User manual

English
 User
manual

English

TEUS00040-02-ING
June – 2010
Dear customer,
Thank your for purchasing our semi-automatic
analyser. This semi-automatic analyser is one of
the most technically advanced and easiest to oper-
ate in the market . We are sure that its features will
make it a valued instrument for your laboratory.
Although it can be operated in a logical and simple
way through its menu options, we recommend you
to read this manual carefully. It will help you for
performing the installation and the maintenance
correctly, and will allow you to get the maximum
benefit from its many possibilities.
Table of contents
1. Introduction............................................................................................ 9
2. Description of the instrument............................................................. 10
Operating theory..................................................................................................................... 10
Description of the keyboard................................................................................................... 10
On/Off button....................................................................................................................... 10
Function keys....................................................................................................................... 10
Pump button........................................................................................................................ 10
Description of the screen........................................................................................................ 10
Front indicator . ................................................................................................................... 11
Description of the communications....................................................................................... 11
Printer....................................................................................................................................... 11
Checking the battery status................................................................................................... 11
Suction system......................................................................................................................... 11
Suction cycle........................................................................................................................ 11
Installation of the suction circuit........................................................................................ 11
Measuring with common cuvettes or tubes.......................................................................... 12
Operating method using the menus...................................................................................... 12
View of a menu onscreen and selection of an option....................................................... 12
Selecting a job. Selection route.......................................................................................... 12
Ending a job.......................................................................................................................... 13
Memory positions for programming tests ........................................................................... 13
Entering data........................................................................................................................... 13
Alphanumerical entry......................................................................................................... 13
Numerical entry................................................................................................................... 13
Options selectable from a pre-defined list........................................................................ 14
Special function keys........................................................................................................... 14

3. General operating method.................................................................. 15

Starting the operation. .......................................................................................................... 15
Main menu .............................................................................................................................. 15
Concentration.......................................................................................................................... 15
Identifying the tubes in differential tests.......................................................................... 16
Multi-standard procedures................................................................................................. 16
Multi-test procedures.......................................................................................................... 17
Resolution in measurements, screen, printer and calculations....................................... 19
Absorbance.............................................................................................................................. 19
Utilities..................................................................................................................................... 19
Service.................................................................................................................................. 19
Installing a new program.................................................................................................... 19
Calendar clock...................................................................................................................... 20
Pump adjustment................................................................................................................ 20
Pump test............................................................................................................................. 20
Manual adjustment............................................................................................................. 20
Automatic adjustment........................................................................................................ 20
Luminous intensity.............................................................................................................. 21
Recover deleted tests.......................................................................................................... 21
5
User manual

Default values...................................................................................................................... 21
Configuration....................................................................................................................... 21
Language.............................................................................................................................. 21
Screen contrast.................................................................................................................... 22
Printer activated.................................................................................................................. 22
Printer contrast.................................................................................................................... 22
Reports headline.................................................................................................................. 22
Beep...................................................................................................................................... 22
Wash modes......................................................................................................................... 22
Patient code......................................................................................................................... 22
Enter laboratory data.......................................................................................................... 22
Communications.................................................................................................................. 22
Programming........................................................................................................................... 23
Tests...................................................................................................................................... 23
How to programme parameters......................................................................................... 23
Exit menu.............................................................................................................................. 27
Reviewing a test................................................................................................................... 27
Deleting a test...................................................................................................................... 27
Creating a new test.............................................................................................................. 27
Copying a test...................................................................................................................... 27
Moving a test........................................................................................................................ 27
Units......................................................................................................................................... 27
Table of units........................................................................................................................ 28
Reviewing a unit.................................................................................................................. 28
Deleting a unit...................................................................................................................... 28
Creating a new unit.............................................................................................................. 28
Quality control......................................................................................................................... 28
Control programming......................................................................................................... 28
Lists and graphs................................................................................................................... 28
Operator code.......................................................................................................................... 28
Historic..................................................................................................................................... 28

4. Measurement procedures and calculations....................................... 30

End Point.................................................................................................................................. 31
Absorbance.......................................................................................................................... 31
Monochromatic / Bichromatic............................................................................................ 31
Concentration...................................................................................................................... 31
Factor........................................................................................................................................ 31
Single Standard................................................................................................................... 31
Multistandard...................................................................................................................... 31
Replicates............................................................................................................................. 31
Blank..................................................................................................................................... 31
Standard............................................................................................................................... 31
Sample.................................................................................................................................. 31
Differential............................................................................................................................... 32
Absorbance.......................................................................................................................... 32
Concentration...................................................................................................................... 32
Factor.................................................................................................................................... 32
Single Standard................................................................................................................... 32
Multistandard...................................................................................................................... 32
6
 Replicates............................................................................................................................. 32
Blank..................................................................................................................................... 32
Standard............................................................................................................................... 32
Sample.................................................................................................................................. 32
Fixed Time................................................................................................................................ 33
Absorbance.......................................................................................................................... 33
Concentration...................................................................................................................... 33
Factor.................................................................................................................................... 33
Single Standard................................................................................................................... 33
Multistandard...................................................................................................................... 33
Replicates............................................................................................................................. 33
Standard............................................................................................................................... 33
Sample.................................................................................................................................. 33
Kinetics..................................................................................................................................... 33
Variation in the Absorbance by time unit.......................................................................... 33
Linearity Check.................................................................................................................... 34
Concentration...................................................................................................................... 34
Factor.................................................................................................................................... 34
Single Standard................................................................................................................... 34
Multiple kinetics.................................................................................................................. 34
Quotient Mode........................................................................................................................ 34
Quotient mode calculations................................................................................................ 34
Replicates............................................................................................................................. 34
Discriminating value (Cut-Off)............................................................................................... 34
Monochromatic / Bichromatic............................................................................................ 34
Concentration...................................................................................................................... 35
Direct reaction..................................................................................................................... 35
Inverse reaction................................................................................................................... 35

5. Handling, packing and re-shipping.................................................... 36

6. Maintenance . ....................................................................................... 37
General rules............................................................................................................................ 37
Maintenance of the suction circuit......................................................................................... 37
Disposal of waste..................................................................................................................... 37
Changing the fan filter............................................................................................................ 37

7. Accessories and spares......................................................................... 38

Warranty limits........................................................................................................................ 38
Technical assistance................................................................................................................ 38

8. Technical specifications........................................................................ 39
Optical system...................................................................................................................... 39
Thermostatic system........................................................................................................... 39
Suction system..................................................................................................................... 39
Feeding system.................................................................................................................... 40
Dimensions and weight....................................................................................................... 40
Environmental conditions................................................................................................... 40
Compliance with applicable directives and legislation.................................................... 41

7
1. Introduction NOTICE This semi-automatic analyser is designed
and built exclusively for professional use.
The semi-automatic analyzer is an In Vitro Diagnostics ap- Users must be duly trained in working in a
pliance designed to perform clinical biochemical analyzes clinical analysis laboratory and in using semi-
and turbidimetric analyzes. It is intended solely for profes- automatic analysers for vitro diagnostics.
sional use. Its function is based on measuring the analyte This manual should be carefully read before
concentration present in a sample by means of absorbency starting to operate, paying attention to all the warning and
measurement, after application of one or several reagents. cautions written in it.
Despite the large number of tasks that this semi-automatic
analyzer can perform, and the complexity thereof, it is very
easy to use, based on its menu’s system and its interaction
logic, in such a way that easily-assimilable communication is
established between the user and the equipment.
Besides great reliability in the optics, this instrument offers
versatility in the measurement devices: common cuvettes,
macro cuvettes, micro cuvettes, semi-micro cuvettes and
tubes. The cuvettes are thermoregulated in a rapid and pre-
cise manner by means of a Peltier system.
Its sophisticated software allows for programming of up to
39 different parameters, which define a specific method. It
can store up to 150 different methods. On the other hand, it
is easy to programme and operations are made easier by the
“copy” and “move” commands. Besides the methods, many
other functions of the instrument can be programmed, such
as: laboratory name, language, wash mode, contents of
the print header, communications, etc.
The functionality of this semi-automatic analyzer is com-
pleted by a series of automatic calculation modes that cover
most options in photometric analysis: end point, differential
mode, fixed time, kinetics, ratimetric mode, cut-off as well
as non-linear methods. The calculations also enable the use
of standard, factor and bio-chromatic measuring.

9
User manual

2. Description of the instrument

Operating theory ESC: This is used to quit one job in order to go to the preceding
one in the programme or to abort a process.
The main function of the semi-automatic analyzer is the PAPER: This key is specifically for manually advancing the
measurement of analyte concentrations present in patient printer paper. While it is held down, the paper ad-
samples. vances.
Before taking the reading, the operator must prepare the WASH: This key lets you operate the pump independently of
sample. For this purpose one or another procedure must be the program, allowing you to perform washes of the
followed, depending on the analyte to be determined. The tubing and of the cuvette at any time.
operator must follow the reagents kit method to prepare the
different tubes for reading. Active function key: The keyboard has five function keys
for use at particular times when the programming is
The semi-automatic analyzer is programmed to perform running. An indication at the bottom of the screen
different calculations for obtaining the analyte concentration tells you what active functions are available at any
values, depending on the method. particular time.
Each method has a different programme associated with it Numerical keys: The numerical keyboard is comprised of keys
with specific parameters to be applied at the time of perform- 0 to 9, next to the decimal point and key C.
ing the concentration analysis.
Cursor keys: There are four cursors on the keyboard, two
When the semi-automatic analyzer is in the concentration called vertical cursors (cursor up and cursor down)
analysing mode, it requests the different tubes for analysis and two called horizontal cursors (cursor right and
that have previously been prepared by the operator. After cursor left).
analysing all the tubes, it displays the calculated value of the
concentration.
The semi-automatic analyzer determines the concentrations Pump button
of the analytes based on optical absorbance measurements.
To measure the concentration of a determined analyte, it aspi- On the left side of the front of the semi-automatic analyzer
rates a predetermined volume of the sample and thermosta- is a button whose function is to activate the peristaltic pump
tises it in the flow cuvette, if this method is programmed. when samples are required to be aspirated. In this manual that
The reactions may be biochemical or turbidimetric. In both button will be referred to as PUMP.
cases, the reaction or chain of reactions produced generate
substances that attenuate certain light wavelengths, either
by absorption or by dispersion. Comparing the variation in Description of the screen
the luminous intensity of a particular wavelength on crossing
the flow cuvette when there is a reaction and if there is no The screen is a 320 x 240 pixel liquid crystal display (LCD).
reaction, the concentration of the respective analyte can be The program screen is divided into four sections: the header,
determined. This comparison is quantified with the physical the work section, the message line and the active function
magnitude known as absorbance. In some cases, the con- section.
centration is directly dependant on the absorbance, and in Header: The header occupies the first two lines of the
others, it depends on the variation of the absorbance over screen.  It provides information of a general nature,
time, based on the analysis method. such as the name of the menu in which the pro-
gramme is located, the date, the time and additional
information about the method that is being changed
Description of the keyboard or executed.
Work section: This takes up the next 15 lines, and displays
On/Off button information on executing the methods, the menus,
Its function is to turn the instrument on and off. Keep the but- the graphs, etc.
ton pressed for a few seconds to turn the instrument on or off. Message line: It is shown in reverse video, and displays mes-
sages to guide the user.
Active function section: it occupies the last two lines on the
Function keys screen. They indicate the active functions of the func-
ENTER: This is used to confirm the menu options and accept tion keys located below the screen. The functionality
the data entered. of these keys depends on the part of the programme
that is being run.

10
Front indicator Printer
The front indicator indicates the instrument status. When the The semi-automatic analyzer has a built-in thermal printer
instrument is about to aspirate a sample, the indicator is green that allows for fast, silent printing of the text. Text is printed
indicating that the user can press the pump button. in forty columns.
When the instrument is operating, that indicator lights up
in red.
Checking the battery status
Description of the communications The information on the battery status is shown through a
series of icons on the top left-hand side of the screen. That
At the back of the instrument are two communication connec- information will only be displayed when the battery pack is
tors, one for the serial channel RS-232 and the other for USB installed. That pack is optional.
devices, in addition to the input of the power cable. This icon indicates that the battery pack is being
charged. Once the batteries are fully charged, the icon
RS-232 serial channel
disappears.
This is used to communicate with the PC-Photometer pro-
This icon indicates that the semi-automatic ana-
gramme via the computer. This application enables us to
lyzer is supplied with power from the batteries. And
update the semi-automatic analyzer firmware and send
the batteries are fully charged.
patient and quality control data.
This icon indicates that the batteries are charged to
A dot-matrix printer with a serial connection can also be con-
half their capacity
nected. The external printer must be EPSON compatible. To
print using the external printer, in the PRINTER SETUP menu, This icon indicates that the batteries have run down.
select the following option: external printer. When the batteries are about to run out, the semi-automatic
analyzer will start to beep, warning that it will soon stop
USB connector
functioning.
This connects an external USB memory. To configure it, go to
Charge the expired batteries immediately. Do not leave the
the menu CONFIGURATION/PRINTER and select the option
appliance for too long without charging the batteries.
USB.
To recharge the batteries, plug the semi-automatic analyzer
This icon will appear on the top part of the screen when
into the electricity mains with the power plug and leave it
a USB memory stick is connected.
plugged in for several hours until the battery-charge icon
Every time the semi-automatic analyzer prints something has disappeared.
out, it will generate a results file. This will be stored in the
USB memory, instead of going to the printer. When printing
graphs, the programme generates another file with the graph
in the bitmap format.
Suction system
The names of the files generated are:  for the text file, the The function of the suction system is to handle the samples.
name starts with the letters PR followed by the date in the This section explains how that circuit operates, and gives a de-
format YY-MM-DD. scription of its components and the parameters that control it.
Example: “PR090620.txt”.
A new file is generated every day. For the graph file, the name Suction cycle
has the format: “CON00001.bmp”. When printing out several
graphs, the number of the file will gradually be increased. This cycle involves aspirating the sample to be measured
and transporting it to the flow cuvette. It consists of three
A file will also be created in the concentration menu, that is
consecutive steps:
stored in the USB memory. Each result obtained is added to
a text file with the name “CON_LIMS.LIM”. Suctioning: The sample is suctioned by by the Teflon tubing
up to the programmed volume. At that moment, the
This file generates one line for each result, with the following
lamp is green.
content:
Pump delay: Waiting period from the moment the suctioning
Patient code, test number, concentration, unit and date.
finishes until the positioning commences. The tube or
Each field is separated by a tab, ASCII code (07) and at the vessel with the sample must be pulled out from the
end of each line, a carriage return, ASCII code (10) and ASCII suction tubing during this time. The lamp will change
code (13). to red.
Positioning: The pump activates again transporting the
sample to the cuvette and positioning it suitably for its
measurement. The measured samples are transported

11
User manual

to the waste bottle when new samples are suctioned

or a wash is performed.
Operating method using the
menus
Installation of the suction circuit The semi-automatic analyzer programme is based on the
use of menus to perform the different functions. A menu is
• A suction tube made of Teflon that runs from the cuvette a set of options grouped together in the form of a list, and
and passes out of the apparatus through a metallic guid- numbered. The following list is an example of a menu, in this
ing tube. This tube has a pre-defined length and must case corresponding to the so-called MAIN MENU.
be of the appropriate quality, for which reason original
tubes must always be used. It should not be folded and
have no cracks or creases. If it does, it must be replaced.
• The input adapter for securing the Teflon tubing to the
cuvette.
• The flow cuvette, where measurements are made. It
must be the original cuvette for which the optical system
has been designed and calibrated. In case of breakage or
loss, contact the Technical Assistance Service in order to
acquire a new one with the appropriate characteristics.
To prevent breakage, always keep it inside the cuvette
holder or in the cuvette housing that is located to the
left for that purpose.
• The outlet adapter to which the dosing tube is con-
nected.
• The dosing tube that connects the flow cuvette to the
waste adapter.
• The peristaltic pump, which is the mechanism that to- View of a menu onscreen and selection of an
gether with the tubing, performs the job of suctioning option
and transporting the samples to be measured.
The menus are displayed in windows on the screen. Each
line corresponds with a menu option and is preceded by a
Measuring with common cuvettes number in order. The selected option is displayed on a black
background. Different menu options are selected by using
or tubes the VERTICAL CURSOR keys. Each time one of these two keys
is pressed, the selection bar moves up or down, thus changing
Common cuvettes may be used for measurements. Cuvettes the selected option. Press ENTER to activate the selected op-
can be macro, semi-micro or micro, made of glass or plastic. tion. A fast way to enter an option is by pressing the number
The optical system of the semi-automatic analyzer is de- in front of the option.
signed to make readings with test tubes having diameters
of 12 mm. Their height must be no more than 75 mm since
otherwise it would be impossible to close the cuvette com- Selecting a job. Selection route
partment lid. To read with test tubes, pull the flow cuvette
out, insert in its housing and insert the test tubes adapter On selecting a MAIN MENU option, another menu appears
into the cuvette-holder on the screen. This is a SECOND LEVEL menu. On selecting a
second level menu option, another menu (THIRD LEVEL) may
NOTICE The semi-automatic analyzer is adjusted for appear on the screen. Sometimes, there are more levels of
square cuvettes of 10 mm, so that the abso- linked menus. In all cases, the options are selected simply by
lute absorbance values read using test tubes pressing the option number. Continuing with the example of
will not coincide with the readings of the the MAIN MENU, if we select option 2 (UTILITIES), the following
same sample made with 10 mm cuvettes. For menu will appear:
that reason, tubes must only be used in
methods with CALIBRATOR.

12
 Memory positions for
programming tests
There are 150 memory positions for programming analytical
tests. Each position has a certain number of parameters that
will depend on the ANALYSIS MODE selected.
Each position may contain a test with any measuring proce-
dure and may be stored permanently. The contents of each
position can be deleted, copied or moved. Onscreen the list
of tests is shown in pages of 10 tests per page. To go from one
page to another, use the PAGE DOWN and PAGE UP function
keys, or the VERTICAL CURSOR keys (UP and DOWN), to move
the selection cursor in the required direction. The pages au-
tomatically change when the selection cursor reaches the top
or bottom ends of the screen. The symbols ↑ and ↓ shown at
those ends indicate that there are more pages accessible in the
And if we then select option 3 (CLOCK-CALENDAR), the fol- indicated direction. There are two digits separated by a point
lowing menu will appear: before each test. The first indicates the page being displayed
and second the order number in the list. To get faster access
to a test, use the PAGE DOWN and PAGE UP function keys until
the page containing the desired test is displayed and then
press the test number (second digit).
On pressing the F3 key, FAST ACCESS an option will be displa-
yed giving direct access to the test, by entering its position
number.

Entering data
Three different types of data may be input into the instrument:
alphanumerical, numerical and selections by list.

Alphanumerical entry
When the programme requires an alphanumerical text to be
Press 3 (or ENTER on the option highlighted in black) to end entered, the writing cursor is automatically placed in the first
the selection process and start the job (in this example, pro- position. To input alphanumeric data, proceed as follows:
gramming the date and time). To start this job, it has been • Using the VERTICAL CURSOR keys, letters, numbers and
necessary to select three consecutive options. The expression: symbols can be selected in a rotating way and following
MAIN MENU / UTILITIES /CLOCK-CALENDAR formed by the se- the order of the ASCII table. Select the desired character
lected options is called PATH. From this point, and throughout on the screen above the writing cursor.
this manual, this will be the method for indicating the set of • Go on to the next position by means of the RIGHT CURSOR
consecutive options in the interconnected menus that must key and select another alphanumeric character using the
be selected to perform the job being explained. Sometimes, VERTICAL CURSOR keys. Repeat this step as many times
suspension points will appear in the middle of a path (OPTION as necessary to complete the text. When the cursor is
/ ... / OPTION), meaning that it is necessary to input a parameter moved one empty position to the right, the last selected
between both options. character is repeated and appears in that position.
• Using both HORIZONTAL CURSOR keys, the text can be
Ending a job. scrolled from one end to the other, and the characters in
each position can be modified as many times as required.
The usual way to leave an option is using the function key Press the C key to erase the character selected with the
EXIT (F5). It allows you to return to the previous program step cursor. If you want to abandon the process, press ESC
(generally a menu). The ESC key stops jobs or operations that and the text will be disregarded.
are being processed or rejects modifications, thereby restor-
ing the original values. • To confirm the text press ENTER. The text will be perma-
nently stored. In alphanumerical entries, the CURSORS

13
User manual

have the repeat function. If they are kept pressed for

more than one second, they automatically move forward.
For the user's comfort, there are two function keys, (LETTERS,
SYMBOLS) that place the cursor on the first letter of the alpha-
bet (depending on the selected language or in the special
symbols area in the table.

Numerical entry
It is used when numerical parameter values are required by
the program. To input numerical data, the NUMERICAL KEYS
and DECIMAL POINT of the keyboard are used. In each case,
the programme restricts the number of digits to be entered.
The writing cursor appears in the first position and goes to
the next position on entering a number (or decimal point). If
you want to correct the number before confirmation, press
C and the complete number will be deleted. To confirm the
number (and quit the process) press ENTER. The number will
be permanently stored. Often, the following titles appear on
the display: Current value: Which is the current value of the pa-
rameter (previous data input or default value). New value: The
one which is input and that will be stored on pressing ENTER.

Options selectable from a pre-defined list

In some cases, the user must choose an item or value from
a pre-defined list. When the window containing the list is
displayed on the screen, use the VERTICAL CURSOR keys to
select the item. Press ENTER to confirm the selection.

Special function keys

PAGE DOWN: When a list is too long to fit on the screen, this
function key is activated. It allows subsequent items
in the list to be displayed.
PAGE UP: When a list is too long to fit on the screen, this func-
tion key is activated. It allows previous items in the list
to be displayed.
CONTROL 1: This function appears if the test has quality con-
trols programmed. It tells the program that the sample
being inserted should be taken as Serum Control
number 1.
CONTROL 2: This function appears if the test has quality con-
trols programmed. It tells the program that the sample
being inserted should be taken as Serum Control
number 2.
PRINT: It allows the different lists to be printed out, depending
on which part of the programme is being executed.
This function appears if the option PRINTER in the
CONFIGURATION menu is activated.
STOP PRINTING: It is used to stop printing the list in process.
MORE OPTIONS: This function is activated when more than one
set of active functions is available. It is used to toggle
between one set and another.
EXIT: Returns to the previous menu or screen.

14
3. General operating method
Starting the operation. • OPERATOR CODE: To enter the operator code, which will
be printed in the concentration results lists.
When the equipment is connected, the display shows a screen • HISTORIC: To view the results of the concentrations in
similar to the example below: the patients

The programme performs a self-check of the internal data. When a USB memory stick is connected and the semi-auto-
If there is no problem, when the status bar has been com- matic analyser displays the error message “USB Failure”, to
pleted, the semi-automatic analyser displays the presenta- recover the USB status, press F5, USB REMOVE, remove the
tion screen with the logo, instrument name and programme memory stick and reconnect it.
release. Press ENTER to access the main menu.
If an error is detected, the programme displays a screen with
information on the error detected. To print out that informa-
tion, press F4. Notify the technical service so the problem
Concentration
can be solved. This option allows the calculation of concentrations by using
any of the METHODS previously programmed and stored in
the 150 available memory locations. On selecting this option,
a screen will pop up with a list of the programmed tests:
Main menu After confirming the selection, and depending on how the
HEADER PRINT option is configured in the CONFIGURATION
Select one of these options depending on the job you want menu, the instrument will either print or not print the header
to perform: containing test details.
When the procedure starts, the instrument will request the
• CONCENTRATION: To measure concentrations in accord- input of a base line to adjust the ZERO (that adjustment is
ance with a pre-defined test, that has been programmed usually done with distilled water).
in a memory position. When the adjustment to ZERO is complete, information about
the saved reagent blank and standard values will be displayed
• ABSORBANCES: To measure absorbances.
on the screen and the date on which they were made.
• UTILITIES: To perform operations of interest to the user
From then on, the program guides the user through the test
like, for example, programming the date and time, adjust-
procedure by means of different messages displayed on the
ing the peristaltic pump, etc.
screen. Entering the samples, reagent blank and standards
• CONFIGURATION: To personalise the instrument's con- is started using the function keys. If a flow cuvette is being
figuration. used, press the push button on the left-hand front panel of
• PROGRAMMING: To programme tests or other parameters the instrument to activate sample suctioning. To read com-
that control the different functions of the equipment. mon cuvettes, press ENTER.
• QUALITY CONTROL: To work with the quality control Each time a reading is performed, the absorbance value read
program. is displayed (if there is more than one replicate, the mean is

15
User manual

calculated). If limit values have been programmed like, for If input of a patient code is activated, the instrument will
example, the blank limit, they are displayed on the screen; if ask for the code before each sample is inserted. The code
the absorbance value is higher or lower than this parameter will identify the sample in the printouts.
(depending on whether it is increasing or decreasing, respec-
tively), arrows are displayed to indicate that the reading is
outside the limits. Identifying the tubes in differential tests
The semi-automatic analyser will request two tubes for
performing the blank in programmed tests with differential
analysis modes. There are two options for preparing the blank
(see Table 3.1), use the most appropriate option depending
on the reagent method.

Temporary modification of parameters

Before entering the baseline, the function key MODIFY appears
active, which allows the user to make a temporary modifica-
tion to the test parameters. Modifications made using this
method are lost on quitting the test.

Tubes requested by the semi-automatic

analyser
Option 1 Option 2
Reagent Working Reagent Working
When reading of all the replicates is complete, they can be blank reagent blank reagent
activated and deactivated by pressing F1 (as long as there is Distilled
more than one), with the absorbance mean being recalcu-    
water
lated each time. Replicate editing is completed by pressing Reagent A 
ENTER. After all the replicates have been entered, the results
Working
are printed out.  
reagent

Table 3.1 Options for performing the blank

Multi-standard procedures
In these calculation modes, several points are used to produce
the standard curve. In programming the test, the number of
standards is programmed and the value of the concentration
of each standard.
After entering the base line, the saved values are displayed
on the screen, including the last saved standard curve (if
there is one).

If the CONTROLS option in the CONFIGURATION menu is

activated, CONTROL 1 and CONTROL 2 function keys are dis-
played as being active during the sample insertion process.
When pressed, the program takes the sample being inserted
as serum-control 1 and 2, respectively.
The program indicates at all times the replicate of the sample
or control to be inserted. If the programmed value of the Lin-
earity Limit is other than zero, the program will indicate if the
concentration result is outside that linearity limit by means
of arrows against the mean absorbance value.

16
If you want to use these values, press the SAMPLE function Multi-test procedures
key to start sample insertion.
This type of procedures is applied in the case of tests requir-
If you want to enter a new blank, press the NEW BLANK
ing two or more readings of the same sample, when several
function key. If you do not want to use the standard curve
samples are processed simultaneously with the incubation
displayed and want to enter a new one, press NEW STANDARD.
performed outside the equipment.
The screen then changes to input new standards.
The absorbance of the samples is read sequentially and the
readings are then repeated for the same samples and in the
same order, at fixed time intervals. In this way, two readings
(multi-fixed time) or more (multi-kinetics) are done for a series
of samples at programmed time intervals.
Once zeroed with the base line, the display requests the
number of samples to be processed. The number must be
within the range displayed, a function of the delay and the in-
terval times programmed. Input the number and press ENTER.
The multi-test process is started by pressing ENTER again. The
display shows the number of the sample to be inserted and
beeps at the precise time it must be suctioned; once the pro-
grammed delay time is completed, the instrument requests
the second sample and sequentially the rest until the first
reading of all the samples is accomplished. In tests using a
standard, it is requested and processed at the beginning of
the test, like in the single-test procedures.
The program asks the user to enter the new standards and The instrument then waits for the interval time to perform
calculates the mean if there is more than one replicate. After the second reading of the first and the following samples,
entering them, press EXIT to accept the data displayed on the displaying a waiting message. The display will show again the
screen. Press ESC to reject them. sample number and a beep warns that it must be suctioned.
After confirmation, the program returns to the previous A second reading of all the samples is thus obtained.
screen and displays the graph of the standards with their read
In the case of multi-kinetics, the process will continue until
absorbances. By means of the cursor keys, you can move a
the programmed number of intervals is completed.
graphic cursor along different points of the curve (with their
corresponding replicates). On the right side of the screen the At the end of the measurement process, the instrument will
values are displayed for each standard (concentration, mean display and print the results obtained for each sample. The
absorbance, etc.). results of the diverse samples and the single delta values are
By pressing ENTER on any of the absorbance points, it changes available using the VERTICAL CURSORS.
to edit mode allowing any value to be cancelled or reactivated
if it has already been cancelled. Resolution in measurements, screen, printer
Pressing F2 again returns to the standard value input screen and calculations
allowing any previously entered value to be edited by pressing
F1 and then the cursor keys. To return to the graphic screen The absorbances are measured with a resolution of 0.0001A,
press F5. although they are displayed on the screen and printed out
rounded to the third decimal. Calculations are made taking
When you consider the curve to be correct, press F1 to save
the measured absorbances with a resolution of 0.0001A. The
the graph. When saved, only the mean values of the replicates
number of decimals used to express the concentration can
are displayed and none of the points can be cancelled.
be programmed within the test parameters.
The program can detect the following errors in the standard
curve (see Table 3.2)
By pressing MORE OPTIONS, a new set of active functions is Absorbance
displayed:
With this option, it is possible to directly read absorbances.
• F1 to change the X axis from linear to logarithmic and
The work section is divided into two parts. At the top, the
vice-versa.
parameters used to make the readings are shown, which
• F2 to change the Y axis from linear to logarithmic. are programmable. The semi-automatic analyser always
• F3 to change the interpolation mode: polygonal, re- saves and displays the last parameters used, with the results
gression straight line, regression curve and spline. (see displayed at the bottom.
Table 3.3) After entering the base line by pressing F1, the program
requests the input of samples. Every time the ENTER key or
17
User manual

Error messages Cause of error Solution

Non-saved graph No value saved. This appears when Taking the readings
executing the test for the first time or
change the number of standards while
programming the parameters.
Non-increasing X values The concentration values in the test Review the concentration values in the
programming are not increasing test programming
Non-monotonic Y values The absorbance values of the standards - Reread the standards absorbance.
are not increasing or decreasing, based - Change the interpolation mode or
on the test programming (increasing or value of the X and Y axes
decreasing)
Negative Y values The absorbance values give a negative - There is an air bubble in the flow cu-
result. vette. Repeat the reading
Table 3.2 Error messages in the multistandards mode

2,2 2,2

2
POLYGONAL 2
SPLINE

1,8 1,8

1,6 1,6

1,4 1,4

1,2 1,2

1 1

0,8 0,8

0,6 0,6

0,4 0,4

0,2 0,2

0 0
1 2 3 4 5 0 1 2 3 4 5 6

2,2 2,2
REGRESSION REGRESSION
2 CURVE 2 CURVE

1,8 1,8

1,6 1,6

1,4 1,4

1,2 1,2

1 1

0,8 0,8

0,6 0,6

0,4 0,4

0,2 0,2

0 0
1 2 3 4 5 1 2 3 4 5

Table 3.3 Interpolation modes

18
pump button is pressed, a new measurement is taken. Dur- Press F1 to configure some of the parameters only for this
ing the sample input process, F4 allows the user to return to module. The parameters to be configured are: screen contrast,
parameter modification to change their values. language and the communications port parameters: baud
rate, time-out and terminal number.
After that the apparatus continues to wait to receive the new
program sent from the PC.
Once transmission of the new programme has started, the
screen displays the number of bytes received. At the end of
the process the following message appears:
End Communications
Once this message appears, you can press the key F5, and
quit this option. The semi-automatic analyser restarts with
a new version program.
The whole operation could take several minutes.
NOTICE If for any reason on leaving this option the
instrument fails to respond, or if an event
occurs such as a power failure during the
programme transmission, there is a method
for restoring control of the semi-automatic
analyser. Turn the semi-automatic analyser
Utilities off and then on again, keeping the PUMP button pressed,
and the CHANGE PROGRAMME screen will appear. The pro-
This menu option allows a series of general utility operations
gramme transmission process will have to be repeated.
to be performed. These operations are described in detail in
the following sections. The programme can be updated through the USB memory
stick. To do this put the USB memory stick in the connector
with the programme that is to be installed.
Press the USB option (F3) and a menu will appear for you to
select which part of the programme you want to update:
1. Application programme (firmware) (.bin)
2. Default setup values (.con)
3. Default test parameter values (.tec)
4. Home screen logo (.bmp)
5. Chinese characters (restricted use)
6. Korean characters (restricted use)
7. Save test parameters (.tec)
Select one of the above options using the UP and DOWN cur-
sors and the ENTER key. A list of all the available files found in
the USB memory will be displayed onscreen. Select the file to
Service be updated and press ENTER.
This option is only of interest to specialist technical staff. Ac- When starting to read and save the programme, a screen
cess to it is restricted by a PASSWORD. will appear with the number of bytes being loaded until the
operation is completed. That process may take a few minutes.
Installing a new program On completion the text “Please waiting” and “Data saving”
will appear and the user is returned to the main menu. Press
This option allows new versions of a program to be installed Exit (F5) twice to return to the new release of the application.
through a PC. To install a new version, the instrument must
be connected to a PC by a serial cable and have a suitable
installation program (PC-Photometer) that is supplied with Calendar clock
the instrument. The program itself gives the instructions to
be followed. This option allows the user to modify the programmed date
and time. Press F1 to change the date and F2 to change the
By selecting this option you enter a different programme that time. Two figures are required for all the fields. Put a 0 before
controls the change of the application programme releases.

19
User manual

a single figure. Press ENTER to accept the change or ESC to On completion of the cycle, check to ensure that the suctioned
reject it. volume is the same as the programmed one and that the
sample is correctly transported to the cuvette.

Manual adjustment
This mode of adjustment allows the pump to be manually
adjusted by entering the parameters explained below using
the keyboard.
SAMPLE VOLUME: This corresponds with the adjustment of
the suctioned volume. Input the number of steps the
pump must run to in order to suction 5 ml and press
ENTER. The theoretical value is 18340, equivalent to
0.2725 ml per step. The number to be input is an esti-
mate and must be determined by the 'trial and error'
method using the TEST function
POSITIONING: This corresponds with the adjustment of the
sample position. Input the number of steps required to
Pump adjustment position the sample in the cuvette, leaving suctioned
sample remains of just 5 mm (0-10) without entering
This option allows the user to adjust the flow of the peristaltic into the cuvette, and press ENTER. The theoretical value
pump and the positioning of the sample in the flow cuvette. is 600 steps. The number to be input is an estimate and
Through usage and the passing of time, the dispensing tube must be determined by the 'trial and error' method
of the peristaltic pump suffers slight deformation which may using the TEST function
lead to the sample volume not being exactly the same as the
PUMP DELAY: The time elapsed between the suctioning cy-
one programmed. Because of this, it is advisable to perform
cle and the flow cuvette positioning cycle. Input the
adjustment of the peristaltic pump periodically and also
number of seconds (2 seconds is recommended) and
after changing the tube.
press ENTER.
On selecting this option, a screen is displayed like the one
below:
Automatic adjustment
To adjust the pump automatically (recommended), proceed
as follows::
• Press the SAMPLE VOLUME function key. The words “Insert
tube with 5 ml of water and press PUMP” appear in the
message line.
• Pipette exactly 5 ml of water into a test tube and position
at the sample input so that the end of the Teflon tube as
at the bottom of the test tube and press the PUMP button.
• The instrument suctions about 4 ml of water at normal
speed and then at slow speed. Then, the following mes-
sage is displayed on the screen: “On suctioning the last
drop press ENTER”. Carefully observe the bottom of the
test tube and, when the last drop is drawn up into the
suctioning tube, press ENTER.
Pump test • Press the POSITION function key. The words “Insert tube
This option allows you to enter a SAMPLE VOLUME between with water and press PUMP” appear in the message line.
100 and 5000 μl, and to perform suctioning cycles in order to • Position the test tube containing distilled water at the
check the programmed parameters. On selecting this option, sample input and press PUMP. The pump is activated and,
input the SAMPLE VOLUME and press ENTER. after a few seconds, the following message is displayed
From that point on, a suctioning and positioning cycle starts on the screen: “Remove the tube and press ENTER.” Follow
each time the PUMP button is pressed. these instructions. The pump is activated and the instru-
ment calculates the position. Throughout this process the
instrument performs photometric readings, so the cuvette

20
 carrier lid must be kept closed. The process takes about NOTICE As this option does not allow you to undo the
70 seconds. action, it must be used very carefully and only
On completion of this process, the suctioning system will have when you are sure that you want to lose all
been automatically calibrated. It is advisable to perform a test user-programmed data and restore the fac-
by pressing the TEST function key. tory data.

Luminous intensity
This allows you to establish the amount of light generated for
each wavelength, and, therefore, to establish the sensitivity
of the instrument for each wavelength.
The instrument reads the sensitivity for each of the wave-
lengths programmed in the table of wavelengths and
displays each wavelength's sensitivity on the screen as well
as the number of counts of the principal photodiode and
the number of counts of the reference photodiode for each
wavelength. On completion, the results are printed.

There is also the option of deleting the saved concentration

values. Each time you perform a concentration measurement,
the value is saved in the semi-automatic analyser memory.
If the results are not read with the PC programme, they will
accumulate in the instrument's memory. The memory has
sufficient capacity for 2000 concentration results, and once
that capacity is reached, the first value stored is lost.

Configuration
This option allows the user to adapt some of the instrument
By pressing ENTER, the test is performed again.
aspects to his/her personal preferences.
This test can be done without cuvettes (sensitivity to air) or
with cuvettes. If a flow cuvette is used, it must be filled with
distilled water (the WASH key can be used for that purpose).
Consult the technical service regarding the reference values
for the integration time values and number of accounts.

Recover deleted tests

This operation allows you to recover tests that have been
deleted from the programming menu. A list containing all
the deleted tests that can be restored is displayed. Select the
test to be restored using the cursor keys and press ENTER to
restore it. Press F3 and the test will be completed deleted.

Default values
This option allows the user to restore the pre-programmed
factory values. Press F1 to restore the Configuration param- Language
eters, F2 for the test parameters, F3 for the saved results values
and F4 for the saved quality control values. This option allows the user to select one of the available lan-
guages that the instrument will use for screen display and
text printouts. To select the language, first press ENTER on the
21
User manual

LANGUAGE option and then use the VERTICAL CURSOR keys in the u ser can select the information printed in the lists while
the displayed window containing a list of available languages. the tests are being conducted. By pressing ENTER on this op-
tion, a window is displayed containing the following three
NOTICE The proper correspondence between pro- options:
grammed names (like tests, units, etc.) when
changing languages, is only made when the SUMMARISED: Only some of the data connected with the test
change is done between western languages are printed out, such as the test name, date and time,
or from western to oriental ones. any saved values (factor, blank, standard) and normal
values (if they have been programmed).E
This means that, for example, when selecting
an oriental language, if editing the name of a test (even COMPLETE: All the test parameters are printed out, including
though western characters are used or simply by entering the programmed values.
the editing mode and leaving without changing anything), NONE: Nothing is printed out.
on changing the oriental eastern language to a western one,
a string of unreadable characters will appear in the place of
the test name. Beep
this option allows the user to activate or deactivate the beep
Screen contrast indicating that a key has been pressed. By pressing ENTER on
this option, a window is displayed containing the ACTIVATE /
This option allows you to adjust the intensity of the screen DEACTIVATE options.
(contrast). The intensity of the screen (contrast) is defined by
a number between 1 and 15, which can be changed by using
the VERTICAL CURSOR keys and then pressing ENTER on the Wash modes
option. The effect produced is immediately visible after each
The WASH key is used to circulate a wash solution or water
press of the VERTICAL CURSOR keys.
through the suctioning circuit for the purpose of cleaning it
at the end of a series of measurements or between samples.
Printer activated By means of this option, it is possible to program the volume
(between 100 and 5000 μl) of wash solution that will be suc-
This option allows you to select one of the following options: tioned each time the WASH key is pressed. If the value 0 is left
in this option, continuous washing will be performed, that is,
• Deactivate the internal printer.
the pump will operate as long as the WASH key is held down.
• Activate the internal printer.
• Print using an external printer connected to the RS-232
serial port. Patient code
• Save the printed results in a text file in the USB memory If activated, each time a new sample is inserted, the program
stick. will request a patient code. By pressing ENTER on this option,
• Print using the internal printer and simultaneously save a window is displayed containing the ACTIVATE / DEACTIVATE
the results in the USB memory stick. options.
On pressing ENTER on this option, a window will pop up with
the previous options. These are selected using the VERTICAL Enter laboratory data
CURSORS and pressing ENTER on the selected option.
This option allows a title of up to 30 alphanumeric characters
to be programmed, using the ALPHANUMERIC INPUT proce-
Printer contrast dure (15 if an oriental language is selected). After entering the
title, press ENTER to accept it or ESC to reject it.
This option allows you to adjust printing on thermal paper
so that slight variations in the paper quality can be compen- The text inserted is printed every time the semi-automatic
sated for. The intensity of the screen (contrast) is defined by analyser is switched on.
a number between 1 and 10, which can be changed by using
the VERTICAL CURSOR keys and then pressing ENTER on the
option. The TEST function key (F1) prints out a line of asterisks Communications
to check the selected intensity.
Allows some parameters to be programmed for communica-
tions between the instrument and a PC.
Reports headline • Baud rate: Select one of the following baud rates: 110,
150, 300, 600,1200, 2400, 4800, 9600, 19200.
When absorbances or concentrations are going to be meas-
ured, a header is automatically printed. Through this option

22
• Timeout: The waiting time between attempts to commu-
nicate if a communications error occurs. Programmable
between 0 and 255 seconds.
• Terminal number: Identification number of the semi-au-
tomatic analyser. If several instruments are connected
to one PC, they must have different terminal numbers
(between 0 and 15).

Programming
This menu has two options: one for programming tests and
the other for programming the table of units.

NOTICE The pre-programmed tests are compatible

with Biosystems reagents. We advise they be
used to complete the system. Reagents whose
measurement procedures, as described in the How to programme parameters
instructions for use, are compatible with the
specifications of the instrument may also be This section explains how to enter or change the parameters
employed. of the tests, which will depend on the analysis mode selected.
On changing or creating a test, only the parameters that have
a meaning in the analysis mode selected will be visible.
Tests Table 3.4 shows the different parameters activated for each
analysis mode.
This option allows the parameters of a test to be programmed
in each of the 150 positions available in the semi-automatic
analyser.
On selecting the TESTS option, a list of available tests is
displayed,as is a set of active function keys with the different
functions available:
PAGE DOWN: Displays the page in the list with the next 10 tests.
PAGE UP: Displays the page in the list with the previous 10
tests.
EXIT: Exits the previous menu.
MORE OPTIONS: Displays a new set of functions on the screen.
MOVE: Allows the order in which tests are displayed to be
changed.
DELETE: Enables tests to be deleted.
ADD: Allows new tests to be created.
COPY: Allows new tests to be created by copying all the pa-
MEMORY LOCATION
rameters of the selected test. A number is added at the
end of the test name to distinguish it from the original. The position of the memory in which the test is stored is not
PRINT LIST: Prints out a list of names of all the programmed a parameter that can be programmed by the user. Locations
tests. are managed automatically by the program. When a new
test is added, it is always placed in the last position in the list,
PRINT CONTENT: Prints out the contents of previously selected
provided there is one free. If none is available, the program
tests. will search for the first empty location in those that have been
deleted (if there are any). However, the user can personalise
the order of the test list displayed by means of the MOVE
function key.
NAME
The name of the test may be any title composed of one
or several words up to a maximum of 20 alphanumeric
characters (10 if an oriental language is selected).

23
User manual

Parameter Calculation mode

PF C MD TF CM TFM MC CO
Test name        
Units        
Analysis mode        
Type of reaction      
Reading mode  
Reading wavelength        
Reference wavelength  
Aspiration vol.        
Temperature        
Decimal places        
Blank replicates   
Sample replicates    
Stabilisation time   
Incubation time    
Reading time    
Delay  
Number of deltas 
Initial absorbance    
Standard      
Factor      
Number of standards   
Conc. standard 1      
Conc standards 2 to 8   
Standard replicates   
Dilution factor   
Calculation function   
Scales   
Numerator coefficient 
Denominator coefficient 
Cut-off value 
Indetermination margin 
Linearity limit      
Blank limit   
Table 3.4 Calculation mode parameters

24
UNITS BICHROMATIC: Two readings are taken of each sample. One
Unit titles can be found in a programmable table. By press- at one wavelength and the other at a secondary or
ing ENTER on this option, the program displays a window reference wavelength
containing the programmed table of units. Select one of The absorbance value used for the calculations in
them by placing the VERTICAL CURSOR keys on it and press this case is the difference between both absorb-
ENTER. Table 3.5 shows the units that are programmed ances:
with the instrument. A = Aλmain - Aλreference
Nº Units READING Wavelength
0 mg/dL It is the wavelength in nanometers at which it is desired to
1 U/L make the measurements. In BICHROMATIC mode, it refers
2 g/L to the main wavelength. Table 3.6 shows the wavelengths
the equipment is usually equipped with and their respec-
3 μkat/L
tive positions.
4 μmol/L
5 mmol/L Position Wavelength
6 μg/L 1 340
7 nkat/L 2 405
8 g/dL 3 505
9 μg/dL 4 535
10 UI/mL 5 560
11 % 6 600
Table 3.5 Pre-programmed units 7 635
8 670
ANALYSIS MODE
Table 3.6 Wavelenght table
By pressing ENTER on this option, the program displays
a window containing all the possible modes of analysis. REFERENCE Wavelength
Those analysis modes may be the following:
Only in BICHROMATIC reading mode. It is the secondary or
PF End point reference wavelength. Table 3.6 shows the wavelengths
the equipment is usually equipped with and their respec-
C Kinetics
tive positions.
MD Differential Mode
ASPIRATION VOLUME
TF Fixed Time
The volume (in mL) of a sample, blank and/or standard
CM Multiple Kinetics to be suctioned for the measurements. The permitted
TFM Fixed Multiple Time margin is between 100 and 5000 ml. Take into account
MC Quotient Mode that the less the volume suctioned, the more the carryover
contamination between two consecutive samples will be.
CO Cut-Off
Table 3.4. shows an evaluation of carryover for different
REACTION TYPE sample volumes (these values may vary considerably,
depending on the nature of the liquid being measured).
On pressing ENTER on this option, the programme displays
a window with the following two options: INCREASING / Sample volume Contamination (%)
DECREASING. Indicating whether the absorbance of the 200 μL < 3%
programmed test increases or decreases with time or
300 μL < 1%
based on the concentration.
400 μL < 0.5 %
READING MODE
For END POINT and CUT-OFF modes only. On pressing
ENTER on this option, the programme displays a window BLANK REPLICATES
with the following two options: The number of blank replicates requested when the test
MONOCHROMATIC: A single measurement is made of each is being performed. The permitted margin is between 1
sample at the selected wavelength. and 3.

25
User manual

SAMPLE REPLICATES CONCENTRATION

The number of sample replicates requested when the test Only displayed for tests with a standard. It is the concentra-
is being performed. The permitted margin is between 1 tion of each standard.
and 3. STANDARD REPLICATES
STABILIZATION TIME The number of replicates that will be requested of each
Time elapsed between the end of the suctioning cycle standard.
and the measurement in END POINT, DIFFERENTIAL and The permitted margin is between 1 and 3.
QUOTIENT modes. It is usually one second, though other DILUTION FACTOR
values can be programmed, allowing the measurement
to be delayed until the liquid homogenises perfectly in Only displayed in MULTISTANDARD mode. This is used
the cuvette, especially when working with highly viscous when all the samples are diluted, but the standards are not.
liquids. CALCULATION FUNCTION
INCUBATION TIME For MULTISTANDARD modes only. The type of graphic
The time lapsing from the pressing PUMP to the first meas- function with which the calculation of the standard curve
urement in the FIXED TIME y KINETICS mode. will be associated. There are four options to choose from:
POLYGONAL
READING TIME
SPLINE
In simple Kinetics, the period of time during which read- REGRESSION STRAIGHT LINE
ings are taken and in multiple Kinetics, the time between REGRESSION CURVE
deltas. For Fixed Times, it is the period between T1 and T2. X AXIS
NUMBER OF DELTAS For MULTISTANDARD mode only. Select the type of data
For MULTIPLE KINETIC mode only. The number of intervals representation on the X axis.
desired. Equivalent to the total number of measurements LINEAR
minus one (deltas). LOGARITHMIC
AXIS Y
DELAY
The time between samples in multiple tests. For MULTISTANDARD mode only. Select the type of data
representation on the X axis. There are two options to
INITIAL ABSORBANCE choose from:
For KINETIC and FIXED TIME modes only. For an increasing LINEAR
reaction, it is the maximum admissible absorbance value LOGARITHMIC
for the first reading. For a decreasing reaction, it is the mini- LINEARITY LIMIT
mum admissible absorbance value for the first reading.
Maximum linearity limit If it exceeds that limit, the pro-
TEMPERATURE gram gives a warning message. If it is not desired to check,
Temperature at which it is desired to thermostat the input 0.
cuvette. Programmable between 23 and 40°C with a reso- BLANK ABSORBANCE LIMIT
lution of one degree. If it is not desired to thermostatize,
The absorbance limit value that a blank can take. If it ex-
input 0.
ceeds that limit, the program gives a warning message. If
DECIMALS it is not desired to check, input 0.
Number of decimals that are displayed for concentration MAXIMUM NORMALITY LIMIT
results.
Maximum limit for normal values. That value is printed
CALIBRATION with the results and is shown onscreen. If not wishing to
On pressing ENTER on this option, the programme displays show it, leave 0
a window with the following two options: STANDARD / MINIMUM NORMALITY LIMIT
FACTOR. Specifies whether the calculation of the concen-
Minimum limit for normal values. That value is printed
tration will be done with standards or a factor.
with the results and is shown onscreen. If not wishing to
FACTOR show it, leave 0
Only displayed if FACTOR is selected in CALIBRATION. This REAGENT 1 COEFFICIENT
will be value used to transform absorbances into concen-
For QUOTIENT mode only. It is the multiplier coefficient
trations expressed in the selected units.
for reagent 1.
NUMBER OF STANDARDS
REAGENT 2 COEFFICIENT
Only displayed in MULTISTANDARD mode. Indicates the
For QUOTIENT mode only. It is the multiplier coefficient
total number of standards to be used by the test.
for reagent 2.

26
CUT-OFF VALUE (DETECTION THRESHOLD) the screen with the options YES / NO. To accept and save the
For CUT-OFF mode only. Minimum concentration of meas- changes and/or new values entered, select YES.
ured substance that gives rise to a physical change or sign
in a qualitative procedure. Reviewing a test
INDETERMINATION MARGIN
To review a test, select the test from the test list using the
For CUT-OFF mode only. The value for the indetermination VERTICAL CURSOR keys and press ENTER.
zone in the detection threshold (cut-off ).
CONTROL 1
Deleting a test
This option allows you to choose whether or not to activate
control number 1. To delete a test, select the test from the test list using the
The two options are: YES / NO. VERTICAL CURSOR keys and press the DELETE function key. The
On selecting YES, a function key is activated while the test program asks for confirmation before proceeding to delete.
is being executed to enter serum-control 1.
NAME OF CONTROL 1 Creating a new test
The name of serum-control 1 may be any title composed of
To create a new test, press the function key ADD and then
one or several words up to a maximum of 16 alphanumeric
programme the parameters that determine it.
characters (8 if an oriental language is selected).
CONTROL BATCH 1
Copying a test
The serum-control 1 reference may be any title composed
of one or several words, containing a maximum of 16 This option is useful if it is wished to create a new test that is
alphanumerical characters. similar to an already-existing one. Proceed as follows: select
CONTROL 1 MAXIMUM the model test from the test list using the VERTICAL CURSOR
keys and press the COPY function key. The programme will
Maximum value foreseen for serum-control1. create a new test with all the parameters of the original test,
CONTROL 1 MINIMUM except the name.
Minimum value foreseen for serum-control1.
CONTROL 2 Moving a test
This option allows you to choose whether or not to activate This option allows you to change the position of a test in
control number 2. the presentation list. Proceed as follows: select the test you
The two options are: YES / NO. want to move using the VERTICAL CURSOR keys and press the
On selecting YES, a function key is activated while the test MOVE function key. From that point on, every time you press
is being executed to enter serum-control 2. a VERTICAL CURSOR key, the name of the test will move up or
down depending on the key pressed. Press ENTER to confirm
NAME OF CONTROL 2
the new location.
The name of serum-control 2 may be any title composed of
one or several words up to a maximum of 16 alphanumeric
characters (8 if an oriental language is selected). Units
CONTROL BATCH 2
The concentration values obtained on executing the different
The serum-control 2 reference may be any title composed tests must be expressed in their corresponding units. In order
of one or several words, containing a maximum of 16 that the user is not at all restricted, the instrument permits the
alphanumerical characters. programming of the units that are desired. Each unit is formed
CONTROL 2 MAXIMUM by a text of maximum eight characters and is stored in a table
with up to 50 positions (22 if an oriental language is selected).
Maximum value foreseen for serum-control2.
CONTROL 2 MINIMUM
Minimum value foreseen for serum-control2.

Exit menu.
After programming all the test parameters, press the EXIT
function key to exit. The message “SAVE VALUES?” will appear
in the message line, and a window will open in the centre of

27
User manual

Control programming
This option displays a list of the names of programmed tests.
After selecting a test, the controls can be activated / deacti-
vated and their values can be programmed (in the same way
as for programming or reviewing a test).
Using the UP and DOWN function keys, the parameters of the
previous or next test are displayed without having to quit the
parameter editing mode.
The DELETE HISTOR.1 and DELETE HISTOR.2 function keys
delete the respective records of the selected test.

Table of units
This option allows you to program the table of units in which
there are 50 available locations (22 if an oriental language is
selected).
On selecting the TABLE OF UNITS option, a complete table of
the programmed units is displayed in columns.

Reviewing a unit
To review a unit, select it from the list using the CURSORS and
press the key ENTER. Lists and graphs
This option displays a list of the names of programmed tests.
Deleting a unit After selecting a test and pressing ENTER, the last 30 controls
are displayed on the screen in Levey-Jennings graphic form
To delete a unit, select one from the list using the CURSOR
applying the Westgard rules if possible.
keys and press the DELETE function key. The program asks
for confirmation before proceeding to delete.

Creating a new unit

To create a new unit, select an empty location in the table
using the CURSOR keys and press ENTER. Input the new unit
using the alphanumeric input method. The unit may be any
title formed by a maximum of 8 alphanumerical characters.

Quality control
This option provides access to the quality control manage-
ment program based on Levey-Jennings graphs and Westgard
rules.
On selecting the quality control option, the following two
options are displayed: The display of data for control 1 or control 2 is selected using
PROGRAMMING CONTROL the CONTROL 1 and CONTROL 2 function keys.
LISTS AND GRAPHS The PRINT LIST function key prints a list of the control values,
and PRINT GRAPH prints a graph.
The semi-automatic analyser keeps a historic record of up to
30 values for each control and test.

28
Operator code
This allows you to activate or deactivate a request for an op-
erator code every time the instrument is turned on. From this
option in the menu you can also modify the last code entered.

Historic
This enables you to see the saved values of the patients'
concentration results. Select the result with the VERTICAL
CURSORS and press ENTER to see all the information on that
result. The following information is displayed:
Date
Patient code
Test
• USB (F3): This option appears when a USB memory stick
Concentration
Factor is connected and the printer setup option is in USB. On
Blank pressing the key, a text file is created in the USB memory
stick with the name: “HIS_ LIMS. LIM”. This file generates
one line for each result, with the following content:
Patient code, test number, concentration, unit and date.
Each field is separated by a tab, ASCII code (07), and at
the end of each line, a carriage return, ASCII code (10)
and ASCII code (13).
• DELETE HISTORIC (F5): This allows you to delete the con-
tent of the memory in which the historic values are stored.
The semi-automatic analyser has sufficient capacity to
memorise up to 2000 results. In the case of there being a large
number of memorised results, for instance, more than 100,
the actions in this menu may take a little while to execute.

The function keys have the following functions:

• MORE OPTIONS (F4): This allows you to change the set of
options of the function keys.
• EXIT (F5): This allows you to exit the option in the historic
menu.
• PAGE FORWARD and BACKWARD (F1, F2): Both options al-
low you to move through the results displayed on screen
in groups of 10.
• 10 PAGE FORWARD and BACKWARD (F1, F2): Both options
allow you to move through the results displayed on
screen in groups of 100. It is only activated if there are
more than 100 results memorised.
• TEST ORDER/DATE ORDER/PATIENT ORDER (F3): This allows
you to order the results by date, patient code or test.
Every time the key is pressed, the box in which the list is
ordered changes.
• CONSUMPTION (F3): This displays the total number of
tests performed on screen. You can choose whether you
want to show the consumption for a certain range of
dates or show the total consumption. To print out this
information press F5.
29
User manual

4. Measurement procedures and

calculations
This chapter reviews the different measuring procedures blanks, standards, controls and samples. Controls are treated
based on the analysis mode and the calculations that are like samples for every calculation.
made to obtain the concentration values. The different formu-
las used are shown. Measurement procedures are the same for

The following abbreviations are used in the formulas:

Ablank Blank absorbance.

Astandard Standard absorbance.
Asample Absorbance of the sample.
[···] λmain
Absorbance at main wavelength.
[···]
λreference
Absorbance at reference wavelength.
[···] R1+R2
Absorbance of the blank, standard or sample with the two reagents (global reaction).
[···] R1
Absorbance of the blank standard or sample with the first reagent (reaction of the sample blank).
[···] T1
Absorbance of the blank, standard or sample measured after incubation 1
[···] T
Absorbance of the blank, standard or sample measured after incubation 2
AFRAC Absorbance of the fraction.
ATOTAL Total absorbance.
∆A/min Velocity of change of absorbance of the blank, standard or sample.
Csample Concentration of the sample.
Cstandard Programmed concentration of the standard.
n Number of replicates.
F Programmed standard factor.
Fixed factor, depending on the type of reaction. Its value is (+1) for increasing reactions and (-1) for decreas-
TR
ing reactions.
Coeffnum Coefficient of the numerator.
Coeffdenom Coefficient of the denominator.
Vcut-off Cut-off value
Id Margin of uncertainty.

30
End Point Multistandard
If a multipoint standard is used, the concentration is calculated
Absorbance
using a standard curve or function. This curve is obtained from
The absorbance of the reaction is measured just once against the programmed concentration values of the standards and
the distilled water baseline. In this procedure, one or two the absorbance values measured for each one with respect to
reagents can be used and the absorbance can be measured the baseline Astandard, using an interpolation method (polygonal
at one or two wavelengths. Calibration is based on the use of or spline) or regression method (linear or quadratic) and linear
standards (one or several) or a programmed factor. A blank is or logarithmic axes, as programmed for each test. Through
prepared for each test with reagent alone. The absorbance of this curve, the analyser calculates the sample concentration
the blank is also measured against the distilled water baseline. based on its absorbance with respect to the baseline

Csample=Func[Asample]
Monochromatic / Bichromatic
The absorbance can be measured at one or two wavelengths.
In the case of bichromatic readings, the absorbance value is Replicates
taken as the difference between the absorbance at the main
Up to 3 replicates can be programmed for each sample, blank,
wavelength and the absorbance at the reference wavelength
standard or control.
Asample=[Asample]λmain-[Asample]λreference

Astandard=[Astandard]λmain-[Astandard]λreference Blank
Ablank=[Ablank]λmain-[Ablank]λreference The blank absorbance is the average of the measured absorb-
ance values

Concentration nblank
1
Based on the value of the absorbance obtained, the concen- Ablank =
nblank
∑A
i =1
i
blank
tration of the analyte in the sample can be calculated.

Factor
Standard
The concentration is calculated, using a programmed factor,
with the formula The average of the measured absorbance values is taken as
the standard absorbance

Csample=TR·F·(Asample-Ablank)
n standard
1
Single Standard
Astandard =
n standard
∑A
i =1
i
standard

If a standard is used at a single point, the concentration is

calculated with the formula

Sample
Asample − Ablank The average values calculated for the blank and standard or
Csample = ⋅ Cstandard
Asample − Ablank standards absorbance is used in the calculations described
in the previous section to obtain the concentration of each
sample replicate. The average value of the calculated concen-
trations is taken as the sample concentration

Considering that TR2 = 1, this formula is equivalent to the

above with a factor nsample
1
Csample =
nsample
∑C
i =1
i
sample

Cstandard
F = TR ⋅
Astandard − Ablank

31
User manual

Differential Multistandard
If a multipoint standard is used, the concentration is calculated
Absorbance using a standard curve or function. This curve is obtained from
the programmed concentration values of the standards and
The absorbances are measured at only one wavelength. For the absorbance values measured for each one with respect to
each test, a blank is prepared using distilled water instead of the baseline Astandard, using an interpolation method (polygonal
the sample or just reagents. The absorbances of this blank, or spline) or regression method (linear or quadratic) and linear
with the first reagent and with both reagents, are also meas- or logarithmic axes, as programmed for each test. Through
ured against the distilled water baseline. Calibration is based this curve, the analyser calculates the sample concentration
on the use of standards (one or several) or a programmed based on its absorbance with respect to the baseline
factor. The absorbance value is the difference between the
absorbance measured with both reagents and the absorbance
measured with just the first reagent Csample=Func[Asample]

Asample=[Asample]R1+R2-[Asample]R1 Replicates
Astandard=[Astandard]R1+R2-[Astandard]R1 Up to 3 replicates can be programmed for each sample, blank,
standard or control.
Ablank=[Ablank]R1+R2-[Ablank]R1

Blank
Concentration The blank absorbance is the average of the measured absorb-
Based on the value of the absorbance obtained, the concen- ance values
tration of the analyte in the sample can be calculated.
nblank
1
Factor Ablank =
nblank
∑Ai =1
i
blank

The concentration is calculated, using a programmed factor,

with the formula

Standard
Csample=TR·F·(Asample-Ablank)
The average of the measured absorbance values is taken as
the standard absorbance
Single Standard
If a standard is used at a single point, the concentration is n standard
1
∑A
calculated with the formula i
Astandard =
n standard i =1
standard

A − Ablank
Csample = sample ⋅ Cstandard
Asample − Ablank
Sample
Considering that TR2 = 1, this formula is equivalent to the The average values calculated for the blank and standard or
above with a factor standards absorbance is used in the calculations described
in the previous section to obtain the concentration of each
Cstandard sample replicate. The average value of the calculated concen-
F = TR ⋅ trations is taken as the sample concentration
Astandard − Ablank

nsample
1
Csample =
nsample
∑C
i =1
i
sample

32
Fixed Time the absorbance values measured for each one with respect to
the baseline Astandard, using an interpolation method (polygonal
or spline) or regression method (linear or quadratic) and linear
Absorbance or logarithmic axes, as programmed for each test. Through
this curve, the analyser calculates the sample concentration
The absorbance of the reaction is read in two specific times based on its absorbance with respect to the baseline
with respect to the distilled water baseline at just one wave-
length. Calibration is based on the use of standards (one or
several) or a programmed factor. Csample=Func[Asample]
The absorbance value is the difference between the absorb-
ance measured at time interval T1 and the absorbance meas-
ured at time interval T2 Replicates
Up to 3 replicates can be programmed for each sample,
Asample=[Asample] -[Asample]
T2 T1 standard or control.

Astandard=[Astandard]T2-[Astandard]T1
Standard
The average of the measured absorbance values is taken as
Concentration the standard absorbance

Based on the value of the absorbance obtained, the concen-

tration of the analyte in the sample can be calculated. n standard
1
Astandard =
n standard
∑A
i =1
i
standard

Factor
The concentration is calculated, using a programmed factor,
with the formula
Sample
Csample=TR·F·Asample The average values calculated for the blank and standard or
standards absorbance is used in the calculations described
in the previous section to obtain the concentration of each
Single Standard sample replicate. The average value of the calculated concen-
trations is taken as the sample concentration
If a standard is used at a single point, the concentration is
calculated with the formula
nsample
1
Csample =
nsample
∑C i
sample
A i =1

Csample = sample ⋅ Cstandard

Astandard
Considering that TR2 = 1, this formula is equivalent to the
Kinetics
above with a factor
Variation in the Absorbance by time unit
The kinetic mode is used to measure the catalytic activity
C of an enzyme. The absorbance of the reaction against the
F = TR ⋅ standard distilled water baseline is measured regularly during several
Astandard cycles, between time intervals Ti and Tf as programmed in
the test. The readings are taken at only one wavelength.
Based on these absorbance readings, the analyser calculates
the variation in the absorbance of the reaction by time unit.
Multistandard Calibration is based on the use of standards (one or several)
or a programmed factor.
If a multipoint standard is used, the concentration is calculated
using a standard curve or function. This curve is obtained from
the programmed concentration values of the standards and

33
User manual

Linearity Check at defined intervals of time. The concentration is calculated

by multiplying the average increases (or decreases) in absorb-
The catalytic activity is measured by the velocity of the reac- ance per minute by a factor or in reference to a standard.
tion, which is proportion al to the slope of the absorbance
curve as opposed to the time. This slope ΔA/Δt is calculated
using the linear regression method for all the absorbances
measured between time intervals Ti and Tf. The most com-
Quotient Mode
mon units for measuring the slope are ΔA/min. The analyser This analysis mode calculates the ratio between two fractions
obtains 30 readings at regular intervals, and then automati- of a sample.
cally calculates the best regression straight line using the
least squares method.
Quotient mode calculations
Concentration The sample concentration is calculated using the following
Based on the value of the absorbance obtained, the concen- formula:
tration of the analyte in the sample can be calculated.

coef num ⋅ AFrac

Factor Csample = F ⋅
coef denom ⋅ ATotal
The concentration is calculated, using a programmed factor,
with the formula
Replicates
∆A
Csample = TR ⋅ F ⋅
∆t sample Up to 3 replicates can be programmed. In this case, the cal-
culation formula is the following:

nsample
1
Single Standard Csample =
nsample
∑C
i =1
i
sample
If a standard is used at a single point, the concentration is
calculated with the formula

∆A
∆t sample Discriminating value (Cut-Off)
Csample = ⋅ Cstandard
∆A The absorbance of the reaction mixture is measured once
against the distilled water baseline. A blank is prepared for
∆t standard each test with reagent alone. The absorbance of the blank is
also measured against the distilled water baseline.

Considering that this formula is equivalent to the above with Monochromatic / Bichromatic
a factor
The absorbance can be measured at one or two wavelengths.
Cstandard In the case of bichromatic readings, the absorbance value is
F = TR ⋅ taken as the difference between the absorbance at the main
∆A wavelength and the absorbance at the reference wavelength
∆t standard
Asample=[Asample]λmain-[Asample]λreference

Astandard=[Astandard]λmain-[Astandard]λreference
Multiple kinetics
To calculate the concentration in multiple kinetics, calculation
by deltas is used. For each sample, a first reading is taken of
the absorbance against the distilled water baseline, after a
programmed incubation period. Then new readings are taken

34
Concentration
Based on the value of the absorbance obtained, the concen-
tration of the analyte in the sample can be calculated. The
result depends on the type of reaction: direct or inverse.

Csample=TR·F·(Asample-Ablank)

Direct reaction
The results follow the criteria established in the following
table:
Margin uncetainty
I d = Vcut −off ⋅
100

Condition Result
Csample > Vcut-off+Id +
Csample < Vcut-off+Id -
Vcut-off-Id < Csample < Vcut-off+Id ?

Inverse reaction
The results follow the criteria established in the following
table:

Condition Result
Csample > Vcut-off+Id -
Csample < Vcut-off+Id +
Vcut-off-Id < Csample < Vcut-off+Id ?

35
User manual

5. Handling, packing and re-shipping

If the semi-automatic analyser
is to be stored for a certain period
of time, it is advisable to clean the
fluids circuit thoroughly. First of
all with a washing solution and
then with distilled water. Empty
the fluid from the circuit after
cleaning. Remove the silicone
dosing tube from the housing
of the peristaltic pump. Protect
the semi-automatic analyser
from environmental aggressions
such as dust, excessive humidity
or direct sunlight.
If it is necessary to re-ship the
semi-automatic analyser, or
move it using a vehicle, use the
original packing to ensure the
appliance does not suffer any
damage.

36
6. Maintenance
To ensure optimal functioning of the semi-automatic ana-
lyser, it is necessary to follow certain minimum standards of
Disposal of waste
maintenance. The semi-automatic analyser has a waste bottle where
the remains of samples and reagents can be stored after the
measuring operation. To dispose of this waste correctly and
General rules safely, the general criteria regarding good laboratory practices
apply, which the clinical laboratory staff should be familiar
Never use detergents or abrasive products to clean the out- with, in addition to the local or national legislation in force in
side of the instrument. Use only a cloth dampened in water the country where the instrument is installed.
and neutral soap. The waste contained in the bottle constitutes
NOTICE
•• If a reagent or corrosive product spills onto the appara- a biological risk for the operator. Always wear
tus, wipe it immediately with a cloth dampened in water. gloves and a laboratory gown and goggles
•• The cuvette holder tray is designed to prevent penetra- when handling the waste bottle.
tion of liquid into the inside of the instrument. If liquid is
spilt onto the tray, wipe it with a damp cloth.
•• If a cuvette breaks in the cuvette holder or liquid pours
into it for any reason, the holder has a drainage hole con- Changing the fan filter
nected to the outside. It will, however, be necessary to
rinse and dry the inside of the cuvette holder. •• Rotate the semi-automatic analyser (1) to access the
base of the instrument.
•• Remove the 4 screws (2) from the fan cover.
Maintenance of the suction circuit •• Change or clean the dust filter (3) of the fan. To clean
the filter, wash it with water and let it dry before putting
•• It is necessary to clean the suction circuit properly after it in place again.
each series of measurements and at the end of the day.
•• Put the filter back into its housing.
•• On completing a series of measurements, wash the suc-
tion circuit with abundant distilled water. At the end of •• Replace the screws.
the working day, wash thoroughly with a detergent solu-
tion such as the one provided with the instrument (code
AC10415). Lastly, rinse with distilled water and empty the
circuit by performing wash cycles with air. 2
•• Lastly, to increase the life of the peristaltic pump tub- 3
ing, it is advisable to remove it from its mounting when
not in use, so that it remains loose and without tension.
On starting a new work session, re-insert it in its place.
•• If the outer end of the suction tube is damaged, several
millimeters can be cut off the end, with a clean, per-
pendicular cut. In that case, readjust the positioning 1
parameter of the peristaltic pump.
•• Replace the tube if it becomes damaged. Always use
original spares.

37
User manual

7. Accessories and spares

If any of the accessories should become damaged or lost, or AC10455 European mains cable
if any consumables should be needed such as paper for the
printer, always use original materials. Below is a list of all the
spares that are necessary. In that case, contact your habitual
distributor and order the spares quoting their respective AC10456 American mains cable
codes. This will make work easier and reduce errors.

Code Description AC14694 English mains cable

AC15416 Installation manual (mul-

ti-language) + User man-
ual (In CD-ROM) AC15055 Voltage adapter

AC10466 RS-232 serial cable

AC15161 Roll of paper

AC10243 “PC‑Photometer” Soft-

AC15056 Flow cuvette
ware CD

AC14773 Battery pack

AC15160 Teflon tube

AC15057 Cuvette outlet fitting

AC10413 Peristaltic pump dosing

tube Warranty limits
Improper use (falls, negligence, electrical mains outside toler-
AC10414 3x6 mm (200 cm) silicone
ances, inappropriate environmental or location conditions)
tube
and the internal manipulation of the instrument by persons
not authorised by the manufacturer or without using original
AC10453 Test tube adapter consumables and spares (tubes, etc.) will render the war-
ranty invalid.

AC10454 Waste bottle Consumer components such as the peristaltic pump tubes,
Teflon tubes and battery pack are not included in the warranty.

Technical assistance
Contact your habitual distributor to request information
AC15111 Fan filter about:
• Training in how to use the semi-automatic analyser.
• After-sales Service Request Protocol.
AC10415 Bottle of washing solu- • Updating the programme.
tion (100 mL)

38
8. Technical specifications
NOTICE The manufacturer declines all responsibility for damages caused due to incorrect use of the equipment.

Optical system
Light source LED lamp
Nominal range –0.2 to 3.5 A
Nº of wavelengths 8
Wavelengths installed 340, 405, 505, 535, 560, 600, 635, 670
Free wavelength positions 2
Band width of each wavelength 10 ± 2 nm
Wavelength error ± 2 nm
Digital resolution 0.0001 A for 2.0 A
Resolution on screen 0.001 A
Baseline stability: better than 0.001A in 60 minutes
Measuring precision For 340, 405 and 505 nm:
CV ≤ 1% at 0.1 A
CV ≤ 0.1% at 2 A
Trueness of the measurement For 340, 405 and 505 nm:
±5% at 0.1 A
±2% at 1.0 A
±2% at 2.0 A
± 5% at 3.0 A
Noise less than 10 within the range of 0 to 2A
-3

Thermostatic system
Thermostatation range 25 to 40º C
Trueness of the temperature ± 0.5ºC
Temperature stability ± 0.2º C in 30 minutes

Suction system
Suction tube (external length) approx. 100 mm
Flow cuvette
Length of light passage 10 mm
Diameter of light passage 1.5 mm
Volume 18 μL
Quality of the glass optical
Normal cuvettes macro, semimicro, micro
Test tubes round base with a diameter of 12 mm x 75 mm in length

39
User manual

Peristaltic pump
Type of operation stepper motor
Nominal flow 10 mL/min
Suction volume 100 μL to 5000 μL
Cross contamination < 3% at 200 μL
< 1% at 300 μL
< 0.5% at 400 μL
Waste bottle capacity 1L

Feeding system
External feeder
Voltage 100 to 240 V AC
Frequency 50/60 Hz
Output voltage 15V CC
Output power 30W
Instrument power consumption
Maximum 12 W without battery module
24W with battery module installed and in full load process
Average 5W performing measurements
Minimum 2W on standby
Optional battery system
Capacity 2000mAh
Minimum duration 2 hour with batteries fully charged

Dimensions and weight

Maximum dimensions 420 x 350 x 216 mm (16.5 x 13.7 x 8.5 in)
Weight with battery pack 4290 gr (9.43 lb)
Weight without battery pack 4000 gr (8.8 lb)

Environmental conditions
Use interior
Height < 2000 m
Room temperature 10º C – 35º C
Maximum relative humidity 85%
Installation Category (Excess voltage Category) II
Grade of contamination 2

40
 Compliance with applicable directives and legislation
EC Directive 98/79 on medical devices for vitro diagnostics.
EN 61010-1:2002 “Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1 - Gen-
eral requirements”
UNE EN 61010-2-101:2004 “Particular requirements for vitro diagnostics (IVD) medical equipment”
UNE EN 61326-1:1999+A1:2000+A2:2003+A3:2005+ERR:2002 “Electrical equipment for measurement, control and labora-
tory use –ECM requirements. Part 1: General requirements”.
UNE EN 55022:2000+A1:2002+CORR:2002 “Limits and methods of measurement of radio interference characteristics of
information technology equipment”.
Continuous conducted: Class B
Radiated: Class B
UNE EN 61000-3-2:2002 “Electromagnetic compatibility (EMC) – Part 3: Limits –Section 2: Limits for harmonics current emis-
sions (equipment input current < 16A per phase)”
UNE -EN 61000-3-2:2002 “Harmonic current”
UNE -EN 61000-3-3:1997+Corr:1999+A1:2002 “Flickers”
UNE -EN 61000-4-2:1997+A1:1999+A2:2001
UNE -EN 61000-4-3:2003+A1:2004 “Radiated inmunity”
UNE -EN 61000-4-4:1997+A1:2001+A2:2002 “Fast transient /Burst”
UNE -EN 61000-4-5:1997+A1:2001 “Surge transients”
UNE -EN 61000-4-6:1998+A1:2001 “Conducted immunity”
UNE -EN 61000-4-11:1997+A1:2001 “Voltage disp short interruptions and voltage variations immunity”
UNE EN 22233-02 (ISO 2233-1986). Test packaging conditions.
UNE EN 24180-2-1992 (ISO 4180-1980) Packing of complete and full shipments.
UNE EN 22247-1992 (ISO 2247-2000). Fixed low frequency vibration test.
UNE EN 22248-1992 (ISO 2248-1985). Vertical free-fall shock test.

The manufacturer reserves the right to modify the technical specifications without notice.

41
 Manufactured by: BioSystems, S.A.
Costa Brava, 30, 08030 Barcelona - Spain Tel: 34-93 311 00 00 Fax: 34-93 346 77 99
e-mail: [email protected] http://www.biosystems-sa.com