Minitecno

USER’S MANUAL

Manual code MAN-090 – Revision 02

Revised May 12, 2010
Minitecno – USER’S MANUAL – MNU-81035-01-B I.S.E. S.r.l.

INSTRUMENT NAME Minitecno

Semi-automated photometer
For clinical chemistry in vitro determinations

INSTRUMENT MANUFACTURER I.S.E. S.r.l.

Via delle Driadi, 45
00133 – Rome – ITALY
Phone: +39 06 206 10 289
Fax: +39 06 20 18 131

INSTRUMENT DISTRIBUTOR I.S.E. S.r.l.

Via delle Driadi, 45
00133 – Rome – ITALY
Phone: +39 06 206 10 289
Fax: +39 06 20 18 131

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I.S.E. S.r.l. Minitecno – USER'S MANUAL

CONTENT
1. INTRODUCTION .......................................................................................................................................... 5
1.1 INTENDED USE............................................................................................................................................... 5
1.2 IMPROPER USE.............................................................................................................................................. 5
2. SAFETY PRECAUTIONS AND POTENTIAL HAZARDS ................................................................................ 6
2.1 ELECTRICAL EQUIPMENT ............................................................................................................................ 6
2.1.1 Electromagnetic Compatibility (EMC) ............................................................................................... 6
2.2 MECHANICAL EQUIPMENT ........................................................................................................................ 6
2.3 LAMP .............................................................................................................................................................. 6
2.4 CHEMICAL .................................................................................................................................................... 6
2.5 BIOHAZARDOUS MATERIAL ....................................................................................................................... 7
2.5.1 Human samples ......................................................................................................................................... 7
2.5.2 Waste solution and solid waste ............................................................................................................. 7
2.5.3 Bio-hazardous parts .................................................................................................................................. 7
2.5.4 Reagents ...................................................................................................................................................... 7
2.5.5 Cleaning instructions ................................................................................................................................ 7
2.6 ADDITIONAL PRECAUTIONS ...................................................................................................................... 8
2.7 RESIDUAL RISKS ............................................................................................................................................. 8
3. DISPOSAL AND RECYCLING .................................................................................................................. 9
3.1 BIO-HAZARDOUS PARTS DISPOSAL .......................................................................................................... 9
4. INSTALLATION .......................................................................................................................................... 10
4.1 SYSTEM DESCRIPTION .............................................................................................................................. 10
5. READING PRINCIPLES .............................................................................................................................. 11
5.1 KINETIC......................................................................................................................................................... 11
5.2 ENDPOINT ................................................................................................................................................... 11
5.3 BICHROMATIC ........................................................................................................................................... 12
5.4 SAMPLE BLANK ........................................................................................................................................... 12
5.5 INITIAL RATE ................................................................................................................................................. 12
5.6 NON LINEAR TESTS ..................................................................................................................................... 12
6. FILTERS ....................................................................................................................................................... 12

7. MINITECNO START UP .............................................................................................................................. 13

7.1 SWITCHING ON .......................................................................................................................................... 13
8. SETUP ......................................................................................................................................................... 14
8.1 INSTRUMENT SETUP .................................................................................................................................... 15
8.1.1 Filters ............................................................................................................................................................ 15
8.1.2 Pump ........................................................................................................................................................... 16
8.1.3 Other ........................................................................................................................................................... 17
8.2 OPERATORS ................................................................................................................................................ 17
8.2.1 How to change the password and profile of existing users ......................................................... 18
8.2.2 How to create new users ....................................................................................................................... 19
8.2.3 How to delete users ................................................................................................................................ 19
8.2.4 How to change user ............................................................................................................................... 20
8.3 BACKUP ......................................................................................................................................................... 20
8.3.1 Database Backup ................................................................................................................................... 20
8.3.2 Archive Data ............................................................................................................................................ 22
8.3.3 Database Restore ................................................................................................................................... 22
8.3.4 Default Configuration ............................................................................................................................ 22
8.3.5 Import new methods .............................................................................................................................. 22
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8.3.6 Removal from the external memory................................................................................................... 22

9. METHODS .................................................................................................................................................. 23
9.1 TEST PARAMETERS ............................................................................................................................................ 23
9.1.1 Test parameters – General .................................................................................................................... 24
9.1.2 Test parameters – Method ..................................................................................................................... 25
9.1.3 Test parameters – Calibration .............................................................................................................. 26
9.2 PROFILES...................................................................................................................................................... 28
10. SAMPLES .......................................................................................................................................... 29
10.1 SAMPLES – SELECTION .............................................................................................................................. 29
10.2 SAMPLES – IDENTIFICATION..................................................................................................................... 30
11. ANALYSIS ......................................................................................................................................... 31
11.1 ANALYSIS – WORKING LIST....................................................................................................................... 31
11.2 ANALYSIS – RUN ......................................................................................................................................... 32
12. RESULTS ............................................................................................................................................ 35
12.1 RESULTS – DAILY RESULTS .......................................................................................................................... 35
12.2 MANUAL RESULT MODIFICATION ........................................................................................................... 36
12.3 RESULTS – SEARCH ..................................................................................................................................... 37
13. QC .................................................................................................................................................... 38

14. SPECIAL FUNCTIONS ...................................................................................................................... 39

14.1 METHODS * ................................................................................................................................................. 39
14.2 EXTRAORDINARY SCREEN CALIBRATION PROCEDURE ..................................................................... 39
14.3 EXTRA FLUSHING ........................................................................................................................................ 39
14.4 DILUTER USING ........................................................................................................................................... 39
15. MAINTENANCE ............................................................................................................................... 41
15.1 FLOW CELL DAILY MAINTENANCE ......................................................................................................... 41
15.2 FLOW CELL EXTRAORDINARY MAINTENANCE .................................................................................... 41
15.3 PERISTALTIC PUMP REPLACEMENT ......................................................................................................... 41
15.4 LAMP ............................................................................................................................................................ 42
15.5 FILTERS.......................................................................................................................................................... 42
16. TROUBLESHOOTING ....................................................................................................................... 43

17. PACKAGING AND STORAGE ........................................................................................................ 43

18. TECHNICAL SPECIFICATIONS ....................................................................................................... 44

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I.S.E. S.r.l. Minitecno – USER'S MANUAL

1. INTRODUCTION
The Minitecno analyzer, is a semi automated photometer, designed to perform clinical chemistry
analyses on human samples.
It’s controlled by an internal PC, driven by a software (Minitecno Manager).

The Minitecno analyzer is capable of meeting almost all the requests of a clinical laboratory. The
instrument has been designed with great flexibility to accommodate the urgent demands of the
medical as well as the laboratory staff. The state of the art technology and the advanced user
friendly software meet the individual requirements of every clinical laboratory.

1.1 INTENDED USE

Minitecno analyzers must be used to only to perform clinical chemistry analyses on human
samples. Samples to be used, the way of collection, storage conditions and analysis details, are
defined on the reagent package inserts. The user has to read carefully the reagent insert before
to start the analysis.
Only reagents which apply a reading principle and use a filter available on the analyzer, can be
used on this analyzer, so please refer to Reading Principles and Filters section in order to know
reagents specifications.
The use of this analyzer is strictly reserved to professional users: only medical personnel with an
adequate training, are authorized to use the analyzer.

1.2 IMPROPER USE

Following uses are considered improper:
1) Analyzer use by non-professional users
2) Use of reagents which apply a reading principle different from those specified in this manual
3) Use of reagents which require a filter different from those specified in this manual
4) Use of samples different from those defined on reagent insert
5) Every attempt to obtain result different from those specified on reagent’s insert
6) Performing analyses without respect instructions supplied by this manual
The above mentioned uses and every attempt to use the Minitecno analyzer with a purpose
different from the intended use, must be considered improper.

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2. SAFETY PRECAUTIONS AND POTENTIAL HAZARDS

Before the operator starts to install and work with the analyzer, he should read the safety
precautions and regulations shown in this chapter. Safety comes first!
The operator, to protect himself from any danger, must know the rules for handling potentially
infectious materials and for the electro-mechanical systems managing.
The cable that connect the instrument to electrical line , is the most important system of
disconnection from the electrical line. For this reason, the cable bust be easily reached by the final
user.
The socket used to connect the instrument to electrical line, must have an earth wire enabled.

2.1 ELECTRICAL EQUIPMENT

As in all electrical equipment the power supply is a potential source of danger. For this reason, avoid
handling parts directly hooked up to the supply without disconnecting them. Never carry out
maintenance on the equipment when it is under electrical tension.
The Minitecno analyzer, being powered by low voltage, doesn’t present the same dangers of the
equipment’s powered by an electrical line, but it is strictly forbidden to perform maintenance when
the analyzer is connected to the electrical line.

2.1.1 Electromagnetic Compatibility (EMC)

The IVD device described, complies with the emission and immunity requirements of IEC 61326.
The IVD device described, has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take measures to
mitigate the interference.
The electromagnetic environment, should be evaluated prior to operation of the device: the final
user should identify electromagnetic field sources (as antennas, wireless devices, devices classified
as CLASS A) and place the device far from these sources.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources) as they may interfere with the proper operation.

2.2 MECHANICAL EQUIPMENT

There is no risk presented by the mechanical parts of the instrument when the instrument is closed.
If the covers of the instrument are removed, mechanical parts could cause personal injury or the
instrument may be damaged if the following advice is not being considered:
DO NOT put your fingers/hands into the pathway of any part while the analyzer is in operation.
DO NOT attempt mechanical repair before having disconnected the instrument from the power
supply.

2.3 LAMP
During operation, the photometric lamp becomes extremely hot. DO NOT look directly into the
light path of the lamp when it is on. DO NOT touch the lamp when it is on! If the lamp needs to be
changed, always switch off the lamp by switching off the instrument and then wait until the lamp
has cooled down.

2.4 CHEMICAL
The operator is responsible for taking all necessary precautions against hazards associated with
the use of clinical laboratory chemicals. Specific recommendations for each reagent used with
the analyzer are normally found on the manufacturer's package inserts or on product information
sheets for each chemical. Wipe up any reagent spillage on the instrument immediately.

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2.5 BIOHAZARDOUS MATERIAL

As with all in vitro diagnostic equipment, patient samples and serum-based quality control (QC)
products that are assayed on this system, as well as all waste from the waste container, should be
treated as potentially bio-hazardous. All materials and mechanical components associated with
the sampling and waste system should be handled according to your facility's biohazard
procedure. Always wear the personal protective equipment recommended by your facility when
use the analyzer.
2.5.1 Human samples
Always wear gloves and eye protective glasses when manage human samples.
Treat all samples as potentially bio-hazardous and infectious. If any sample is spilt on the
instrument, utilize the correct personal protective equipment (PPE-gloves, lab coat, etc.), wipe it
up immediately and clean the contaminated surface with a disinfectant (like sodium hypochlorite
0.5%) solution.
2.5.2 Waste solution and solid waste
Avoid direct contact with waste solution and/or solid waste. Both should be handled as
potentially bio-hazardous. Dispose of waste solution and/or solid waste according to local
governmental regulations. Consult the reagent manufacturer for information on reagent’s
disposal.
2.5.3 Bio-hazardous parts
Avoid direct contact with the sipper tubing and all parts of the sample flow path. Treat these
areas as potentially bio-hazardous and/or infectious and adopt the same precautions described
above for what concerns their handling and or disposal.
2.5.4 Reagents
Serum based reagents must be considered as potentially infectious, so follow the same
precaution used when handling human samples. Avoid direct body-contact with reagents. Direct
body-contact may result in irritation or damage to your skin. Refer to the manufacturer's reagent
kit box and package inserts, or product information sheets for specific instructions. Avoid direct
body-contact with cleaning solutions. Direct body-contact may result in skin irritation or damage.
Refer to the manufacturer’s kit box and package inserts, or product information sheets for specific
instructions.
2.5.5 Cleaning instructions
Dust can be removed using an ordinary vacuum cleaner.
When not in use, cover the instrument with the dust cover that is supplied as an accessory. Do not
clean with liquids or damp cloths since the entry of liquids can cause considerable damage to
the instrument.

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Minitecno – USER’S MANUAL – MNU-81035-01-B I.S.E. S.r.l.

2.6 ADDITIONAL PRECAUTIONS

On the instrument, to assure a correct use of the instrument, may be placed the following symbols:

Attention: read use instruction For in vitro diagnostic use only

ELECTROSTATIC DISCHARGE SENSITIVE DEVICE (ESDS):

The device could be damaged by electrostatic potentials

BIOHAZARD RISK
Adopt protective measures to avoid any contamination (gloves, glasses etc…)

HOT SURFACE
Do not touch when the instrument is operating.

2.7 RESIDUAL RISKS

Despite of the measures taken in the designing of the machine to guarantee a safe use of it, there
might happen reasonably predictable occurrences, whose risk was possible to reduce, but not to
eliminate completely.

RESIDUAL RISKS PROTECTION MEASURES

The operator must wear always gloves and

Biological contamination protection glasses, as prescribed by
laboratory regulations.

Do not open the peristaltic pump window

when the instrument is working. If the
operator needs to check the pump
Peristaltic pump
functionality, open the window very
carefully without inserting anything inside
the pump.

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I.S.E. S.r.l. Minitecno – USER'S MANUAL

3. DISPOSAL AND RECYCLING

Herewith we declare that this instrument is subject to the European Directive
2002/96/EC (RAEE Directive).
Therefore the instrument must be disposed separately, not as urban waste and
delivered to the specific collection center in according to the Directive
2002/96/EC.
The user can ask to the dealer the collection of the instrument if a new
instrument is ordered to replace the old one. On the instrument there is a label
with the symbol shown in this page. The symbol means that the instrument
cannot be disposed as urban waste:
3.1 BIO-HAZARDOUS PARTS DISPOSAL
All parts which have a direct contact with samples and or/reagents, must be disposed as
POTENTIALLY INFECTIOUS. Follow local regulations to do it properly.

Potentially infected parts in particular are:

1) The sipper tubing
2) All the tubing
3) The flow cell
4) The waste bottle

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Minitecno – USER’S MANUAL – MNU-81035-01-B I.S.E. S.r.l.

4. INSTALLATION
The Minitecno must not be placed near centrifuges, oscillating agitators or other vibrating
instruments which might cause movement of the bench. The bench must be flat and level. The
instrument can be placed on a bench top, thus saving space in the laboratory environment. At
least 10 cm of space is required to ensure a free flow of air. At no time should the airflow of the fan
located at the rear of the instrument be obstructed.
Direct light on the instrument and sudden changes of temperature should be avoided.
After unpacking, check:
• The presence of a power cable
• The presence of the spare part lamp and thermal paper
To power the instrument, use a 'clean' line, with no variations in voltage, and provided with an
effective ground To install the Minitecno, once unpacked, put it on a work bench, not under
direct sunlight and far enough from air conditioning hoses. Connect the tubing for the waste and
connect the power cord to an AC outlet paying attention to the voltage corresponding to the
indications on the instrument. A UPS power supply it is recommended:

ATTENTION! Before switching on the instrument, be sure that it is arrived at room temperature.

4.1 SYSTEM DESCRIPTION

PRINTER
Touch screen color
display

Sipper Unit

Aspiration Button

Printer: Is directly connected to the instrument and it prints out automatically results,
when an analysis is finished
Display: Back-lighted display, showing instrument status
Keyboard: The instrument use a touch screen. Therefore an external keyboard can be
connected if desired, by the back connector
Sipper unit: Situated on the outside of the instrument, the sipper unit is made up of a
plastic, flexible tube and a rigid part. The plastic tube is for aspirating
sample/reagent mixture and cleaning solutions
Aspiration Button: To aspirate a reagent sample, place the vessel containing the fluid under
the sipper tube. Ensure the tube is deep enough in the fluid to aspirate the
necessary amount of fluid. Push the button quickly and the aspiration will
start

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5. READING PRINCIPLES
Minitecno is able to perform analyses, using the following reading principles.
When the operator chooses reagents, has to know which principles are supported by the
analyzer.

5.1 KINETIC
Kinetic method is mostly used for enzyme activity tests. This kind of reaction can be done with or
without sample blank. The reaction is monitored during the whole programmed measuring time.
The measurement is checked for linearity, the operator can decide if the R value is acceptable or
not. Measures are done every second.
The calculation of Kinetic methods is as follows:

U /L = Ab sMIN x (VTOT x 100/x d x VSAMPLE)* = Ab sMIN x F

* This part of the formula corresponds to the FACTOR (F) Normally this factor can be found in the
package insert of the test.

5.2 ENDPOINT
An endpoint measurement is performed in 2 seconds on the analyzer. Different calculations are
available:

WITHOUT BLANK

Conc = (AbsSAMPLE/AbsSTD) ConcSTD

where
ConcSTD / AbsSTD = F

so

Conc = AbsSAMPLE x F

WITH BLANK

Conc = [(AbsSAMPLE – AbsREAG )/(AbsSTD – AbsREAG)] x ConcSTD

Where

Factor = ConcSTD /(AbsSTD – AbsREAG)

So
ConcSAMPLE = (AbsSAMPLE – AbsREAG) x F

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5.3 BICHROMATIC
Also bichromatic calculations can be done with or without blank measurement.
In a bichromatic measurement, 2 different filters must be selected, and measurements are done
using 2 different wavelengths ().

Conc = [(AbsSAMPLE 1AbsSAMPLE 2) / (AbsSTD 1 – Abs STD 2)] x ConcSTD

To calculate F, see the ENDPOINT method.

If BLANK is measured, see ENDPOINT method.

5.4 SAMPLE BLANK

For each sample and standard, must be measured also its blank signal.

Concentration =

[(AbsSAMPLE – AbsREAG) – (AbsSAMPLEB – AbsSAMPLEBL) / (AbsSTD – AbsREAG) – (AbsSTDB – AbsREAGBL)]x ConcSTD

Where

F = ConcSTD / (AbsSTD – AbsREAG) – (AbsSTDB – AbsREAGBL)]

So

Concentration = [(AbsSAMPLE – AbsREAG) – (AbsSAMPLEB – AbsSAMPLEBL)] x F

5.5 INITIAL RATE

Absorbance is measured at 2 different times. Can be done with or without blank calculation.

Conc = [(AbsSAMPLEt1 – AbsSAMPLE t0 )/ (Abs STD t1 – Abs STD t0)] x ConcSTD

5.6 NON LINEAR TESTS

Curve fitting for non-linear tests is done using different mathematical methods (like spline and so
on). This method establishes a curve of best fit from a series of standards.

6. FILTERS
On this analyzer are available the following filters:

340, 405, 510, 546, 578 and 620 nm.

Two positions are free and can be used to add 2 additional filters. Contact I.S.E. for details on how
to order additional filters.

Only reagents which use these filters can be used on this analyzer.

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7. Minitecno start up
Before starting work with Minitecno, check the following points:
1 - insert the drain tube into the waste liquid outlet and then into the waste bottle. Position the
waste bottle on the same level as the instrument or under it. Do not position the waste bottle
above the instrument in order to prevent drainage difficulties (waste bottle is not supplied).
2 - Check that there is paper inside the internal printer.
3 – Connect the power cable to the instrument and to a power socket which is suitable for the
instrument specifications, then switch the instrument on, moving the ON-OFF button on the lower
instrument panel, near the power
supply socket, to the ON (“I”) position. In this way, the instrument is live but still switched off. To
switch it on, press the front aspiration button.

7.1 SWITCHING ON
When switched on, the
instrument displays the screen
shown on the right.

The factory settings envisage

two types of users with different
privileges (see paragraph 8.2).
Touching the screen on the
USER NAME field allows the
following profiles to be chosen:

USER - U with user password

ADMIN – S with admin password

The “admin” profile can access

parts of the menu which are
inaccessible for the “user”
profile. For further details, see
paragraph 8.2.

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Minitecno – USER’S MANUAL – MNU-81035-01-B I.S.E. S.r.l.

Once the profile has been selected and the corresponding password entered in the password
field, press the login button to access the main menu. If the user name and password entered are
correct, the following screen appears:

From this screen, it is possible to access the various menus.

8. SETUP
Pressing the SETUP menu button brings up the following screen:

From this screen, it is possible to access 3 different submenus, INSTRUMENT SET UP, OPERATORS and
BACKUP.

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8.1 INSTRUMENT SETUP

8.1.1 Filters
The first page reached is the filters page. Here, the values of the trimmers for the various filters are
displayed.
From this page, it is possible to perform calibration of the filters (zeroing the photometer). To
perform calibration, press the “start calibration” button, position a container with bidistilled water
under the sipper tube and press the aspiration button 3 times in a row. Once aspiration is
complete, the calibration of the various filters will begin: this operation requires a few minutes.

If filter calibration is successful, a green circle will appear next to each filter. When all the filters are
calibrated, it is possible to exit the page by pressing EXIT.

If the calibration procedure is not successful, a red circle will appear next to the filter which
cannot be calibrated.

ATTENTION: even if the filter is not successfully calibrated, it is nevertheless possible to work with
the instrument and use the other filters. In the event that certain filters are not calibrated, it is
advisable to perform flushing of the cuvette with distilled water and suitable detergents, and leave
distilled water inside the cuvette for at least an hour (see paragraphs 8.1.2 and 15.2 for cuvette
flushing). Afterwards, repeat the filter calibration procedure.
If, even after this procedure, the filter cannot be calibrated, contact the assistance service.

The Calibration must be always performed in the following cases:

1) When you install the photometer for the first time.

2) Every time when blank calibration is not accepted.
3) Every time the lamp is replaced.
4) Every time is performed the cuvette maintenance.
5) Every time the operator wants to check the photometer.

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8.1.2 Pump
From this menu, it is possible to set the aspiration parameters during the sampling and flushing
phases.

Pressing the “speed” field allows the operator to modify the aspiration speed of the peristaltic
pump, while pressing the “time” field allows the operator to modify the pump “ON” time,
expressed in milliseconds.
Once the parameters have been modified, the approximate volume which is aspired using the
set parameters appears.

The instrument already has factory set aspiration values.

Extra Time Function: by completing this field, further sampling takes place, which is added to the
sampling volume set in the “speed” and “time” fields. This function is recommended when using
small working volumes (350 – 400 microlitres), as setting further aspiration recovers the sample
which is found inside the sampling tube. The extra time is a value expressed in milliseconds and it is
normally sufficient to set 1 millisecond of extra time to allow the sample which is found in the
sampling tube to reach the cuvette.
ATTENTION: Only use the extra time function at slow pump speeds (150). If higher values than 1-2
milliseconds of extra time are set, there is a risk of letting air enter the cuvette.
In order to make the modified parameters effective, press the “save” button or the changes will
be lost on exiting the page.

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8.1.3 Other
From this menu, it is possible to modify the following parameters:

DATE: it is possible to modify the date and format: European (dd/mm/yyyy) or American
(mm/dd/yyyy).
TIME: it is possible to modify the time and format: 24h or using AM/PM.
HEADER: it is possible to modify the laboratory header. A maximum of 24 characters can be
entered.
TEMPERATURE: touching the temperature button, it is possible to change the flow cell temperature.
The system is in fact provided of a Peltier system able to warm up or cool down the flow cell. The
operatore can choose among the following temperature: 37 °C – 30 °C – 25 °C and OFF. When
OFF is selected, the Peltier is disabled and the flow cell temperature is not controlled.
AUTOPRINT RESULTS: with this option, it is possible to choose whether the result is printed
automatically at the end of each analysis (if YES is checked) or not (if NO is checked).
ENABLE FREE TEST: free tests are those marked with *. These tests are explained at section 14.1 of
this manual. The operator can choose if he want to have these methods available among the
methods list or not. The instrument is set as default with this tests disabled. See section 14.1 for more
details.
TOUCH SCREEN CALIBRATION: using this function, it is possible to calibrate the touch screen
function. Use this function if entering data using the touch screen function is difficult. Choosing this
menu, a screen will appear which displays “X”s: each time an “X” is displayed, the operator must
press the centre of the X, using the pen supplied.
SOFTWARE UPDATE: every time a software update is available, the Minitecno software can be
updated inserting an USB pen drive in the rear panel. Touch this button after inserting the USB pen
drive with a I.S.E. software update file stored.

8.2 OPERATORS
The operators menu allows the management of the various machine users. This menu cannot be
access by USER (U) profiles.
The instrument should only be used by qualified and trained personnel. For clinical tests, the
instrument should be used under the management of a doctor or qualified laboratory
technician/technologist in compliance with local regulations.
The instrument has factory settings for 2 different operators: ADMIN – S and USER – U:

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The “admin” and “user” operators have different privileges, in fact USER (U) type profiles cannot:
- Access the Operators menu
- Access the Backup menu
- Validate patients
- Modify the results of the analyses manually
- Print the results

For admin – S and user - U operators, the manufacturer sets the passwords admin and user
respectively. It is advisable to change these passwords once the instrument has been installed.

8.2.1 How to change the password and profile of existing users

To change the password

and profile of existing users,
choose the user to change
from the operator list, then
press the “type” field to
change the profile and
choose USER (U) or SUPER
USER (S). Press the
“password” field to change
the password.
Once these fields have
been changed, to make
them effective, press the
“update”, button, otherwise
the changes will be lost on
exiting the page.

ATTENTION! If you lose the Password, it won't be possible to access the program anymore. Keep
passwords safe.

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8.2.2 How to create new users

To create new users, clear all
the fields by pressing the
“reset” button.
Then press the “operator”
field and enter the name to
be given to the user
(maximum 15 alphanumeric
characters).
Now press the “type” field to
choose the profile (U) or (S)
according to the privileges
to be granted to the new
user.
Press the “password” field to
set the password (maximum
15 alphanumeric
characters)
Now press “add” to add a
new user.

8.2.3 How to delete users

To delete a user, select the user to
delete from the “operator list” then
press “delete”. A confirmation message
appears: to continue with deletion,
press “yes”, otherwise press “no”.

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8.2.4 How to change user

To change user, go back to the home page and press the shut down button.
A screen appears from which it is possible to proceed with switching off the instrument or
changing user.

8.3 BACKUP
The Backup panel allows the
user to access the various
functions which regard the
data saved on the
instrument.
All the functions present on
this panel require a mass
storage device (normally a
flash memory drive) in the
USB port located on the
lower instrument panel. The
software will automatically
detect the presence of this
device when one of the
function buttons on the
panel shown in the figure is
pressed.

8.3.1 Database Backup

This function allows the user to create a backup copy of the database used by the software,
containing both the configuration data and all the data relative to the methods, patient details,
results and QC data.
To create a Backup copy, simply insert an external memory drive into one of the USB ports on the
rear instrument panel, press “Database Backup” and wait until the hourglass disappears and the
message appears showing successful copying. The software will create a copy of the database

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file (which can be identified by date and time of creation) in a specifically created folder.
Attention: the database file is password protected and it is not possible for the user to access its
content. It is not advisable to attempt any kind of modification as this could jeopardize its
integrity.

It is advisable to perform the Backup operation on a regular basis in order to safeguard the data
present in the instrument. Keep the external memory drive in a safe place.

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8.3.2 Archive Data

This function allows the user to make a copy of the whole database used by the software on an
external memory drive, differing from the previous function in that all the patient result and QC
data from the instrument database is deleted in order to free space on the internal disk of the
machine. It is therefore necessary to pay attention when performing this operation because, once
it has been done, the data regarding patient results and QC will not longer be present in the
instrument.
The free space remaining on the disk is shown at the top of the panel.

8.3.3 Database Restore

This operation allows the user to restore a
database which has been backed up.
The current database used by the
machine is replaced with the one
present on an external memory drive
where a backup copy was made
previously.
Attention! With this operation, the
database present in the instrument will
be overwritten, therefore all the data
present in it will be lost!
To perform a restore, simply insert the
external memory drive on which the
database backup file is present in one of
the instrument’s USB ports. Click on
“Database Restore”.
A window similar to the one shown in the
figure will appear:
The user can choose the file to restore, identified according to the date and time at which the
backup was created, from the list.
8.3.4 Default Configuration
This operation allows the user to reset the database conditions to the way they were the first time
the instrument was switched on. This allows any incorrect changes to the database to be cleared.
Attention! This operation leads to the deletion of all the data entered since the first time the
instrument was switched on.
8.3.5 Import new methods
This function allows the user to import new methods to the instrument. The new methods to be
imported must be saved in an external memory and in a particular (protected) format created by
I.S.E..
8.3.6 Removal from the external memory
To remove the external USB memory
safely, it is necessary to click on the icon
(or message) “Click here to safely
remove your hardware” and wait for the
message which authorizes the user to
remove the memory from the USB port. If
the memory is removed without
performing this operation, or while a
backup is being made, the operation of
the external memory and the instrument
is jeopardized!

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9. METHODS
Choosing the “methods”
menu from the main page
displays this screen.
From here, it is possible to
access the “test parameters”
and “profiles” submenus.

9.1 TEST PARAMETERS

Entering the “test parameters”
this screen is displayed.
From this panel, it is possible to
modify all the parameters of
the methods in the left-hand
“test list” column.

The instrument has a series of

factory set parameters. The
most common clinical
chemistry parameters are
normally present, but other
methods may also be added
(see further down).

By selecting one of the tests

from the “test list”, it is possible
to print the method, by
pressing “PRINT” or delete it by
pressing “DELETE”. If “delete” is
selected, confirmation is requested before deleting the method permanently from the instrument
memory.

To modify the parameters of one of the tests present, it is first necessary to select the test to be
modified. To scroll through the list, press the arrows.
Once the test to modify has been selected, press the various fields to be modified.
There are 3 different settings pages: “general”, “method” and “calibration”. Each page allows the
various method parameters to be modified.

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9.1.1 Test parameters – General

On this page, it is possible to

modify the following
parameters:
TEST CODE: from this field, it is
possible to modify the code
which identifies the test. It is
possible to enter up to 4
characters.
TEST NAME: from this field, it is
possible to modify the name
of the test. It is possible to
enter up to 22 characters.
UNIT: from this field, it is
possible to modify the unit of
measurement. Once this field
has been pressed, a window
opens up from which it is
possible to choose the
appropriate unit of
measurement, using the arrows to move.

N. DECIMAL: from this field, it is possible to set the number of significant decimal places.
N. CONTROLS: from this field, it is possible to set the number of controls which are available for that
test (0, 1 or 2).

QC PARAMETERS: pressing this

button gives access to the
control setup page. It is
always necessary to
complete this section if the
number of controls set is
different to zero.

On this page, it is possible to

enter the control values for
level 1 (right) and level 2 (left).
In the “control name” field,
enter the control (up to 20
characters), then complete
the “lot number” and
“expiration date” fields. In the
“min” field, enter the lower
limit of the range of
acceptability, while in the
“max” field, enter the upper
limit of the range. The “mean”
and “SD” values are automatically calculated after inserting the “min” and “max” values. If the
user wishes, it is nevertheless possible to modify the mean and SD values by pressing the field.
Pressing “COPY” automatically copies the data entered in the control name - lot number and
expiration date fields for level 1 into the relative part for the “level 2” control.
To make the changes made effective, press “UPDATE”, otherwise all changes will be lost on exiting
the page. By pressing “RESET”, on the other hand, it is possible to clear all the fields relative to the
controls.

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MALE AND FEMALE NORMAL RANGE: from this field, it is possible to set the normal values for men
and women.

To make any changes made on the “general” page effective, press the update button, otherwise
the changes will be lost on exiting the page.
9.1.2 Test parameters – Method
On entering the “method”
page, this screen appears:
METHOD: pressing this field
sets the method. It is possible
to choose between End
Point, Bichromatic, Kinetic,
Initial Rate and Sample
Blank.
The method must be chosen
based on the information
shown in the method of the
reagent used for the analysis.
See paragraph 5 for more
information about methods.
MAIN FILTER: pressing this field
sets the reading filter. If the
“Bichromatic” method has
been chosen, a further field,
“SUB FILTER”, will be present,
through which it is possible to
choose the second filter to use in the test.

REFERENCE: pressing this field, it is possible to choose whether to perform the analysis referring to
the absorbency of the water (if WATER is chosen) or that of the reagent (if REAGENT BLANK is
chosen). If Reagent Blank is chosen as a reference, 2 fields are activated, BLANK MIN and BLANK
MAX in which the minimum and maximum absorbencies acceptable for the reagent must be
entered.
SMPL: VOL: Pressing this field, it is possible to set the sampling volume, expressed in microlitres.
REAG. VOL.: Pressing this field, it is possible to set the reagent volume, expressed in microlitres.
DILUTION: Pressing this field, it is possible to set the dilution factor. This factor will only be applied if
the analysis is repeated, diluting the sample (see paragraph 11.2)
INC. TIME: This field is used to set the incubation time OUTSIDE the instrument, which is expressed in
seconds.
STAB. TIME: This field is used to set the incubation time INSIDE the instrument. This is the stabilization
time before reading and is expressed in seconds.
READ. TIME: This is the sample reading time and is expressed in seconds.
LINEARITY: This is the maximum concentration of analyte up to which the behaviour of the curve is
linear.

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9.1.3 Test parameters – Calibration

On entering the “calibration”
page, this screen appears:
It is possible to modify the
various parameters related to
method calibration. It is
possible to choose whether to
calibrate against a factor
(factor) or a standard
(standard).

Calibration against a factor:

This type of calibration can be
activated by pressing the
FACTOR button: a field is
activated in which it is
possible to enter the value of
the factor against which
calibration is to take place.

If a kinetic method has been chosen, the INCREASING and

DECREASING buttons appear: it is necessary to check one of the two,
according to whether the method is increasing or decreasing
absorbencies.

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Calibration against a
standard:
By checking this field, a
choice is made to calibrate
the method using one or
more standards.
Set the number of standards
available in the field next to
the “standard” button.
According to the number of
standards set, blank fields
appear on the right-hand side
of the screen in which the
concentrations of the
standards must be added.

If the user wishes, it is also

possible to make duplicates of
the same standards. Simply
enter the same concentration
value for 2 successive
standards:

NEW CALIBRATION: if no
calibration curve is memorized,
a new calibration is requested
as default.
SKIP CALIBRATION: if a
calibration curve is stored in
the memory, it is possible to
check this field. In this way,
when the test begins, the
standards are not requested
and the memorized calibration
curve is used.
CALIBRATION STORED: if a
calibration curve is stored in the memory, it is possible to view it by pressing VIEW CURVE.

LOT N.: enter the lot number of the reagent used in this field.
CORRECTION FACTOR: if a factor other than 1 is entered, each result obtained will be multiplied
by the factor set. In general, a factor other than 1 is set when it is necessary to correct and/or
compensate the results obtained.

N.B.: Whenever changes are made to any menu page, in order to make them effective, it is
necessary to press the UPDATE button, otherwise the changes will be lost on exiting the page.

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9.2 PROFILES
On entering this menu, this
screen appears:

Using this panel, it is possible

to program up to 5 profiles,
which can then be used
when adding patients (see
paragraph 10.1)
It is, in fact, possible to
programme the analysis
profiles which are requested
most frequently, so as not to
have to select them
individually.

The profiles are programmed

by pressing the buttons
corresponding to the tests
which the user intends to
choose for that profile. The
tests chosen will turn yellow.
To save the profile, press
UPDATE.
Using the RESET button, on
the other hand, deselects
the tests.

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10. SAMPLES
Using this menu, it is possible to
program the patients to
analyze.
Pressing INPUT, 2 submenus are
available: SELECTION and
IDENTIFICATION.

10.1 SAMPLES – SELECTION

On this page, it is possible to
choose the tests to be
performed on the samples.
Press the buttons which
correspond to the tests to be
performed, then press ADD: in
this way, a new patient is
added to the list.
If the user wishes to program
a list of analyses using the
“PROFILES” function, press the
profiles button followed by
the chosen profile.
If the same tests are to be
repeated for different
patients, once the tests have
been selected, press the
“Repeat N times” button and
enter the number of patients
which the same tests are to
be performed on: these new patients will then be added to the patient list.

Using the “Archive all” button, it is possible to clear the patient list, as all the data regarding the
patients present in the patient list will be transferred to the instrument memory.
Using the “Reset” button, it is possible to deselect the tests selected
Using the “Delete” button, it is possible to delete one or more programmed patients

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10.2 SAMPLES – IDENTIFICATION

On this page, it is possible to
enter the patient identification
data such as ID, name, age
and sex.
If this data is not entered, the
patient is only identified by the
sequential programming
number.

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11. ANALYSIS
Once the patients to analyze
have been programmed
using the “input” function,
enter this menu to perform
the analyses. Once on this
menu, it is possible to choose
between two submenus:
“RUN” and “WORKING LIST”.

11.1 ANALYSIS – WORKING LIST

On entering this menu, it is
possible to display the
working list.
By selecting one of the tests
from the test list, the “patient
work list” window displays
the data relative to the
patients for whom the
chosen test has been
programmed.
If the user presses the “print
selected” button, the
working list relative to the
selected tests is printed,
while if the “print all” button
is pressed, the whole working
list is printed.

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11.2 ANALYSIS – RUN

On entering this menu, it is
possible to display all the tests
which have been
programmed.
The programmed tests
appear in the left-hand
column.
The operator can now decide
which test to start with,
choosing one of the
programmed tests.
Once the test has been
chosen, this screen appears:

The sample to read is shown

on the light blue line.
To perform reading, position
the photometer sipper tube
inside the sample container
and press the button.
The photometer performs
reading and, at the end, the
data relative to the sample
which has just been read
appears and the light blue
line moves to the next
sample.

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Each time that the

instrument analyses the
sample, the display shows
the information relative to
the various phases of
analysis. In this case, for
example, the sample
stabilization phase is shown.
The stabilization time
remaining is shown (in the
count down field), as is the
temperature of the cuvette
(in the Temp. °C field).

During the analysis phase, on the other hand, the progress of the curve is shown.
If the user does not wish to see the progress of the curve, it is possible to press “HIDE CURVE”.

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If, for the test selected, it is

necessary to perform
calibration, the instrument will
request the analysis of the
standards programmed in
the method.
In the same way, if the
method envisages blank
reading, this will be requested
by the instrument.

“Repeat last” button: if the

user decides to repeat the
sample which has just been
analysed, it is possible to press
“repeat last”. In this way,
though, the data relative to
the sample which has just
been analysed will be lost,
and the light blue line will
once again position itself on the sample which has just been analysed.
The user can decide to repeat a sample by simply pressing the line corresponding to the sample
to be repeated (which does not necessarily have to be the last one on the list). In this way, the
light blue line positions itself on the desired sample. Also in this case, the data relative to that
sample will be replaced by the data obtained with the new reading.

“Diluted” button; if the user wishes to perform the test, diluting the sample, it is possible to select
the option “diluted”. At this point, the user must prepare a sample with the same dilution
programmed in the method (see paragraph 9.1.2 under DILUTION), then read the sample. If the
dilute option has been selected, the software will take into account the dilution factor set in order
to calculate the concentration.

“Exit” button: pressing this

button exits the “run” menu.
Every time the menu is exited,
the instrument requests the
flushing of the cuvette.
Once flushing has been
performed, the user returns to
the main screen.

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12. RESULTS
On entering this menu, it is
possible to choose between
the two submenus “daily
results” and “search”.

12.1 RESULTS – DAILY RESULTS

On selecting the “daily

results”, menu, the patients
who have been analysed in
the day are displayed. The
patients can be chosen from
the “patient list” column.

“VALIDATE” button: If the user

is an “S” type (super user)
user, using this button, it is
possible to proceed with
patient validation.
ATTENTION: only validated
patients can be printed!

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“VIEW BY TESTS” button: if the

user wishes to display the
results based on the tests, it is
possible to press this button.
The following screen appears
and the user can select the
test whose results are to be
displayed.

“PRINT ALL” button: pressing

this button prints all the results
of the day if validated, or
only those which are
validated.

“PRINT SELECTED” button:

pressing this button prints the
results relative to the test or
patient selected, if validated.

12.2 MANUAL RESULT MODIFICATION

Type “S” users (super users) can modify the results
manually. To do so, press the test whose result is to
be modified. A window appears in which the user is
requested to confirm if the result is really to be
modified. If “YES” is chosen, it is possible to enter the
new result.

This option is not active for type “U” users

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12.3 RESULTS – SEARCH

Using this menu, it is possible to search for patients memorized in the instrument database.
The search can be performed:
- by patient name: in this case, select the option “By name” and enter the name of the
patient to search for in the blank field.
- By operator: in this case, select the option “By operator” and enter the name of the
operator in the blank field.
- Display all data: in this case, check the option “display all”.
Once the patient has been found, it is possible to display the information by pressing “VIEW”.

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13. QC
Using this menu, it is possible to
display the Levey Jennings
chart for each control
performed.

To display the graph of a test,

simply select it in the test list.

It is possible to display the

results referring to 30 or 90
days, according to whether
the user chooses the 30 or 90
day option.
The data relative to the
control selected can be
printed by pressing “print”.

The QC data remains

permanently memorized in
the database. The graph,
though, only shows the data
relative to the current lot.

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14. SPECIAL FUNCTIONS

14.1 METHODS *
The methods marked with an
asterisk (*) are free methods
which the user can use to
control the functionality of the
filters and/or the various types
of methods.
These methods do not, in fact,
require calibration and/or
controls, and they can always
be selected: by entering the
“RUN” menu, when no patient
has been added, only the list
of (*) methods appears.
The (*) methods are pre-
programmed by the
manufacturer but can be
modified and/or deleted by
the user if deemed necessary.
During production, the
manufacturer programs the
following methods (*):
1 – One asterisk method for each filter
2 – One asterisk method for each method

14.2 EXTRAORDINARY SCREEN CALIBRATION PROCEDURE

If it is not possible to use the touch screen function correctly and it is not possible to enter the
calibration menu (see paragraph 8.13), it is possible to perform a calibration procedure while
switching on the instrument.
To start the forced screen calibration procedure, it is necessary to switch on the instrument and
hold down the aspiration button until the display calibration procedure appears.

14.3 EXTRA FLUSHING

Whenever the aspiration button is blue, if the user holds down the button, the instrument performs
a flushing procedure.

14.4 DILUTER USING

The operator can choose also to prepare every kind of analysis
pipetting reagents and samples with the diluter. This particular
accessory allows user to dilute automatically reagent and
sample with high precision and avoiding manual pipetting
errors. The diluter gets all the information about volumes to
aspirate from method parameters and dispense these volumes
following the sequence “ASPIRATE REAGENT-AIR GAP-ASPIRATE
SAMPLE-AIR GAP-DISPENSE REAGENT AND SAMPLE-WASH”. User
has only to press the central black button when requested by
software.

The diluter has to be connected to the instrument by the

connector indicated by the “DILUTER” label, placed in the rear panel of the instrument.

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WARNING: The diluter connector is NOT a standard serial port. Don’t connect any other device
except the Vital Diagnostics diluter to this connector. Vital Diagnostics is not responsible for every
kind of damage to the instrument or external devices derived by the improper use of this
connector.

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15. MAINTENANCE
Some parts of the instrument require some special maintenance in order to avoid their damage.
Only these parts can be handled by the final user, following the instructions given. All the other
parts of the analyzer don’t need maintenance. In case the operator need to operate on these
parts, has to call the technical assistance.

15.1 FLOW CELL DAILY MAINTENANCE

In order to avoid flow cell damage, it is highly recommended to perform several flow cell flushing,
with distilled water, at the end of each test. The number of flushing depends on the kind of
reagent used. Look at 8.1.2 section to perform this operation correctly.

15.2 FLOW CELL EXTRAORDINARY MAINTENANCE

Every week it is suggested to perform a special washing procedure of the flow cell by the
aspiration of an Hypochlorite solution (10%). Maintain the solution inside the flow cell for at least 1
minute, then operate several flow cell flushing with distilled water, in order to eliminate all the
hypochlorite solution and residuals.

In case the user has a low reproducibility in results, bubbles and/or scraps inside the flow cell. It
could be necessary an extra cleaning process of the flow cell using proteolitic agent, like Extran or
Contrad 2000. These agents must be aspirated and maintained inside the flow cell for 1 or 2
minutes then, perform several cuvette flushing with distilled water

15.3 PERISTALTIC PUMP REPLACEMENT

To replace the peristaltic pump cartridge, disconnect the instrument from the electrical power
supply and wait for at least 1 hour before intervening to allow the bulb to dry.
Then open the front panel, pushing the central metal button located in the middle of the upper
panel. Press the levers positioned on the sides of the pump cartridge (photo 1). Once the
cartridge has been removed (photo 2), detach the tubes from the hose connection (photo 3)
and replace the cartridge with a new one, supplied by I.S.E., taking care to insert the tubes in the
hose connection and press the new cartridge down as far as it will go to lock it in place (photo 4).

Figure 1 Figure 2 Figure 3

Photo 4
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15.4 LAMP
In case of zeroing problems and/or lamp burning, it could be necessary to replace the lamp.
In order to perform this operation safely, disconnect the instrument form the electrical line and
wait at least 1 hour in order to have the lamp completely cooled down. After the lamp has been
replaced, it is necessary to perform a new calibration of the instrument.
Contact I.S.E., to obtain the correct replacing lamp. In case the operator uses lamps different
from those specified by the manufacturer, the warranty will decay.

To replace the lamp, open the front panel, pushing on the central metal button located in the
middle of the upper panel and unscrew the three screws which secure the bulb, as shown in
figure 5. Remove the bulb and disconnect the cables from the green connector (photo 6).
Replace the damaged lamp with a new one, taking care to reconnect the connector and
tighten the three fixing screws.
The new bulb supplied does not require aligning as it is supplied aligned by the manufacturer.

Photo 5 Photo 6
15.5 FILTERS
In case a filter is damaged or the operator needs to add a new filter in free positions available,
follow instructions given at “troubleshooting” paragraph.

Contact I.S.E., to obtain the correct replacing filters. In case the operator uses filters different from
those specified by the manufacturer, the warranty will decay.

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16. TROUBLESHOOTING

Problem Solution
Water value too low or When you receive this message: "Attention!
Water value too high Water signal is too low." it means that may be
the cuvette is unclean or there are some
bubble.
Keep the blue button of the instrument
pressed for few seconds to aspirate water and
to wash a lot, then try again.
If this doesn’t solve the problem, perform a
flow cell extraordinary maintenance as
described in section 15.2.
If this doesn’t solve the problem or if the
message "Attention! Water signal is too low." Is
shown, you must repeat the instrument
calibration.
Problems during aspiration Replace the peristaltic pump (see section
15.3)
Problems with lamp (how to replace the lamp) To replace the lamp you just have to
disconnect the green connector on the main
board and to unscrew the 3 screw of the lamp
support. Then just replace with a new lamp
already mounted in its support (see section
15.4)
It's necessary to repeat the calibration of the
instrument.
How to replace a filter To replace a filter first you have to open the
frontal panel, then dismount photometric
group (just unscrew the 2 knobs in the frontal
side) and then, on the right side of the
photometric group, remove the 2 screws to
open a small panel to access the filter wheel.
Here remove the screw and push the small
sledge to remove the filter. Then insert the new
filter (attention to the right side) . It's necessary
to repeat the calibration of the instrument.
Touch screen does not work properly Look at section 8.13 and/or 14.2

17. PACKAGING AND STORAGE

Minitecno is supplied packaged as follows:
1 – External carton box
2 – Plastic envelope on the analyzer
3 – Lamdex inserts between the analyzer and the carton box to protect the analyzer from
transportation collisions.
Inside the carton box there is the analyzer, the power cord, the power supply, the user manual
and the Final control quality card (RQC).

The analyzer, can be stored inside its original package, in a dry place (15-85% humidity) and at
temperature between -10 and +55 °C.

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18. TECHNICAL SPECIFICATIONS

Area of application: Biochemical Analyses

Instrument size: 230 x 260 x 400 mm ( WxHxD)

Weight: about 9 kg

Internal power supply unit input power: 100 - 240 VAC 50/60 Hz

Power consumption: 0.5 A

Operating Conditions: temperature 15 °C – 30 °C room temperature

humidity: 45% - 85% not condensed
altitude: 2000 m above the sea level
pollution degree 2: normally only non-conductive pollution
occurs. Occasionally, however, a temporary conductivity
caused by condensation, must be expected.

Light Source: Quartz halogen lamp 6V 10W

Wavelength range: 340/405/510/578/620 nm plus two free positions

Photometric range 0 to 2.5 absorbance

Detector: Photo diode (320-1000 nm)

ADC ADC converter 16 bit

Blanking: Automatic zero setting

Operator Interface: User-friendly embedded software for standalone

functioning

Result Backup: Automatic backup of all results in a data base.

Easy access to historical data.
Measurement procedures: End point; Kinetic; Initial Rate;Bichromatic; Sample blank

Reference: with or without reagent blank

Measuring time: programmable 1 to 998 seconds.

Delay time: programmable 0 to 998 seconds

Flow cell: Glass measuring volume 35 µl

Carryover: < 1%

Aspiration system: internal peristaltic pump.

Quality Control QC survey of all controls- Levey Jennings Charts

Temperature control: fixed at 37°C +/- 0.1°C

Warm up: less than 5 minutes

Display: LCD color 5,7” 640 x 480 touch screen

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I.S.E. S.r.l. Minitecno – USER'S MANUAL

Calibration: Standard; Multi-standard; Factor; linear; polynomial; 4

parameters
Spline.
Regulations: CE – IVD

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