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USERS MANUAL
BrioWin version 2.00
BRIO
BASIC ROBOTIC IMMUNOASSAY OPERATOR
USERS MANUAL
BrioWin version 2.00
SEAC S.R.L.
Via di Prato, 72/74 - Calenzano Firenze
Tel: 055 8877469 - Fax: 055 8877771
Code 53872262
INDEX
1.
GENERAL DESCRIPTION........................................................................................1-1
1.1. Introduction ..........................................................................................................1-1
1.2. Technical features................................................................................................1-7
2.
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
3.5. Work plan .............................................................................................................3-5
3.5.1. Setting the work list......................................................................................3-15
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 .....................................................................................................3-54
3.6.6. Allergens......................................................................................................3-56
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
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. ....................................................................................4-4
4.3. Replacing the syringes pistons............................................................................4-4
4.4. Replacing the dilutor valve tubing. .......................................................................4-6
4.5. Replacing the needle ...........................................................................................4-7
4.6. Replacing the peristaltic pump tubing. .................................................................4-9
4.7. Troubleshooting guide........................................................................................4-10
5.
APPENDIX ................................................................................................................5-1
5.1. Level sensor management ...................................................................................5-1
5.2. Connection to the host ........................................................................................5-1
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10
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.
11
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 Manufacturers Assistance Service.
Power supply
: 220 VAC
Distribution
Frequency
: 50 - 60 Hz
Consumption
: 420 VA
Line fuse
: T 4.0A
Compressor fuse
: T 4.0A
: D 2.0A 6x32 mm
12
Number
Symbol
Description
Alternating Current
Functional ground
ON
OFF
Fuse
Biological hazards
13
1.
GENERAL DESCRIPTION
1.1.
INTRODUCTION
The BRIO 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 a dispensing needle and washing manifold, with XYZ movements
(Fig. 1.1).
A dilutor consisting of two syringes of 2500 L and 1000 L for aspirating and
dispensing the samples and reagents (Fig. 1.2).
A stand for 4 microplates with thermostats fitted with stirrers (Fig. 1.2).
All the devices indicated above are controlled by an external 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 7 L;
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 (Fig. 1.3);
simultaneously thermostat and/or stir the microplates.
The basic setup consists of:
a stand for stirring and thermostating of 4 plates;
a stand for 120 12 x 75 mm tubes;
1-1
1-2
1-3
STANDARD
AND REAGENT
DILUTOR
MICROPLATERS
HOLDER
SAMPLES
ROBOTIZED ARM
NEEDLE AND MANIFOLD
CONTROL AND
COMPUTING CIRCUIT
1-4
RESISTANCE
DILUTOR
DISPENSER NEEDLE
SHAKER
MANIFOLD
WASHING
SOLUTION
ASPIRATION
MAGNETIC POSITION
SENSOR
MOTOR
1-6
1.2.
TECHNICAL FEATURES
Dispenser unit:
2500 L syringe
1000 L syringe
Needle for aspirating and dispensing samples and reagents
Minimum serum volume
:
7 L
Maximum serum volume
:
300 L
Minimum reagent volume
:
20 L
Maximum reagent volume
:
300 L or 2200 L in the case of sample dilutions
Precision sample
:
CV < 4.0% with 10 L (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 7 L is always used.
1-7
General features:
Interface
Software management
Power supply
Consumption
:
Safety
Line fuse
Compressor fuse
Motor card fuse
Dimensions
Weight
Operating conditions
:
RS232 bidirectional
:
Personal Computer Pentium
:
220 VAC 50Hz-60Hz
420 VA
:
CEI EN 61010-1 STANDARD CLASS I INST.GROUP II
:
2 x T4.0A
:
2 x T4.0A
:
2 x D2.0A mm 6x32
:
44 x 84 x 60 cm
:
62 Kg
:
from 15C to 32 C (in operation)
1-8
2.
FOREWORD
The following paragraphs explain the procedure to follow for correct installation of the
BRIO Robotic immunoassay operator. This information regards:
2.2.
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 unpacked instrument weighs approximately 62 kg and therefore requires the
intervention of at least two people for ensuring ease of transport, loading and unloading of
the boxes.
The handling of the latter, while not requiring particular equipment, must however be
carried out in full observance of the warnings attached to the outside (TOP-BOTTOM).
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
CODE
Compressor
Code 62030071
Code 29800410
Code 33002841
Tanks:
Code 51029891
- Waste
Code 44501520
- Internal needle washing solution (10 liters)
- External needle washing solution (5 liters) (only in 4 Code 44505150
plates model)
Set of peristaltic tubes
Code 63011430
Sampling needle
Code 63030350
Code 28010060
Code 63030390
Code VSM2
Code VSM3
Users manual
Code 53872262
2-2
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 84 x 60 cm
however it is recommended leaving sufficient space all around in order to facilitate
maintenance operations.
2.3.1. CORRECT INSTALLATION OF THE ROBOTIC IMMUNOASSAY OPERATOR
The primary points necessary for installing the instrument are as follows:
-
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.
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.
2-3
Temperature
Relative humidity
Altitude
2.4.
2-4
Warning:
The 10-liter tank and the buffer tank must be positioned on the same level as
the BRIO, in order not to compromise the precision of the dispensations.
Washing solution
Washing solution
Waste
Waste
Level sensor
Level sensor
2-5
3.
USE
3.1.
INTRODUCTION
Throughout all the work phases the interfacing between the operator and the automatic
analyzer for the BRIO microplate takes place by means of dedicated software.
The software works in Windows 98 (II edition) 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.
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 BrioWin application contained on the
desktop of Windows 98, as the methods requested by the operating system.
On starting up the window in Fig. 3.2 will appear.
3-3
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.
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 carry out a reading of the microplates in a 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
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).
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
3-7
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
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).
3-9
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.
3-10
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.
3-12
3-13
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.
By pressing RESTART 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
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).
3.5.1. 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):
3-15
3-16
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):
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.
3-18
3-19
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):
3-20
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):
3-21
3-22
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:
PREDILUTIONS
From the work list page, select the option Predilutions, to display the corresponding page
(Fig. 3.27):
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:
3-25
The final details of the control serums will be visible once the results have been
processed.
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
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.
3-29
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.
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.
3-30
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.
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.
3-31
3-32
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:
3-33
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:
3-36
3-37
3-38
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
3-40
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
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):
3-42
3-43
Reagent dispensation + .. :
This allows for editing the reagent dispensing phase combined with the dispensing of
another type as set (Fig. 3.53):
3-44
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
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):
3-46
Control Dispensation:
This allows for editing the control sample dispensation (Fig. 3. 58):
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:
3-50
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):
3-52
3-53
3.6.4. GROUPS
From the main page of the methods, select the option Groups, for visualizing the following
page (Fig. 3. 68):
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.
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):
3-54
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.
3-55
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).
3.6.6.1
By using this page (Fig. 3.73) it is possible to set the parameters of the allergen families
and the allergens themselves.
3-57
3-58
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:
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.
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.
3-60
3-61
3-62
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.
The central window lists all the allergens present in file (store). The list visualizes the
following data for each allergen:
3-63
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 L 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):
3-64
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.
3-65
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).
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.
3-66
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:
3-67
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.
3-68
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):
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.
3-69
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.
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):
3-71
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):
3-72
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):
3-73
3.8.2. TOOLS
By selecting the Tools option a page is visualized that allows for using several offline
functions (Fig. 3.94)
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):
3-75
Departments:
This allows for filing the names of the departments for the report.
Washing solution:
This allows for setting the type of washing solution.
3-76
PASSWORD MANAGEMENT
Among the various options in the Setup menu, there is an option for setting the password
(Fig. 3.98):
PARAMETERS
3-78
3-79
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.
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:
3-80
3-81
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):
3-82
3-83
4.
MAINTENANCE
4.1.
MAINTENANCE OPERATIONS
IMPORTANT:
4.1.1.1
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.
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
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
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.
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 )
4-2
Teflon Piston
Syringes
1000L
Teflon Piston
Syringes
2500 L
Peristaltic
pumps
tubing
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
E.V.
tubing
Syringes
Lubrific.
4-3
4.2.
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.
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.
-
4-4
4-5
4.4.
Before carrying out the following procedures switch off the power and disconnect
the plug.
In order to replace the tubing refer to Fig. 4.1, that illustrates the details of the Dilutor Unit.
-
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).
4-6
4.5.
Before carrying out the following procedures switch off the power and disconnect
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.
Turn off the instrument.
Lift up the transparent cover.
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.
A
B
4-7
4-8
4.6.
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).
4-9
4.7.
TROUBLESHOOTING GUIDE
Possible causes
Solution
Connect the plug to the
power supply.
Ensure that the power
supply reaches the power
point.
A fuse is blown.
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 monitor is turned off.
4-10
Problem
Possible causes
Solution
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.
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.
4-11
Possible causes
Solution
The
needle
something.
hits
solution-filling
4-12
Problem
The instrument stops running.
Possible causes
The door is open.
Mechanical
error.
or
Solution
Ensure that the door is
closed.
the
reading
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.
4-13
Possible causes
Solution
Washing volume
insufficient.
4-14
Problem
Possible causes
The manifold is dirty.
Solution
Clean the manifold.
4-15
5.
APPENDIX
5.1.
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.
Name=
Surname=
Id=
Ward=
Sex=
Sex (M or F)
B_Day=
B_Month=
B_Year=
Ins_Day=
Ins_Month=
Ins_Year=
Pregnancy=
Test=
Result=
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
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).
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.
RECEIVER
<--------->
<--------->
<NAK>
<--------->
<--------->
<-----
<NAK>
<ACK>
<ACK>
<ACK>
<--------->
<--------->
<ACK>
<ACK>
5-3