Operator Manual BT4500-00ING PDF

OPERATOR MANUAL
P/N: MO6313-00ING
Rev. 1, Feb. 2012
This product conforms to the safety requirements of the Council Directives 98/79/EEC of 27
October 1998 (European Parliament) regarding the In-Vitro Diagnostic Medical Devices. This
directive is in accordance with the Article 2, Paragraph 2 of the Directive 89/336/EEC, which
ceases to apply to the products complying with the present directive. Refer to Paragraph 7,
Article No.1 of the IEC Official Gazette No. L331 of Dec. 1998.
It also conforms to Italian Regulations CEI EN 61010-01 and CEI EN 61326-1 (EMC).
The conformity is attested when the equipment is installed in accordance with the conditions
outlined in the manual
Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
Tel. +39-06-4112316
Fax +39-06-4103079
E-mail: bt@biotecnica.it Website: www.biotecnica.it
IMPORTANT NOTICE ON THE USE OF THE UPS DEVICE
ATTENTION!
BIOTECNICA INSTRUMENTS ANALYZERS MUST OPERATE

ONLY IF CONNECTED TO AN UPS DEVICE.
BIOTECNICA WILL NOT BE RESPONSIBLE FOR ANY DAMAGE

TO THE ANALYZER OR INJURY TO PERSONS IF THE
ANALYZERS ARE OPERATED WITHOUT THE PROPER
CONNECTION TO THE UPS DEVICE OR WITHOUT THE UPS
ITSELF.
BT4500 OPERATOR MANUAL
CHAPTER 1
GENERAL INFORMATION & SYSTEM DESCRIPTION Page
1. MANUFACTURER........................................................................................ 2
2. ANALYZER IDENTIFICATION AND INTENDED USE..................................2
3. STORAGE AND HANDLING........................................................................ 3
4. WARNINGS AND PRECAUTIONS............................................................... 3
5. ANALYZER INTRODUCTION....................................................................... 5
6. BASIC OPERATING PRINCIPLES OF THE ANALYZER.............................6
7. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS......7
8. BRIEF DESCRIPTION OF THE SYSTEM..................................................10
8.1. Front view of the analyzer........................................................................................ 10
8.2. Modules.......................................................................................................................11
IMPORTANT NOTICE
The introduction of access passwords has been
rendered mandatory since 2004 for safeguarding
sensitive data.

Via Licenza, 18
Chapter 1 General Information & System Page 1 of 11

Description
1. MANUFACTURER
The BT4500 analyzer is produced by Biotecnica Instruments S.p.A., in its factory located in Rome,
Italy.
Biotecnica was founded in 1972, based on a lot of technical expertise and manufacturing know-how
in the design, production, sales and technical assistance of standard and OEM clinical chemistry
equipment and relevant reagent products destined for private and state clinical laboratories
(hospitals, clinics, day hospitals, and universities etc.). Since that time the company has developed
and produced the instruments of uncompromising performance characteristics, which has enabled
Biotecnica to become one of Europe’s leading manufacturers of clinical chemistry instruments.
Biotecnica is headquartered in Rome (Italy) and markets products both domestically and
internationally through a network of distributors.
Our actual range of instruments is composed basically of:
- Automatic analyzers for clinical chemistry.
- Flame photometers
- I.S.E. analyzers
Biotecnica has over 3000 square meters of manufacturing facility, which houses the latest in
engineering, manufacturing, testing and quality control equipment and is staffed by highly
experienced personnel.
The company supplies more than just products – it provides highly efficient technical and
manufacturing support based on the requirements of its customers supported by ongoing training
programs to keep you current on advances in technology. With a global network of distributors and
sales engineers, you can be assured of the most comprehensive customer support wherever you
are in the world.
For more information about Biotecnica, visit the Biotecnica web site at w w w. b i o t e c n i c a . i t
Please do not hesitate to contact us and we will be only too pleased to assist with any inquiries you
may have.
2. ANALYZER IDENTIFICATION AND INTENDED USE

The BT4500 analyzer is an automatic analyzer for clinical chemistry and I.S.E. determination in
serum, urine, plasma, CSF.
It is equipped with an external computer for the operative program and data management.
Although the BT analyzer system uses high performance components, which provide a high degree
of safety, it is essential that the user takes the usual precautions to safeguard himself and to ensure
a safe working environment.
Biotecnica Instruments S.p.A. only guarantees the workmanship and materials of its products. It is
the duty of the user to take care of safe operation and no amount of warnings can take place of
such care.
As regards the moving parts in the analyzer, these have been appropriately protected to avoid any
potential risks to the user, and for proper instrument operation and safety. However, it is highly
recommended to exercise extreme care during analyzer operation and especially when working
close to the devices.
The analyzer is to be used in laboratories by well qualified personnel. To avoid accidental
contamination during work, the operators should use suitable guards and/or personal protection,
such as overall and gloves. When handling reagents, it is advisable to observe good laboratory
practice (GLP) rules.
Chemicals, serum samples and reagents must be handled with extreme caution. Patient samples
may be biologically hazardous. The reagents or any other substances that may enter in contact with
samples should be treated in the same way as samples themselves.
The materials of human origin, such as control sera, are tested for the detection of HbsAg, anti-HCV
anti-HIV-1 anti-HIV–2 antibodies. Even if the result is negative, as no known analytical method can
exclude any infection’s risk with certainty therefore these materials must be considered as
potentially infective and thus must be handled with extreme caution. The reagents must be
Description
manipulated (before, during and after the use) by qualified personnel familiar with their
characteristics in order to safeguard the user as well as the quality of the reagent itself.
Operating Principles
Generally, adding a sample to its reagent determines a chemical reaction (involving enzymes and/or
substrates) whose effect is to increase (or decrease) the solution color and thus the optical density
in the cuvette. As the reaction proceeds, it is "read" by the analyzer in terms of "absorbance" ("A" or
"Abs" for absorbance).
As every analyte has its own reagent with its proper characteristics, it becomes necessary to use
different methodologies (preparation and reading) based upon different wavelengths for each test.
Many tests are based on similar principles, hence they will have in common the method and the
wavelength, but not necessarily the incubation and reading times.
To obtain the concentration of an analyte in a sample, the analyzer multiplies the absorbance (or the
absorbance delta ∆A = absorbance variation) developed by that sample reaction with a
multiplication factor.
Besides some analyses for which a theoretical factor is used, usually the factor is calculated by
means of a calibration. During the calibration the analyzer reads the reaction obtained with a known
concentration sample called "standard". The factor is calculated by dividing the known concentration
value by the absorbance read for the standard.
For the non-linear analyses (e.g. immunoturbidimetric tests) it is necessary to create an interpolation
curve by means of several standards at different concentrations.
3. STORAGE AND HANDLING

The analyzer can be stored, when packed, at room temperature. In any case the analyzer must be
kept, both packed or operating, between 18 °C and 32 °C, 10% to 90% RH, non condensing.
For moving the analyzer at least two persons are necessary. The analyzer is equipped with four
wheels for easier transportation.
4. WARNINGS AND PRECAUTIONS

The following warnings will aid the user to provide adequate safeguards to assure safe
trouble-free performance:
1. before operating this system, be sure to read the operator manual thoroughly and carefully.
Afterwards, keep it handy for future reference.
2. take special care to follow the warnings and cautions indicated on the system rear panel as well
as in the operator manual.
3. system’s use should be restricted to lab’s qualified personnel only.
4. slots and openings in the case, back panel, and bottom are provided for ventilation. This
ensures reliable operation of the system and protects it from overheating. Do not block or cover
these openings.
5. before using the system, check that the voltage matches the local line voltage.
6. to guarantee safety the system must be properly grounded. In case of doubts contact the
nearest qualified electrician.
7. in case of need, replace fuse as marked. Prior to the removal of any fuse, turn power off and
unplug the cord from the wall.
8. under no circumstances is this instrument case to be opened. This instrument is not user
serviceable, unless where stated in this manual. Dangerous high voltages inside the instrument
case. In event of difficulty, please notify your dealer for prompt service.
9. for operating safety, do not install the system in a location where it will be exposed to heating
equipment or radiators, direct sun light, or any other source of extremely high temperatures.
10. do not operate the system in the presence of flammable fluids or gaseous atmosphere,
disinfecting agents, cleaning agents, etc., due to possible fire or explosion.
11. do not kink, bend, lay object on, or otherwise damage or restrict cables and tubes.
Description
12. be sure that the power switch on the side panel of system is off when plugging in, or removing
the power cord from a wall outlet.
13. turn off the mains power switch on the side panel whenever the system is not in use. this
prevents damages due to surge in the mains power.
14. do not attempt to alter the shape of any part of the system.
15. if the system is not operating properly and the trouble-shooting section does not provide a
satisfactory solution to the problem, then do not use the system until the defects are remedied.
16. inspect all accessories and system cords. Do not use if damage can be seen such as cut
insulation or outer covering, frayed or broken wires, corroded or broken connectors etc.
17. to reduce the risk of fire or electric shock, do not allow fluids or any foreign object to enter the
system. Wipe off spills immediately.
18. do not use benzene, thinner, any kind of solvents, or abrasive detergents to clean the case.
Clean with soft dusting cloth dampened with distilled water. If necessary use only neutral
detergent.
19. do not stick objects of any kind into the system through back panel or case slots as they may
touch dangerous voltage points or short out parts that could result in fire or electric shock.
20. install the system in such a way that adequate ventilation is provided all around to properly
dissipate the heat.
21. use only original Biotecnica’s replacements. Do not use conventional parts/replacements. This
will cause malfunction of the system.
22. make sure all fluid lines are free of kinks, nicks, sharp bends, punctures, or occlusions before
installing on system.
23. the halogen lamp must be replaced some minutes after the instrument has been turned off and
power cord unplugged.
24. always allow the burnt out lamp to cool down before handling or attempting replacement.
25. never touch the lamp or the reflector with bare fingers. use a rag when changing.
26. if the lamp is touched inadvertently during installation, clean the lamp or reflector with alcohol
and dry with a clean, soft cloth before burning. Contamination of the lamp or reflector may
reduce lamp performance.
27. this lamp (when lit) emits UV (ultraviolet) radiation. prolonged exposure to this lamp may cause
skin and eye irritation.
28. the analyzer system must not be dismantled or repaired by anyone who has not been qualified
by the manufacturer. Incorrect work may cause fire or irreparable damage to the system.
29. do not overload accessories power outlets and extension cords as this can result in fire or
electric shock.
30. use only secure power source to protect the analyzer system against power surges.
31. do not oil any part of the system.
32. empty waste containers whenever they are full. Ensure that the container lids are screwed on
tightly to prevent leakage or dispersion into the environment.
33. the safe disposal of the analyzer waste material with minimal environmental impact is the
responsibility of the user and will have to meet the local laws and dispositions.
34. do not attempt to remove any panels or coverings of the analyzer system while the system is in
operation.
35. after operation/servicing, cover the system with a protective plastic or cloth sheet.
36. do not use software disks of unknown origin in the analyzer computer as they may introduce
viruses.
37. do not use the computer of the analyzer for any other purpose than the one for which it is
designed for.
38. be particularly cautious that no parts of your body (e.g. fingers hair, etc.) or loose objects (e.g.
cables, tubing, etc.) can be trapped by any moving or rotating parts (e.g. sampling arm, plates,
washer module, pump rollers etc.) of the analyzer system.

Description
NOTE:
a) the careful observation of the proceeding warnings should result in a long and satisfactory
performance. If the above-mentioned notices are not fully observed, then any form of warranty is no
longer valid and Biotecnica Instruments S.p.A. will not be responsible for any subsequent damage
or loss. (see warranty conditions).
b) the information in this manual is based upon the hardware and software currently in use.
Biotecnica Instruments S.p.A. reserves the right to make software and hardware changes or
improvements for product enhancement without notice and without imposing any obligation upon
itself to install these changes or improvements on its products previously manufactured.
5. ANALYZER INTRODUCTION
This instrument is an automatic analyzer for Clinical Chemistry, I.S.E. and Immunoturbidimetry
manufactured by Biotecnica Instruments S.p.A. Rome, Italy.
The analyzer software is based on Windows 7 operative system. The external PC allows easy
management of the operative system and of the stand alone operative program.
The software is easy to learn and offers the operator the maximum flexibility.
MAIN FEATURES
- throughput of 450 tests/h and up to 690test/h including I.S.E.
- sequential access
- routine, urgent samples (STAT – Single Test in Actual Time) and batch programming
- calibrations and quality controls, immediate or time-programmable
- 18 normality classes: 3 fixed (male, female and children) and 15 editable
- dedicated auto-diagnostic function to help the operator in the maintenance of the analyzer
- operative 24h/24
- equipped with the I.S.E. (Ion Selective Electrodes) module
- analytical parameters are flexible and open
- can work with up to four reagents, ready to use or concentrated, dilution can be performed with
water or dedicated diluent
- every reagent can have its duplicate on board, for backup purposes
- refrigerated reagents chamber (40+40 positions) and standard tray (26 positions) ensures a longer
stability of the products in use.
- positive barcode identification of reagents and samples position reduces the possible errors
- repetitions (Re-run) upon operator's request or automatically (pathological and hyperactive results)
- sample pre- and post-treatment
- connection to the Host Computer
- internal software for managing quality control (statistics of control sera and population) and
patients’ archive with data display and printouts
- 100 positions sample tray
- auxiliary solutions in dedicated containers (three, for sample dilution or pre-teatment)
- reading tray of 84 circular 6mm special glass cuvettes
- one single cycle allows two dispensations per arm (two of the first reagent, two sample
dispensations, two dispensations of the second reagent), a reading of all the cuvettes and the
related washings
- washing is done in stages over several cuvettes simultaneously, each of which is subject to a
particular stage of washing
- sampling arms are equipped with a new mechanic for the detection of a crash and new devices for
quick movement of the needle for efficient mixing of reagents and solutions
- the arms have clot sensors and vacuum sensors which can monitor the operations of each cycle of
the machine indicating hydraulic malfunctions

Description
- the control PC is connected to the analyzer via USB port. This allows to use external computers as
laptop or desktop with the specific settings of each country
The methods programming is fully open. The operator can program the mostly used methodologies,
which are already in memory, or brand new methodologies. The most common methods are: End
Point, Fixed Time, Kinetic, Sample Blank. It is possible to store up to 500 different test codes, plus
Relation Tests with no limit. In the stored analyses list the operator can generate customized test
codes sequence for the reagent tray in use, including the relation tests.
The BT 4500 is a compact instrument, based on three levels: in the upper level there are the
devices accessible by the user, protected by a lid that provides state of cleanliness and safety. At
the central level there is a front drawer that allows easier access and maintenance of dilutes and
and tanks and a rear drawer to access the tray of the unified waste pumps. At the lowest level there
are two doors that permit easy access to distilled water tanks, detergent container and waste
containers. A set of supplied fittings allows the use of containers of various sizes.
6. BASIC OPERATING PRINCIPLES OF THE ANALYZER

The automatic analyzer is based upon the spectrophotometry principles.
The light absorption laws rule the performance of spectrophotometers.
The amount of light radiation that passes through a homogeneous absorbing medium is defined as
transmittance, T, where:
T = I / I0
I0 = incident light radiation intensity
I = transmitted light radiation intensity
The absorbance, A, (or extinction, E) is defined as:
A = log (1/T) = log I0/I
The Lambert-Beer law states the relation between absorbance, concentration of a compound
absorbing light and sample thickness:
A=ε cd
ε = molar extinction coefficient of the compound absorbing light at a certain (λ) wavelength.
c = molar concentration of the compound absorbing light
d = optical path of the radiation into the solution
The absorbing spectrum of a compound is represented by a graph where the absorbed light (=
absorbance) is related with the wavelength. For a colored solution, the graph will show one or more
absorbance peaks. These may be in the visible part of the spectrum (400-700 nm) as in the
ultraviolet (200-400 nm) region.
The analyzer uses a photometric system specially designed by the R&D Dept. of the Biotecnica
Instruments S.p.A.
A light beam is sent through a cuvette that contains the solution that has to be read. The exiting light
beam is transmitted to a photometer containing 10 interference filters of different wavelengths. The
signal is amplified and then processed by the specific electronics and by the computer. The program
then makes all the necessary calculations and controls, so that it can finally present the
concentration of the compound in the sample and the any irregularities found in the reaction.
The general principle upon which the photometry in clinical chemistry is based is the following: the
increasing or the decreasing of the color intensity in a specific solution is proportional to the
searched compound concentration. Generally speaking, when a sample is added to a specific
reagent, it starts a reaction carried out by specific enzymes or substrates. This reaction causes the
increasing (or decreasing) of the solution color inside the cuvette. During the reaction process, the
instrument “reads” it by means of its absorbance. The final data processing is done with reference to
a calibration or a theoretical factor, so as to give at the end the concentration of the compound into
the sample.

Description
The I.S.E. (Ion Selective Electrodes) module is a device dedicated to the determination in the
samples of the electrolytes (see chapter L). This device is defined as ion selective as the used
sensors react with the corresponding ions in accordance with the following Nernst law:
E = E0 + RT/nF log aM+
+ +
aM = M ion activity
E = potential in Volt
E0 = constant (H+ electrode redox semi-reaction std potential)
R = gas constant
F = Faraday’s constant
T = temperature expressed in Kelvin degrees
n = ion charge
The sensors life is dependent upon the number of sample runs and the routine maintenance
procedures outlined in this manual.
7. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS

As the analyzer software is based upon Windows, it uses the Windows style, icons, quick
commands, function keys and curtain-shaped menus.
Every screen has its own icons and specific menus that will be described hereafter. The full
meaning of each command will be explained in the corresponding chapters.
At the start-up, the program will display the following main window:
2
1
5
4
6
① Main menu: each menu generates other commands and/or options

② Direct access icons: selecting each icon the relative command is directly activated
③Vertical Bar - Commands: Direct access to function commands
④ Program code: operative program software version
⑤ Access level: is the access level of the operator: it is password dependent
⑥Messages bar: clicking here opens a window showing the messages received by the program

Description
ICONS BAR
Patients: gives access to the routine entry page

Batch: gives access to the batch entry page
Analyses: opens the analyses list with the analytical parameters for each test
Profiles: opens the profiles page
Tray: shows the reagents tray with volumes and related commands
Standard: allows calibrations programming and run
Controls: allows controls programming and run
Results: shows results per patient, calibrations and controls run
Results RT: shows results per test as soon as ready
Graph: shows the reaction graphs
Status: shows the analyzer (cuvettes status)
GENERAL ICONS
It is used to clear a page
It is used to delete
It is used to close a window
It is used to start a run
It is used to modify editable fields
It is used to enter into the print preview page
It is used to save data to the archive
As far as the analyzer program runs under Windows O.S., almost all Windows short-cuts are
available. For instance, in the editable fields it is possible to right click to copy and paste the text, or
it is possible to use CTRL+C to copy and CTRL+V to paste.

Description
IVD SYMBOLS: PRINTED PACKAGING ITEMS*

Caution, consult instructions for use
In vitro Diagnostic Medical Device
Catalog number
Manufacturer
Lot number or Batch code
Storage temperature
Expiry date
Biological hazard
Risk symbols
CE Logo (Directive 98/79/CE)
Electrical and electronical devices: collect and dispose separately.
* Not all symbols are listed here. These are only some examples.
IEC STANDARD SYMBOLS

A compilation of the main nameplate and warning symbols used for the IEC standards based
on Table 1 of IEC 61010-1 Second Edition.
Direct current
Alternating current
Both direct and alternating current
Earth (ground) Terminal
Protective earth conductor terminal
Frame or chassis (ground) terminal
Equipotentiality
ON (Main supply)
OFF (Main supply)
Equipment protected by double insulation or reinforced insulation
Caution, risk of electric shock (black on yellow background)

Caution, refer to accompanying documents
(black on yellow background)
Description
8. BRIEF DESCRIPTION OF THE SYSTEM
The BT 4500 is a compact instrument, based on three levels: in the upper level there are the
devices accessible by the user, protected by a lid that provides state of cleanliness and safety. At
the central level there is a front drawer that allows easier access and maintenance of dilutes and
and tanks and a rear drawer to access the tray of the unified waste pumps. At the lowest level there
are two doors that permit easy access to distilled water tanks, detergent container and waste
containers. A set of supplied fittings allows the use of containers of various sizes.
8.1. Front view of the analyzer
1 ON/OFF BUTTON FOR COMPUTER

2 STANDARD TRAY
3 REFRIGERATED REAGENT COMPARTMENT
4 SAMPLES TRAY
5 SAMPLING ARM R1
6 SAMPLING ARM R2
7 SAMPLING ARM SAMPLE
8 ISE MODULE
9 EXTERNAL PC

Description
8.2. Modules
Modules definition
• READING STATION MODULE: comprises cuvette plate, photometer, reading unit,
washing station and electronics.
• POWER SUPPLY MODULE: houses the main power supply of the analyzer.
• REAGENT TRAY MODULE: is composed of the rotating reagent's tray, the refrigeration
chamber, the bar-code reader and the electronics.
• SAMPLE TRAY MODULE: is composed of the rotating samples tray, the bar-code
reader, the sample tube sensors and the control electronics.
• ISE MODULE: consists of the sensors panel, hydraulic path and the electronics.
• SAMPLING ARM: is composed of a two-axes based mechanical system
accommodating sampling needle head with built-in electronics including correct position
sensor (Encoder).
• REAGENT 1 ARM: is composed of a two-axes based mechanical system
sensor (Encoder).
• REAGENT 2 ARM: is composed of a two-axes based mechanical system
sensor (Encoder).

Description
CHAPTER 2
INSTALLATION Page
1. UNPACKING INSTRUCTIONS .................................................................... 2

2. INSTALLATION ........................................................................................... 3
2.1. Electrical connections ...............................................................................................3
2.2. External PC and peripherals connection .................................................................4
2.3. Fluidic connections....................................................................................................4
3. STARTING THE INSTRUMENT................................................................... 5
3.1. Turning on the instrument for the first time ............................................................7
1.3.2. Preliminary checks...............................................................................................8

Via Licenza, 18
Chapter 2 Installation Page 1 of 8

1. UNPACKING INSTRUCTIONS
The crates can be easily opened by applying the lever action, with a large screwdriver, to remove all
the spring clips at the base of the crate as shown in the figure below. Carefully remove the upper
covering. Remove the analyzer and place it on a stable vibration-free surface. Carefully unpack all
the accessories and place them in a protected place. Store the empty wooden crate in a safe place
for future use.
CAUTION: two persons are necessary to move the analyzer.
Arrow Pointing
Upwards
Base
Spring Clip
Verification of the contents of the wooden crates

Verify upon receipt of the analyzer system that all parts are present and intact when opening the
wooden crates and packaging. Please use Mod. 05_28spr, which is included in the shipment. This
document is specific for each analyzer and lists in detail which items are present in the packages.
The analyzer and accessories are contained in wooden boxes adequate for the shipment.
Verifying eventual damages occurred during shipment
It is highly recommended to accurately verify the instrument and its accessories for any damages
that could have occurred during shipment. In case there is a damage or missing items then please
fill out all the sections of the Mod. 05-35a in this manual in the WARRANTY CONDITIONS. Send it
to your nearest sales/service office or directly to Biotecnica Instruments S.p.A. Rome, Italy. After
appropriate evaluation, Biotecnica or its branch office will provide the best solution to the problem.

2. INSTALLATION
The analyzer should be easily accessible to allow the operator to load samples, consumables,
reagents, etc. Avoid exposure to direct light, heat, air streams and draught. The instrument’s left,
right and rear sides must be left free (min. 20 cm from the wall) to ensure the produced heat
dispersion and easy tubes and cables connection. Room temperature must not exceed 32°C. It is
very important to place the analyzer away from strong electromagnetic fields, such as centrifuges,
electric motors, big refrigerators, X-ray instruments, etc.
The analyzer refrigerator produces water condensation in the reagent chamber. This is important for
cooling the reagents in the bottles.
NOTE:
All the components, when present, shown in the following figures may undergo
modifications over the time. Therefore, it is recommended to verify them accurately prior to
any repair or installation (refer to eventual specific manuals included).
2.1. Electrical connections

The analyzer and its PC must be connected to an UPS unit to avoid damages in case of electrical
spikes. This is important also to let the operator know when there is a power failure in order to take
the necessary actions.
Connect main power cable from the instrument to the UPS and connect the latter to the main wall
outlet (Figure 2). Power circuit should respect current laws and have a good earth connection.
FUSE The printer and peripheral devices should be

connected to the appropriate accessory power
FROM UPS
connectors on the analyzer rear panel (adjacent to
main power inlet) or to the UPS.
ACCESSORY
POWER CONNECTORS

2.2. External PC and peripherals connection

For the external PC, keyboard, mouse and printer installation, refer to the appropriate manuals.
The analyzer must be connected to the external PC by means of the supplied USB cable.
One of the available USB ports from the PC should be connected to the USB port on the right side
of the analyzer. The analyzer should be turned on (green button on the left side) before turning on
the analyzer operative program.
2.3. Fluidic connections

The analyzer has four liquid containers: one for distilled water, one for the acid solution, one for the
waste and one for the water and acid overflow. The analyzer uses double distilled water added with
surfactant (use Biotecnica surfactant in ratio 1:1000ml). The four containers are located inside the
analyzer. Open the front/rear doors to access the analyzer base. Here are the tubes coming from
the analyzer hydraulic circuit.
The transparent tube indicated with a blue ring numbered as 6 is the tube for loading the distilled
water. The corresponding tube identified by blue and black rings is the water overflow.
The transparent tube indicated with a red ring numbered as 2 is the tube for loading the acid
solution. The corresponding tube identified by red and black rings is the acid overflow.
The blue tube connected with its special screw cap is the waste tube. The special screw cap must
be fastened on the waste container.
All containers should be placed inside the analyzer.
Water load Acid load
Water overflow Acid overflow

Waste screw
cap

3. STARTING THE INSTRUMENT

Before starting the analyzer, make sure that the peripherals and the external PC are correctly
connected. It is advisable to connect the analyzer and the PC to the UPS. The other peripherals
may be connected to the analyzer accessory power connections as well as to the PC.
Before turning the analyzer on, it is necessary to put in seat some items that are shipped separately:
1. I.S.E. sensors and pumps
2. diluent bottles
I.S.E.: the sensors and the peristaltic pumps are placed in

separated packs. Open the containers and install the sensors and
the pumps (for further details, see the I.S.E. dedicated chapter).
To have access to the I.S.E. area it is necessary to lift and remove
the I.S.E. panel.
I.S.E. SENSORS
1. Remove the sensors support sliding it out of its grooves.

2. Unlock the retaining clip by rotating it clockwise.
The slide offers an enlargement to allow the sensors insertion. This enlargement
corresponds to the Ref sensor position. To insert the sensors, Introduce the back
of the sensor into the slide groove, insert the front and then push the sensors to
slide into position. Start from the Inlet, then K, Li, Na and Cl. Let the sensors slide
to their final positions. Then enter the Outlet sensor and fully slide it to the left. The
Ref must be the last one inserted.
3. Pay attention to the correct order of the sensors in the stack.
4. Place the retaining clip back to block the sensors.
5. The sensors stack can be placed into the module, by inserting it into the
dedicated slot. Make sure that the slide is correctly in place and fully pushed
inside. Close the retaining clips.
Retaining
clips
I.S.E.
slide

I.S.E. PERISTALTIC PUMPS AND REAGENTS

There are two couples of peristaltic pumps. One drives the waste and reference solution, while the
other drives the A and B solutions. The pumps are connected to transparent tubes ending with a
colored rubber. The rubbers have to be inserted into the corresponding colored cap of the reagents
bottle as follows: red to waste, blue to reference solution, black to A solution and green to B
solution.
To install the pumps, simply insert the two axes in the pump holes and push until in seat. Then fix
the pumps by means of the screw placed at the center of the pumps assy.
The reagents container is composed of four bottles. The waste is empty, while the
others are filled with the I.S.E. reagents.
Put the I.S.E. container in its place, then replace the original caps with those with
the connector for the colored rubber.
Insert the colored rubbers in the
connector of the corresponding color
cap.
After these operations, run an I.S.E. prime to fill the I.S.E. hydraulic circuit.
DILUENT BOTTLES
The analyzer is equipped with three diluent bottles for diluting the samples. Two of these bottles are
located between the Samples arm and the R1 arm. The other one is located next to the I.S.E.
funnel.
The three diluent bottles, for convenience, have been defined in the software as follows:
 Saline solution
 Diluent
 Sample treatment
The operator can fill these bottles with any necessary working solution and change the definitions as
necessary (see Setup, chapt. 9 par. 2.4)
Before turning the analyzer on, verify also that all necessary parts are in place (covers, trays, etc…)

3.1. Turning on the instrument for the first time

1) Turn on the UPS device as described in the appropriate manual.
2) Verify that the PC and peripherals are turned on.
3) Turn the analyzer on by means of the green button on the left side of the analyzer.
4) Load the analyzer operative program from the PC.
The start-up process includes the loading of the operating system (bootstrap) into the memory. At
the end of the boot (loading of the operating system), the instrument activates all the devices and
performs mechanical, hydraulic and electronic checks.
Once turning on procedure has completed (lasting few minutes), wait for the system to warm up.
In the meanwhile, it will be necessary to perform a series of primes to make sure all the hydraulic
circuits are filled and there are no bubbles left. From the menu Analyzer, select Analyzer Utilities.
Alternatively, open the Special functions menu on the side bar and select Analyzer Utilities. The
following window will appear.
Perform the following:

- Needles prime
- Washing station prime
During warm-up phase the temperature indicator flashes on the bottom right of the display until the
appropriate temperature is reached. The instrument reaches the steady state after approximately 30
minutes.

1.3.2. Preliminary checks

Before using the analyzer, it is recommended to perform the preliminary checks outlined below.
Some of these checks should be performed daily and others are periodical.
DESCRIPTIVE TABLE
OPERATIVE CONTROL When
Verify distilled water container Daily

Verify that there is sufficient washing solution in the external tank for the needs of the working day. The
washing solution is prepared by adding to double distilled H2O the Surface Active Agent –
tensioactive - 1ml per liter of water (i.e. ratio 1:1000). See technical specifications regarding double
distilled water below.
Verify the acid container Daily

Verify that there is sufficient acid solution in the external tank.
Verify the waste container Daily
Note: Check that the waste container is empty or that there is sufficient capacity for at least containing
washing solution corresponding to the daily waste liquid volume.
Zeroing of the photometer Twice a day
Wash the cuvettes with the proper solution Daily
When: Before turning off or at the end of the working day
Extra wash of the cuvettes with acid solution Weekly

When: When turning off or at the end of the working day
DOUBLE DISTILLED WATER SPECIFICATIONS:

Resistivity: > 5 M Ω/m
Conductivity: < 1µS/cm
pH: 6,4
Residual Ions: < 1µg/l

CHAPTER 3
FUNCTIONS Page
1. BASIC THEORY........................................................................................... 2
1.1. Methods description ..................................................................................................4
2. DESCRIPTION OF THE PROGRAM MENU................................................ 6
2.1. Printing interface........................................................................................................9
3. APPLIED MATHEMATICAL FUNCTIONS ................................................ 11
3.1. Initial Computation...................................................................................................13
4. HOW TO PROGRAM THE ANALYSES .................................................... 14
4.1. Creating a new code ................................................................................................14
4.2. Relation tests............................................................................................................14
4.3. Introduction to the clinical chemistry tests ...........................................................16
5. ANALYSES PROGRAMMING ................................................................... 17
5.1. GENERAL ............................................................................................... 17
5.2. REACTION.................................................................................................................18
5.2.1. REAGENTS .........................................................................................................18
5.2.2. TIMES ..................................................................................................................20
5.2.3. REACTION...........................................................................................................20
5.2.4. BLANK.................................................................................................................23
5.3. SAMPLE ....................................................................................................................24
5.4. CHECK.......................................................................................................................28
5.5. SUPPLEMENTARY ...................................................................................................32
6. CALIBRATIONS......................................................................................... 34
7. CONTROLS................................................................................................ 38
8. PROFILES .................................................................................................. 39
9. APPENDIX ................................................................................................. 41

Via Licenza, 18
Chapter 3 Functions Page 1 of 43

1. BASIC THEORY
The basic operating principles of the analyzer are described in chapter 1, par. 6.
The BT4500 operates with fixed cycles of 16 seconds. Each cycle allows two dispensations, reading
and washing of the cuvettes. The cuvettes are automatically washed with water and a special acid
solution to avoid possible cross contamination. In every cycle, three arms can operate
simultaneously.
Every test can be freely programmed, with the following limitations:
1. the first reagent is always inserted at cycle 1
2. the sample is always inserted at cycle 2
3. the minimum total cycles is of 7
4. the maximum total cycles is of 35
In the software, the programming of some of the basic test methods is already available (end point,
fixed time, kinetic and sample blank).
As far as every method can be freely programmed (with the above limitations), it is very easy to
create all possible tests using the already available formulas.
For instance the end point test formula is:
Point[Final]-Blank, i.e. the analyzer will use the last cycle absorbance subtracted of the blank
absorbance. But the same formula can be written as Point[30]-Blank, if the last cycle is 30 or if the
last cycle is 34, but the method requires the reading to be performed before the last cycle. Again,
the same formula can be written as Point[Final-4]-Blank.
The same versatility applies to all formulas.
For what concerns the reagent blank, it can be read on the same cuvette used for the reaction. In
this case every sample will have its own blank. On the other hand, it is possible to perform the
reagent blank on a separated cuvette. In this case, the reagent blank will be calculated on the basis
of a specific formula, that usually is Point[Serum-1], i.e. the analyzer will use as blank the cycle
before the sample insertion.
For all those tests that start with the sample insertion (R1, then R2, then Sample), the blank can be
performed on the same cuvette as the test. For the tests that start with the second reagent (R1, then
Sample, then R2), it will be necessary to perform the blank in a second cuvette.
The analyzer works with couples of cuvettes, one in the internal ring and one in the external ring. At
the beginning of every working session, the analyzer will wash the first series of cuvettes, then it will
go on washing until the last sampling. If in the run there are only I.S.E. tests, the analyzer will
anyway start a the first washing series. The cuvettes wash is performed in a sequence that starts
with the aspiration of the cuvettes content and the dispensing of acid solution, followed by the
rinsing with water and drying of the cuvettes.
Once the cuvettes are washed, the sampling starts, using the cuvettes in couples. After the
reagents and sample dispensing, the analyzer will wait the end of the incubation and reading times,
will acquire the absorbances for the results calculation and will then wash again the cuvettes so that
the cycle can continue. The analyzer can work 24h/24, therefore the samples can be loaded
continuously.
The test results are then displayed in the real time results pages. In the Results RT page, the single
results are displayed as soon as ready, while in the Results page, the results are displayed as soon
as the whole patient is completed. Then results can be printed or saved into the Archive.
All results, archives pages as well as reaction graphs can be also saved as *.pdf files. Archives can
also be exported in *.csv or *.rtf formats.

The calibrations, as well as the Quality Controls, have dedicated archives. The QC has also a real
time archive where the controls results can be verified in real time.
In the analyses programming page, there are the analytical parameters, the standards and the
controls. In the same page it is possible to display only the tests on line or all the tests.
The position of the reagents, as well as the positions of the standards or controls on the tray are
programmed in different dedicated windows.
Samples can be programmed in Routine mode (which includes running of STATS or controls) or in
batch mode.
In Routine it is possible to select the type of sample (serum, urine, CSF or other) and eventually the
automatic pre-dilution. Batch runs can be performed on serum or on urine.
Before every run, it is possible to perform a reagents volume check (the analyzer will present the
question) to allow the analyzer to use the backup reagents.

1.1. Methods description

End Point
Once the sample has been added to its reagent, a reaction occurs first causing a variation in the
solution’s color i.e. the absorbance, followed by a phase in which the reaction’s color is stable,
defined as "plateau".
Generally, the absorbance value (A) I.S.E. read at the beginning of the plateau or is the first point
after the incubation time. This value is then multiplied by the factor computed during calibration, to
obtain the concentration of the analyte in the sample.
Conc. in sample = Factor x (Final absorbance - Reagent Blank)
Insert sample Last abs
Insert R2
Incubation time
Fixed Time
In this type of reaction, there is an increase (or decrease) of the absorbance during both
incubation’s and reading’s phases. However, the slope of the line may not be the same during the
two phases. The reaction graph displayed to the user is not always linear, but can also appear as
piecewise linear. During reading time, the absorbance delta (ΔA) is computed, which is used for
calculating the final concentration for the analyte in the sample.
Concentration is calculated by multiplying the absorbance delta by the factor obtained from the
calibration:
Conc. in Sample = Factor x (Abs delta)
Insert sample Insert sample

Insert R2 Insert R2 Abs delta
Abs delta
Reading time Reading time

Kinetics
This kind of reaction is very similar to the previous one, with the difference that the reaction and the
graph derive both from the computation of regression lines. The regression line for the reading
phase is then scaled to minutes to compute absorbance delta (ΔA/min.). This value is then
multiplied by the factor to compute the concentration of the analyte in the sample:
Conc. in Sample = Factor (Abs delta)

Insert R2
Abs delta
Reading time
Insert sample
Sample Blank
This method is used whenever it is required to eliminate the photometric interference of the sample
(for example turbid sera) from the reaction. These are double-reagent End Point reactions. The
reaction and the computation are performed during two distinct phases: in the first phase (sample
blank) the reaction between the first reagent and the sample (R1+S) takes place, while in the
second phase the second reagent is added to R1+S (R1+S+R2). The final absorbance used for
computing the concentration of the analyte is obtained from the difference in absorbance between
the two phases:
Conc. in sample = Factor x {Abs(R1+S+R2) – [Abs(R1+S) x k]} where k is the volumetric factor
Insert sample Final abs (R1+S+R2)

Insert R2
First abs (R1+S)

2. DESCRIPTION OF THE PROGRAM MENU

The analyzer operative program is built to work under Windows O.S., therefore it works with the
same philosophy. The access to the operating commands is possible trough menus and icons.
There are five main menus: Patients, Analyses, Analyzer, Utility and Archives.
Patients
Routine/STAT Management & Batch Management: these commands
are used to enter samples in Routine/STAT and Batch mode.
Delete Work list: deletes the entire memorized patients list. The analyzer
will request confirmation before deleting.
Analyses
Parameters: with this command the analyzer will open the analyses page
where it is possible to enter and program new analyses or to modify the
existing ones.
Manage Reagents: this icon gives access to the reagents map, where it is
possible to create the on-line map and to have general information on reagents,
such as residual volume, position, lot number and expiry date.
Profiles: is used to create the analyses lists (profiles) which can be used for
programming patients.
Manage Standard: gives access to the standard page, where the standard
positions and lot number can be viewed. From this page it is possible to run
calibrations.
Manage Controls: gives access to the controls page, where the assigned
positions and lot number can be viewed. From this page it is possible to run the controls.
Export: copies in any desired location, the analytical parameters, optionally with the profiles and the
analyses tray. There are two available options: Back-up (for exporting all the analyses) and Single
Test (exports a selection of single tests).
Import: copies the above-mentioned parameters from any location into the analyzer memory. There
are two available options: Restore (will import all parameters) and Single test (imports the exported
single tests).
NOTE: when a back-up is imported, all data will be overwritten. When a single parameter is
imported, it will be placed in the list of available analyses, not in the "in tray" list. The
operator will have then to correctly place it in the analyses tray.
Analyzer
Mechanical Calibrations: gives access to the page dedicated to the
mechanical devices adjustment (arms and trays).
Analyzer Utilities: this command opens a page where the operator can
select to perform one or more of the available utilities, such as washing the
cuvettes or zeroing the photometer.
Diagnostic: this line gives access to further options as viewing the FCC or the optical transmission.
It also gives access to the general diagnostic page, which is normally used only by the well-qualified
technical assistance personnel.

Utility
Setup: it is used to define the system parameters, such as the language,
the communication, the bar-code, etc. This command is disabled during
analyzer operation.
View Reaction Graph: this command displays the reaction’s curves on a
graph, with all reaction information and print capability.
Log-Off: this command is used for logging off and on the different users.
When logging off, a window will appear where the user must enter the
user name and password
Switch-off analyzer + PC: with this command it is possible to turn off the
analyzer program together with the PC operative program. The analyzer
itself will remain turned on. Press the ON/OFF button on the side of the
analyzer to turn also the analyzer off off.
Note: The analyzer’s program will guide the operator through screen messages in the analyzer
turning off procedures. He will be invited to place the solutions when needed and to ensure the
correct execution of washing procedures. Bear in mind that it is not possible to ensure data
precision and accuracy if the normal washing and maintenance procedures are not observed.
Serial: this option allows the analyzer to send data to the host computer, upon operator’s request.
The type of data transportation can be selected in the Setup.
Log Files: this read-only area is very important for the Technical Assistance/service personnel.
Under this option there are the following:
- View Logs: gives access to the files where the operations performed by the analyzer are stored,
together with the logged users.
- View Test Counter: in this page it is possible to view the total of the tests performed by the
analyzer, divided into blanks, controls, standards, etc.
- Lot's management: shows all the reagents' lots with the expiry dates. The positions on the tray,
as well as if the reagent is the 1st or 2nd are not displayed.

Archives
This menu gives access to all the archives: patients archive, population
archive, quality control archive, calibrations' archive and real time QC
archive. The latter gives information in real time on the performed
controls.
MAIN ICONS BAR
In this bar are presented the most common and most useful icons.
Opens the routine programming page
Opens the batch programming page
Gives access to the analyses analytical parameters, standard and controls
Opens the profiles programming window
Gives access to the reagent tray pages (volumes information, make tray function)
Opens the page for programming positions and running standards
Opens the page for programming positions and running controls
Opens the real time results page (per patient)
Opens the real time results page (per test)
Gives access to the reaction graphs pages
Gives information on the analyzer status.

ANALYZER PROGRAM GENERAL ICONS
It is used to clear a page
It is used to delete
It is used to close a window
It is used to start a run
It is used to modify editable fields
It is used to enter into the print preview page
It is used to save data to the archive
2.1. Printing interface

In many parts of the analyzer program it is possible to find a Print function. The Print button will
open a printing interface, which allows many different choices.
Click on the printer icon to print the document. The printer interface will allow the operator to select
the printer, the copies, the number of pages, etc….

Click on the ""paper" icon to export the document in different type of file formats. The available file
formats are:
*.pdf => will save the document as Adobe document.
*.rtf => will save the document in rich text format. This can be opened
with Word, Notepad, Wordpad, etc…
*.csv => will save the document in comma separated values format.
This can be opened with Excel. The older versions of Excel will
correctly open (in columns ) these files only following this procedure.
Open Excel, the click on "Open" or "Open a file". In the "Open" window select "All files (*.*)" at the
line "File type". Then browse for the *.csv file and open it.
Text (matrix printer) *.prn => will save the document in a text file for dot-matrix printers.
Click on the Adobe icon to export the document directly to *.pdf.

The analyzer will open the Export to PDF interface and
then will allow the operator to save the file in any
location in the HD.
Click on the "binoculars" icon to find a text in the open document.

3. APPLIED MATHEMATICAL FUNCTIONS

♦ Correlation Coefficient
where:
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings
♦ Linear Regression
where:
M : Angular coefficient for the line
Q : Final point for the line
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings
♦ Distance point-line
where:
M : Angular coefficient for the line
Q : Final point for the line
X : Point Abscissa
Y : Point Ordinate

♦ Distance between two points
where:
X : X axis
Y : Y axis
x0 : First Point X Axis
x1 : Second Point X Axis
y0 : First Point Y Axis
y1 : Second Point Y Axis
MATHEMATICAL FUNCTIONS FOR CLINICAL CHEMISTRY

♦ Volumetric factor (used in sample blank A tests)
where:
K : Volumetric factor
vS : Serum volume
vR1 : First reagent volume
vR2 : Second reagent volume
♦ I.S.E. Module Functions, see I.S.E. dedicated chapter.

3.1. Initial Computation

The initial computation is important for transforming the microprocessor data into
compatible data for the program to generate the single absorbance value, which will be
used afterwards for the final absorbance computation.
♦ Clinical Chemistry
where:
Z : Zeroing with water
F1 : First Filter’s Value
F2 : Second Filter’s Value
Fz1 : First Filter’s Zero-Value
Fz2 : Second Filter’s Zero-Value
Op : Optical path
Of : F.C.C.

4. HOW TO PROGRAM THE ANALYSES

The analyses programming page can be accessed from the main menu (Analyses) or from the
specific icon that gives direct access (Analyses) to the Analyses Management page.
To set out new analyses it is necessary first to create the code and then to assign the parameters,
the standards and the controls.
The analyzer can store virtually endless analysis codes (with parameters). It is possible to view only
the analyses which are on the tray (Only in tray), only the analyses which are not on the tray (Only
not in tray) or all programmed codes (All Codes). To create the working tray it is possible to use
the Make Tray command in the Reagents Management window (Tray icon).
4.1. Creating a new code

Open the analyses management page and select New. Enter the test’s
code and select the test type between Clinical Chemistry and Relation (click
on the button "u"). The test type defines whether the programmed test is a
Clinical Chemistry test or a relation test (mathematical computation). Use
the button Save to memorize the test, or press Cancel to exit and abort
programming. Any code can be deleted by using the Delete option in the
Utility menu of the Analyses management page.
For every code the Parameters, Standard and Controls pages are
opened together. Click on the corresponding tag to change among these pages.
4.2. Relation tests

Once the code has been created, the relation test will be placed in the All Codes list, but it will be
automatically moved into the Only in tray list when closing the Analyses management window.
Select the code by clicking on it (it becomes red, bold and underlined) to program its general
parameters and the related mathematical function. The Parameters page is the first displayed.
In the General parameters page enter the following information:

Name: complete test name
Units: measurement unit.
Primary: write the primary measurement unit.

Secondary: write here the secondary unit, if necessary. In the Factor field, write the
conversion factor from the primary unit to the secondary one.
Limits: insert the min. and max. values of the normal range with reference to the selected group
(male, female, etc).
Decimals: it is possible to choose the number of decimals after the point. Leaving the Automatic
option the analyzer will follow this principle of the floating point:
for values like 0.XXX three decimals
for values up to 9.XX two decimals
for values up to 99.X one decimal
for values over 100 no decimals
Otherwise it is possible to decide how many digits must be shown after the point, with a maximum of
6 digits.
Instrumental Factor: this function introduces a constant correction of the final data of the
calculated test. It may be used for making adjustments to test data obtained from analytical methods
or different type of instruments. Calculation: final result = value x instrumental factor
Shift: this function introduces a constant quantitative correction of the final data. It may be used for
making adjustments to test data obtained through analytical methods or instruments of different
types. Calculation: final result = value + shift.
To enter the mathematical function select Formula
A window divided in two parts will be displayed: one for the calculator and one for the analyses list.
The mathematical function can be composed of simple values and operations or can recall sample
results acquired by the analyzer on other tests (complex function). To enter a simple mathematical
function avail yourself of the displayed calculator. To enter a complex function, select the code of
the test to be inserted into the function. A small field will appear, where it is possible to select the
type of sample (among serum, urine, CSF and Other) result for that test. Then complete the function
with the needed operations.
To create more complex functions (involving more than one test’s result) it is advisable to use the
parenthesis as for all normal mathematical functions. Ex. For the creatinine clearance with urine/24h
= 900ml [(urine CRE x urine ml 24/h)/(serum CRE x 1440)] the formula would be: ( [CRE&U] * 900) /
([CRE&S] * 1440).
NOTE: use only the numbers and symbols on the screen, by clicking on each and remember that
the same operators on the keyboard are disabled.

4.3. Introduction to the clinical chemistry tests

Open the analyses management page and select New. Enter the test’s code, select the test type
Clinical Chemistry and save. Once the code has been created it is possible to program its
parameters. The newly created code will be saved in the All Codes list. To move it to the working
tray it is possible to use the Make Tray command in the Reagents Management window (Tray icon)
In the analyses list click on the code and the parameters window will be displayed. In this window
there are three tags: Parameters, Standard and Controls. Each tag gives access to dedicated
pages. The Parameters page is the first displayed. The analyses programming is fully described in
the next paragraph.
There are some commands which are in common for all the analyses and these commands are
available in the menu bar.
Print menu. From this menu it is possible to print the analytical parameters, the calibrations and the
controls. It gives access to other choices: it is possible to print the actual test, the selected tests (if
more than one test is checked) or the whole area (only in tray, only not in tray or all codes).

5. ANALYSES PROGRAMMING
The first page shown is the Parameters page. In this page there are five buttons: General,
Reaction, Sample, Check and Supplementary. Each of these choices opens a different dedicated
page.
5.1. GENERAL
In this page the operator must give some general information on the test.
Putting the check in the bar-code checkbox, the bar-code field will be displayed. By means of the
Bar-Code it is possible to assign a numerical code for positive identification of the reagents. It
enables, if activated in the Setup, the bar-code scanning to correctly identify the bottle during
reagent’s insertion phase.
Method: write in this field the reaction principle used for the test (for example: Jaffè, IFCC, etc.).
This option is useful when recalling the tests from the Quality Control archive, in accordance with
different principles.
Filters: the operator can select the desired filter value for the Filter 1 and the Filter 2 (normally
used as reference filter) from the available filter wavelengths: 340, 380, 405, 436, 480, 510, 546,
578, 630 and.
For the tests in dichromatic, click on the Filter 1 and select the desired filter from the cascading
window and then go to Filter 2 and select the desired filter from its cascading window.
For the tests in monochromatic, select the desired filter in the Filter 1 cascading window. Since the
second filter is not used in this type of test, therefore select the last position, Ref, in the cascading
window of Filter 2. In this case the analyzer will use a reference filter only to stabilize the readings.
Process: defines the kind of test’s calibration: with factor, linear, or with curve. The following
choices are available: cubic spline, polynomial, best fit, multi points, log-logit 4, log-logit 5 and semi-
log.
linear: this function is used for linear reactions, it requires analytical test calibration to process the
computing factor;
with factor: it is used for linear reactions whenever the computing factor used is theoretical;
with curve: non-linear tests, distinguished in:
- cubic spline: the typical cubic interpolation is used. There is a good connection between
subsequent point couples. Approximation is perfect on single points, but is not flex point free;
- polynomial: a third degree polynomial function is used. It has a very good approximation, but
sometimes it may show anomalies;
- best fit: a second or third degree polynomial interpolation is used. It gives the best
approximation to the minimum squares. It is a very simple curve, but sometimes may be distant
from the standard points;
- Multi-point: Linear interpolating function for several standard concentrations (max 6);
- log-Logit 4 and log-Logit 5. It is a logarithmic approximation on four or five points, used for non-
linear tests;

- Semi-log: a second degree curve is used, which is function of the concentration logarithm, and
gives the best approximation to the standard points minimum squares. It is asymptotical on the
last point, has no flex points and well approximates the standard points. It may be used for
highly non linear processes.
Always bear in mind that the serum parameters will be used for the calibrations, regardless of the
sample that is going to be used.
Analyses With Factor

Calibration executed by the analyzer is not required for these tests, but a theoretical factor for
calculation needs to be entered. This is a parameter to convert the absorbance values (ABS),
determined by the analyzer, in final concentration values. A box appears where it is possible to
enter a known factor value, declared in the method.
Analyses with Linear Calibration

In this type of test the analyzer executes a calibration with a known concentration standard. Based
on the absorbance values detected for the standard, the analyzer calculates the factor, which will be
used to convert the absorbance values (ABS) of samples to final concentration values. After each
new calibration the analyzer calculates and updates the factor. Alternatively, it is possible to directly
enter a known value in the Factor field.
The used calibrators or standards must be placed in the positions assigned on the
standard tray in the page Manage Standard
In linear analysis it is possible to use up to 3 different standard concentrations or execute up to a
maximum of 3 repetitions on a single point. It is possible to program the same positions for various
analyses if a multi-calibrator is used.
In analyses with curve, the standard positions available are:
- cubic, polynomial, best fit, multi point and semi-log 3 to 6 positions.
- log logit4: 4 positions
- log logit5: 5 positions
5.2. REACTION
In the Reaction page the operator must give those parameters that are necessary to define the
reaction, from the number reagents, to the type of calculation to be used for the test itself.
5.2.1. REAGENTS
Number of reagents: enter the number of reagents the methodology requires, max. 4. Use
up/down arrow keys "v" or move the cursor directly on the box and enter the value. Remember that
the number of reagents is the only parameter that must be defined before moving the test into the
on line tray.

The selected number of reagents will appear at the page base with one tag for each reagent. For
every reagent the operator must enter the following information.
Reagent Quantity (µl): insert the volume of each reagent (in micro liters) by selecting the
corresponding table (Rgt 1, Rgt 2, Rgt 3 & Rgt 4) in accordance with number of reagents
programmed. Always bear in mind that there are some limits for the final solution (reagent +
sample) as well as for sample or reagents (for limitations see table 1 at the end of par. 5.3).
Dilution: this field refers to concentrated reagents. If ready-to-use reagents are used the Type
field should be set to None. If the reagent has to be diluted, in the Type field it is necessary to
select the diluent, whether to use a dedicated Diluent or distilled Water. Then insert in the
Diluent Quantity (µl) text box the volume of the diluent to be added to the concentrated reagent.
For example: for a dilution ratio of 1:3 write 100µl for the concentrated reagent and 200µl for the
diluent. The dedicated diluent is considered by the analyzer as a further reagent and will
therefore take a position of its own in the reagents’ tray. If the diluent is the distilled water, the
analyzer will take it from the main reservoir.
In case the test is already in the tray, selecting the dedicated diluent will cause the test to be
removed from the tray in order to program the position for the dedicated diluent.

5.2.2. TIMES
The times are expressed in cycles. Every cycle is 16 seconds.
The max number of programmable cycles is 35, corresponding to 560 seconds.
As far as the reagent 1 and sample insertion cycles are fixed (respectively to cycle 1 and cycle 6),
the only programmable times are for the total reaction time and the other reagents insertion.
One single cycle allows two dispensations per arm (two of the first reagent, two sample
dispensations, two dispensations of the second reagent), a reading of all the cuvettes and the
related washings.
End Cycle: use the arrows to enter the final cycle of the reaction.
Reagent 1 & Sample: these fields are fixed as the first reagent's and the sample's cycles are fixed
by the program, respectively at the first and sixth cycle.
Depending on the number of reagents, the following fields will appear.
Reagent 2, Reagent 3 and Reagent 4. In these fields it is necessary to enter the number of cycle at
which the corresponding reagent must be introduced in the reaction cuvette. Using the mouse
cursor, click on the arrows until it reaches the correct value. In case of cycles overlapping with other
reagents, the cycle number will become red, and in case of overlapping with sample cycle, the
number will become red on yellow background.
NOTE: in every reagent cycle it is possible to insert two reagents. If one of the reagents is diluted,
the reagents become three, so it will be necessary to move the insertion of one reagent to the next
semi-cycle. The sample cycle allows the insertion of the sample and of two reagents.
5.2.3. REACTION
Calculation type: the type of calculation may be quantitative, qualitative or a combination of these
two. Select the desired calculation and, except for the quantitative calculation, enter the cut-off
value.

Formula: the final absorbance, to be used in the result concentration calculation, will be calculated
on the basis of the given formula. It is possible to select one of the already present calculations, or it
is possible to introduce brand new calculations. Use only round parenthesis when entering the
formula, as the square parenthesis are used by the program for the already available formulas.
For instance, an End point test formula will be: Point[Final]-Blank, thus meaning that the analyzer
will use the last read point absorbance subtracted of the reagent blank. A Fixed time test formula
will be: Point[Final]-Point[LastInsert], thus meaning that the analyzer will calculate the delta between
the absorbance read at the moment of the last insertion cycle and the absorbance read at the final
point.
When using the cycles, bear in mind that the analyzer will, in the same cycle, perform the insertion
first, followed by the reading phase. The reading phase will always be the last thing performed in a
cycle.
Clicking on the f(x) icon, it is possible to display the available Functions or the
formula parameters (Help).
Generally speaking, the formula can contain the following elements:
Blank: reagent blank value
Point[X]
[X] definition "X" meaning
[LastInsert] absorbance read at the last insertion cycle
[Final] absorbance read at the final cycle
[n] Number of the corresponding cycle. Where min. n=1
Eg:
Point[LastInsert]: uses the absorbance read when the last item (reagent or sample)
was introduced in the reaction
Point[LastInsert-1]: uses the absorbance read one cycle before the last item (reagent
or sample) was introduced in the reaction
Point[Final]: uses the absorbance read at the final cycle of the reaction
Point[6]: uses the absorbance read at cycle number 6

Regress[1,2], with the same definitions as above for X: is the linear regression calculated from
point 1 to point 2.
RegrxMinute[1,2], with the same definitions as above for X: is the linear regression calculated per
minute, from point 1 to point 2.
Mean[1,6]: with the same definitions as above for X: is the mean value calculated from point 1 to
point 6.
Sample: uses the absorbance read in the same cycle when introducing the sample in the reaction
Reagent[n]: uses the absorbance read in the same cycle when introducing reagent number "n" in
the reaction
Other elements that can be added to the formula are:

µlSample: indicates the sample volume in µl
µlReagent[n]: indicates the reagent "n" quantity in µl
These elements can be used for instance for calculating the volumetric factor when needed.
The reaction formulas already present are:

End Point: Point[Final]-Blank
Fixed Time: Point[Final]-Point[Final-0]
Kinetic: RegrxMinute[LastInsert+0,Final]
Sample Blank: Point[Final]-(Point[LastInsert-1]*VolumetricFactor)
The "0" in the formula must be changed by the operator with the necessary number of cycles.
These formulas are only examples and should be used only as guidelines to start the reaction
programming. The above mentioned formulas may also be different from the presented ones.
When programming formulas, bear in mind the absorbance sign that is expected for the calculation.
This and other info will be very important when programming the checks page.
Some examples of applied formulas are in this chapter appendix.

5.2.4. BLANK
This page is dedicated to the reagent blank calculation. As for the final absorbance in the test, also
the blank must be calculated by means of a specific formula.
The reagent blank, when performed in the same cuvette where the reaction will also take place, will
be automatically read for every single sample. The absorbance value of the blank is then displayed
in the reaction graph. In the standard page will only be displayed the last blank read.
Use another cuvette: click on this checkbox to let the analyzer use a second cuvette for performing
the reagent blank. This option is useful every time the blank must calculated with a dynamic
different from the sample, or when the reagent blank must be calculated with reagents that are
inserted after the sample. In this case it is necessary to introduce the formula for calculating the
absorbance. The formula is based on the same criteria as the one for the reaction.
End cycle: use the arrow to select the number of the last cycle to be used.
Reagents used: use this option when more reagents are used for the test, considering that not
all of them are necessary to calculate the reagent blank. Just select by means of the checkbox
the reagents that participate to the blank calculation, then move the corresponding arrows until
the correct insertion cycle is displayed. In case of cycles overlapping with other reagents, the
cycle number will become red.
Repetition: when the reagent blank is performed in the same cuvette as the test, it does not
need to be repeated as it is read for every sample, but when it is performed in another cuvette,
the operator should decide when to perform the reagent blank reading.
The reagent blank, depending on the reagent itself, may need to be performed once a week, as
well as every four hours, for instance. This option gives the possibility to select when to perform
the blank.

Every run: the absorbance determination for the reagent will be performed at every work
start-up for the analyses that are going to be run.
Every day at: the absorbance determination for the reagent will be performed every day at
the specified hour. For example, setting "03"
"03" "15" determination will be performed every
every day at 03:15 in the morning.
Days + hours interval: the absorbance determination for the reagent will be performed at the
time intervals as programmed into the Days +
Days + Hours boxes. For example, setting
setting "02 + 8" determination will be
performed every two days and eight hours.
hours. Setting "00 + 8" the blank determination will be performed every eight hours.
Every "n" samples: the absorbance determination for the reagent will be performed every
"n" samples. For example, setting 15, the
analyzer will perform the reagent blank every
every 15 samples.
5.3. SAMPLE
This page is dedicated to the sample parameters, necessary for the reaction. At the bottom left of
the page there are the four tags with the various type of samples: serum, urine, CSF and Other.
The "Other" tag is left free for any other type of sample that the operator will use. For every type of
sample, it will be necessary to fill the fields described below, in order to allow the analyzer to
correctly perform the necessary calculations and to use the correct references.
Name: write here the full name of the test. The name written here will be used in the real time pages
and in the final report.
Quantity (µl): write the sample volume, expressed in µl.
Limits: the limits that have to be selected here are the normal range and the panic range, each
defined for every group: male, female, children and the other 15 available groups that have been
defined in the Setup (see chapter 9, par. 2.1 ).
Group: select the desired group for assigning the ranges.
Normal values: enter the minimum and maximum values for the normal range of the selected
group. All results falling within this range will be considered as normal and will not be flagged.

Results below the minimum or above the maximum, will be considered as pathological and
will be flagged with "-" and "+" respectively.
Panic values: enter the minimum and maximum values of the panic range for the selected
group. All results falling within this range will be simply considered as pathological and will not
be repeated when pathological repetition is active. Results below the minimum or above the
maximum, will be repeated if the pathological repetition is active. In this case, samples can be
automatically repeated with or without dilution. Attention: the pathological repetition criteria
are selected in the sample page, but the check and the automatic repetition are selected in
the Check page.
The type of sample treatment is set in the Sample management page, explained hereafter.
Sample management: the sample can be pre-diluted as well as post-treated. The sample handling
performed after the first result of the test (post-treatment) can be a sample dilution or a sample
"concentration". The sample pre-treatment, which is the only automatic pre-dilution, is applied to all
samples performing the test. It is also possible to program the pre-dilution of a single sample, but
this can be done in the Routine programming of the sample.
First it is necessary to select the type of treatment, then to set the correct treatment parameters and
to activate the sample management by clicking the Active checkbox. This procedure will only
activate the sample management parameters. Then, to allow the analyzer to perform the
corresponding check and eventually the repetition, it will be necessary to separately activate also
these other options (see par. 5.4).
Example
Sample Parameters:
Check Parameters:
The analyzer will perform the pathological check (with respect

to the panic values), but the automatic repetition is not active.
The analyzer will perform the pathological check and if

necessary, the automatic repetition with the above parameters.
The different types of sample management can be

selected, and the corresponding parameters set,
one by one. The Pre-treatment, the Pathological
High, the Hyperactive and Out of curve Above
can give place to a sample repetition with dilution.
The Pathological Low or Out of curve Below can
give place to a "concentration" of the sample.
Pre-treatment: this parameter is set when all samples need a pre-dilution and this is the only type
of pre-treatment, as all the other options are treatments performed after the first sampling result and
are activated only in certain conditions.
Pathological High: when a result is higher than the max value of the panic range, it may be useful
to repeat it with dilution.

Hyperactive: when a result is hyperactive (out of Test Limit, Max Abs Delta and/or Final Abs), it is
necessary to repeat the diluted sample in order to bring the absorbance back into the linearity
range.
Out of curve Above: in analyses with non linear calibration, the absorbances falling out of the
calibration curve may be misinterpreted. For this reason, it is necessary to dilute the sample and
repeat the test.
Dilution: the preparation of the diluted sample may be performed with water (from the reservoir)
or any other diluent as necessary. The type
of diluents can be edited in the Setup page
(see chapt. 9, par. 2.4) as every lab may
need different and specific diluents. The
default diluents are defined as follows:
saline solution, diluent and sample treatment
solution. Select the Type of solution to be
used, then write in the corresponding fields
the Sample volume and the Diluent volume. These two volumes will be mixed in a dedicated
cuvette from which the analyzer will withdraw the sample volume as set in the sample Quantity
field. This diluted sample will then be used for the reaction. The minimum volume for
Sample+Diluent is 120µl.
For instance, setting the parameters as follows:
Type: saline
Sample volume: 30µl
Diluent volume: 90µl
Sample Quantity
The analyzer will dilute 30µl of original sample with 90µl of saline solution (1:4), then will
withdraw 16µl of the diluted sample for performing the reaction. The read absorbance
will be then multiplied by 4 to give the final result already included of the performed
dilution.
The minimum volume for Sample+Diluent is 120µl if the Sample Quantity is less than 120µl. If the
Sample Quantity is more than 120µl, the minimum volume for Sample+Diluent would be "Sample
Quantity" + 5µl.
Pathological Low & Out of curve Below: in case of a result below the minimum panic range or
below the minimum point of the calibration curve, it may be useful to increase the sample volume to
bring the sample absorbance back into the range or the curve. Pay attention that in this case the
reaction stoichiometric ratio will be changed.
Enter the Sample volume to be withdrawn in place of the volume set in
the Quantity field.
The analyzer will calculate the multiplication factor (which will be <1) in
order to correctly calculate the result.
For instance, setting the parameters as follows:

Original Sample Quantity: 2µl
Sample volume: 4µl
The analyzer will take 4µl instead than 2µl of sample, then will read the absorbance.
The result will be then multiplied by 1/2 to give the final result already included of the
performed "concentration".

SUMMARY OF THE SAMPLE MANAGEMENT
Sample management Action Check to activate Flag

Before sampling
Pre-treatment pre-dilution
After sampling
Pathological High dilution Pathological +
Pathological Low concentration Pathological -
Hyperactive dilution Test limit I
Max Abs Delta d
Final Abs A
Out of curve Above dilution Out of curve Above >
Out of curve Below concentration Out of curve Below <
INDICATIVE VOLUME LIMITS – Table 1
Min Max
Sample volume 1.0 150
Reagent volume 1.0 320
Reagent diluent volume 1.0 320
Volume in cuvette (reagents and sample) 150 420
SAMPLE MANAGEMENT
Sample 1 150
Diluent 1 320
Sample + diluent 120 320
The minimum volume for sample + diluent in sample management is "Sample
quantity" + 5µl when the Sample quantity is lower than 120µl

5.4. CHECK
The check parameters page contains a list of checks that are necessary and useful to verify the
correct reaction evolution and end.
As for the other parameters, there is the possibility to set the checks in different ways for serum as
well as for urines, CSF and other liquids.
In the Check list there are two columns: on the left side there are
the checkboxes to activate the automatic repetitions, on the right
side there are the checkboxes to activate the checks themselves.
On the right side of the page there are the check tags, one for each
check. Click on the tags to set the parameters for every control that
the analyzer will have to perform. Once the limits have been set for
one of the sample types (for instance "serum"), it is possible to copy
the same information to the other sample types by clicking on the
Copy these data to other types button.
Reagent Limit
The reagent limit verifies the good quality of the reagent.
For every test it is possible to set an Upper limit and a Lower
limit. Usually for an increasing reaction it may be expected that the
reagent blank increases, while it may decrease for a decreasing
Example for an increasing test
reaction. In some cases it may be useful to set both upper and
lower limits. If the reagent’s absorbance is beyond these limits, the
analyzer will check the results with O flag (Reagent out of limit).
This parameter allows monitoring reagents quality, as well as
checking any variation from the specific techniques.
Example for a decreasing test
Note:
This control has the highest priority on all the other check flags and inhibits the automatic
repetition functions. In case of reagent out of limit, the blank will be repeated every time the test
is performed in a run.

Final Abs Sign

This check verifies the sign of the final absorbance as calculated with the
Reaction Formula. For instance a decreasing fixed time test will have a
negative sign.
In case of discrepancy between the programming and the calculated abs,
the result will be flagged with ! (exclamation mark).
Form
This check is performed at three levels: reaction form,
reaction direction and tolerance within the previously
selected options.
Select the kind of absorbance variation to be verified during

Example for an End Point test reaction. First of all select the Reaction type among
Kinetic, End Point and Exponential.
In a Kinetic type reaction, the analyzer is expecting the
absorbance points to be distributed approx on a straight
line. The user can enter a tolerance in %, that will prevent
the analyzer from giving an error every time there is a small
variation in the reaction points.
Example for a Kinetic test Tolerance %: at the end of the reaction the analyzer
calculates the correlation coefficient in percentage among
the points of the reaction. If the tolerance is set to 100%, the analyzer will accept every variation and
no flag will be given. If the tolerance is set to 10%, the analyzer will accept a correlation coefficient
of 0.9 or 90%.
In an End Point reaction, the analyzer is expecting the final reaction points to be distributed approx
on a flat line. In an Exponential reaction the analyzer is expecting the reaction points to increase
after a relatively flat starting.
In this case (both end point and exponential), the Tolerance (mABS) is expressed in mAbs. After
the last dispensing cycle the analyzer will verify the delta read between every two readings (two
cycles). The calculated delta should be consistent: always>0 or always<0 (depending on the
reaction direction). In case the delta calculation results in an inverted sign, the analyzer will verify
whether this inverted delta is within the stated tolerance. If not, the result will be flagged with F.
n o p q t
r s
m
...
In the above example, the delta are always increasing up to point o, then the two couples p-q and
q-r have a decreasing delta. The delta calculated for the two couples must remain within the given
tolerance.

Test Limit
This parameter is used in all methodologies and it allows verification
of the final concentration of the analyses. It represents a threshold
value beyond which the analyzer detects an out-of-linearity condition
(hyperactivity). The concentration should be expressed with the same units used for the standard.
When the test result exceeds this value, the analyzer will flag the result as hyperactive (I flag =
Hyperactive Sample – out of Test Limit). If the Repeat check is enabled, the analyzer will also
automatically repeat the sample with the criteria expressed in the Sample Management page for
hyperactive situations.
Max Abs Delta

The Max ABS Delta represents the maximum
acceptable delta, expressed in mABS, calculated
during the reaction.
This parameter is calculated with the Formula
entered in the dedicated field. When this parameter
is exceeded, the analyzer will flag the result as
hyperactive (d flag = Hyperactive Sample – out of Max Abs Delta). If the Repeat check is enabled,
the analyzer will also automatically repeat the sample with the criteria expressed in the Sample
Management page for hyperactive situations.
Sample Interference
The sample interference is used to verify whether there is any
interference in the absorbance reading due to the sole sample (ex.
lipemic sample). The reading is performed after sample insertion,
therefore at cycle 7. The absorbance expected for this cycle is supposed to be a sum of the reagent
absorbance + a normal sample absorbance. If the absorbance read exceeds this value, the sample
will be flagged with i flag.
Hook
In this check the analyzer verifies the whole reaction with relation to
the reaction direction. The analyzer will verify the delta read between
every two readings (two cycles). The calculated delta should be
consistent: always>0 or always<0 (depending on the reaction direction). In case the delta
calculation results in an inverted sign (delta<0 in an increasing reaction or delta >0 in a decreasing
reaction), the analyzer will keep in memory the absorbance of the first inverted absorbance delta
point. Then it will go on calculating the delta between every couple of readings until the delta is
inverted again. The analyzer will then calculate the total delta between the first inverted absorbance
delta point and the last one, when the absorbance delta is again normal.
u
o p
...
q t
r
s

In the above example, the Hook will be calculated between points o and r. If this delta exceeds the
given value, the result will be flagged with H flag. If the Repeat check is enabled, the analyzer will
also automatically repeat the sample with the criteria expressed in the Sample Management page
for hyperactive situations.
Final Abs
This check verifies the final reaction absorbance. It indicates the limit
(upper limit for increasing analyses, lower limit for decreasing ones). If
the set absorbance is exceeded, the analyzer will detect an out-of-
linearity situation and will flag the result with A flag (= Hyperactive Sample – out of Final ABS).
This check can be selected only if also the Form check is selected, this to allow the analyzer to
know which is the reaction direction. If the Repeat check is enabled, the analyzer will also
automatically repeat the sample with the criteria expressed in the Sample Management page for
hyperactive situations.
Pathological
The results falling outside the normal range are flagged with + if above the range and with – if below
the range. The pathological check will verify if the results fall within the panic range.
If the Repeat check is enabled, the analyzer will also automatically repeat
the sample with the criteria expressed in the Sample Management page for
Pathological situations.
Out Of Curve Above

With this check, the analyzer verifies the absorbances falling outside the calibration curve on the
high side. The corresponding results will be flagged with > flag.
If the Repeat option is enabled, the analyzer will automatically repeat the sample with the criteria
already selected in the Sample Management for the out of curve above condition. If, after the
repetition, the absorbance is still outside the calibration curve, the result will be flagged with >> flag.
Out Of Curve Below

With this check, the analyzer verifies the absorbances falling outside the calibration curve on the low
side. The corresponding results will be flagged with < flag.
If the Repeat option is enabled, the analyzer will automatically repeat the sample with the criteria
already selected in the Sample Management for the out of curve below condition. If, after the
repetition, the absorbance is still outside the calibration curve, the result will be flagged with << flag.
NOTE 1: the available checkboxes must be enabled to allow the analyzer to correctly flag the
results. If programmed but not checked, the analyzer will use the internal default values, thus giving
wrong flags (ex. a decreasing fixed time test should have the Final Abs Sign selected to Negative, if
the check is not enabled, the analyzer will use the default setting which is Positive and the result
would be <NC>).
NOTE 2: when the Repeat check is enabled, but the corresponding Check is not, the automatic
repetition does not take place.

5.5. SUPPLEMENTARY
The supplementary parameters are used to define the measurement units, the decimals, the
instrumental factor and shift.
UNITS: the measurement units will be used to report the sample's final result in the correct
concentration unit. Enter for the Primary unit the Dimension. The units may be the same as used
for the standard or may be different. In this case it is necessary to enter the Std Conv. Factor,
which is a factor by which the concentration, calculated with the standard units, will be converted
into the Primary unit.
If necessary, a second unit can be used. In the Secondary part, check Present, then enter the
secondary unit dimension and a multiplication factor to convert the primary unit into the secondary.
In the Decimals field it is possible to decide whether to use the floating point algorithm for the
decimals in the results, or to have them fixed. In this last case, disable the Automatic check and set
the number of fixed decimals desired (max 6).
The Supplementary parameters must be programmed for every type of sample independently.
NOTE ON URINE UNITS

Many chemistries are run on serum and also on urines. The calibration is normally performed with a
standard or calibrator which has the same dimensions of the serum.
The urines dimensions may be different and are in any case linked to the urine/24H volume. These
two factors must be verified and, if necessary, used to correctly calculate the results.
Example 1. units are mg/dl both for serum and for its calibrator. For urines the dimension is mg/24h.
This value is calculated as follows:
=> mg/24H
therefore if the diuresis is given (patient entry – see chapter 5 par. 4.2.1.) in dl, the dimensional
equation will turn out correctly. But if the diuresis is given in a different unit, such as liters, the
dimensional equation must be corrected and the same is for the Std Conv. Factor.
(dl=l*0.1)
=> 0.1 * l/24H the correction factor is 0.1.

Example 2. units are mg/dl both for serum and for its calibrator. For urines the dimension is g/24h.
This value is calculated as follows:
(mg=gr*0.001)
=> 0.001 * g/24H => the correction factor is 0.001.
To print the analytical parameters, go to the menu bar, select print and then select what to print.

6. CALIBRATIONS
The calibration parameters are accessible from the same page of the analytical parameters,
selecting the Standard tag.
The standard parameters must be programmed for all type of processes: with factor, linear, with
curve, to allow the analyzer to correctly calculate the results on the basis of the read absorbance.
PROCESS WITH FACTOR

According to the analytical parameters, the calibration may be linear or with
curve. It is also possible to calculate the result by means of a theoretical
factor. In this case, in the analytical parameters the process selected should
be With Factor. In these type of analyses the standard page would be as
the one presented here on the right. In the Factor field, simply type the
value of the theoretical factor that the analyzer will use to calculate the final
result for the test. The Last Blank field is updated by the analyzer with the
latest reagent blank read.
LINEAR PROCESS
The analyses with linear process will display a standard page as the following.
Factor
In the Factor section there are three fields that must be programmed.
Value: in this field the analyzer will automatically update the factor value calculated in the
calibration.
Min: enter the minimum acceptable value of the calculated factor.
Max: enter the maximum acceptable value of the calculated factor.
The Min and Max factor fields are necessary to verify the validity of the calibration. In case of out of
range factor value, a warning is given and the calibration is not saved, keeping the previously
memorized factor.

Calculation: if known concentration and absorbance values are available, it is possible to

mathematically process the factor using the Calculation button.
The Last Blank field is updated by the analyzer with the latest reagent blank read (this might be a
standard as well as the last sample read).
Standard: in this section it is possible to program the standard parameters, but not
the standard positions on the standard tray. This setting is possible only from the
Manage Standard page.
N. of points: select the number of points to use in the calibration, from 1 to 3.

When assigning the positions on the standard tray to the standards, remember that every standard
has a sequential number that corresponds to a certain concentration. The same sequential number
is present also in the Manage Standard page, to allow a correct positioning of the cups.
Serial dilution: if desired, a serial dilution can be

automatically performed by the analyzer. Type the
concentration value of the highest standard in the
Conc field, then select a serial dilution value, ex.
1:2. The analyzer will automatically update the other
Conc fields with the serial concentrations and the
Dilution 1: fields with the corresponding dilution
ratio. This parameter is only necessary to perform
calculations and update fields. To activate the serial
dilution, see below (Automatic Serial Dilution). When opening the standard page again, after saving
the changes, the Serial dilution field will be again set to 1:1.
Diluent type: if the serial dilution has been programmed, select also the type of diluent to be used
for the standard dilution. Bear in mind that the diluent solutions are user-defined (see Setup, chapt.
9, par. 2.4).
Dilution 1: : if the standard is diluted, but not serially, it is possible to assign the specific dilution
ratio in this field, together with the corresponding concentration in the Conc fields.
Conc: the standard concentration that the analyzer will use to calculate the factor must be typed in
these fields.
ABS: the absorbance read by the analyzer, for every standard will be updated in these fields.

AUTOMATIC SERIAL DILUTION: the automatic serial dilution is always performed directly in
cuvette, therefore there is no need to put three cups on the standard tray. Only the highest standard
must be placed on the standard tray. The automatic serial dilution is automatically activated when
the standard positions assigned in the Manage Standard page are all the same. Only the position
corresponding to the higher standard must be programmed, repeated for the number of standard
used. For instance, if the calibration will be performed as in the example below, the standard
positions should be programmed as in part A of the table.
Standard parameters page

Std#1 Std#2 Std#3
Dilution 1:1 1:2 1:4
Manage Standard page
Automatic pre-dilution performed by the
Part A Tray pos. 1 1 1 analyzer in cuvette taking three times the
standard from pos 1.
No pre-dilution: it is supposed that the
Part B Tray pos. 1 2 3
standards have been externally pre-diluted.
ATTENTION: the dilution ratio (both Serial dilution 1: and Dilution 1: ) allows the
use of the floating point. It is therefore possible to type a dilution such as Dilution
1: 3.22. The arrows will increment or decrement by 0.5.
MULTIPLE STANDARDS: when more than one standard is used, its position on the standard tray
must be defined in the Manage Standard page. In the following example it is possible to see that
the analyzer can take the standard three times from the same cup or one time each from three
different cups.
Standard parameters page

Std#1 Std#2 Std#3
Dilution 1:1 1:1 1:1
Manage Standard page
No pre-dilution. The analyzer will take the
Part A Tray pos. 1 1 1
standard three times from pos 1.
No pre-dilution. The analyzer will take the
Part B Tray pos. 1 2 3
standards from the three different positions.
Use sample pre-dilution: enable this check if you want the analyzer to pre-dilute the standard in
the same as it pre-dilutes the sample (see par. 5.3 Sample – Sample management – Pre-treatment)
Variance%: this parameter allows the good quality of the calibration verification. It represents the
acceptable difference (in percentage) among the factors calculated if various standards are used or
if replicates are executed on a single point. After a variation above the programmed limit, a warning
is given and the previously memorized factor is not changed.
Last Calibration: in this field it is updated the date for the last positive
calibration performed for the test.
The calibrations have a dedicated archive (menu Archives – Calibrations' Archive) where all the
performed calibrations are stored. Here it is possible to view whether the calibration had a positive
result or not and the type of error. The calibrations that had problems of no reagent or no standard
are not stored.
Calibrations can also be time-programmed in order to let the analyzer remember the operator when
to run them. This feature is in the Manage Standard page (see chapt. 5 par. 3.1).
NON LINEAR PROCESS

Non Linear analyses require from 3 to 6 standards. In the analyses with Log logit 4 & 5 curve,
programming is the same but the required positions are 4 and 5, respectively.
Select the number of standards to be used to construct the curve. The fields for entering the dilution
and concentration of the various standards appear automatically. The values in the ABS boxes are
automatically updated during the calibration phase, if known they can be entered by the operator.
Programming is similar to that for analyses with factor.
To use the standard pre-dilution function, program the standards and enter the calibrator
concentration (the most concentrated point of the curve) at the first position. Then click in the Serial
Dilution box the desired dilution ratio.
The analyzer will automatically calculate and update the scalar concentrations starting from the
highest concentration value already present in the fields. In the Dilution fields the dilution ratio will
be automatically updated for each point.
ATTENTION: the dilution ratio (both Serial dilution 1: and Dilution 1: ) allows the
use of the floating point. It is therefore possible to type a dilution such as Dilution
1: 3.22. The arrows will increment or decrement by 0.5.
Zero: used to automatically reset the concentration of the lowest point of the curve to zero. During
the predilution phase of the standards the analyzer will dispense the diluent in this position.
Use sample pre-dilution: some analyses are programmed with the automatic sample pre-dilution.
It is possible to use the same pre-dilution also for the standards. The standards will be diluted as set
in the Sample Management page at the Sample pre-treatment option.
Clicking on the button Graph the analyzer will display the calibration graph for the test.

For all the tests with calibration curve, the analyzer will warn the operator if samples (patients) have
results above or below the calibration curve. The associated flag, next to the result, will be: below
curve "<" and above curve ">". It is possible to select automatic re-running of samples outside the
calibration curve in the Check parameters (see par. 5.4) considering also that the repetition
parameters are set in the Sample Management page.
To print the calibrations, go to the menu bar, select print and then select what to print.
Calibrations as well as controls can be programmed in order to let the analyzer remember when a
timed repetition is necessary. The programming is performed in the same pages where the physical
positions on the standard & control tray are assigned: Manage Standard pages (see chapter 5, par.
3.1).
7. CONTROLS
The controls are divided into Known and Unknown,. For every type there are three levels.where
Known: Level 1, 2, 3
Unknown: Level 1, 2, 3

Enter the Lot ID# both for known and unknown controls, then complete the fields for the known
control, assigning the minimum, theoretical and maximum values of the lot in use.
To print the controls, go to the menu bar, select print and then select what to print.
The physical positions for the controls as well as the timed repetitions are programmable in the
Manage Controls page (see chapter 5, par. 3.2).
.
8. PROFILES
Analyses can be grouped in coherent lists which are called profiles. Having these
lists already programmed can make the
patients programming easier. Click on
the Profiles icon on the main icon bar. The following
page will be displayed.
The list of available profiles is displayed in the left column,
while the tests belonging to each profile are listed in the
right column.
Click on the button New Entry to enter a new profile. The following window will appear.

In the Name filed, write the name of the profile, then select a number to be assigned to this profile
(for instance for bar-coded programming). All possible tests, available or not on the tray, can be
added to a profile.
INSERT/MODIFY PROFILES: this function creates/modifies analyses groups, useful when

checking-in patients. It can be accessed from Tests menu or from the specific icon that allows direct
access (Figure 28).
It is possible to delete, update and print an already existing profile.
Creating a profile: click over New button: the Profile Name textbox will appear. Enter the name for
the profile and click on Analyses: this will open a window where it will be possible to select the
analyses for the profile. Click "Save" to store the selected analyses (Fig. 29). It is possible to enter
in the Code for Bar-Code field a numerical code. The analyzer, when reading the bar-code labels
of Patients, will recognize it. This code is used for completely computerized acquisition of the
analyses assigned to the patient. The bar-code settings are explained in chapter 9, par. 1.4.
To update an existing profile, select it from the list and click on Modify, and then proceed as
outlined previously. To delete an existing profile, select its name and press Erase, confirmation is
requested prior to erasing.
Attention: during the patient acquisition, only the analyses present on the tray are displayed for
each profile.

9. APPENDIX
In the following pages are presented some examples on how to program the times of an end point,
a fixed time and a kinetic test, starting from the BT3500 parameters.
End Point:
GLY
BT3500
Method End Point
Kind Of Process Linear
Filters 510 / 700
Reaction Direction Increasing
Reagent #1 (µl) 200
Reagent # 2 (µl) 0
Sample Starter Inactive
Delay Time (sec) 0
Incubation Time (sec) 360
Reading Time (sec) 10
Insert R1+S Reading 10"
BT3500 Inc. R1+S= 300"
Insert R1 Insert S
Inc. R1= 6 cycles=96" Incubation + Reading=16 cycles=256"

BT4500
Reading = Point[Final]-Blank
Cy. 6 Cy. Final (22)
In a mono-reagent test, the blank is read automatically in the same cuvette where the reaction will
take place, therefore every single sample will have its own blank value.

AZO This type of test can be programmed in the BT4500 as R2 starter or

BT3500
Method Fixed Time
Sample starter. When programmed as sample starter, the reagent
Kind Of Process Linear blank can be performed in the same cuvette where the reaction will
Filters 340 / 700
Reaction Direction Decreasing
take place. When programmed as R2 starter, the reagent blank will
Reagent #1 (µl) 180 have to be performed in a second cuvette (see par. 5.2.4).
Reagent # 2 (µl) 45
Delay Time (sec) 0
Incubation Time (sec) 120 / 60
Insert R1+S Insert R2
BT3500 Inc. R1+S= 120" Inc. R1+S+R2=60" Reading 120"
BT4500
R2 starter
Insert R1 Insert S Insert R2
Inc. R1+S= 8 cycles=128" Inc. R+S= 4 cycle=64" Reading=8 cycles=128"

Reading = Point[Final]-Point[18]
Cy. 6 Cy. 14 Cy. 18 Cy. Final (26)
The reaction formula can also be written as: Reaction: Point[Final]-Point[Final-8]

The reagent blank must be set on a second cuvette. It is possible to program R1 and R2 times at
cycles 1 and 2 respectively and set Point[6] as formula for reading the blank itself.
BT4500
Sample starter
Insert R2
Insert R1 Insert S
Inc. R1= 2 cycles=32"

Inc. R1+R2= 4 cycle=64" Incubation + Reading=11 cycles=176"
Total Inc. R1+R2= 6 cycles=96" Incubation Reading = Point[Final]-Point[10]
Cy. 2 Cy. 6 Cy. 10 Cy. Final (17)
The reaction formula can also be written as: Reaction: Point[Final]-Point[Final-7]

GGT This type of test can be programmed in the BT4500 as R2 starter or

BT3500
Method Kinetic Sample starter. When programmed as sample starter, the reagent
Kind Of Process
Filters
Linear
405 / 700
blank can be performed in the same cuvette where the reaction will
Reaction Direction Increasing take place. When programmed as R2 starter, the reagent blank will
Reagent #1 (µl)
Reagent # 2 (µl)
180
45
have to be performed in a second cuvette (see par. 5.2.4).
Delay Time (sec) 0
Incubation Time (sec) 60 / 60
Insert R1+S Insert R2
BT3500 Inc. R1+S= 60" Inc. R1+S+R2=60" Reading 120"
BT4500
R2 starter
Insert R1 Insert S Insert R2
Inc. R1+S= 4 cycles=64" Inc. R+S= 4 cycle=64" Reading=8 cycles=128"

Reading = RegrxMinute[14, Final]
Cy. 6 Cy. 10 Cy. 14 Cy. Final (22)
The reaction formula can also be written as: Reaction: RegrxMinute[LastInsert+4,Final]

The reagent blank must be set on a second cuvette. It is possible to program R1 and R2 times at
cycles 1 and 2 respectively and set Point[6] as formula for reading the blank itself.
BT4500
Sample starter
Insert R2
Insert R1 Insert S
Inc. R1= 2 cycles=32"

Inc. R1+R2= 4 cycle=64" Incubation + Reading=11 cycles=176"
Total Inc. R1+R2= 6 cycles=96" Incubation Reading = RegrxMinute[10, Final]
Cy. 2 Cy. 6 Cy. 10 Cy. Final (17)
The reaction formula can also be written as: Reaction: RegrxMinute[LastInsert+4,Final]

CHAPTER 4
TECHNICAL SPECIFICATIONS Page
1. PERFORMANCE AND LIMITS .................................................................... 2

Via Licenza, 18
Chapter 4 Technical specifications Page 1 of

1. PERFORMANCE AND LIMITS
GENERAL INFO
Operating Mode: Sequential access
Methods: Clinical Chemistry, I.S.E., Immune-Chemistry, DOA
Test Mode: Routine, Batch, Emergencies (STAT), Profiles
Tests in memory: 500 single or double- reagent + unlimited Relation Tests
Test Re-runs: automatic or on demand
Calibrations and Controls: automatic or on demand
Quality Control: 3 known levels and 3 unknown levels
Maintenance: Automatic program
TIME REQUIRED TO REACH STEADY STATE

Ambient conditions: 21 °C R.T., 33% RH
Time required for the analyzer to reach steady state: 20 min.
Time required for refrigerated bottles to reach steady state: approximately 2 hours
OPERATING AMBIENT TEMPERATURE 18 °C to 32 °C, 10% to 90% RH, Non condensating
PERFORMANCES
Tests on line: 80 refrigerated reagents + relation test (40 large + 40 small bottles)
Measurement: direct reading of 84 cuvettes in optical glass
Samples Tray: 100 samples positions
Standard & Controls Tray: 26 refrigerated positions
1 arm for Samples
Sampling arms:
2 arms for Reagents
2 distinct barcode scanners for positive identification of samples and
Bar code scanner:
reagents
Direct on serum (K, Na, Cl, Li), pre-diluted urine sample (K, Na, Cl),
I.S.E. Module:
Microsample
Analytical Throughput: Up to 450 test/hour clinical chemistry; up to 690 test/hour with I.S.E.
VOLUMES
WORKING SOLUTIONS
Min / Max Sample Vol. µl 1.5 / 100
Min / Max Reagent Vol. µl 1.5 / 300
Min / Max reaction (reag +
180 / 400
sample) µl
UTILITY EXECUTION TIMES

TIME USED WASHING SOL. (approx) USED DEDICATED SOL. (approx)
Wash with water 5’ 200 ml
Wash cuvettes 7’ 250 ml 15 ml
Extra wash cuvettes 11’ 500 ml 15 ml
Zeroing on water 6’ 200 ml
FCC Function 15’ 300 ml 15 ml
Cuvette single wash 6 ml
Needle single wash 2 ml

Consumption per test 8 ml
BT3500 TIME USED WASHING SOL. (approx) USED DEDICATED SOL. (approx)
Wash cuvettes 7’ 250 ml 15 ml
Sleep mode wash 5’ 200 ml
Cuvette single wash 2.5 ml
Consumption per test 4.5 ml
BT1000 & BT2000Plus TIME USED WASHING SOL. (approx) USED DEDICATED SOL. (approx)
Wash cuvettes 7.5’ 250 ml 15 ml
Cuvette single wash 6 ml
Consumption per test 8 ml
BT1500 TIME USED WASHING SOL. (approx) USED DEDICATED SOL. (approx)
Wash cuvettes 6’ 230 ml 6.6 ml
Extra wash cuvettes 12’ 350 ml 6.6 ml
Cuvette single wash 2.5 ml
Consumption per test 4.5 ml
NOTE: stated times and liquid consumptions should be considered only as indicative as they
may vary in different conditions.
Operating Limits
The instrument cannot guarantee the preceding performance specs in the following conditions:
1) Ambient conditions beyond the specified range.
2) Use of non-conformant clinical chemistry products such as washing solution, distilled water, and etc.
3) Maintenance schedule and expiry date ignored.
4) Use of non-original spare parts and consumables.

The manufacturer does not guarantee the correct instrument performances in case of implementation of
unanticipated methodologies. Consult your nearest sales/service office or factory for the use of different
methodologies.

CHAPTER 5
OPERATIVE PROCEDURE Page
1. TURNING ON PROCEDURE ....................................................................... 2

2. REAGENTS MANAGEMENT....................................................................... 3
2.1. Make tray.....................................................................................................................3
2.2. Insert / Remove Reagents and volumes check .......................................................6
2.3. Reagents swap procedure.........................................................................................8
3. CALIBRATIONS & CONTROLS .................................................................. 8
3.1. Calibrations.................................................................................................................9
3.1.1. Programming Standards (Immediate) ..............................................................10
3.1.2. Linear calibrations with or without automatic dilution...................................11
3.1.3. Non linear calibrations with or without automatic dilution ............................13
3.1.4. Running calibrations..........................................................................................13
3.1.4. Programming Standards (Timed) .....................................................................14
3.2. Controls.....................................................................................................................16
3.2.1. Programming Controls (Immediate) .................................................................17
3.2.2. Running controls................................................................................................20
3.2.3. Programming Controls (Timed) ........................................................................22
4. SAMPLES .................................................................................................. 24
4.1. Batch entry................................................................................................................24
4.2. Patients entry............................................................................................................26
4.2.1. Programming patients .......................................................................................26
4.2.2. Programming STATs..........................................................................................31
4.3. Running samples .....................................................................................................31
4.4. Current and Extra work-lists ...................................................................................33
4.5. Samples Performed work-list..................................................................................34
4.6. Patients Management Options................................................................................36
4.6.1. Repetitions for analyses.......................................................................................36
5. TURNING OFF PROCEDURE ................................................................... 37

Via Licenza, 18
Chapter 5 Operating procedure Page 1 of 37

1. TURNING ON PROCEDURE
Turn on the analyzer by pressing the green on/off switch on the left side (refer to Chapter 2,
paragraph 3.1. Turning on the instrument for the first time).
analyzer itself and does not load the program. To properly turn on all the analyzer system, turn on
the external PC and load the analyzer program. Once the analyzer program is fully loaded, the
following main screen will appear.
On the lower bar right side there will be a number blinking. This number is the cuvettes temperature
read by the analyzer. This number will blink until the correct cuvettes temperature is reached.
The analyzer displays also the room temperature, the reagents

chamber and the standard and controls temperature. To see the
temperatures in an enlarged window, double click on the
temperatures bar.
On the lower bar left side there is the messages area. Double click on this area to view the
messages displayed by the analyzer.
At the center of the lower bar there is the software version of the main program and the authorized
protection level.
After the turning on procedure, allow the analyzer to warm-up. The instrument is ready for use after
approx 20 minutes, when the temperature in the cuvettes tray has reached the proper value and the
photometric lamp is stable. At this point the analyzer will require a zeroing of the photometer

2. REAGENTS MANAGEMENT
This function is accessed either by pressing F10 key or by clicking on the specific icon.
In the management pages it is possible to view the reagent volumes, insert and remove reagents,
create the current analyses tray, assign the reagent lot and expiry date and duplicate the reagents.
First of all it is necessary to create the on-line tray.

Remember that the number of reagents for every
test must have been already defined, before
creating the on-line tray.
Then assign the position on the tray to every test,

together with lot number and expiry date.
2.1. Make tray

To create the on line reagents tray, it is necessary to move the reagent codes from the general to
the current tray list, assigning the physical position on the tray, as well as the lot number and expiry
date. In the same pages it is possible to decide if a reagent must have its duplicate on board (for
backup purposes).
Remember that the number of reagents for each test has to be defined before moving it into the on
line tray.
In every position of the tray it is possible to place maximum 20 reagents and the bottle will be
identified by the symbol (+). It is important to know that the lot number and expiry dated are
assigned to the physical position on the tray, not to the single code in that position. Therefore all
reagents placed in the same position will have the same lot ID and the same expiry date. When one
expiration is deleted, all the other codes in the same position will have their expiration deleted and
will therefore be removed from the tray.
For what concerns duplicates, every reagent can be duplicated only twice for a total of three bottles:
one master and two duplicates. Remember that the duplicates must be placed in higher positions
respect to the master (i.e. if the master is in position 12, the duplicated can be placed in any position
from 13 to 40).
To create the on line tray, select from the Available list the code or codes to move. Keep pressed
the CTRL key while clicking on the codes, to select codes randomly. Keep pressed the SHIFT key
while clicking on the first and the last code of a series to select them all.

Use the dedicated icons to move the codes.
Click here to move only the selected code or codes to the on line tray.
Click here to move all available codes to the on line tray.
Click here to remove only the selected code or codes from the on line tray.
Click here to remove all codes from the on line tray.
When moving the codes, the analyzer will use the following criteria to assign the position on the
tray:
- first will fill the empty positions
- then will fill the positions with lower number of reagents already present.
For the type of bottle, the analyzer will first place the reagents in the large /small order, then large /
large, then small / small.
REAGENT INFO
Once all the codes have been moved, it is possible to customize the tray.
Click on this icon to enter the reagent info. The following page will be displayed.
The upper section is dedicated to the reagents, while the

lower is dedicated to the possible reagent diluents.
When some reagents or diluents are not used, the
corresponding area will be completely blank.
For every code, enter the following information.

Position: select the physical position on the tray for the corresponding reagent. Max 20 reagents
can be programmed in a single position.
Type: set the type of bottle, among those presented by the analyzer. The reagent bottles may be of
80ml, 50ml, 20ml, 10ml.
Lot ID#: type the reagent lot number.
Expiry: type the reagent expiry date.
ATTENTION
Remember that the lot number as well as the expiry date are linked to the position, not to the code
in that position, therefore, all reagents in a single physical position will have same lot and expiry
date. It is advisable to set the lot and expiry date only after all reagents in a single physical position
have been programmed to that position. The lot and expiry will be automatically copied to all the
codes in that position. Adding another reagent in the same position will automatically delete the
already present lot and expiry.
REAGENT DUPLICATION
It is possible to duplicate a reagent in order to have a backup bottle on board, already available. A
reagent can be duplicated a max of two times, for a total of three bottles on board. The analyzer will
automatically switch from the first to the second and then to the third bottle as soon as the reagent
is finished. Note that the analyzer will not switch from the third to the first bottle. Before every run
the analyzer will ask if the operator would like to perform a volumes check. This will update the
reagent volume in the bottles and enable the analyzer to use a backup bottle if necessary. The
samples performed with the backup bottle will be marked with the K flag, meaning that a new
calibration is necessary for the test.
Click on the + (plus sign) to duplicate a code or on the – (minus sign) to delete the
duplicates.
The duplicated reagents will be added on the list after the master and will be
identified as BAK and colored in light green.
The duplicated reagents must be programmed in higher positions respect to the master. To set lot
number and expiry date, proceed as for the other reagents.
Once all necessary settings have been made, click on the Save button, or click on Cancel to abort
all modifications made. Click on the Print button to print the reagents map.

2.2. Insert / Remove Reagents and volumes check

This function helps the user to correctly position the reagent bottles, as programmed in the current
tray.
The reagent tray is divided into sectors, identified by the letters A, B, C, D and E. Each sector
has 8 positions. The screen displays the representation of 8+8 bottles. The analysis codes of
large bottles are displayed on the lower positions, while the upper positions indicate the
codes used for small bottles. The diluents and I.S.E. reagents are displayed below the
chemistry reagents.
The symbols (+) or 1.XXX and 2.XXX can be displayed inside the bottles. The symbol (+) indicates
that the position is used for more than one code, while the symbols 1.XXX, 2.XXX, 3.XXX and
4.XXX indicate the position of the first, second, third and fourth bottle pertaining to a multi-reagent
code.
SECTORS
In the Sector area, the five sectors are represented on a rotating wheel. Click
on the letter corresponding to the sector and this will be presented in the
reagents page. The letter indicating the present sector is in capital letters and it
is placed at the bottom center of the wheel.
To insert a sector, select it first as explained above, then click on the Insert
Sector button. Open the reagents cover and introduce the sector, then answer
to the analyzer's question. Click on the Check sector volumes button. The
analyzer will now verify the volumes present in the sector's bottles and will
update the graphical representation. When using the bar-code, it is possible to identify the reagent
bottles by scanning the sector. Click on the Scan sector button. The bar-code settings are
explained in chapter 9, par. 1.4.
The analyzer will read the bar-code labels and assign the reagent positions automatically. In case of
errors or misreading a window will appear listing the occurred errors.

BOTTLES
To insert a single bottle, right click on it and the analyzer will display the following options.
Insert bottle: allows the operator to enter a reagent in the correct position. The
requested bottle will be presented right in front of the reagents chamber. Open
the cover and opportunely answer the analyzer's question. Then the analyzer will
verify the volume present in the bottle and will update the graphical
representation.
Present position: the analyzer will only present the required position.
Scan position: the analyzer will read the bar-code label and assign the correct code and analytical
parameters to the selected position. The bar-code settings are explained in chapter 9, par. 1.4.
DILUENTS AND I.S.E. SOLUTIONS

In the lower part of the Reagents Management window there is the graphical representation of the
diluents and I.S.E. solutions bottles. Click on the Check volumes button to verify the solutions in
the bottles. The analyzer will then update the graphical representation. Right clicking on one of the
diluent bottles or on the I.S.E. sample diluent, it is possible to verify the volume in the single bottle.
The I.S.E. Pack is not verified. Its volume is estimated by means of the software and the number of
available tests is updated together with the residual volume percentage. When the I.S.E. waste
volume reaches 88%, the analyzer will warn the operator to replace the I.S.E. pack with a new one.
When the I.S.E. waste volume reaches 99% the I.S.E. functions are blocked. To replace the I.S.E.
Pack, follow the instructions in the I.S.E. dedicated chapter and then press the Change I.S.E. Pack
button. Remember that an I.S.E. prime is mandatory after having replaced the I.S.E. Pack.
VOLUMES
For every reagent and diluent bottle is graphically indicated the remaining volume in a green to red
fading scale. The I.S.E. Pack and I.S.E. Sample diluent display also the approx number of tests still
available with the remaining volume.
To see the remaining volume and tests available in the
chemistry bottles, left-click on the corresponding
position.
The upper bottle corresponds to a 10ml or a 20ml
bottle, while the lower bottle corresponds to a 50ml or
80ml bottle.
When clicking on the desired bottle, a small window
will appear showing the test name, the remaining
reagent volume and the number of tests which can be
performed with the remaining volume, according to the
set parameters.
When more than one test in the same position, the analyzer will show the list
of codes, the remaining volume and, for each code, the available number of
tests, according to the set parameters.

2.3. Reagents swap procedure

When backup reagents are programmed, the analyzer will swap to the backup bottle when the
volume in the reagent bottle has reached the following percentages:
10ml bottles 20%
20ml bottles 20%
50ml bottles 5%
80ml bottles 5%
The analyzer asks for a volumes check before starting every run in order to update the volumes in
the bottles. If a reagent bottle has already reached the percentage limit, the analyzer will start the
sampling directly with the backup bottle. A reagent can be duplicated a max of two times, for a total
of three bottles on board. The analyzer will automatically switch from the first to the second and then
to the third bottle as soon as the reagent is finished. Note that the analyzer will not switch from the
third to the first bottle.
If the percentage limit is reached during a run, the analyzer will swap to the backup bottle
automatically. In case, for any reason, a reagent gives the No reagent alarm, the analyzer will
automatically swap to the backup bottle, but a max of four samples may be lost. In this case the
results will be flagged with the R flag and it will be possible to repeat the sampling with the
Repetition for analyses procedure (see par. 4.6.1).
3. CALIBRATIONS & CONTROLS

As already seen, the calibrators and controls parameters are programmed in the analytical
parameters pages.
The positions on the standard & controls tray are programmed by clicking on the dedicated icons on
the main icons bar.
Click on this icon to access the calibrations page.
Click on this icon to access the controls page.

3.1. Calibrations
In the Manage standard page it is possible to select all the codes stored in memory, as well as only
those that are not in the tray or only those that are on line. Click on the corresponding button on the
top icon bar.
The selected code type list will be displayed in the page. In this page there are two tags: one is for
the Immediate standards, the other is for the Timed standards. The only difference between the
two pages is in the timed standards programming, which appears in the last column on the right and
will be explained afterward.
If the Lot ID# is not assigned, the analyzer will not run the calibration.
The buttons on the right side of the window are in common for both tags.
Select/deselect: allows simultaneous selection/deselection of all listed codes.
Modify lot name: allows the modification of the lot name for multiple codes simultaneously.

Print: opens the printing interface (see chapt. 3, par. 2.1). From this page it is possible to print the
calibrations, to save the file in pdf format or to export it in other formats.
The printout will list the codes, the positions on the tray and the Lot ID. The codes selected to run
the calibration will be marked with an X.
Run: click on this button to run the calibrations. See also par. 3.1.4. Running calibrations.
Exit: click on this button to close the Manage standard window.
3.1.1. Programming Standards (Immediate)

In this page it is possible to select which tests will have to be calibrated and in which position on the
dedicated tray. The tray allows a total of 26 positions freely shared between standards and controls.
The first column in the page, Select, is dedicated to the check-boxes for selecting the calibrations to
be performed. In the second column there is the list of the codes.
The following columns are identified as #1, #2, #3, #4, #5 and #6. These numbers correspond to the
same numbers in the standard analytical parameters page.
Immediate standard
Std. analytical parameters
It is necessary to respect the above described relationship between numbers, in order to correctly
assign the positions on the tray.
In the above picture there are three analyses programmed. The ALBC test has a calibration curve
on positions from 4 to 9 of the standard & controls tray. The tests CRE and GLY are linear tests
both programmed to repeat three times the calibrator in position 1. It is possible to notice that the
positions assigned concomitantly to more than one test are highlighted in bold red. The same
character format is used also if the same test is repeated three times in the same position: again the
position will be in bold red.
To change the position assigned to a standard, click on the number and use the arrows or type a
different number. The field in editing will be the only white one in a line with blue background.

NOTE: the standard & controls tray positions are now in share between standards and
controls. When the analyzer is already running calibrations (or controls) and the operator
runs controls (or calibrations) which are in the same physical positions on the tray, the
analyzer will not run all of those controls which are in the same positions of the already in
run calibrations.
3.1.2. Linear calibrations with or without automatic dilution

The way standards are programmed in the analytical parameters and in the Manage standard page
will automatically give the analyzer the necessary information to perform the calibrations in different
ways.
LINEAR CALIBRATION WITH THREE SAMPLINGS FROM THE SAME POSITION
In the standard analytical parameters page, the test

must have no dilution and the same concentration
repeated three times.
In the calibrations page, the three standard must be in the same position on the tray.
With this programming the analyzer will take the calibrator three times from the same cup.
The positions on the tray are in bold red, thus meaning that the same position is used for all the
three standards.

LINEAR CALIBRATION WITH THREE SAMPLINGS FROM DIFFERENT POSITIONS AND NO

AUTOMATIC DILUTION
In the standard analytical parameters page, the test

must have no dilution and three different
concentrations.
In the calibrations page, the three standard must be in different positions on the tray.
With this combination, the analyzer will take the standards from the three different cups, without
performing any automatic dilution and will calculate the factor as a mean of the three factors
calculated each on every single point.
LINEAR CALIBRATION WITH THREE SAMPLINGS FROM THE SAME POSITION AND WITH
AUTOMATIC DILUTION
In the standard analytical parameters page, all
three standards must have their dilution, manually
entered or automatically calculated by means of the
serial dilution.
The three standards must also have three different
concentrations, according to the respective dilution.
The lower concentration standard is automatically
placed as first standard.
In the calibrations page, the three standard must be in the same position on the tray.
With this combination, the analyzer will take the standard from the cup in position 1 of the tray for
three times. For the standard #1 and #2, the analyzer will also perform an automatic dilution.
It is also possible to program the analyzer to take the standards from three different cups,
performing the programmed dilution for each, but usually this is only a waste of calibrator.
The automatic dilution is performed as follows. The analyzer will take the standard from the cup and
will dilute it into a first cuvette, then it will take the diluted standard from the first cuvette and use it
for the reaction in a second cuvette. The separated preparation of every standard allows the
analyzer to dilute the standards (or the samples) with the maximum flexibility.

3.1.3. Non linear calibrations with or without automatic dilution

The same descriptions seen above for the linear calibrations apply to the non linear calibrations.
In the standard analytical parameters page, all six standards must have their dilution, manually
entered or automatically calculated by means of the serial dilution.
The six standards must also have different concentrations, according to the respective dilution.
The lower concentration standard is automatically placed as first standard.
CALIBRATION WITHOUT DILUTION
In the calibrations page, every of the six standards must be in a different position.
The analyzer will simply take the standard from each cup to perform the reaction.
CALIBRATION WITH DILUTION
In the calibrations page, the six standards must be programmed in the same position.
The analyzer will take the standard from the cup six times, performing every time the necessary
dilution in a separated cuvette.
It is also possible to mix the two methods, if necessary.
3.1.4. Running calibrations

To run the calibrations it is necessary to select the codes by checking the desired check-boxes.
Remember that in the Manage standard window it is possible to view the codes that are on-line,
the codes that are not on-line or all codes. Select one of these options and then proceed.
Verify that the selected codes have their Lot ID#. To assign a Lot name or number, double click on
the Lot ID# field of the desired code. It is also possible to select multiple codes to assign
simultaneously the lot name. Click on scattered codes keeping the CTRL key pressed or click on the
first and last code in a sequence keeping the SHIFT key pressed. Then click
on the Modify lot name button. Enter the lot name and press Save.
To run the calibrations, it is possible to select or deselect all codes clicking

on the dedicated buttons on the top right of the window..
Once all desired codes have been selected, press on the Run button. The
analyzer will display the following question.

In case of positive answer, the analyzer will start the sampling. In case of negative answer, the
analyzer will display the standard positions map.
Clicking on every position number, the analyzer will rotate the standard tray to present the correct
position where the operator can insert the standard cup. The already inserted standards will turn
background color from white to green.
Once finished, click on the button Accept to run the calibrations. Press Exit to abort the procedure.
When there are calibrations in run, these will have a different background color in the Manage
standard page.
Attention: when a code is in run in the Immediate standards, it will be of the same color also in the
Timed standards page.
3.1.4. Programming Standards (Timed)

The timed calibrations page is similar to the immediate calibrations page, with the only difference of
the last column, where it is possible to program the calibration repetition parameters.
For all other info, please refer to the previous pages.

The timed calibrations programming window will be opened by double clicking on the Program
column field corresponding to every code. The programming will only activate a warning reminder
message: the calibrations will not run automatically. It will be on the user responsibility to verify the
presence of the cups and reagents and then to run the determination.
Every day at: the reminder message will be presented every day at the specified hour. For
example, setting "08" "30" the message will be
displayed every day at 08:30 in the morning.
Days + hours interval: the reminder message will be displayed at the time intervals as
programmed into the Days + Hours boxes. For
example, setting "02 + 8" the reminder will be
presented every two days and eight hours.
Setting "00 + 8" the message will be displayed
every eight hours. Setting "1 + 0" the reminder
will be presented 24 hours after the last determination.
In the Timed Standard page the programmed timers will be displayed synthetically in the Program
column as follows.
Every day at 8:30 in the morning

Every eight hours
Every 3 days and 5 hours
Every two days
Every day (24 hours after the last time the calibration was run)

3.2. Controls
All the Controls pages are very similar to the same page dedicated to the controls.
In the Manage controls page it is possible to select all the codes stored in memory, only those that
are not in the tray or only those that are on line. Click on the corresponding button on the top icon
bar.
The selected code type list will be displayed in the page. In this page there are two tags: one is for
the Immediate controls, the other is for the Timed controls. The only difference between the two
pages is in the timed controls programming, which appears in the last column on the right and will
be explained afterward.
If the Lot ID# is not assigned, the analyzer will not run the control.
The buttons on the right side of the window are in common for both tags.
Select/deselect: allows simultaneous selection/deselection of all listed codes.
Modify lot name: allows the modification of the lot name for multiple codes simultaneously.

Print: opens the printing interface (see chapt. 3, par. 2.1). From this page it is possible to print the
controls, to save the file in pdf format or to export it in other formats.
The printout will list the codes, the positions on the tray and the Lot ID. The codes selected to run
the control will be marked with an X.
Run: click on this button to run the controls. See also par. 3.1.4. Running controls.
Exit: click on this button to close the Manage control window.
3.2.1. Programming Controls (Immediate)

In this page it is possible to select which tests will have to be run and in which position on the
dedicated tray. The tray allows a total of 26 positions freely shared between standards and controls.
The first column in the page, Select, is dedicated to the check-boxes for selecting the controls to be
performed. In the second column there is the list of the codes.
The following columns are identified as Known #1, Known #2, Known #3, Unknown #1, Unknown
#2 and Unknown #3. These definitions correspond to the same in the control analytical parameters
page.
In the controls analytical parameters both
the known and unknown sections offer three
levels (#1, #2 and #3).
Because of the limited space, the definitions

have been shortened and the correlation
between the analytical parameters and the
Manage controls page definition is
explained here below.
Analytical parameters Manage controls

Known Level 1 Known 1
Unknown Level 1 Unknown 1

To allow the analyzer to correctly elaborate the results, it is necessary to respect the above
described relationship between numbers, in order to correctly assign the positions on the tray.
In this picture it is possible to see some programming conditions.

Test CRE: as it is possible to see from the Info column, both known and unknown controls are
programmed and the test is selected, but the three unknown controls are correctly programmed in
three different positions, while the three normal controls are programmed all in the same position.
Test GGT: the only programmed control is the known and positions are correctly assigned.
Test I.S.E.: all type of controls are correctly programmed and positions are all correctly assigned.
Test STRE & INC: these tests have no controls programmed, therefore the analyzer will highlight
this situation writing ** ERROR ** on red background.
All positions used for more than one control are in bold red.
To change the position assigned to a control, click on the number and use the arrows or type a
different number. The field in editing will be the only white one in a line with blue background.
For all controls the different levels are the selected by means of the following checks.
Once the Known Level 1 is selected, the analyzer will

perform it for all selected codes.
In case the operator does not want this type of simultaneous running, it is possible to program the
analyzer in order to skip on certain levels, as shown in the picture below.
In this case, instead of a numerical position on the tray, the Known #1, Known #2 and Unknown #3
levels show an empty field. This is obtained by typing 0 (zero) instead of a number in the position
field. In this condition the analyzer will not consider the empty positions.
When the test is highlighted, it is possible to see the "0" in white on blue background.

For instance, if the operator wants to program these controls.

TEST Known L1 Known L2 Known L3 Unknown L1 Unknown L2 Unknown L3
AAA YES YES NO NO NO NO
BBB YES YES NO NO NO NO
CCC YES YES YES NO NO NO
DDD YES YES NO YES YES NO
EEE YES YES NO YES NO NO
FFF YES NO YES YES YES YES
it will be necessary to program the analyzer as follows:
AAA 10 11 0 0 0 0
BBB 10 11 0 0 0 0
CCC 10 11 12 0 0 0
DDD 10 11 0 14 15 0
EEE 10 11 0 14 0 0
FFF 10 0 12 14 15 16
If usually the known and unknown third level are not used, it is simply possible to program the
analyzer as in this picture.
The analyzer will ignore the positions programmed for these two levels and will not perform them.
NOTE: the standard & controls tray positions are now in share standard and controls. When
the analyzer is already running controls (or standards) and the operator runs standards (or
controls) which are in the same physical positions on the tray, the analyzer will not run all of
those standards which are in the same positions of the already in run controls.

3.2.2. Running controls

To run the controls it is necessary to select the codes by checking the desired check-boxes.
Remember that in the Manage control window it is possible to view the codes that are on-line, the
codes that are not on-line or all codes. Select one of these options and then proceed.
Verify that the selected codes have their Lot ID# programmed for all selected levels. To assign a Lot
name or number, double click on the Info field of the desired code.
The controls analytical parameters page

will be displayed. Type the necessary info
and then save.
It is also possible to select multiple codes to assign simultaneously the lot name. Click on scattered
codes keeping the CTRL key pressed or click on the first and last code in a sequence keeping the
SHIFT key pressed. Then click on the Modify lot name button. Enter the lot name and press Save.
To run the controls, it is possible to select or deselect all codes clicking on

the dedicated buttons on the top right of the window..
Once all desired codes have been selected, press on the Run button. The
analyzer will display the following question.
In case of positive answer, the analyzer will start the sampling.

In case of negative answer, the analyzer will display the control positions map.
Clicking on every position number, the analyzer will rotate the control tray to present the correct
position where the operator can insert the control cup. The already inserted controls will turn
background color from white to green.
Once finished, click on the button Accept to run the controls. Press Exit to abort the procedure.
When there are controls in run, these will have a different background color in the Manage control
page.

Attention: when a code is in run in the Immediate controls, it will be of the same color also in the
Timed controls page.
3.2.3. Programming Controls (Timed)

The timed controls page is similar to the immediate controls page, with the only difference of the last
column, where it is possible to program the control repetition parameters.
For all other info, please refer to the previous pages.
The timed controls programming window will be opened by double clicking on the Program column
field corresponding to every code. The programming will only activate a warning reminder message:
the controls will not run automatically. It will be on the user responsibility to verify the presence of
the cups and reagents and then to run the determination.

Every day at: the reminder message will be presented every day at the specified hour. For
example, setting "08" "30" the message will be
displayed every day at 08:30 in the morning.
Days + hours interval: the reminder message will be displayed at the time intervals as
programmed into the Days + Hours boxes.
For example, setting "01 + 6" the reminder will
be presented every one day and six hours.
Setting "00 + 8" the message will be displayed
every eight hours. Setting "1 + 0" the reminder
will be presented 24 hours after the last determination.
Every "n" samples: the controls determination will be performed every "n" samples. For example,
setting 20, the analyzer will remind to run the
controls every 20 samples.
In the Timed Controls page the programmed timers will be displayed synthetically in the Program
column as follows.
Every day at 8:30 in the morning

Every eight hours
Every 3 days and 5 hours
Every day (24 hours after the last time the calibration was run)
Every 20 samples

4. SAMPLES
The samples, i.e. the patients can be programmed easily in batch mode or in a better detailed way
using the routine mode (Patients menu).
It is possible to program STAT samples at any moment in the Patients work-list.
Click on the Patients or Batch icon to enter in the dedicated pages.
4.1. Batch entry
As in other parts of the program it is possible to display all test codes, only codes in the current tray
or only codes not in the current tray. Select the desired list by clicking on the button.
The list of the codes is displayed. Click on a code to program the batch. The samples tray has 100
positions available. To make the programming easier, use the Select and Deselect buttons after
having entered a numerical range to operate with.
For instance: select as range "38" and "48" and click on Select: all positions in this range will be
selected. On the opposite, if all 100 positions (or less) are selected and it is necessary to free other
positions, select the range, again "38" and "48" and click on Deselect: all positions in this range will
be deselected.

After having selected the positions on the tray, it is necessary to confirm which tests
will have to be performed. This is done by clicking on the checkbox near each
analysis code. When the check is present, the test will be performed.
The type of sample used in the batch is by default the serum. It is possible
to select a whole batch to be on urine by clicking on the checkbox Batch
on urine.
In this case all samples will be dealt with as urines.
When the batch has been selected (positions, codes and sample type) click on the Run button to
perform the tests selected.
The analyzer will display the following question.
The patients already programmed in the current work-list will not be lost, but will be moved to the
extra list. This is an additional list, where the positions on the tray are not assigned. In a second
moment it will be possible to move again the programmed patients to the current list (see par. 4.4).
Answering no, the procedure will be aborted. Answer yes if the current list is empty or if there are no
problems in moving the patients. The analyzer will display the following question.
Answer yes if the cups are already positioned in the tray, or answer no to let the analyzer guide you
in the cups insertion. In this case the analyzer will display the batch list as below.
Click on a single position and the analyzer will rotate the tray in order to insert easily the cup in the
correct position. The inserted cups' positions will turn from red to blue background.
Once all selections are done, click on the Accept button to let the analyzer start the run.
To start the run immediately, skipping on the above mentioned procedure, answer Yes to the
question "Do you have already inserted the samples?.
The volumes check is useful when there are backup reagents on board. With the check the analyzer
will update all reagents volumes and will be therefore able to swap to the backup reagent when
necessary.
NOTE: the swapping procedure is explained at par. 2.3.

The running samples are always loaded into Current list. To view these, click on the Patients icon.
There it will be possible to view all the work-lists: Current list, Extra list and Samples performed.
The samples programmed in batch will be identified as Batch XX.
4.2. Patients entry
Clicking on the Patients icon all the work-list will be displayed.
There are three work-lists:

Samples performed: here are listed all the performed samples, which are present also in the Real
time pages. Once data are stored, the samples listed here will be archived and will not be available
any more.
Current list: here it is possible to program the routine and are shown all programmed and running
samples.
Extra list: in this list it is possible to store samples which has been already programmed, but do not
have a position on the samples tray already assigned.
These buttons are available for easy access to the functions.
New entry: to program a new sample.

STAT: to program a new STAT sample.
Run all samples: to run all programmed samples.
Close: to close the patients programming and go back to the main page.
4.2.1. Programming patients

The positions on this list correspond to the number of positions available on the samples tray, i.e.
from 1 to 100. The positions are color-coded.
Green: free and available for programming
Blue: already programmed
Red: programmed and running
Beside every position number there is a small cup. These cups indicate the type of sample and are
color-coded.
Gray: free and available for programming
Yellow: normal sample
Red: STAT
Blue: control

To program new patients it is possible to click on the New Entry button or to click on the number of
any free position in the list. The Sample's Data window will be displayed.
On the right and bottom sides of this window there are respectively the Profiles and Analyses
fields. Click on these fields to open/close the corresponding lists. When the Sample's Data window
is opened, by default it will have the analyses list open and the profiles list closed as in the picture
below.
Samples can be saved only if a code is assigned. If analyses have not been assigned, the analyzer
will warn the operator with a message, but the sample can be saved and completed later.
In this page the number of the position in programming is reported in the header.

Code: type in this field the ID code for the patient. This ID# can be used for fast search in the
archives. It is the only mandatory information for saving the
sample. The user can also enter the code of a patient saved in the
work list, even if in execution. In this case, a message asks the
user to confirm patient’s data cloning. All the data relevant to the patient are instantly displayed and
are linked to the current position. The cloning of a patient’s code allows the user to obtain one report
in case different samples are used.
The "plus" symbol allows the duplication of the patient. A duplicate can be changed in every part of
its programming. Clicking on this symbol the following window will appear.
Enter the Number of duplicates as desired, considering that the
final number will be "master+duplicates". The ID code can be auto-
assigned (Autobatch XX) or can be assigned by the operator.
Enter in this case the Start code ID#. It is possible to use numbers
and letters. The codes assigned by the analyzer will follow these
criteria:
Numeric code: it is increased by 1 unit
Alphanumeric code: one character is added, starting from 1.
The "0" at the beginning of the numeric codes will be deleted.
Examples:
Start code ID# is 001 – four duplicates
Start code ID# is 20 – four duplicates
Start code ID# is 0A10 – three duplicates
Start code ID# is 0 – five duplicates (codes from 1 to 5 have been skipped as already present
in the work-list)
When entering the Start code ID# and the Number of duplicates in an already existing work-list,
remember that the already present codes will be skipped. For instance if codes 10-11-12 and 13 are
already present and the starting code for duplication is 9, the analyzer will create code 9, followed
by 14-15-16, etc.

PATIENT DATA
Surname and Name: enter the patient's data. Then enter in the Note field the necessary
information to complete the patient's clinical situation. These information will also be saved into the
Patients Archive.
Then it is necessary to select the following.
Element: select the type of processing for the sample. It may be a normal Routine, a STAT or a
Control.
In case the operator wants to run a control among the samples, it is possible to set
here the control parameters. Select the Type if known or unknown and the Level if
Level 1, Level 2, or Level 3.
Group: select one of the available groups. Remember that groups are user-defined (see Setup,
chapt. 9, par. 2.1). The group definition is necessary to correctly assign the
pathological flags and to allow the automatic repetitions (when programmed) for
the samples that fall outside the panic range.
Type: in this field select the type of sample. As every type of sample has separated parameters, it is
necessary to correctly assign this option to allow the analyzer to correctly
process the sample.
When the Urine are selected, the analyzer will display an

additional field where the operator should enter the urine volume
in the 24 hours.
Always remember that the volume unit used here and the units
entered in the analytical parameters must be related (see
chapter 3, par. 5.5. Supplementary – Note on urine units.
Birth date: entering the patient's birth date in this field, the analyzer will automatically calculate and
update the Age field. It is also possible to write the Age, in this case the
analyzer will calculate the Birth date (only the year, day and month will be the
current). The birth date field will be updated when saving or clicking on it.
Draw date: the current date is automatically updated here. Click on the calendar icon to select a
different date or type it in the field.

External dilution factor: this field has two functions:

- allows entering a dilution factor for externally pre-diluted
samples, to correctly recalculate the result.
- allows the automatic sample pre-dilution.
These two functions are used alternatively, depending on the programming. If the programming is
as in the picture, none of the two functions is enabled.
Inactive
Programming in one of
these two ways, there
is no pre-dilution and
no result recalculation
With Predilution
Pre-dilution is performed with the programmed pre-
dilution factor, using the diluent which is programmed in
the Sample Management (see chapter 3, par. 5.3). The
analyzer will look for the suitable diluent into the Sample
Management items, searching for an active option,
starting from the Pre-treatment. If none of these is active, the analyzer will use the saline
solution.
In these condition the analyzer will also disregard all other sample treatments programmed in the
analytical parameters of the assigned tests. If a repetition of the sample is necessary, the
analyzer will again use only the dilution programmed in the patient data and will skip on the
Sample Management parameters.
With External Factor
In this conditions, the analyzer will manage the sample
for every test as programmed in the analytical
parameters (Sample management), but the final result
will be multiplied by the external dilution factor.
ANALYSES
As already seen for the analytical parameters, it is possible to display, when programming the
patient, the current analyses tray or all the programmed codes.
To assign the analyses to a patient, click on the test code button or on the checkbox.
Selected tests will have the check next to the code, in the check-box. To deselect the
assigned analyses, click again.
To assign the profiles, first open the profiles list by clicking on the right side of the window, on the
Profiles bar. Click once on each profile to see the analyses belonging to it,
or double click to assign the profile to the patient.
Once profiles are assigned it is still possible to change the patient's analyses by clicking singularly
on each.
It is also possible to restart all the patient's analyses programming by clicking
on the Deselect all button. This will deselect all assigned analysis, without
changing anything in the patient data.

To move back and forth inside the work-list it is possible to use the two arrows.
When a patient programming is finished, click on the Save button and the analyzer will automatically
show the next free position.
Press Cancel to abort the programming and to go back to the work-list.
4.2.2. Programming STATs

The urgent patients programming is done exactly as for the normal routine. A STAT patient can be
entered in two ways.
Click on an empty position and then select STAT from the Element options,
Or click on the STAT button on top on the work-list.
The same window as for the routine is displayed.
After having programmed the urgent sample, press the Save button. The analyzer will display the
following question.
The user can run immediately the sample or save it in the work-list.
If the sample is run immediately, the analyzer will ask if the sample has already been inserted in the
tray, if not, the analyzer will guide the operation in placing the cup in the correct position on the
samples tray (see par. 4.3. Running samples).
After the STAT sample has been run, the analyzer will have to complete the R1+S phases that were
already started. This means a waiting time that may vary from 0 to 6 cycles, for a maximum of 90".
After the STAT sampling is completed, the analyzer will go back to the normal routine work.
4.3. Running samples

There is more than one way to run the programmed samples.
If all programmed samples are ready to be run simultaneously, then simply
press the Run all samples button.
Alternatively it is possible to select the samples one by one, clicking on each check-box.
Then click on the Options menu, go to Selected samples and select Run.
As already seen for batches, the analyzer will display the following message.
Answer yes if the cups are already positioned in the tray, or answer no to let the analyzer guide you
in the cups insertion. In this case the analyzer will display the work-list as below.
Click on a single position and the analyzer will rotate the tray in order to insert easily the cup in the
correct position. The inserted cups' positions will turn from red to blue background.
Once all selections are done, click on the Accept button to let the analyzer start the run.
To start the run immediately, skipping on the above mentioned procedure, answer Yes to the
question "Do you have already inserted the samples?.
The volumes check is useful when there are backup reagents on board. With the check the analyzer
will update all reagents volumes and will be therefore able to swap to the backup reagent when
necessary.
NOTE: the swapping procedure is explained at par. 2.3.
The current work-list will appear in this way: the red colored samples are in run, while the blue
colored samples are already programmed, but not in run.
When the bar-code reading is active (see bar-code settings in chapter 9, par. 1.4), the patients
samples can be placed directly on the tray for positive identification.
When the tubes are positioned, click on the Options menu of the Current list, select Bar-code and
then one of the available commands for running samples: see next par. 4.4.

4.4. Current and Extra work-lists

When entering the patients, it may be useful to have a supplementary list where these can be stored
until the sample cup or tube is available. In the Extra list it is possible to move all the 100 patients
programmed in the Current list and also to add many more samples. The characteristic of the
samples in the Extra list, is that they do not have an assigned position on the samples tray,
therefore, when receiving the sample tube, it can be placed anywhere and in the most convenient
position among the available free.
The patients present in the Current list can be moved to the Extra list and vice versa.
In the Current list Options menu, there are the following functions.
Select and Deselect All: these two functions allow the operator to
select or deselect all programmed patients.
Print all samples: this line opens the printing interface (see chapt.
3, par. 2.1). From this interface it is possible to print on paper, export
or save in a pdf the current list.
Selected samples: this option opens another menu where there are
the functions dedicated only to the selected samples.
The already selected samples (all together or one by one) can do
one of the following.
Move to extra list: the samples are moved to the extra work-list for
future use.
Print: opens the printing interface (see chapt. 3, par. 2.1).
Run: the selected samples are run.
Delete: the selected samples are deleted. A question will ask for confirmation before deleting.
Bar-code: when the bar-code on samples is enabled, clicking on this line will open another menu
with the following functions.
Scan all tray: starts a reading of all bar-coded tubes on the samples
tray.
Scan single position: reads the bar-code in a position selected by
the operator.
Scan all tray and run: makes a bar-code reading and starts the run
of the positively identified samples. Errors, if present, will be
displayed on the screen.
Scan single position and run: makes the bar-code reading of a
selected position and runs the sample.
Extra list Options. In the Extra list options, the functions are similar to those seen for the Current
list. The Run line is not available as the extra is a storage list with
no position assigned.
When using the bar-coded tubes and the Host computer, it is possible to send the work-list from the
Host and to use it immediately or to store it into the Extra list. When the tubes are introduced into
the samples tray they are read with the bar-code reader. The analyzer will match every read code
ID with those present in the Extra list and will move only these samples to the current list for
running.

4.5. Samples Performed work-list

While the analyzer is working, the samples results are available in the real time pages.
The Results RT page displays all test results as they arrive.
The Results page displays the results per sample as soon as the
whole sample is finished. In this page it is also possible to save results into the archive. Once
results are archived, the Samples performed list will be cleared (see also chapt. 8).
The Samples performed list stores all the information of the performed tests, including the reaction
graph which is not available in the archive.
Every patient is color-coded. The red background means that there are
flags, the yellow background means that something was missing during
the sampling (sample, reagent), the blue background means that all
sample results are correct. The text in italic means that the sample is in
repetition or that it is a clone.
To Repeat a single sample, click on the numeric position. The analyzer

will show the sample's original position if available, or the first position
free. The operator has the possibility
to change the position if necessary.
Once saved, the analyzer will open
the Sample's Data window. The
patient's private data fields will be closed. It will be possible to add or
remove tests or to change the External pre-dilution factor.
Once samples are performed, it is also possible to repeat a group

samples all together, using the Options command in the Patients
Management main menu bar. See following par. 4.6.1. Repetitions for
analyses.
It is possible also to view all the test results and reaction graphs by double clicking on the sample's
code. In this case, the analyzer will open a window like the following.

On the left side there are the patient's data, while on the right side are listed the performed tests
with their own result. The red background indicates the presence of flags for the test.
Next to each code there is also a small icon representing a graph. Click on this icon to view the test
graph.
The same information that are shown clicking the Graph icon in the main icons bar are shown here,
but these info refer strictly to the selected test belonging to a specific patient. In the upper part of the
window there is the reaction graph. On the left there are the absorbances read, with the cycle they
were read at. On the lower part of the window there is a summary of the reaction the information
and the information used for calculation. The Print button opens the printing interface (see chapt. 3,
par. 2.1).

4.6. Patients Management Options

The Patients Management window has an Options menu, where a few commands are available.
New Entry: this command will open the Samples Data window for
programming a new patient.
Close: this command will close the whole Patients management window.
4.6.1. Repetitions for analyses

This option allows the repetition of the patients, selecting the test codes and then selecting which of
the samples will have to be repeated. This function is useful, for instance, when a test runs out of
reagent and the corresponding patients are all flagged with "R".
After clicking on the command, the analyzer will
display the following window. Here are listed all the
already performed test codes.
Select the test codes to be repeated by clicking on
the checkboxes.
It is also possible to Select / Deselect all the codes
by clicking on the appropriate buttons.
Once finished the codes selection, click on the
Accept button.
The analyzer will display the codes window.
Here are listed the patient's codes available for the

already selected tests.
Click on the checkboxes to select the codes or use
the Select / Deselect commands.
Once finished, click on the Accept button.
At this point the analyzer will ask the following
question:
Answering YES, the analyzer will place the

selected samples again into the Current list, in the
positions the same samples occupied in the first
run.
In case the positions are already programmed with other samples, the analyzer will place the
repetitions in the first free positions.

5. TURNING OFF PROCEDURE

To turn off the instrument, the shut down procedure must be performed. It is a software guided
procedure. Once the analyzer program has been turned off, it is also possible to turn off also the
analyzer by means of the green button located on the analyzer's left side. This will fully turn off the
analyzer, including the refrigerated compartments.
The shut down procedure proposes the wash of the cuvettes with appropriate washing solution
before turning off. The analyzer indicates the position where the detergent should be inserted.
Switch-off analyzer + PC: with this command, the analyzer

program will be closed, but it will also close the operative system
and the whole PC.
Exit from the program: with this command, only the analyzer
program will be closed. The PC will remain turned on.
NOTE: if cuvettes are not properly washed at the shut-down, at the following start up the
analyzer will ask for the cuvettes extra wash. Performing the normal cuvettes wash (with the
cuvettes washing solution) will not prevent the analyzer from warning again that the extra
wash is needed.
Conditions are:
a. If no test has been performed before the shut-down, at the following start-up of the program, no wash
message will appear.
b. If no test has been performed before the shut-down and the shut-down wash has been started but it did not
complete correctly, then at the following start-up of the program, the analyzer will warn the operator that the
preceding wash was not correctly completed.
c. If tests have been performed and the shut-down wash was not performed, at the following start-up of the
program, the analyzer will ask for the Extra wash cuvettes and will warn the operator that the preceding wash
was not correctly completed.
NOTES:
1) Having performed a test: it means having performed either a single test with reagents and sample or any
procedure involving colored solutions, such as the FCC.
2) The analyzer asks for the Extra wash cuvettes as it does not know how long the solutions were left inside
the cuvettes before washing them.

CHAPTER 6
QUALITY CONTROLS Page
1. QUALITY CONTROLS ................................................................................. 2

1.1. New data......................................................................................................................3
1.2. Manage data................................................................................................................4
1.2.1. Westgard graph ....................................................................................................5
1.2.2. Daily chart .............................................................................................................6
1.3. Youden graph .............................................................................................................7
1.4. Utility ...........................................................................................................................8
2. QUALITY CONTROLS IN REAL TIME ........................................................ 9

Via Licenza, 18
Chapter 6 Quality Controls Page 1 of 9

1. QUALITY CONTROLS
This is an external program used to enter, change and process quality

controls. The program can process data from the analyzer (controls run in
routine or dedicated positions) and from other instruments (with the New
function). The Quality Controls (Real Time) is the archive where the newly
performed controls (not yet saved) can be displayed, together with the already
saved QCs, using the QC statistical elaboration.
As all the external archives, the QC has a backup function. It is advisable to perform a periodical
backup of the archive, every 3 or 6 months, depending on the amount of data which are present in
every archive. The backup file format is not readable by a program different from the Analyzer.
It is also possible to export the archives in different file formats as pdf, rtf and csv (see Chapter 3,
par. 2.1 Printing interface) that can be easily read with an appropriate program on the PC.
From the Data menu it is possible to enter external QC data, view the QC stored
data and also the Youden graph.
In the Utility menu, there are the Backup and Restore functions, together
with the Manage external data and Delete data functions.

1.1. New data

Here it is possible to process data obtained externally from the analyzer. It requests a series of
information used to statistically process the inserted
values.
To enter a new name in the Analyses, Lot and

Method field, click on the button.
In the appearing field, type the requested

information and save.
Analyses: insert a name for analysis or select one

from the existing list.
Method: insert a method or select one from the
existing list.
Lot ID#: insert the lot number or select one from the
existing list.
Level: select the level to assign the correct range.
Type: select if the control is a known or unknown
type.
Test date: enter the date in which the test was performed.
Test time: enter the time when the test was performed.
Result: enter the known data.
When the button Save is pressed, the control range window will appear. Type the control range for
the selected type and level and save with the button Yes.
At this point statistical processing of the data becomes available.

Data inserted manually will be managed exactly like the data from the analyzer.

1.2. Manage data

In this page it is possible to view, make
searches with, and print the QC data.
To obtain data processing it is necessary
to provide the analyzer with all the
information related to the control:
Analysis, Method, Lot ID#, Level and
Type – Known/Unknown.
If the All option is left in the Lot and
Method fields, the search will be done for
all the lots and all the methods relative to
the test selected in the Analyses field. In
this condition the Range and Westgard
Decision values will not be displayed.
Data searches can be run for a single date or for an interval of dates. Use the From date and To
date fields to select a single date or a date interval.
Make all the selections necessary for processing the data, then press the Search button.
The results will be displayed as a list. The data are ordered by date and time. Out of range controls
are indicated with an asterisk and have red background.
In the QC in Real Time, the new controls have green background.

To delete a record, refer to the Delete data at paragraph 1.4.

When the search is run on unknown controls the range and Westgard classes are not displayed.
1.2.1. Westgard graph
Click on the dedicated button.
The Westgard graph provides a global vision of a given lot by plotting data on a diagram having the
origin at 0 line representing the lot mean value, calculated as (lot min + lot max)/2, which usually
corresponds to the lot theoretical value. As division, are reported values such as Mean±1S ±4S. All
data within the given range will be displayed with a green circles while the out of range data will be
plotted using red circles.
It is a procedure for classifying values of a Known lot taken into consideration for processing.
Mean: mean between the maximum and minimum lot value
S: (Maximum lot value – Minimum lot value) / 8
The following procedure is observed for classification:
Class A (1-2S): One result exceeds Mean by +/- 2S.
Class B (1-3S): One result exceeds Mean by +/- 3S.
Class C (2-2S): Two consecutive results exceed mean by 2S in the same direction.
Class D (R-4S): Difference between two consecutive results is higher than 4S and at least one
result exceeds mean by +/- 2S.
Class E (4-1S): Four consecutive results exceed mean by more than 1S in the same direction
and at least one result exceeds mean by +/-2S.
Class F (10x): Ten consecutive results are all in the same direction of the mean value and at
least one result exceeds the mean by +/- 2S.

Classes are controlled from F to A. The classes are mutually exclusive, that is, if a given value is
mapped to one class then it can't be part of another class.
Example:
2 E classes means that 5 consecutive results exceed Mean by more than 1S in the same direction
and at least one result exceeds mean by +/-2S; alternatively two groups of 4 consecutive results
exceed the mean by more than 1S in the same direction and at least one result exceeds mean by
+/-2S.
Click on the Print button to print the graph and/or to export it (see printing interface chapt. 3, par.
2.1).
1.2.2. Daily chart
Click on the dedicated button.
The Daily Chart graph provides a global vision of a given lot, plotting data on a diagram having the
origin represented by the actual mean (not by the theoretical value) of the same lot and as divisions
values such as Mean+Standard Deviation*1, Mean+Standard Deviation*2 to Mean+Standard
Deviation*4. In addition the red dashed lines indicate the upper and lower limits of the lot. All data
within the range will be represented by a green circle, while the out of range data will be plotted
using red circles.
2.1).

1.3. Youden graph
After selecting the general search parameters Analyses, From Date, To Date, choose the specific
Level, Lot ID#, Method for the X and Y axes. Data processing and visualization is performed
pressing the button Search. The controls are ordered by date and in case of known controls the Out
of limit condition is indicated.
This function relates two different levels for the same lot displaying distribution of controls within the
limits of lots.
2.1).

1.4. Utility
The UTILITY menu contains a few functions: the backup, the restore
Backup: it is used to make a backup copy of the present archive. The
exported archive can be restored in any moment, but it will overwrite the
existing QC archive. The backup function will keep a copy of the archive in
a safe place (the files can be copied in any other location or PC). It is
advisable to make a backup every 3 to 6 months and to delete completely
the QC archive every time a backup is performed. An important alternative
is to use the export functions available in the printing interface chapt. 3, par.
2.1
To perform a backup it is first necessary to

select the desired criteria for listing the
controls. If a backup of the whole archive is
desired, open the Backup and then click on
the button Search, leaving in all fields the
default values.
The selected controls will be listed in the
window. Click on the Backup data button. A
window will
appear where it
will be possible to
select the location
for saving the QC
archive backup.
Restore: the restore function will import and overwrite the present archive with one of the available
backup.
The backup and restore functions are very important as every PC may face memory or hard disk
problems. In this cases it is possible that the archives are lost or damaged. A copy of the archives
stored in another PC or any other device, different from the analyzer's PC may allow the total
restoration of data.
Manage external data: this function allows to view an exported archive (backup) without restoring it
into the analyzer's HD.
Select the location where the archive was saved and open it.
The Manage external data sentence will be displayed on the
main title bar and in the Utility
menu there will be the check
sign indicating that the analyzer
is dealing with the External
data. Once the external archive
has been loaded, just click on
the Manage data button to view
it, exactly as is normally done
with the internal archive. To go
back to the internal archive, just remove the check sign by clicking again on the Manage external
data line.

Delete data: data in the archive can be deleted with the same search criteria already seen in the
backup search. It is possible to delete the whole archive
performing a search leaving in the criteria fields all the
default values. Otherwise it is possible to perform a
search by lot number, by date, etc..
Exit: this function will close the QC archive.
2. QUALITY CONTROLS IN REAL TIME

The QC in real time allows to view the just performed controls, together with the controls already
stored in the QC archive. This program has the same functions as the QC archive, but does not
allow entering new data, deleting data, exporting or importing data, etc…

CHAPTER 7
EXTERNAL ARCHIVES Page
1. EXTERNAL ARCHIVES ............................................................................... 2

2. PATIENTS ARCHIVE ................................................................................... 2
2.1. Manage data................................................................................................................2
2.1.1. Functions and Sort Order....................................................................................4
2.2. Utility and Data menu.................................................................................................5
3. POPULATION .............................................................................................. 6
3.1. New data......................................................................................................................7
3.2. Manage data................................................................................................................7
3.3. PRINCIPAL STATISTICS FORMULAS USED IN POPULATION ............................11
3.4. Utility and Data menu...............................................................................................13

Via Licenza, 18
Chapter 7 External Archives Page 1 of 14

1. EXTERNAL ARCHIVES
The External Archives are: Patients Archive, Population Archive, Quality
Controls, Calibrations Archive and Quality Controls in Real Time. The
two Quality Controls archives are explained in Chapter 6.
With the exception of the QC in real time, all the external archives have a
backup function. It is advisable to perform a periodical backup of the
archive, every 3 or 6 months, depending on the amount of data which
are present in every archive. The backup file format is not readable by a
program different from the Analyzer.
The backup and restore functions are very important as every PC may
face memory or hard disk problems. In this cases it is possible that the archives are lost or
damaged. A copy of the archives stored in another PC or any other device, different from the
analyzer's PC may allow the total restoration of data.
It is also possible to export the archives in different file formats as pdf, rtf and csv (see Chapter 3,
par. 2.1 Printing interface) that can be easily read with an appropriate program on the PC.
2. PATIENTS ARCHIVE
The Patients Archive module stores
the patients reports. For every patient
the given personal information are
saved together with the analyses
results, possible flags and notes.
It is possible to perform searches in
the archive, based on different criteria.
The archive can be exported, copied
as internal backup, viewed as external
archive, deleted and printed.
In the archive main page there are two
main menu: Utility and Data. Two
buttons allow: entering in the Manage
page and Exit from the archive.
2.1. Manage data

In this page it is possible to view all
performed patients or to make a
patient search using the available
criteria.
The Manage Data page has also the
following menu: Functions and Sort
Order (see following paragraphs).

The patients in the Archive can be searched for, with a certain number of criteria:
From code / To code: indicate the first code and the last code within which the search must be
performed.
Surname / Name: these options are useful when searching for a known patient.
From date / To date: allows to select a range of dates within which the analyzer can search
patients data.
Once the criteria are specified, click on the button Search. To repeat the search with different
criteria, click on Clear search.
Leaving all fields unchanged (default values), and clicking on the Search button, the analyzer will list
all available patients.
When patients are listed, click on one line to view that patient's data and results in the right side of
the window. The tests with red background also have an asterisk to remember there is a flag.
Double click on one of these red lines to read the flag.
Select a patient from the list.
View the patient's data.
Double click on one red background test.
For printing reports, see the following paragraph.

2.1.1. Functions and Sort Order

Print: allows the operator to print a single patient or all the
patients belonging to the present query. The print function
introduces to a number of other options, as already explained in
Chapt. 3, par. 2.1 Printing interface. Among these options there is
the possibility to export the patient/archive as csv or pdf file
formats.
Example of a patient printout.
Send to host: this function allows the operator to send to the

host computer the selected patient or all the patients belonging to
the performed search.
Administrator: this function is under password. The Administrator

can view the users that have performed the tests.

Sort order: the patients can be listed in a specific order, that can be
decided by the operator.
The available options are: by code (alphanumeric order), by Draw date
or by Surname. With the None option, patients will be listed by date.
2.2. Utility and Data menu

Backup: it is used to make a backup copy of the present archive. The exported
archive can be restored in any moment, but it will overwrite the existing archive.
The backup function will keep a copy of the archive in a safe place (the files can
be copied in any other location or PC). It is advisable to make a backup every 3 to
6 months and to delete completely the archive every time a backup is performed.
An important alternative is to use the export functions available in the printing
interface chapt. 3, par. 2.1

select the desired criteria for listing the patients.
If a backup of the whole archive is desired,
open the Backup and then click on the button
Search, leaving in all fields the default values.
The selected patients will be listed in the
window will appear where it will be possible to
select the location for saving the archive
backup.
Restore: the restore function will import and

overwrite the present archive with one of the
available backup (see also Data menu for
viewing external archives).
Delete data: data in the archive can be deleted with the same
search criteria already seen in the backup search. It is possible to
delete the whole archive performing a search leaving in the criteria
fields all the default values. Otherwise it is possible to perform a
search by code, by date, etc..
Exit: this function will close the QC archive.

The DATA menu offers, besides the possibility to open the Manage data
window, also the Manage external data option. This function allows to
view an exported archive (backup) without restoring it into the analyzer's
HD.
main title bar and in the Data menu there will be the check sign
indicating that the analyzer is dealing with the External data.
Once the external archive has been loaded, just click on the
Manage data button to view it, exactly as is normally done with
the internal archive. To go back to the internal archive, just
remove the check sign by clicking again on the Manage
external data line.
3. POPULATION
The Population module stores all test

results performed by the analyzer.
New tests can be manually entered and
the Population archive can perform the
desired statistical elaboration also on
these data.
It is possible to perform searches in the
archive, based on different criteria.
The archive can be exported, copied as
internal backup, viewed as external
archive, deleted and printed.
In the archive main page there are two
main menu: Utility and Data. Three
buttons allow: entering in the Manage page, entering in the New page and Exit from the archive.

3.1. New data

With this option it is possible to process data
obtained externally from the analyzer. It requests a
series of information used to statistically process
the inserted values.
To enter a new name in the Analyses and Method

field, click on the button.
In the appearing field, type the requested

information and save.
Analyses: insert a name for analysis or select one

from the existing list.
Method: insert a method or select one from the
existing list.
Group: select the correct one from the existing list.
Type: select sample type.
Test date: enter the date in which the test was performed.
Result: enter the known data.
Press the Save button and go ahead with the following result. Close when finished. At this point
statistical processing of the data becomes available.
Data inserted manually will be managed exactly like the data from the analyzer.
3.2. Manage data

In this page it is possible to view all performed
tests or to make a data search using the
available criteria.
The Population can be searched for, with a
certain number of criteria:
Analyses: choose one of the analyses available
in the list
Method: select the method.
Group: choose a group among those available.
Type: choose a sample type
From date / To date: allows to select a range of
dates within which the analyzer can search
data.
Use numeric range: this field is optional.
Activate the checkbox to enable also a search performed between the extremes of a numerical
range.

Once the criteria are specified, click on the button Search. To repeat the search with different
criteria, click on Clear search.
Leaving all fields unchanged (default values), and clicking on the Search button, the analyzer will list
all available data.
The statistics related to the search will be displayed in the
colored area on the right side of the window. The analyzer will
calculate:
Number of (selected) records
Minimum result
Maximum result
Mean
Standard Deviation
Correlation coefficient
Variation coefficient
Variance
Deviance
Median
The performed search can be printed or exported (see printing interface chapt. 3, par. 2.1), by
clicking on the Print button.
It is possible to print only the statistics or these and the search data, as in the above example.
The search can also be plotted on a graph.

Click on the Graph button. The analyzer will freeze all the search criteria fields and will show the
following buttons for selecting the type of graph to be displayed.

The Data Sequence graph simply shows the data in a sequence.
The Trender graph shows the data sequence together with its related minimum square line in the
lower part of the graph the equation for the line is shown.
The L. Jennings graph shows data plotted with the mean and the standard deviation.

The Histogram graph shows a simple histogram of the selected data.
The Statistic Histogram graph shows the histogram for the selected data with respect to the mean
value, used a origin line.
The graphs, with the related statistical data,

can be printed with or without the List of data.

In every search it is possible to delete one or more records. It is also

possible to delete the whole search.
3.3. PRINCIPAL STATISTICS FORMULAS USED IN POPULATION

Mean:
X: X1 ..Xn selected elements; being "n" the number of elements:

X1 + X2 + … + Xn
X=
n
Standard Deviation:
SD: is a quantity that measures the spread of data across its mean value. If data is mostly located
near the mean SD assumes a small value, otherwise a large value indicates large data spread.
n
DS =
Σ (Xi – X)
i=1
2
n-1
Variation coefficient:
CV%: is computed as the ratio between mean square error and arithmetic mean. CV% is a relative
quantity and independent from the measurement unit used.
DS*100
CV=
X
Minimum square line y = ax + b
Where: Σ XY-nΣxΣy
a=
Σ X2 - n(ΣX)2
b= ΣY-aΣx
Correlation Coefficient:
Σ[(Y-Y)*(X-X)]
CC =
Σ(X-X)*(Y-Y)
Variance:
[ X* X]
ΣΧ2 - Σ nΣ
V=
n-1

Deviance:
( ΣX)2
D =Σ X2 - n
Median:
The Median for an ordered ser of data is the central value or the arithmetic mean of the two central
values, depending on the fact that the number of elements in the set be odd or even. In particular
the median for N odd elements, is the X[(N+1)/2]th element.
Example.: given the following 9 elements set
1, 2, 2, 17, 21, 34, 34, 34, 67
Median = [X (N+2)]/2 = X[(9+1)/2] = X[5] = 21
median is 21, the fifth element.
The median for N even elements, is the { X(N/2) +X[(N+2)/2] }/2 element.
Ex.: be given the following 8 elements set
1, 2, 12, 24, 26, 45, 45, 46
{X[4]+X[5]}/2 = (24+26)/2 = 25
median is 25.
By comparing the median and the arithmatical mean, one can assume the existence of a
measurement error or an asymmetry in the distribution function, in case these two quantities differ
greatly.

3.4. Utility and Data menu

Backup: it is used to make a backup copy of the present archive. The exported
archive can be restored in any moment, but it will overwrite the existing archive.
The backup function will keep a copy of the archive in a safe place (the files can
be copied in any other location or PC). It is advisable to make a backup every 3 to
6 months and to delete completely the archive every time a backup is performed.
An important alternative is to use the export functions available in the printing
interface chapt. 3, par. 2.1

select the desired criteria for listing data. If a
backup of the whole archive is desired, open
the Backup and then click on the button
Search, leaving in all fields the default
values.
The selected data will be listed in the
window will appear where it will be possible
to select the location for saving the archive
backup.
Restore: the restore function will import and

overwrite the present archive with one of the
available backup (see also Data menu for
viewing external archives).
Delete data: data in the archive can be deleted with the same
search criteria already seen in the backup search. It is possible to
delete the whole archive performing a search leaving in the criteria
fields all the default values. Otherwise it is possible to perform a
search analyses, by date, etc..
Exit: this function will close the Population archive.

The DATA menu offers, besides the possibility to open the New Data and
Manage data windows, also the Manage external data option. This
function allows to view an exported archive (backup) without restoring it into
the analyzer's HD.
main title bar and in the Data menu there will be the check
sign indicating that the analyzer is dealing with the External
data.
Once the external archive has been loaded, just click on the
Manage data button to view it, exactly as is normally done
with the internal archive. To go back to the internal archive,
just remove the check sign by clicking again on the Manage
external data line.

CHAPTER 8
DISPLAYING AND PRINTING RESULTS Page
1. DISPLAYING AND PRINTING RESULTS ................................................... 2

1.1. Results page ...............................................................................................................2
1.2. Results RT page .........................................................................................................6
1.3. Graphs page ...............................................................................................................7
1.4. Flags list ......................................................................................................................9

Via Licenza, 18
Chapter 8 Displaying and Printing Page 1 of 9

1. DISPLAYING AND PRINTING RESULTS

In the analyzer main page, there are three buttons
dedicated to the displaying of results.
Results: this button will open the pages where the patients results in real time are displayed. This
page is updated every time a patient is completed and is the only RT page that includes other
commands.
Results RT: in this page all results, independently from the patient to whom they belong, are
updated as soon as every test is completed.
Graph: this page shows all the available test graphs.
Calibrations and controls are listed in these pages together with the test results. Calibrations are
written with green text and controls are written with blue text.
1.1. Results page
In this pages are updated the information related to patients, calibrations, controls and possible
errors that occurred during execution.
If there is no data the page appears blank. A color code makes it possible to quickly identify the
information:
red text: presence of flags in at least one test of the sample
blue text: controls
green text: calibrations
black text: no anomaly in the test or the entire sample
It is a brief representation of data and allows visualization of results of patient in execution as the
tasks for the single patients are completed.
Once the results are archived, the information present in this page will no longer be available.
At the bottom of this page there are the following buttons:

The following information are displayed for each sample:
a) Sample Position (#XX) Physical position of the sample in the samples tray or in the standard
& controls tray.
b) Sample Code Patient ID#, batch or autobatch number, standard or control code..
c) Surname, Name Patient’s personal data.
d) Sample Type Between parenthesis it is indicated the type of sample, whether
Routine, STAT, control or standard type.
e) Date and time Indicates when (date and time) the sample was performed.
f) Results The patients results are represented as follows:
- full name of the analysis

- method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)
For automatic re-runs the values of the first and second determination are represented.
<NC> WRITTEN INSTEAD OF THE RESULT

Sometimes it is possible to read <NC> “not calculable” in place of the value. This refers to values
that cannot be calculated for one of the following errors during the result elaboration:
- no serum
- no reagent
- no washing solution
- no diluent
- no solution (I.S.E.)
- incorrect parameters
- expired reagent
- inverse curve
<NC> results can normally be archived (only in the patient archive) with the other results (see
chapter 9, par. 2.2.) or they can be stored in the work lists to let the operator re-run the sample as
soon as possible. In this case, the patient with the <NC> result will be regularly archived and a copy
will be left in the work lists.
<NC> only appears on the result page in real time, it will be replaced by a series of dots “….” in the
patient archive.

At the top right of the Results page there is a small button Info flags.
Click here to see a summary of the flags that are used in the Results page.
At the bottom of the Results page there are more useful buttons.
Print: click here to print the Results page. This button will open a printing interface as already
described in Chapter 3, par. 2.1 Printing interface.
For Analyses: with this button the analyzer will arrange the results per test instead than per patient.
Adjust: this function allows results recalculation. Note that recalculated results will be flagged with
the additional flag E.
The Adjust button gives the following choices.
With standard: this function will re-calculate the results in case there is a new calibration available.
The analyzer runs the recalculation starting from the absorbance memorized for the test, thus the
various analytical parameters and the last valid
calibration are taken into consideration. In this
case, if the instrumental factor and shift have
been set in the analytical parameters, they will
be used in calculating the new value.

With factor: this correction is performed in percentage and may be increasing as well as
decreasing.
Once the type of correction, with factor, has been selected,
the analyzer will display the analyses that can be re-
calculated.
Click on one code to open the correction window.
Select the percentage of the re-calculation and then if it

has to be in increment or in decrement.
On the right side of the window are shown the available
type of tests: routine, STAT, control. It is possible to decide
the re-calculation for one or all of them.
Once all decisions are taken, click on the Accept button.
The analyzer will re-calculate the results and will flag them
with the E flag.
With standard (only if performed with backup reagent): this type of correction is performed when
a certain number of tests have been partially performed with the backup reagent and a calibration
with the backup reagent has been performed too, but after the test results. In this case it is possible
to recalculate the results with the new calibration.
Store data: Click this button to save the results into the patients archive. Bear in mind that once the
results are archived, the graphs are not available anymore. Therefore, it is a good idea to print any
pertinent graph before archiving data.
It is possible to save all results or to save data for a selected group of samples.
In the same way, iy is possible to decide whether to archive also the not completed samples.
If the uncompleted samples are not stored, they will remain in the work-list in order to be run and
completed in a second moment.

Clicking on the Select samples line, the analyzer will show the following window. Here it is possible
to select the single patients by
means of the check sign next to the
ID code. There is also a small arrow
near each code. Click on this arrow
to view the list of tests performed for
that sample. With this option it is
possible to select, not only the
sample, but also the single test that
has to be stored.
Clear: click on this button to delete all results in this page. All data will be definitively lost.
Sort: click on this button to arrange the results with the criteria selected in the Setup (see chapter 9,
par. 2.3.).
Close: click here to close the results window.
NOTE: once the results are archived, the information present in the results page will no longer be
available.
1.2. Results RT page
The data refer to the results obtained by the analyzer in real time, i.e. as the tests are completed.
For this reason the results of tests with a shorter incubation and reading time may appear first even
if they belong to later patients. The results are not sorted in any way, not per patient, not for type of
test. The data display is synthetic.
Once the results are archived, the information present in this page will no longer be available. The
results of tests associated to flags are shown in red.

The following information are displayed for each single test:
a) Sample Position (#XX) Physical position of the sample in the samples tray or in the standard
& controls tray.
b) Sample Code Patient ID#, batch or autobatch number, standard or control code..
c) Sample Type Between parenthesis it is indicated the type of sample, whether
Routine, STAT, control or standard type.
e) Date and time Indicates when (date and time) the sample was performed.
f) Results The patients results are represented as follows:
- full name of the analysis

- method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)
With the Print button it is possible to print this page, and with Close it is possible to close the page.
1.3. Graphs page

The page that opens displays the first available graph. The graphic pages are available only after
test runs and before data are stored in the archives.
Graphs pages are divided into three parts: one shows the reaction graph, one shows the
absorbance read per each cycle and the last one, on the lower part of the page, summarizes the
reaction information.
It is possible to print the graphs or export the data (see Chapter 3, par. 2.1 Printing interface).

The reaction graphs are divided into parts by dashed red axes, each of which indicates an
absorbance value used in the result calculation. The above example is a fixed time test. In this case
the result is calculated by means of an absorbance delta, which is determined between the two
cycles (17th and 6th) corresponding to the red dashed lines.
The X axe indicates the cycles (time) and the Y axe indicates the absorbance.
The single absorbance per cycle is indicated in the two columns at the right of the graph.
In the Statistic area, there are the most important information concerning the reaction. This area is
divided in two parts. The left part lists the absorbances in relation to the whole reaction, while the
right part refers only to the absorbances used in the result calculation.
The last line in this area gives the final reaction result and the reagent blank value.
When opening the graphs page, the analyzer will show the first available graph.
Use the left/right arrows to see the other reaction graphs of the
same patient.
Use the up/down arrows to select the preceding or the
following sample.
It is also possible to click on the Code line to choose one of
the available sample codes and view its graphs.

1.4. Flags list

The analyzer uses flag symbols to properly check analyses result. These symbols are printed
adjacent to the result.
The following priority exists for the flags indicating hyperactivity:
I (Test Limit),
A (Reaction Limit)
d (Max ABS Delta)
The flags and their meanings are tabulated below:
O Reagent Limit
! Final Abs Sign
I Test Limit
d Max Abs Delta
A Final Abs
H Hook
F Form
+ Path High - Range Normal Values >Max
- Path Low- Range Normal Values <Min
K Test performed with backup reagent
> Out Of Calibration Curve – Above
< Out Of Calibration Curve – Below
>> Out Of Calibration Curve After Repetition - Above
<< Out Of Calibration Curve After Repetition - Below
i Sample Interference
S No Sample
R No Reagent
-- Negative Concentration
? Not Calculable – Relation test – one or more of the built-in analyses is missing
* Relation Test - Error In Built-In Analyses – there are error flags
X Result Impossible – negative value
P No Data To Calculate – data are not enough
E Sample Recalculated
d No Diluent (saline, diluent, etc)
N Reagent Expired
M Error In Instr Fact/Shift
I.S.E.
Y I.S.E. Hydraulic Malfunctioning – funnel does not empty
B Bubbles In I.S.E.
D Drift On I.S.E.
++ Concentration Too High
a No Sol A (I.S.E.)
b No Sol B (I.S.E.)
c No I.S.E. Sample Diluent
r No Reference (I.S.E.)
U Urine Calibration is missing
w I.S.E. Waste Full

CHAPTER 9
SETUP Page
ANALYZER SETUP ......................................................................................... 2

1. System ......................................................................................................... 2
1.1. Language ....................................................................................................................2
1.2. Printer ..........................................................................................................................2
1.3. Access Passwords.....................................................................................................3
1.4. Bar-code ......................................................................................................................3
1.4.1. Bar-code on samples ...........................................................................................3
1.4.2. Bar-code on reagents ..........................................................................................4
1.5. I.S.E. Module ...............................................................................................................5
1.6. Temperature................................................................................................................5
1.7. Administrator ..............................................................................................................5
2. Patients ........................................................................................................ 6
2.1. Samples' Groups ........................................................................................................6
2.2. Communication ..........................................................................................................6
2.3. Sort Results ................................................................................................................8
2.4. Diluents Identification ................................................................................................9

Via Licenza, 18
Chapter 9 Setup Page 1 of 9

ANALYZER SETUP
The analyzer setup is used to customize certain aspects of the analyzer program, such as the report
format.
To open the Setup, click on the Utility main menu and select the command Setup.
The Setup window is divided in two parts. On the left there are the two main menus, System and
Patients which can be alternatively selected. On the right there is a window where all the details
dedicated to each setting are available.
1. System
In this menu are available all of those settings generally applied to
the whole system.
1.1. Language
In this window it is possible to select the desired
language among those available. To select a
language it is first necessary to have saved the
external translations.
The external translations are text files that can be
easily translated in other languages, therefore it is
virtually possible to translate the analyzer software
in every language. The only limitation is that the
computer Operative System should support the
same language.
Click on the button Load external translations.
Select the folder where these translations are
stored and click OK. The available translations will
be visible in the list Stored Translations. Double
click on the desired language and save the Setup.
1.2. Printer
The Printer page can be used to customize the
analyzer reports with the name and address of the
Lab and the name of the Lab responsible. There
are two areas where it is possible to add the text:
the header and the footer. The text character can
be formatted as desired.

1.3. Access Passwords

This windows allows the operator to change the
system passwords. Bear in mind that, once
changed, the passwords must be stored in a safe
place. In any case, it is not advisable to change
these passwords, since if they are forgotten or lost
it will no longer be possible to access the system.
1.4. Bar-code
This option enables the bar-code scanning. It can
be separately enable on samples or on reagents or
on both.
The bar-code on reagents can simply be enabled
or disabled, with no further settings.
1.4.1. Bar-code on samples

The bar-code can start with the patient ID as well as with another type of information. Therefore it is
necessary to tell the analyzer from which position the information starts.
Patient ID#: enter here the information concerning the patient ID#. In the N. Digits field, type the
length of the patient ID#, i.e. how many digits it will be from 1 to max 20. In the Digit position field
enter the position to start from, among those composing the bar-code (see below the example).
In the Supplementary information it is possible to activate/deactivate the use of one or more digits
to identify the sample type or to assign a profile number.
Sample type: the analyzer allows four type of samples: each has a single digit to identify it.
0 for serum
1 for urine
2 for CSF
3 for Other
When this field is active, it is also necessary to indicate which, among the bar-code digits, gives this
information.
Profile: the profile number can be identified by 1,2 or max 3 digits. Select the N. Digits and then
type the position, within the bar-code, where the profile code starts from.
Here are some examples.
Example number 1: 20 digits bar-code.
1 2 0 9 8 7 6 5 4 0 1 0 0 1 3 0 2 0 1 2
Lab code Patient ID# sample profile date
The bar-code starts with the Lab code: 120
The Patient ID# is made: N. digits = 6 and the Digit position = 4.
The Sample type is Active and the sample is serum, therefore the Sample type = 0 and the Digit
position = 10.
The Profile is active and the profile code is made of two digits, therefore: N. digits = 2 and the Digit
position = 11.
The date expressed as mmddyyyy uses the last 8 digits of the code.

Example number 2: 30 digits bar-code.

1 2 6 5 1 1 2 3 4 5 6 7 8 9 0 1 2 3 5 2 1
Lab code Patient ID Profile Other info
The bar-code starts with the Lab code: 1265
The Sample type is Active and the sample is urine, therefore the Sample type = 1 and the Digit
position = 5.
The Patient ID# is made: N. digits = 13 and the Digit position = 6.
The Profile is active and the profile code is made of three digits, therefore: N. digits = 3 and the Digit
position = 19.
The last digits are available for other information.
ENTERING PATIENTS
Tests to be run can be acquired from the Host Computer, from those stored after manual input and
through barcode scanning (see chapt 5, par. 4.2.1, 4.3 and 4.4).
Manual programming: the patient is programmed manually (code and analyses), then his position
on the sample tray is checked by barcode reading. In this case the samples can be inserted
randomly on the tray, since the barcode reader will assign the position on the tray to the patient
corresponding to each code read which has the same ID code.
Programming via Host Computer: The patient is programmed (code and analyses) on the Host
Computer and transferred to the analyzer. The position on the sample tray is checked by barcode
reading as described above.
Entering patients with and without bar-code on the same tray
Patients with barcode and those without can be run together. Patients without barcode must be
inserted exactly into the positions assigned during programming. Patients with bar-code can be
freely placed in any of the free position with no need to respect the assigned position number.
In case a bar-coded sample is found in the same position where a manually programmed patient is
stored, the analyzer will move the manually programmed patient to the Extra list.
Supported Symbologies
- Barcode (1D): JAN/UPC/EAN incl. add on, Codabar/ NW-7, Code 11, Code 39, Code 93, Code
128, GS1-128 (EAN-128), GS1 DataBar (RSS), IATA, Industrial
- 2of5, Interleaved 2of5, ISBN-ISMN-ISSN, Matrix 2of5, MSI/Plessey, S-Code, Telepen, Tri-Optic,
UK/Plessey
- Postal code: Chinese Post, Korean Postal Authority code
- 2D code: Composite codes, MicroPDF417, PDF417
EAN13
If the bar-code used is an EAN13, there are some limitations: the first number must not be 0 and the
actual number of digits is 12 as the last digit is the checksum X (automatically created).
1.4.2. Bar-code on reagents

The main objective of the reagent bottle barcode is the positive identification of the bottle to avoid
positioning errors. The barcode can be used only with specific labels produced by the manufacturer
of the reagents.
The instrument can be configured in the following different modes of operation
Use of reagent bottles without barcode, independent use.
Use of reagent bottles with barcode (analysis code), only for positive identification of the bottle.

1.5. I.S.E. Module

This function is available only with the
The I.S.E. Module-4P is always present in the analyzer and it is always active. It can be used or not.
In this page it is possible to set the length, expressed in cycles,
of the I.S.E. prime, of the calibration and of the single test.
The Prime length range is from 3 to 10 cycles (default value is
3). The Calibration length range is from 3 to 20 cycles (default
value is 3). The Single test length range is from 6 to 20 cycles
(default value is 7).
1.6. Temperature
There are three devices that are temperature-controlled. The cuvettes, the standards and the
reagents trays. All the three devices can be separately enabled or disabled.
Cuvettes tray: the cuvettes are kept at a
temperature of 37°C. The heating of the
cuvettes can be disabled if necessary. For
instance when the room temperature is
higher than the cuvettes temperature. It
makes no sense to have the system heating
the cuvettes at 37°C when the room
temperature is at 40°C.
Reagents tray: the reagent are normally
stored at controlled temperatures. The
ensure a longer life to the reagents on
board is useful to have the reagents chamber at a relatively low temperature. The choice of the
temperature depends on many factors: the room temperature, the time the reagents will remain on
board, etc… The lower the temperature is, the more will be the analyzer effort to keep it down. If the
reagents will last only a few days on board, there is no need to keep the temperature too low..
Standards tray: the standard and control tray is refrigerated to ensure a longer stability to the
solutions. In any case, once poured into the cups, the standards or controls cannot be re-introduced
in the original vials, to avoid contamination, therefore also here it is not advisable to keep the
temperature too low.
1.7. Administrator
The Administrator has the possibility to use or not the reagents Lots' control. When this option is
disabled, the analyzer will not perform any control on the reagents lot or expiry date. On the other
side, when this option is enabled, it is possible to enable also the following checks.
Check dates: this check will allow the analyzer to warn the user when
a reagent has reached its expiry date. An expired reagent will be
automatically removed from the reagents tray and will not be useable
anymore.
Check volumes: this is an additional check that will allow the analyzer
to verify if the reagent has been added to an existing bottle. The
analyzer will verify the volume increment to avoid bottles re-filling. If
the analyzer detects a volume increment higher than 15%, it will consider that bottle as
counterfeited and will remove it from the tray. In the Reagents Lot Management are listed all the
analyses with the Expiry date and volume.

2. Patients
In this menu are available those settings applied generally to the
patients and patients results.
2.1. Samples' Groups

In the analyses parameters, as well as in the patients entry,
there is a field dedicated to the Group. In the analyses
analytical parameters it is necessary to define the values
normal range for each group, while in the patients entry it is
necessary to select the group for every patient in order to
correctly refer each result to its normal range.
The analyzer provides automatically the three basic groups:
Male, Female, Children. Beside these, the user can define
other 15 groups. Simply click on the group and type the new
definition for it.
For certain analyses it may be useful to have a specific group
and specific normal values range, for instance, for newborns.
In this case the group can be defined as Baby<1.
The same applies to groups under specific therapies e.g. Male therapy xxx or to limited populations
with normal values different from the rest of the population, such as people living in high mountains,
whose diet is different from people living by the coasts.
2.2. Communication
The Communication page allows to set the parameters for the communication between the
analyzer and a host computer.
Once the communication is activated, all the
parameters will be displayed. These parameters
are different for the two type of Transport. This can
be Serial or TCP/IP.
Selecting TCP/IP it will be necessary to select the
Port.
The default communication port is 8888. It can be
set by the technical assistance personnel with their
password. If the communication port is changed, it
will be necessary to turn the external PC off and
then on to activate the new port.
The TCP/IP protocol version used is version 4 (not
version 6).

Then set the other parameters as explained below.

Selecting Serial, the appropriate parameters will be displayed. The default parameters are listed
below. If necessary, seek the advice of the technical personnel who has interfaced the analyzer.
COM Port: select the appropriate communication port. (for example COM 1, COM 2 etc.)
Baud-Rate: Sets data transmission speed between the analyzer and
the host computer. Click u to view all the possible transmission speeds.
To select, click on the desired value.
Parity: None
Word Length: 8
Stop Bits: 1
Hand-Shake: Enables Data Flow Control to be used during data
transmission. Click u to view the available options. To select, click on
the desired option.
Protocol: it is possible to use the ASTM protocol or a variable protocol. When choosing the variable
protocol, it will be possible to set the protocol options by clicking on the
dedicated button Modify Scripts. Only expert operators should set the
variable protocol.
ONLY WITH ASTM PROTOCOL. In case the analyzer, after having read the
bar-code on the tray, does not find in its programmed work-lists the patient
corresponding to that code, it will require this information to the host computer.
These options concern the real time results

Send results without validation: when this option is enabled,
all results from the analyzer are sent automatically and
immediately to the communication buffer (it will be then the host
computer to require the data). If the option is not enabled, then
the operator will decide when to send the data.
Send partial results: with this option it is possible to send to the communication buffer also the
partially performed patients. This may happen when some patients have been programmed with
tests that are on the tray and tests that are not. After the first run, it is possible to put the remaining
tests on the tray and run again the patient. In this case, the communication buffer will receive twice
the same patient. It will be the host computer to eventually merge it.
Send results without value: by selecting this option the non-calculable results will also be sent to
the communication buffer, if the option is not enabled the <NC> results will not be sent . In this case
the <NC> results can be run again and if there are valid results, they will then be sent to the
communication buffer.

These options concern the patients sent via host computer

Send on supplementary list: when the check is enabled, the
analyzer will load the patients sent via host computer in the
supplementary list, in order to place them in the work-list only
upon receiving the sample. It is possible to decide between two
options. Only if not empty: the analyzer will send the patients to
the supplementary list only if this one is not empty. In all cases: the patients will always be sent to
the supplementary list.
2.3. Sort Results

This window allows the operator to select the way to arrange the results in the real time results
page. Select the desired combination of options and save. To let the analyzer sort the results in the
real time Results page, click on the Sort button.
It is possible select the sorting criteria for Patients, Analyses, I.S.E. results and Relation tests
results.
Selecting NONE for all options, the analyses will not be sorted, but will be listed as they arrive to the
Real Time pages.
PATIENTS
BY CODE: sorting is done by alphanumerical order of the ID code. The alphanumerical order means
that codes can be ordered as follows: CODE1, CODE10, CODE2, or as follows, depending on the
way numbers are written, CODE01, CODE02 AND CODE10
BY POSITION: patients are ordered by their position on the tray. In case of patients programmed in
the same position, the analyzer will insert them in the new order as it finds them in the Result page.
BY TIME: patients are ordered upon the execution date and time. Within every date, patients are
ordered by time.
ANALYSES
Within every patient, analyses can be sorted with their own criteria.
BY CODE: analyses are sorted by the alphanumerical order of the code. If codes are all
alphabetical, the codes will be ordered in alphabetical order, but if there are alphanumerical codes,
these will be ordered as for patients.
BY POSITION: analyses are ordered upon their position on the tray.
BY TIME: analyses are ordered upon the execution time.
SPECIAL ANALYSES: I.S.E. & Relation tests
Both I.S.E. and Relation tests can be ordered specifically. If set to NONE, the tests will be inserted
in the list in the order as the analyzer finds them in the Result page.
AT TOP: the special tests will be placed in the new order at the beginning of the list.
AT BOTTOM: the special tests will be placed in the new order at the end of the list.

2.4. Diluents Identification

The analyzer has three available positions for the use of
diluents dedicated to the samples. Positions 1 & 2 are
located between the standard & controls tray and the
cuvettes tray. The third position is between the I.S.E. and
the samples tray. These positions allow 50ml bottles that
may contain any necessary solution. By default these
bottles are named as follows:
#1 saline solution
#2 diluent
#3 samples treatment
As far as every Lab may have or use special solutions for different needs, these three bottles’
definitions have been left "open", to let the operator name them as necessary.
To assign a definition, simply click on the editable field and type the solution's name.

CHAPTER 10
TECHNICAL FUNCTIONS Page
TECHNICAL FUNCTIONS ............................................................................... 2

1. ANALYZER UTILITIES ................................................................................ 2
2. MECHANICAL CALIBRATIONS ................................................................. 3
3. DIAGNOSTICS ............................................................................................. 7

Via Licenza, 18
Chapter 10 Technical Functions Page 1 of 7

TECHNICAL FUNCTIONS
In this chapter are first explained the analyzer utilities, the mechanical calibrations and then the
available diagnostic functions.
In the normal routine use, there are only a few adjustments that may become necessary. On the
other side, there are many utility functions that are commonly used. The diagnostic pages are
normally reserved to the technical assistance personnel.
1. ANALYZER UTILITIES
The analyzer utilities can be accessed by the main menu Analyzer or from the side bar, under the
option Special Functions.
To activate any of the following commands click on the corresponding button.

Wash cuvettes: is used for complete washing of the hydraulic circuit and reading cuvettes. Once
the command is given, a message appears asking to insert the bottle containing the dedicated
washing solution in the indicated position. This function must be run daily when the analyzer is shut
off (using the guided shut down procedure) or at the end of the day if the analyzer is not turned off.
Wash and fill up cuvettes: washes, with the washing solution in the external tank (bidistilled water
and surface active agent) the cuvettes and leaves them filled with water. This function is
recommended when a work session has ended and the analyzer is not going to be used again
immediately.
Extra wash cuvettes: is used for complete washing of the hydraulic circuit and reading cuvettes
with a special solution. Once the command is given, a message appears asking to insert the bottle
with the special washing solution in the indicated position. This wash is run with an acid solution and
is necessary at least once a week or if the analyzer returns inconsistent results for no apparent
reason.
Needles prime: performs a filling-up cycle with distilled water of the hydraulic circuit and sampling
system.
Prime I.S.E.: starts the I.S.E. prime. Once the reagent pack and the sensors are in place, press
this button. The peristaltic pumps R, A and B will begin to aspirate the Reference (which will be
emptied first) , the STD A and the STD B solutions respectively until their presence is detected
by the needle sensor. It is important that the Prime I.S.E. is performed every time, when a new
reagent pack is used.

Empty Fluidics: This command completely empties the fluidic circuit. It is to be used exclusively as
preliminary operation for maintenance or eventual moving of the instrument.
Zeroing on water: Performs photometer zeroing with distilled water. It is important to remember
that zeroing is necessary to avoid any drift of the photometer zero and has to be performed after the
analyzer has reached the steady state (approx 20 minutes after turning on).
F.C.C. calculation: This procedure is for calculating the optical correction factor for the reading
cuvettes. A screen message invites to insert a bottle with appropriate solution into the reagents tray.
Generally a solution of Potassium Bichromate with absorbance around 0,500 Abs (read at 340 -
700nm) is used. The analyzer guides the user through the procedure. This function is password
protected.
It is performed only when one or more cuvettes are replaced or after a thorough service is
performed on the instrument computer (e.g. hard disk substitution) where correction factors may be
lost.
Lamp Setup: this function is only necessary after the photometric lamp has been changed. It is
used to align the new lamp to preset internal values. It also carries out photometer zeroing at the
same time. It is advisable that only technical assistance personnel use this function.
Washing station prime:
Na Conditioning: The Na sensor requires reconditioning of its proper pH value. The
reconditioning procedure is simple and rapid and a specific solution "Na conditioning solution"
has to be used. When to perform: usually once a week or when one notices a sharp decline of
the Na Slope, beyond 6 mV. In practice the Na Slope descends a couple of mV per day, but it is
also dependent upon the number of tests executed. The procedure consists in placing a serum
cup with at least 500µl of Na conditioning solution in the serum plate in the position indicated on
the displayed message and then press start. This procedure will last for approximately 4
minutes (after the aspiration of the Na solution into the sensors, the analyzer will wait for approx
3 min) and ends with the release of the solution A into the sensors. Then it is suggested to run
a calibration (slope).
2. MECHANICAL CALIBRATIONS
This function allows mechanical centering and adjustments for the different positions of the
sampling arm, cuvettes plate, sample plate and reagents tray. Bear in mind that the analyzers are
already factory-calibrated and a new adjustment is seldom necessary.
The mechanical calibrations are divided into two
main sections: Arms and Trays
Each section, once opened gives access to the
specific and dedicated functions.
To perform calibrations, click on the desired
function: the Left and Right command keys will be
enabled on the screen, which determine the
movement of the selected object either clockwise or
counterclockwise, step by step. The [!] Test key
lowers and lifts the sampling needle or the wash
piston to check centering.
NOTE:
It is highly recommended to calibrate the trays first and then the positions of sampling arm.

ARMS
There are three sampling arms. Two for the reagents and one dedicated to the samples. Each arm
must be calibrated in all positions. Click on the line corresponding to each position, then use the
arrows buttons to adjust the needle, which has to be centered above the selected position. To test
the centering, use the Test button. The Height adjustment is normally performed in factory. Please
read carefully the dedicated paragraph before using this function.
Arm on first and second reagent
The arms must be centered on the

washing position and on the internal
and external cuvettes rings. Then the
1st reagent arm must be centered on
the neck of the large bottle. The 2nd
reagent arm must be centered on the
neck of the small bottle.
Arm on sample
The sampling arm must be centered on

the wash position, on the internal and
external cuvettes rings, on all three
samples rings, on the two standard
rings, on the I.S.E. sample diluent
bottle, on the I.S.E. funnel and on the
three diluent bottles (diluent, saline and
sample treatment).
TRAYS
There are four trays. Each has to be positioned in order to center the needle. Follow the same
instructions as for the arms.
Samples tray
Click on every arm position: the needle
will move to that position to allow the
tray adjustment.
The samples tray must be adjusted in
order to have the needle centered on
the three samples rings. Then it has to
be set the position of the tray respect to
the bar-code readers. The external and
internal samples' tray rings are read
from the external bar-code reader,
while the internal samples ring is read
from the internal bar-code.

Reagents tray
Click on every reagent position: the
needle will move above that position to
allow the tray adjustment.
The reagents tray moves in order to
allow the needle centering on the
reagent bottles (first and second, large
and small). It has also to be centered to
the reagent insertion position and on
the bar-code reader position.
Cuvettes
The cuvettes tray is adjusted when the

washing station descends correctly into
the cuvettes.
Standards and controls

Select one of the two options: the
needle will move above the selected
position.
The standards and controls small tray
has to be adjusted in order to center the
needle on both the internal and external
rings.
NOTE: the position presented when adjusting the needle on the tray's rings is always the
first position for that ring, i.e. the position in that ring having the lowest number. For
instance, in the samples tray, the first position of the external ring is #1, of the central ring is
#37 and of the internal ring is #73.
HEIGHT ADJUSTMENT: this button is used to memorize the maximum descent of the needle in the
selected position. For the reagents positions, including the I.S.E. sampling diluent, an empty bottle
must be in place. For samples positions a primary tube must be in place. For standards and controls
a cup must be placed on the tray. The needle will go fully down until the crash sensor is activated. In
this way the analyzer memorizes the maximum possible descent in every position.

3. DIAGNOSTICS
Diagnostic pages are accessible from Analyzer’s main menu. The
Diagnostic functions are partially reserved for approved service personnel
only. Therefore the access to some of the functions is password protected.
It contains the following options: View F.C.C., View Optical Transmission
and General Diagnostics.
Show F.C.C.: It shows the optical correction factor calculated for all the reading cuvettes. For each
cuvette, the mABS and the F.C.C. values are
reported. It also indicates the cuvettes with
correction factor exceeding the preset limits
(± 3%). It is possible to print this page.
Show Optical Transmission: After each photometric zeroing, it indicates the

percentage transparency of the cuvettes. The cuvettes with poor
transparency are highlighted. If the optical transmission of a cuvette falls
below a specific percentage (40% less than the mean of the calculated O.T.),
the analyzer will eliminate it and will work with one less cuvette. If it becomes
necessary to eliminate four or more cuvettes, the analyzer generates an
alarm and will not allow work to continue. It is possible to continue to work
with three damaged cuvettes.
Optical transmission of the cuvettes tends to decrease due to a series of
factors, including lamp performance, opaque cuvettes etc.
General Diagnostic: This function is reserved for the Technical Assistance

personnel for diagnosing problems that cause analyzer malfunction. There is
no free access to this program: it is password protected.

Operator Manual BT4500-00ING PDF

Uploaded by

Operator Manual BT4500-00ING PDF

Uploaded by

OPERATOR MANUAL

Rev. 1, Feb. 2012

Biotecnica Instruments S.p.A.

BIOTECNICA INSTRUMENTS ANALYZERS MUST OPERATE

BIOTECNICA WILL NOT BE RESPONSIBLE FOR ANY DAMAGE

Biotecnica Instruments S.p.A.

Chapter 1 General Information & System Page 1 of 11

2. ANALYZER IDENTIFICATION AND INTENDED USE

3. STORAGE AND HANDLING

4. WARNINGS AND PRECAUTIONS

Chapter 1 General Information & System Page 4 of 11

Chapter 1 General Information & System Page 5 of 11

6. BASIC OPERATING PRINCIPLES OF THE ANALYZER

Chapter 1 General Information & System Page 6 of 11

7. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS

① Main menu: each menu generates other commands and/or options

Chapter 1 General Information & System Page 7 of 11

Patients: gives access to the routine entry page

It is used to clear a page

It is used to close a window

It is used to start a run

It is used to modify editable fields

It is used to enter into the print preview page

It is used to save data to the archive

Chapter 1 General Information & System Page 8 of 11

IVD SYMBOLS: PRINTED PACKAGING ITEMS*

In vitro Diagnostic Medical Device

Lot number or Batch code

CE Logo (Directive 98/79/CE)

Electrical and electronical devices: collect and dispose separately.

IEC STANDARD SYMBOLS

Both direct and alternating current

Earth (ground) Terminal

Protective earth conductor terminal

Frame or chassis (ground) terminal

OFF (Main supply)

Equipment protected by double insulation or reinforced insulation

Caution, risk of electric shock (black on yellow background)

8. BRIEF DESCRIPTION OF THE SYSTEM

8.1. Front view of the analyzer

1 ON/OFF BUTTON FOR COMPUTER

Chapter 1 General Information & System Page 10 of 11

Chapter 1 General Information & System Page 11 of 11

1. UNPACKING INSTRUCTIONS .................................................................... 2

Biotecnica Instruments S.p.A.

Chapter 2 Installation Page 1 of 8

CAUTION: two persons are necessary to move the analyzer.

Verification of the contents of the wooden crates

Chapter 2 Installation Page 2 of 8

2.1. Electrical connections

FUSE The printer and peripheral devices should be

Chapter 2 Installation Page 3 of 8

2.2. External PC and peripherals connection

2.3. Fluidic connections

Water load Acid load

Water overflow Acid overflow

Chapter 2 Installation Page 4 of 8

3. STARTING THE INSTRUMENT

I.S.E.: the sensors and the peristaltic pumps are placed in

1. Remove the sensors support sliding it out of its grooves.

Chapter 2 Installation Page 5 of 8

I.S.E. PERISTALTIC PUMPS AND REAGENTS

Chapter 2 Installation Page 6 of 8

3.1. Turning on the instrument for the first time

Perform the following:

Chapter 2 Installation Page 7 of 8

1.3.2. Preliminary checks

OPERATIVE CONTROL When

Verify distilled water container Daily

Verify the acid container Daily

Verify the waste container Daily

Zeroing of the photometer Twice a day

Wash the cuvettes with the proper solution Daily

When: Before turning off or at the end of the working day

Extra wash of the cuvettes with acid solution Weekly

DOUBLE DISTILLED WATER SPECIFICATIONS: