The purpose of the automated microplates analyzer ELISYS 2 is to analyse samples on microplates; it
has been specifically conceived to automatically process up to 2 plates on line.
This manual provides the operator with all the necessary instructions for a safety, suitable use as well as
the instrument maintenance recommendations.
Manual content:
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This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at
the maintenance operator’s availability.
For accurate installation, use and maintenance, please read the following instructions carefully.
In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY WARNINGS”
Section 1, describing the suitable operating procedures.
In case of breakdowns or any troubles with the instrument, apply to the local Technical Service.
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HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any
defect in material or workmanship, provided that this warranty shall apply only to defects which become
apparent within one year from the date of delivery of the new instrument to the purchaser.
- warranty information and the CE conformity declaration
general safety-warnings;
general information such as the producer data, instrument description;
instrument performances, technical data;
installation and start up;
operating instructions;
the user’s periodic maintenance and checking and the repair policy;
- how to put the instrument out of service, packaging, transport instructions;
– Appendices including instrument decontamination and spare parts list .
The HUMAN representative shall replace or repair any defective item at no charge, except for
transportation expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any item considered as
expendable in the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes,
tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used
in accordance with the manufacturer's instructions, not regularly maintained, used with equipment not
approved by HUMAN or used for purposes for which it was not designed.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation /
warranty registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be
reported to the freight carrier for settlement or claim.
User Manual ELISYS 2 Rev. 65/75
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The producer declares that the instrument:
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123456
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conforms to the following EEC Directives, included the last modifications:
73/23/EEC regarding low voltage
89/336/EEC regarding Electromagnetic Compatibility
93/68/EEC regarding the CE marking
and that the below harmonized standard specifications have been applied:
Safety:
CEI EN 61010-1 (1994) / CEI 66-5 ” Safety requirement regarding electrical equipment for
measurement, control and laboratory use ”
Electromagnetic Compatibility:
Emission: EN 55011 (1989) (CEI 110-6)
In this manual the following symbols are to remind the user of the safety rules:
This is a symbol of generic DANGER. It means that serious dangers might occur to the operator if
the described precautions are not fulfilled.
This is a symbol of high electrical voltage; by touching parts reporting this label, lif e endanger
might occur. Parts reporting this label can be handled only by qualified operators after having
unplugged the power supply cable.
This symbol indicates that the instrument makes use of chemical reagents and other dangerous
(corrosive, irritant and harmful) CHEMICAL SUBSTANCES which c an cause damages to people
and material. When this label is found, pay attention to the producer’s recommendations
This symbol indicates that the instrument involves the handling of s amples which can be infected
(urine and human serum). In this condition INFECTIONS or CONTAMINATION might occur. Pay
attention to the general safety warnings when in presence of such biological substances. Use
protective clothes, gloves and glasses.
This symbol indicates that damages to the instrument and/or its inc orrect results c ould occur if the
given warnings are not respected.
This symbol is to advise that the instrument or part of the manual which is particularly important
has to be consulted.
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The instrument is intended to be used in the following working conditions:
!
reading of medical substances as specified in the technical data;
!
only use the chemical reagents and accessories supplied and/or mentioned in this manual;
!
work at room temperature and humidity, according to the specified data;
!
do not power the instrument in a potentially explosive environment or at risk of fire.
The instrument has to be used as described in this manual. Any other use has to be regarded as
improper.
User Manual ELISYS 2 Rev. 67/75
BAIA146&F8&926&#<49DHS6<9
The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in this manual, according to
the safety rules.
This manual contains instructions for qualified operators.
!
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the use and maintenance are proper, according to the general safety rules as well as to the
particular precautions described in the manual (although he is not entitled to repair the instrument).
!
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received and using the original spare parts.
has to make sure that environmental condition is suitable, the installation is correct,
is entitled to maintain and fix the instrument, according to the instructions
Should the instrument need extraordinary maintenance, ask for
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or for licensed service
centres. The maintenance will be carried out by Specialised Technicians that will be able to fix the
instrument using the original spare parts to replace the defective ones.
ELISYS 2 (fig.2.1) is an automated instrument designed to carry out tests on microplates by optical
density reading. It is able to mix organic samples (by pre-diluting them, if necessary) with reagents and
to process up to 2 plates on line.
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fig. 2.1
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User Manual ELISYS 2 Rev. 69/75
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The instrument that is shown in figure 2.2 is composed of:
- Instrument framework and protection lid
- Control system run by electronic parts
- Aspirating and dispensing system
- Mechanical arm carrying a dispensing needle
- Movable photometer and plate washer
- Work area with: two microplate places, a washing basin, reagent trays, a tray for samples and two
predilution plates.
Arm
Needle
Protection lid
Photometer and
Plate washer
Work area
fig. 2.2 Front view (Lid lifted up)
10/75User Manual ELISYS 2 Rev. 6
'AJA#<49DHS6<9&/6;4HD3<R&YD3<C3E76
Below (fig. 2.3) is the diagram representing the main functional elements of the instrument photometric
section.
A monochromatic filtered beam of light produced by a lamp goes through the well containing the sample.
Part of the light is absorbed by the sample, the remaining one is detected by a photodiode. The
photodiode converts the received light in an electrical signal that is once again transformed into
frequency. By this frequency the microprocessor calculates the absorbance, taking in account of the
blank measure carried out at the beginning. The following is the formula to calculate the absorbance:
ELISYS 2 is a fully automated analyzer able to carry out up to 8 tests on two microplates.
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Max capacity 40 samples in 16 mm primary tubes or 60 samples in 10 mm primary tubes (optional).
Samples predilution on two 20 well plates, programmable for each assay.
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Modular trays for calibrators, controls, conjugate, chromogen, stop solution, reagents and sample
dilution.
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Max location of 2 microplates with 96 wells each which can be incubated at programmable temperature.
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An arm with three directions (x, y, z axis) carrying a level sensor dispensing needle.
In the aspiration phase, the sensitive needle stops at liquid meniscus level to reduce contamination.
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Needle: external surface by dipping it into the washing basin with flowing water;
internal surface by dispensing the washing solution in the washing basin discharge.
Plates: one 8-channel dispensing manifold, able to run two independent washing solutions
one 8-channel manifold to drain a row of wells at one time
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Reader: 8 photometric channels equipped with lenses, interferential filters and lamps.
Results: available at the end of the work session to be stored and printed.
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External containers are delivered with the instrument to contain washing solutions, dispensing solution
and the liquids waste (each container is equipped with a level switch),
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A PC software, run by WINDOWS ’95/’98, allows to:
!
set up the requested analysis and to process on line different methods
!
give to the instrument the relevant commands
!
receive and transfer the analysis result
!
print and file the results
!
memorise the calibration curves.
12/75User Manual ELISYS 2 Rev. 6
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PROCESS CAPABILIT Y
WORK AREA
" Microtiter plates
" Sample tray
" Common reagent trays
" Specific reagent trays
" Predilution plates
PREDILUTION
DISPENSATION
DISPENSATION SYRINGE
PIPETTING SPEED
CARRY OVER
LIQUID SENSORS
MICROPLATES W ASHING
NEEDLE W ASHING
" Total volume
" Minimum volume
" Accuracy
" Samples
" Reagents
" Sample dead volume
" R eagent dead volume
Combination up 8 ass ays on 2 micr otiter plates on line
Modular composition:
2 microplates with 96 wells (12 strips, each one with 8 wells)
one tray f or 60 primary tube Ø10#12 x 100 mm, replaceable with a 40 primary tube
Ø14#16 x 100 mm tray
different types (depending on the assay category), f or substrate, stop solution,
cleaner, dilution solution bottles, common reagents
different types (depending on the specific assay), for calibrators, controls, specific
reagents
2 plates, eac h one with 20-wells
Programmable for each sample,
Three freedom degr ees Arm (x, y, z axis) c arrying the needle
1000 µl
10 µl
Better than 1% at a volume of 100 µl
35 minutes for 96 wells for a washing volume of 1 ml
7 minutes for 96 wells for a washing volume of 1 ml
Minimis ed to less than 3% by washing the pipetting system after each single
sample dispensing and after each reagent dispensation phase
Sample and reagent levels are sensed by the needle used as a capacitive
sensor
Less than 150 µl
Between 100 µl and 400 µl depending on the bottles used
8-channel moving manifold with separate filling and aspiration ports
2 different washing s olution to choosing from within a work session
External and internal washing
REAGENT W ASTE
EXTERNAL TANKS
" Wash buffer 1and 2
" Wash solution
" Waste
INCUBATION
PHOTOMETER
" Light source
" Filters
" Detectors
" Measurement range
" Accuracy
from 0.000 to 1.500 OD
from 1.500 to 3.000 OD
" Stability (short term)
About 10% (*) of reagent aspirated for all the assays
(*) used for cleaning the sampling system
two 2-liter bottles
a 5-liter bottle
a 10-liter tank
Each one is equipped with a level switch to check whether the tank is full or empty
At room temper ature (Ta) or programmable from T a+5°C up to 45 °C in steps of
1°C
Moving 8 channel device with automatic blanking and internal calibration
Tungsten lamps
2 standard interferential filters: 450 and 630 nm, bandwidth 8 nm
Other wavelength values on request .Two more optional filters to be added .
Silicon photodiodes
0.000 - 3.000 OD (Optical Density)
$ 1% or $ 0.010 OD whichever the bigger
$ 2%
0.001 OD in 1 minute
User Manual ELISYS 2 Rev. 613/75
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(B&,GH,20I5
SERIAL INTERFACE
ELECTRICAL POW ER REQUIREMENT Standard 220 or 110 Vac 50/60 Hz
RS232
POWER CONSUMPTION
OPERATING CONDITIONS
Temperature
Relative Humidity
SHELF CONDITIONS
Temperature
Relative Humidity
DIMENSIONS
" Width
" Height
" Depth
WEIGHT
" Instrument
" Packed instrument
EUROPEAN REFERENCE DIRECTIVES
HARMONIZED STANDARD
SPECIFICATIONS
INSTRUMENT OUTFIT
PC (optional supply)
(*) The described features can be altered at the producer’s discretion without f orewarning.
500 W Max
from +15°C to +30°C
up to 80%
from "10°C up to +60 °C
up to 85%
790 mm
595 mm (980 mm with lifted up lid)
600 mm ( 650 mm with lifted up lid)
72 Kg
97 Kg (wooden box dimensions: 89x68x75 cm)
" 73/23/EEC regarding low voltage electrical material
" 89/336/EEC regarding Electromagnetic Compatibility
" 93/68/EEC r egarding the CE mark
Safety:
EN 61010-1 (1994) / CEI 66-5 ”Safety requirements for measurement
electric al equipment checking and laboratory use”
Electromagnetic Compatibility:
Emission: EN 55011 (1989) (CEI 110-6)
Immunity: EN 50082-1 (1992) (CEI 110-8)
The instrument is equipped with:
! User’s manual
! Mains power cable.
! Modular reagents trays (kit)
! Two predilution plates
! A tray for 40 samples
! Two 2-liter bottles for wash buffer 1and 2.
! A 5-liter bottle for wash solution.
! A 10-liter waste tank
! RS232 PC connection c able
! Software for PC to master the instrument
! (On request: BDE Installer f or Microsoft Windows 98 II.Edition)
The PC minimum requirements are:
! Microsoft Windows 95 or 98 (for Microsoft W indows 98 II.Edition you
need the BDE-Installer version 1.0)
! 15 MB free on hard disk
! 1.44Mb floppy driver
! RAM 32 Mb
! Pentium or compatible processor at 166 MH z
! Display adapter standard VGA 640x480
! Printer
Figure 4.3-a and fig.4.3-b show a typical work area layout.
Needle
Washing
basin
Micropla te s
Reade r/ W asher
Group
1
11
21 31
2
3
4
5
6
7
8
9
10
Samples
tray
Dilution
solution
bottles
S u b str ate
S top so lu t io n
Cleaner
Reagents
tray s
fig. 4.3 - a
fig. 4.3 - b
18/75User Manual ELISYS 2 Rev. 6
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The sample tray is a support for sample vials (primary tubes) to be analysed.
The tray may be for 60 primary tubes sized 10#12 mm in diameter and 100 mm in height (optional) , or
40 primary tubes sized 14#16 mm in diameter and 100 mm in height.
Vials are manually loaded, according to the program instructions (see paragraph 5.3).
JAKA'A,D;P4&8FD&(6;R6<94&;<5&>F<9DF74
Different types of reagent trays may contain dilution solutions, substrate, stopping solution, cleaner,
conjugate, calibrators and controls. Part of them are common for all the assay methods of the session,
wile other trays contain the reagents for the specific assay methods.
The reagent vials have to be placed on particular positions as shown as typical example in fig. 4.3-a and
according to the given program instructions (see paragraph 5.3) for the specific assay method.
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The pre-dilution plate is a molded 20 wells plastic container. The needle dispenses the sample along
with dilution solution into each cup according to the running program.
There are two pre-dilution plates, so that a total of 40 pre-dilution cups are available.
The program advises to locate the pre-dilution plates before starting the process (see paragraph 5.3).
JAKAJA/3CDFE7;96
The microplate is a support for 96
reaction wells. One or two microplates
have to be located on their relevant
places.
The washer and the photometer are able
to run through the plate in order to read
and wash the related wells.
Each microplate can host up to 12 strips,
each strip containing 8 wells.
The PC program advises to locate the
microplates before the start of the
running process (see paragraph 5.3).
In order to wash the external part of the dispensing needle, it is dipped into the wash basin where the
washing liquid continuously flows. To wash the internal part of the needle the dispensation liquid is
pumped into it.
To prevent samples contamination, the needle washing system is automatically activated, when
necessary.
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The reader–washer group is located on the top of the microplates area. It allows to run automatically
both the photometric reading and the microplates washing, in succession according to the program.
fig.4.3 -b
User Manual ELISYS 2 Rev. 619/75
JALA!734P4&'&G&Y>&>F<<6C93F<
The instrument is equipped with an RS232 serial port for PC connection.
A 9-pin connector is available on the instrument right side panel (see fig. 4.4).
Generally two serial ports to choose from are located on the rear panel of a PC: COM1 and COM2, a 9pin male connector and/or a 25-pin male connector.
A connection cable PC- ELISYS 2 with two 9 pin connectors (female- male) is supplied with the
instrument. An adapter 9-25 pin may be necessary on the PC side connection.
Fig. 4.4 RS232 serial port located at the instrument right side
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JAMABAY>&/3<3SHS&(6WH3D6S6<94
"
Microsoft Windows 95 or 98
"
15 MB free on hard disk
"
1.44 Mb floppy driver
"
RAM 32 Mb
"
Pentium or compatible processor at 166 MHz
"
Display adapter standard VGA 640x480
"
Printer .
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AP 2 is the program specifically developed for ELISYS 2.
5
2
374
2 Tx
3 Rx
4 DTR
5 GND
7 RTS
To install AP 2 program on the PC place ELISYS 2 CD in the CD-ROM drive. If the installation program
does not start automatically, proceed as follows:
"
Start Explorer from the Start menu and select the letter of the CD drive.
"
Start the
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program by double clicking with the left key on the mouse.
The installation program is now initialised. Follow the instructions shown on the screen.
The program is now installed and the ELISYS 2 icon is available on the desktop. Double click on it to run
the program.
The instrument requires the use of chemical reagents and other dangerous (corrosive, irritant and harmful)
CHEMICAL SUBSTANCES which can cause damages. When this label is found, be careful and pay attention
to the producer recommendations
The instrument requires to handle samples which can be infected (urine and human serum). In this condition
INFECTIONS or CONTAMINATION might occur. Pay att ention to the general safety warnings as to the
presenc e of such biological substances. Use protective clothes, gloves and glasses.
In particular:
!
Wear protective clothes and gloves.
!
At the end of a work Session, clean the work panel and its acc essories carefully by using a cloth s oaked
in a 0.5% sodium hypochlorite solution.
!
Waste material produced by the analytic al and cleaning process is a dangerous material which might
contaminate people and material. Get rid of the waste material according to the local regulations.
PC switch ing on
and program start
WO RK SESSION
Work session
setup
Run Analysis
Start w ork ses sion
or
other functions?
Par. 5.2
Par. 5.3
,;:76&KAB&f&Q6<6D;7&FE6D;93<R&87FU&53;RD;S
OTHER FUNCTIONS
Par. 5.4
Par. 5.5
Par. 5.6
Par. 5.7
Databases
Settings
Commands
Help
User Manual ELISYS 2 Rev. 621/75
KABA'AYFU6D3<R&926&#<49DHS6<9
Switch on the instrument (the switch is located on the right side).
On the front side of the instrument there are three coloured lamps as below specified: