Brio2 Uso UK

BRIO 2
BASIC ROBOTIC IMMUNOASSAY OPERATOR
USER’S MANUAL
Brio 2 version 1.10

BRIO2 Automatic Analyser - User’s Manual
BRIO 2
BASIC ROBOTIC IMMUNOASSAY OPERATOR
USER’S MANUAL
Brio 2 version 1.10
SEAC S.R.L.
Via di Prato, 72/74 - Calenzano – Firenze - ITALY
Tel: +39 055 8877469 - Fax: +39 055 8877771
Code 53872901
Revision date 02/11/06
2
INDEX
3
1. GENERAL DESCRIPTION........................................................................................1-1
1.1. Introduction ..........................................................................................................1-1

1.2. Technical features................................................................................................1-3
1.3. Block diagram ......................................................................................................1-7
1.4. Devices ................................................................................................................1-8
1.5. Devices and electric connections on the back panel..........................................1-10
1.6. Hydraulic connections on the back panel ...........................................................1-12
1.7. Hydraulic ............................................................................................................1-13
1.7.1. Generalità ..................................................................................................1-13
1.7.2. Dilutor hydraulic circuit...............................................................................1-13
1.7.3. Washing solution hydraulic circuit..............................................................1-14
1.7.4. Waste hydraulic circuit...............................................................................1-14
1.8. Operational precautions and limitations .............................................................1-16
1.8.1. Use ............................................................................................................1-16
1.8.2. Performance ..............................................................................................1-16
1.8.3. Protection ..................................................................................................1-16
2. INSTALLATION AND PREPARATORY OPERATIONS...........................................2-1
2.1. Foreword ..............................................................................................................2-1

2.2. Transportation, storage and unpacking................................................................2-1
2.2.1. composition of supplied material..................................................................2-2
2.3. Preparation of the installation site ........................................................................2-3
2.3.1. Correct installation of the robotic immunoassay operator ............................2-3
2.4. Installation of the instrument ................................................................................2-5
2.5. Testing to be carried out with the user .................................................................2-7
2.6. Disinstallation .......................................................................................................2-7
3. USE ...........................................................................................................................3-1
3.1. Introduction ..........................................................................................................3-1

3.2. Software structure ................................................................................................3-1
3.2.1. Password.....................................................................................................3-2
3.3. Start up ................................................................................................................3-3
3.4. Work sequence ....................................................................................................3-4
4
3.5. Work plan .............................................................................................................3-5

3.5.1. Setting the work list....................................................................................3-16
3.5.1.1 Patient data .........................................................................................3-17
3.5.1.2 Summary .............................................................................................3-23
3.5.1.3 Predilutions..........................................................................................3-24
3.5.1.4 Suspended ..........................................................................................3-25
3.5.2. Control serums ..........................................................................................3-26
3.5.3. Setting the calibrations ..............................................................................3-27
3.6. Methods .............................................................................................................3-29
3.6.1. Editing........................................................................................................3-30
3.6.1.1 Spatial parameters ..............................................................................3-31
3.6.1.2 Temporal parameters ..........................................................................3-39
3.6.2. Archive.......................................................................................................3-52
3.6.3. Utility..........................................................................................................3-52
3.6.4. Groups.......................................................................................................3-54
3.6.5. Reagents ...................................................................................................3-55
3.6.6. Allergens....................................................................................................3-57
3.6.6.1 Families and allergens.........................................................................3-58
3.6.6.2 Panels .................................................................................................3-61
3.6.6.3 Store....................................................................................................3-64
3.7. Results ...............................................................................................................3-65
3.7.1. Visualization of the plate results ................................................................3-68
3.7.2. Visualization of test results ........................................................................3-70
3.8. Setup menu........................................................................................................3-74
3.8.1. System date setting ...................................................................................3-75
3.8.2. Tools..........................................................................................................3-75
3.8.3. Setup .........................................................................................................3-77
3.8.3.1 Password management.......................................................................3-78
3.8.3.2 Parameters..........................................................................................3-80
3.9. Quality control ....................................................................................................3-82
3.10. Historic menu .....................................................................................................3-84
3.11. Service ...............................................................................................................3-85
4. MAINTENANCE ........................................................................................................4-1
4.1. Maintenance operations .......................................................................................4-1

4.1.1. Daily maintenance .......................................................................................4-1
4.1.1.1 Before turning on the instrument ...........................................................4-1
4.1.1.2 At the end of the work session ..............................................................4-1
5
4.1.2. Weekly maintenance ...................................................................................4-2

4.1.3. Monthly maintenance...................................................................................4-2
4.1.4. Periodic maintenance ..................................................................................4-2
4.1.5. Preventive maintenance ..............................................................................4-3
4.2. Cleaning of the drain well. ....................................................................................4-3
4.3. Replacing the syringes pistons............................................................................4-4
4.4. Replacing the dilutor valve tubing. .......................................................................4-5
4.5. Replacing the needle ...........................................................................................4-6
4.6. Replacing the peristaltic pump tubing. .................................................................4-8
4.7. Troubleshooting guide..........................................................................................4-9
5. APPENDIX ................................................................................................................5-1
5.1. Level sensor management ...................................................................................5-1

5.2. Connection to the host ........................................................................................5-1
6
INDEX OF THE FIGURES
Fig. 1.1 – Detail of the 8-needle manifold .................................................................... 1-4

Fig. 1.2 - Block Diagram .............................................................................................. 1-7
Fig. 1.3 - Brio 2 Details and configuration .................................................................... 1-9
Fig. 1.4 - Brio 2S Configuration.................................................................................... 1-9
Fig. 1.5 - Back Panel: Electric devices....................................................................... 1-10
Fig. 1.6 - Back Panel: Hydraulic devices.................................................................... 1-12
Fig. 1.7 – hydraulic circuit .......................................................................................... 1-15
Fig. 2.1 – Tank arrangement........................................................................................ 2-6
Fig. 3.1 – Main menu ................................................................................................... 3-1
Fig. 3.2 – Initialization of the program .......................................................................... 3-3
Fig. 3.3 – Initialization of the instrument....................................................................... 3-3
Fig. 3.4 –Instrument fails to respond............................................................................ 3-3
Fig. 3.5 – Worklist restore ............................................................................................ 3-4
Fig. 3.6 – Work plan, initial conditions.......................................................................... 3-5
Fig. 3.7 – Selection of layout........................................................................................ 3-7
Fig. 3.8 - New layout .................................................................................................... 3-8
Fig. 3.9 – Selection of samples.................................................................................... 3-9
Fig. 3.10 – Work plan, pre-processing status............................................................. 3-10
Fig. 3.11 – Plates configuration ................................................................................. 3-11
Fig. 3.12 – Plate status .............................................................................................. 3-11
Fig. 3.13 - Work plan, ready to run status .................................................................. 3-12
Fig. 3.14 - TMS .......................................................................................................... 3-12
Fig. 3.15 – Work plan, running status ........................................................................ 3-13
Fig. 3.16 – Interrupted wolrklist.................................................................................. 3-14
Fig. 3.17 - Work plan carried out................................................................................ 3-15
Fig. 3.18 – Work list ................................................................................................... 3-16
Fig. 3.19 – Patient data.............................................................................................. 3-17
Fig. 3.20 – Summary of work list................................................................................ 3-18
7
Fig. 3.21 – Progressive IDs........................................................................................ 3-19

Fig. 3.22 – Associate function.................................................................................... 3-20
Fig. 3.23 – Suspend tests/patient .............................................................................. 3-20
Fig. 3.24 - Interrupt tests/patients .............................................................................. 3-21
Fig. 3.25 - Allergology tests ....................................................................................... 3-22
Fig. 3.26 – Summary of lists ...................................................................................... 3-23
Fig. 3.27 - Predilutions ............................................................................................... 3-24
Fig. 3.28 - Selection of tests to be pre-diluted............................................................ 3-24
Fig. 3.29 – List of suspended patients ....................................................................... 3-25
Fig. 3.30 – Control serums......................................................................................... 3-26
Fig. 3.31 - Allergology control serums........................................................................ 3-26
Fig. 3.32 - Calibrations............................................................................................... 3-27
Fig. 3.33 - Methods.................................................................................................... 3-29
Fig. 3.34 - Editing Methods ........................................................................................ 3-30
Fig. 3.35 - Spatial parameters for quantitative method .............................................. 3-32
Fig. 3.36 - Criteria for samples and blanks ................................................................ 3-33
Fig. 3.37 – Editing standards ..................................................................................... 3-33
Fig. 3.38 - Editing control samples............................................................................. 3-34
Fig. 3.39 – Editing dilutions........................................................................................ 3-34
Fig. 3.40 - Codification of dilution ratios ..................................................................... 3-35
Fig. 3. 41 - Refertation data ...................................................................................... 3-35
Fig. 3.42 - Editing associations .................................................................................. 3-36
Fig. 3.43 - Spatial parameters for qualitative method................................................. 3-37
Fig. 3.44 – Editing controls ....................................................................................... 3-37
Fig. 3. 45 - Spatial parameters for avidity method .................................................... 3-38
Fig. 3. 46 – Editing avidity controls .......................................................................... 3-38
Fig. 3.47 - Spatial parameters for allergologic method............................................... 3-39
Fig. 3.48 - Temporal parameters for quantitative method .......................................... 3-40
Fig. 3.49 - Copy temporal phase................................................................................ 3-41
Fig. 3.50 – Editing the standard dispensation ............................................................ 3-42
Fig. 3.51 – Editing the sample dispensation .............................................................. 3-42
Fig. 3.52 – Editing the reagent dispensation.............................................................. 3-43
Fig. 3.53 – Editing the combined dispensation phase................................................ 3-44
8
Fig. 3.54 – Editing the incubation phase .................................................................... 3-45

Fig. 3.55 – Editing the washing page ......................................................................... 3-45
Fig. 3. 56 – Setting the final reading phase............................................................... 3-47
Fig. 3. 57 – Temporal parameters for qualitative method.......................................... 3-47
Fig. 3. 58 – Editing the control dispensation phase .................................................. 3-48
Fig. 3. 59 – Editing the final reading phase............................................................... 3-48
Fig. 3. 60 – Alarm criteria.......................................................................................... 3-49
Fig. 3. 61 - Cut-off formula ........................................................................................ 3-49
Fig. 3. 62 – Temporal parameters for avidity method................................................ 3-50
Fig. 3. 63 – Editing the avidity reading phase ........................................................... 3-51
Fig. 3. 64 - Temporal parameters for allergologic method ........................................ 3-51
Fig. 3. 65 – Method archive ...................................................................................... 3-52
Fig. 3.66 - Utility......................................................................................................... 3-52
Fig. 3.67 – Print method............................................................................................ 3-53
Fig. 3. 68 – Method groups ....................................................................................... 3-54
Fig. 3. 69 - Reagents ................................................................................................ 3-55
Fig. 3. 70 - New reagent ........................................................................................... 3-55
Fig. 3. 71 – Modify the reagent data ......................................................................... 3-56
Fig. 3. 72 – Allergen archive ...................................................................................... 3-57
Fig. 3.73 – Families and allergens ............................................................................. 3-58
Fig. 3.74 – New family ............................................................................................... 3-59
Fig. 3. 75 – Modify family name ................................................................................. 3-59
Fig. 3. 76 – New allergen .......................................................................................... 3-60
Fig. 3. 77 – Modify allergen....................................................................................... 3-60
Fig. 3.78 - Panels...................................................................................................... 3-61
Fig. 3.79 – New panel ............................................................................................... 3-62
Fig. 3.80 – Modify panel............................................................................................ 3-63
Fig. 3.81 - Store ........................................................................................................ 3-64
Fig. 3.82 – Menu of results ....................................................................................... 3-66
Fig. 3. 83 – Export session ........................................................................................ 3-67
Fig. 3.84 - Plate results .............................................................................................. 3-68
Fig. 3.85 – Well characteristics .................................................................................. 3-69
Fig. 3. 86 - Modify OD................................................................................................ 3-69
9
Fig. 3.87 - Results for quantitative method ................................................................ 3-70

Fig. 3.88 - Repeated samples validity criteria ............................................................ 3-71
Fig. 3.89 - Result printout........................................................................................... 3-71
Fig. 3. 90 - Qualitative method results ....................................................................... 3-73
Fig. 3. 91 - Chart for the qualitative method............................................................... 3-74
Fig. 3.92 – Setup menu.............................................................................................. 3-74
Fig. 3.93– Setting the date......................................................................................... 3-75
Fig. 3.94 – Tool menu ................................................................................................ 3-75
Fig. 3.95 - Priming ..................................................................................................... 3-76
Fig. 3.96 – Exiting the program.................................................................................. 3-76
Fig. 3.97 – Setup menu.............................................................................................. 3-77
Fig. 3.98 – Password menu ....................................................................................... 3-78
Fig. 3.99 – Setting the password ............................................................................... 3-79
Fig. 3.100 – Entering the password ........................................................................... 3-79
Fig. 3.101 - Parameters ............................................................................................. 3-80
Fig. 3.102 - Quality control....................................................................................... 3-82
Fig. 3.103 - Control serum diagram ......................................................................... 3-83
Fig. 3.104 – Historic menu ......................................................................................... 3-84
Fig. 3.105 - Statistics ................................................................................................. 3-85
Fig. 4.1 – Detail of the Dilutor Unit. .............................................................................. 4-4
Fig. 4.2 – Replacing the needle (unlocking)................................................................. 4-6
Fig. 4.3 – Replacing the needle (extraction) ................................................................ 4-7
Fig. 4.4 – Replacing the peristaltic pump tubing .......................................................... 4-8
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WE VALUE YOUR OPINION
Reference: BRIO 2 - Basic Robotic Immunoassay Operator

User’s manual Brio 2 Win vers. 1.10 - Code 53872901
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Send this form to:

SEAC S.r.l. – Via di Prato, 74 – Calenzano (Firenze) - ITALY
Thank you for your cooperation.
11
I. RESPONSIBILITY DECLARATION
SEAC declines all responsibility for damage due to any type of modifications made to the
Hardware or Software and damage due to connections with other instruments not carried
out by our personnel or previously authorized.
In the event of the device being damaged do not switch it on until it has been repaired by
our personnel.
All operations of an electrical nature required for installing or repairing the instrument must
be carried out by our personnel; avoid all other types of installation.
The instrument must be installed in suitable environmental conditions as described in
points II and III of this chapter, in order to ensure that the performances of the instrument
comply with those illustrated in the technical specifications.
Use the device only after reading this manual
II. SAFETY PRECAUTIONS
The BRIO 2 Robotic immunoassay operator guarantees maximum safety for the operator
during operation. Nevertheless, as there is dangerous internal voltage, the operator must
follow the general safety rules:
∗ Make sure that the Power Supply has the required voltage before switching on the
instrument.
∗ The instrument must have a ground connection. In case of an electric short circuit the
ground connection eliminates the danger of electric contact with the external metal
parts.
∗ In case of a current surge (due to a short circuit or another malfunction within the
instrument or due to sudden line voltage variations) the protection fuse located on the
back will intervene; in this case, if the new fuse burns out again after having replaced it
with another of the same kind, the instrument must be disconnected and the Service
Technicians must be contacted.
∗ Do not use the commands or adjustments inside the instrument and notify the service
staff as soon as any anomaly occurs during functioning.
∗ Before starting any type of intervention inside the instrument switch it off and
disconnect the power cable. Switch the instrument off from the Main Switch. (Press O
to switch off). Unplug the power cable to disconnect it; do not pull the cable.
12
∗ All repairs must be carried out by the Technical Assistance Personnel.
∗ Any electric operation that is necessary to the installation must be carried out by
qualified staff.
∗ If the device is damaged do not turn it on until it has been repaired by a technician from
the Manufacturer’s Assistance Service.
∗ Disconnect the instrument if it is left inactive for a long period.
III. TECHNICAL FEATURES AND LINE DISTURBANCE
Disturbances on the power line may be caused by several factors such as:
- Starting and stopping of the electric motors.

- Atmospheric phenomena.
- Connection and disconnection of high line loads.
We must stress that serious power supply line disturbances have negative effects on the
system.
An efficient ground connection is necessary to reduce line disturbances and guarantee the
maximum safety to the operator.
Power supply : 230 VAC

Distribution : 1 phase, neutral and earth
Frequency : 50 - 60 Hz
Consumption : 810 VA
Line fuse : T 4.0A
Compressor fuse : T 4.0A
Motor card fuse : D 2.0A 6x32 mm
13
TABLE OF SYMBOLS
Number Symbol Description
1 Alternating Current
2 Functional ground
3 ON
4 OFF
5 Fuse
6 Warning high voltage (risk of electric shock)
7 Consult the documentation attached (e.g. user manual ).
8 CE Mark
9 Biological hazards
10 Waste for electronic device
14
1. GENERAL DESCRIPTION
1.1. INTRODUCTION
The BRIO 2 device is a high speed automatic system for 96 wells microplates preparing
for immunoenzymatic and Allergologic assays.
The apparatus consists of the following:

• A mobile arm with dispensing needle, washing manifold and grabber transfer device,
with XYZ axis movements.
• A dilutor consisting of two syringes of 2500 µL and 1000 µL for aspirating and
dispensing the samples and reagents
• A stand for 4 microplates with thermostats fitted with stirrers
• Photometric unit for the measurement procedure
• Internal PC capable of memorizing up to 120 different tests.
The analyzer is capable of carrying out the following operations:

• pre-rep-dilution of the serums according to all the programmed dilution ratios as long
as a serum volume is used that is higher than 10 µL;
• distribution the serums, standards and controls;
• distribution of the primary and secondary reagents via multi-dispensing at high
speed;
• wash the microplate with the 8-needle manifold
• simultaneously thermostat and/or stir the microplates.
• photometric plates reading
The basic setup consists of:

• a stand for stirring and thermostating of 2 plates;
• a stand for 120 12 x 75 mm tubes;
• a stand for:
25 bottles with a diameter of 22 mm (5ml);
1 bottle with a diameter of 52 mm (100ml).
• a stand for:
1 bottle with a diameter of 52 mm (100ml).
1-1
The versatility of the system is exalted by the simple and intuitive management software
which, thanks to a special series of options, greatly simplifies intervention by the operator.
The BRIO 2 management program is a high-performance software that is carried in
Windows XP. This is characterized by a User-program interaction based on the dialogue
and menu windows displayed on the screen which guide the operator in the correct work
procedure.
The main menu also includes utilities of a general nature and a special function entirely
dedicated to technical assistance.
The software is able to simultaneously manage the preparation of various tests calculating
the times in order for the time foreseen by the method for carrying out the test to be
complied with. The reading of the test is carried out via internal microplate reader.
The possibility exists of automatic recovery from errors generated by the electric power
fault or any other type of malfunctioning like an interruption in the electric energy.
There is also the signaling of reagents loss (level errors).
The conducting of tests with a high risk of interserum entrainment is reliable thanks both to
the introduction of interserum washing equal to 5000 µL (two syringe-loads of 2500 µL)
during the analysis Editing phase and with an extension of up to 2500 µL of the washing
volume between the repeats of the same serum during the parameter-setting phase, and
also thanks to the possibility of carrying out an SMP priming with a serum rate equal to the
dispensing one.
It is possible to carry out a simulation of the preparation of the EIA tests or the CARLA
dosage thus passing directly onto the reading phase.
In the environment dedicated to the report-making refertation the historic research

modality exists for obtaining a single report by changing the dates associated with the
single tests.
There is also the possibility of correcting the reports and exporting the data to an ACCESS
format in order to allow for the use of this data with other analyzing programs.
It is possible to set the language on which to base the interaction program. In this case the
description of the controls and the controls themselves will be displayed in the language
set.
1-2
1.2. TECHNICAL FEATURES
Dispenser unit
Syringe : 2500 µL
Syringe : 1000 µL
Needle for aspirating and dispensing samples and reagents
Minimum serum volume : 10 µL
Maximum serum volume : 300 µL
Minimum reagent volume : 20 µL
Maximum reagent volume : 300 µL or 2200 µL in the case of sample dilutions
Precision sample : CV < 4.0% with 10 µL (reading on microplate)
Precision reagent : CV < 1%
Carry over sample : < 0.3 ppm (0.3*10e-6)
Carry over reagent : < 0.3 ppm
Predilution
Consisting of the above-mentioned elements. All the dilutions programmed are possible
as long as the volume of serum higher than 10 µL is always used.
Washing unit of wells an microplate

8-needle manifold for aspirating and feeding the washing solutions (Fig. 1.1).
1-3
Fig. 1.1 – Detail of the 8-needle manifold
1-4
Reagent and serum unit (standard)

2 Serum holder stand for 60 tubes diameter 12 mm
1 Reagent holder stand for 40 bottles diameter 22 mm (5ml)

10 bottles diameter 32 mm (20ml)
1 Reagent holder stand for 25 bottles diameter 22 mm (5ml)

Incubation and stirring unit

2 independent thermostats fitted with stirrer for microplates with 96 wells. Temperature
settable from the SW in a range of between TA and 40°C with 2°C intervals.
Temperature accuracy : +/- 0.5 °C
Transfer and reading module

Grabber transfer device with xyz axys movements
Photometric unit : with 5 interferential filters
Measuring range : from 0.100 to 3.000 OD units
Accuracy : 2,5% @ 0,150 .O.D.

1,5% @ 1,000 O.D.
1,5% @ 2,500 O.D.
Precision : +/- 1,5%
Linearity : +/- 1,0%
Photometric wavelength spectral : from 400nm to 850nm

range
Wavelength selection : 5 interferential filters @ 405, 450, 492, 550 620nm
Option up to a maximum for 8 filters
Light source : 20 W halogen lamp
Reading time : Single wavelength <3 Sec

Double wavelength <10
1-5
Grabber transport device with xyz axis movements
Temperature: accuracy : ± 0.5 °C
General features
Distribution : 1 phase, neutral and earth
Power supply : 230VAC 50Hz÷60Hz
Consumption : 810VA
Line fuse : 2 x T4.0A
Compressor fuse : 2 x T4.0A
Motor card fuse : 2 x D2.0A mm 6x32
Operating conditions
Temperature : 15 ÷ 32 °C (on)
0 ÷ 50 °C (off)
Relative Humidity : < 80%
Altitude : <2000 m
Environmental coefficient : 2
Sonic Pressure : <85dBA
Safety EEC 73/23 and EEC 93/68 DIRECTIVE
Electromagnetic compatibility : EEC 89/336 DIRECTIVE
In Vitro Diagnostic : EEC 98/79 DIRETTIVE
Dimensions : 44 x 111 x 60 cm
Weight : 80 Kg
1-6
1.3. BLOCK DIAGRAM
The following figure shows a summarizing scheme of the instrument functional parts.
Fig. 1.2 - Block Diagram
1-7
1.4. DEVICES
All the instrument devices are identified in the following table which gives the user a brief
description of their function. The listed devices are marked with a character that identifies
them in Fig. 1.3.
Table 1.1 Instrument Devices
Ref Type Description

1 Reagent Tray Located to the left tray for insertion of reagents.
2 Serum Tray Located to the centre tray for insertion of sera.
3 Reaction Table In the right, with 6 thermostated independent supports, able to

(Incubator - Mixer) shake at different speeds.
4 Arm This slides in the direction X and supports the

Needle/Manifold/Gr needle/manifold/grabber unit which slides in the direction Y,
abber enabling the preparation, washing and shifting of the plates.
5 Dilutor They are made up of two precision syringes (2500µL and

1000µL) connected to the needle.
6 Photometer Enables the reading of the prepared plates.
7 Rack boards This houses the electronic power supply and control boards
8 Monitor Allows for displaying all the information coming from the internal
PC.
Not present in the Brio 2S instrument
1-8
Fig. 1.3 - Brio 2 Details and configuration
Fig. 1.4 - Brio 2S Configuration
1-9
1.5. DEVICES AND ELECTRIC CONNECTIONS ON THE BACK PANEL
All the devices and the electric connections which are on the back panel (Fig. 1.5) are
listed in the following table which gives the user a brief description of their function.
instrument itself.
Fig. 1.5 - Back Panel: Electric devices
Table 1.2 - Devices and electric connections
Ref Name Type Description
1 Connector 1 RCA Connector Connection for the solution tank level

sensors for thrust and external washing of
needle
2 Connector 2 RCA Connector Connection for the level sensor of the

drainage tank
3 Serial Port Female connector Connection of the analyzer with an

SUB-D 25 pins external computer.
4 Main Outlet For the connection to the power network

(through the cable supplied with the
instrument).
Fuse Holder It holds the fuses.
Fuse They protect the instrument in case of an

excessive absorption.
1-10
5 Compressor Socket Compressor Power Supply.
6 Switch ON/OFF switch Starter instrument.
7 Serial Port Male connector Connection of photometer with external

SUB-D 9 pins computer.
8* Parallel Female connector Connection of the internal PC

SUB-D 25 pins
9* Seriale Male connector Connection of the internal PC

SUB-D 9 pins
10* USB Female connector Connection of the internal PC

USB Type A
11* Keyboard Female connector Connection of the internal PC

mini din 6 pins
(PS/2)
12* Lan Female connector Connection of the internal PC

RJ45
* Not present in the Brio 2S instrument
The connectors identified with numbers 3, 7, 8, and 9 are installed for

protecting against electrical discharges.
Only ever remove these protections with the instrument turned off and in
the event of using the connections to hook up to any external devices.
1-11
1.6. HYDRAULIC CONNECTIONS ON THE BACK PANEL
The following table lists all the devices and the hydraulic connections which are on the
back panel. It gives the user a brief description of their function. All the listed devices are
marked with a number and a name that identify them either in Fig. 1.6 or the instrument
itself.
Note: The hydraulic Connector and the Level Sensor relative to the same element have
the same Reference Number.
Fig. 1.6 - Back Panel: Hydraulic devices
Table 1.3 - Devices and hydraulic connections
A Connector A Hydraulic Connector This is the input connector of the thrust

solution used by the diluter.
B Connector B Hydraulic Connector It is the input connector of the Washing

Solution of the Plate 1.
C Connector C Hydraulic Connector Output connector for the waste of the

washing external needle solution. It has
to be connected to the waste tank.
D Connector D Hydraulic Connector This is the connector for draining the

plate washing solutions. It must be
connected to the waste container.
1-12
E Connector E Hydraulic Connector Input connector of the Washing Solution

of Plate 2.
F Connector F Hydraulic Connector Input connector of the Washing Solution

of external needle.
G Pump G Peristaltic Pump Peristaltic pump for the external needle

washing solution.
H Pump H Peristaltic Pump Peristaltic pump for the manifold solution.
1.7. HYDRAULIC
1.7.1. GENERALITÀ
The hydraulic part of the instrument is made up of 3 functional blocks:

– washing solution circuit
– waste circuit
– dilutor circuit
1.7.2. DILUTOR HYDRAULIC CIRCUIT
It is made up of 1 dilutors which is composed of the following parts:

– no. 1 2500 µL syringe
– no. 1 1000 µL syringe
– no. 4 electrovalves (two N.C. valves and two N.O. valves)
Make sure there are no air bubbles inside the hydraulic circuit in order to guarantee its
correct function. This is possible by driving the 4 solenoids and the syringes in the
appropriate manner during the priming cycle before starting work.
It also includes:
– Flush solution external tank
– external container of the external needle washing liquid
1-13
1.7.3. WASHING SOLUTION HYDRAULIC CIRCUIT
Consists of:
– External tanks for the washing solution (from 1 to 2)
– Peristaltic pump
– N.C. valve placed on the mobile arm
– 1 2-way valves for switching one the 2 tanks on the manifold feed.
– manifold
The N.C. valve which is near the manifold allows the system to obtain the maximum
accuracy in distribution (it opens after the peristaltic pump pressurized the duct) and it
prevents liquid emission from the manifold during the mobile arm movements.
1.7.4. WASTE HYDRAULIC CIRCUIT
It is made up of the following parts (Fig. 1.7):

– waste container
– vacuum pump
– needle waste well
– washing needle chamber
– vacuum valve
The waste tank is kept at negative pressure (-300 mbar) by the external vacuum pump.
For correct operation of the preparation unit it is very important that there be no leaks in
the vacuum circuit. Make sure the waste tank cap has a perfect seal.
The external WASTE tank is connected to the back panel through 2 tubes;
Tube D
This is connected to the 2-way switchover vacuum valve, normally connected to the
aspiration tubes of the manifold and the external needle washing chamber; from where the
washing solution is aspirated that comes from the external-needle washing peristaltic
pump (Needle Washing Pump).
The other valve way is connected to the manifold feeding circuit and allows it to be
emptied after having partially recuperated the feeding solution by the peristaltic pump.
This permits the use of a minimum quantity of solution for the circuit start-up every time the
user changes the washing solution tank.
This system allows for limiting any waste of washing solution during rinsing.
Tube C
This is connected to the recovery tank of the internal needle washing solution and the
manifold rinsing tank. (Washing Bachwater Tank).
1-14
1-15
2 1
N.O.
Fig. 1.7 - Hydraulic circuit

PANEL FITTING
VALVES
2500uL
SYRINGE
N.C.
2 1
FILLING N.O.
SOLUTION
TANK
VALVES
1000uL
NEEDLE SYRINGE
WASHING N.C.
SOL. TANK
NEEDLE
Dilutor circuit WASHING PUMP DISPENSING NEEDLE
WASHING
CHAMBER
VACUUM
VALVE
2 1
WASHING MANIFOLD
PLATE
N.C.
Wash circuit PUMP
VALVE
2 1
WASHING
2 1 BACKWATER TANK
1 WASHING WASHING
SOLUTION VALVE
2 TANKS
2 1
S E A C F.C.
WASTE
VACUUM Title
TANK BRIO 2 HYDRAULIC CIRCUIT
PUMP
Size Document Number Rev
Waste circuit B IDRBRIO2 DIAGRAM
Date: Thursday, November 02, 2006 Sheet 0 of 0
1.8. OPERATIONAL PRECAUTIONS AND LIMITATIONS
1.8.1. USE
The Brio 2 is intended for In Vitro Diagnostic use in laboratories performing clinical assays
on patient samples in microplates. It may also be used in other laboratories requiring the
automation of tests which are carried out in the general EIA format in microplates. The
instrument can be used only by qualified and trained personnel.
That handling of clinical samples presents a significant biological safety

hazard and should be carried out with extreme caution.
Use protection gloves and mask to handle sample tubes and reagents vials.
Use protection gloves and mask to clean the internal of the instrument with
diluted hypochlorite in case of liquid leakage.
Use protection gloves and mask to avoid contact or aerosol contamination
while emptying the waste tank by the relative pump.
The instrument must be used in conjunction with the kits for diagnostic in vitro operations.
For all clinical applications it is necessary to refer to the relative instructions for use. The
user shall be responsible for ensuring that these kits are certified for use in conjunction
with the instrument.
For all information regarding disposal of the waste material together with the instrument
please refer to the instructions for use of the kit.
1.8.2. PERFORMANCE
The Brio 2 is an open system which can be programmed to carry out a wide range of
biological tests. The performance characteristics of the system will vary widely depending
on the parameters set by the user. They MUST be verified in cases where new assays
have been implemented. It is the responsibility of the user to ensure compliance with
the requirements of each individual assay manufacturer.
1.8.3. PROTECTION
The instrument is designed for maximum protection of the user during normal operation.
The sampling arm of the device however, is controlled by the instrument program and may
move suddenly and unexpectedly during a run, having the potential to cause physical
injury. Always keep the protective cover closed when in operation and never reach
into the work area when a run is in progress without first pausing the program or
turning off the system.
1-16
2. INSTALLATION AND PREPARATORY OPERATIONS
2.1. FOREWORD
The following paragraphs explain the procedure to follow for correct installation of the
BRIO 2 Robotic immunoassay operator. This information regards:
– instructions for transportation, storing and unpacking of the instrument;
– procedure and particular requirements for the installation (interfacing with other
instruments, controls etc.);
– testing procedure that verifies if the instrument has been correctly installed and if it is
able to carry out its function.
2.2. TRANSPORTATION, STORAGE AND UNPACKING
There are certain precautions to keep in mind during transportation, storage and
unpacking of the instrument in order to avoid damages also due to storage in an
unsuitable environment.
TRANSPORTATION
The instrument with packaging weights 170 Kg and has130x93x93(h) cm as individual

dimensions
In order to facilitate the transport operation, suitable device for the load and unload the
packaging are required.
The packaging requires to be handled with care observing the warnings reported on the
packaging (high – low)
STORAGE
The instrument must be stored in its original packing composed of wooden crates. The
packing must be stored taking heed of the TOP-BOTTOM signs written on the outside.
When placing cases in the storage room leave necessary space around for easy handling,
removal and inspection.
Should the crates be damaged during transportation or storage the instrument must be
inspected to check that no evident damage has occurred; a new integral packaging must
be provided before storage.
If any damage is found, please contact the Manufacturer.
The type of packaging guarantees reliable protection and insulation as long as the crates
are stores in a suitable environment; the storage room must be dry and free from dust.
2-1
UNPACKING
Due to the weight of the instrument several operators will be required to carry out the
following procedure:
- Carefully remove the packaging from the instrument (keep the packaging in case the
instrument needs to be returned).
- After removing the lid and side strip, remove the 4 anchoring bolts located on the sides
of the instrument.
- Remove the anchoring brackets after unscrewing the 8 anchoring screws on the base
plate.
- Insert the 4 handles supplied in the same holes used for anchoring the instrument.
- Use the aforementioned handles to position the instrument on top of the work surface.
- Remove the handles and make sure to keep them for any future handling operations.
2.2.1. COMPOSITION OF SUPPLIED MATERIAL
Proceed with the unpacking operations. The following accessories are also included inside
the packing:
Q.ty Description
1 Power Supply cable
1 Kit mouse and keyboard
1 Multiple anti-dusturbance socket
1 Triple socket
1 Sampling needle
2 Sera rack
1 C Reagent Rack
1 D Reagent Rack
1 Compressor
1 Waste tank
1 Internal needle washing solution tank (10 liters)
1 External needle washing solution tank (5 liters)
3 Peristaltic pump tube
2 Washing tubes
1 Set of internal washing solution caps
1 Set of external washing solution caps
1 Set of waste tank caps
1 Level adaptor cable
1 L shaped spanner
1 Kit of instrumentation accessories
1 Kit of basic instrumentation (containing TRITON X100)
1 Software CD
1 User’s Manual
2-2
2.3. PREPARATION OF THE INSTALLATION SITE
The operative requirements are very important with regard to the selection of the room
where the installation is to be carried out.
The Robotic immunoassay operator must never in any case be installed in dusty sites or
where there are corrosive fumes.
The overall dimensions of the Robotic immunoassay operator are 44 x 111 x 60 cm
however it is recommended leaving sufficient space all around in order to facilitate
maintenance operations.
Leave at least 10 cm on the back, it allows all the electric connections, the right position for
the tubes (straight) and a good heat dissipation.
2.3.1. CORRECT INSTALLATION OF THE ROBOTIC IMMUNOASSAY OPERATOR
The primary points necessary for installing the instrument are as follows:
- Identification of a person to be in charge of the installation procedures who will get
in touch with the Manufacturer for all clarifications.
- Selection of the environment where the installation is to take place.
- Definition of the best layout of the system in the installation site.
- Purchase of any additional accessories apart from those supplied.
Although the Robotic immunoassay operator has been designed with components capable
of operating in unfavorable operating conditions, a thorough check of the environment is
recommended in order to ensure the most reliable performance.
- High temperatures will accelerate the aging process of the components of the
Robotic immunoassay operator, causing temporary and even permanent
transformation in these components.
- A particular dusty environment may cause an abrasive action on the components

and therefore reduce their life.
- Vibrations may cause wear and tear of the mechanical parts of the system.
- High frequency and high intensity pulses generated in the electric lines or induced
by the surrounding environment may cause errors in the system.
- Do not position the instrument near any heat sources like radiators, hot air tubing, or
places subjected to direct sunlight.
- Avoid rooms subjected to sudden changes in temperature.
- Always allow adequate ventilation in order to avoid internal overheating.
2-3
- Install the instrument on a flat surface, not inflammable; the surface must have at
least the same dimension of the instrument.
- The instrument must be placed on its own feet.
Distribution : 1 phase, neutral and ground
Power Supply : 230VAC

50 - 60 Hz
Power Requirement : 810 VA
A cable with three wires and a plug with 3 contacts is supplied for each instrument for
connection to the power supply and grounding. Connect the instrument to a plug with the
protection earth contact, controlled by a differential switch.
Grounding that does not comply with standards may be a hazard for the users and cause
malfunction of the instrument.
environmental characteristics of the installation room
Temperature : between +15 and + 32 °C (on)

between -0 and + 50 °C (off)
Relative humidity : < 80 %
Altitude : < 2.000 m (on)
2-4
2.4. INSTALLATION OF THE INSTRUMENT
The device comes with a power supply of 230VAC 50Hz-60Hz.
Ensure that the power supply outlet in the room where the device is to be installed
complies with the one specified and that a good earth connection is guaranteed. At the
time of positioning the BRIO 2 make sure that the work surface is completely level and that
it is not close to heat sources or walls that could prevent correct aeration and it’s also
preferable to place the instrument far from other instruments in order to avoid mutual
interactions.
Use the relative L-shaped spanner supplied with the instrument to remove the lower screw
and open the front panel where the PC is positioned. Make the panel to slide up and to
have the panel out of its upper housings: In this way you obtain the panel to be removed.
Connect the keyboard and mouse “V” cable to the appropriate connector and connect the
repeater of the wire less system to this cable having it to pass firstly through the opening
positioned on the back of the instrument. At the same way, when needed, the cable for the
printer and for the LAN connection should be connected having the cables to pass
through the back opening. Re- assemble the front panel by inserting the two hooks in the
appropriate housings by sliding down the panel. Fix the panel with the low screw. Put the
keyboard an the mouse on the same table where the BRIO 2 is positioned
Place all the tanks on the same bench as the BRIO 2 and put the waste tank and the
compressor on the floor.
The external needle washing solution ( 5 liter tank) must be prepared with deionized water
and 25 mL of Triton X200. (VSM3 Basic Kit).
The internal needle washing solution (10 liter tank) must be prepared with deionized water
and 50 mL of Triton X200. (VSM3 Basic Kit)
In some cases and when indicated by specialists of the product, this solution may be of a
different nature.
Connect the tubes and the level sensors of the tanks marked A-B-C-D-E*-F*-1-2 to their
matching connectors in the rear section of the instrument as shown on the nameplate
attached to the rear panel of the BRIO 2 (Fig. 2.1).
Check that the tubes are not squashed or twisted preventing a normal circulation of the
fluids.
Insert the power supply cable of the compressor into the specific socket of the BRIO 2.
Insert the power supply cables of the BRIO 2 and the PC into the anti-spike multiple-
socket (supplied with the instrument) and turn on in sequence the BRIO 2 - Personal
Computer – Drive.
Warning: It is recommended never to position the compressor on the same work bench
as the "system", in order to prevent the vibrations from compromising the
correct functioning of the devices.
2-5
Warning: The 10-liter tank and the buffer tank must be positioned on the same level as
the BRIO 2, in order not to compromise the precision of the dispensations.
Warning: In the case of connecting to an Ethernet line install a suitable insulating

device to protect against any atmospheric discharges.
Es. D-LAN-CAT.5E.
Warning: for any movements carried out at high acceleration the instrument only
works with the front panel closed.
Fig. 2.1 – Tank arrangement
A Washing solution internal needle

B Manifold Washing solution 1
C Waste
D Waste
E Manifold Washing 2 solution
F External needle Washing solution
1 Level sensor needle washing tanks
2 Level sensor drainage tank
2-6
2.5. TESTING TO BE CARRIED OUT WITH THE USER
During testing to be carried out with the user, the technician must:
– Verify the self test procedure execution
– Explain the features of the Analyzer.
– Explain the function of each device.
– Explain the various operating procedures. Make the user repeat these operations so
that he understands their function.
– Make sure the user fully understands the features of the Analyzer and is perfectly
capable of using it correctly. Explain the maintenance procedure.
2.6. DISINSTALLATION
Insert all the tank cups in a distilled water tank; disconnect the level sensor; run at list
three wash and preparatory priming. Empty completely the waste tank using the pump
and, if necessary, manually (use protective mask and gloves).
Disconnect the hydraulic and electric connection on the rear panel (tanks, compressor,
power cable, host connection).
2-7
3. USE
3.1. INTRODUCTION
Throughout all the work phases the interfacing between the operator and the automatic
analyzer for the BRIO 2 microplate takes place by means of dedicated software.
The software works in Windows XP Home SP2 allowing the operator to select the various
operative options, and to manage the work cycles of the device. The selection of options
and setting of data takes place via the use of the mouse and keyboard, as described in
this chapter.
3.2. SOFTWARE STRUCTURE
The dialogue software consists of a series of menus, each of which guide the operator in
carrying out all the various activities. All the menus are listed on the main menu page (Fig.
3.1), to which the operator can gain access at any time by pressing the Main button.
Fig. 3.1 – Main menu
3-1
By clicking with the mouse on one of the options, the operator can access the selected
submenu. To pass from one submenu to another, return to this page and then select the
desired option; the only exception is the menu Results, which can be accessed directly
from the other submenus.
The options available are as follows:
− Work plan:
this allows for setting up the work list with the patients’ data, tests to be conducted
and the carrying out of the work plan;
− Methods:
this allows for managing the files containing the descriptions of the methods;
− Results:
this allows for visualizing the results of the analyses carried out;
− Quality Control:
this allows for accessing the quality control database;
− Historic :
this allows for accessing the test database of tests and patients;
− Service:
this allows for manually carrying out several procedures and checking the conditions
of the various systems during the maintenance phases;
− Setup:
this allows access to specific utility functions, setting the time and date and Editing
the instrument.
3.2.1. PASSWORD
A password can be set during the configuration phase of the software to allow access to
certain functions/areas only to qualified personnel. The procedure for setting the password
is described in detail in the Setup paragraph.
3-2
3.3. START UP
In order to access the software functions, launch the Brio 2 Win application contained on
the desktop of Windows XP, as the methods requested by the operating system.
On starting up the window in Fig. 3.2 will appear.
Fig. 3.2 – Initialization of the program
Following, if the Off-line button is pressed within 5 seconds, the program will start up in
this mode and therefore none of the functions requesting the use of the Robotic
immunoassay operator will be available.
If the contrary, the initialization phase of the instrument will be enabled with the displaying
of the window in Fig. 3.3.
Fig. 3.3 – Initialization of the instrument
In the event of the instrument accidentally being left with the cover open, the window in
Fig. 3.4 will be displayed.
Fig. 3.4 –Instrument fails to respond
3-3
By pressing Yes the off-line mode will be activated, by pressing No the request for
initialization of the Robotic immunoassay operator will be repeated which will have been
turned on in the meantime.
Note: In order to access the Robotic immunoassay operator turn the general switch to
the ON (I) position;
When the initialization process is over the window in Fig. 3.6 will be visualized.
If the worklist is stopped (by user or in case of black out ) appear Fig. 3.5.
Fig. 3.5 – Worklist restore
By pressing Yes the interrupted worklist is restored, by pressing No it is definitively

stopped and a new worklist can be started.
3.4. WORK SEQUENCE
This paragraph describes the operating procedures necessary for using the instrument
and the relative software pages, in the logical sense in which they must be used.
This is the working sequence that must be followed in order to use the program correctly:
− Create a file of the methods if one does not already exist.

− Check that the structure of the reagent and serum layout corresponds to the one
actually installed on the instrument (first phase of the work plan).
− Create a work list and confirm this (second phase of the work plan).
− View and prepare the serum holder tray and the reagent holder tray.
− Load the micro-plates.
− Activate the Start control to carry out the analyses.
− At the end of the operation the instrument reads the microplates in the inside
photometric reader.
− Check and print the results and, if necessary, file these.
All the procedures are carried out by the operator using the interface software, as
described in the following paragraphs.
3-4
3.5. WORK PLAN
This is the operative menu via which the operator sets the necessary working parameters
for carrying out the tests. This menu can be selected from the main menu page, by
selecting the Work Plan option. The instrument automatically sets on this page when it is
switched on (Fig. 3.6).
Fig. 3.6 – Work plan, initial conditions
This menu can be accessed at any moment by the operator, even while the instrument is
working, without altering its function. The software displays a mimic table showing in real
time the situation of the instrument; in this case it displays the starting conditions (initial
conditions).
In particular, the work plan layout is visualized in its initial status, with two empty sample
trays, two vial trays in a pre-defined configuration (when the instrument is switched on it
keeps the most recent configuration in its memory) and the empty plate holder.
This page has three fields with active buttons. The first field consists of three buttons for
the physical preparation of the work plan: Select Layout, Select Sample and Plates.
These buttons are described below.
The second field contains two buttons: the Reset button (by pushing this button all the
settings are reset and the software sets the initial page of the work plan), and the button
that activates the different phases, according to the status of the instrument (initial status,
standby condition, etc.).
3-5
The third field contains the following buttons:
− Work List:
in the initial condition, a complete work list can be created; with the device working it
allows for visualizing the work list in order to read it or complete it with the patients’
personal data;
− Results:
This allows access to the menu that shows the results of the processing;
− Errors:
This allows for viewing the list of possible anomalies that could have occurred during
the operation.
In the event of an error being detected during the carrying out of the work plan, a red
blinking frame will appear on this button. If the error is visualized via the pressing of
the button itself, the frame will turn yellow until another error occurs which makes it
change back to red again.
− Main:
This displays the main menu (Fig. 3.1).
The procedure for setting the parameters can be subdivided into two parts: a first part, for
the physical Editing of the work plan, with the selection of the serum and reagents layout
which must be carried out before the tests; and a second part, for the creation of work lists
with the tests and the anagraphical data of the patients to be tested. To program the
physical parameters of the work plan (reagent and serum plates), use the options which
correspond to each parameter, as described below.
3-6
SELECTION OF LAYOUT
With this option the operator can modify the layout of the vials containing the
reagents used to carry out the tests (Fig. 3.7):
Fig. 3.7 – Selection of layout
The operator can choose one of the already defined layouts by double clicking on the
pertinent name on the Available list and then clicking on OK to return to the previous
page; the operator can also set the automatic layout by clicking on the relative key, or
create a New Layout, that allows for displaying the window in Fig. 3.8.
The basic layout base may be modified beforehand on which to build the preset one. By
pressing the button Load a window will appear from which it is possible to select the
desired layout. By pressing the button Set the same will be set as the basic layout.
3-7
Fig. 3.8 - New layout
From the Fig. 3.8 it is possible to choose the vials to be allocated to the trays according to
the test to be performed, by double clicking directly on the name of the text in the central
window. It is also possible to allocate one vial at a time by double clicking on the name of
the reagent in the right hand window.
The names of the vials already located appear in the left window, while the position of
each vial is viewed on the mimic table of the plates It is also possible to change the
position of the vials on the trays, by clicking directly on the mimic table and then moving
them to the desired position. Once the configuration is complete it can be saved (Save
as). In this case the saved file will appear in the available pre-defined layout window.
Following the same procedure, it is possible to open (Open) a file already saved in order
to use it or modify it and then save it in its new configuration (Save).
By pressing the New button each time it is possible to create a new layout, while by
pressing Print it is possible to print the configuration created. Once the setting has been
carried out, press Exit to return to the previous page.
From here, by pressing OK you return to the page of the work plan that appears with the
configuration of the trays set.
N.B. The selection of a predefined layout of the vials can only be carried out in this
phase, before beginning the setting of the work to be carried out, that is, before
loading a work list.
3-8
SELECTION OF SAMPLES
By choosing this option, the following page will be displayed (Fig. 3.9).
Fig. 3.9 – Selection of samples
This option allows for setting the type of serum tray be used by loading the
configuration of one of the trays (Load button) and pressing the button Set Current
layout.
By pressing OK you return to the work plan and the settings made are maintained.
After setting the trays, or checking the settings present, the operator must choose New
Work List or Work List in order to create the lists of patients and test to be processed
(see paragraph 3.5.1).
After creating and confirming the Work List, the software processes the data contained on
the list and then, if correctly configured, it asks for the setting of the data relating to the
control serums described in paragraph 3.5.2. Once this data has been entered, the
software, if correctly configured, asks for the compiling of the data relating to the lots and
calibrations described in paragraph 3.5.3.
Once the internal checks are finished, the page illustrated below (Fig. 3.10) is displayed,
with the updated work plan situation (pre-processing status):):
3-9
Fig. 3.10 – Work plan, pre-processing status
The serum containers, tubes for dilution, and the vials of products to be used in the tests
are already displayed on the trays. By pressing the buttons located under the relative trays
or double clicking on the image of the same, access is gained to the pages that show all
details of the compositions for displaying the same, but it is not possible to make any direct
modifications (to modify press Reset to restore the initial status).
The only active options are those which allow for printing and/or saving the current
configuration file.
The same applies for the plates: with a double click (equivalent to Plate button) the
operator opens the window in Fig. 3.11, showing the details of the single wells.
Both in this window and in the mimic table of the work plan, by clicking with the right button
on a plate, the layout of the same can be displayed with details of the single strips that
indicate the tests foreseen for each one.
PLATES
This allows for checking the configuration of the plates (Fig. 3.11).
3-10
Fig. 3.11 – Plates configuration
By double clicking on a single plate, the situation of the same will be displayed in
detail (Fig. 3.12):
Fig. 3.12 – Plate status

By pressing Exit you return to the work plan page (Fig. 3.6).
3-11
The module for displaying the plates also supplies information regarding the plate
status during the entire life cycle of a work plan: the preparation phase to which the
plate has been subjected, the temperature, incubation times and tests of the strips.
The data pertaining to every individual well of the plates is also indicated.
The Work List button remains active on this page which allows for accessing the list in
order to add any missing personal data of the patients.
By pressing the Compile Work List button the device compiles all the final settings and
the software prepares the work phase. When the compiling is complete, the work plan
page is displayed again, with the addition of the TMS graph (Fig. 3.13), in which all the
temporal sequences foreseen the entire cycle and the duration of the test are shown. The
Compile Work List button becomes Start.
Fig. 3.13 - Work plan, ready to run status
By double clicking on the TMS area a page showing a close-up of the TMS graph appears
(Fig. 3.14). By clicking on the different areas of the graphic a window appears showing in
detail the data of the selected phase.
Fig. 3.14 - TMS
3-12
From this moment on, by pressing the Reset button, the software carries out the resetting
of the scheduling. Press Start and the device asks for confirmation to start the work plan,
after which it will start in automatic, processing the scheduled test. The new layout will be
displayed on the monitor (running status) on which the buttons Stop and Pause will
appear (Fig. 3.15).
Fig. 3.15 – Work plan, running status
By pressing Pause the device interrupts the operation in order to allow for the cover to
open; by pressing Continue the device starts up again with the working cycle. By pressing
Stop the device comes to a halt, appears Fig. 3.16.
3-13
Fig. 3.16 – Interrupted wolrklist
By pressing RESET and then Yes in Fig. 3.5 the worklist can be restored; by pressing No
it is definitively stopped.
WARNING In this case all the work is lost; the operator must unload the plates and
all the serums arranged on the trays in order to be able to start a new
scheduling.
When the work plan is finished, the device displays (Fig. 3.17) the layout relating to the
current status (work plan carried out):
3-14
Fig. 3.17 - Work plan carried out
Press the Work List Results in order to switch over to the results menu where the results
of the compiling carried out will be displayed (see paragraph 3.7).
By pressing Reset the device automatically carries out the resetting of the various settings
and prepares for a new work cycle; the initial status will be displayed on the terminal (Fig.
3.6).
N.B. During this phase of the work plan it will only be possible to display the results. If
Reset has not been pressed the results will automatically be displayed when the
Work List Results button is pressed (current session).
3-15
3.5.1. SETTING THE WORK LIST
By selecting the New Work List option on the work plan page (Fig. 3.6); the software
loads the methods and displays the following page (Fig. 3.18):
Fig. 3.18 – Work list
This menu allows the operator to insert patients’ lists with the corresponding tests to be
processed. By using the active options the operator can create a complete new list, or
open one already filled out and saved in the file. The operator can also access this page
during the working phase in order to complete the list with the patient’s’ personal data,
without interrupting its function.
The page is subdivided into four areas, on the inside of which are the following active
buttons:
− List:
This displays the name of the file corresponding to the active list and contains the
following buttons: New, for creating a new list, Open for recalling a list already filled
out and memorized, Delete for eliminating a list from the files.
Besides setting a list already existing in the file (Open), data can be obtained from a
list memorized on a central computer, a computer in a net system or with a serial
connection, by selecting the Host option. For the creation of a new list, one of the
procedures described in the following subparagraphs can be used.
− Data List:
This contains the buttons for setting the list of the patients and the processing;
3-16
− Execution:
This contains the buttons for confirming of the list created and for choosing the
execution procedures:
− Complete:
The instrument carries out all the analytical procedures;
− Read only:
The instrument carries out the photometric reading of the microplates and
processes the results;
− Carry out Predilutions:

The instrument carries out the predilutions (this is active only if predilutions have
been set).
− Print:
The instrument prints the list.
Once the list has been completed, press Start to enable the setting of possible calibrations
and complete the setting out of the work list. The software checks the list and informs the
operator if there are any anomalies, necessary data missing, etc. At the end, the work plan
page is displayed in the pre-processing status (Fig. 3.10).
3.5.1.1 PATIENT DATA
Press the Patient Data button to access the menu for entering the patient data for each
sample placed on the trays (Fig. 3.19):
Fig. 3.19 – Patient data
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Two fields displaying the position of the single samples and the type of tube (diameter) are
present in the top right hand corner. The samples can be displayed individually using the
Previous and Next buttons, or it is possible to display the first and last sample directly
with the First and Last buttons.
The operator can enter the anagraphical data requested for each sample, and choose the
test to be carried out by clicking on the tests in the list.
N.B. In this phase the only data necessary is the ID identification code; all the other
data can be entered later on, while the instrument is running.
The List button allows the operator to enter a window where a work list summary appears
(Fig. 3.20). This list indicates the position, identification code and name of the patient for
each sample.
Fig. 3.20 – Summary of work list
Press OK to return to the previous page.
The other active buttons in the patients’ anagraphical data page are as follows:
− Summary:
This allows for displaying the summary page described in paragraph 3.5.1.1;
− Progressive IDs:
This allows for accessing the following page (Fig. 3.21):
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Fig. 3.21 – Progressive IDs
A series of samples and a series of tests can be set using this menu. These are the
same for all the samples which are entered onto the list with progressive IDs. The ID
for each patient is automatically allocated.
Press OK to return to the patients’ data page. The fields for setting the ID
characteristics are located on the left hand side of the page:
− How Many: the number of patients that must be entered onto the work list. The
maximum number depends on the serum-holder layout used and on the
configuration of the plate.
− From position: number of the first position for inserting the patients.
− First ID: indicates the number that will be assigned to the first ID created.
− Step: indicates the increase between the IDs inserted. The default value (1)
causes the creation of consecutive IDs (1, 2, 3…).
− Prefix: (optional) appears at the beginning of each ID created (e.g.: laboratory

initials).
− Postfix: (optional) appears at the beginning of each ID created.
The IDs created in this manner have the following syntax: <Prefix><Number><Postfix>.
Example: First ID=100, Increase=20, Prefix = A, Postfix = B

The IDs created will be: A100B, A120B, A140B, A160B.
3-19
− Associate:
displays the following page (Fig. 3.22):
Fig. 3.22 – Associate function
Each test can be associated to a series of patients, and their positions are within the
limits set on the right (Patient). Press OK to return to the patients’ anagraphical data.
If the option All is selected, the tests are associated with all the patients in the list.
− Suspend:
This allows for suspending the settings made and a page will appear asking for
confirmation to interrupt the test or the patient (Fig. 3.23):
Fig. 3.23 – Suspend tests/patient
Once the selection is made, a page appears (Fig. 3.24) which allows for selecting the
patients/tests to be suspended.
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Fig. 3.24 - Interrupt tests/patients
All the tests/patients interrupted are memorized in a Suspended List that can be
recalled at any time (paragraph 3.5.1.4). Press OK to confirm the suspension and
return to the anagraphical data of the patient; press Cancel to cancel the
suspension.
− Delete:
By pressing this button it is possible to delete the data set on the patients’ page: the
software will ask for confirmation of this control before deleting.
If there is an allergology test among the selected tests, the Allergology button will be
activated automatically on the patients’ anagraphical data page (Fig. 3.19).
When this button is pressed, the computer asks to save the settings and visualizes the
allergology test page (Fig. 3.25):
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Fig. 3.25 - Allergology tests
In this page the single allergens can be selected. It is possible to visualize the test in the
central window divided into Families/Allergens/Panels.
The active options organized in this page are the same as those in the patients’
anagraphical data page (Associate, Summary, Suspend, Previous, Next, First and
Last). Press Exit to maintain the settings and return to the page of Fig. 3.19.
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3.5.1.2 SUMMARY
It is possible to access the summary page (Fig. 3.26) from the work list page and the
patients’ data page:
Fig. 3.26 – Summary of lists
This page allows the operator to visualize the patients’ list created with the relative tests
carried out on each patient. It is also possible to enter new patients, with the tests to be
processed, or to modify the tests already activated for a patient. In particular, the operator
can enter the main data of each patient (ID, name, surname), by clicking directly on the
relative fields.
In order to activate new tests or disable those already activated, it is sufficient to click on
the window of the relative text (red window: test activated; white window: test not
activated).
With the Previous and Next buttons all the possible texts can be scrolled.
The following buttons are located in the top part of the page:
− Data (for visualizing the patient’s anagraphical data page);
− Progressive IDs;
− Associate;
− Suspend;
− Allergology.
The function of the buttons is identical to the one described for the patient’s anagraphical
data (paragraph 3.5.1.1). Press OK to visualize the work list page and confirm the data.
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3.5.1.3 PREDILUTIONS
From the work list page, select the option Predilutions, to display the corresponding page
(Fig. 3.27):
Fig. 3.27 - Predilutions
From this page the tests can be selected one by one, by clicking on top the following
pages can be displayed (Fig. 3.28) which indicates the patients for whom the selected test
is scheduled:
Fig. 3.28 - Selection of tests to be pre-diluted
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This page displays the predilution ratios set for the selected test (up to a maximum of
eight). The red boxes indicate that the predilution set on the column is active for the
corresponding patient. Select the boxes to activate or disable the corresponding
predilutions, according to what was set in the programming phase of the same (par.
3.6.1.1). Double click on box containing the ratio alternatively activates or disables a
predilution for all the patients.
After carrying out the modification procedures, press OK to confirm or Cancel to close the
window without memorizing the modifications; the software will show the work list page.
3.5.1.4 SUSPENDED
From the work list page, select the Suspended option, to visualize the list (Fig. 3.29) of
patients suspended during the processing of the work list:
Fig. 3.29 – List of suspended patients
The operator can select the different patients by clicking on the description line and then
choosing the following options:
− Delete:
the patient and the corresponding data are eliminated permanently;
− Insert:
the patient and the corresponding data (including the tests that is to be elaborated)
are entered on the current work list.
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3.5.2. CONTROL SERUMS
Whenever the operator starts the processing of the work list which has just been set and in
which the tests have been selected foreseeing the use of control serums (activated during
the method setting phase), the device will display a page allowing the operator to manage
the serums (Fig. 3.30):
Fig. 3.30 – Control serums
The window shows the data of the tests for which a control serum is required and allows
the operator to confirm the activation of the control (Active) or to disable this option, in
order to carry out the test without the control serum. If the serum is activated, the operator
must complete all the other fields. The Concentration (or Index for qualitative test)
values, represent the required range of results for the control serums (Min, Typical, Max).
If one of the tests requiring control serums is an allergology test, the active Set button
appears in the Concentration column, on the line corresponding to the test. Once the
option is selected, a page appears (Fig. 3.31), asking for the data relative to the
concentration of each allergen associated to the control serum.
Fig. 3.31 - Allergology control serums
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The final details of the control serums will be visible once the results have been
processed.
3.5.3. SETTING THE CALIBRATIONS
If curve memorization management is activated (Setup menu), after pressing the Start
button on the work list, the page (Fig. 3.32) that allows for setting the calibration method to
be used in the current session will appear. Six possible tests for the current working
session are listed on this page.
Fig. 3.32 - Calibrations
The operator must enter or update the following data regarding the kit to be used for the
same:
− Version: the version of the test kit. This information is optional and it is often found on
the package of the kit used.
− Lot: the kit manufacturing lot, shown on the package.
− Expiry: the expiry date of the lot, shown on the package.
Depending on the data entered, the text appears in different colors in order to visually
inform the operator of the correctness and/or completeness of the data. The colors
appearing in the text in relation to the different anomalies are as follows:
− Red : the kit has expired or the date format is incorrect
− Blue : information is missing regarding the versions and/or the lot used;
− Black : all the data is present and correct.
3-27
For quantitative and allergology tests it is possible to select the type of calibration to be
used for each test in the current working session. Total calibration is compulsory the first
time a certain lot is used; subsequently when a specific lot is used, each of the following
options (Total, Partial, None) can be selected. The operator is informed of the status of
the calibrations carried out for a certain test by the following fields:
− Total date:
This is the date of the last calibration carried out. if the field is empty no total
calibration has ever been carried out for the test with the lot currently set.
− K Factor:
the K factor is the factor between the total and partial calibration defined as follows:
• TODi = optical density of total calibration for the nth standard;
• PODi = optical density of partial calibration for the nth standard;
• Ki = PODi / TODi
• K = (K1+K2+….+Kn)/n.
− Partial date:
the date of the most recent partial calibration carried out. If the field is empty, it
means that no partial calibration has ever been carried out for the test with the
current lot.
To choose the type of calibration for a certain test, the operator must select one of the
three options present in the central column of the window:
− Total:
a total calibration will be carried out on the corresponding test in the current working
session.
− Partial:
a partial calibration will be carried out on the corresponding test in the current
working session using the standards selected in the method of the same test (see
par 3.6.1.1). This section is not permitted, if total calibration has never been carried
out on this test.
− None:
no calibration will be carried out on the corresponding test in the current working
session. This section is not permitted, if total calibration has never been carried out
on this test.
WARNING The software checks the different variations carried out on the Lot field.
When the lot is changed, the system automatically sets total calibration.
If that lot has been modified, a message appears when the operator
exits the window warning that the system has set a total calibration.
3-28
The buttons to confirm (OK) or cancel (Cancel) the modifications carried out and the
Curve button that allow for visualizing any possible memorized curve for the test selected
are located in the lower part of the page.
3.6. METHODS
In order to carry out a test, this procedure must be present inside the method file, so that
when a work list is created, the software can access the file to find the relative method
used for each different test.
In order to manage the methods, the operator must access it directly from the main menu
(Main), selecting the option Methods.
N.B. If the menu is password-protected, the software will show a window asking the
operator to type the password and confirm (OK), to access the menu.
The following page is displayed on the monitor (Fig. 3.33):
Fig. 3.33 - Methods
This page shows the list of methods (tests) already present in the file, indicating their
position, full name, mnemonic (abbreviated initials), type (if quantitative, qualitative, avidity
or allergologic) and the frozen condition (Frozen).
3-29
The page indicates the name of the file in which the memorized data is found as well as
the hardware layout of the instrument. The page also places a series of active buttons at
the operator’s disposal; the active buttons represent the different working options for the
management of the method file.
N.B. The operator may also access the methods while the instrument is running,
modifying or editing new methods, seeing that modifications carried out will not
affect the current processing.
Described below are the procedures for using the different method management options.
3.6.1. EDITING
Use this option to edit a new method or modify the data of an existing method. The
operator must select one of the positions in the list shown in the Editing Methods page
(Fig. 3.33) and press the Editing button to access the editing window (Fig. 3.34). The
operator can access the same window by double clicking on the position/method to
add/modify.
Fig. 3.34 - Editing Methods
WARNING The procedure for editing a new method and then filing it in afterwards
is carried out by the software in the current file (indicated in the page of
Fig. 3.33); therefore, before carrying out any modification, the operator
must verify whether the file is correct. If it is not, the operator must find
the right file with the Archive option (paragraph 3.6.2).
This page allows for setting the characteristic data of the method and accessing the
submenus of the spatial and temporal parameters, for complete editing of the methods.
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WARNING The data relative to the Name, Mnemonic and Kind fields, are
mandatory; there cannot be two methods with the same name and/or
mnemonic.
Besides the main data (which also appear in the list of Fig. 3.33), the operator can set:
− Host Code: name or code of the same method filed on the central system (if present);
− Test Stand Alone: if selected, it always obliges the instrument to carry out this test
autonomously;
− Type of support: this indicates the type of physical support (strip) of the wells for the
tests;
− Import: this is an option for recalling a complete method, already memorized in another
file, in the selected position.
N.B. Import button will only be activated if the selected position is empty.
Once the three mandatory parameters are set, two buttons are activated on the page:
Spatial Parameters and Temporal Parameters. Their function is described below.
3.6.1.1 SPATIAL PARAMETERS
By pressing the Spatial Parameters button from the previous page, access is gained to
the menu that allows for setting the various parameters of a spatial type. According to the
type of method selected (quantitative, qualitative, avidity and allergologic), a different page
will appear.
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Quantitative method
Shown below is the Spatial Parameters page (Fig. 3.35):
Fig. 3.35 - Spatial parameters for quantitative method
The parameters to be inserted are subdivided into fields:
− Blank:
the operator must set the number of wells reserved for the Blank (Replicate) and
indicate whether they must be placed at the beginning and/or end of the sample
sequence.
− SMP:
the operator must insert the number of times that the samples are to be repeated
(Replicated); the volume of the samples (Volume) expressed in µL (acceptability
range 7- 300µL) and the volume of the washing solution (Vol. Wash) expressed in µL
(acceptability range 0-9500µL).
N.B. The needle is washed after every distribution of the sample.
By pressing the Criteria button it is possible to set the criteria for assessing the
results (Fig. 3.36):
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Fig. 3.36 - Criteria for samples and blanks
− Standard:
the operator must insert a number (from 1 to 10) of standard samples, which are
used for the creation of the calibration curve (How Many) and whether these
samples are to be inserted at the beginning or at the end of the plates, or on all the
plates used (Each Plate); the volume of the standard samples (Volume) is
expressed in µL (acceptability range 7-300 µL).
WARNING The standards must be entered in increasing order of concentration.

The first and last standards must not be used as partial calibrators: only
the central standards may be used as calibrators.
By pressing the Edit button relating to the standard field, the page (Fig. 3.37) will be
displayed that allows for a complete editing of all the standards entered:
Fig. 3.37 – Editing standards
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- Test Samples :
if the method requires test samples, the operator must enter the number of samples
(from 0 to 5) and whether they are to be entered at the beginning or at the end of the
plates and how many samples are to be repeated.
The number of samples to be repeated must also be entered, together with the
minimum number of valid repeats, the volume of the same in µl (acceptability range
7-300 µl) and the washing volume. By pressing the relative Editing button it is
possible to display a page (Fig. 3.38) that allows for a complete programming of the
control samples:
Fig. 3.38 - Editing control samples
− Predilutions:
the different dilutions can be edited by pressing the relative Editing button (Fig.
3.39):
Fig. 3.39 – Editing dilutions
3-34
In this page the operator can set the different diluent to be used and the dilutions to be
carried out. Selecting the Single option you oblige the software to perform only one of the
programmed dilutions (the first one among the programmed or the one defined as Main, if
nothing different is set in the predilutions selection dialog (par. 3.5.1.3). It is also possible
to codify the different dilutions according to the characteristics of the sample, with the
Modify button (Fig. 3.40), or delete any dilution already codified using the Cancel button.
Selecting the Main option you set the predilution as main.
Fig. 3.40 - Codification of dilution ratios
− Refertation data: By pressing this button the operator can visualize a page (Fig. 3. 41)
that allows for setting the reference values to be associated with each individual
method, and to be repeated on the reports:
Fig. 3. 41 - Refertation data
3-35
On this page it is possible to choose the unit of measurement, there are also two
buttons: Delete Association, to cancel an association already made, and Add
Association, to display a page (Fig. 3.42) that allows for setting the editing
characteristics of the different associations:
Fig. 3.42 - Editing associations
Once the editing is over, press the Cancel button to cancel any possible modifications or
OK to confirm them and return to the page of Fig. 3.34.
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Qualitative method
The following is the spatial parameters page (Fig. 3.43):
Fig. 3.43 - Spatial parameters for qualitative method

This page is identical to the one for the quantitative method, the only exception is that in
place of the Standard field there is a Control field. The operator can set the parameters
Begin, End and Each Plate which define the positions in which the controls must be
distributed in relation to the plate; the parameter Each Plate indicates that the controls
must be repeated after a number of samples equal to that one preset. With the Editing
button it is possible to visualize a page (Fig. 3.44) that allows for editing the controls:
Fig. 3.44 – Editing controls
3-37
The data can be set pertaining to the type of control, the number of repetitions, the name,
the type of vial, the volume and the validity criteria.
Avidity Method
The following is the spatial parameters page (Fig. 3. 45):
Fig. 3. 45 - Spatial parameters for avidity method
This page is identical to the one for the qualitative method, the only exception is that in
place of the Control field there is a Controls Avidity field. The settable parameters are
the same, Begin, End and Each Plate. Press the Editing button to visualize the following
page (Fig. 3. 46):
Fig. 3. 46 – Editing avidity controls
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The operator can edit all the parameters relating to the avidity controls (number of
replicates, name, vial, volume, and validity criteria).
Allergologic method
The page of the spatial parameters is illustrated in Fig. 3.47 and is identical to the one for
the quantitative method:
Fig. 3.47 - Spatial parameters for allergologic method
3.6.1.2 TEMPORAL PARAMETERS
Select the Temporal Parameters button to gain access to the page for setting the
temporal sequence of the working phase and the corresponding characteristics. According
to the type of method selected (quantitative, qualitative, avidity and allergologic), a
different page will appear.
3-39
Quantitative method
The following is the page of the temporal method (Fig. 3.48):
Fig. 3.48 - Temporal parameters for quantitative method
In the central window the operator can create the sequence of the working phases that the
instrument must carry out in temporal order. In order to modify the sequence (adding or
removing phases), the operator may use the buttons located on the page, by following the
procedures indicated below :
− Adding a phase:
The operator must select from the list the phase with the next number to be assigned
to the new phase; then press the button corresponding to the phase to be entered.
The monitor will visualize one window for each phase, in which the characteristic
parameters of the phase itself can be entered (described further on). The phase
added will assume the order number of the existing phase, while this existing phase
and all the following ones will be shifted on a position.
− Removing a phase:
The operator must select the phase to be removed and then press the Delete button;
the software asks for confirmation, then removes the phase, scaling all the following
phases down one position.
− Copying a phase and using it to replace another already set:

select a phase to copy from the list and press the Copy button; on the monitor the
following page is displayed (Fig. 3.49):
3-40
Fig. 3.49 - Copy temporal phase
On the new window select the phase after which the copied one has to be entered
and press OK. The software asks for confirmation, then copies the selected phase.
− Modifying a phase:
select the phase on the list and press the Modify button (or double click directly on
the phase); the page for the selected phase, described further on, is visualized on the
monitor. Modify the desired data on the page and the press OK to confirm the
modification.
− Freezing a working phase:

select the phase to be frozen and press Modify. On the top of each page there is the
option Suspend. By setting this option the phase remains in the programmed list, but
is not carried out (the letter F appears in the list).
− Unfreezing a phase:
select the phase on the list with the symbol F and then deselect the option Suspend
or restore the processing of all phases with the No Freeze button.
The pages relative to the different phases for setting the parameters of the operation are
described below:
3-41
− Standard dispensation:
This allows for editing the standard dispensation phase (Fig. 3.50):
Fig. 3.50 – Editing the standard dispensation
It is possible to edit the type of dispensation and it is also possible to suspend this
phase. By activating the Suspend option the phase will be entered onto the list but
remains frozen (which means it is not carried out during the work plan).
N.B. The Suspend option is common to all the phases, therefore it will not be
repeated.
N.B. This phase can only be edited (active button) for the quantitative and allergologic
methods.
− Control dispensation:
This phase is deactivated for this type of method.
− Serum dispensation:
This allows for editing the sample dispensation phase (Fig. 3.51):
Fig. 3.51 – Editing the sample dispensation
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It is possible to set the type of dispensation and the volume of the priming or
washing.
− Reagent Dispensation:
This allows for editing the reagent dispensation phase (Fig. 3.52):
Fig. 3.52 – Editing the reagent dispensation
The operator must enter the name of the reagent to be dispensed, the type of vial to
be used and the volume of the reagent.
The type of dispensation must also be set, if the reagent is to be distributed on

blanks, samples, control samples, standards, as well as the priming volume and the
warning time. The latter is a period of time (in minutes) that must be programmed if
the operator wants to set an acoustic alarm for the preparation of the reagent. The
alarm will ring for the set time (the set time is calculated on the basis of the preceding
incubation phase).
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− Reagent dispensation + ….. :

This allows for editing the reagent dispensing phase combined with the dispensing of
another type as set (Fig. 3.53):
Fig. 3.53 – Editing the combined dispensation phase
The operator must set the data relating to the reagent as for the Reagent
Dispensation phase, the dispensation time and the priming/washing volume.
Moreover, the typology (BLK, STD, SMP) to be combined with the dispensation of
the reagent must also be set.
3-44
− Incubation:
This allows for setting the incubation phase (Fig. 3.54):
Fig. 3.54 – Editing the incubation phase
The operator must enter the total incubation time and the moment the counting
starts, activate/disable the thermo-station during incubation, the temperature
(centigrade) at which the plate must be kept in incubation and the temporal
parameters concerning the duration, the delay and the stirring speed (if activated).
− Washing:
This allows for editing the washing phase (Fig. 3.55):
Fig. 3.55 – Editing the washing page
The operator must set the number of washing cycles to be carried out, the type of
wash, the type of solution and the volume of the wash.
3-45
The type of wash can be selected from: Strip, Plate with delay, Plate without
delay, Pre-aspiration Plate, Extra Plate, Plate without final aspiration and
Overflow:
Strip
Each individual strip is washed and dried before moving onto the next one. For
example, by setting the number of washes = 5 it means that the same strip will be
washed five times before passing on to the next one .
Plate with delay

Each wash is carried out on all the strips of the plate. after each washing phase the
manifold stops for a period equal to the amount of time required to wash the entire
plate (that is, 12 strips).
Plate without delay

As the previous one but without the delay.
Plate pre-aspiration
As above but preceded by a preliminary aspiration phase on every strip to be
washed.
Extra plate
As with Plate without delay but with an additional dispensation of the washing
solution with the manifold in the lowered position.
Strip without final aspiration

As with Strip but without the final aspiration of the washed strips.
Overflow
Each washing cycle is carried out with the positioning of the aspiration needle inside
the well at a preset depth. The dispensation is carried out in this position at the same
time as the aspiration of the washing solution.
− Reading:
This allows for setting the final reading phase (Fig. 3. 56):
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Fig. 3. 56 – Setting the final reading phase
The operator must set the wavelength of the filters for the reading and fitting
characters for reading the results.
Qualitative method
The following is the page of the temporal method (Fig. 3. 57):
Fig. 3. 57 – Temporal parameters for qualitative method
3-47
This option is identical to the one relating to the quantitative method. The rest of the
operations present on the page and the possible working phases are also identical, except
for the final reading phase which has different options.
N.B. With this type of method the Standard Dispensation will be disabled.
− Control Dispensation:
This allows for editing the control sample dispensation (Fig. 3. 58):
Fig. 3. 58 – Editing the control dispensation phase
The operator must set the type of dispensation.
− Reading:
This allows for setting the reading phase (Fig. 3. 59):
Fig. 3. 59 – Editing the final reading phase
3-48
As well as setting the filters to be used, the operator must also set a series of
parameters during this phase that relate to the alarm criteria and the ranges within
which the results must not be taken into consideration (CutOff and Grey Zone).
Selecting the K Factor options, the software will ask you the factor for the CutOff
calculated as par the selected formula By pressing the Criteria button access is
gained to the page (Fig. 3. 60) where is it possible to set the alarm criteria:
Fig. 3. 60 – Alarm criteria
Once the different criteria have been set and confirmed, the operator can eliminate
one or more from the list, by selecting them and then pressing the Cancel button. By
pressing the Cut-Off Formula button it is possible to access the page (Fig. 3. 61) for
setting the cut-off formula:
Fig. 3. 61 - Cut-off formula
3-49
Avidity Method
The following is the page of the temporal method (Fig. 3. 62):
Fig. 3. 62 – Temporal parameters for avidity method
The possible options and the active working phases are identical to those indicated for the
qualitative method. Likewise for the parameters of the single phases, they all remain the
same except for the final reading phase.
− Reading:
This allows for setting the final reading phase (Fig. 3. 63):
3-50
Fig. 3. 63 – Editing the avidity reading phase
Besides setting the filters to be used, the operator must also set the percentage
reference values from which the software starts considering the results as Low
Avidity or High Avidity results.
Allergologic Method
The following is the page of the temporal method (Fig. 3. 64)
Fig. 3. 64 - Temporal parameters for allergologic method
3-51
All the possible options and the different working phase parameters are identical to those
for the quantitative method.
3.6.2. ARCHIVE
From the main page of the methods, by selecting the Archive option it is possible to
visualize the following page(Fig. 3. 65):
Fig. 3. 65 – Method archive
This option allows for recalling methods already preset and filed, or to enter a new name in
order to created a new method archive.
3.6.3. UTILITY
From the main page of the methods, select the Utility option in order to visualize the
following page (Fig. 3.66):
Fig. 3.66 - Utility
3-52
On this page there are options the operator can use for either printing or modifying the
method list.
− Print Method:
This allows for printing the methods (Fig. 3.67):
Fig. 3.67 – Print method
The operator can choose whether to print the complete list (Print all), or select one
or more methods to be printed (Print).
− Delete methods:
This allows for deleting one or more methods from the list; a page appears which is
identical to the previous one and the active buttons are: Delete All, to cancel all the
list; Delete, to cancel the method selected; Delete File, to cancel the entire file. For
each operation, the software asks the operator to confirm the request.
− Copy method:
This allows for copying a method in an empty position of the list. The operator must
select the method to be copied, press the Copy button and then select an empty
position on the list to copy the method into.
− Swap over of method positions:

This allows for swapping the position of two methods on the list. The operator must
select the two methods and then press the Invert button.
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3.6.4. GROUPS
From the main page of the methods, select the option Groups, for visualizing the following
page (Fig. 3. 68):
Fig. 3. 68 – Method groups
The page allows for an already set groups, or a group of methods to be created for
application to the patients.
N.B. These groups can be recalled from the Patient Data page during the processing
phase of the working page.
After pressing the New button, the operator must select all the methods to be grouped
together on the list and save them with a new name (Save). Every time that this page is
visualized, the tests selected refer to the group indicated in the window at the top of the
page from which the operator can recall all the memorized groups.
When the operator presses the Delete button and then confirms, the group indicated in the
window will be deleted.
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3.6.5. REAGENTS
From the main page of the methods, select the Reagent option in order to view the
following page (Fig. 3. 69):
Fig. 3. 69 - Reagents
A complete list of the reagents programmed on the instrument is shown. On this page
there are a series of options for viewing the list of reagents per type, measurement and
reading.
The operator can add a reagent to the list by pressing the New button; a page (Fig. 3. 70)
will appear that allows for entering the new reagent data; the new reagent is automatically
entered into the first empty position on the list.
Fig. 3. 70 - New reagent
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The operator must set the name, type of vial, and the type of reagent. The data of a
reagent already inserted can be modified by selecting and pressing the Modify button on
the list or by double clicking on the position of the reagent (Fig. 3. 71):
Fig. 3. 71 – Modify the reagent data
It is also possible to eliminate a reagent, by selecting it on the list and pressing the Delete.
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3.6.6. ALLERGENS
The page of the allergen archive can be viewed by selecting the Allergen option from the
main page of the methods (Fig. 3. 72):
Fig. 3. 72 – Allergen archive
On this page there are a series of options for managing the file:
− Allergen families: this allows for defining the parameters of the families and allergens
(paragraph 3.6.6.1);
− Panels: this allows for defining the allergen panels (paragraph 3.6.6.2);
− Store: this allows for managing the warehouse availability of allergens (paragraph
3.6.6.3).
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3.6.6.1 FAMILIES AND ALLERGENS
By using this page (Fig. 3.73) it is possible to set the parameters of the allergen families
and the allergens themselves.
Fig. 3.73 – Families and allergens
The Families window lists the names of the families present in the file. By selecting one of
the families, the Allergens window displays all the allergens that belong to that specific
family. The following data is displayed for each of the allergens associated to the family
selected:
− Code: code of the allergen.

− Name: full name of the allergen.
− Stock: minimum stock requested for this allergen.
− Min. Ord.: (reordering quantity) suggested for this allergen.
Two printing options are also available on this page:
− Family: this allows for printing the allergens belonging to the family selected;
− All: this allows for printing the list of families and corresponding allergens.
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New family
The operator can insert a new family, by pressing the New button and the following page
will appear on the page (Fig. 3.74):
Fig. 3.74 – New family
Enter the name and press OK in order to define the new family and return to the previous
page.
Modify family
To modify the name of an existing family, select the family and press the Modify button, in
order to make the page of Fig. 3. 75 appear.
Fig. 3. 75 – Modify family name
Modify the name and press OK to enter the family with the new name on the list.
Delete family
In order to eliminate a family of allergens, select the family, press the Delete button and
then confirm the elimination.
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New allergen
In order to add a new allergen to a family, press the New button located in the allergen
field and the page of Fig. 3. 76 will appear:
Fig. 3. 76 – New allergen
The operator must first insert the data requested (code, producer, name of the allergen,
minimum stock and the minimum order), and then press OK to enter it on the list.
WARNING Every time the availability of X Allergen vials falls below the quantity set as
the necessary supply, the software will generate the warning message
indicating that the X Allergen is below the minimum stock level.
Modify allergen
In order to modify the data of an allergen already present in the archive, it is necessary to
select the allergen before and press the Modify button in order to make the page of Fig.
3. 77 appear:
Fig. 3. 77 – Modify allergen
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Modify the data and then press OK to confirm the modification.
Delete allergen
In order to eliminate an allergen from the list, select the allergen and press the Delete
button.
3.6.6.2 PANELS
By using this page (Fig. 3.78) it is possible to set the parameters of a panel of Allergology
tests in which it is also possible to enter the allergens belonging to different families.
Fig. 3.78 - Panels
This page contains the list of panels present in file and the list of allergens belonging to the
panel selected. The function of the panels is to create a group of allergology tests (of
different families) that can be applied to a patient.
This page also contains two printing options:
− Panel: for printing the list of the allergens belonging to the selected panel;
− All: for printing the list of the allergens belonging to all the panels.
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New panel
To create a panel press the New button to visualize the page in Fig. 3.79:
Fig. 3.79 – New panel
The operator must enter the name of the panel and select the allergens belonging to
different families to which it is to be associated. Each time a family in the relative list is
selected, the allergens belonging to that family are displayed in the field on the right, inside
which the operator can select the ones to be associated with the panel by clicking on top
of them.
Use the Add All button to associate all the allergens of the selected family to the panel.
The codes of all the allergens already associated with the panel will be visualized in the
last field on the left.
Modify panel
After selecting the panel to be modified, press the Modify button to visualize the
characteristics of the panel (Fig. 3.80):
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Fig. 3.80 – Modify panel
The operator can modify both the name and the list of its associated allergens. In order to
carry out this modification, it is necessary to select the families of allergens one at a time
and then move the mouse onto their lists (field on the right) either selecting (to add) or
disabling (to remove) the allergens.
Use the Add All button to add all the allergens of the family selected.
Delete panel
A panel already memorized in the file can be deleted by selecting it, pressing the Delete
button and then confirming the elimination command.
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3.6.6.3 STORE
By using this page (Fig. 3.81) it is possible to modify the number of allergen vials available
in the warehouse and in this way manage the warehouse in real time.
Fig. 3.81 - Store
The central window lists all the allergens present in file (store). The list visualizes the
following data for each allergen:
− Code: code of the allergen.

− Name: full name of the allergen.
− Avail.: (availability) of allergen vials in the warehouse.
− Res.: residual volume left in the vial in use.
− Stock: minimum stock requested for this allergen.
− L.S.: (under stock signal) (<<).
− Min. Ord.: (reordering quantity) suggested for this allergen.
Three printing options are also available on this page:
− Available: this prints the list of allergens available in the warehouse;

− Low stock: this prints the list of allergens which in a below-stock condition;
− All: this prints the list of all the allergens in the warehouse.
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Using this page the operator can interact directly with the warehouse, carrying out the
allergen load/unload operations via the options present in the Handling field.
Allergen load/unload
The operator can load/unload a new supply of allergens in the warehouse, by selecting it
on the list. To carry out this operation, it is necessary to enter the number of vials to be
loaded or unloaded in the Quantity field, then press either the Load button to add this
number of vials to the ones already available, or the Unload button to subtract the quantity
of vials typed from the number of vials available.
WARNING If when removing the allergen vials, a number of vials is entered which
takes the allergen to the under-stocked level, the symbol (<<) will
appear in the left hand side column.
Set quantity
The operator can modify the value of the Available vials by selecting the allergen and
typing the number to be entered directly in the Quantity and then pressing the Set.
Modify residue
The operator can modify the residual volume by selecting the allergen and typing the
residue expressed in µL in the Volume field and then pressing the Set button.
N.B.: The above-mentioned operations can either be carried out for the allergen
selected or for all the ones listed in the Allergen field(s).
3.7. RESULTS
The results of different working sessions can be read in the results menu. It is possible to
access the result menu at any moment (even while processing) either from one of the
pages illustrating the work plan (Result button), or from the main menu (Main) by pressing
the Results option.
If the operator accesses the result menu after finishing a work plan, the page which
appears refers to the results of the current session (just ended); otherwise an empty page
appears with no session loaded (Fig. 3.82):
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Fig. 3.82 – Menu of results
At the top of the page there is a window which indicates the session the results refer to
(Open Session). The operator has two options at his disposal:
− Current Session:
This allows for visualizing the results of the current session;
− Open:
This allows for opening and therefore visualizing the results of a previous session
which has been memorized in the file.
− Delete:
This allows for eliminating the sessions contained in the file after having selected
them.
WARNING The operator cannot open more than two sessions at a time, the current
one plus one of the memorized sessions.
− Validation:
In order to permanently validate the results obtained by transferring the session to
the archives it is possible to select the test that you want to validate.
N.B. When the operator opens a session of results from the archives (a session
already validated and saved) the Validate button is disabled.
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The operator can still modify the results of the current session that has not yet been
validated. This allows the operator to intervene on the results themselves and modify
them, something that is no longer possible once the session has been validated. For
sessions still to be validated (not yet closed) it is only possible to test summary
printout. Vice-versa only the printout of the report (from the Historic archive) can be
printed from the validated sessions.
WARNING If the operator closes the session without validating it, it is still however
registered in the archives with a name connected to the execution date
and a progressive number (day/month/year/progressive number of that
particular day). When this session is recalled, the operator can carry out
any modifications and validate the session under that name.
− Host:
This allows for sending the results of the active session to a central computer.
− Export session:
This allows for exporting from the session currently displayed to an ACCESS database.
If the exporting database has already been created, the operator will be asked if he
intends to add the session to the exporting database or recreate the database only with
the session being exported (Fig. 3. 83).
Fig. 3. 83 – Export session
− Historic :
This allows for accessing the Historic archive.
At the center of the page are two windows listing the plates used in the session
(Plate) and the test carried out (Test). The operator can choose whether to read the
results relative to each plate or each test.
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3.7.1. VISUALIZATION OF THE PLATE RESULTS
The operator must select one of the plates on the previous page and press the View Plate
button to make the page of Fig. 3.84 appear.
Fig. 3.84 - Plate results
N.B. This display is identical for all the types of test (quantitative, qualitative, avidity
and allergologic) which can be preset on the plate.
This page contains a chart illustrating the plate with all the wells. Each well is codified with
a color code (the color legend is indicated on the page) and shows the type of sample and
the obtained result.
WARNING The figure reported on each well refers to the result of the optical
density (OD) without taking into consideration the basic value of the
BLK well.
By selecting one of the wells and pressing the key View, the page (Fig. 3.85) is displayed
which shows in detail the characteristics and results of the well:
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Fig. 3.85 – Well characteristics
Double click on the well, or select it and then press Exclude/Enable, to exclude the result
of that well (considered not valid) or restore it (the well changes color). Select a well and
press the Modify button to visualize a page (Fig. 3. 86) to modify the OD value of the well:
Fig. 3. 86 - Modify OD
WARNING If a password for access to the results has been activated in the Setup
menu (paragraph 3.8)the correct password must be entered on the
page that automatically appears in order to be able carry out any
modifications.
WARNING The buttons present on the page of the plate results, with the exception
of the View button (which is always active), are disabled if the session
has already been validated; therefore the operator can only visualize
the details of the results of each well.
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3.7.2. VISUALIZATION OF TEST RESULTS
The operator must select the test to view and press the View Test button; the software
shows a page corresponding to the results of that particular test on the different plates.
N.B. Display and management of the test results different according to the type of test
(method).
Quantitative method
Press View Test to visualize the following page (Fig. 3.87):
Fig. 3.87 - Results for quantitative method
The page shows a table summarizing the values of the standard and blank wells in detail.
The Previous and Next buttons are necessary for skimming through the tests while the
Criteria button views a page (Fig. 3.88) which shows the validity criteria used for the
repeats set under method.
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Fig. 3.88 - Repeated samples validity criteria
The calibration curve for the method is shown in the lower part of the page. If the session
has not been validated, the operator can modify the characteristics of the curve, which are
shown on the right side of the page (Conc., OD, Fitting).
If the session has already been validated, this information can only be viewed but not
modified. Use the Result button to access a page (Fig. 3.89) showing the test printout,
where it can be printed.
Fig. 3.89 - Result printout
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N.B. The printout does not refer to the report, but to a service printout used by the
operator.
By pressing the Memorize button on the test results page the operator is able to make the
software use the calibration curve displayed in the page for the following calibrations, if the
method has any programmed calibrations.
N.B. The indication Plate Curve shows which plate the curve refers to; when there are
tests that require the curve to be repeated for each plate, this option makes it
possible pass from one curve to another, without going back to the previous
page.
WARNING If the calibration for that method is programmed and the operator exits
the result menu without memorizing the curve, the software issues a
warning message. If the operator fails to memorize the curve, the
software will keep the latest curve memorized in its memory.
By using Zoom curve it is possible to enlarge the layout of the results printout.
Allergologic method
The results display is identical to the quantitative method.
Qualitative method
Press View Test to visualize the following page (Fig. 3. 90):
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Fig. 3. 90 - Qualitative method results
In the top part of the page is a chart showing the details of the controls. The Previous,
Next and Criteria options have the same functions as indicated for the quantitative
method. No modifications may be carried out on the results.
The reporting criteria and the alarm criteria are shown in the lower part of the page.
By pressing the Results button the result chart can be visualized and printed (Fig. 3. 91):
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Fig. 3. 91 - Chart for the qualitative method
Avidity method
The method for displaying the results is identical to that of the qualitative method.
3.8. SETUP MENU
Select the Configuration option from the main menu page to access the menu for setting
the configuration of the management software (Fig. 3.92):
Fig. 3.92 – Setup menu
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3.8.1. SYSTEM DATE SETTING
By pressing the System Date option the standard page of windows (Fig. 3.93) will be
visualized which allows for setting the date and time:
Fig. 3.93– Setting the date
3.8.2. TOOLS
By selecting the Tools option a page is visualized that allows for using several offline
functions (Fig. 3.94)
Fig. 3.94 – Tool menu
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− Initialize :
This allows for carrying out the initialization of the instrument.
− Washing:
This allows for manually activating the washing cycle.
− Priming:
This allows for manually activating priming cycles for the devices and the lines
selected. (Fig. 3.95)
Fig. 3.95 - Priming
Press OK to activate the cycle.
− Windows:
This option allows for exiting the software program directly without passing via MAIN
to activate the shutting down procedure of the instrument; the request to confirm this
operation will be visualized (Fig. 3.96).
Fig. 3.96 – Exiting the program
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3.8.3. SETUP
By selecting the Setup option access is gained to the menu that allows for setting the
various characteristics used in the visualization pages (Fig. 3.97):
Fig. 3.97 – Setup menu
The page for each operation can be viewed by pressing the corresponding button; the
operator can then set different parameters present within the pages and in particular:
− TMS:
This allows for setting the parameters relating to the TMS (Time Management
System).
− Report:
This allows for defining the printed heading of the report for the patients.
− Unit of measure:
This allows for adding/deleting the units of measure used for the results, or modifying
a unit of measure already present.
− Password:
This allows for entering the password (see paragraph 3.8.3.1).
− Host:
This allows for enabling/disabling the connection with a remote unit and setting the
parameters for exchanging data.
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- Departments:
This allows for filing the names of the departments for the report.
− Washing solution:
This allows for setting the type of washing solution.
− Language:
This allows for setting the language in which the pages are presented.
− Parameters:
This allows for setting the configuration parameters of the system (see paragraph
3.8.3.2).
− Vials:
This allows for setting the vial features.
− Clean Solution:
This allows for setting the relative vial.
− Layout:
This allows for managing the configuration of the plates for the reagents by setting or
memorizing the various layouts in the file.
− Connections:
This allows for selecting the doors for connecting up to the instrument, the
photometer and the host, and also of selecting the type of photometer.
3.8.3.1 PASSWORD MANAGEMENT
Among the various options in the Setup menu, there is an option for setting the password
(Fig. 3.98):
Fig. 3.98 – Password menu
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The operator can set up to four passwords (they can all be identical of different), each of
which is valid for managing a specific menu. In order to set these the operator must select
the option relating to the menu to be protected; the software will visualize the following
page (Fig. 3.99):
Fig. 3.99 – Setting the password
The operator must type the new password in the first window and then type the verification
password and confirm by pressing OK.
If a password is already present and the operator wants to replace it, after he selects the
menu to be protected, the following page appears (Fig. 3.100):
Fig. 3.100 – Entering the password
The operator must enter the password and confirm it with OK; the software will display the
modification page (Fig. 3.99) in which the operator can set the new password (as
described above).
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3.8.3.2 PARAMETERS
Fig. 3.101 - Parameters
Type of Robotic immunoassay operator

Select the type of Robotic immunoassay operator connected.
Date Format
Date format: UE (dd/mm/yy) or USA (mm/dd/yy).
Time for washing strips

Waiting time for every strip not to be washed in the “with delay” washing mode.
Preheating time.
Time of preliminary turning on of the incubators in the case of thermostated methods.
Complete CTRLSMP data

If marked, this requires the entering of the data regarding the control serums.
Memorizing the Curves

If marked, this activates the management of the partial calibrations.
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Complete data
If marked, this requires the entering of all the data regarding the calibrations
curves.
Temperature Monitor
If marked, this activates the visualization of the time curves of the temperatures of
the incubators.
Tank tests
If marked, this performs the test of the levels of the tanks during the carrying out of
the work plan.
Managing the allergen storage

If marked, this enables the management of the allergen storage (checking the
availability of the allergens).
Vial storage
If marked, this enables the support interface for eliminating the vials no longer
needed for the layout.
Merge Test
If marked it forces to allocate more than one tests, if their methods are compatible,
over the same plate.
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3.9. QUALITY CONTROL
Select the Quality Control option from the main menu page to access the menu to verify
the results of the control samples. This page (Fig. 3.102) shows the data only if at least
one session has been validated in which there were control samples.
Fig. 3.102 - Quality control
The page shows three different lists showing the test name, the controls and the batches
of control samples used in the validated sessions. To visualise the data of the various
control samples, the operator must select, in the following order, the test name, the control
and afterwards the lot of control samples.
Then he must press the View button to access the data visualisation page (Fig. 3.103),
shown here:
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Fig. 3.103 - Control serum diagram
The page shows the data for the selected sample (test name, control name, lot and
expiring date) and if it is an allergologic test the different allergens can be selected, by
recalling them in the proper space.
The page also shows a list of the control sera, with the date and the session in which they
were used, the concentration and the progressive number of the session. The page also
displays all the parameters for the control sera (N. Samples, Time interval, Average, SD,
CV, Min, Max).
The page displays two graphs illustrating the results for the MINIMUM, TYPICAL and
MAXIMUM values of concentration of the selected control sample (graph on the left); and
the standard deviation of the samples used for the average of the results (graph on the
right), called SHEWART CHART.
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3.10. HISTORIC MENU
This menu, which can be selected either from the main menu page, or from the result page
and the work plan, allows for managing the patients’ reports and processing a series of
statistics on the results obtained in the different sessions. Once the Historic option has
been selected, the first page will appear on the monitor (Fig. 3.104):
Fig. 3.104 – Historic menu
This page manages the reports that have to be printed. The operator must insert in the
different fields the patient’s data, the ward (if relevant) and the admittance date, all
corresponding to the report to be printed. All the selected patients are indicated in the
windows on the bottom of the page, which show the list of patients and the tests carried
out on each of them. Using the buttons on the page the reports of the patients selected
can be printed (Print) or have a video print preview (Print Preview). By pressing Notes it
is possible to enter a comment on the patient printout. By selecting the Historic Report
option the results are shown in the historic format.
N.B. If the command is given to print without having selected a patient, the software
will print all the reports.
By pressing Delete a page appears which asks for the period of the sessions to be
cancelled. By confirming this command the sessions carried out during that period of time
will be deleted from the file. Use the Result button, to access the result (paragraph 3.7).
By selecting the Statistics button, from the previous page access is gained to the
following page (Fig. 3.105):
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Fig. 3.105 - Statistics
The page shows a series of options for processing a series of statistics regarding the
sessions carried out (selected by the operator). In the lower part of the page are the same
printing options present in the Report menu.
3.11. SERVICE
The operator can access this menu from the main menu, by selecting the Service option.
This allows for carrying out certain manual procedures on the instrument as well as a
series of tests of the status of the different sensors.
These procedures are particularly useful during the maintenance and troubleshooting
phases, or for resetting after the replacement of a damaged component.
For this reason the description of this menu is given in the Service Manual of the automatic
analyzer for the BRIO 2 microplate.
WARNING If in the Configuration menu (paragraph 3.8) the password for the
Service menu has been activated, in order to access the options of this
menu, the operator must enter the correct password in the page that
automatically appears.
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4. MAINTENANCE
4.1. MAINTENANCE OPERATIONS
Periodic maintenance keeps the instrument in proper working order. It is recommended to

carry out the following operations:
handling clinical represents a significant hazard and all the operations

must be carried out in full observance of all precautions and using
protective clothing. (protective gloves and mask).
4.1.1. DAILY MAINTENANCE
4.1.1.1 BEFORE TURNING ON THE INSTRUMENT
– Keep the external surfaces of instrument clean using a soft cloth dampened with a
warm, mild detergent solution.
– Check the sample needle: for the best results it is recommended to wipe the tip with a
swab soaked in alcohol to prevent any buildup of protein.
N.B.:Take great care not to bend the needle.
– Clean up any accidental spills in the work area: if hazardous biochemical has been
spilt it is recommended cleaning a sterilizing agent.
– Check the FLUSHING level and if necessary top up. It must be remembered that the
solution consists of a dilution of one 50 mL bottle of Tritone solution for every 10 liters
of distilled or deionized water.
TIME NECESSARY: 10 minutes
4.1.1.2 AT THE END OF THE WORK SESSION
– Carry out the washing procedure by following the instructions in the window displayed
by the program in order to clean the needle and manifold.
TIME NECESSARY : 2 minutes
4-1
4.1.2. WEEKLY MAINTENANCE
Prepare the flushing solution by adding 50 ml of triton solution to every 10 liters of distilled
or deionized water. Top up the tank with the specific liquid.
Wash the sampling needle and the manifold by following the WASHING procedure in the
CONFIGURATION /TOOLS submenus.
TIME NECESSARY: 15 min.
N.B.: If the instrument is not used on a daily basis it will be necessary to carry out the
priming operation every week in order to prevent the tubing from closing inside the
N.C. valves.
4.1.3. MONTHLY MAINTENANCE
With the instrument turned off:
– Check if there are any leaks from the syringes. In this case the Teflon seals of the
syringes must be replaced.
– Check the washing well for any obstructions. These can be removed by using a fine
piece of steel wire, taking care not to damage the tubing.
– Check the sliding rails: If these are dirty, clean them using a cloth dampened slightly
with lubricant oil.
– Check the peristaltic tubing: in the event of any liquid spilling out they must be
replaced.
– If the dilutor makes a lot of noise when the syringes are in movement it will be
necessary to lubricate the screws with a suitable grease.
TIME NECESSARY: 20 minutes (if no replacements are necessary )
4.1.4. PERIODIC MAINTENANCE
– When reconstituting the FLUSHING solution we recommend eliminating the old

residues and washing the tanks with distilled water in order to avoid any contamination
(the solution does not contain any preserving agents).
– When emptying the waste tanks we recommend adding approximately 100 ml of 5%
bleach in order to clean the tanks. The bleach can be added via the manifold washing
well while the instrument is turned on and no tests are being conducted.
TIME NECESSARY: 30 min.
4-2
4.1.5. PREVENTIVE MAINTENANCE
Depending on the number displayed by the counter located above the mother board, the
instrument could require preventive maintenance as indicated in the following chart.
Spare parts / operations
Teflon Piston Teflon Piston Peristaltic

N. E.V. Syringes
Syringes Syringes pumps
Counter tubing Lubrific.
1000µL 2500 µL tubing
50,000 9 9 9
100,000 9 9 9 9 9
150,000 9 9 9
200,000 9 9 9 9 9
250,000 9 9 9
300,000 9 9 9 9 9
350,000 9 9 9
400,000 9 9 9 9 9
Each preventive maintenance operation requires one hour’s work.
4.2. CLEANING OF THE DRAIN WELL.
Any blocks in the drainage well should be removed by using a piece of fine steel wire
introduced into the hole at the bottom of the well itself.
4-3
4.3. REPLACING THE SYRINGES PISTONS
Before carrying out the following procedures switch off the power and disconnect
the plug.
In order to replace the piston refer to Fig. 4.1. In this figure the various elements making
up the Dilutor are indicated separately.
- Turn off the instrument.

- Lift up the transparent cover.
- Identify the Dilutor Unit which is in the front left at the top.
- Unscrew the locking knob (1).
- Extract the piston (2) from its pin (3).
- At the same time, while holding the syringe slightly inclined forwards (4), extract the
piston pulling it gently downwards.
- Prepare a new piston.
- While keeping the syringe slightly inclined, insert the new piston.
- Push the piston in as far as possible until the hole in the rod is in the exact position,
that is, in front of the pin (3) and insert it.
- Screw up the locking knob (1).
Fig. 4.1 – Detail of the Dilutor Unit.
4-4
4.4. REPLACING THE DILUTOR VALVE TUBING.
the plug.
In order to replace the tubing refer to Fig. 4.1, that illustrates the details of the Dilutor Unit.

- Identify the Dilutor Unit which in the front left at the top.
- Unscrew the locking knob (1).
- Unscrew the syringe locking knob (5) and extract it.
- Pull the syringe (4) forwards and extract the piston rod from the pin (3).
- Unhook the two tubing (6) (7) pulling them gently by their sides in order to be able to
extract them from the side grate of the pinch valve (11).
N.B.: Warning during this phase the syringe will be remain hanging from the small tubing
only (6) and (7).
- Remove one of the tubing (6) and (7) from one end of the tubing-union end (9) and
the other from the other end of the tubing union (10).
- Prepare the new tubing.
- Insert the new tubing into the tubing union (9) (10).
- insert the tubing (6) and (7) into the grate of the pinch valve (11).
- Reinsert the syringe unit (4) into its housing.
- Restore the position of the piston by inserting it into its hole in the pin (3).
- Reinsert syringe locking knob (5) and screw it up.
- Reinsert the locking knob (1) and screw it up.
N.B.: The same steps can be followed for replacing tubing (8) and (12).
4-5
4.5. REPLACING THE NEEDLE
the plug.
USE PROTECTIVE GLOVES.
In order to carry out the replacement of the needle please refer to Fig. 4.2 and Fig. 4.3.
- Extract the Sample and Reagents stands from their housings.
- Manually shift the mobile arm in line with the sample housing.
- Unscrew the hydraulic union of the needle.
- Disconnect the gudgeon (electrical connection of the level sensor).
- Unlock the needle from its seat by rotating it as indicated in Fig. 4.2 points B & C.
- Pull the needle out towards the top as indicated in Fig. 4.3.
- Prepare the new needle.
- Insert the new needle in the housing and repeat the same steps in the reverse.
Fig. 4.2 – Replacing the needle (unlocking)
4-6
Fig. 4.3 – Replacing the needle (extraction)
4-7
4.6. REPLACING THE PERISTALTIC PUMP TUBING.
Carry out the following steps by referring to Fig. 4.4:
- Pull the tubing unions (1) up out of the locking support (2).
- Remove the locking springs (3) and disconnect the tubing unions (1).
- Connect the unions to the new tubing and put the locking springs back into place.
- Fit the new tubing back into the support (2).
Fig. 4.4 – Replacing the peristaltic pump tubing
4-8
4.7. TROUBLESHOOTING GUIDE
Use the guide below for troubleshooting any technical problems:
Problem Possible causes Solution

The instrument fails to start Mains not connected.. Connect the plug to the
when turned on. power supply.
Ensure that the power

supply reaches the power
point.
A fuse is blown. Call the Technical Service

Center.
The instrument fails to move The front cover is not Close cover to trigger
the arm. closed (safety interlock sensors.
engaged)
No display appears on turning Power supply cable not Connect the power supply
on PC. connected. cable or the video cable
at the back of the PC.
The instrument turns off during The power supply is not Turn the instrument off
processing. stable. check the electric panel of
the laboratory. If the
circuit breaker has
tripped, reconnect it. If
this is a recurrent
problem, check the power
supply line.
A fuse of one of the Call the Technical Service

instruments has blown. Center.
4-9

The washing liquid floods out of Waste tank not fitted into Reconnect the waste
the washing well manifold or place correctly. tank.
the strip during their washing
operations, or the Flushing Replace the cap of the
Solution floods out of the waste tank or the waste
needle washing chamber. tubing connector.
If flooding of the waste

occurs due to the waste
tubing breaking, turn off
the machine, unload the
plates and clean up the
excess fluids.
Faulty waste pump. Ensure that the power

supply reaches the power
point.
Check the fuses (if the

pump is connected to the
instrument).
Check the cable.
Replace the pump.

The aspiration tubes of the Clean these with a thin
manifold are blocked. metal wire.
The aspiration tube is Check the tubing. If

either cracked, blocked or defective, call the
leaking. Technical Service Center.
.
4-10

Flooding of a liquid from a The syringe is defective. Replace the syringe.
syringe.
The needle hits against Layout selection incorrect. Ensure that the reagent
something. plate matches the
diagram selected in the
layout of the EIA module.
The caps have remained in Remove all the caps from

the vials of reagents. the reagent vials to use
before positioning the
vials on the layout.
The layout is incorrectly Ascertain that the layout

positioned on the is correctly fitted into the
instrument. instrument.
The strips are incorrectly Ensure that all the strips

positioned on the plates or are correctly positioned
the plates are badly and that the plates have
positioned on the been properly inserted
instrument . into the instrument.
The mobile arm does not Clean the axles.

work smoothly
Call the Technical Service
Center.
The needle loses liquid and There’s not liquid in the Fill the solution-filling
does not distribute sufficient solution-filling bottle (10- bottle.
liquid. liter tank).
The syringe connections Ascertain that the syringe

have become loose. connections are all
tightened.
The needle tube is cracked Replace the needle.

or broken.
4-11

The instrument stops running. The door is open. Ensure that the door is
closed.
Mechanical or software Turn off the instrument

error. and start it up again.
Error in reading the plates. The reader lamp has burnt Replace the reading
out. lamp.
Test unsuccessful Vials incorrectly positioned Start the test again.

in the layout.
Insufficient filling of vials. Ensure that the volume of

the reagents is sufficient
and that vials of the
correct size are used.
Liquid errors detected in vials The level of the liquid is too Do not overfill the vials.
which are full. high for the vials. The
liquid/air limit has not been
detected.
Plates not sufficiently washed. Peristaltic pump tube worn Replace the tube.
out.
Insufficient aspiration for Check the aspiration

drawing up the liquid from pump connections, check
the plate. the correct pump
operation.
4-12

Carry over The reagent bottles have Only use bottles of new
been used again. or sufficiently washed
vials.
The needle is dirty. Clean the needle.
The manifold is dirty. Clean the manifold.
The Teflon layer on the Replace the needle.

needle is damaged.
High CV Air bubbles in the hydraulic Carry out the priming in

circuit. order to remove all the air
bubbles. If they continue
to form inside the
syringes, preventive
maintenance will be
necessary: Call the
Technical Service Center
The bottle of filling solution Fill the bottle of filling
is empty. solution.
The needle is defective. Replace the needle.
Washing volume Call the Technical Service

insufficient. Center.
Flooding of the liquids due Call the Technical Service

to too high a speed of the Center.
mixer.
A bottle washing liquid is Fill up the empty

empty. containers of washing
liquid with adequate
buffer. Please refer to
chapter 2, Supplies.
The washing tubes are not Ensure that the washing

correctly positioned. tubes B and E are
suitably positioned inside
the washing bottles.
4-13

The manifold is dirty. Clean the manifold.
The syringes are defective. Replace the syringes.
The syringe check is Call the Technical Service

defective. Center.
The printer fails to respond. The printer is not Check the power supply
connected correctly. cable of the printer.
Check the setting of the

printer. Please refer to
the printer user’s manual.
The printer is not on-line. Press [On Line] on the

printer.
The paper is missing in the Add paper.

printer.
The printer alarm light is on. The paper is either missing Reload the paper
or blocked in the printer.
Remove any pieces of
paper blocking the printer.
There is a fault requiring Call the Technical Service

assistance. Center.
4-14
5. APPENDIX
5.1. LEVEL SENSOR MANAGEMENT
The current management of the liquid detection in the vials carried out a control three
times in the case of absence of liquids as the needle descends. On the third control the
error will be signaled by means of an acoustic alarm.
The user can in any case still carry on with the readings as these will remain visible. On
carrying out the visualization of the results, any error due to the lack of liquid in a vial will
be evidenced.
In the average of the OD, concentrations and results these errors are not taken into
account in order to ensure a correct assessment.
Before filing the results in the historic archive, the user can in any case re-enable any of
the wells with errors.
5.2. CONNECTION TO THE HOST
STRUCTURE OF DATA FILES

The files containing both the input and the output data have been structured according to
the typical standard of .INI Windows files. Each section (consecutive numbers in
ascending order starting from 1) contains data regarding a patient together with the
following entries.
[n] Patient number in ascending order
Name= Patient’s first name (max. 14 characters)
Surname= Patient’s surname (max. 14 characters)
Id= Identification (max. 20 characters)
Ward= Ward (max. 20 characters)
Sex= Sex (M or F)
B_Day= Day of birth (numerical)
B_Month= Month of birth (numerical)
B_Year= Year of birth (numerical)
Ins_Day= Date of entry (numerical)
Ins_Month= Month of entry (numerical)
Ins_Year= Year of entry (numerical)
Pregnancy= Week of pregnancy (numerical)
Test= Code/test to be carried out
Result= Results per test (only towards host)
5-1
The entries ‘id’, ‘Ins_Day’, ‘Ins_Month’, ‘Ins_Year’ and ‘Test’ are always compulsory whilst
the ‘Result’ entry is compulsory (and permitted) only towards the host.
If several tests are required for a patient, they must be entered under ‘Test’ on the same
line, and the entries must be separated from one another by commas.
The results are indicated in the same order as under the ‘Test’ entry. They are separated
by commas and contain the same notes as those used in the medical reports.
For allergologic tests, a test must be indicated for each allergen to be dispensed, and
combine the test code of the allergologic type with the allergen code, and contain the
notes (following is an example of the code number of the test of the allergologic type on
the assumption of dosing the allergens d1, d2, f5, f221, w19 to the patient together with
any other tests):
Test = […..,]n/d1,n/d2,n/f5,n/f221,n/w19[,…..]
For the Avidity type tests with repeats towards the host, a test will appear following by a
result for every repeat (following is an example of the code number of the Avidity type test
with three repeats):
Test = […..,]n,n/Rep2,n/ Rep3[,…..]
RESULTS FORMAT
QUANTITATIVE TESTS
The result is expressed in the form of a seven-figure decimal number (including the point
and two decimal places).
If the value of the concentration is outside the curve, the result is expressed as < or > of
the extremes of the curve (as a concentration).
If the result cannot be expressed, it is marked ‘NV’.
For the allergologic tests the concentration results are followed by the class consisting of
three characters (c ?, c>?, c<?)
(Example: 123.45, 123.45 c 5, 2.87, 2.87 c 2, > 240.00, > 25.00 c>3, < 10.00, < 1.10 c<2,
NV)
QUALITATIVE TESTS
The result is expressed in the form of an index (or ratio) followed by ‘POS’, ‘Dub’ or ‘neg’.
The index is expressed in the form of a seven-figure decimal number (including the point
and two decimal places).
If the OD value cannot be measured (overflow), the index is expressed as > of the index
value in relation the maximum measured OD.
If the result cannot be expressed, it is marked ‘NV’.
For the Avidity-type tests the result is expressed in the form of the avidity percentage
followed by LA, MA, HA or in the form of ND.
(Example: 1.25 POS, 0.66 neg, 1.01 Dub, > 40.38 POS, NV, 13.45 LA, 40.67 MA, 67.33
HA, ND)
5-2
N.B.: The examples indicated above represent the positions relating to the different
result components and not of the absolute positions, seeing that these can be
preceded, followed or interspersed by a varying number of spaces (ASCII 32).
XMODEM protocol definition
SOH - Start of Header (01H). This opens every block of data.
ACK - Acknowledgement (06H). The receiver sends this character after every block
that has been received correctly.
NAK - Negative Acknowledgement (15H). the receiver sends this character after every
block that is incorrectly received.
EOT - End of Transmission (04H). This character informs the receiver that the last
block has been sent and that the transmission is finished.
BLOCK format in XMODEM (128 bytes with checksum)

<SOH><ID block><NOT ID block><128 bytes data><8 bit checksum>
SENDER and RECEIVER Protocol
SENDER RECEIVER
<----- <NAK>
<SOH> 01 FE <128 data bytes > <checksum> ----->
<----- <ACK>
<SOH> 02 FD <128 data bytes > <checksum> ----->
If there is an error during transmission :

<----- <NAK>
<SOH> 02 FD <128 data bytes > <checksum> ----->
<----- <ACK>
<SOH> 03 FC <128 data bytes > <checksum> ----->
<----- <ACK>
If the sender does not recognize ACK :

<----- <ACK>
<SOH> 03 FC <128 data bytes > <checksum> ----->
<----- <ACK>
<EOT> ----->
5-3

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BRIO 2

BASIC ROBOTIC IMMUNOASSAY OPERATOR

Brio 2 version 1.10

1.1. Introduction ..........................................................................................................1-1

2. INSTALLATION AND PREPARATORY OPERATIONS...........................................2-1

2.1. Foreword ..............................................................................................................2-1

3.1. Introduction ..........................................................................................................3-1

3.5. Work plan .............................................................................................................3-5

4.1. Maintenance operations .......................................................................................4-1

4.1.2. Weekly maintenance ...................................................................................4-2

5.1. Level sensor management ...................................................................................5-1

INDEX OF THE FIGURES

Fig. 1.1 – Detail of the 8-needle manifold .................................................................... 1-4

Fig. 3.21 – Progressive IDs........................................................................................ 3-19

Fig. 3.54 – Editing the incubation phase .................................................................... 3-45

Fig. 3.87 - Results for quantitative method ................................................................ 3-70

WE VALUE YOUR OPINION

Reference: BRIO 2 - Basic Robotic Immunoassay Operator

Send this form to:

Use the device only after reading this manual

II. SAFETY PRECAUTIONS

∗ All repairs must be carried out by the Technical Assistance Personnel.

∗ Disconnect the instrument if it is left inactive for a long period.

III. TECHNICAL FEATURES AND LINE DISTURBANCE

- Starting and stopping of the electric motors.

Power supply : 230 VAC

Number Symbol Description

6 Warning high voltage (risk of electric shock)

7 Consult the documentation attached (e.g. user manual ).

10 Waste for electronic device

The apparatus consists of the following:

The analyzer is capable of carrying out the following operations:

The basic setup consists of:

There is also the signaling of reagents loss (level errors).

In the environment dedicated to the report-making refertation the historic research

1.2. TECHNICAL FEATURES

Needle for aspirating and dispensing samples and reagents

Minimum serum volume : 10 µL

Maximum serum volume : 300 µL

Minimum reagent volume : 20 µL

Maximum reagent volume : 300 µL or 2200 µL in the case of sample dilutions

Precision sample : CV < 4.0% with 10 µL (reading on microplate)

Precision reagent : CV < 1%

Carry over sample : < 0.3 ppm (0.3*10e-6)

Carry over reagent : < 0.3 ppm

Washing unit of wells an microplate

Fig. 1.1 – Detail of the 8-needle manifold

Reagent and serum unit (standard)

1 Reagent holder stand for 40 bottles diameter 22 mm (5ml)

1 Reagent holder stand for 25 bottles diameter 22 mm (5ml)

Incubation and stirring unit

Temperature accuracy : +/- 0.5 °C

Transfer and reading module

Photometric unit : with 5 interferential filters

Measuring range : from 0.100 to 3.000 OD units

Accuracy : 2,5% @ 0,150 .O.D.

Precision : +/- 1,5%

Linearity : +/- 1,0%

Photometric wavelength spectral : from 400nm to 850nm

Light source : 20 W halogen lamp

Reading time : Single wavelength <3 Sec

Grabber transport device with xyz axis movements

Temperature: accuracy : ± 0.5 °C