t ∆t concentration of each replicate of the sample. The average
sample blank value of the calculated concentrations is taken as the
Csample= Ccalibrator
concentration of the sample.
∆A ∆A nsample

ΣC
∆t ∆t 1 i
Csample= sample
calibrator blank
nsample
i=1

39