Maroche MG164 UM

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IMMUNOASSAY AUTOMATIC ANALYZER 74

(EIA-ELISA) “MG 164” Issued:
18/05/2011
OPERATOR’S MANUAL REV. 3.3
OPERATOR’S MANUAL
MG 164
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INDEX
DESCRIPTION AND DESTINATION USE 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 Feature 8
2. Infection And Microbe 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 Auto diagnostic Tests Devices 11
8. Manufacturer Informations 11
INSTALLATION PROCEDURE 13
 UNPACKING & CHECKING 13
 INSTRUMENT FIRST RUN 16
SOFTWARE USE 17
 PARAMETERS & METHODS INPUT 19
 METHODS INTRODUCTION - QUANTITATIVE 21
 METHODS INTRODUCTION - QUALITATIVE 26
 FORMULA’S SELECTION & INTERPRETATION 30
 INSERT SAMPLES 32
 LOADING AND STARTING PROCEDURE 42
 CURVE MANAGING 54
 QUALITY CONTROL 56
 ADDITIONAL OPTIONS 64
 Only Reading 64
 Strip Washing 66
 Instrument Shutdown 68
DISMANTLING INSTRUMENT 70
PROGRAMMED MAINTENANCE 71
INFORMATIVE NOTE................................................................................... 72
TECHNICAL SPECIFICATIONS 73
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DESCRIPTION AND DESTINATION USE
“MG 164” it’s an automatic immunoessay analyzer realized by MAROCHE s.r.l. working 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 analyzer was planned as a system that fits the majority of immunoessay 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 on immunoessay 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
“MG 164” is an 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
The automatic analyzer, because of its 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 instrument.
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INSTALLATION
Automatic analyzer must be installed in closed environment, adequately protected from

atmospheric agents, on a suitably pre-setted 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 analyzers in not suitable environments.
Always leave an appropriate clear zone around the instrument, 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 analyzer are found in the electric schemes.
Instrument 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 consumption: 450 watt.
P
L
Fig. 1
• Dimensions :
P = 57 cm , H = 37 cm , L = 16 cm
Weight: About 20 Kg
P.S.: Instrument has to be put 5 cm far from the back wall.

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ESSENTIAL REQUIREMENTS
In succession “MG 164” automatic immunoessay analyzer manifacturer 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 auto diagnostic 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 do 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 all its functions, described in previous
chapters of this document; it gives expected performance, regarding analytical
sensibility, diagnostic sensibility, analytical specificity, diagnostic specific, 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 requires 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 Microbe Contamination

2.1. The device is planned in order to reduce infection risks for health workers that
works with dangerous substances. Samples loading space is located on instrument
the front side, in order to allow an easy loading for samples and 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
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(HBV) and many others. Manipulation of these substances then, must be done
following licensing laws for safety of the laboratories, in order to reduce as possible
any risk for personnel, wearing suitable productions 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.
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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.
4. Device Built With Measurements Instruments

4.1. The device is able to analyze samples by using immunoessay 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 are 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 Auto diagnostic Test Devices

These requirements are not relevant because the analyzer for immunoessay test is not
considered as a auto diagnostic 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 targeted 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 equipment 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, dilution).
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 MG 164, check every accessory 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 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)
3 4
Fig. 3
1. Power Cable socket + Power Switch

2. RS232 Socket
3. Waste Bottle Connection
4. Waste Bottle
P.S.: If you need to move the instrument, please would you follow these simple steps in
order to safely block it:
- Turn ON the instrument
- Press RESET button
- Once RESET movements are done, turn OFF the instrument and put the blocking
knob on the backside again
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Connect serial cable adapter into USB port of PC, according to the number of modules
used at the same time. (see fig. 4)
P.C. BACK
VIEW
Fig. 4
Be sure to set (in your Windows device manager) Module 1 in COM 1, Module 2 in COM3
and Module 3 in COM 4, because COM2 is usually dedicated to the PC system.
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INSTRUMENT FIRST RUN

Power switch is located on instrument back side. On front side a led will shown system
status (ON/OFF).
On left front side (see Fig. 5) is located the STRIP loading zone, to load samples. These has
to be handled by qualified staff.
EMERGENCY BUTTON
( RESET )
STRIP LOADING ZONE
Fig. 5
Once you’ve started the procedure, all the operations will be done automatically by the
analyzer, managed by a central system that works with different operations, according with
the method that is running.
Samples must be introduced inside instrument by qualified and

authorized staff.
On front side is also located and easy to reach, an emergency button. When pushed it stops
instrument and restart it.
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SOFTWARE USE
To open software from Windows, double-click on the “MG164” icon.
You will enter the main page:

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All the buttons are here explained:
It allows you to get into the Technical Assistance Menù (Password

required).
This button is for opening Manual procedure (Technical Assistance

Reserved).
Button for Methods Setting.
Button for Working List.
Button for Loading Sample and Starting Procedure.
Button for the end-procedure washing.
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 :
From here you can choose your kind of method and open its panel:
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For example: “Thyroid”
You can change the name of the exam in this page and the button in the main panel will be
also modified.
Then choose method by pushing its button.
Doing this you will get into method parameters panel.

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Method Introduction – Quantitative Test:
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
Soak time (expressed in seconds) indicates how many time

instrument will leave buffer solution inside each well before aspires it away, during washing
steps
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, shaking for all incubation (yes/no). 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
In this area you can choose the name of the third reagent, edit dispensation volume for
In this area you can choose the fourth reagent and its dispensation volume.
Selection of the number of standards required to make the

curve.
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Concentration of the standard to work with.
Unit of Measure
Well Type Selection
Do this selection to allow the machine to do an automatic regulation for washing and
dispensations with parameters introduced during assembly. Doing this the user will not
modify parameters any more.
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.
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Method type Selection (Curve or Cut-Off).

Advice: Select Method type before loading parameters.
Activation of reading with 620 nm wavelength filter.
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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Method Introduction – Qualitative Test
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
Soak time (expressed in seconds) indicates how many time

instrument will leave buffer solution inside each well before aspires it away, during washing
steps
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.
In this area you can choose the name of the first reagent, edit dispensation volume for the
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cuvettes, incubation, temperature, shaking for all incubation (yes/no). 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
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.
In this area you can choose the name of the third reagent, edit dispensation volume for
the cuvettes, incubation, temperature, shaking for all incubation (yes/no).
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In this area you can choose the fourth reagent and its dispensation volume.
Well Type Selection:

Do this selection to allow the machine to do an automatic
regulation for washing and dispensations with parameters
introduced during assembly. Doing this the user will not modify
parameters any more.
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.
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Formula’s Selection & Interpretation
Menù for formula selection.

For Qualitative methods, 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: Just Cut-Off
 Formula 7: Stored Cut-Off to load a pre-saved Cut-Off value
K1 and K2 are given by kit manufacturer.

Grey-Zone is given by kit manufacturer and depends on kit tolerance.
* P.S.: The blank will be set in the strip for the first well, negative control or cut-off in the
second and if required positive control in the third.
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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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When you have more than a module installed, please select the module:
You will get into insert panel:

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For a good use of the program follow this steps:
Select first exams by pushing
You will reach methods panel. Here choose the group of methods.
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Then choose the test:

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And you will automatically brought back to the insert panel:

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When you run quantitative methods select the calibration:
If you select YES, the number of calibration points required will be shown. Now select the
number of samples for the first method:
When you run quantitative methods the software will provide to insert automatically
blank, controls or cut-off.
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If you want to run a second method, which is compatible with the first, follow this steps.
You will reach methods panel. Here choose the group of methods.
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Then choose the test:

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And you will automatically brought back to the insert panel:
Choose the number of samples for the second method:
When you run quantitative methods the software will provide to insert automatically
blank, controls or cut-off.
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On the left of the screen you have the resume of the running session.
Calibration Curve
Here we can see our sample loading. IN THIS

CASE we can see calibration curve for the first
method, blank, negative control and positive
control for the second.
First Method Samples
Blank, Controls or cut off for the

second method
Second Method Samples

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In the end click on load sample to insert the strip into the instrument.
Or, if you want to get back to main menu and saving this loading settings, click on:
During loading you could see video message like these:
This means that these two methods can not be run together because they have different
parameters, so check or erase the second method.
This means that you have loaded a wrong number of samples. Check back the loading.
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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:

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Now you can load the strip and start the system:
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Choose your module (the system

choose the first in default)
Put reactive in the correct sequence

given by the software
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Put tips in blue-coloured spaces (white means that no tips are

required)
Introduce washing solution prepared with dilution given by the

software. (the software checks dilution loaded for the method)
FIRST METHOD
SECOND METHOD
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Insert samples, controls, standards in wells and then put that into the strips pushing on
the wells to block them in the strips.
EMPTY FIRST METHOD

EMPTY SECOND METHOD
Push reset button and wait the light circle to become green (not red)
After that insert strip into the machine in the strip loading zone pushing it inside.
Start instrument pushing:
Give a confirm that you’re really beginning to work:

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This message means that pc and analyzer are going to communicate:
P.S.: Never reset or switch off instrument when you see this message. If you need to
switch off and/or reset instrument wait for this message to disappear.
When the message disappears the analyzer will begin his work that will be indicated on the
screen with times of every steps and progress percentage.
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When the work will be over the machine will tell automatically absorbances to computer
that will unlock keys. End-work spy will be switched on together with times resetting
and progress bar.
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Now click on calculate to get results.
You will have:
When you have active calibration:
MG 164
SAVE THE CURVE?
YES NO
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The software will ask you to save curve.
If active calibration was not done you will directly get concentration
Curve is stored automatically

and not shown
Samples calculated with

stored curve
Samples calculated with

second method
Then print results on paper, if you want, with this button:

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If the work is over click on
P.S.: To switch off instrument refer always to “Instrument Shutdown” paragraph.

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Curve Managing
If you want to get to curve panel, double click on the curve.
You will see this panel:

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You will find:

Calibration Date
Patient Id(s), absorbances and results.
For example
Absorbances & Concentrations of calibrators. You can edit them by clicking on it and
taping new information. Then click on redraw and on save curve if you want to store this
changes.
If you want to do a history 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.
Print just the curve on paper by pushing this

button
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Quality Control
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.
CONTROLLO
When procedure is over and you’ve got concentrations, double click on cuvette number.
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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
Control Range
Page 58 of
18/05/2011
If you want to accept the control obtained, click on Control and then click on Save
control:
P.S.: Range, Name, Lot, Exp. Date cannot be modified in this page. You can edit them in
Managing control panel.
Page 59 of
18/05/2011
To get to managing control panel double click, in the start page, on the curve area to
open curve managing.
Double
Click
Page 60 of
18/05/2011
You will find these buttons:

Page 61 of
18/05/2011
If you click on it/them, you can open control managing panel:
Where you will find
Date & Concentrations of stored controls
Exam Name
Control Name, click on it to edit and type new text

Page 62 of
18/05/2011
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
reset in all its parameters
Page 63 of
18/05/2011
This button save a record of the control in a directory, decided by

user.
This button loads a page recorded previously.
Point graphic of the quality control obtained

Page 64 of
18/05/2011
Additional Options
Only Reading
“MG 164” can be used as a simple reader.

To do this follow this steps:
Do a normal id and samples number inserting;

Load wells filled manually and insert strip in the machine;
Go then on loading page:

Page 65 of
18/05/2011
Push RESET button to allow MG 164 to communicate with pc and wait for the button to
become green.
Push “LOAD STRIP” to load strip in the correct way:
When button is green again, push “READ ONLY”:
When automatic reading process is over, proceed with normal calculations
“UNLOAD STRIP” button allows you to unload the strip manually.

Page 66 of
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 Strip Washing
When you do a new method and you have worked previously with another, washing of
the strip with distilled water is suggested:
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In working panel push the button “WASH” and you will see this page:
If you follow the procedure described in the text you will wash the strip automatically.
Page 68 of
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 Instrument Shutdown
After you have completed daily work, before you switch off instrument you should wash
it with cleaning solution, in order to keep instrument clean.
From main page push:

Page 69 of
18/05/2011
You will see this page :
If you follow the procedure described in the text you will do shutdown washing
automatically.
Now you can quit the program.

Page 70 of
18/05/2011
DISMANTLING INSTRUMENT
Adopt all possible measurement to recycle all different materials that

has been used in analyzer 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.

Page 71 of
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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
Semestral 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
Page 73 of
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TECHNICAL SPECIFICATIONS
Page 74 of
18/05/2011

Maroche MG164 UM

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Maroche MG164 UM

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Page 1 of

IMMUNOASSAY AUTOMATIC ANALYZER 74

OPERATOR’S MANUAL REV. 3.3

OPERATOR’S MANUAL REV. 3.3

DESCRIPTION AND DESTINATION USE 3

OPERATOR’S MANUAL REV. 3.3

DESCRIPTION AND DESTINATION USE

Manufacture decline every responsibility for damage or injuries to

Results obtained on immunoessay systems, can be changeable relating

OPERATOR’S MANUAL REV. 3.3

TRANSPORT AND MAINTENANCE

Just qualified personnel can deal with transport and installation

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

OPERATOR’S MANUAL REV. 3.3

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

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

Always leave an appropriate clear zone around the instrument, to allow an

OPERATOR’S MANUAL REV. 3.3

INSTALLATION PLACE’S REQUIREMENTS

P.S.: Instrument has to be put 5 cm far from the back wall.

OPERATOR’S MANUAL REV. 3.3

In succession “MG 164” automatic immunoessay analyzer manifacturer measurements are

OPERATOR’S MANUAL REV. 3.3

Planning And Manufacturing Requirements

1. Chemical And Physical Characteristics

2. Infection And Microbe Contamination

OPERATOR’S MANUAL REV. 3.3

3. Manufacturing And Environmental Features

OPERATOR’S MANUAL REV. 3.3

3.6. Analysis results are processed by a proper software: productors companies of

4. Device Built With Measurements Instruments

5. Protection Against Radiations

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

OPERATOR’S MANUAL REV. 3.3

7. Requirements For Auto diagnostic Test Devices

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

Calibration information are reported, with indication about realization modality.

OPERATOR’S MANUAL REV. 3.3

Finally is also reported publication date of user instructions.

OPERATOR’S MANUAL REV. 3.3

Unpacking and Checking

Put the instrument upon a flat plan.

LATERAL VIEW BACK VIEW

OPERATOR’S MANUAL REV. 3.3

1. Power Cable socket + Power Switch

OPERATOR’S MANUAL REV. 3.3

OPERATOR’S MANUAL REV. 3.3

INSTRUMENT FIRST RUN

STRIP LOADING ZONE

Samples must be introduced inside instrument by qualified and

OPERATOR’S MANUAL REV. 3.3

You will enter the main page:

OPERATOR’S MANUAL REV. 3.3

All the buttons are here explained:

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

This button is for opening Manual procedure (Technical Assistance

Button for Methods Setting.

Button for Working List.

Button for Loading Sample and Starting Procedure.

Button for the end-procedure washing.

This Button closes the program.

OPERATOR’S MANUAL REV. 3.3

Parameters & Methods Input

Pushing this button from the main page: