Human Elisys 2 Plus User manual
User Manual
!"#$%$&'&()*+
Cat.-No.: 17300/1p
,-./!./$
0. INTRODUCTION 4
0.1. DESCRIPTION 4
0.2. USER WARRANTY 4
SECTION 1 5
1. GENERAL SAFETY WARNINGS 5
1.1. DANGER-WARNING SYMBOLS 5
1.2. INTENDED USE OF THE INSTRUMENT 5
1.3. USE OF THE INSTRUMENT 6
SECTION 2 7
2. GENERAL INFORMATION 7
2.1. INSTRUMENT DESCRIPTION: PURPOSE AND FEATURES 7
2.2. MANUFACTURER’S IDENTIFICATION LABEL 7
2.3. INSTRUMENT DESCRIPTION 8
2.4. INSTRUMENT MEASURING PRINCIPLE 9
SECTION 3 10
3. INSTRUMENT TECHNICAL DATA 10
3.1. MAIN FEATURES 10
3.2. INSTRUMENT TECHNICAL SPECIFICATIONS (*) 11
SECTION 4 13
4. INSTALLATION AND START-UP INSTRUCTIONS 13
4.1. UNPACKING 13
4.2. PLACING THE INSTRUMENT 14
4.3. POWER SUPPLY 14
4.4. WASH AND WASTE CONTAINER INSTALLATION 15
4.5. WORK AREA 16
4.5.1 Samples Tray 17
4.5.2. Trays for Reagents and Controls 17
4.5.3. Pre-dilution Plate 17
4.5.4. Microplate 17
4.5.5. Wash Basin for the Needle 17
4.5.6. Reader – Washer Group 17
4.6. ELISYS 2 PLUS - PC CONNECTION 18
4.7. SOFTWARE INSTALLATION ON PC 18
4.7.1. PC Minimum Requirements 18
4.7.2. Software Installation 18
SECTION 5 19
5. OPERATING INSTRUCTIONS 19
5.1. INTRODUCTION 19
5.1.1. Operating Overview 19
5.1.2. Powering the Instrument 20
5.1.3. PC Program Starting 20
5.1.4. Operating Menu 20
5.2. WORK SESSION SETUP 22
5.2.1. Select Profile 23
5.2.2. Set Parameters 24
5.2.3. Sample Setting 25
5.2.4. Single Step Operation 26
5.2.5. Entering the Patient Card 29
5.3. RUN ANALYSIS 30
5.3.1. Run the Process 31
5.3.2. Work Area Preparation 31
5.3.3. Analysis Execution (Running Phase) 32
5.3.4. Displaying the Results and Their Acceptance Evaluation 33
5.3.5. Patient Reports 34
5.4. DATABASES 35
5.4.1. Medical Reports 35
5.4.2. Patient Cards 36
5.4.3. Notes 37
5.4.4. Assays 37
5.5 ASSAY PARAMETER SETUP 38
5.5.1 Working Parameters 45
5.6 RACK ARRANGEMENTS 51
5.6.1 Disposition on the Working Area- Standard Racks 51
5.6.2 Disposition on the Working Area -Universal Racks 52
5.6.3 Disposition on the Working Area - Mixed Arrangement 52
5.6.4. Working with Two Substrates 53
5.6.5. Definitions for BLOCK-, RACK TYPE- AND GROUP PARAMETER 53
5.7. SETTINGS 53
5.7.1 Break on Error 53
5.7.2 External Incubation 54
5.7.3 Simulation Mode 55
5.7.4 92 Positions for Predilution 56
5.7.5 Substrate Incubation at 37° 56
5.7.6 Dilution and Wash Buffer Names 57
5.8 COMMANDS 57
SECTION 6 58
6. MAINTENANCE 58
6.1. CHECKS AND PREVENTIVE MAINTANANCE 58
6.2 CLEANING THE INSTRUMENT’S PARTS 59
6.3 TUBING, DILUTER AND MANIFOLD DECONTAMINATION 59
6.4 GENERAL INSPECTIONS AND CHECKS 60
6.5 REPLACE THE SYRINGE TIP 60
SECTION 7 61
7. PUTTING THE INSTRUMENT OUT OF SERVICE 61
7.1. GENERAL WARNINGS 61
7.2. PUT THE INSTRUMENT OUT OF SERVICE 61
7.2.1. Momentary Stocking 61
7.3. INSTRUMENT TRANSPORT AND HANDLING 62
7.4. INSTRUMENT STORAGE 62
APPENDIX A 63
INSTRUMENT DECONTAMINATION 63
DECONTAMINATION PROCEDURE 63
DECONTAMINATION DECLARATION 64
APPENDIX B 65
SPARE PARTS - CONSUMABLES – ACCESSORY PARTS 65
APPENDIX C 66
ELISYS 2 PLUS RACK DESCRIPTION 66
APPENDIX D 67
GROUP – RACK-BLOCK -DIVISION 67
APPENDIX E 68
DEFINITIONS FOR GROUPS 68
GROUP No.1 68
GROUP No.2 68
GROUP No.3 69
GROUP No.4 69
GROUP No.5 70
GROUP No.20 70
GROUP No.131 70
APPENDIX F 71
ON LINE MODULE 71
PROCEDURE 72
APPENDIX G 74
OPERATING FLOW DIAGRAMM 74
2/74 User Manual ELISYS 2 PLUS
0!1#$#-.&"#$/&-2&/3!&45.65"
No. DATE / Rev. REVISION DESCRIPTION
6 030217
NEW: Integration of new ELISA Tests
for ELISYS 2
1 28.10.2003
01/2003-10
CHANGE: Updated rack description
Update ELISYS 2 PLUS
User Manual ELISYS 2 PLUS 3/74
78 #./0-96,/#-.
78:8 9!$,0#(/#-.
The purpose of the automated microplates analyzer ELISYS 2 PLUS is to analyse samples on microplates; it
has been specifically conceived to automatically process up to 2 plates on line.
This manual provides the operator with all the necessary instructions for a safety, suitable use as well as the
instrument maintenance recommendations.
Manual content:
;& <=>?@A*B><@=&
;& +CB><@=&:&;&
;& +CB><@=&'&;&
;& +CB><@=&D&;&
;& +CB><@=&E&;&
;& +CB><@=&F&;&
;& +CB><@=&G&;&
;& +CB><@=&H&
;& +CB><@=&I&
This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the maintenance operator’s availability.
For accurate installation, use and maintenance, please read the following instructions carefully.
In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY WARNINGS” Section
1, describing the suitable operating procedures.
In case of breakdowns or any troubles with the instrument, apply to the local Technical Service.
- warranty information and the CE conformity declaration
general safety-warnings;
general information such as the producer data, instrument description;
instrument performances, technical data;
installation and start up;
operating instructions;
the user’s periodic maintenance and checking and the repair policy;
- how to put the instrument out of service, packaging, transport instructions;
– Appendices including instrument decontamination and spare parts list .
78'8 6$!0&J5005./%
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.
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.
4/74 User Manual ELISYS 2 PLUS
$!,/#-.&:
:8 K!.!05"&$52!/%&J50.#.K$
:8:8 95.K!0;J50.#.K&$%4L-"$
In this manual the following symbols are to remind the user of the safety rules:
:8'8 #./!.9!9&6$!&-2&/3!&#.$/064!./
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, life 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 us e of chemic al reagents and other dangerous (corrosive, irritant and harmful) CHEMICAL SUBSTANCES which can c ause damages to
people and material. When this label is f ound, pay attention to the producer’s rec ommendations
This symbol indicates that the instrument involves the handling of samples which can be infected (urine and human serum). In this c ondition INFECTIONS or CONTAMINATION might
occur. Pay attention to the general safety warnings when in pres ence of such biological substances. Use protective clothes, gloves and glasses.
This symbol indicates that damages to the instrument and/or its inc orrect results could 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.
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 PLUS 5/74
:8D8 6$!&-2&/3!&#.$/064!./
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.
M*N)<O<CA&6+C?
!
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).
M*N)<O<CA&/CBP=<B<N=
!
using the original spare parts.
has to make sure that environmental condition is suitable, the installation is correct, the use
is entitled to maintain and fix the instrument, according to the instructions received and
5)>C?N><@=+&@O&>PC&<=+>?*QC=>&N?C&R?@P<S<>CA8&/PC&*+C?&<+&)<NS)C&O@?&N=T&<=+>?*QC=>&<QR?@RC?&Q@A<;
O<BN><@=&N+&UC))&N+&>PC&AC?<V<=W&B@=+CX*C=BC+8
Should the instrument need extraordinary maintenance, ask for
3*QN=&$C?V<BC&
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.
6/74 User Manual ELISYS 2 PLUS
$!,/#-.&'
'8 K!.!05"&#.2-04 5/#-.
'8:8 #.$/064!./&9!$,0#(/#-.Y&(60(-$!&5.9&2!5/60!$
ELISYS 2 Plus (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.
fig. 2.1
'8'8 45.625,/60!0Z$ !./#2#,5/#-.&"5L!"
4NAC&<=&!,
4N=*ONB>*?CA&O@?&3645.
KQS3&KC?QN=T
5((508Y
,N>8;&.@ $!0#5"&.8
25L0#,5/!9
User Manual ELISYS 2 PLUS 7/74
'8D8 #.$/064!./&9!$,0#(/#-.
The instrument that is shown in figure 2.2 is composed of:
Instrument framework and protection lid
Control system run by electronic parts
Aspirating and dispensing system
Mechanical arm carrying a dispensing needle
Movable photometer and plate washer
Work area with: two microplate places, a washing basin, reagent trays, a tray for samples and two predilution
plates.
Protection lid
Arm
Photometer and
Plate washer
Needle
Work area
fig. 2.2 Front view (Lid lifted up)
8/74 User Manual ELISYS 2 PLUS
'8E8 #.$/064!./&4!5$60#.K&(0#.,#("!
Below (fig. 2.3) is the diagram representing the main functional elements of the instrument photometric section.
A monochromatic filtered beam of light produced by a lamp goes through the well containing the sample. Part of
the light is absorbed by the sample, the remaining one is detected by a photodiode. The photodiode converts the
received light in an electrical signal that is once again transformed into frequency. By this frequency the microprocessor calculates the absorbance, taking in account of the blank measure carried out at the beginning. The
following is the formula to calculate the absorbance:
!"#$%&'$()*+,-$./0120,345$6$%&'$(7+89*0$./0120,345
:&&&"54(&
'&&&"!.$
D&&&9#5(305K4
E&&&J!""
F&&&#./!02!0!./ #5"&2#"/!0$
G&&(3-/-9#-9!
1
3
2
4
2
5
2
6
X
8
fig.2.3
User Manual ELISYS 2 PLUS 9/74
channels
$!,/#-.&D
D8& #.$/064!./&/!,3.#,5"&95/5
D8:8 45#.&2!5/60!$
!"#$%&'("$)*!'
ELISYS 2 PLUS is a fully automated analyzer able to carry out up to 8 tests on two microplates.
#*'+,(#
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.
%(*-("$#
Modular trays for calibrators, controls, conjugate, chromogen, stop solution, reagents and sample dilution.
%(*.$!/")*%(*
Max location of 2 microplates with 96 wells each which can be incubated at programmable temperature.
0!#+("#*$!/"
An arm with three directions (x, y, z axis) carrying a level sensor dispensing needle.
In the aspiration phase, the sensitive needle stops at liquid meniscus level to reduce contamination.
1*#2!"-
Needle: external surface by dipping it into the washing basin with flowing water; internal surface by dispensing
the washing solution in the washing basin discharge.
Plates: one 8-channel dispensing manifold, able to run two independent washing solutions
one 8-channel manifold to drain a row of wells at one time
/+$!.*,)#3#$('
Reader: 8 photometric channels equipped with lenses, interferential filters and lamps.
Results: available at the end of the work session to be stored and printed.
(4$(%"*,),!5&!0)./"$*!"(%#
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),
#/6$1*%(
A PC software, run by WINDOWS ’95/’98, allows to:
set up the requested analysis and to process on line different methods
give to the instrument the relevant commands
receive and transfer the analysis result
print and file the results
memorise the calibration curves.
10/74 User Manual ELISYS 2 PLUS
D8'8& #.$/064!./&/!,3.#,5"&$(!,#2#,5/#-.$&[\]
PROCESS CAPABILIT Y
WORK AREA
Microtiter plates
"
Sample tray
"
Common reagent trays
"
Specific reagent trays
"
Predilution plates
"
PREDILUTION
DISPENSATION
DISPENSATION SYRINGE
Total volume
"
Minimum volume
"
Accuracy
"
PIPETTING SPEED
Samples
"
Reagents
"
CARRY OVER
LIQUID SENSORS
Sample dead volume
"
Reagent dead volume
"
MICROPLATES W ASHING
NEEDLE W ASHING
Combination up 8 assays on 2 microtiter 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 ass ay category), for substr ate, stop solution,
cleaner, dilution s olution bottles, c ommon reagents
different types (depending on the specific assay), for c alibrators, controls, specific
reagents
2 plates, eac h one with 20-wells
Programmable for each sample,
Three freedom degrees Arm (x, y, z axis) carrying 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 s ession
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 O.D.
from 1.500 to 3.000 O.D.
Stability (short term)
"
About 10% (*) of reagent aspirated for all the assays
(*) used for cleaning the s ampling 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 temperature (Ta) or programmable fr om Ta+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 O.D. (Optic al Density)
$ 1% or $ 0.010 O.D. whichever the bigger
$ 2%
0.001 O.D. in 1 minute
User Manual ELISYS 2 PLUS 11/74
:;<=>?@A;=$=ABC;:BD%$<EAB :F:BD=:!;<
(B&,GH,20I5
SERIAL INTERFACE
ELECTRICAL POW ER REQUIREMENT Standard 220 or 110 V ac 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 f eatures 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 electric al material
"
89/336/EEC r egarding Electromagnetic Compatibility
"
93/68/EEC regarding the CE mark
"
Safety:
EN 61010-1 (1994) / C EI 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 s olution.
!
A 10-liter waste tank
!
RS232 PC connection cable
!
Software for PC to master the instrument
!
(On request: BDE Installer for Microsoft Windows 98 II. Edition)
!
The PC minimum requirements are:
Microsoft W indows 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 MHz
!
Display adapter standard VGA 640x480
!
Printer
!
12/74 User Manual ELISYS 2 PLUS
$!,/#-.&E
E8 #.$/5"" 5/#-.&5.9&$/50/;6(&#.$/06,/#-.$
#=+>N))<=W&N=A& +C>><=W&*R&>PC& <=+>?*QC=>^&>PC&+NOC>T&UN?=<=W+& N=A& WC=C?N)&?*)C+&AC+B?<SCA& <=& $CB><@=&:
Q*+>&SC&@S+C?VCA8
JN?=<=W_&&UPC=&Q@V<=W&@?&)<O><=W&>PC&<=+>?*QC=>&B@=+<AC?&Y
#.$/064!./&J!#K3/&
!
(5,`!9&#.$/064!./&J!#K3/&
!
&I7&`W
%%%%
&:77&`W
%%%%
E8:8 6.(5,`#.K
The instrument is packed with a plywood box, which can be easily moved by a lifting trolley.
Be careful when placing the instrument onto the work area.
To unpack the instrument follow the instructions as below described:
" Remove the packaging band around the plywood box.
" Lift the plywood box straight up from the bottom plate and place it beside the instrument.
" Remove the packaging band and the protective plastic sheets around the instrument.
" Unscrew the four 10 MA screws fixing the instrument body to the bottom plate of the box.
" Save the empty box and the fixing screws for future transportation.
If the instrument was already in use check for the
manual).
("!5$!&$51!&/3!&!4(/%&L-a&_
used in future transportation.
This box is designed and manufactured for this instrument only and should be
9!,-./54#.5/#-.& 9!,"505/#-.
(see Appendix A of this
User Manual ELISYS 2 PLUS 13/74
E8'8 ("5,#.K&/3!&#.$/064!./
The instrument has to be placed on a levelled bench, assuring enough free space around the instrument to allow
#
maintenance operations (35
Room temperature has to be between 10 and 30 °C with relative humidity below 80%; protect it from direct sunshine.
50 cm on the rear and on the lateral sides).
E8D8 (-J!0&$6(("%
Once the instrument and its outfit have been placed, plug it to the right power source using the supplied cable.
fig.4.1
JN?=<=WY&QNbC&+*?C&>PN>&>PC&C)CB>?<BN)&R@UC?&+@*?BC&<+&>PC&@=C&N+&?CX*C+>CA&N=A&<=A<BN>CA&@=&>PC
)NSC)&SC+<AC&>PC&<=+>?*QC=>&R@UC?&+@BbC>&_
c&&''7&1d&&@?&&::7&1d&e
JN?=<=WY& QNbC& +*?C& >PN>& >PC& O*+C+& VN)*C& B@??C+R@=A+& >@& >PC& @=C& <=A<BN>CA& SC+<AC& >PC& O*+C
P@)AC?_
''7&1NB&QN<=+&&&
::7&1NB&QN<=+&&&&
&'&&X*<Bb&O*+C+&D8F&5
&&&&
&'&&X*<Bb&O*+C+&&&H&5
&&&&
14/74 User Manual ELISYS 2 PLUS
E8E8 J5$3&5.9&J5$/!&,-./5#.!0&#.$/5""5/#-.
In figure 4.2 are shown the washing/discharging containers and their connections with the instrument.
Blank
Red
$
5
L
WASTE
WASTE
RS 232
LEV EL CONTROL
0
Wash
buffer 1
Blank
J5$3
JN+P
S*OOC?&
&&&&:
$
5
L
/:
/'
/D
/E
/D
Precision Syringe
Peristaltic Pump for needle external washing
Peristaltic Pump for Microplate washer
JN+P&S*OOC?&:Y
JN+P&S*OOC?&'Y
JN+P
: bottle for the needle external washing solution (see note 1).
JN+>CY&
tank to collect the waste.
bottle for the microplates washing solution (see note 1).
bottle for the microplates washing solution.
/:
Wash
buffer 2
JN+P
S*OOC?&
&&&&'
/'
Red
J5$/!
/E
0
Level control connector
fig. 4.2
User Manual ELISYS 2 PLUS 15/74
0
Before switching on the instrument:
" fill up the T1, T2, T3, bottles with the right solution according to the method requirement
" place the T4 empty container (waste)
" connect the tubing to their relevant container as shown in figure 4.2.
" make sure that the tubing are properly connected and that they are in good condition.
" plug the lead of the level sensor to the instrument socket (connector R).
;&G0$J$K$DG$GL0$0,I$&.$+$M&/-$7077H&,N$&/$.&/$73L0I2*0I$8+H,G0,+,30N$GL0$H,7G/280,G$/012H/07$+$M+7LH,'$343*0O$:,$GLH7$3+7
P
"
)&GG*0$ =J$L+7$ G&$ )0$ 72)7GHG2G0I$MHGL$ +,$ 012HQ+*0,G$ )&GG*0$ 3&,G+H,H,'$ IH7GH**0I$M+G0/$ &/$ I03&,G+8H,+G H,'$ 7&*2GH&,$ .&/
8+,H.&*I$3*0+,H,'$(700$<03GO$R5O
"
)&GG*0$=S$L+7$G&$)0$72)7GHG2G0I$MHGL$+,$012HQ+*0,G$)&GG*0$3&,G+H,H,'$I03&,G+8H,+GH,'$7&*2GH&,$.&/$,00I*0$H,G0/,+*$+,I
0TG0/,+*$3*0+,H,'$(700$<03GO$R5O
E8F8 J-0`&50!5
Figure 4.3-a and fig.4.3-b show a typical work area layout.
Needle
Washing
basin
M icroplates
Reade r/ W ash er
Group
1
11
21 31
2
3
4
5
6
7
8
9
10
Samples
tray
Dilution
solution
bottles
S u b s tra te
S top so lu t io n
Cleaner
Reage nts
tray s
fig. 4.3 - a
fig. 4.3 - b
16/74 User Manual ELISYS 2 PLUS
E8F8: $NQR)C+&/?NT
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).
E8F8'8 /?NT+&O@?&0CNWC=>+&N=A&,@=>?@)+
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.
E8F8D8 (?C;A<)*><@=&()N>C
The pre-dilution plate is a moulded 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).
E8F8E8 4<B?@R)N>C
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).
1789:9;<)=>)?8@A@9=):9B=8CD@9=)=8>CEF@B)GC8:9;)D:H8>?F7=@)I7BJ:9;)B@KC@9H@L)7FF)=J@)8@KC@B=@G)B=:?B)DCB=
E@)H>D?F@=@G)I:=J)=J@)M)I@FFB)N
fig.4.3 -b
E8F8F8 JN+P&LN+<=&O@?&>PC&.CCA)C
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.
E8F8G8 0CNAC?&f&JN+PC?&K?@*R
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.
User Manual ELISYS 2 PLUS 17/74
E8G8 &!"#$%$&'&("6$&;&(,&,-..!,/#-.
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 9-pin male
connector and/or a 25-pin male connector.
A connection cable PC- ELISYS 2 PLUS 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.
5
2
374
2 Tx
3 Rx
4 DTR
5 GND
Fig. 4.4 RS232 serial port located at the instrument right side
7 RTS
E8H8 $-2/J50!&#.$/5""5/#-.&-.&(,
E8H8:8 (,&4<=<Q*Q&0CX*<?CQC=>+
"
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 .
E8H8'8 $@O>UN?C&#=+>N))N><@=
AP 2 is the program specifically developed for ELISYS 2 PLUS.
To install AP 2 program on the PC place ELISYS 2 PLUS 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
$C>*R8CgC
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 PLUS icon is available on the desktop. Double click on it to run
the program.
%@D78O<)6>8)':H8>B>P=)1:9G>IB)QM) !!R)(G:=:>9) S>C) 9@@G) =J@) T0(U!9B=7FF@8) A@8B:>9) VRW)) X) B=78=) T0(U!9B=7FF@8
7FB>)I:=J)#@=C?R@Y@ZR
18/74 User Manual ELISYS 2 PLUS
$!,/#-.&F
F8 -(!05/#.K&#.$/06,/#-.$
F8:8 #./0-96,/#-.
The instrument requires the use of chemical reagents and other dangerous (corrosive, irritant and harmful)
F8:8:8 -RC?N><=W&-VC?V<CU
Table 5.1 shows the general operating sequence.
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 c an be infected (ur ine and human serum). In this condition
INFECTIONS or CONTAMINATION might occur. Pay attention to the general safety warnings as to the
presenc e of such biological substances. Use protective c lothes, gloves and glasses.
In particular:
Wear protective clothes and gloves.
!
At the end of a work Session, clean the work panel and its access ories carefully by using a cloth soaked
!
in a 0.5% sodium hypochlorite solution.
Waste material produced by the analytical and cleaning process is a dangerous material which might
!
contaminate people and material. Get rid of the waste material acc ording to the local regulations.
WO RK SESSION
Work session
setup
Run Analysis
PC sw itch in g on
and program start
Start w ork ses s ion
or
other functions?
Par. 5.2
Par. 5.3
/NS)C&F8:&f&KC=C?N)&@RC?N><=W&O)@U&A<NW?NQ
OTHER FUNCTIONS
Par. 5.4
Par. 5.5
Par. 5.6
Par. 5.7
Databases
Settings
Commands
Help
User Manual ELISYS 2 PLUS 19/74
F8:8'8 (@UC?<=W&>PC&#=+>?*QC=>
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:
(-J!0
06.
!00-0
green lamp
yellow lamp
red lamp
indicating that the instrument is switched on
indicating that the instrument is in running phase
indicating that no liquid is inside some container of the work panel
(
;&G0$J
)
;&G0$JP$=L0$8+3LH,0$M&,UG$7G&9N$)2G$GL0$IH79*+4$7L&M7$GL0$Q&HI$9&7HGH&,7O
F8:8D8 (,&(?@W?NQ&$>N?><=W
The ELISYS 2 PLUS icon is available on the desktop. Double click on it to run the
program.
The main menu will appear:
F8:8E8 -RC?N><=W&4C=*
Tables 5.2 and 5.2a show the instrument operating menus and their function.
4C=*&O*=B><@=&CgR)N=N><@=
20/74 User Manual ELISYS 2 PLUS
$C++<@=
New To start a new work session.
Modify
To modify the setting of the last loaded session, if processed or not. If no
session has been programmed, it assumes the New function as the previous
paragraph.
Show lab results Display of existing Labfiles
Lab Printing
To print all the information concerning each analysis session already processed, values for the samples, controls and standards, as well as any mistake if any.
Printer Set-up
Single Steps
To set up the printer
Activates the single steps operation
Run This command runs the working procedure, if a session has been set up.
Last results
display
Activates the display of the results of a processed but not stored working
session.
Exit Exit from the program.
9N>NSN+C+
Medical report
Displays the stored medical reports. They can be accessed or by the patient's name and/or the execution session date.
Patient card To display, modify and insert the patients in the database.
Notes
To display, modify and insert the sentences frequently used and associated
to the notes in the report.
Assays To display, modify and insert the parameters for each method.
$C>><=W+
Lab name To set the heading to be printed on the lab printing reports.
Doctor’s name To indicate the doctor's name on the analysis report.
Serial port To choose the serial port or simulation mode
Password To insert or modify the password.
Ext. incubation Enables the external incubation function.
,@QQN=A+
Needle prime To prime the needle.
Washer prime To prime the washer.
Micro-plate
To set the number of strips to be washed.
washing
Micro-plate
To set the number of strips to be emptied.
aspiration
Temperature test To set the reference temperature and to monitor it continuously.
Movements test To check the instrument's moving parts and show any bad functioning.
3C)R
About…. To display all the information concerning that software version.
Software To display the software interactive guide.
User Manual ELISYS 2 PLUS 21/74
F8'8& J-0`&$!$$#-.&$!/6(
From the
Remark:
From the
<077H&,
B*H3-H,'$&,$V;0MV$GL0$808&/4$3&,G0,G7$&.$GL0$+99*H3+GH&,$+/0$/070G$+,I$GL0$9/0QH&27$/072*G7$+,I$70G$297$+/0$*&7GO
<077H&,
menu, click on
menu, click on
to access the
;0M$
@&IH.4
previous working session can be modified.
$! "!, /
(0 - 2 #"!
Par. 5.2.1
E/&.H*07$<0*03GH&,
window which shows the blank fields.
to access the Profiles Selection window. The stored setting up of the
STA RT
SESSION
New
SELECT PR OFILE
Modify
$! /
(5054 !/ !0$
Par. 5.2.2
$5 4 ( " !
$!//#.K
Par. 5.2.3
OK
SET PARAMETERS
page 1/4
SAMPLE SETTING
OK
RUN ANALYSIS
Par. 5 .3
CALIBRATION CURVE
(for Quantitative assays only)
PATIENT CARD
Par . 5 .2 . 3. 1
PATIENT DATABASE
/NS)C&F8D&f&$C++<@=&+C>;*R
22/74 User Manual ELISYS 2 PLUS
Loading...