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IMMUNOASSAY AUTOMATIC ANALYZER of 70

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OPERATOR’S MANUAL REV. 2.0

OPERATOR MANUAL

ATOM
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INDEX

DESCRIPTION AND USE DESTINATION 3

WORKING PRINCIPLE 4
TRANSPORT AND MAINTENANCE 4
INSTALLATION 5
INSTALLATION PLACE’S REQUIREMENTS 6
ESSENTIAL REQUIREMENTS 7
 GENERAL REQUIREMENTS 7
 PLANNING AND MANUFACTURING REQUIREMENTS 8
1. Chemical And Physical Features 8
2. Infection And Microbic Contamination 8
3. Manufacturing And Environmental Features 9
4. Device Built With Measurement Instruments 10
5. Protection Against Radiations 10
6. Requirements For Device Linked To Or Equipped With Power Supply 10
7. Requirements For Autodiagnostic Tests Devices 11
8. Manufacturer Informations 11
INSTALLATION PROCEDURE 13
 UNPACKING & CHECKING 13
 STARTING MACHINE 15
SOFTWARE USE 16
 PARAMETERS & METHODICS INPUT 18
 METHODIC INTRODUCTION - QUANTITATIVE EXAM 20
 METHODIC INTRODUCTION - QUALITATIVE EXAM 25
 FORMULA’S SELECTION & INTERPRETATION 29
 INSERT SAMPLES 31
 LOADING AND STARTING PROCEDURE 39
 QUANTITATIVE RESULTS 48
 CURVE MANAGING 52
 QUALITY CONTROL 54
 QUALITATIVE RESULTS 62
 INSTRUMENT SHUT-DOWN 66
DISMANTLING INSTRUMENT 67
PROGRAMMED MAINTENANCE 68
TECHNICAL SPECIFICATIONS 69
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DESCRIPTION AND USE DESTINATION

“ATOM” device, realized by MAROCHE s.r.l. company, is an automatic immunoassay

analyser with reagents, useful to do diagnostic measurement “in vitro” of analytes in
plasma’s samples. It can satisfy versatility and accuracy requested in a modern clinical lab.
The analyser was planned as a system that fits the majority of immunoassay tests that
require photometric measurements.

Usages different from normal instrument usage are not and won’t
be allowed.

Manufacture decline every responsibility for damage or injuries to

people and thing deriving from device’s wrong or unauthorized
usage.
Note

Results obtained with immunoassay systems, can be changeable relating

to specific features of reagents kit used. Before proceeding with using
the system to use the system to make the effective analysis of collected
samples, the user has to set methods for every test (and for any reagent
Note productor) – for example using “ECCLS" or “NCCLS” standards – to
establish correct test parameters. MAROCHE s.r.l. declines any
responsibility for possible errors in analysis results, caused by reagent
kits, and/or by test parameter not given directly by MAROCHE s.r.l.
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WORKING PRINCIPLE
“ATOM” is a immunoessay device that automates all of the different activities that
samples analysis requires.

TRANSPORT AND MAINTENANCE

Just qualified personnel can deal with transport and installation

operations. Personnel must be able to do electric and mechanic
operations, respecting current safety licensing laws.
Note

Automatic analyser, because of his small size, is shipped assembled and ready for the
installation.
Shipping is on buyer’s charge, unless different indications are given in the contract.
In this case, manufacture is not responsible for damages during transport and shipping of
instrument(s).

Don’t throw away pack in environment, put it in a separate collector of

rubbish.

Please pay always attention during moving and unpacking; considering the small size and
the light weight of the pack and of the machine, device lifting can be done manually, by an
authorized operator.
Device lifting must be done very slowly, avoiding sharp movements; equipment must be
placed on an appropriate shelf, resisting and stable, with right dimensions to allow an easy
access and use of the machine.
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INSTALLATION

Automatic analyser must be installed in closed environment, adequately protected from

atmospheric agents, on a suitably pre-set plain, with opportune dimensions to allow an
easy use.

In case of insufficient lighting, is necessary providing installation of an appropriated light

system, so that the staff can act in conditions of normal light.

The building company, MAROCHE s.r.l. is not responsible for the use of some of the
automatic analysers in not suitable environments.

Always leave an appropriate clear zone around the machine, to allow an easy
handling of the well loading strip.

For the installation of automatic analyser arrange a lacing to the power supply attached to
the ground and protected from short circuits, as told in security regulations; power supply
characteristics of automatic analyser are found in the electric schemes.
The machine is equipped with electrical system, according to law 46/90 regarding security
of the plants
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INSTALLATION PLACE’S REQUIREMENTS

- Choose a position for the machine that has to be far from direct sun exposition and
dust.
- Temperature should be inside 15-30 °C range.
- Support Desk must be flat, with no vibrations, and able to support a >40 kg weight.
- Power supply system’s requirements are: 110-240 V A.C.
- Maximum Absorption: 450 watt.

Fig. 1

• Dimensions:

L = 46 cm, H = 49 cm, W = 54 cm

Weight: 30kg

N.B.: The machine has to be put 10 cm far from the back wall.
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ESSENTIAL REQUIREMENTS

In succession “ATOM” automatic immunoassay analyzer manufacturer measurements

are reported to meet safety requirements provided by Community Directive 98/79/CE,
concerning medical-diagnostic “in vitro” devices, and by Legislative Decree 8 September
2000, n. 332, that brought this Directive in Italy.

Particularly, considering that this instrument is not included in devices listed in annex II, A
and B lists, in over mentioned directive and relative decree, and considering that this is not
a device for autodiagnostic test, the manufacturer followed indications listed in Annex III,
that provides for editing a CE declaration of conformity by manufacturer or by his agent.

General Requirements

1. The device was planned and designed in order to avoid that its use compromises,
directly or indirectly, safety and health oh its health operator and third persons. The
device does not get directly in contact with patients, so there’s no danger to
compromise or modify their safety or their clinical situation.
2. Solutions adopted for device construction attained to safety respect principles,
considering developing progress state at manufacturing time.
Manufacturer adopted the best solutions following these principle:
- Risks elimination, as possible;
- Adoption of opportune protection measurements again those risks that are
impossible to eliminate, assuring a suitable information to exposed personnel.
3. The device was projected in order to carry out its all functions, described in previous
chapters of this document; it gives expected performance, regarding analytical
sensibility, diagnostic sensibility, analytical specificity, diagnostic specificity, accuracy,
repeatability, reproducibility, and it does explicate the control of relative known
interferences.
All tests are executed according to well-determined measurement procedures and
bearing in mind measurement systems reference.
4. Features and performance described in previous points, will not be altered in any way,
doing this would compromise safety or health of operators and third parties, and
accuracy of obtained results, for all validity period reasonably expected for this device,
being understood that strains and pressure applied on the device must respect normal
use conditions.
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5. The device was designed, manufactured and packed, in order to protect his features and
performance during stocking and shipping period. Shipping does not require any
particular attention that is different from normal cautions.

Planning And Manufacturing Requirements

1. Chemical and Physical Characteristics

1.1. The device was built and planned in order to give particular attention to analytical
and diagnostic deterioration possibilities, caused by incompatibilities between used
materials and samples, bearing in mind the real use destination of the whole
system. The manufacturer provided to supply sellers with materials in order to grant
high products qualitative performances.
1.2. The device does not give any risk of substances leaking, pollutant or wastes during
the transport; during normal working time, the use of the instrument has to be held
by specialized personnel.

2. Infection and Microbic Contamination

2.1. The device is planned in order to reduce infection risks for health workers that
works with dangerous substances. Analyzing samples loading space is located on the
front of the machine, in order to allow an easy loading of them and of the reagents.
The system must be located on a work shelf that has to have the right dimensions
for an easy work.
2.2. The operator is responsible for adopting all required measurements to avoid risks
linked with the use of chemical substances for clinical laboratories. Specific advices
for used reagents with the device are generally given in the sheets that come with
any chemical substances, included in the packaging.
2.3. Any leak of reagent on the instrument must be eliminated immediately, washing the
surface using a disinfectant.
2.4. All controls, patients samples, and resulting liquids are potentially infective:
manipulation of these substances must be done following international and national
licensing laws regarding laboratories safety.
2.5. Samples (either collected from patients and controls) and resulting liquids must be
considered potentially infective and able to transmit pathogenic agents, carried by
blood, just like, for example, Human Immunodeficiency Virus (HIV), B hepatitis virus
(HBV) and many others. Manipulation of these substances then, must be done
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following licensing laws for safety of the laboratories, in order to reduce as possible
any risk for personnel, wearing suitable protections like gloves, protective masks,
etc. The contact with skin and with mucous membranes must be absolutely
avoided. The same rule is valid also for all the components of the devices exposed
to these substances.
2.6. The requirement is not relevant because the device does not contain biological
substances that can give infection risks. Substances that has to be analyzed will be
treated with caution by specialized and authorized personnel, in order to eliminate
all contamination risks.
2.7. The requirement is not relevant because the device is not destined to be sterilized
and it doesn’t need a particular microbiological state, just a level of cleaning suitable
with a laboratory instrument.
2.8. Packing of the device is done in order to preserve the product without
compromising its cleaning level; anyway all precautions are adopted to guarantee a
correct manipulation of various components that are contained in the device.

3. Manufacturing and Environmental Features

3.1. If the system is used together with other devices or instruments, compromising
expected performance of single machines will be prevented; in this manual,
instructions to do safe connections between different systems will be explained
widely.
3.2. In manufacturing phase we individualized all substances that, during normal use,
will get in contact with the device, that are samples and reagents, chosen according
to the kind of test that has to be run. Preparation of operators responsible for
handling this substances is a safe way to prevent and minimize all the risks
connected with the use of these substances.
3.3. The device was designed in order to advantage ergonomic features and to reduce all
risks connected with external factors, in particular those connected with
electromagnetic fields. The device is screened by a metal cage, linked with
grounding system.
3.4. The device is manufactured in order to reduce fire or explosion risks during normal
use and during the first breakdown.
3.5. The analyzer was designed and built in order to allow an easy disposal of produced
waste, that are reagents that have lost their performance features: Cans for these
reactive were arranged with reduced dimensions compared with to other common
used can, but anyways able to execute the number of tests expected.
3.6. Analysis results are processed by a proper software: productors companies of
reagents will provide, together with reagent, for a sample scale, used to compare
results of analysis obtained, with it.
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4. Device Built With Measurements Instruments

4.1. The device is able to analyze samples by using immunoassay method.
Activity measurement is done by using spectrophotometry relevation methods, able
to give accurate measurements with proper tolerances.
4.2. Readings, in figure, are expressed in legal units, congruent with directive
80/181/CEE of 20 December Council instructions.

5. Protection against Radiations

5.1. The device was planned, manufactured and packed in order to reduce as possible
the exposition of users and third parties to radiations
5.2. The requirement is not relevant because, in normal working conditions, the device
is not addressed to beam radiations.

6. Requirements For Device Linked To Or Equipped With Power Supply

6.1. The device is interfaced by RS 232 Serial com port to a computer provided with the
software, studied to manage methods, patients, curves: this system is designed in
order to guarantee repeatability, reliability, and performances.
6.2. To reduce electromagnetic disturbances a metal cage was built to enclose and
contain the whole instrument, with screening function.
6.3. In normal working conditions, accidental electrical shocks risks are really low. It is
forbidden to operators to work on components under voltage. Just authorized
personnel is allowed to do maintenance or reparation works.
6.4. Protection against mechanical and thermal risks.
6.4.1. Mechanical risks are really reduced, the device is enough stable and able to
resist to strains and stress of working place in which it is located.
6.4.2. There’s no real risks deriving from vibrations; the device is suitably stable.
6.4.3. Sound emissions are not to consider lee shores.
6.4.4. All terminal connected to electric energy has been realized in order to
reduce any possible risk.
6.4.5. In normal working conditions, none of the accessible part of the machine
will reach dangerous temperatures.
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7. Requirements for Autodiagnostic Test Devices

These requirements are not relevant because the analyzer for immunoassay test is not
considered as an autodiagnostic test device.

8. Manufacturer Informations

8.1. The device, upon buying act, comes with all informations required for a correct and
safe use. These informations, prepared by manufacturer, are reported on the label
and in the proper instruction manual, that will be included in the package.
8.2. All informations will come with proper symbols, congruent with licensing laws.
8.3. The requirement is not relevant because the device does not contain dangerous
substances.
8.4. The label placed on the machine report company name and manufacturer address,
device denomination, register number, serial number and manufacturing year.
8.5. Device destination is clearly told in instructions.
8.6. Detachable parts are identified by a lot number and they will be clearly
individualized in instruction manual.
8.7. Manual of Instructions, contains company name and manufacturer address, specific
preservation conditions and use instructions, as well as instructions for a correct use
of the device.

Reagents used are not described because reagent’s choice will be done directly by
technician responsible for analysis; He/she will also decide on the correct
maintenance of work reagent used.

There’s no description about special support equipments for a correct use of the
device, because there’s no need of them.

In the manual is described measurement process, with an indication about

measurement method and measure unit system; find described also some
treatments carried out on samples before being processed by the device
(incubation, diluition).

Calibration information are reported, with indication about realization modality.

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Besides, the number of samples that can be performed in the same time and
independently is clearly indicated, with the description of machine characteristics
that allows to different modules to work in random and independent way.

Periodic controls are expected every 6 months, in order to guarantee the correct
working and safety of the device.

Find listed also washing modality expected for the instrument, always remembering
that device does not need sterilization or special microbiologic state.

The manual lists all the precautions to take, in normal environment conditions,
against exposition to magnetic fields, electric disturbances, electrostatic shocks and
thermal combustion sources.

Find also reported all the conclusions deriving from the analysis of unforeseen risks
connected with use and disposal of the device.

Finally is also reported publication date of user instructions.

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INSTALLATION PROCEDURES

Unpacking and Checking

After you have unpacked ATOM, check that every accessory is present and ensure that
instrument has not broken parts or dents.

Put the instrument upon a flat plan.

ATTENTION:
Remove the blocking knob on the back (Fig. 2) to make the instrument active.

LATERAL VIEW BACK VIEW

Fig. 2
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Now you can go on with cables and wastes bottle installation (Fig.3)

BACK VIEW

Fig. 3

1. Power Cable socket

2. Power Switch
3. RS232 Socket
4. Buffer Bottle
5. Waste Bottle

NOTE: Buffer bottle connection goes on the left side (from back view), while the waste
bottle goes on the right side (from back view).
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STARTING MACHINE
Power switch is located on the back part of the machine. In the front part, on the right side
a led will indicate the state of the system (ON/OFF). It stands beside the RESET button.
In the left part of the front (see Fig. 5) is located the loading zone, to load samples and
reagents. These has to be handled by qualified staff.

Fig. 5
Once you’ve starter the procedure, all the operations will be done automatically by the
analyser, managed by a central system that works with different operations, according to
the exam that is running.

Sample must be introduced in the machine just by qualified and

authorized staff.

On the front is also located and easy to reach, an emergency button, the RESET button.
When pushed it stops the machine and restart it.
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SOFTWARE USE
To open the software in Windows, click on the icon “ATOM”.

You will see the main page:

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All the buttons are here explained:

It allows you to get into the Technical Assistance Menu (Password

required).

Button for Methods Setting.

Button for Working List.

Button for Loading Sample and Reagents.

Button for Starting Procedure.

This Button closes the program.

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Parameters & Methods Input

Pushing this button from the main page:

You will get to this main panel:

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From Here you can choose your kind of test and open its panel:

For Example: “Thyroid”

You can change the name of the test in this page and the button in the main panel will be
also modified.

Then choose the exam by pushing its button.

Doing this you will get into method parameters panel.

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Method Introduction – Quantitative Exams:

In this panel you will see:

Method Name & Description; If you want to make change just click on name and/or
description and tape new text. Previous Panel button will also edited doing this.
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Reminder for samples/standard/controls volumes

Washing Numbers for wells

Concentration of washing buffer, required for automatic

calculation of buffer percentage in washing solution

Time for the water’s soaking inside the well (seconds)

Time of washer’s aspiration inside the well (seconds)

__________________________________________________________________________

When you select YES on ULTRAWASH instrument will perform a

special washing, that it works like this: it will leave each well filled with BUFFER solution
with an automatic SOAK time based on samples number. In this way washing procedure will
be faster and more accurate.
When ULTRAWASH is active, instrument will not take care of SOAK time you have expressed
in TEST PARAMETER page.

In this area you can select an incubation standard, its temperature, and if washing is
necessary or not.
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In this area you can choose the name of the first reagent, edit dispensation volume for
the cuvettes, incubation, temperature, reagent category (conjugate, stop solution etc.).
Then you can choose if washing your cuvettes after.

In this area you can choose the name of the second reagent, edit dispensation volume for
the cuvettes, incubation, temperature, reagent category (conjugate, stop solution etc.).
Then you can choose if washing your cuvettes after.

In this area you can choose the name of the third reagent, edit dispensation volume for
the cuvettes, incubation, temperature, reagent category (conjugate, stop solution etc.).
Then you can choose if washing your cuvettes after.
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In this area you can choose the fourth reagent and its dispensation volume.

Selection of the number of standards required to

make the curve.

Concentration of the standards to work with.

Unit of Measure

Activation of checking cycle. Doing this, the starting procedure

tool will do an optic checking on wells, if the number of cuvettes
is less than required, a video error message will appear on the
screen.

Methodic type Selection (Curve or Cut-Off).

Advice: Select Method type before loading parameters.
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Activation of reading with 620 nM wavelength filter.

With these options you can choose to perform reading

using filter 450 nM + filter 620 nM as reference (450/620), or only 450 nM, or only 620
nM.

This buttons are for exporting or importing parameters with windows

file.

This button makes the program check the parameter loaded. It will tell
if something is unusual or seems to be wrong.

Print on a sheet paper the method just edited.

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Method Introduction – Qualitative Exams

Method Name & Description; If you want to make change just click on name and/or
description and tape new text. Previous Panel button will also edited doing this.
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Reminder for samples/standard/controls volumes

Washing Numbers for wells

Concentration of washing buffer, required for automatic

calculation of buffer percentage in washing solution

Time for the water’s soaking inside the well (seconds)

Time of washer’s aspiration inside the well (seconds)

__________________________________________________________________________

When you select YES on ULTRAWASH instrument will perform a

special washing, that it works like this: it will leave each well filled with BUFFER solution
with an automatic SOAK time based on samples number. In this way washing procedure will
be faster and more accurate.
When ULTRAWASH is active, instrument will not take care of SOAK time you have expressed
in TEST PARAMETER page.

Choose here a standard incubation, his temperature and if wells washing is needed.
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In this area you can choose the name of the first reagent, edit dispensation volume for the
cuvettes, incubation, temperature, reagent category (conjugate, stop solution etc.). Then
you can choose if washing your cuvettes after.

With this option you can activate the dispensation in the first well. You can
choose no when you do tests where dispensing the first reagent is not
needed for the blank.

In this area you can choose the name of the second reagent, edit dispensation volume for
the cuvettes, incubation, temperature, reagent category (conjugate, stop solution etc.).
Then you can choose if washing your cuvettes after.

With this option you can activate the dispensation in the first well. You can
choose no when you do tests where dispensing the second reagent is not
needed for the blank.
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In this area you can choose the name of the third reagent, edit dispensation volume for
the cuvettes, incubation, temperature, reagent category (conjugate, stop solution etc.).

In this area you can choose the fourth reagent and its dispensation volume.

Activation of checking cycle. Doing this, the starting procedure tool

will do an optic checking on wells, if the number of cuvettes is less
than required, a video error message will appear on the screen.

Activation of reading with 620 nM wavelength filter.

Method type Selection (Curve or Cut-Off).

Advice: Select Method type before loading parameters.

With these options you can choose to perform reading using

filter 450 nM + filter 620 nM as reference (450/620), or only 450 nM, or only 620 nM.
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Formula’s Selection & Interpretation

Menu for formula selection.

For Qualitative method, you have to set a formula for Cut-Off calculation, between the
following.

 Formula 1: Cut-Off = Cut-Off * K1

 Formula 2: Cut-Off = K1 * [(NEG CONTR)+(POS CONTR)]

 Formula 3: Cut-Off = K1 + (NEG CONTR)

 Formula 4: Cut-Off = [(NEG CONTR) + (POS CONTR)] / K1

 Formula 5: Cut-Off = K1 * (NEG CONTR) + K2 * (POS CONTR)

 Formula 6: Only Cut-Off

 Formula 7: Stored Cut-Off

K1 and K2 are given by kit manufacturer.

Grey-Zone is given by kit manufacturer and depends on kit tolerance.

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With this selection we decide if patient is positive when his absorbance is more or less of
the obtained Cut-Off.

This buttons are for exporting or importing parameters with

windows file.

This button makes the program check the parameter loaded. It will tell
you if something is unusual or seems to be wrong.

Print on a paper sheet the method just edited.

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Insert Samples

To begin with choice of tests and samples inserting, push this button:
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You will get into insert panel:

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For a good use of the program follow this steps:

Select first test by pushing SELECT in the first column:

You will reach methods panel. Here choose the group of exams.
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Then choose the test:

And you will automatically brought back to the insert panel

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You can load up to 8 different (but compatible) tests and 16 samples.

When you run quantitative methods select the calibration:

Choose Yes or No for calibration

If you want to run a second method, which is compatible with the first,
click on select and follow the same procedure listed above.
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Choose to dispense the standard automatically or not

In the SAMPLE column type in

or load names with a barcode
reader.
Then select in the 1° TEST
column which patient has to
run the first test by clicking on
NO, the button will turn into
YES.
Combine all your patients with
their test, for example:

 Patient n°1 will run Test

1 and 2
 Patient n°2 will run
only Test 1
 Patient n°3 will run Test
2, ETC.

If you want to disable a test for

all the patients, you should
push the OFF button.
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This is an example of a running session with 4 patients and 4 tests:

In the bottom of this screen you will see:

The number of cuvettes of a Mycroplate. When you load tests and samples
this number will decrease, if it reaches 0 you’ve just reached the maximum load
possibility of the device

Open or close the tray.

Once you’ve loaded all tests and samples information click on SAVE WORK or you will
lose your session:

If you want to load a previous work click on load work

Once you’ve done, REMEMBER TO SAVE THE WORK and then click on
LOAD SAMPLE to access the next screen
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In the end click on load sample to insert the strip into the machine.

This means that these two methods can not be run together
because they have different parameters, so check or erase the second method.
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Loading And Starting Procedure

We can reach the direct loading by using the button “load sample” from the main menu,
or run the loading from insert panel, like we have seen in previous pages.
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This is loading panel

On the screen you will see a representation of the throughput and the software tells you
how to fill it out.

This panel shows you the percentage of buffer and water, needed for
the procedure. You can also proceed an hydraulic filling by pushing the
proper button.
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On the left part of this panel you will see the

samples position, those marked in yellow
has to be filled with the right patient sample
(see below) to run the procedure you
loaded.

On the right part of this panel you will see

reagent position, those marked in green has
to be filled to run the procedure. The
software calculates which reagents you have
to use and their quantity (see below).

The small circles are for disposable tips,

those marked in black has to be filled with
tips

On the left part of the screen you have a

resume of the patients you’ve loaded with their names or codes, and their needed
volume.
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In the lower part of the screen the software tells you what reagents to use and their
quantities.

This panel, located in the left part of the screen is a representation of a standard
microplate for ELISA tests, and the grey cuvettes are those that has to be filled.

By pushing “SAMPLE DETAILS” you will access to another screen (see below)
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This is a SAMPLE DETAILS panel of a more complex session with 2 patients and 3 tests.
Basically on the left side of the screen you will see the cuvettes you have to put in the
microplate. The yellow one and the blank one has not to be filled, while you should fill
manually the positive control cuvettes (red one), negative control (green one) and
standard cuvettes with the volumes listed on the lower part of the screen and the
concentrations reported on the blue panels.
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Starting a Procedure
By pushing start on the main screen or in the loading page, you will access the start page:

This is an example of a start page of a session running 4 patients and 3 tests, you will see the ID of
the patients and the curves of the exam or the cut off panel. By clicking on cut off you will access
the formula panel, while clicking on the curves you will access the curve panel (see below)

Push reset button and wait the light circle to become green (not red)
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After that close the tray by pushing the proper button and Start the machines pushing:

Give a confirm that you’re really beginning to work:

This message means that pc and analyser are communicating:

 N.B.: Don’t reset or switch off instrument when you see this message. If you
have to switch off wait for this message to disappear.
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When the message disappears the analyser will begin his work that will be showed on
the screen with times of every steps.

When the work will be over the machine will unlock keys, and End-work spy will be
switched on together with times resetting
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Now you can click on the showed curve or cut-off to get results.
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Quantitative (curve calibration) Results

In this page you need to press “CALCULATE” button to have results , and if you put also
calibration the new curve is shoved on the graphical, and this window will be appear
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If you want to save the curve as showed you must push “YES” now , or you have the
absorbances interpolated whit the old curve stored
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Then print results on paper, if you want, with this button:

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If you want to make an historical record of patients and curves, you can store all of them,
just clicking on Save Record and open that in future clicking on Open Record.

File will be stored in a directory that the user will choose.

If the work is over click on

 N.B.: For switching off instrument refer always to “Machine Standby” Chapter.
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Curve Managing

Starting from ATOM software 2.1.0 version you have opportunity to choose curve between
B-Spline, T-Spline and 4 parameters (Bi-Quadratic)

You will find:

Calibration Date

Patient Id(s), absorbances and results.

For Example
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Absorbances & Concentrations of calibrators. You can edit them by clicking on them and
taping new information. Then click on redraw and on save curve if you want to store this
changes.
And if you want know new interpolation of absorbances press on “CALCULATE” button
near that

Print just the curve on paper by pushing this

button

If the work is over click on

 N.B.: For switching off instrument refer always to “Machine Standby” Chapter.
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Quality Control (Quantitative Results)

If you need to use quality controls, software is able to manage 2 levels for every single
test.

Control must be loaded like a normal sample.

When procedure is over and you’ve got concentrations, double click on the name.
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So you will see quality control-saving page:

6
CONTROL
6.5
4.0 1234
9.0 01/01/2020

ID of control 6 Control Name

CONTROL
Concentration Obtained 6.5

1234 N° lot
4.0

9.0 01/01/2020 Expiration Date

Control
Selection
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Control Range

If you want to accept the control obtained, click on Control and then click on Save
control:

*N.B.: Range, Name, Lot, Exp. Date cannot be modified in this page. You can edit them
in Managing control panel.
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To get to managing control panel click, in the start page, on the curve area to open curve
managing.

Simple
Click
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You will find these buttons:

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If you click on it/them, you can open control managing panel:

Where you will find

Date & Concentrations of stored controls

Exam Name
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Control Name, click on it to edit and type new text

Expiration Date, click on it to edit and type new text

Lot number, click on it to edit and type new text

Control Range, click on voices to edit and type new text

Mean Calculated, SD &

CV percentage

Button to print control page

Reset button for control. If you click on it and then you click on YES, the control will be
resetted in all its parameters
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The “SAVE” button allow you to save the control in a directory,

decided by yourself.

This button loads a page previously recorded.

Graphic point of the quality control obtained

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Qualitative Results

When the page open , we will find the absorbances of all sample ,cut-off and/or control .
To obtain the result we need only to press the “CALCULATE” button :
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Example of results
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Means that sample is “Positive”

Means that sample is “Negative”

Means that sample is on “Grey Zone Positive side”

Means that sample is on “Grey Zone Negative side”

Means that sample have the same absorbance of Cut-Off

This is the formula setted on the test’s parameter

This is the measured blank value

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These are the (in this case we select 3 times neg control) measured absorbances of
NEGATIVE CONTROL , software will provide to make mean value of these

These are the (in this case we select 3 times Pos control) measured absorbances of
POSITIVE CONTROL , software will provide to make mean value of these

Final Value of Cut-Off

This bottom is used if the customer wants to save Cut-Off

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Instrument Shutdown

After you have completed daily work, before you switch off the machine you should wash
it with cleaning solution, in order to keep the instrument clean. You can do this by
providing an Hydraulic Filling (refer to Loading Sample section).

Now you can quit the program. And shut down the device
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DISMANTLING INSTRUMENT

Adopt all possible measurement to recycle all different materials that

has been used in analyser construction.

Electric Parts, conductors and copper and insulation materials, has to

be directly collected as special wastes.

Dismantling operations have to be done following instructions about safety to avoid on-the-
job injuries.
These operations must be done just by qualified personnel, capable to perform necessary
mechanical and electric works respecting safety licensing laws.
Dismantling operations do not give any particular safety risk for personnel or environment;
anyways follow this simple advice:

 Close the access to dismantling zone for unauthorized personnel;

 Close every electrical link with external environment;
 Perform a differentiated dismantling.

Destroy or erase the label.

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PROGRAMMED MAINTENANCE

Maintenance works has to be performed when the device is not active, to avoid any risk or
danger for the operator, and has to be performed by authorized and trained personnel. For
trained personnel we intend:
- People that attended to a Training course about ordinary and extra-ordinary
maintenance
- People demonstrating good skills on maintenance
A periodic control of device is expected every 6 months to verify efficiency, performance
and correct working.

Daily Maintenance
 Empty out the strip (change reactive can, put away cuvettes, put away tips,
disposed clean the tube for washing solution).
 Shutdown with washing solution

Six - monthly Maintenance

 Change tip and O-ring of the syringe;
 Clean and oil mechanic movement parts;
 Clean electrovalve;
 Clean tip grip;
 Clean washer grip.

Annual Maintenance
 Change tips grip;
 Change silicone tubes;
 Change syringe;
 Check photometry;
 Check belts tension.
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INFORMATIVE NOTE:

To the attention of Operator using MG 164, if something following could occure:

1.a. every dysfunction, fail, instrument changing in features or performance,
nonetheless every lack in label and/or this manual that could, directly or indirectly,
cause or participate in been cause of death or going worst of patient health status or
user or third person;
1.b. every cause of technical or sanitary order related to instrument features or
performance that could force, because of one or more than one of the points expressed
in 1.a, an instrument call back from market by producer;

must be immediately communicate to Maroche S.r.l. using following contacts:

phone: 0039 095 7557039

or
E-mail: info@maroche.it
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TECHNICAL SPECIFICATIONS