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MAP-LAB plus
Auto Analyser for Biochemical Tests

USER'S GUIDE

Release 610062_3.doc
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TABLE OF CONTENTS

HOW TO USE THE MANUAL ................................................................................................................ 7


1. INSTRUMENT INSTALLATION................................................................................................. 8
1.1. Unpacking the instrument ............................................................................................................................. 8
1.2. Instrument description................................................................................................................................... 9
1.3. How to change the voltage according to the country 110V/220V............................................................... 13
1.4. First installation of the instrument .............................................................................................................. 14
1.5. Instrument maintenance .............................................................................................................................. 16
1.6. Waste processing......................................................................................................................................... 17
2. INSTRUMENT SETUP ................................................................................................................ 18
2.1. Self Test ...................................................................................................................................................... 18
2.2. Date and Time setting ................................................................................................................................. 18
2.3. Connection/disconnection of the printer and language selection ................................................................ 18
2.4. Calibration of peristaltic pump.................................................................................................................... 20
2.5. Memory organization and Special Tests ..................................................................................................... 20
3. PRINTING ..................................................................................................................................... 23
3.1. Printing and display of the analysis name list ............................................................................................. 23
3.2. Printing of analytic parameters of one analysis........................................................................................... 23
3.3. Printing of results ........................................................................................................................................ 23
3.4. Printing of all analyses parameters.............................................................................................................. 23
3.5. Using the graphic printer............................................................................................................................. 24
4. EXECUTION OF ANALYSIS USING CUVETTES ................................................................. 25
4.1. Absorbance readings and 00 analysis.......................................................................................................... 25
4.2. Selection of the analysis.............................................................................................................................. 27
4.3. Execution of an End-point type analysis using K-factor ............................................................................. 27
4.4. Execution of an End-point type analysis using standard............................................................................. 28
4.5. Execution of a Multistandard type analysis ................................................................................................ 29
4.6. Execution of a Kinetic type analysis ........................................................................................................... 29
4.7. Execution of a Fixed-time type analysis with K.......................................................................................... 30
4.8. Execution of a Fixed-time type analysis using standard.............................................................................. 30
4.9. Reading at incubator temperature lower than 37 °C. .................................................................................. 31
4.10. Modifying the progressive number ......................................................................................................... 31
5. EXECUTIONS Of ANALYSES WITH MICROWELL............................................................ 32
5.1. Execution of analyses using blank (Use Blank = YES) .............................................................................. 32
5.2. Execution of analysis without using the Blank (Use Blank = NO) ............................................................. 33
5.3. Example of MULTISTANDARD analysis using microwell. ..................................................................... 34
5.4. Execution of QLT analysis.......................................................................................................................... 35
6. Entering new analysis parameters or modifyng existing ones (including K and Standard)... 37
6.1. How to use the decimal points .................................................................................................................... 40
6.2. Modifying parameters of an End-point analysis with K.............................................................................. 40
6.3. Modifying parameters of an End-point analysis using standard ................................................................. 42
6.4. Modifying parameters of a Kinetic analysis................................................................................................ 44
6.5. Modifying parameters of a Fixed-time analysis with K .............................................................................. 46
6.6. Modifying parameters of a Fixed-time analysis with standard.................................................................... 48
6.7. Modifying parameters of a Multistandard and EIA concentration analysis................................................ 50
6.8. How to perform a full recalibration in a MULTISTANDARD analysis..................................................... 52
6.9. How to perform a 2-point recalibration....................................................................................................... 53
6.10. How to switch from microwell to cuvette analysis ................................................................................. 55
6.11. How to enable/disable the Blank in microwell........................................................................................ 55
6.12. How to enable/disable Bichromatic filter................................................................................................ 56
6.13. Programming a QLT analysis ................................................................................................................. 57
6.14. Programming EIA analysis .................................................................................................................... 58

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7. CALCULATIONs PERFORMED BY MAP-LAB plus ..................................................... 60
7.1 2-point recalibration algorithm for Multistandard analysis......................................................................... 62
7.2 Qualitative test: Latex agglutination ........................................................................................................... 63
7.3 Bichromatic filter ........................................................................................................................................ 67
8. Quality control ............................................................................................................................... 68
8.1 Quality Control program ............................................................................................................................. 68
8.2 How to enable/disable Quality Control program for the current test .......................................................... 68
8.3 How to collect a QC sample........................................................................................................................ 68
8.4 Viewing QC data and graph ........................................................................................................................ 69
9. TECHNICAL FEATURES of MAP-LAB plus ........................................................................... 71
APPENDIX A: MESSAGES AND ERROR SIGNALS ........................................................................ 73
APPENDIX B: Conversion factors ......................................................................................................... 75
APPENDIX C: Serial transmission protocol.......................................................................................... 76
APPENDIX D: EIA ANALYSIS WITH PC........................................................................................... 77
APPENDIX E: Maintenance ................................................................................................................... 79
APPENDIX F: REDUCING CARRY-OVER USING AIR-GAP ........................................................ 80
APPENDIX G: READING A STANDARD CUVETTE WITH LESS THAN 1500 µL.................... 81
APPENDIX H: WEEE and RoHS Directives......................................................................................... 82
APPENDIX I: IMPORTANT NOTICE ABOUT BIOHAZARD RISK.............................................. 83

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RELEASE HISTORY

RELEASE DATE MODIFICATIONS


_2 11/01/2006 Inserted Appendix H. Corrected Drift specification
_3 06/09/06 Inserted Appendix about Biohazard Risk

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INTRODUCTION

Map-Lab plus is interferential filter analyser, completely managed by microprocessors, that execute photometric
measurements and elaborate them according to the corresponding programs.
This instrument has been designed to perform spectroscopic measurements at predetermined wavelengths of
analyte concentration and enzyme activity using various reagents.
In this instrument analyses can be performed either in cuvettes or in microwells through two separated optical
groups. Various parameters can be inserted by the operator. In particular, the following determinations can be carried
out:

• ABSORBANCE
• END-POINT (Concentration)
• KINETICS
• FIXED-TIME
• MULTISTANDARD
• QLT
• EIA 1
• EIA concentration 1

Map-Lab plus has a 2-way flow cell system that ensures low carry-over values even with limited sample
volumes. Disposable macro and micro cuvettes (glass or plastic), with an optical path of 1 cm, can be used by simply
removing the flow cell from the reading compartment and placing it in the right-side one.

Ten interferential filters are included in the instruments: 4 for microwells (405, 450, 492, 630 nm)and 6 for the
cuvettes (340, 405, 505, 546, 578, 630 nm). The selection of the interferential filter is automatic, with powered
handling managed by a microprocessor. This characteristic makes reading easier and eliminates filter- selection errors
that may occur in instruments with manual selection. The instrument’s optics is very sophisticated: a high-power
halogen lamp (20 W) in the cuvette section of Map-Lab plus. The light beam is centred by a quartz lens, allowing a
high measuring accuracy even when reduced-volume cuvettes are used.
The optics consists of a special lens-ended krypton filled lamp (2 W) and a sophisticated lens system that ensures a
high reproducibility of analysis. A high precision step motor allows an accurate positioning of the strip-holder inside
the reading block.
A 10-position dry incubator is installed in the instruments and can contain either square or cylindrical cuvettes. The
temperature of the thermostat unit is equal to that of the cuvettes contained in it, i.e. 37°C. The instrument can be
programmed by means of a keyboard: the required parameters are inserted by a 32-character alphanumeric display.
This display also visualizes the state of the instrument, eventual errors or malfunction signals. The analytic results are
directly displayed in the pre-set measuring units.
The instructions on the display can be chosen in any of the following languages: English, Italian, German, French
and Spanish. Furthermore, the instrument have the possibility to be completely reprogrammed with an additional
language (upon customer’s request). For such operation, contact your nearest dealer.
The instrument is provided with a 20-column thermal graphic printer that can print both the analytic results and
their programming parameters or plot calibration curve in MULTISTANDARD analyses.
The use of the instrument is assisted by an advanced software that guides and controls the operations made by the
user. The instrument is equipped with an acoustic signaller that further helps the user. A tone different from the usual
one warns the operator in case he pressed the wrong key. 90 programs can be stored. To execute an analysis it is
necessary to insert all its parameters correctly, including the K-factor and standard values. The instrument is already
programmed when supplied to its user. It is however necessary to check that the inserted parameter values correspond
to those required in the methods. Analytic parameters can be modified by the operator before an analysis.
The instrument is entirely re-programmable: however, HCT and ERY programs must not be used for other
methods. In fact, these programs have a specific software for Biochemical Systems International products.
Analyses from 1 to 50 can be programmed as QLT(Qualitative), Kinetic, End-point, Fixed Time determinations,
but not as Multistandard. Analyses starting from 51 to 90 can programmed for all methods. When the instrument is
shipped the method from 1 to 50 are programmed for chemistry analyses. Analysis 51 is dedicated to multistandard
analysis, 61 to LATEX, 71 to EIA, 81 to EIA concentration.
Furthermore by the meaning of a sophisticated algorithm it is possible to execute a recalibration of a multistandard
analysis using only 2 standard. All the method parameters and the results are sent to a serial port (RS-232) on the back
of the instrument. This feature allows the instrument to communicate with a PC: it is then possible to elaborate the
results through this serial link.

1 Only row data. For complete results calculation you need an additional software that runs on a PC.

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For complete EIA calculation an additional analysis is provided. This analysis is the number 94, and it is a
special type. It requires an additional software running on a PC IBM compatible, with Microsoft Windows 95, 98,
WinNT. This software can handle data output from the instrument and return the results of EIA analysis (qualitative
and quantitative). It keeps also a database of method and results, automatically giving you the composition of each
strip according to the analysis type.

The instrument has the possibility to be reprogrammed with a short report (6 lines maximum) in order to be
customized according to the customer needs (lab. name, street address, telephone, etc..). Contact your distributor for
this operation.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
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HOW TO USE THE MANUAL

In order to understand this manual better, the functions in the instrument are explained in a schematic way,
referring to examples. These examples are explained as follows:

a. On the left side of the page and in Italics, you can read what appears on the display during the different
stages of the analysis.
b. On the right side you find a list of possible keys that you may press.

c. The last key of the list in bold type is the one you must press in order to carry out the analysis.

The following table shows the symbols and explains the formalisms used in the manual:

SYMBOLS MEANING

Warning or Caution advice: they are related to user’s and/or instrument


safety

Enter analysis Example of characters shown on the display


Number < >

 [ENTER] Press the key in brackets


(in this example, the ENTER key)

 [1/YES] or [0/NO] Press one of the keys in brackets (in this case, either 1/YES or 0/NO).
The instrument passes to the following operation.

 [ENTER] You may press any of these keys. By pressing the key in bold type you
 [PG] pass to the following operation shown below. By pressing one of the
other keys, you can select alternative functions.
 [LIST]
 [READ]
 [0]  [1]  [ENTER] Sequence of keys to be pressed. In this example, you must press key 0,
key 1 and key ENTER, one after the other.

 [0, ......., 9, CL] You can insert a number by using keys 0 to 9.


The CL key cancels any number that appears on the display.
 [ANOTHER KEY] The operator can press any key different from the previous ones

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1. INSTRUMENT INSTALLATION

1.1. Unpacking the instrument


Check if the package is in perfect condition and with the original seals intact. If the package shows an serious damage,
it may have suffered from improper handling: contact your dealer for instructions.

The box should contain, besides this manual, the following items:

1) MapLab Plus instrument;


2) the instrument dusty-cover;
3) the Power cable;
4) a plastic waste bottle;
5) the serial port cable;
6) a CD-ROM disk with the MapLabPlus software for Windows platforms;
7) 2 rolls of printing paper;
8) one meter of plastic pipe;
9) a spare 20W/12V halogen lamp already cabled;
10) 2 spare 2A fast fuses;
11) a box with 100 1cm optical-path cuvettes;
12) the Quality Control report;
13) the warranty document;

Do not lose the original envelope and package since they are required in case of moving or shipping the instrument.

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1.2. Instrument description

FRONT SIDE:

Figure 1: Global view of the MAPLAB PLUS analyser

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Keyboard. (Fig.2) The keyboard sends to the instrument both numeric and functional data. Data entry is
facilitated by the emission of a beep each time a key is pressed. The keyboard consists of 16 keys; 10 are numerical
and 8 functional. Two keys (1/YES and 0/NO) are both digital (1 and 0) and functional (YES and NO) keys. The
following table shows the action of each functional key.
Functional keys Action
[ENTER]: Enter
[LIST]: Display or printing of a list of parameters
[STOP]: The operation in progress is interrupted.
[READ]: Execution of photometric readings or parameter storing
[]: Paper line feed
[CL]: Cancel
[1/YES]: Acknowledgement

Enter analysis
number <00>

ENTER
ENTER
7 8 9
QC1 QC2

4 6 LIST
5

STOP
1/ Y 2 3

READ
CL 0 / No PG

WASH

EJECT

Figure 2: MAPLAB PLUS KEYBOARD

[0/NO]: Cancel
[•]/[PG]: Modification of analytic parameters
[EJECT]2 Eject the strip-holder
[WASH]3 Perform an internal wash, withdrawal of
distilled water from aspiration tube.

Display. a background-illuminated liquid-crystal type, consisting of two 16-character lines. Usually, the first
line displays the main parameters of the analysis in progress (analysis number, name and K). The second line guides
the operator in executing the analysis.

Printer. a 20-column thermal type. It can be enabled by the operator and prints both analytic results and
parameters. The paper feed button is located on the back panel.

2 This key is active only outside of a method. Inside an analyses this key is automatically disabled.
3 This key is present and active only in the flow-cell version.

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Incubator. a single aluminum unit set at a temperature of 37°C with 10 housings for both cylindrical and square
cuvettes, arranged on two rows of 5. Thermosetting is obtained by means of semiconductor devices, assuring a high
accuracy. A separate housing serves as a reading cell.

Strip-Holder. It carries the strip during a determination. Only 8-microwell Universal Strips are suitable (either
flat or round bottomed).An additional adapter for special strips can be ordered at Biochemical Systems International.

Aspiration spout. A teflon tube which protrudes from the front panel of the instrument and intakes the sample
into the flow cell.

Sample lever (Push Button). Situated under the aspiration spout. When pressed, it turns on the peristaltic pump.

Flow cell (Fig. 3). The instrument can read either in flow cell or in standard cuvette. Instrument can be equipped
with 18uL flow cell (standard flow cell) and (upon request) also with 80uL flow cell, to reduce carry over and
reagent/sample volume. Pay attention to the polarity of the flow cell when you insert it in the reading compartment. Be
sure that the red point in the flow cell meets the red one in the instrument. The inclination of the flow cell inside the
reading compartment is optimal since it ensures that no air bubbles are formed inside the cell itself. To clean the cell
inside, press WASH key aspirating sodium hypochlorite and air. A diluted solution of sodium hypochlorite or a liquid
detergent for glassware is recommended to clean the flow cell outside.

Figure 3: MAPLAB PLUS flow cell compartment

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Instrument back side:
In the back side of the instrument (Fig. 4) you can find the following items:

• RS-232 connector for connection with an external serial printer or PC through the serial port. Refer to the
Appendix C of this manual for the serial transmission protocol used by the instrument to output results. You can
use Biochemical Systems International software to connect the instrument to a PC.
• Serial number of the instrument. On request, this label will also report K-factor for HCT and ERY tests. This 2
tests are special ones and can be used only with the K-factors specified in this label.
• ON/OFF switch to switch ON and OFF the instrument after a working session.
• 110/220V voltage switch. To change input voltage according to the country. Refer to the next paragraph for
further details.
• Cooling fan.
• Fuse holder, containing number 2 fuses. Refer to technical specification paragraph for fuses value.
• Waste connector: attach here the waste tank pipe.

Figure 4: View of the back side of the instrument

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1.3. How to change the voltage according to the country 110V/220V


The instrument is equipped with an external voltage adapter switch (Figure 5) to allow the user to change the
voltage tension according to the country in which the instrument is used.
Usually the instrument is shipped with the suitable voltage for that country, anyway is recommended to check the
switch position before switching the instrument on.

To check this follows this procedure:

1) In the back of the instrument find the voltage adapter switch.


2) Check if the position match your country voltage.
3) If not, with a flat-tip screwdriver set the switch to the suitable voltage tension

Figure 5: Detail of the voltage setting switch

WARNING: SETTING THE INSTRUMENT TO A WRONG VOLTAGE MAY HARM THE


USER AND WILL DAMAGE THE INSTRUMENT SERIOUSLY. ASK OUR NEAREST
DISTRIBUTOR IF YOU HAVE ANY DOUBT ABOUT THE PROPER VOLTAGE SETTING.

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1.4. First installation of the instrument

This procedure allows the User to install the instrument. Please, in the case of any doubt or ambiguity in
understanding this procedure, contact our nearest distributor since an improper installation may damage seriously the
instrument.
The instrument can work either with 220V - 50Hz (working range is from 200 to 250V) power supply, or 117V -
60Hz (working range is from 100 to 125V). Working with different tension will damage the instrument and may
harm the user. Usually the instrument is shipped already set with the user's country voltage, but before connecting
the instrument to the main plug be sure that the voltage used in your country match the one that was set on the
instrument. There is a warning sheet that comes with the documentation of the instrument and explain the voltage
value. Anyway you should refer to paragraph 1.3 How to change the voltage according to the country 110V/220V
to select the suitable voltage according to your country.

WARNING: MAKE SURE THE CHOSEN SUPPLY SOCKET HAS A SUITABLE


EARTH CONNECTION, SINCE IT IS REQUIRED TO ASSURE USER’S SAFETY

• Place the instrument on a stable and vibration-free support. Avoid its placing near heat sources (e.g. heaters,
ovens, under high power lamps), under direct sunlight, near strong electromagnetic sources (e.g. motors) or
with the instrument’s back close to a wall, which could block the cooling air flow. The operational temperature
range is 15-30Cº and humidity must be under 80%.
• Before connecting the instrument to the power supply, make sure that it is switched off. In this case, the switch
on the polysnap module in the backside of the instrument must be in the 0 position.

 Once switched off, wait for few seconds before switching on the instrument again; this precaution ensures
reliable functioning of the instrument.

EIA STRIPHOLDER INSTALLATION:


The instrument has been shipped with a mechanical protection on the stripholder. A short screw block the
stripholder to its basement, to avoid damage during the instrument transportation.
Before switching on the instrument the first time, you have to remove completely the screw that fixes the
stripholder to its basement. Do not throw away this screw, but keep it with the original packing.

  WARNING !!  

- BEFORE SWITCHING ON -
Remove the screw that
secure the stripholder
to the basement .

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• Connect the waste discharge tube to the outlet on the instrument back panel and place its cap inside the waste
tank.
• Remove the stick on the flow cell compartment and open it.

FLOW CELL
COMPARTMENT

REMOVE THE STICK


REMOVE THE STICK

Figure 6: Close view of flow cell compartment

• Open the flow cell compartment and remove the protection used for the package of the flow cell.

• Switch on the instrument.

• Insert the aspiration spout inside about 1.5 ml of distilled water (this quantity can not be exact, it is only used
for internal blanking and to initialize the flow cell)

• Wait for Self Test to complete

• Set date and time (refer to the paragraph below)

• When the main prompt is displayed ("Enter analysis number <00>" for English language), start aspirating
distilled water by pressing the WASH key until the whole hydraulic circuit is completely filled with water
(distilled water begins to exit from the instrument going in to the Waste Tank).

• If you have any problem during this step (like pump seems not to have enough power to aspirate this distilled
water) you can use a syringe (Figure 7) to inject the first 5 ml water directly in the aspiration spout, while
pressing the WASH key to keep the peristaltic pump motor running. In such a way you will initialize the
peristaltic pump hydraulic and the flow cell, and you will be able to aspirate normally using the WASH button
and the Sample lever.

Distilled
water
ASPIRATION SPOUT

Figure 7: External injection of water towards the peristaltic pump

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• Aspirate sodium hypoclorite (concentration between 6% and 10%) using the WASH key, for a volume amount
of 20-30 ml.

• Aspirate distilled water using the WASH key for a volume amount of 20-30 ml.

• Now the instrument is installed and ready to work.

IMPORTANT: WAIT AT LEAST 15 MINUTES BEFORE EXECUTING ANY ANALYSIS, THUS


ALLOWING THE INCUBATOR TO REACH AN OPTIMAL THERMAL STATUS.

1.5. Instrument maintenance


Before an instrument is shipped it is entirely tested through several procedure by the factory. Temperature
calibration is performed to ensure a 37° C temperature of the incubator and of the reading hole, and absorbance and
linearity are adjusted in order to fit the best reading point.

For any problem with the instrument refer to the troubleshooting section (see Appendix A: Messages and
error signals). If you need to recalibrate the instrument contact service to get the suitable hardware/software device
and the specific documentation given by Biochemical Systems International.

In order to ensure a long time measuring stability of the instrument some measures must be taken:

• Avoid cleaning the instrument with water or alcohol. Use a dry cloth.

• Avoid dropping moisture and water in the reading hole and in the incubator.

• Avoid to place the instrument in a wet place, since humidity contributes to filter deterioration and time stability.

• Avoid inserting objects into the cooling openings.

• Always remove the microwell strip from the strip-holder at the end of the day: don’t leave a microwell strip
inside the instrument.

• Keep the instrument covered with its plastic sheet when is not used. Also keep clean the strip holder. This will
avoid dust infiltration inside the reading hole.

• To remove organic stain on the cover of the instrument use hypoclorite solution or glass detergent.

• A periodic cleaning of the reading cell is advised, by aspiration of sodium hypocloryte.

• Use maximum care when handling the flow cell. Flow cell connections with the tubing are very weak and there
is no warranty covering them.
• At the end of a working session is recommended to aspirate distilled water inside the flow cell in order to clean
peristaltic pump and remove dirty and solution sedimentation outside flow cell. Use the WASH button and 10-20
ml of distilled water for this purpose. Leave the instrument with distilled water inside the flow cell for the night.
• If you plan not to work with the instrument for more than 3 days, prepare it for a long inactivity time. Refer to the
following paragraph for this case.

INACTIVITY PERIOD
If the instrument has to be prepared for long inactivity time (more than one week), is recommended to follow this
procedure:

• Store the instrument at 0°C to 50 °C, avoiding moisture and wet place.

• Use always Biochemical Systems International original package to pack/ship the instrument.

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• Aspirate sodium hypoclorite (concentration between 6% and 10%) using the WASH key, for a volume amount of
20-30 ml.

• Aspirate distilled water using the WASH key for a volume amount of 20-30 ml.

• Completely deplete the instrument inside (this means press the WASH button and let the instrument aspirate air,
until no more water is output to the waste tank).

CAUTION: If the instrument is used differently and not as described above by the
producer, its integrity could be compromised.

1.6. Waste processing


Always follow the common clinical laboratories rules to process the waste bottle content, exhaust reagents, used
cuvettes and any other object that may be contaminated with organic and/or chemical fluids.

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2. INSTRUMENT SETUP

2.1. Self Test


The instrument performs a SELF TEST at start-up. During this time the internal optics is checked with the relative
mechanics and electronical parts. Generally this Self Test takes about 60 seconds to be accomplished and no message
is displayed if everything works properly. The instrument will return to its normal prompt waiting for an input from
keyboard and displaying the message "Insert analysis number <00>".
During "SELF TEST" can be printed out some code relative to warning or error: refer to (see Appendix A:
Messages and error signals) for a description of the reported error and for possible solutions and workarounds.

NOTE: It is normal that the instrument after having been switched on could make a short intensive sound for few
seconds when Self Test is displayed.

After self test, calibration is performed, then a general blanking on the 6 cuvette filters. If everything is passed, the
instrument will display date and time.

2.2. Date and Time setting


The instrument has permanent date and time clock inside, that is in a backup by an internal battery which doesn't
need to be changed.
When date and time is displayed it can be edit. This happens only once per session (after Self Test execution): the
instrument display date and time and wait for your confirmation.

05/01/01 12.30

Press [STOP] if they are correct.

Press [ENTER] to switch from one field to an other, press any numeric key to change the value.

Press [READ] to store any changes, press [STOP] at any time to discharge changes.

2.3. Connection/disconnection of the printer and language selection

The printer can print the following information:


a. analytic results c. list of analyses names
b. parameters of an analysis d. list of analytic parameters
It is possible to connect or disconnect the printer, to set the number of white rows required between a printed row and
the next one and moreover to select the language: English, Italian, German or French.
When the printer is disconnected, it is possible to carry out the analysis without printing any data.
When the printer is connected, any information (a-d) can be printed upon request. The information a e b can be printed
also in automatic mode. If the automatic mode is selected, the list of parameters is printed automatically each time an
analysis is selected; the results are then printed at the end of each analysis. To connect/disconnect the printer and for
automatic printing of information a and b, operate as follows:

DISPLAY: KEYBOARD:
Enter analysis
number < >  [9]  [8]  [ENTER]
Program Set-up
Enable print YES  [READ] to store.
 [1/YES] or [0/NO] 
[ENTER] to connect or
disconnect the printer

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Enable plot YES  [READ] to store.


 [1/YES] or [0/NO] 
[ENTER] to enable or disable
the plot of graphics

Program Set-up
Print meth. YES  [READ] to store.
 [1/YES] or [0/NO] 
[ENTER] to connect or
disconnect automatic printing of name and limit
values of analysis
Program Set-up
Print result YES  [ENTER] to go on.
 [1/YES] or [0/NO] 
[READ] to connect or
disconnect the automatic printing of results
Program Set-up  [0,...,9][ENTER] to set the number of white rows
Number rows 00 between a printed row and the next one.

Program Set-up
AutoReset ID  [1/YES] or [0/NO] to enable or no (see note below)

Program Set-up  [1/YES] or [0/NO] to select the language


Language  [READ] to store

Program Set-up
Save (Yes/No)  [0/NO] to continue the printer set-up.
 [1/YES] to store the new entry.
Enter analysis
number < >

Note: MAP-LAB Plus has 2 additional fields for handling the flow cell system. The quantity of air intake after a
measurement and the time gap between the end of an aspiration of the sample and the aspiration of air.

Program Set-up
Air aspir. 00000  [0, ....., 9]  [ENTER] to insert the air-gap volume in µL.
It is advisable to insert up to 00150; above such volume air
may enter into the cuvette

Program Set-up
Delay mS 00000  [0, ...., 9]  [ENTER] to enter the delay time between
sample intake and air-gap intake. Time
is measured in mS.

NOTE:
AutoReset ID: This parameter set to YES means that ID is reset every time you enter a new test. If disabled you have
one unique ID per session, that is reset only when you switch the instrument off.

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2.4. Calibration of peristaltic pump


The peristaltic pump guarantees the maximum precision in the intake volume of the liquid (or air) into the flow
cell. The pump must be calibrated when the instrument is used for the first time and also periodically. The calibration
of the intake system can be carried out by entering into the program [96]:

DISPLAY : KEYBOARD :

Insert number  [9]  [6]  [ENTER]


analysis < >

Calibration pump
Insert 5 mL

Place a cuvette containing exactly 5 ml of distilled water under the intake spout. Press the sample lever. The pump
is now in action and draws the liquid from this cuvette (make sure it does not draw air). When the pump has drawn all
the liquid, press the sample lever again. Intake stops and a number will appear on the display, only for a few seconds,
such a number, divided by 1000, indicates the time, in seconds, necessary for the intake of 5 mL of liquid. The
instrument now returns automatically into the main menu.

2.5. Memory organization and Special Tests


Memory is organized in this way in the Maplab Plus analyzers:

TEST NUMBER TEST Function


00 ABS Raw and continuos absorbance readings
01-50 EP, KIN, FXT,QLT Standard test, completely reprogrammable
51-90 EP, KIN, FXT,QLT + MSD Standard test, completely reprogrammable + Multi Standard

Special Tests
91 Quick Diagnostic Executes a quick diagnostic of the instrument
93 Measuring Unit Editing Measuring Unit Editing program
94 Connection to PC Used with Data Management Software ®
95 Help Printout a short help report
96 Pump calibration Peristaltic pump calibration
97 Print analysis data Print a report of analysis test
98 Setup program General setup program
99 Debug program Used for service/maintenance operation

Legend:
KIN= Kinetic (for cuvette only)
FXT= Fixed time
EP= End Point
QLT= Qualitative (only for microwell)
MSD= Multi Standard, with linear interpolation

2.5.1. Absorbance readings


Plain absorbance readings can be determined with program <00> and since absorbance is an absolute measurement
it does not need any particular programming or calculation. You only need to select the right wavelength value for the
desired absorbance measure. Proceed as follows:

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DISPLAY : KEYBOARD :
Enter analysis
number < >  [0] [0]  [ENTER]
ABS PROGRAM
Read Filter 340  [1/YES] or [0/NO] [ENTER] to select the
wavelength
ABS PROGRAM
Insert Blank  [READ] to set the instrument to zero
00 ABS PROGRAM
Abs. value XXXX  [STOP] to interrupt the operation

The absorbance value is continuously shown until [STOP] key is pressed. This method, applied to sample control
solutions with known absorbance value at a wavelength supported by the instrument, can be used to check filters and
lamp integrity or verify the instrument general accuracy.

NOTE: DEFECTIVE FILTERS OR LAMP WILL LEAD TO UNCORRECT MEASURES

2.5.2. PG: 91 Quick Diagnostic


By entering analysis number 91 the analyzer will perform a quick diagnostic test, printing a report of its
characteristics and other internal parameters useful for service operation.

2.5.3. PG: 93 Measuring Unit Editing


Maplab Plus ® analyzer has 23 selectable measuring Units. All of this measuring Units are completely
customizable through the special program 93.
In this program you can select the measuring unit you wish to modify by the up and down arrows. By pressing the
ENTER key you go in editing mode, and you can easily change this values with the key on the keyboard. If you want
to SAVE your changes, you can do it by pressing the READ key at any time.

2.5.4. PG: 94 Connection with PC


By entering analysis number 94 the analyzer will start a connection to PC through the serial port. The PC must run a
special Software, provided by Biochemical Systems International. See APPENDIX D: EIA ANALYSIS WITH PC

2.5.5. PG: 95 Help program


By entering analysis number 95 the analyzer will print a short description of memory context as a reminder to help
the user selecting a special test.

2.5.6. PG: 96 Peristaltic pump calibration


To use this program for peristaltic pump calibration, refer to 2.4. Calibration of peristaltic pump for more
information.

2.5.7. PG: 97 Printing Test parameters


This program lets you printing the parameters for a selected test or the whole memory. Refer to 3.4. Printing of all
analyses parameters for more details.

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2.5.8. PG: 98 General Setup program
This special program provides you a general setup of the instrument like language selection, printer enabling and so
on. Refer to 2.3. Connection/Disconnection of the printer and language selection

2.5.9. PG: 99 Debug program


By entering analysis number 99 the analyzer go in debug mode. Do not enter this program unless is specified by
your distributor for specific service operation. Press STOP to return to main menu.

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3. PRINTING

3.1. Printing and display of the analysis name list

DISPLAY: KEYBOARD:
Enter analysis
number < >  [LIST] The names of the first four analyses appear
on the display. Example:
01ALB 02ALP
03 AMYL 04CALC  [STOP] to interrupt the operation
 [ANOTHER KEY] to display the next 4 names
 [LIST] to print the list of analyses’ names.

The instrument prints the analyses’ name list . During printing, you can press [STOP] to interrupt the operation.

3.2. Printing of analytic parameters of one analysis


The parameters of an analysis can be printed by pressing [LIST] after one of the following messages has appeared on
the display:
Insert blank
Insert sample
Insert standard

3.3. Printing of results


The results of an analysis can be printed in the automatic mode (if enabled) at the end of the analysis; otherwise, they
can be printed by pressing [LIST] once the result is shown on the display. The printed result includes the following
information (common to all analyses):

- Progressive number (1 to 9999)


- Measuring unit
- Value
- A signal if the result exceeds the pre-set limit values of the analysis. If the result is less than the lower
limit value, the letter L appears on the right side of the result. In case it exceeds the higher limit value,
the letter H appears this time.
- A symbol * in case a Fixed-time or kinetic analysis is carried out at a temperature different from 37°C.
Such symbol appears on the right side of the result.

3.4. Printing of all analyses parameters


It is possible to print the list of parameters of all the stored analyses as follows:
DISPLAY: KEYBOARD:
Enter analysis
Number < >  [9]  [7]  [ENTER]
Print analysis
first analys.  
[0, ......., 9] [ENTER] to select the number of first
analysis to print
Print analysis

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last analys.  
[0, ......., 9] [ENTER] to select the number of last
analysis to print

3.5. Using the graphic printer


The instrument includes a high quality thermal graphic printer. This printer can plot graphs during recalibration
procedures in MULTISTANDARD analysis (see 7.1 2-point recalibration algorithm for Multistandard analysis, )
or during the print-out of the results in Kinetic analyses. You can enable or disable graph plotting, simply by entering
in the special method number 98. The figure below is an example of the results printed out referring to a Kinetic
analysis:

D.Abs ........0008 D.Abs ........0008


D.Abs ........0006 D.Abs ........0006
D.Abs ........0007 D.Abs ........0007
D.Abs ........0006 D.Abs ........0006

0 0
7 0
5 3
0 0

s
s b
b A
A .
D

0 0
4 0
5 0
0 0
0060 Sec. 0180 0060 Sec. 0180

0010 U/L 0042 0007 U/L 0056

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4. EXECUTION OF ANALYSIS USING CUVETTES
Analyses using cuvettes are performed on the cuvette filters: 340, 405, 505, 546, 578, 630 nm.

NOTE: If common laboratory cuvettes are used, insert the cuvette in the analyzer with
its FLAT face towards the operator (Figure 10)

Figure 8: Cuvette correct orientation

WARNING: ALWAYS WEAR GLOVES WHEN HANDLING CUVETTES,


REAGENTS AND ALSO WHEN CLEANING THE INSTRUMENT

4.1. Absorbance readings and 00 analysis


Plain absorbance readings can be determined with program <00> and since absorbance is an absolute
measurement it does not need any particular programming or calculation. You only need to select the right wavelength
value for the desired absorbance measure. This analysis can be performed either in cuvette or in microwell strip. The
environment can be set by choosing the desired filter (see 6.10. How to switch from microwell to cuvette analysis).

To perform such an analysis follow this procedure:

DISPLAY : KEYBOARD :

Enter analysis
number < >  [0]  [0]  [ENTER]
Abs. Program

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Cuvette/ Strip Filter  [1/YES] or [0/NO] 
[ENTER] to select the
wavelength. Choose a strip filter to perform the
analysis in microwell strip.

Choose a cuvette filter to perform the analysis in the


cuvette.

Sample asp. 1000  Change with any key to the desired aspiration volume
[READ] to confirm your selection
Abs. Program
Insert Blank  [READ] to set the instrument to zero.
If you are using cuvette you must insert a blank
cuvette.
If you are using microwell strip you must insert a
blank strip or a strip with the first well containing
blank.

IF USING CUVETTES:

The user can insert the sample and its absorbance value will be displayed by the instrument immediately, without
pressing additional keys.

00 ABS PROGRAM
Abs. value XXXX  [STOP] to interrupt the operation

[PUSH button] to read using flow cell


[LIST] key at any time, will print the data that is actually on the display.

IF USING MICROWELL STRIPS:

The user can insert the samples. To read the desired well press the corresponding key number on keyboard and its
absorbance value will be displayed by the instrument immediately.

Available keys are:

0. Eject the strip holder.


1. Place the strip holder for reading well number 1.
2. Place the strip holder for reading well number 2.
3. Place the strip holder for reading well number 3.
4. Place the strip holder for reading well number 4.
5. Place the strip holder for reading well number 5.
6. Place the strip holder for reading well number 6.
7. Place the strip holder for reading well number 7.
8. Place the strip holder for reading well number 8.

00 ABS PROGRAM
Abs. value XXXX  [STOP] to interrupt the operation

Both in cuvette or microwell strip environment the absorbance value is continuously shown, until [STOP] key is
pressed.
Pressing the [LIST] key at any time, will print the data that is actually on the display.

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4.2. Selection of the analysis

When switching on the instrument the display shows:

Enter analysis
number < >

Enter the number (1 to 90) corresponding to the desired analysis using the keyboard: press [ENTER]. If you do not
remember the number of the desired analysis, press [LIST]: a list of analyses names and their corresponding numbers
will be shown on the display. Once an analysis is selected, its parameters are printed (if automatic printing has been
enabled). On the display, the first line indicates the number of the analysis, the analysis name, the letter K and the
constant K value. Example:

DISPLAY: KEYBOARD:
Enter analysis
number < >  [0]  [1]  [ENTER]
01 ALB K 335
Insert blank ................................

4.3. Execution of an End-point type analysis using K-factor

Such analysis can be performed either in cuvette or in microwell. Select the desired reading apparatus (refer also to
6.10. How to switch from microwell to cuvette analysis) , enter the analysis and proceed as follows.

DISPLAY: KEYBOARD:
01 ALB K 335
Insert blank  [ENTER] to modify the progressive number of analysis
 [PG] to modify the parameters of the analysis.
 [LIST] to print the parameters of the analysis
 [READ] to read the blank cuvette
01 ALB K 335
Insert sample  [ENTER] to modify the progressive number of analysis
 [PG] to modify the parameters of the analysis.
 [LIST] to print the parameters of the analysis
 [READ] to read the sample cuvette
01 ALB K 335
Temp 37 XXXX

The analyzer will wait XXXX seconds before reading the sample. It displays the result of the analysis and will print it
if automatic printing is pre-set. The progressive sample number, the measuring unit and the digital value appear on the
lower display line.

01 ALB K 335
0001 g/dL 007.1  [LIST] to print the analysis result
 [ANOTHER KEY] to continue.

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4.4. Execution of an End-point type analysis using standard

This analysis can be performed either in cuvette or in microwell. Select the desired reading apparatus (refer also to
6.10. How to switch from microwell to cuvette analysis) and the analysis and proceed as follows.

DISPLAY: KEYBOARD:

01 ALB K 335
Insert blank  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the blank cuvette
01 ALB K 335
Calibration Y/N  [0/NO] to omit calibration; the instrument uses the
K-factor calculated in its last calibration.
 [1/YES] to perform calibration
01 ALB K 335
Insert standard  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the standard cuvette

The instrument determines the new K and shows its value on the display:

01 ALB K 347
Insert sample  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the sample cuvette

After reading the sample, the result of the analysis is shown on the display and, if automatic printing is pre-set, the
result is also printed. The progressive sample number, the measuring unit and the digital value appear on the lower
display line.

01 ALB K 335
0001 g/dL 007.1  [LIST] to print the analytic result
 [ANOTHER KEY] to continue.

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4.5. Execution of a Multistandard type analysis

Programs between 51 and 90 are open and can also be used for MULTISTANDARD-type analyses.
Multistandard analysis as well as End Point type can be performed either in cuvette or in microwell. To select the
desired reading apparatus refer to section 6.10. How to switch from microwell to cuvette analysis.
Suppose you have only 3 standards in this method. To select a different standard number (up to 7) you have to
enter into the method programming mode. Refer to 6.7. Modifying parameters of a Multistandard and EIA
concentration analysis for a detailed description of the procedure.

DISPLAY: KEYBOARD:
55 OPEN 1
Insert blank  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the blank cuvette
55 OPEN 1
Insert standard 1  [READ] to read the first standard cuvette
55 OPEN 1
Insert standard 2  [READ] to read the second standard cuvette
55 OPEN 1
Insert standard 3  [READ] to read the third standard cuvette

55 OPEN 1
Insert sample  [READ] to read the sample cuvette

The instrument executes a linear interpolation between each pair of concentration values of the various standards. If
the concentration of the sample is less than that of the lowest standard, LLLL is shown on the display. On the contrary,
if the concentration of the sample is greater than that of the highest standard, HHHH is shown on the display: in this
case, dilute the sample and repeat the analysis.

4.6. Execution of a Kinetic type analysis

This kind of analysis can be performed only in cuvette. Select the desired analysis and proceed as follows:

DISPLAY: KEYBOARD:
03 AMYL K 3953
Insert sample  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the sample cuvette
03 AMYL K 3953
Temp 37 XXXX

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XXXX is a timer that continuously indicates the residual time (in seconds) to complete the analysis. When the timer
shows 0000, the sample determination is completed and the result is displayed; if automatic printing is set, this result is
also printed. The progressive sample number, the measuring unit and the digital value appear on the lower display line.

03 AMYL K 3953
0001 U/L 047.1  [LIST] to print the analysis result
 [ANOTHER KEY] to continue

4.7. Execution of a Fixed-time type analysis with K

This kind of analysis can be performed only in cuvette. Enter the desired analysis and proceed as in the following
example.

DISPLAY: KEYBOARD:

18 CREAT K 523
Insert sample  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the sample cuvette
18 CREAT K 523
Temp 37 XXXX

XXXX is a timer that continuously indicates the residual time (in seconds) to complete the analysis. When the timer
shows 0000, the sample determination is completed and the result is displayed; if automatic printing is pre-set, this
result is also printed. The progressive sample number, the measuring unit and the digital value appear on the lower
display line.

18 CREAT K 523
0001 mg/dL 002.5  [LIST] to print the analysis result
 [ANOTHER KEY] to continue.
4.8. Execution of a Fixed-time type analysis using standard

This kind of analysis can be performed only in cuvette. Enter the desired analysis and proceed as follows.

DISPLAY: KEYBOARD:

18 CREAT K 512
Calibration Y/N  [0/NO] to omit calibration: the instrument uses the K-
factor calculated in its last calibration
 [1/YES] to perform calibration

18 CREAT K 512
Insert standard  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis

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 [READ] to read the standard cuvette
18 CREAT K 523
Temp 37 XXXX

XXXX is a timer that continuously indicates the residual time (in seconds) to achieve the calibration. When the timer
shows 0000, the calibration is completed. The instrument determines the new K and displays its value.

18 CREAT K 523
Insert sample  [ENTER] to modify the progressive number
 [PG] to modify the parameters of the analysis
 [LIST] to print the parameters of the analysis
 [READ] to read the sample cuvette
18 CREAT K 523
Temp 37 XXXX

XXXX is a timer that continuously indicates the residual time (in seconds) to complete the analysis. When the timer
shows 0000, the sample determination is completed and the result is displayed; if automatic printing is pre-set, this
result is also printed. The progressive sample number, the measuring unit and the digital value appear on the lower
display line.

18 CREAT K 523
0001 mg/dL 002.5  [LIST] to print the analytic result
 [ANOTHER KEY] to continue.

4.9. Reading at incubator temperature lower than 37 °C.


The analyses can also be performed at a temperature below 37 °C. In this case the message " No temp" will appear
instead of "Temp OK". An asterisk will be printed beside the result of a Fixed-time or a Kin type analysis .

4.10. Modifying the progressive number


The progressive number is a four-digit number that increases automatically by 1 unit whenever an analysis is
carried out. This number is displayed and printed as the first datum before the measuring unit.
This value can be modified when the following data appears on the second display line:

Enter analysis
number <00>  Press [READ] to modify.
 Press [STOP] to exit.

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5. EXECUTIONS OF ANALYSES WITH MICROWELL

To execute analyses with microwell you have to set the correct filter in the analyses parameter (filters named
“strip filters” by the instrument). Such filters are handled by a different optical group that allows microwell analyses at
405, 450, 492 and 630 nm.
When you perform an analysis with the strip reader you can choose to use blank or not. If you say YES, the first
well of the first strip is considered as blank sample. If you say NO, the instrument will automatically set the blank in
air.

5.1. Execution of analyses using blank (Use Blank = YES)


In this case, the instrument will always consider that the first well of the first strip is a blank.

N. of samples <00> Digit the number of samples then


press ENTER

Such number can be between 1 and 99 Note that each sample corresponds to a well. If you enter 00 the instrument
presumes there is nothing to analyse and it will exit from the current analysis).

Insert strip 01 Insert the first strip of microwell and


press ENTER

The instrument automatically disposes the microwell strip in the optimal position and begins to read the values of the
‘Blank’ and, where necessary, of the standard(s). You must therefore dispense the Blank solution in the first well, the
standard(s) in the second (and next wells, if necessary); finally all the samples in the following wells.

EXAMPLE:
You want to determine 5 samples; the analysis requires a Blank and one standard . You have to prepare 7 wells in the
strip, as shown below:

WELL A = BLANK
WELL B = STANDARD
WELL C = SAMPLE 1
WELL D = SAMPLE 2
WELL E = SAMPLE 3
WELL F = SAMPLE 4
WELL G = SAMPLE 5
WELL H = -Unused-
After having read a whole strip the instrument outputs results to the thermal printer with the ID (progressive) number.
After a strip has been completely read, the instrument asks for the next strip, and so on, until the whole session is
completed.

Insert strip 02 Insert the next microwell-strip and press ENTER

At the end of the analysis the instrument displays:

continue Yes/No Select Yes if you want to read another microwell strip
without repeating the Blank and/or the standard
or select No if the analysis is completed.

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If you choose to continue, the instrument automatically asks for the number of samples to be determined, maintaining
all the parameters of the current analysis (i.e. you do not have to repeat the Blank or the standard for such analysis).
The progressive number is preserved and increases each time a well is read.

5.2. Execution of analysis without using the Blank (Use Blank = NO)
In this case the instrument will consider that you are working without the blank; so it does not consider the blank
sample as inside your strip. Enter the number of samples you want (each sample corresponds to a well):

N. of samples <00> Digit the number of samples then


press ENTER

Such number can be between 1 and 99 ( if you enter 00 the instrument presumes there is nothing to analyse and it will
exit from the current analysis).

EXAMPLE:
You want to determine 5 samples; the analysis requires one standard . You have to prepare 6 wells in the strip, as
shown below. The strip should be prepared in the following way:

WELL A = Standard
WELL B = Sample 1
WELL C = Sample 2
WELL D = Sample 3
WELL E = Sample 4
WELL F = Sample 5
WELL G = -Unused-
WELL H = -Unused-

NOTE: Working without using blank is the same thing to set your blank in air. If you wish to work with blank you can
quickly enable it by entering in the method programming mode and setting the value “YES” for the Use Blank field
(see 6.11. How to enable/disable the Blank in microwell).

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5.3. Example of MULTISTANDARD analysis using microwell.


Programs between 51 and 90 are open and can also be used for MULTISTANDARD-type analyses.
Multistandard analysis as well as the End Point type can be performed either in cuvette or in microwell. To select the
required apparatus refer to section 6.10. How to switch from microwell to cuvette analysis.
Suppose you have only 4 standards in this method. To select a different standard number (up to 7) you have to enter in
the method programming mode. Refer to 6.7. Modifying parameters of a Multistandard and EIA concentration
analysis for more details. An example: a MULTISTANDARD analysis (requiring 4 standards and Use Blank) on 10
samples using microwells:

N. of samples <00> 10 , press ENTER

Prepare two strips as shown below:

STRIP 1:

WELL A = BLANK
WELL B = STANDARD 1
WELL C = STANDARD 2
WELL D = STANDARD 3
WELL E = STANDARD 4
WELL F = SAMPLE 1
WELL G = SAMPLE 2
WELL H = SAMPLE 3

STRIP 2:

WELL A = SAMPLE 4
WELL B = SAMPLE 5
WELL C = SAMPLE 6
WELL D = SAMPLE 7
WELL E = SAMPLE 8
WELL F = SAMPLE 9
WELL G = SAMPLE 10
WELL H = Empty

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5.4. Execution of QLT analysis
QLT analysis can be carried out only in microwells. To perform a QLT analysis simply enter the analysis number
and the number of controls required . This analysis can be performed either with 2 threshold controls (positive and
negative) or a one (cut-off). In the latter case, you can choose to read the cut-off value from cut-off sample or enter it
directly using keyboard. For this operation refer to method programming section (6.13. Programming a QLT
analysis). You can choose to work or not with a Blank sample, by programming Use Blank field.

• CASE 1: 1 CUTOFF sample, Use Blank =Yes.


Prepare the microwell strip as follow:

STRIP 1:

WELL A = Blank
WELL B = Cut-off sample
WELL C = Sample 1
WELL D = Sample 2
WELL E = Sample 3
etc……..

• CASE 2: 1 CUTOFF sample, Use Blank =No.

In this case you don't have to put the blank in the first well of the strip. Prepare the microwell strips as follow:

STRIP 1:

WELL A = Cut-off sample


WELL B = Sample 1
WELL C = Sample 2
WELL D = Sample 3

• CASE 3: no CUTOFF sample, Use Blank =Yes.


In this case enter the cut-off value directly through keyboard in programming mode (refer to 6.13. Programming a
QLT analysis). Prepare the strip as follows:

STRIP 1:

WELL A = Blank
WELL B = Sample 1
WELL C = Sample 2
WELL D = Sample 3
……

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• CASE 4: no CUTOFF sample, Use Blank =No.


In this case, enter the cut-off value directly through the keyboard in the programming mode (refer to 6.13. Program-
ming a QLT analysis). There is no need to insert a Control in the microwell strip. Prepare the microwell strips as
follows:

STRIP 1:

WELL A = Sample 1
WELL B = Sample 2
WELL C = Sample 3
WELL D = Sample 4

• CASE 5: 1 Negative threshold Control, 1 Positive threshold Control, Use Blank =Yes.

Prepare the microwell strip as follow:

STRIP 1:

WELL A = Blank
WELL B = Negative threshold control
WELL C = Positive threshold control
WELL D = Sample 1
WELL E = Sample 2
….

• CASE 6: 1 Negative threshold Control, 1 Positive threshold Control, Use Blank =No.

In this case you do not need to insert the blank in the first microwell. Prepare the microwell strips as follow:

STRIP 1:

WELL A = Negative threshold control


WELL B = Positive threshold control
WELL C = Sample 1
WELL D = Sample 2
WELL E = Sample 3
And so on…..

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6. ENTERING NEW ANALYSIS PARAMETERS OR MODIFYNG EXISTING ONES


(INCLUDING K AND STANDARD)
Parameters of an analysis refer to all information required by the instrument to carry out that analysis according to the
pre-set methods. The following table shows the parameter list.

Parameter Abbreviations Values Description

Name It identifies the analysis to be carried out. One of


the 42 different names stored in the instrument can
be selected.

Method EP, KIN, FXT, Identifies the type of analytic method:


MSD,QLT EP = End-point method
KIN = Kinetic method
FXT = Fixed-time method
MSD = Multistandard method
QLT= Qualitative

K 0-9999 Value of the analytic constant

Standard S 0-9999 Value of standard concentration

Filter WL 340, 405, 505, Value of the wavelength used in the analysis
546, 578, 630 nm
405,450,492,630 nm

Units Measuring unit

Decimal point DP, Decimal P. 0-3 Number of decimal points

Delay DLY 0-999 KIN and FXT: it is the time from the moment
[READ] is pressed and the first reading.
EP: it is the time between the introduction of the
sample and the achievement of the result.

Reaction time React t, Rt, R. t 0-999 Time between the first and the last reading in KIN
and FXT methods.

Repeat blank YES/NO In EP methods, [YES]must be pressed if a Blank


reading for each sample is necessary. Press [NO] if
only one Blank is required for a series of samples.

Low limit Lval, L 0-9999 Lower limit value. If ( 0) is entered and the analytic
result is lower than this limit, the letter L is printed
beside the result.

High limit Hval, H 0-9999 Higher limit value. When ( 0) is entered and the
analytic result is higher than this limit, the letter H
is printed beside the result.

Bichromatic filter Bichrom. 340, 405, 505, Set the filter used for bichromatism. If
546, 578, 630 nm bichromatism isn’t used you have to set this to no
405,450,492,630 nm Bichromatism.

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The following table indicates the required parameters for each type of analysis (End-point, kinetic, Fixed-time).

For CUVETTE analysis:


METHOD END-POINT END-POINT KINETIC FIXED-TIME FIXED-TIME MULTI
(EP) WITH K (EP) WITH (KIN) (FXT) WITH K (FXT) WITH STND
STANDARD STANDARD

Parameters
Cuvette filter × × × × × ×
Method × × × × × ×
Bichromatic filter × × - - - ×
Standard - × - - × ×
K × - × × - -
Name × × × × × ×
Units × × × × × ×
Decimal point × × × × × ×
High limit × × × × × ×
Low limit × × × × × ×
Repeat blank × × - - - ×
Reaction time - - × × × -
Delay × × × × × ×
Standard [1-7] - - - - - ×

For MICROWELL ANALYSIS:

METHOD END QLT MULTISTND


POINT
Parameters
Strip filter × × ×
Method × × ×
Bichromatic filter × × ×
Standard - - ×
K × - ×
Name × × ×
Units × - ×
Decimal point × - ×
High limit × - ×
Low limit × - ×
Use Blank × × ×
Standard [1-7] - - ×

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The parameters of an analysis can be modified when one of the following messages appears on the display:

Enter analysis
number <??>

Number of analysis
you wish to modify
Press [PG] to execute the modifications. The operations required to modify one or more parameters of an End-point,
kinetic and Fixed-time analysis are shown below.

During these operations, the values to be modified will appear on the display in two different ways:

1) value with active cursor (underlined). To modify the value it is necessary to use digital keys to insert the
required value. Press [ENTER].

2) value without cursor (not underlined). To modify the value, it is sufficient to use the cursor keys: [1/YES]
and [0/NO] to select one from the list of inserted values that appear on the display. When the desired value
appears on the display, press [ENTER].

NOTE:

→ Each time you press [ENTER], the display passes from one parameter to the next.

→ During any stages, if you press [STOP], parameter modification is interrupted and the new values will not be
stored, while if you press [READ] and [YES] for a confirmation the inserted parameter values will be stored for that
method.

→ An analysis can be performed either in cuvette or in microwell. To perform an analysis in cuvette select a suitable
cuvette filter in programming mode. If you want to perform the same analysis on microwell strips, simply change that
filter with a strip filter (see 6.10. How to switch from microwell to cuvette analysis).

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6.1. How to use the decimal points
Depending on the number of decimal points you want to express the result with, you must insert the k-factor and the
standard value in the following way:

K-Factor Decimal points K-Factor to insert Results


1745 0 1745 45
1745 1 17450 45.X

Standard Decimal points Standard to insert Results


8 0 8 8
8 1 80 8.0
8 2 800 8.00
75 0 75 75
75 1 750 75.0
2.7 1 27 2.7
2.7 2 270 2.70

The first column shows the k-factor or the nominal value of the standard, the second one the decimal points, the
third one the k-factor or standard value you have to insert, the fourth one the results.

NOTE: PG key, when a result is displayed acts as decimal point key, and change decimal point instantly.

6.2. Modifying parameters of an End-point analysis with K


Proceed as indicated in the following example:
DISPLAY: KEYBOARD:
Enter analysis
number < >  [0]  [1]
 [PG] to modify the parameters of the analysis

01 ALB K 335
Strip/Cuvette Filter WL  [READ] to store values
 [1/YES] or [0/NO] until you find the desired
wavelength.
Strip filter for analysis with microwell
Cuvette filter for analysis with cuvette.
 [ENTER] to select this wavelength.

01 ALB K 335
Method EP  [READ] to store values
 [1/YES] or [0/NO] to select the type of methods:
(EP, KIN, FXT, MSD) if you selected a cuvette filter.
(EP, QLT, MSD) if you selected a strip filter.
Select desired.
 [ENTER]

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01 ALB K 335
Bichr. Filtr.  [READ] to store values
 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to
enable/disable Bichromatic filter).
 [ENTER] to go on.

01 ALB K 335
Use standard YES/NO  [READ] to store values
 [0/NO]  [ENTER] since no standard is required.
01 ALB K 335
New K  [READ] to store values
 
[0, ......., 9] [ENTER] to insert the value of the new
K. This value shall be entered without any decimal
point (ex. K=0.335; enter: K=00335).
01 ALB K 335
New name ALB  [READ] to store values
 [1/YES] or [0/NO] until you find ALB,  [ENTER]
01 ALB K 335
Units g/dL  [READ] to store values
 [1/YES] or [0/NO] until you find g/dl,  [ENTER]
01 ALB K 335
Decimal p. 1  [READ] to store values
 [1/YES] or [0/NO] until you find 1,  [ENTER]
01 ALB K 335
Repeat blank YES  [READ] to store values
 [1/YES]  [ENTER] if the blank must be repeated
for each sample. Otherwise  [0/NO].
01 ALB K 335
Low limit 40  [READ] to store values
 
[0, ......., 9] [ENTER] to insert the lower threshold
value. Insert 40 if the desired value is 4. See par. 6.1
01 ALB K 335
High limit 95  [READ] to store values
 
[0, ......., 9] [READ] to insert the higher threshold
value. Insert 95 if the desired value is 9.5. See par.6.1.
01 ALB K 335
Delay 300  [READ] to store values
 
[0, ......., 9] [ENTER] to enter the waiting time, in
seconds . Enter the desired value (e.g. 300).

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01 ALB K 335
Save (YES/NO)  [0/NO] if you need to make other modifications, without
storing the previous ones.
 [1/YES] to store values
Enter analysis
number < >
At this point it is possible to carry out the analysis with the new parameters.

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

6.3. Modifying parameters of an End-point analysis using standard


To modify parameters of an End-point analysis with standard, proceed as indicated in the following example:

DISPLAY: KEYBOARD:

Enter analysis
number < >  [0]  [1]
 [PG] to modify the parameters of the analysis
01 ALB K 0000
Method EP  [READ] to store values
 [1/YES] or [0/NO] until you find EP  [ENTER] .
01 ALB K 0000
Use standard YES/NO  [READ] to store values
 [1/YES]  [ENTER] .
01 ALB K 0000
Standard val 000  [READ] to store values
 
[0, ......., 9] [ENTER] to enter the concentration
value of the new standard. This value shall be entered
without any decimal point
(ex. Std = 2.2; insert. val=022).
01 ALB K 0000
New name ALB  [READ] to store values
 [1/YES] or [0/NO] until you find ALB. [ENTER]

01 ALB K 0000
Units g/dL  [READ] to store values
 [1/YES] or [0/NO] until you find g/dL [ENTER]
01 ALB K 0000
Decimal p. 1  [READ] to store values
 [1/YES] or [0/NO] until you find 1. [ENTER]

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01 ALB K 0000
Repeat blank YES  [READ] to store values
 [1/YES] or [0/NO] 
[ENTER].
Press YES if blanking must be repeated for each
sample.

Low limit LL  [READ] to store values


 [0, ......., 9] 
[ENTER] to set the lower threshold
value. Insert 40 if the desired value is 4. See 6.1.
How to use the decimal points

High limit HH  [READ] to store values


 [0, ......., 9] 
[ENTER] to set the higher threshold
value. Insert 95 if the desired value is 9.5. See 6.1.
How to use the decimal points

01 ALB K 0000
Delay 300  [READ] to store values
 [0, ......., 9]  [ENTER] to enter the waiting time, in
01 ALB K 0000
Save (YES/NO)  [0/NO] to make other modifications, without
storing the previous ones.
 [1/YES] to store values
Enter analysis
number < >
At this point it is possible to carry out the analysis with the new parameters.

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

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6.4. Modifying parameters of a Kinetic analysis
To modify the parameters of a kinetic analysis proceed as follows:

DISPLAY: KEYBOARD:

Enter analysis
number < >  [0]  [2]
 [PG] to modify the parameters of the analysis
02 ALP K 3027
Strip/Cuvette Filter WL  [READ] to store values
 [1/YES] or [0/NO] until you find the desired
wavelength. Strip filter for analysis with microwell
Cuvette filter for analysis with cuvette.
02 ALP K 3027  [ENTER] to select this wavelength.
Method KIN  [READ] to store values
 [1/YES] or [0/NO] to select the type of methods:
(EP, KIN, FXT, MSD) if you selected a cuvette filter.
(EP, QLT, MSD) if you selected a strip filter.
Select desired.
 [ENTER]

02 ALP K 3027
Bichr. Filtr.  [READ] to store values
 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to enable/
disable Bichromatic filter).
 [ENTER] to go on.

02 ALP K 3027
New K  [READ] to store values
 
[0, ......., 9] [ENTER] to enter the value of the new
K. This value shall be entered without any decimal
point (e.g. K = 3.027 ; enter: K = 3027).
02 ALP K 3027
New name ALP  [READ] to store values
 [1/YES] or [0/NO] until you find ALP.  [ENTER]

02 ALP K 3027
Use Blank Y/N  [READ] to store values
 [1/Y] or [0/N] to use/disable blank.  [ENTER]
02 ALP K 3027
Units U/L  [READ] to store values
 [1/YES] or [0/NO] until you find U/L.  [ENTER]
02 ALP K 3027

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Decimal p. 0  [READ] to store values
 [1/YES] or [0/NO] until you find 0.  [ENTER]
02 ALP K 3027
Delay 30  [READ] to store values
 
[0, ......., 9] [ENTER] to set the delay time in sec.
Insert the desired value (.30 , in this case )
02 ALP K 3027
React t 120  [READ] to store values
 
[0, ...., 9] [ENTER] to set the kinetic reading time
in seconds. Insert the desired value ( 120 ).

Low limit LL  [READ] to store values


 
[0, ......., 9] [ENTER] to set the lower threshold
value. Insert 40 if the desired value is 4. See 6.1.
How to use the decimal points

High limit HH  [READ] to store values


 
[0, ......., 9] [ENTER] to set the higher threshold
value. Insert 95 if the desired value is 9.5. See 6.1.
How to use the decimal points
02 ALP K 3027
Save (YES/NO)  [0/NO] if you need to make other modifications,
without storing the previous ones.
 [1/YES] to store the inserted values
Enter analysis
number < >
At this point it is possible to carry out the analysis with the new parameters.

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

EX:
When a Kinetic test is executed the following parameters are shown on the display:

02ALP K 03027
Tok Abs0004 0111
(1) (2) (3)

(1): Tok, Not. The instrument displays the temperature status.


Tok=37°C +/- 0.2°C
NoT=37°C Not reached
(2): Absorbance value at the actual time of the current solution.
(3): Countdown of the reading time until result is displayed.

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6.5. Modifying parameters of a Fixed-time analysis with K

To modify the parameters of a Fixed-time analysis with K proceed as follows:

DISPLAY: KEYBOARD:
Enter analysis
number < >  [1]  [8]
 [PG] to modify the parameters of the analysis
18 K K 0000
Strip/Cuvette Filter WL  [READ] to store values
 [1/YES] or [0/NO] until you find the desired
wavelength.
• Strip filter for analysis with microwell
• Cuvette filter for analysis with cuvette or flow cell

18 K K 0000  [ENTER] to select this wavelength.


Method FXT  [READ] to store values
 [1/YES] or [0/NO] to select the type of methods:
(EP, KIN, FXT, MSD) if you selected a cuvette filter.
(EP, QLT, MSD) if you selected a strip filter.
Select desired.
 [ENTER]

18 K K 0000
Bichr. Filtr.  [READ] to store values
 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to enable/
disable Bichromatic filter).
 [ENTER] to go on.
18 K K 0000
Use standard YES/NO  [READ] to store values
 [0/NO]  [ENTER]
18 K K 0000
New K  [READ] to store values
 
[0, ......., 9] [ENTER] to enter the value of the new
K. This value shall be entered without any decimal
point ( e.g. K = 1.25; enter: K = 1250 ).
18 K K 0000
New name ALP  [READ] to store values
 [1/YES] or [0/NO] until you find K.  [ENTER]
18 K K 0000
Units mg/dL  [READ] to store values

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 [1/YES] or [0/NO] until you find mg/dL.
 [ENTER]
18 K K 0000
Decimal p. 1  [READ] to store values
 [1/YES] or [0/NO] until you find 1.  [ENTER]
18 K K 0000
Delay 10  [READ] to store values
 [0, ......., 9]  [ENTER] to set the delay time in
seconds. Insert the desired value ( 10 ).
18 K K 0000
React t 120  [READ] to store values
 [0, ...., 9] 
[ENTER] to set the kinetic reading time
in seconds. Insert the desired value ( 120 ).

Low limit LL  [READ] to store values


 [0, ......., 9] 
[ENTER] to set the lower threshold
value. Insert 40 if the desired value is 4. See 6.1.
How to use the decimal points

High limit HH  [READ] to store values


 [0, ......., 9] 
[ENTER] to set the higher threshold
value. Insert 95 if the desired value is 9.5. See 6.1.
How to use the decimal points

Save (YES/NO)  [0/NO] to make other value modifications, without


storing the previous ones.
 [1/YES] to store values

Enter analysis
number < >

At this point it is possible to carry out the analysis with the new parameters.

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

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6.6. Modifying parameters of a Fixed-time analysis with standard
To modify the parameters of a Fixed-time analysis with standard proceed as follows:

DISPLAY: KEYBOARD:

Enter analysis
number < >  [1]  [8]
 [PG] to modify the parameters of the analysis
18 K K 0000
Strip/Cuvette Filter WL  [READ] to store values
 [1/YES] or [0/NO] until you find the desired
wavelength.
Strip filter for analysis with microwell
Cuvette filter for analysis with cuvette.
18 K K 0000  [ENTER] to select this wavelength.
Method FXT  [READ] to store values
 [1/YES] or [0/NO] to select the type of methods:
(EP, KIN, FXT, MSD) if you selected a cuvette filter.
(EP, QLT, MSD) if you selected a strip filter.
Select desired.
 [ENTER]

18 K K 0000
Bichr. Filtr.  [READ] to store values
 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to enable/
disable Bichromatic filter).
18 K K 0000
Use standard YES/NO  [READ] to store values
 [1/YES]  [ENTER]
18 K K 0000
Standard val  [READ] to store values
 [0, ..., 9][ENTER] to enter the value of the new
standard. This value shall be entered without any
decimal point (e.g. Std = 1.2; enter: val = 0012)
18 K K 0000
New name K  [READ] to store values
 [1/YES] or [0/NO] until you find K.
 [ENTER]

18 K K 0000
Units mg/dL  [READ] to store values
 [1/YES] or [0/NO] until you find mg/dL.
 [ENTER]

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18 K K 0000
Decimal p. 1  [READ] to store values
 [1/YES] or [0/NO] until you find 1.  [ENTER]
18 K K 0000
Delay 10  [READ] to store values
 [0, ......., 9]  [ENTER] to set the delay time in
seconds. Enter the desired value ( 10 ).
18 K K 0000
React t 120  [READ] to store values
 [0, ......., 9] 
[ENTER] to set the kinetic reading
time in seconds. Enter the desired value ( 120 ).

Low limit LL  [READ] to store values


 [0, ......., 9] 
[ENTER] to set the lower threshold
value. Insert 40 if the desired value is 4. See 6.1.
How to use the decimal points

High limit HH  [READ] to store values


 [0, ......., 9] 
[ENTER] to set the higher threshold
value. Insert 95 if the desired value is 9.5. See 6.1.
How to use the decimal points
18 K K 0000
Save (YES/NO)  [0/NO] to make other value modifications, without
storing the previous ones.
 [1/YES] to store the inserted values

Enter analysis
number < >

At this point it is possible to carry out the analysis with the new parameters.

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

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6.7. Modifying parameters of a Multistandard and EIA concentration analysis


To modify parameters of a Multistandard (or EIA concentration) analysis, proceed as indicated in the following
example (only analyses between number 51 to 90 can be programmed as Multistandard):

DISPLAY: KEYBOARD:

Enter analysis
number < >  [5]  [1]
 [PG] to modify the parameters of the analysis

Strip/Cuvette Filter  [READ] to store values


 [1/YES] or [0/NO] until you find the desired
wavelength.
 [ENTER]

Method MSD  [READ] to store values.


 [1/YES] or [0/NO] until you find MSD . 
[ENTER].

Bichr. Filtr.  [READ] to store values


 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to enable/
disable Bichromatic filter).
 [ENTER] to go on.

N. Standard  [1/YES] or [0/NO] Enter the number of the standard

Standard val  [READ] to store values


 [0, ..., 9][ENTER] to enter the value of the new
standard. This value shall be entered without any
decimal point (e.g. Std = 1.2; enter: val = 0012)

New name XXXX  [1/YES] or [0/NO] Enter the new name for the 
analysis [READ] to store values

Units  [READ] to store values


 [1/YES] or [0/NO] until you find the desired units
 [ENTER]
Decimal p.  [READ] to store values
 [1/YES] or [0/NO] to change.
 [ENTER]

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Low limit LL  [READ] to store values
 
[0, ......., 9] [ENTER] to set the lower threshold
value. Insert 40 if the desired value is 4. See 6.1.
How to use the decimal points.

High limit HH  [READ] to store values


 
[0, ......., 9] [ENTER] to set the higher threshold
value. Insert 95 if the desired value is 9.5. See 6.1.
How to use the decimal points.

Save (YES/NO)  [0/NO] to make other value modifications, without


storing the previous ones.
 [1/YES] to store the inserted values
Enter analysis
number < >

At this point it is possible to carry out the analysis with the new parameters.

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

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6.8. How to perform a full recalibration in a MULTISTANDARD analysis


To perform a full recalibration of a curve in a MULTISTANDARD analysis, proceed as indicated in the following
example (the example assumes that you already have a method programmed with a MULTISTANDARD analysis; if
not, refer to 6.7. Modifying parameters of a Multistandard and EIA concentration analysis):

DISPLAY: KEYBOARD:

Enter analysis  [5]  [1] ENTER the number


Number<00>
The instrument gives you the possibility to perform either a FULL or PARTIAL recalibration. The partial
recalibration is a 2-point recalibration of the whole curve, but it needs only 2 standards (avoiding the use of other
standards, See 7.1. 2-point recalibration algorithm for Multistandard analysis, and 6.9. How to perform a 2-point
recalibration).
Full recalibration requires all the standards of the curve, according to the number of points entered in the
programming mode of the analysis. To enter a MULTISTANDARD analysis with full recalibration (e.g. a microwell
analysis with a 6-point curve), proceed as follows):

MICROWELL STRIP

Likewise, for a cuvette analysis with a 6-point curve, the following cuvettes must be inserted, in the respective
order:

CUVETTE (OR TUBE FOR FLOW CELL)

Blank Std1 Std2 Std3 Std4 Std5 Std6

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6.9. How to perform a 2-point recalibration

During MULTISTANDARD analysis, MAP-LAB PLUS has the possibility to re-calibrate itself with a specific
algorithm that requires only 2 points for the operation. For example, a MULTISTANDARD analysis based on seven
standards can be re-calibrated using only two standards instead of all seven. Such recalibration can be achieved using
cuvettes, flow cell or microwells. Follow this procedure to recalibrate the instrument using only 2 standards:

DISPLAY: KEYBOARD:

Enter analysis number < >  [5] [1]

Select a MULTISTANDARD analysis to achieve this recalibration. Suppose that number 51 is a MULTISTANDARD
analysis.

51 MSD 1
CALIBRATION(Y/N)?  [1/YES] to recalibrate
 [0/NO] to omit calibration
51 MSD 1
Full calibration(Y/N)  [1/YES] to perform the calibration using all standards
 [0/NO] to perform a 2-point calibration

51 MSD 1
First point  Enter the number of the first point used to perform
the 2-point recalibration. This can be a value between
1 and n-1, where n is the number of standards used
for the analysis (max 7 standards).

51 MSD 1
Second point  Enter the number of the second point used to perform
the 2-point recalibration. This can be a value between
2 and n, where n is the number of standards used for
the analysis (max 7 standards).

Enter the strip with the microwell (if the analysis is of a strip type) or the series of cuvettes (if the analysis is program-
med for cuvette filters). For example, the microwell strip will appear as follows:

MICROSTRIP

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In case you use cuvettes, they will appear as below:

CUVETTE (OR TUBE FOR FLOW CELL)

Blank Standard 1 Standard 2

Both for full recalibration or for 2-point recalibration

At the end of this operation, the instrument will display the values of the standards you entered, the new values of all
the standards and the re-calibrated curve, as shown in the figure below (in this example we have re-calibrated the curve
by changing the value of the 2nd and the 7th point):

51 MSD 1
Hval: 3000
Lval: 0100
Standard 2
U/L 0001 Abs: 0098
Standard 7
U/L 0007 Abs: 0204
Standard 1
U/L 0100 Abs: 0403
Standard 2
U/L 0200 Abs: 0876
Standard 3
U/L 0300 Abs: 1501
Standard 4
U/L 0400 Abs: 2093
Standard 5
U/L 0500 Abs: 2456
Standard 6
U/L 0600 Abs: 2500
Standard 7
U/L 0700 Abs: 2578

ABS

0100 U/L 0700

Note: Since the factory values for MULTISTANDARD analysis are all set to zero, you need to execute a full
calibration when you perform this analysis for the first time. Before doing this, however, you must enter in the
programming mode as follows:

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DISPLAY: KEYBOARD:

Enter analysis number < >  [5] [1]


 [PG] to modify the parameters of the analysis
Press ENTER key to select the desired field and use the numerical key to enter the number of standards.
Press READ to store eventual modifications, or press STOP to discharge them. For more information refer to 6.7.
Modifying parameters of a Multistandard and EIA concentration analysis.

6.10. How to switch from microwell to cuvette analysis


In the programming mode, it is possible to select where an analysis should be executed (cuvette or microwell).
This is simply done by selecting the right filter for that analysis. Let us assume we wish to modify analysis number 18 :

Enter analysis number < >  [1] [8]


 [PG] to modify the parameters of the analysis
CUVETTE FILTER 340, 405, 505, 546, 578, 630 nm Press [Yes] or [NO] to change filter and to switch to
microwell filters.
STRIP FILTER 405, 450, 492, 630 nm Press [Yes] or [NO] to change filter and to switch to
cuvette filters.

Press [READ] to save data. Press [YES] to confirm the storing. If you want to discharge changes press [STOP].

6.11. How to enable/disable the Blank in microwell


For analyses in microwells, you can choose to use the Blank or not . The Blank is a single sample in the first
microwell used for blanking and calculating all the other sample respect to this value. If your kit provides a blank in air
or do not need a blank, simply say No to Use Blank field in test programmation.
To enable/ disable the use of the Blank in an analysis ( e.g. analysis number 61), proceed as follows:

Enter analysis
number < >  [6] [1]
 [PG] to modify the parameters of the analysis

……………  Press [ENTER] to change, until Use Blank is


displayed.

61 Use Blank
 Press [Yes] or [NO] to enable or disable use of blank
for this analysis.

Press [READ] to save data. Press [YES] to confirm the storing. If you want to discharge changes press [STOP].

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6.12. How to enable/disable Bichromatic filter

In End-point methods (using K or standard) and MULTISTANDARD ones, it is possible to perform the
photometric measurement using the Bichromatic filter as well as the reading one. The use of such filter reduces the
photometric background noise in the chemical reaction. The instrument measures the absorbance of the reading filter at
the corresponding wavelength and that of the Bichromatic filter at another wavelength. It determines the difference
between these two absorbance values and gives the final result.
To put on the Bichromatic enter in the programming mode (let us assume that we want to set Bichromatic filter for
analysis number 18):

Enter analysis number < >  [1] [8]


 [PG] to modify the parameters of the analysis

Press [ENTER] until Bichromatic filter field is displayed.

Bich. Filtr Y/N  [Yes]/ [No]

To enable the filter, simply press [YES] or [NO] keys and set the desired filter value for bichromatism. Press
[READ] to save data. Press [YES] to confirm the storing. If you want to discharge unsaved changes press [STOP].

NOTE: Bichromatism is not achieved if you choose a filter for bichromatism that has the same value used for normal
reading. However to disable bichromatism is better to set the value of Bichromatic filter to “No Bichromatism”.

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6.13. Programming a QLT analysis
Qualitative analysis can be programmed in any analysis between 01 to 90, but in microwells. The instrument is
shipped with a programmed qualitative method (LATEX) on program number 61. Before starting to measure the
sample you may need to enter the desired parameters of the analysis. To program a QLT analysis (let us assume in
number 61) follow this procedure:

Enter analysis
number < >  [6]  [1]
 [PG] to modify the parameters of the analysis

Strip/Cuvette Filter  [READ] to store values


 [1/YES] or [0/NO] until you find the desired
wavelength.  [ENTER]

Method CRP  [READ] to store values.


 [1/YES] or [0/NO] until you find CRP .
 [ENTER].

Bichr. Filtr.  [READ] to store values


 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to enable/
disable Bichromatic filter).
 [ENTER] to go on.

61 CRP
Direct Y/N?  [READ] to store values
 [Yes]/[No] to select or no to read in direct positivity.
If select YES the positive threshold control value has to
be greater than the negative one. The instrument will
display an error message if not so.
If select NO then INDIRECT positivity is chosen and so
the negative threshold control must have an absorbance
value greater than the positive one (Inhibition). The
instrument will display an error message if not so.

61 CRP
USE + - thrl  [READ] to store values
 [Yes]/[No] to select or no a negative threshold control
Choose YES if you want to read both positive and
negative threshold controls.
Choose NO if you want to enter only cut-off sample or
nothing.

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61 CRP
Read cut-off?  [READ] to store values
 [Yes]/[No] to select or no cut-off sample
Choose YES if you want to read the cut-off sample.
Choose NO if you want to enter the CUT-OFF value
manually.

61 CRP
Cut-off val.? _____  [READ] to store values
 [1]…[9] Enter the threshold for the desired cut-off value

61 CRP
 [READ] to store values
 [YES] to confirm
 [NO] to discharge changes

→ During any of above steps, if you press [STOP], parameter modification is interrupted and the new values will not
be stored.

By doing so you can choose to perform an analysis reading or no in agglutination and entering the desired
threshold control (positive value, negative value, manually).
For detailed information about the meaning of the parameter and the recommended quantity of reagent you
can refer to the section 7.2. Qualitative test: Latex agglutination.

6.14. Programming EIA analysis

EIA test is a row absorbance test. He analysis is executed as a MSD one and can be execute only in microwell.
Analysis 71 is already programmed by the factory to perform this test, but it outputs only row data. To program/change
this analysis follow this procedure:

Enter analysis
number < >  [7]  [1]
 [PG] to modify the parameters of the analysis

Strip/Cuvette Filter  [READ] to store values


 [1/YES] or [0/NO] until you find the desired
wavelength. Select a desired STRIP FILTER.
 [ENTER]

Method EIA  [READ] to store values.


 [1/YES] or [0/NO] until you find MSD .
 [ENTER].

Bichr. Filtr.  [READ] to store values

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 [1/YES] or [0/NO] until you find the desired filter for
bichromatism reading (see 6.12. How to enable/
disable Bichromatic filter).
 [ENTER] to go on.

 [READ] to store values


New name -----  Enter the name of the analysis
 [ENTER] to go on.

 [READ] to store values

You can obtain absorbance value for all of the wells, either printed out on paper and sent by RS-232. The whole data
elaboration can be performed by an external software that runs on PC. To understand data format output through RS-
232 refer to APPENDIX C: Serial transmission protocol.

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7. CALCULATIONS PERFORMED BY MAP-LAB PLUS

a) End-point analysis
The instrument measures the sample absorbance, multiplies it by a factor (K) and displays the results directly in the
inserted concentration units. The calculation factor can be entered directly or calculated by the instrument itself. If a
standard is used in the method, the factor is obtained as follows:

C std
K =
ABS std

C std = Concentration of the standard

ABS std = Absorbance of the standard

The factor value is then used to determine the sample concentration as follows:

C sample = ABS sample × K

Csample = Concentration of the sample

ABSsample = Absorbance of the sample

b) Kinetic analysis
In a kinetic analysis, the reaction speed is determined by measuring the variation of sample absorbance with time.
The instrument executes the first reading after a pre-set wait time (delay). It then executes other four readings at
intervals corresponding to 1/4 of the total pre-set analysis time (reaction time). The instrument determines the
absorbance difference between one measurement and the previous one (ABS) and calculates the average of the four
absorbance differences, referred to 1 minute ( ABS/min.). Multiplying the ABS /min by the pre-set factor (K), the
instrument calculates the sample activity, as shown below :

Enzymatic activity (U/L) = ABS/min. x K

Please note that K, usually indicated by the reagents’ manufacturer and referred as Kfactor, can be obtained using the
following formula:

V tot × 1000
K factor =
V sample × e × s

Vtot = Total volume of the reaction mixture


Vsample= Sample volume
e = Molar extinction coefficient of chromogen
s = Optical path ( in cm )

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NOTE:
During Kinetic test is printed out (along with the result of the test) a sequence of parameters that should be read as
follows:

Ref 0 0024 (or Abs 0), if you use blank


D.Abs 0 0020
D.Abs . . . . . . 0005
D.Abs . . . . . . 0005
D.Abs . . . . . . 0005
D.Abs . . . . . . 0005

0000 Sec. 0150

0001 U/L 0030

Kinetic test are generally composed of 2 delays:

- Delay time (initial delay in order the reaction to start)


- Reaction time (time where generally the result is calculated).

Total time is displayed during Kinetic test execution, and is the sum of Delay Time + Reaction Time.

Ref 0 (or Abs 0, if you enable blank on Kinetic) is the initial absorbance value, at t=0, at the very beginning of the
delay time.
- Ref 0 :Initial absorbance value of the solution compared to air.
- Abs 0 :Initial absorbance value of the solution compared to blank sample (in this case the instrument will ask you to
insert a blank sample before the solution sample).
- D. Abs 0 :Delta Absorbance during Delay Time (t=0, t= Total Delay Time). Is the difference between the absorbance
of the solution at the beginning of Delay Time, until the reaction begins (beginning of the reaction time).
- D. Abs :Delta Absorbance during Reaction Time divided for the number of readings (4). Is the difference between
the absorbance of the solution during Kinetic test execution. This are 4 delta.

c) Fixed-time analysis
In this operating mode the instrument performs two ABS measurements on the sample:

- The first measurement after a delay time from the moment you press [READ]

- The second one after a reaction time which starts from the moment the first measurement is completed.

The instrument determines the Absorbance difference between the two readings (ABS). It then calculates the
concentration value by multiplying the ABS by a suitable K. This K can be:

1) entered directly by the operator (Fixed-time method with K)


2) calculated by the instrument using a standard (Fixed-time method with standard)

The calculation procedure is similar to the one used for End-point analyses.

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7.1 2-point recalibration algorithm for Multistandard analysis.


During Multistandard analysis MAPLAB PLUS has the possibility to re-calibrate itself with a specific algorithm
that requires only 2 points for the operation. For example if you have a Multistandard analysis based on 7 standards
and you need to recalibrate it, you can perform the recalibration using only 2 standards instead of 7.
The algorithm used for such a calibration is the following:

 ( A p1 − B p1 ) ⋅ (V n − V p 2 ) ( A p 2 − B p 2 ) ⋅ (V n − V p1 ) 
An = B n ⋅  1 + − 
 B ⋅ (V − V ) B ⋅ (V − V ) 
 p1 p1 p2 p2 p1 p2 
where:

An = Absorbance value of the nth point of the new calibration curve


Bn = Absorbance value of the nth point of the old calibration curve
Vn = VAL of the nth point of the new calibration curve
Bp1, Bp2 = Absorbance value of the 1st and 2 nd point of the old calibration curve
Vp1, Vp2 = VAL of the 1st and 2 nd point of the new calibration curve
Ap1, Ap2 = Absorbance value of the 1st and 2 nd point of the new calibration curve

NOTE : To perform good recalibrations avoid using points with concentration values too near. We recommend to pick
the 2 points near the maximum and the minimum value of the whole concentration range. In this way the 2 points re-
calibrated absorbance curve will fit very well the real one.

Example showing recalibration of a curve using only the 1st and 6 th standard.

900
Concent. Values of New std. New 800
Values the old std. values (A)
(B) 700

600
0 820 780 780
500
0,5 652 619
1 548 520 400
2 470 445 B
300
5 412 387 A
10 367 340 340 200

20 336 303 100


40 312 266
0
80 300 226
0 20 40 60 80 100

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7.2 Qualitative test: Latex agglutination
Latex agglutination has found a large application in diagnostics, and many tests are available on the fields of
human and veterinary health, environment and agriculture.
Most of these tests give qualitative results ( positive or negative ) and are performed by visual reading . However
latex agglutination can be quantified by instruments which measure transmitted or scattered light. Latex tests usually
measure affinity reactions between two molecules, particularly antigen/antibody interactions, involving antigen or
antibody-coated particles. The reaction leads to the agglutination of the solid phase and corresponds to a rapid decrease
of the Optical Density of the medium.
Unfortunately few quantitative QLT tests are commercially available.
Nevertheless, a visual qualitative test can be easily adapted, if necessary, to give sensitive and precise
quantifications. Such a test can be run quickly ( from 5 to 20 min ) on microwell strips and does not require any
separation or washing steps.

Some conditions are necessary:

• Reaction occurs usually at 405 nm.


• Latex particles must be white and homogeneous.
• Final volume of test must be comprised between 50 and 100 µL.
• Latex reagent must be diluted until the final reaction-medium contained in the microwell gives an O. D. ~1.0 at
405 nm. A 5-fold dilution is generally sufficient.
• Latex/ sample volume ratio must be kept unchanged in the new test as in the visual one. Using an 5X latex
dilution, samples should be consequently diluted or their volumes properly reduced in the test.
• Time must be increased. A 5 to 10 times increase is generally sufficient.
• Physiological sol. ( 0.9 % NaCl ) can be used for dilutions.
• A standard solution or calibrator must be used to evaluate the analyte concentration of the positive solution
contained in the kit. In this way, it is possible to use the “positive” solution, properly diluted, to plot a standard
curve or, more simply, to obtain threshold values in the assay.

Latex analysis can be performed in several ways by Maplab plus: by reading two Control threshold samples (one
positive and the other negative), by reading a single cutoff sample or by entering a cut-off value manually.

NOTE :You can choose to read or not using AGGLUTINATION.


Read in agglutination means to use DIRECT POSITIVITY for results calculation.
Read inhibiting agglutination means to use INDIRECT (COMPETITION) result calculation.

The following paragraphs will explain all the cases in details.

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7.2.1 Cut-off sample direct positivity reading


This is the case of a direct positivity reading (reading in agglutination). You can choose to insert cut-off sample
or none. If no cut-off sample is set, you must enter a value of the cut-off threshold directly to the instrument using the
keyboard. The situation is inverted than reading indirect absorbance and is shown in the figure below:

DIRECT
POSITIVE (+)

CUT OFF

NEGATIVE (-)

7.2.2 Two threshold controls direct reading


In this case you perform a direct reading (agglutination reading), entering both positive and negative threshold
controls.
The situation is shown in the following figure:

DIRECT
ABS values greater than this threshold
are considered as POSITIVE (+)

+ Positive threshold control

WEAK AREA (+/-)

- Negative threshold control

ABS values less than this threshold are


considered as NEGATIVE (-)

It is clear that the absorbance value of the positive threshold control must be GREATER than the negative
threshold control. The instrument compares these two values and when performing the calibration at the beginning of
the analysis.

NOTE: In this case the ABSORBANCE value of the positive threshold control has to be GREATER than
the negative one: an error message is displayed if this condition is not satisfied (“READING ERROR”).

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7.2.3 Cut-off sample, competition reading (indirect)
Maplab Plus has the possibility to execute QLT analysis reading in competition (agglutination inhibited). In this
case you must choose indirect reading by entering in the method programming mode (see 6.13. Programming a QLT
analysis).
Maplab Plus can also works with a single threshold; in this case the cut off value can be read as a cut-off sample
by the instrument or user can enter it directly using the keyboard..

COMPETITION (INDIRECT)
NEGATIVE (-)

CUT OFF
POSITIVE (+)

7.2.4 Two threshold controls, competition reading.

In this case the instrument is able to divide the absorbance value in three fields, using the read values as
positive/negative thresholds, reading in indirect way (inhibit agglutination).

COMPETITION (INDIRECT)
ABS Value less than this threshold are
considered as NEGATIVE (-)

- Negative threshold control

WEAK AREA (+/-)

+ Positive threshold control

ABS Value greater than this threshold


are considered as POSITIVE (+)

NOTE: In this case the ABSORBANCE of the positive threshold control has to be LESS than the
negative one. An error message is displayed if this condition is not satisfied ("READING ERROR").

When you perform an analysis with 2 threshold controls (positive and negative), sample values exceeding these
thresholds are considered to be positive (flag + in the printout) or negative (flag – in the printout), depending on their
absorbance values. Values which lie between the negative and the positive threshold are in the weak area. In this case
the instrument will warn about the situation with a special flag in the printout (-/+).

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7.2.5 QLT results printout format.
Whatever is the QLT analysis performed by Maplab Plus, the results are printed in the following format: analysis
number, value of the negative and positive controls. The number of the strip is also printed in a progressive way, and
similarly the value of each well of the strip. A flag (+, -, +/-) is printed near the results, as explained above.
To perform a QLT analysis refer to 5.4. Execution of QLT analysis. An example of a printout of a Direct
positivity (aggl.) test using cut-off is given:
61 CRP
Cut-off= 0661

Strip 001
0001 0306 -
0002 0417 -
0003 1041 +
0004 1568 +
0005 0393 -

An example of a printout of an Direct reading (aggl.) test using 2 threshold controls is given:

61 CRP
Neg.= 0026 Pos.= 0153

Strip 001
0001 0006 -
0002 0017 -
0003 0041 -/+
0004 0068 -/+
0005 0193 +

An example of a printout of a Indirect/Competition Reading (Inhibit aggl.) test using cutoff is given:

61 CRP
Cut-off= 0646

Strip 001
0001 0416 +
0002 0437 +
0003 1201 -
0004 1472 -
0005 0378 +
An example of a printout of an Indirect/Competition Reading (Inhibit aggl.) test using 2 threshold controls, is given
below:
61 CRP
Neg.= 0425 Pos.= 0130

Strip 001
0001 0006 +
0002 0017 +
0003 0341 -/+
0004 0668 -
0005 0793 -

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7.3 Bichromatic filter


In End-point methods (using K or standard) and Multistandard ones, it is possible to perform the photometric
measurement using the Bichromatic filter as well as the reading one. The use of such filter reduces the photometric
background noise in the chemical reaction. The instrument measures the absorbance of the reading filter at the
corresponding wavelength and that of the Bichromatic filter at another wavelength. It determines the difference
between these two absorbance values and gives the final result.
The chromogen formed in the reaction must not absorb at the wavelength selected for the Bichromatic filter. In this
way, the background noise can be subtracted from the photometric determination; such a noise is usually constant at all
wavelengths. Bichromatic filter is also useful for reducing eventual imperfection of the plastic material of the cuvettes
or the microwells. In microwell analysis, bichromatism is achieved through a step motor that quickly switchs to the
wavelength of bichromatism, reducing the execution time of analyses.
To set-up a test with bichromatism see 6.12. How to enable/disable Bichromatic filter

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8. QUALITY CONTROL

8.1 Quality Control program


For cuvette methods it is possible to have up to 2 quality control program for each channel, for a maximum number
of 30 total quality control programs.
The quality control collects the last 30 results, and calculates (after a complete acquiring of the 30 samples) the
more important statistical parameters, such as :

Mean = Mean Value


SD = Standard Deviation
CV = Coefficient of variation

With the analyzer can print Levey-Jennings control chart, with 2s and 3s interval. The acquired result can be
recalled at any time. See section below for more details.

8.2 How to enable/disable Quality Control program for the current test
In each test that is performed inside the cuvette section (cuvette or flow cell) can be enable/disable the QC
program. For each test it is possible to enable 2 different QC program, with the limitation that the total numbers of
enabled QC program cannot exceed 30.
To enable or disable the QC program for a test enter in test programming mode (by typing the test number and
pressing PG key) and then press ENTER, until the following messages is displayed:

10 CREA K 00476
Enable QC1 Y/N? Y

Note that this example refers to test number 10 (CREA). Answering YES you will enable QC1 for the test number 10,
in this case CREA. Answering NO you will disable the QC1 for that test.
Pressing ENTER you will switch to the next field (enable/disable QC2):

10 CREA K 00476
Enable QC2 Y/N? N

Note that also this example refers to test number 10 (CREA). Answering YES you will enable QC2 for the test
number 10, in this case CREA. Answering NO you will disable the QC2 for that test.

Important:
Disabling QC and saving the changes (READ + YES key) will erase the existing QC memory, loosing the QC
parameters and data.

8.3 How to collect a QC sample


In each test that in which QC is enabled you can access to QC menu by pressing the key number "7" or "9" while
the message "Insert sample" is displayed.

10 CREA K 00476 10 CREA K 00476 10 CREA K 00476


Insert sample Insert QC1 Insert sample
7 7

Pressing again the same key will return to the previous status.
10 CREA K 00476 10 CREA K 00476 10 CREA K 00476
Insert sample Insert QC2 Insert sample

9 9

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When "Insert QC" is displayed you can insert your QC sample and press READ or PUSH button (depending
on whether you are using cuvette or flow cell).
Once the sample has been read the analyzer will store it in the QC memory. If the memory is full the
instrument will ask you the following questions:

10 CREA K 00476
QC1: Shift data?

Answering YES you will tell the analyzer that the all samples inside the memory will be shifted of one step.
The first sample is erased and the current sample is stored as the last sample acquired.
The examples below show this case.

SMP1 SMP2, SMP3, …. SMP29, SMP30 SMP31

If you answer NO the instrument will ask you if you want to recalculate the statistical parameters:

10 CREA K 00476
QC1: Recalc.?

Answering YES you will tell the analyzer that the statistical parameters (such as MEAN, SD, CV and 2s, 3s
interval) will be recalculated using last 30 parameters inside the memory as sample QC history.
If you answer NO the instrument will only ask you if you want to erase the QC memory, preserving the
statistical parameters calculated in a previous session.

10 CREA K 00476
QC1: Erase?

Answering YES you will tell the analyzer that the statistical parameters (such as MEAN, SD, CV and 2s, 3s
interval) will remain the same and only the 30 QC sample data will be erased.

Note that example above refers to QC1 on CREA, channel 10. You will have the same behavior with a
different test and QC2.

8.4 Viewing QC data and graph


To access to QC data you simply have to press LIST when the following "Insert QC" message is displayed.

10 CREA K 00476
Insert QC1

If the QC memory is not empty, will be reported the data stored in the non volatile memory. If statistical
parameters have already been calculated then the Levey-Jennings control chart it is also plotted (Fig. 9)

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QC1
Units: U/L
Num. = 18
Mean = 03.34
SD = 0.002
CV = 1.4

15 Oct 08:00 3.30


16 Oct 08:04 3.38

. . .

12 Nov 08:03 3.34


14 Nov 08:09 3.34

-3S -2S +2S +3S

Figure 9: Levey-Jennings control chart

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9. TECHNICAL FEATURES OF MAP-LAB PLUS

General characteristics

Size: 17×40×40 cm.


Weight: 18 kg
Power supply: 220 V, 50 Hz; 117 V, 60 Hz; 50 W
Working temperature: 15°-30° C
Instrument class: I
Installation category: II
EMC Class: A

CUVETTE SECTION

Photometric system
Light source: 20 W long-life iodine incandescent lamp
Spectral field: 320 to 690 nm
Filter change: automatic by a synchronous AC motor
Filters for cuvette: 340, 405, 505, 546, 578, 630 nm; 6 nm pass-band
Detector: solid state device
Cuvette type 1cm optical-path square or cylindrical cuvettes

Thermostat
Heating element: semiconductor
Temperature: 37°C
Temperature accuracy: ±0.2°C
Stabilization time: at least 15 min
Thermostatic unit: 10-position

Measuring system:
Reset: automatic
Measuring range: -0.200 to +2.500 OD
Photometric linearity: 1%
Photometric accuracy: ± 1% from 0 to 2.000 OD
Precision: CV < 1% @ 2.0 O.D.
Drift: lower than 0.005 O. D. per hour
Reagent volume: 1 ml (minimum)
Methods: End Point, Multistandard, Fixed Time, Kinetic, Differential

Flow cell:

Flow cell: 18 or 80 µL, two ways


Typical working volume: 500 µL with 18 µL flow cell.
1000 µL with 80 µL
Minimum working volume: 350 µL with 18 µL flow cell
800 µL with 80 µL
Carry over: less than 1% on the above condition
Aspiration: Peristaltic pump with programmable sipping volume
and air gap setting

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MICROWELL SECTION

Photometric and positioning system


Light source: 2 W High pressure Lens-end Krypton Gas Filled Lamp. 4500 hours of lifetime.
Spectral field: 405 to 690 nm
Filter change: automatic by a high precision 30 Ω/phase step motor
Filters for microwell: 405, 450, 492, 630 nm; 6 nm pass-band
Microwell positioning: automatic by a high precision 30 Ω/phase step motor
Detector: solid state device

Measuring system:
Reset: automatic
Measuring range: -0.200 to +3.200 OD
Photometric linearity: 2%
Photometric accuracy: ± 1% from 0 to 2.500 OD
Drift: lower than 0.005 O. D. per hour
Reagent volume: 1 mL (minimum)
Microwell type: either round and flat bottom 8-microwells strips
Methods: End Point, Multistandard, Qualitative

Data display and programming:


Keyboard: 11 digital keys + 3 functional keys
Display: back-illuminated liquid crystal alpha-numeric, 32 characters
Thermal printer: 20 columns
Printer paper roll: thermal type, 57mm wide, 44 mm roll diameter
Memory capacity: 90 programs
Serial output: RS-232 standard

Serial transmission of data:


Every time MAP-LAB performs an analysis the results are sent by the instrument through the serial port.
The serial output, standard type RS-232, uses the following transmission parameters: 9600, N, 8, 1.

Serial connection:
The output connector, 9-pole standard type, is located on the back of the instrument. The connections are as follows:

pin 2: input
pin 3: output
pin 5: reference signal

The pin number of the 9-pole connector is adapted for the personal computer IBM type or IBM compatible and follow
the RS232 standard..

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 73 of 84
APPENDIX A: MESSAGES AND ERROR SIGNALS
The following table shows the error messages: most of them are related to issues that the user can normally solve
himself: if the problem persists, or a problem not listed below arise, contact your dealer.

Excluding the main plug fuses, the instrument has no user serviceable parts: only trained technicians are allowed
to service the instrument. An unauthorized action on the instrument may invalidate its safety and features,
beside void the warranty.

MESSAGE DESCRIPTION POSSIBLE OPERATIONS

Out of range The sample absorbance is too high or the Press [READ] to repeat the reading.
reading is impossible, due to faulty
instrument

Printer error Error when printing Press [STOP] to disable the printer, or any
other key to try again

Command error An internal error has occurred Call service

No temp The thermostat has not yet reached 37°C Wait*

Filter selection The instrument is positioning the selected Wait


filter

Filter error Error in the filter selection Press [STOP] to interrupt the filter selection,
or any other key to try again.

Wait time XXX XXXX = time (in seconds) required to Wait or press [STOP] to interrupt the analysis
complete the analysis.

Reading error In QLT analysis Check the positive negative control position in
the microwell.
--- In a KIN or FXT analysis, the absorbance- Dilute the sample.
variation of the sample is too high during the
first time-interval (Delay).

W_1_cd: n Printed only at the start-up (during self test). Warning: few light Analysis can still be
N is a number between 1 and 10. performed, but call service as soon as
possible.
E_1_cd: n Printed only at the start-up (during self test). Instrument halted.
N is a number between 1 and 13 Call service.
LLLL In an MSD analysis, the sample concentration The sample concentration is lower than the
is less than that of the lowest standard minimum range of the method.

HHHH In an MSD analysis, the sample concentration Dilute the sample.


is greater than that of the highest standard

Internal Error May be due by different cause. Printer is not Check the printer header, if it is jammed with
responding because of a feed jam, or the thermal paper.
stripholder is blocked inside the linear lead. Call service.

*This message appears only during kinetic or Fixed-time analyses. The operator can however carry out the analysis.
An asterisk will appear on the right side of the printed result.

In the next page follows an explanation of all the errors that can be printed out by the instrument during its "Self Test".

Basically there are 2 different types of message that can be printed out during "Self Test": these are "Warning Codes"
and "Error Codes".

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 74 of 84
Warning CODES:

All the interferential filters are checked during SELF TEST and a warning message is printed out if a filter seems to
be deteriorated. The warning message looks like:

W _1_CD: (followed the number of the defective filter).


Note that this is a warning message, so that you can still work with the instrument, also in TEST where such a filter is
involved. Result will not be affected by this message, but you should call service in order to replace the defective filter
as soon as possible, because you can loose accuracy at the defective wavelength. Anyway it is still possible to perform
reliable and accurate measurement at all the other wavelengths.

Error CODES:

If an error is encountered during self test the system will be HALTED in this phase: the instrument is stucked
displaying "SELF TEST" and an error message is printed out in the paper. This error message looks like:

E_1_CD: (followed by the error code).


Error codes are generally critical. And compromised the functionality of one of the 2 section of the instrument. Is
possible , however, to continue to work with the instrument by excluding the defective section (for example, if cuvette
section lamp has burned out, you can still work with the instrument in the EIA section).
The instrument, in fact, is composed by 2 independent sections: cuvette and microstrip. If one of those section is
defective the instrument will return an error like:

Cuvette Failure. Continue? Ex: cuvette lamp burned


EIA Failure. Continue? Ex: strip lamp burned

If you say Yes, the defective section will be disabled. The instrument however will continue to work only with the
operative section.
Anyway, in this case you should contact to your nearest distributor for service/maintenance operation.

NOTE:
In case of suspect malfunctioning of the analyser, use control serum of known value to check the accuracy of the
results. Alternative, you can use coloured solution.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 75 of 84
APPENDIX B: CONVERSION FACTORS
CONVERSION FACTORS OF ENZYMATIC ACTIVITIES (I.U.) AT DIFFERENT TEMPERATURES

ENZYME
25°C 30°C 37°C

ALAT (GPT)
at: 25°C 1 0.72 0.50
30°C 1.39 1 0.69
37°C 2.01 1.45 1
ALP
at: 25°C 1 0.77 0.57
30°C 1.29 1 0.74
37°C 1.74 1.35 1
α-AMYL
at: 25°C 1 0.81 0.65
30°C 1.23 1 0.81
37°C 1.53 1.24 1
ASAT (GOT)
at: 25°C 1 0.72 0.47
30°C 1.39 1 0.65
37°C 2.14 1.54 1
CK
at: 25°C 1 0.69 0.42
30°C 1.44 1 0.60
37°C 2.40 1.67 1
γ-GT
at: 25°C 1 0.73 0.56
30°C 1.37 1 0.77
37°C 1.79 1.31 1
LDH
at: 25°C 1 0.69 0.42
30°C 1.44 1 0.60
37°C 2.40 1.67 1

EXTINCTION COEFFICIENTS ( cm²/mole x 106 )

WAVELENGTH 334 340 365 405 505


(nm)
CHROMOGEN

NADH 6.18 6.3 1.33

NADPH 6.18 6.3 1.33

p-nitrophenol 18.8

Quinone imine 6.89

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 76 of 84
APPENDIX C: SERIAL TRANSMISSION PROTOCOL
MAP-LAB plus has the possibility to output all the results through the serial port on the back of the instrument. The
output connector, 9-pole standard type, is located on the back of the instrument. The connections are as follows:

pin 2: input
pin 3: output
pin 5: reference signal

The pin number of the 9-pole connector is adapted for the personal computer IBM type or IBM compatible. Signals
voltage level follow the RS-232 specifications.

The string used to output a results is:

pppp nnnn uuuuu rrrrrr aaaa t s fl <CR,LF>

where:

pppp = Progressive number


nnnn = Method name
uuuuu = Measuring units
rrrrrr = Result
aaaa = Absorbance value
t = 32 + Method number
s = 32 + Special number type
fl = Flag (if more than one are separated by a space ASCII (32))

The string used to output a standard is:

Sppp nnnn uuuuu rrrrrr aaaa<CR,LF>


WHERE:
ppp = Standard NUMBER (001-999)
nnnn = method name
uuuuu = empty
rrrrrr = standard concentration
aaaa = Standard absorbance value

The string used to output a QLT result is:

++++ nnnn uuuuu rrrrrr aaaa<CR,LF>


WHERE:
BLNK = Blank identification
nnnn = method name
uuuuu = EMPTY
rrrrrr = EMPTY
aaaa = control absorbance value

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 77 of 84
APPENDIX D: EIA ANALYSIS WITH PC

A special analysis is provided in Maplab Plus analyzers that can perform EIA calculations by the use of an external
software that runs on PC. This analysis is analysis number 94. To make measurements with analysis 94 you need a PC,
a serial cable, a Maplab Plus analyzer and the Data Management Software, that comes in a CD-ROM. The software on
the PC allows you to perform a complete management of the EIA readings, dividing them in 2 categories:

- QUALITATIVE
- QUANTITATIVE

This software can handle replicates for blank, sample, standard and control. In qualitative test a Cut-Off equation can
be entered manually, to calculate the required threshold.
In quantitative test there is the possibility to use various type of fitting for standard interpolation and the possibility to
adjust/correct the single standard.
Refer to Maplab Plus Data Management Software User Guide for further documentation (the file is available in the
installation CD-ROM).

System requirements
A IBM-compatible PC is needed to run this software with a Microsoft Windows 32 bit operative system
already installed. Not fast environment is required by this software. The software can run with any Intel 32-bit
processor, but a Pentium (or higher) is recommended. You can install the software on Windows 95, Windows 98 or
Win NT. To run the software you need also a free RS232 port on your PC.

Before installing the software is strongly recommended to read the README.TXT file in the root of the CD-
ROM. In the CD-ROM you will find also 2 different folders (the first for ODBC32, the latter for Maplab Software),
with 2 separated Setup programs. Remember to install ODBC32 before the Maplab Data Management Software.
The software comes in a CD-ROM with an installation shield inside, that guides the user towards all the
installation process. We recommend you install the software using this installation shield. When the installation shield
is running you have 2 possibility (note: you can exit anytime from the installation shield by clicking on the "Exit"
button):

- Install Maplab and Maplab Plus SW. This feature automatically guide you through the whole
installation process, installing the software for EIA analyzer.
- Explore Biochemical Systems International products (inside the CD-ROM). You can navigate with
system default browser inside Biochemical Systems International products.

If you want to install the software choose the first choice and click "Go!" button. The software then asks you to:

- Install Microsoft ODBC32 driver (recommended).

NOTE: It is recommended to install ODBC32 before installing Maplab Plus Data Management Software.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 78 of 84

If you are using Windows 98 you may already have ODBC32 with Microsoft Access driver installed in
your system (in this case you can skip this installation). Windows 95 users may need to install ODBC32.

- Install Maplab and Maplab Plus Data Management Software. Installs the main application of the
program. Install this application after ODBC32 drivers have been installed on your system.

If you encounter problem with installation shield or you wish to install the software without using this Wizard, you can
install the software manually at any time. To make this installation easier 2 different setup program were provided (one
with ODBC32 driver, the other with the main application). Please, follow the 2 step below:

1. Install Microsoft ODBC32 driver for Access 97. Run setup program in ODBC32 folder. When the
installation is complete it will ask you to run the program. Choose YES in the check box, in order to install the
Microsoft Access 97 Database Driver. Follow the instruction on the screen until installation of this driver is complete.

2. Install the Maplab and Maplab Plus Data Management Software. Installing this software on your
hard disk it will automatically configure ODBC32 driver with the program database file.

After having installed the software you need to connect the RS-232 connector on the back of the Maplab Plus
with a free com port on your PC. Then run the Maplab Plus Data Management Software and enter in analysis
number 94 in Maplab.
You will see Maplab connected to PC, displaying the message ''CONNECTED". In your monitor the program
will display the message "INSTRUMENT CONNECTED".
If you receive the message "Instrument not connected" on PC (that corresponds to "CONNECTING…" on
Maplab) it means that you have a problem with the connection or with the serial port. Check the connection cable to be
completely inserted on its connectors, and check the com port number using setup button in Maplab Plus Data
Management Software. Assign to the program the COM value of the port in which the serial connector was plugged
in.

NOTE: The serial protocol used by Maplab to communicate with the PC works only with the special analysis number
94. On other analysis communication will not take place, and the program will remain UNCONNECTED.

For further information refer to Maplab Plus Data Management Software User Guide.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 79 of 84
APPENDIX E: MAINTENANCE

Before an instrument is shipped it is entirely tested through several procedure by the factory. Temperature
calibration is performed to ensure a 37° C temperature of the incubator and of the reading hole, and absorbance and
linearity are adjusted in order to fit the best reading point.

For any problem with the instrument refer to the troubleshooting section ( APPENDIX A: Messages and
Error signals). If you need to recalibrate the instrument contact service to get the suitable hardware/software device
and the specific documentation given by Biochemical Systems International.

In order to ensure a long time measuring stability of the instrument some measures must be taken:

• Avoid cleaning the instrument with water or alcohol. Use a dry cloth.
• Avoid dropping moisture and water in the reading hole and in the incubator.
• Avoid to place the instrument in a wet place, since humidity contributes to filter deterioration and time stability.
• Always remove the microwell strip from the strip-holder at the end of the day. Don’t forget a microwell strip
inside the instrument.
• Keep the instrument covered with its plastic sheet when is not used. Also keep clean the strip holder. This will
avoid dust infiltration inside the reading hole.
• To remove organic stain on the cover of the instrument use hypoclorite solution or glass detergent.
• Make sure the voltage at the available supply socket is as provided for and a suitable earth connection is
assured.
• A periodic cleaning of the reading cell is however advised, by means of aspiration of sodium hypocloryte.
• Use maximum care when handling the flow cell. Flow cell connections with the tubing are very weak and there
is no warranty covering them.
• At the end of a working session is recommended to aspirate distilled water inside the flow cell in order to clean
peristaltic pump and remove dirty and solution sedimentation outside flow cell. Use the WASH button and 10-20
ml of distilled water for this purpose. Leave the instrument with distilled water inside the flow cell for the night.
• If you plan not to work with the instrument for more than 3 days, prepare it for a long inactivity time. Refer to the
installation chapter for this case.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 80 of 84
APPENDIX F: REDUCING CARRY-OVER USING AIR-GAP
Carry-over is the residual solution inside the flow cell that affects the final result of a photometric measurement.
This quantity depends by several factors, but the most important for our purpose are:

• The density of the solution used


• The absorbance value of the solution
• The internal cleanliness of the flow cell
• The quantity of aspirated volume (sample volume)
• The flow cell volume. The instrument can work either with 80 uL flow cell (that is the standard flow cell) or with
the 18 uL flow cell (upon request).

The instrument is shipped with its carry-over value indicated in the documentation that refers to its internal
Quality Control. This sheets are usually enclosed in the first page of the manual. Anyway instrument carry-over must
be less than 1% to pass the Quality Control.

To reduce instrument carry-over several measures can be taken:

• Use 18 uL flow cell instead of 80 uL flow cell.


• Wash the instrument with sodium hypoclorite to clean internally the flow cell.
• Use a greater quantity of reading solution.
• Use air-gap.

Air-gap can reduce dramatically carry-over effects, but requires a little of experience in working with it. Air-gap is
an instrument features that allows the User to set up a Sample volume, a Delay time and an Air aspiration volume.
Basically the instrument performs a DOUBLE ASPIRATION (the first for the sample , the second for the air).In fact,
after each sample the peristaltic pump is turned OFF for a programmable amount of time (User should remove the
reading solution from the aspiration spout during this delay) and is turned ON again for a certain amount of time
in order to aspirate a programmable volume of air.

This parameters are General Setup Parameters (not test parameters) so will remain the same for all the test.

DELAY = 0000 ms
ANSP. VOL. = 0000 uL

The instrument is shipped with this 2 parameters disabled (that is their values set to 0000).

Recommended value for beginner are:

DELAY = 3000 ms
ANSP. VOL. = 0150 uL

In this way the instrument (when a sample in flow cell is executed during a test) makes a double aspiration
described in these 3 steps:

1. Aspirate the sample volume programmed for that specified test.


2. Wait for the programmed Delay time
3. Aspirate the programmed quantity of air.

You can use program 98 to set this 2 parameters. Refer to General Setup paragraph in this document.

According to the test you are executing and to the test manufacturer you can change these parameters in order to
fit their best values.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 81 of 84

APPENDIX G: READING A STANDARD CUVETTE WITH LESS THAN 1500 µL


The analyzer is shipped with the reading height that exactly matches the reading aperture in the flow cell (the same
height for 18 or 80 uL flow cell). In this condition the analyzer can work correctly in the flow cell and with a
minimum reading volume of 1500 uL in standard plastic cuvette (10 mm optical path), like the ones supplied with the
instrument.
Some kits however have a reading volume of less than 1500 uL (for example 1000 uL). With such kit it is not possible
to work with the instrument unless:

1) Use reduce volume cuvette (same 10 mm optical path). Contact your nearest distributor for more information.
2) Adjust the PVC screw in the incubator chamber in order to increase the reading height. In this way you can reduce
the volume according to your needs, but remember that the light beam does not match anymore the flow cell
reading aperture and you have to setup it again if you want to work again with the flow cell.

The figure below explains how to adjust the reading height (regulating the height of the PVC screw) in order to work
with flow cell of reduced volume. Refer to the following table for more information:

PVC Screw HEIGHT (h) FLOW CELL REDUCE VOLUME CUVETTE STANDARD CUVETTE
0 * -Figure A - OK OK (Minimum Volume 1500 uL)
2.5 turn * -Figure B- NO OK OK

*: Note that the screw height is measured according to the turn from the down position.

B
PVC SCREW

CAUTION! Use maximum care when performing this operation, since an excessive
strength may damage permanently the PVC screw inside the reading incubator chamber.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 82 of 84

APPENDIX H: WEEE AND ROHS DIRECTIVES

BSI complies with WEEE EC Directive (2002/96/CE) about recycling of electrical and electronic equipment waste.
This EC Directive forbid to collect no more used electrical and electronic equipment waste with normal rubbish and
entrust the producers the collection and the recycling of such kind of waste.
When you have to dismiss a BSI instrument, please don’t throw it with normal rubbish, but contact BSI or the
authorized dealer.
Wasting should be performed in the country were the instrument has been sold.

Contact BSI at:

HeadQuarter:

Via G. Ferraris 220, ZIP code 52100, Arezzo


Tel: 0575 984164, Fax: 0575 984238
e-mail: biosys@biosys.it
Internet: www.biosys.it

Instrument Division:

Via B. Buozzi, 253 – Campi Bisenzio , ZIP code 50013 Firenze


Tel: 055 8963140, Fax 055 8997086
e-mail: biochfi@biosys.it

The label present on each instrument certifies that BSI complies with WEEE Directive:

BSI also assures that no one of the materials listed by RoHS Directive (2002/95/05) is used to build and assemble its
instruments.

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 83 of 84

APPENDIX I: IMPORTANT NOTICE ABOUT BIOHAZARD RISK


The following notes regard this label you find on the instrument:

Working with analytical instruments for in-vitro diagnostics involves the handling of human samples and
controls, which should be considered at least potentially infectious. Therefore, every part and accessory of
the instrument which may have come into contact with such samples must also be considered as potentially
infectious.

Before servicing the instrument it is very important to thoroughly disinfect all possibly contaminated parts.
Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by a well-trained, authorized person, observing all necessary safety
precautions.
Instruments to be returned must be accompanied by a decontamination certificate completed by the
responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory
will be responsible for charges resulting from non-acceptance of the instrument by the servicing center or
from any authority’s intervention.

Should you have any questions please do not hesitate to contact us:

HeadQuarter:

Via G. Ferraris 220, ZIP code 52100, Arezzo


Tel: 0575 984164, Fax: 0575 984238
e-mail: biosys@biosys.it
Internet: www.biosys.it

Instrument Division:

Via B. Buozzi, 253 – Campi Bisenzio , ZIP code 50013 Firenze


Tel: 055 8963140, Fax 055 8997086
e-mail: biochfi@biosys.it

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY
Page 84 of 84

DICHIARAZIONE DI CONFORMITÀ CE
EC STATEMENT OF COMPLIANCE
DECLARATION DE CONFORMITE CE
EG-KONFORMITÄTSERKLÄRUNG

Fabbricante: Biochemical Systems International S.r.l.


(Producer/Producteur/Hersteller)
Indirizzo: Via G. Ferraris, 220 - 52100 Arezzo - ITALY
(Address/Adresse/Anschrift)

Dichiara che l’apparecchiatura: Map Lab Plus


Hereby states that the device known as:
Déclare que l’appareil :
Erklärt, daß das nachfolgend aufgeführte Gerät :
MODELLO : Map Lab Plus
(MODEL/MODEL/MODELL)

È conforme alle seguenti direttive CE:


73/23CE, 89/336CE, 92/31CE, 93/68CE, 98/79/CE, come modificate e recepite dalla
legislazione italiana
The machinery meets the requirements set by the following EEC Directives:
Directives 73/23EC, 89/336EC, 92/31CE, 93/68CE, 98/79/CE as amended and implemented under Italian law
L’appareil est conforme aux Directives CE suivantes:
Directive 73/23EC, 89/336EC, 92/31CE, 93/68CE, 98/79/CE telle que modifiée et accueillie formellement par la législation italienne.
Im entspricht das Gerät den folgenden EG-Richtlinien:
EG Richtlinie 73/23EC, 89/336EC, 92/31CE, 93/68CE, 98/79/CE wie von der italienischen Rechtsprechung modifiziert und aufgefaßt

Sono state applicate le seguenti Norme Nazionali, che traspongono le Norme Armonizzate CE:
The following national standards and technical specifications, conforming to EEC Harmonized Regulations, were followed:
Les normes nationales transposant les normes harmonisées CE qui ont été appliquées sont les suivantes:
Folgende nationale Normen wurden angewandt, die den vereinheitlichten EG-Normen entsprechen:
EN 61000-6-3 (2002/10), EN 55011 (1999/05), EN 55022 (1999/06) Class B
CEI EN 61000-3-2 (2002/04), CEI EN 61000-3-3 (1977/06)
EN 61010-2-101 (2002/01)

Arezzo, 31 Ottobre 2003

………………………………
Dr. Oliviero Giusti

MapLab Plus User’s Guide Biochemical Systems International s.r.l., via Galileo Ferraris, 220- Arezzo ITALY

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