SmartChem 450 User Manual

SMARTCHEM 450 USER MANUAL REV.01 JUNE 2020

SMARTCHEM 450 - USER MANUAL

CHAPTER 01 – CONFIGURATION SHEET

SMARTCHEM 450 USER MANUAL REV.01 JUNE 2020 PAGE 1 OF 2

CHAPTER 01 – CONFIGURATION SHEET

CHAPTER

DESCRIPTION

REVISION

01

CONFIGURATION SHEET

01

02

SYSTEM DESCRIPTION

01

03

SOFTWARE DESCRIPTION

01

04

USER INSTALLATION

01

05

DIAGNOSTIC PROGRAM

01

06

FORMULAS AND CALCULATION MODELS

01

07

USER MAINTENANCE

01

08

DAILY ROUTINE

01

09

ERROR SIGNALLING AND TROUBLESHOOTING

01

10

LIMS COMMUNICATION

01

CHAPTER 01 – CONFIGURATION SHEET

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1 Configuration Sheet

1.1 MANUAL HISTORY

Chapter

Release

Date

Description

Chapter 01

01

June 2020

First Release

Chapter 02

01

June 2020

First Release

Chapter 03

01

June 2020

First Release

Chapter 04

01

June 2020

First Release

Chapter 05

01

June 2020

First Release

Chapter 06

01

June 2020

First Release

Chapter 07

01

June 2020

First Release

Chapter 08

01

June 2020

First Release

Chapter 08

01

June 2020

First Release

Chapter 09

01

June 2020

First Release

Chapter 10

01

June 2020

First Release

CHAPTER 02 – SYSTEM DESCRIPTION

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USER MANUAL

CHAPTER 02 – SYSTEM DESCRIPTION

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Summary

2 Description of the system .................................................................. 3

2.1 Introduction ................................................................................................... 3

2.2 Sampling Arm ................................................................................................. 4

2.3 Diluter ............................................................................................................ 4

2.4 Reactions Plate ............................................................................................... 5

2.5 Samples Plate ................................................................................................. 5

2.6 Reagents Plate ............................................................................................... 6

2.7 Photometer .................................................................................................... 7

2.8 Washing Station ............................................................................................. 8

2.9 Reagents and Samples barcode readers ......................................................... 8

2.10 ISE Module (Optional) .................................................................................... 9

2.11 Cadmium Module (Optional) ........................................................................... 9

2.12 Instrument Characteristics and Specifications ............................................. 10

2.13 Specifications and minimum requirements for the operative system and PC 11

2.14 Limitations of use ......................................................................................... 11

2.15 Certification .................................................................................................. 11

CHAPTER 02 – SYSTEM DESCRIPTION

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2 Description of the system

2.1 INTRODUCTION

The Smartchem 450 is a benchtop, fully automatic, random access, open analyzer for clinical and immunoturbidimetric assays.

It communicates with a computer through either a USB port (with a USB to Serial adapter) or an RS 232 port.

The Smartchem 450 has a photometric analysis throughput rate of 287 tests per hour and a 15 seconds machine cycle time.

The first time the system is used for normal laboratory operations, the user must configure the system based on the specific needs of that laboratory. In other words, the chemistry parameters and the reagents racks, along with the normal, calibrated and control values, must all be defined.

The Smartchem 450 is an open system instrument that allows configuration with reagents chosen by the user.

IMPORTANT NOTE: in order to guarantee overall analytical performance levels of the

“Instrument + Reagents” system, the Laboratory is responsible for using reagents,

controls and calibrators that have been validated and certified for use on the Smartchem

450.

The Smartchem 450 instrument is composed of the following main parts:

 Sampling Arm;  Diluter;  Reactions Plate;  Samples Plate;  Reagents Plate;  Photometer;  Washing Station;  Barcode Readers (optional);  ISE Module (optional);  Cadmium Module (optional).

CHAPTER 02 – SYSTEM DESCRIPTION

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2.2 SAMPLING ARM

One mechanical Arm performs all sampling operations. It is able to reach the aspiration point of the Reagents Plate, the aspiration point of the Samples Plate, the delivery point of the Reactions Plate and the two Washing Wells. A specific sampling Probe is connected on its head. The Sampling Arm can move vertically and horizontally with respect to the Raising Top of the instrument by means of two stepper motors, respectively. The horizontally movement take place along an arch of circumference. The heated needle performs a reagent pre-warming at 37.0 °C. Moreover, one Digital Level Sensor Board - opportunely connected to the Sampling Probe - allows the liquid level sensing

2.3 DILUTER

The Diluter allows to perform all the operations of aspiration and delivery of the liquid up till the capacity of 1000 μl. It is connected to the Sampling Arm and to its electro valve and micro pump. It is able to sample volumes of 0.25 μl, with a CV less than 1%.

The device works through the movement of a unique central piston for the operations of aspiration and delivery of liquid. The piston is moved through a stepper motor without use of step-down gears to minimize the backlash. Moreover, in this device are implemented some solutions to avoid the presence of air micro bubble inside it and inside the hydraulic circuit.

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2.4 REACTIONS PLATE

The Reactions Plate of the instrument contains 80 cuvettes. Each of them has an optical path of 10 mm. Each cuvette can be removed individually. The plate is covered by a specific plate cover.

The plate rotates through a stepper motor. This motor assures a high precision of positioning, superior to ± 0.1°.

The basic operating cycle includes: aspiration and dispensing of the reagents and the samples by the Sampling Arm in the reaction cuvettes, optic reading of the cuvettes in incubation by the Photometer, along with the relative positioning of the Reactions Plate, washing of the filled cuvettes by a Washing Station.

The incubation temperature in the reactions cuvettes is controlled at 37° C ± 0.3° C by a controlled heating unit (Reactions Plate Resistor) placed inside the Reactions Plate .

2.5 SAMPLES PLATE

The Samples Plate is composed by a main plate revolving around its axis and four Satellite Racks (“A”, “B”, “C” and “D”), each of them revolving at the same time around its own axis. Therefore, the Samples Plate is able to describe a substantially hypocycloidal motion.

CHAPTER 02 – SYSTEM DESCRIPTION

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The main plate rotates through a stepper motor, whereas the four Satellite Racks rotate through another stepper motor. These two motors assure a high precision of positioning. The two different rotations are controlled through the respective Home Sensors.

The four separate Satellite Racks (“A”, “B”, “C” and “D”) are universal racks for continuous loading of samples, calibrators and controls.

Two different configurations are available for the samples plate:

 100 Samples Plate

Each Satellite Rack contains up to 18 tubes with a volume of 5 ml. Moreover, 28 extra positions - for the same tubes - are positioned on the main plate for further samples, calibrators and controls.

 68 Samples Plate

Each Satellite Rack contains up to 15 tubes with a volume of 10 ml. Moreover, 8 extra positions - for the same tubes - are positioned on the main plate for further samples, calibrators and controls.

The Samples Plate is covered by means of two covers: Samples Plate cover and Samples Plate safety protection. Removing only the Samples Plate safety protection allows the replacement of the Satellite Racks for continuous loading.

2.6 REAGENTS PLATE

The Reagents Plate is composed by a main plate revolving around its axis and four

Satellite Racks (“A”, “B”, “C” and “D”) each of them revolving at the same time around its

own axis. Therefore, the Reagents Plate is apt to describe a substantially hypocycloidal motion.

The main plate rotates through a stepper motor, whereas the four Satellite Racks rotate through another stepper motor. This two motors assure a high precision of positioning. The two different rotations are controlled through the respective Home Sensors.

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Each of four removable universal racks (“A”, “B”, “C” and “D”) contains 8 positions for trapezoidal bottles of 50 ml. Each of the trapezoidal bottles of 50 ml can be replaced with two trapezoidal bottles of 25 ml. Moreover, 8 extra positions for rounded bottles of 5 ml are positioned on the main plate.

All the bottles inside the Reagents Plate are cooled by four Cooler Modules positioned on its border. Each module is composed by two Peltier cells and a fan opportunely powered. One of them allows mounting of a Cooler Temperature Sensor in order to control the refrigeration temperature.

The plate is covered by a specific plate cover.

2.7 PHOTOMETER

The Photometer allows the direct reading of the Optic Density (O.D.) of the reaction that take place in any cuvette of the Reactions Plate.

The device is composed from two reading channels: Sample Channel for the direct reading of the O.D. value and Reference Channel for its reference value. Each of them is provided of a Pre-Ampl./ADC board for the conversion in a digital signal of the light beam that pass through the cuvette.

The light source is a halogen lamp (6V/10W). It is powered by a Photometer Lamp Board.

The device contains a Filters Wheel that allows reading the reaction at different wavelengths. The wavelengths of the 9 narrow band interferential filters placed on the wheel are the following: 340 nm, 420 nm, 480 nm, 520 nm, 550 nm, 590 nm, 630 nm, 660 nm and 880 nm; each of the previous filters can be changed with one of the following three: 505 nm, 570 nm or 815 nm. Moreover, the Filters Wheel has a dark position.

The Filters Wheel rotates through a stepper motor. The selection of the exact reading filter is controlled by means of the Filters Wheel Home Sensor and its reference on the wheel.

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2.8 WASHING STATION

The Washing Station allows the washing operations of the Reactions Plate cuvettes.

The Washing Station is made up of a series of five small probes. It is situated beside the Reactions Plate and each probe is able to go down into a single cuvette.

The five probes are opportunely connected to the washing station electro valves and micro pumps for the emptying, washing and drying operations of the cuvettes. In particular, the last probe has a pad for the drying operations.

The vertical movement of the Washing Station on the Reactions Plate is allowed by its lead screw connected to a stepper motor.

2.9 REAGENTS AND SAMPLES BARCODE READERS

Two barcode readers can be installed (optional) for reagents and samples on the SAT 450 instrument.

The bar codes families expected on the Samples Plate to be read from the Samples Barcode Reader are only the following: Code 2/5, Code 39, Code 128 and CODABAR. The features of this families are reported in the following table.

Code

Family

Family Members

Check Digit Control

Options

Code Length

Min

Max

Code 2/5

Interleaved 2/5

Yes or No

NA

4

16

Code 39

Standard Code 39

Yes or No

NA

1

16

Code 128

Standard

No

NA

1

16

CODABAR

Standard

NA

No transmission

start/stop

1

16

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2.10 ISE MODULE (OPTIONAL)

An ISE Module can be installed (optional) on the Smartchem 450 instrument.

This module is used to determine the pH, Conductivity and Redox values. The analyzer places the sample in the ISE well of the module. A peristaltic pump positions the sample inside the electrodes, waits for the reading of the sample to be completed and finally moves the sample in the discharge line.

The second peristaltic pump is used to wash the electrodes with the distilled water contained in the appropriate container.

In order to optimize the reading of the results, the sample, taken from the sampling arm, is dispensed in three successive parts:

 The first part called "washing part", used to remove residues of distilled water used to

wash the electrodes after each analysis;

 The second part called the "rinse part", used to approach the electrodes with the

sample;

 The third part called "reading part", used to perform the reading of the values.

2.11 CADMIUM MODULE (OPTIONAL)

A Cadmium module can be installed (optional) on the Smartchem 450 instrument.

This module is used to analyze nitrates by reducing nitrates to nitrites. The analyzer places the sample in the NO3 well (the same ISE well) of the module. The two peristaltic pumps perform a cyclic switching, circulating the sample inside the cadmium column. Once the cycle has been completed, the needle retrieves the reduced sample and transfers it, together with the reagents, to the reaction cuvettes.

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2.12 INSTRUMENT CHARACTERISTICS AND SPECIFICATIONS

TYPE OF SYSTEM

Completely automated random access, computer controlled, countertop instrument for environmental analysis

ASSAY METHODS

End Point, Fixed Time, Kinetic, Bichromatic

TEST SCHEDULING MODES

Random, Batch, Strictly Batch or NELAC/EPA

THROUGHPUT RATE

240 tests/hour without the ISE Module

OPERATING TEMPERATURE

37C ± 0.3

IN LINE REAGENTS

4 removable sectors (Peltier cooling fully covered and insulated) Each removable sector can house 8 positions for 50 ml bottles (trapezoidal) Each 50 ml bottle position can be divided into two 25 ml positions (trapezoidal). 4 non-removable sectors (peripheral); each sector can house two cylindrical 5 ml bottles.

SAMPLES LOADING

 100 Samples Plate

Four satellite racks; each Satellite Rack contains up to 18 tubes with a volume of 5 ml. Moreover, 28 extra positions - for the same tubes - are positioned on the main plate for further samples, calibrators and controls.

 68 Samples Plate

Four satellite racks; each Satellite Rack contains up to 15 tubes with a volume of 10 ml. Moreover, 8 extra positions - for the same tubes - are positioned on the main plate for further samples, calibrators and controls.

The samples area is protected by its own dedicated cover lid to limit evaporation. The samples cover lid is divided into two parts so as to allow continuous feed; it is monitored by a sensor.

MINIMUM REACTION VOLUME

300 μl

MAXIMUM REACTION VOLUME

640 μl

SAMPLING ARM

A single mechanical arm carries out all the sampling operations and is equipped with a sampling needle, liquid level sensor, reagent preheating and internal needle washing

DILUTER

Integrated syringe-free module having the following specifications:

 Sample volume: 2.0 μl  388 μl (0.25 μl incr.)  Reagent 1 volume: 0 μl  388 μl (1 μl incr.)  Reagent 2 volume: 0 μl  388 μl (1 μl incr.)  Reagent 3 volume: 0 μl  388 μl (1 μl incr.)  Reagent 4 volume: 0 μl  388 μl (1 μl incr.)

PRECISION

CV < 1 % at 2 μl

READING SYSTEM

Direct reading

OPTICAL SYSTEM

Photometer: dual channel, interferential filters Wavelength: 9 narrow band interferential filters (340 nm, 420 nm, 480

nm, 520 nm, 550 nm, 590 nm, 630 nm, 660 nm and 880 nm); each of the previous filters can be changed with one of the following three: 505 nm, 570 nm or 815 nm

Light source: 6V/10W halogen lamp Linearity range: [0.001  4.2] Abs Resolution: 0.0001 Abs

CUVETTE OPTICAL PATH LENGTH

10 mm

WASHING STATION

Made up of 4 probes plus one drying pad which empty, wash and dry the reaction cuvettes

REACTIONS PLATE

80 cuvettes. Non-stop computer managed cuvette Quality Control Incubation temperature: 37°C ± 0.3

NOISE SPECIFICATIONS

Max: 68 dBA

POWER REQUIREMENT

350 Watt

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2.13 SPECIFICATIONS AND MINIMUM REQUIREMENTS FOR THE OPERATIVE SYSTEM AND PC

OPERATING SYSTEM AND OTHER SOFTWARE

 Microsoft Windows 7

®

or Windows 10®

 Microsoft .NET Framework 4.5.1  SQLite .NET Data Provider  VSP Driver for FTDI Chip (USB Driver)

HARDWARE

 CPU: Intel i5

®

 RAM: 8 GByte  Hard Disk: 500 GByte  Monitor: 19’’  Display resolution: 1366 x 768  Touch Screen: Projected capacitive  I/O Ports: 1 Serial port or USB port (with a USB/serial converter)

for the PC-Instrument connection, 1 USB port for the printer, 1 Ethernet port for the LIMS connection (optional), 1 USB port for the touch screen, 1 USB port for the mouse, 1 USB port for the keyboard, 1 HDMI port for the monitor

LANGUAGES AVAILABLE

Language management via external file containing strings that can be translated into the required local language

PLEASE NOTE: in case the computer used is not provided by AMS along with the instrument, it is strongly suggested to test computer + instrument prior to installation at the Customer laboratory. AMS Alliance declines any and every responsibility for software problems that may arise due to computer purchased locally.

2.14 LIMITATIONS OF USE

The Smartchem 450 instrument cannot be used by the blind as the user must interact with the instrument by reading/writing on the monitor. Furthermore, the instrument must be used with extreme care by color-blind users as the user interface graphics employs and associates different colours to provide the user with important information.

2.15 CERTIFICATION

The Smartchem 450 instrument is CE marked. This compliance is certified by the hereillustrated symbols placed on the instrument.

CHAPTER 03 – SOFTWARE DESCRIPTION

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USER MANUAL

CHAPTER 03 – SOFTWARE DESCRIPTION

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Summary

3 Software description .......................................................................... 4

3.1 Software Start and the System Monitor mask................................................. 4

3.1.1 Reagents Plate ................................................................................................................. 6

3.1.2 Cuvettes Plate .................................................................................................................. 8

3.1.3 Samples Plate .................................................................................................................. 9

3.1.4 Start Operation ............................................................................................................... 16

3.1.5 Pause Operation ............................................................................................................. 20

3.1.6 Stop Operation ............................................................................................................... 20

3.1.7 Warnings and Emergency Stops ........................................................................................ 20

3.1.8 Legend .......................................................................................................................... 21

3.2 System Setup ............................................................................................... 22

3.2.1 Materials ........................................................................................................................ 22

3.2.2 Methods ........................................................................................................................ 35

3.2.3 ISE Methods ................................................................................................................... 48

3.2.4 Calculated Methods ......................................................................................................... 57

3.2.5 Quality Control Rules ....................................................................................................... 63

3.2.6 Profiles .......................................................................................................................... 66

3.2.7 Print Order ..................................................................................................................... 67

3.2.8 Display Order ................................................................................................................. 69

3.2.9 Sampling Order .............................................................................................................. 70

3.2.10 Special wash rules .......................................................................................................... 72

3.3 Checks .......................................................................................................... 75

3.3.1 Water Blank Level of the different cuvettes ........................................................................ 75

3.3.2 Reagents Configuration .................................................................................................... 78

3.4 Routine ......................................................................................................... 84

3.4.1 Calibration & QC operations ............................................................................................. 84

3.4.2 Work plan Setup ............................................................................................................. 89

3.4.3 Calibration results ........................................................................................................... 92

3.4.4 Quality Control results ................................................................................................... 104

3.4.5 Work Plan Results ......................................................................................................... 112

3.5 Archive ....................................................................................................... 115

3.5.1 Test Counters ............................................................................................................... 115

3.5.2 Event Logs ................................................................................................................... 117

3.5.3 Admission Logs ............................................................................................................. 118

3.5.4 Backup and Restore ...................................................................................................... 119

3.6 Maintenance ............................................................................................... 121

3.6.1 Preventive Maintenance ................................................................................................. 121

3.6.2 Technical Support Files .................................................................................................. 123

3.7 Options ....................................................................................................... 124

3.7.1 Systems Options ........................................................................................................... 124

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3.7.2 Accounts Management ................................................................................................... 135

3.7.3 Change password ......................................................................................................... 137

3.7.4 Automatic Start-up and Shutdown procedures .................................................................. 138

3.8 Help ............................................................................................................ 142

3.8.1 Info ............................................................................................................................. 142

3.8.2 Guide .......................................................................................................................... 143

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3 Software description

3.1 SOFTWARE START AND THE SYSTEM MONITOR MASK

To access the software double click on the dedicated “Smartchem 450” icon (located on the computer’s Desk Top); following page will be displayed during the software starting

procedures.

Once completed the software starting procedures, the login window will be displayed; please enter a valid User and Password pair.

The first time the user accesses the software, please type “admin” as User and “0” as

password.

When the user has been logged in, the software will show the scheme/status of the Smartchem 450 instrument. This mask, is called System Monitor.

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The user shall be able to select and view:

 the Reagents Plate (the bigger one in figure);  the Cuvettes Plate (the right up one in figure);  the Samples Plate (the right down one in figure).

The upper right corner of the mask hosts the acronym of the logged user followed by the

icon that represents the log-out button; tapping it the login mask will appear (please refer to the first picture).

The upper left corner of the mask hosts:

 the Shutdown button; tapping this button, following window will appear.

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The previous window allows the user to choose different settings related to the shutdown and eventually to the following automatic startup:

 SHUTDOWN MODE – the user can choose among following options: CLOSE

SOFTWARE, Close software and SUSPEND or Close software and HIBERNATE;

 SHUTDOWN POSTPONE – checking this option, the user can choose to ask for the

shutdown at a later time;

 SHUTDOWN TIME – modifying this time field, the user can choose to ask for the

shutdown at a later time;

 SHUTDOWN PROFILE – the user can choose to use one of the automatic shutdown

profiles he/she had previously defined;

 AUTOMATIC RESTART ENABLED – checking this option, the user can request for the

automatic startup of the instrument at a specific time; please note that in order to complete the automatic startup procedures, the instrument has to be left switched on and the PC has to be left switched on or suspended or hibernated;

 AUTOMATIC RESTART DATE – modifying this date field, the user can choose to ask

for the automatic restart at the preferred day;

 AUTOMATIC RESTART TIME – modifying this time field, the user can choose to ask

for the automatic restart at the preferred time;

 AUTOMATIC RESTART PROFILE – the user can choose to use one of the automatic

restart profiles he/she had previously defined.

 Minimize button, allows the user to hide the window, but keep the application running

and accessible;

 Microsoft® Windows button, equivalent to the button in the Microsoft® Windows bar,

allows the user to access to any installed program on the Smartchem 450 PC.

3.1.1 REAGENTS PLATE

Each element of the Reagents Plate is tappable. Once the element has been tapped, the software will show the related information about the reagents/diluent/special liquids.

Tapping a reagent rack (the user has to tap the letter of the rack), the mask will display in a dedicated table information related to the reagents/diluents that are loaded in the selected rack as well as will show the actions that the user can execute with the selected rack.

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With reference to the liquids present in the selected rack, the details table will display following info: Position, Bottle Type (5 ml, 25 ml, 50 ml), Residual Volume, Reagent/Diluent Name, Reagent/Diluent Lot Number, Reagent/Diluent Expiration Date Loading date, remained stability days, Barcode if read, Alarm (Low, Empty…).

The user can tap the icon in order to view the table at full screen; re-tapping the same icon the table will be resized.

Following actions are available with the selected reagents rack:

 READ BARCODE - active only if the instrument is in Pause or in Stand-by; allows to

request the barcode reading;

 EXPORT – allows the user to create an xlsx file that reports all the reagents/diluents

that are present in the selected rack;

 PRINT - allows the user to print a page that reports all the reagents/diluents that are

present in the selected rack.

Tapping a single reagent/dilution bottle, the mask will display in a dedicated table some information related to the selected reagent/diluent as well as will show the actions that the user can execute with the selected rack.

With reference to the selected reagent/diluent bottle, the details table will display following info: Position, Reagent/Diluent Name, Reagent/Diluent Lot Number and the Residual Volume. Furthermore, for each method that uses the selected reagent/diluent,

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the method Name, the needed volume requested by the method, the residual tests and the residual tests warning limit set for the specific method will be displayed.

Following actions are available with the selected reagent/diluent bottle:

 CHANGE BOTTLE - active only if the selected reagent volume is low or completed and if

the instrument is in Pause or in Stand-by or Search; allows the user to communicate to the software that the bottle has been changed; the change bottle operation will update the loading date and the volume will be set to Unknown;

 LIQUID CHECKED - active only if the selected reagent volume is liquid level not found or

overfilled and if the instrument is in Pause or in Stand-by or Instrument not Available;

allows the user to communicate to the software that a verification of the liquid has been performed; following to this operation the volume will be set to Unknown. This action allows the instrument to restart using the liquid checked;

 READ BARCODE - active only if the instrument is in Pause or in Stand-by; allows to

request the barcode reading of the bottle present in the selected position.

Please note that if the ISE module is configured, the MilliQ bottle is visible in the Reagents plate area. Tapping on it the software will show the residual volume expressed either in milliliter or in percentage.

3.1.2 CUVETTES PLATE

Tapping once on the Cuvettes Plate, this plate will be moved in the left part of the screen and will be enlarged (the plate that was in the left position will pass in the right position and will be scaled down).

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Tapping any cuvette, the mask will display in a dedicated part, the table with the WBL results.

For each WBL execution, the table will show for each filter the WBL result and will indicate if the cuvette will be used (Opaque check) or not and if the related execution is the initial one or not. It is important to note that the WBL result is displayed in red for each filter out of the validity check; the single cuvette will not be used for test execution only for those filters that are not considered good.

The user can tap the icon in order to view the graph and the table at full screen; retapping the same icon the graph and the table will be resized.

3.1.3 SAMPLES PLATE

Tapping once on the Samples Plate, this plate will be moved in the left part of the screen and will be enlarged (the plate that was in the left position will pass in the right position and will be scaled down).

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The Samples Plate will host two different types of racks:

 Calibration & Quality Controls racks: these racks will host Calibrators, liquid for

RBL and Quality Controls; Calibrators and the liquid for RBL can be placed using the Calibration Setup Mask; Quality Controls can be placed using the QC Setup Mask; all these type of liquids are represented as rings; these racks will include only liquids represented as rings;

 Sample racks: these racks will host samples and Quality Controls positioned among

the samples; samples and Quality Controls positioned among the samples can be positioned using the Work List Setup Mask; these racks will include liquids represented as disks (samples) and liquids represented as rings (controls).

Tapping a Calibration & Quality Controls rack, the mask will display in a dedicated table (Details table) some information related to the liquids that are loaded in the selected rack as well as will show the actions that the user can execute with the selected rack.

With reference to the liquids present in the selected rack, the details table will display following info: Position, Bottle Type, Name, Lot Number and Expiration Date, Volume,

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number of Residual tests, number of Running tests, number of tests with range errors, number of tests with masked results and number of tests with critical errors.

The user can tap the icon in order to view the table at full screen; re-tapping the same icon the table will be resized.

Following actions are available with the selected Calibration & Quality Controls rack:

 PLACE RACK – allows the user to request for the physical loading of the selected rack in

the instrument; following this request, the instrument will bring the selected rack (please refer to the letter of the rack; i.e. A, B, C or D) in the position accessible to the user; as soon as the rack will be physically placed in the correct position, the software will show the mask depicted in the following figure.

After the completion of the rack loading operation, the user can decide to request for another physical rack loading (previous on next rack) as well as to close this mask.

 LOAD WORK PLAN – visible only if the selected Calibration & Quality Controls rack has

not pending or scheduled or running operations; allows to put in the system monitor a previous defined work plan starting from the selected rack; this is a software loading and it is not a physical loading (please refer to the previous action);

 EXPORT – allows the user to create an xlsx file that reports the data listed in the

Details table;

 PRINT - allows the user to print a page that reports the data listed in the Details table.

Tapping each liquid present in the Calibration & Quality Controls rack, the mask will display in a dedicated table the information related to the selected liquid; the displayed information will depend on the type of selected liquid: liquid for RBL, Standard and control.

Following picture shows the Standard information example.

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With reference to the selected Standard, the details table will display following info: Position, Liquid Name, Lot Number, Residual Volume (in the header of the table) and for each associated test Method Name, Optical Density, Concentration, Measurement Unit, Replicate (n/total), Flags (ranges), Flags (test), Flags (Calibration & QC), Starting Date and Time and finally Execution Date and Time.

The user can tap the icon in order to view the table at full screen; re-tapping the same icon the table will be resized.

Tapping a Samples rack, the mask will display in a dedicated table some information related to the liquids that are loaded in the selected rack as well as will show the actions that the user can execute with the selected rack.

With reference to the liquids present in the selected rack, the details table will display following info: Work Plan Name, Rack Number, Number of samples, Total number of tests (in the header of the table) and for each position in the rack, Position, SID, number of Total tests, Residual tests and Running tests, number of tests with Range errors, number of tests with Masked results and number of tests with critical errors.

The user can tap the icon in order to view the table at full screen; re-tapping the same icon the table will be resized.

Following actions are available with the selected Samples rack:

 PLACE RACK – allows the user to request for the physical loading of the selected rack in

the instrument; following this request, the instrument will bring the selected rack (please refer to the letter of the rack; i.e. A, B, C or D) in the position accessible to the user; as soon as the rack will be physically placed in the correct position, the software will show the mask depicted in the following figure.

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After the completion of the rack loading operation, the user can decide to request for another physical rack loading (previous on next rack) as well as to close this mask.

 LOAD WORK PLAN – visible only if the current Work plan is not running; allows to put in

the system monitor a previous defined work plan starting from the selected rack; this is a software loading and it is not a physical loading (please refer to the previous action);

 UNLOAD WORK PLAN – visible only if the work plan currently loaded in the system

monitor is not running.

 EXPORT – allows the user to create an xlsx file that reports the data listed in the

Details table;

 PRINT - allows the user to print either a page that reports the data listed in the Details

table or the reports related to the samples loaded on the selected rack.

Tapping each liquid present in the Samples rack, the mask will display in a dedicated table the information related to the selected liquid (either a sample or a quality control positioned among the samples); the displayed information will depend on the type of selected liquid.

Following picture shows the sample information example.

With reference to the selected sample, the details table will display following info: Position, Work Plan Name, SID and Rack Number (in the header of the table) and for each associated test Method Name, Type, Automatic Dilution, Post Dilution, Optical Density, Result, Measurement Unit, Relative Percentage Difference (%), evaluated for the duplicates, Recovery (%), evaluated for the Spikes, Flags (ranges), Flags (test), Flags (Calibration & QC), Start Time and End Time.

The user can tap the icon in order to view the table at full screen; re-tapping the same icon the table will be resized.

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Following actions are available with the selected sample:

 PRECISION CHECK – following this request, the software will show the mask depicted in

the following figure reporting statistics related to the tests associated to the selected sample.

 EXPORT – allows the user to create an xlsx file that reports the data listed in the

Details table;

 PRINT - allows the user to print either a page that reports the data listed in the Details

table or the reports related to the selected sample.

Following actions are available with an empty rack:

 PLACE RACK – allows the user to request for the physical loading of the selected rack in

the instrument; following this request, the instrument will bring the selected rack (please refer to the letter of the rack; i.e. A, B, C or D) in the position accessible to the user; as soon as the rack will be physically placed in the correct position, the software will show the mask depicted in the following figure.

After the completion of the rack loading operation, the user can decide to request for another physical rack loading (previous on next rack) as well as to close this mask.

 LOAD WORK PLAN – visible only if the current Work plan is not running; allows to put in

the system monitor a previous defined work plan starting from the selected rack; this is a software loading and it is not a physical loading (please refer to the previous action);

 LOAD NEXT WORK PLAN RACK – visible only if the current Work plan is not completely

loaded; this action is useful in case the user has to load new samples to a previously defined work plan;

 UNLOAD WORK PLAN – visible only if the work plan currently loaded in the system

monitor is not running.

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Next table will list the available actions following the selection of a test associated to:

 Liquid for the RBL (H2O)  Standard  Control  Sample

Action

Description

Test associated to

INFO

Following this request a dedicated window will be displayed to the user.

In this message the user obtains detailed information regarding the specific test. In particular the user can read the description of the flags associated with the selected test and he can add a note to the test if needed. If a note is added to a test, a triangle in the upper right corner of the result field will appear.

 Liquid for the RBL  Standard  Control  Spike  Sample  Spike Duplicate  Sample Duplicate

REPLICATE

Allows the user to request for a replicate of the selected test; the user can decide how many replicates to be performed (from 1 to 20)

 Spike  Sample  Spike Duplicate  Sample Duplicate

RERUN TEST

Allows the user to request for a rerun of the selected test; the user can decide either the post concentration ratio or the post-dilution ratio

 Sample

SHOW CALIBRATION CHART

Allows the user to view the calibration chart built with the selected test; this graph is automatically updated as soon as arrive the different results

 Standard

SHOW REACTION CHART

Allows the user to view the reaction chart (absorbance versus time)

 Liquid for the RBL  Standard  Control  Spike  Sample  Spike Duplicate  Sample Duplicate

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SHOW REPLICATES CHART

Allows the user to view in the same chart the reactions chart of the different replicates (absorbance versus time)

 Liquid for the RBL  Standard

VALIDATE RESULT

Allows the user to validate a result; this action is important if the same test has more than one result (e.g. in case of manual/automatic rerun); furthermore is needed if the sample has associated a calculated test (validation of the test used by the calculated test allows the computation of the calculated test)

 Sample

VIEW CALIBRATION

Allows the user to view the calibration curve used by the test

 Control  Spike  Sample  Spike Duplicate  Sample Duplicate

VIEW METHOD DETAILS

Allows the user to view the complete settings of the method at the moment of the test running; this action opens the Methods mask

 Liquid for the RBL  Standard  Control  Spike  Sample  Spike Duplicate  Sample Duplicate

VIEW QC RESULTS

Allows the user to view the control results executed before the execution of the selected test; by default last 30 days results are shown

 Spike  Sample  Spike Duplicate  Sample Duplicate

3.1.4 START OPERATION

In order to start the operations the user has to tap the button.

Following this tap a new mask will be shown to the user.

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Thanks to this mask the user can ask for:

 PRIME LIQUIDS – this action consists in the hydraulic priming of the different tubes and

should be performed after a period of inactivity of the instrument; this action will be the first performed by the instrument;

 NO3 PRIME LIQUIDS – this action, visible only if the NO3 module has been set, allows

the liquid priming of the NO3 module;

 CUVETTES WASHING – this action will activate the cuvettes washing running cycle; the

user can decide to wash either all the cuvettes or the cuvettes remained dirty from a previous run (e.g. after a stop request of the user); this action will be executed after the liquid priming if requested;

 WBL – this action will activate the Water Blank Level running cycle; this action will be

executed after the cuvettes washing if requested;

 RUN CALIBRATIONS & QC – this action will activate the Calibration and the QC

operation requested before thanks to the Calibration & QC Setup Mask; this action will be executed after the WBL if requested; if the user selects this action, the mask will allow the user to request for the samples rack positioning in order to physically load the calibration & QC rack(s);

 SAMPLES – this action will activate the execution of the work plan loaded in the system

monitor; this action will be executed after the calibration and QC if requested; if the user selects this action, the mask will allow the user to request for the samples rack positioning in order to physically load the sample rack(s);

 STARTUP PROFILE 1 OR PROFILE 2 – this action will allow the user to request for the

execution of the actions that are included in the Profile 1 or in the Profile 2 as set in the automatic startup procedure mask (for more details please refer to section 3.7.4); checking one of the Startup Profile, the Start operation mask will show also the actions that can be performed with the automatic startup procedure.

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 SHUTDOWN PROFILE 1 OR PROFILE 2 – this action will allow the user to request for the

execution of the actions that are included in the Profile 1 or in the Profile 2 as set in the automatic shutdown procedure mask (for more details please refer to section

3.7.4); checking one of the Shutdown Profile, the Start operation mask will show also the actions that can be performed with the automatic shutdown procedure.

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Please note that after having tapped the Start button following chooses can be requested to the user:

 READ BARCODE – after the first start of the software or after the reagents cover

opening, the software prompts the user with a specific message in order to allow the user to perform or not the reagent barcode reading;

 SCHEDULE A NEW CALIBRATION – requesting for the execution of methods, associated to

samples or controls, with an invalid calibration or with an expired calibration, the software prompts the user with a specific message in order to allow the user to setup the calibration of the involved methods;

 CHANGE/CHECK THE REAGENTS BOTTLE – requesting for the execution of tests

(sample/controls/calibration), having on board reagents/diluents bottles characterized by Empty volume, Low volume, Level to high or Level not detected, the software prompts the user with a specific message in order to allow the user to change the involved bottles (Empty volume, Low volume) or check the involved bottles (Level to high or Level not detected).

 RESTART THE CALIBRATION OPERATION – after any interruption of the calibration

operation of one or more methods, the software prompts the user with a specific message in order to allow the user to restart the calibration operation of the method(s) or to continue the already started operation.

Finally please note that the starting operations can be stopped (or not allowed) if one of the following conditions will be met:

 one of the covers has been left open;  the cuvettes tray temperature does not fall within the permitted range (it could be that

the cuvettes tray temperature has not yet reached the target temperature and the user has just to wait for it); this check is performed every time the users is starting the Calibration, Quality Control, Samples and WBL operations;

 one of the hydraulic procedure checks fails; the hydraulic procedure checks are

performed every day after the Initialization procedure of the instrument.

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3.1.5 PAUSE OPERATION

In order to bring the instrument in the Pause state, the user has to tap the button.

Following this tap the instrument will pass in the Pausing state. In this state the arm is completing the different operations in order to reach the Pause state coming from the Running state.

As soon as the arm will reach the Pausing state with the sample compartment available, it will be possible to load a new rack.

As soon as the arm will reach the Pause state the user will be able to refill a reagent or add a new bottle.

3.1.6 STOP OPERATION

In order to immediately stop any ongoing operation, the user has to tap the button.

Following this tap the instrument will interrupt the ongoing operations. Due to this forced operation, some cuvettes can remain dirty; it is highly recommended to wash them after a new restart of the instrument.

3.1.7 WARNINGS AND EMERGENCY STOPS

In presence of any Warning message or Emergency Stop message a special icon starts flashing on the top bar of the window (at the left of acronym of the logged in user) as well as in the left part of the window that hosts the menu.

Tapping the icon, the software will open a mask that include a table that reports the unsolved Warnings and Emergency Stops.

In order to view all the Warnings and Emergency Stops occurred during the instrument life, please refer to section 3.5.2.

Please note that in presence of at least one emergency stop, the reset alarm will be automatically performed by the software; for this reason, at the next start, the Instrument Initialization will be performed.

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3.1.8 LEGEND

In the bottom right part of the mask, it is always visible the present the action.

Tapping the Legend action, it will be opened an area dedicated to the description of:

 the colors assumed by the different liquid in presence

of any alarm;

 the colors that can assume a reagent;  the colors that can assume either a Sample or a

Control or a Calibrator or the liquid for the RBL. The samples will be shown as disks while the other liquids will be represented as rings;

 the colors that can assume a cuvette.

At the right of the colors, appears a symbol that will appear if the user has set the option Show status icon in the System Option window – User interface tab.

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3.2 SYSTEM SETUP

3.2.1 MATERIALS

The Material mask is dedicated to inventory the different liquids to be used in the instrument. Note that the liquids can be preventively stored using this mask or they will be stored directly adding these liquids from the Methods mask.

A material can be defined using the first level menu SYSTEM SETUP and the second level menu MATERIALS.

Tapping this menu, the following mask will appear.

This mask is divided in different tabs, each dedicated to a different type of materials:

 CALIBRATORS  CONTROLS  SPIKES  REAGENTS AND DILUENTS  SPECIAL LIQUIDS

3.2.1.1 CALIBRATORS

This tab is divided in three sections: LIQUIDS, the left one, reports the list of previously defined calibrators and liquids for the RBL, LOTS, the middle one, reports the associated

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lots to the selected calibrator and TARGET VALUES, the right one, reports the reference value of the methods associated to the selected calibrator and to the selected lot.

The calibrator tab is depicted in the following picture.

The LIQUIDS section lists, in the alphabetical order, the previously defined liquids; this list will include the stock standards, the prepared calibrator points and the liquids for the RBL. Each liquid is characterized by:

 NAME – the name of the liquid; this is the code that will be used in the software in

order to individually select the calibrator and/or the liquid for RBL;

 ID – this is the code that can be used to identify the calibrator/liquid for RBL through

the barcode reader.

In this list, if the number of liquids is equal or greater than 20, a search field will be displayed; the string will be searched in any part of the name of the list; it will be

possible to remove the filter using the button at the right of the filter.

Please note that once the material has been used it will not be possible to change the name or the ID of the calibrator (these liquids are grey displayed while the editable ones are blue displayed).

Furthermore, with reference to this section, the user can:

 ADD – it allows to add a new liquid thanks to the button; following a tap over this

button the software will automatically display the keyboard in order to define the liquid name; after having inserted the name of the new liquid, the addition of a new liquid will imply the automatic creation of a new lot associated to the liquid;

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 DELETE – it allows to delete a previously defined liquid thanks to the button;

deletion of a liquid will be a soft removal; following a new re-enter of the same liquid previously used and deleted, the software will show the previous properties of the liquid;

 CLONE – it allows to duplicate a previously defined liquid thanks to the button;

following a tap over this button the software will automatically display the keyboard in order to define the liquid name; the Clone operation will provide to automatically create the same active lot of the starting liquid as well as all the methods associations and reference value of the active lot of the starting liquid.

The LOTS section lists, in the alphabetical order, the previously defined lots associated to the selected liquid in the Liquids section. Each lot is characterized by:

 LOT – lot number of the selected liquid;  EXPIRATION DATE – expiration date of the selected liquid;  ACTIVE – check used in order to define the active lot; no more than one lot can be the

active one; please note the changing the active lot will imply the usage in the instrument of the method target values associated to the new lot.

In this list, if the number of liquids is equal or greater than 20, a search field will be displayed; the string will be searched in any part of the lots of the list; it will be possible

to remove the filter using the button at the right of the filter.

Furthermore, with reference to this section, the user can:

 ADD – it allows to add a new lot thanks to the button; following a tap over this

button the software will automatically display the keyboard in order to define the lot number; after having inserted the new lot of the liquid, the addition of a new lot will imply the automatic creation of the methods previously associated to the active lot with the reference value set to 0;

 DELETE – it allows to delete a previously defined lot thanks to the button; deletion

of a liquid will be a soft removal; following a new re-enter of the same liquid previously used and deleted, the software will show the previous properties of the lot;

 CLONE – it allows to duplicate a previously defined lot thanks to the button;

following a tap over this button the software will automatically display the keyboard in order to define the liquid lot; the Clone operation will provide to automatically create the same methods associations with the same reference values of the starting lot.

The TARGET VALUES section lists, in the alphabetical order, the previously associated methods to the selected lot in the Lot section of the selected liquid in the Liquids section. The user can define as PRE-DILUTED the selected lot: thanks to this option the predilution of a method will not be applied to the calibrator.

Each target value is characterized by:

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 METHOD NAME – name of the method associated to the selected lot of the selected

liquid;

 MEASUREMENT UNIT – not editable field, the measurement unit used for the method;  TARGET VALUE – this is the reference value to be used for the calibrator of the specific

method; for the liquid of the RBL this value has to set equal to zero.

Furthermore, with reference to this section, the user can:

 ADD – it allows to associate a new method to the selected lot thanks to the button;

following a tap over this button the software will automatically display in the right panel the list of previously defined methods;

 DELETE – it allows to delete a previously associated method to the selected lot defined

lot thanks to the button; deletion of a liquid will be a soft removal; following a new re-enter of the same liquid previously used and deleted, the software will show the previous reference values of the method;

 USER UNITS – it allows to show the target values of all the methods that use the

selected material and lot, expressed in the user defined unit; this action appears only if the target values of at least one method are shown using the primary unit but the method has a user defined unit;

 PRIMARY UNITS – it allows to show the target values of all the methods that use the

selected material and lot, expressed in the primary unit; this action appears only if the target values of at least one method are shown using the user defined unit.

With reference to this tab, following actions are available:

 SAVE – after the creation or modification of a liquid, this action is mandatory in order

to save the new list;

 DISCARD CHANGES – after the creation or modification of a liquid, allows the user to

return in the state of the last save;

 CLOSE – allows the user to close this mask.

3.2.1.2 CONTROLS

This tab is divided in three sections: LIQUIDS, the left one, reports the list of previously defined controls, LOTS, the middle one, reports the associated lots to the selected control and TARGET VALUES, the right one, reports the target values of the methods associated to the selected control and to the selected lot.

The controls tab is depicted in the following picture.

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The LIQUIDS section lists, in the alphabetical order, the previously defined liquids. Each liquid is characterized by:

 NAME – the name of the liquid; this is the code that will be used in the software in

order to individually select the spike;

 ID – this is the code that can be used to identify the spike through the barcode reader.

In this list, if the number of liquids is equal or greater than 20, a search field will be displayed; the string will be searched in any part of the name of the list; it will be

possible to remove the filter using the button at the right of the filter.

Please note that once the material has been used it will not be possible to change the name or the ID of the control (these liquids are grey displayed while the editable ones are blue displayed).

Furthermore, with reference to this section, the user can:

 ADD – it allows to add a new liquid thanks to the button; following a tap over this

button the software will automatically display the keyboard in order to define the liquid name; after having inserted the name of the new liquid, the addition of a new liquid will imply the automatic creation of a new lot associated to the liquid;

 DELETE – it allows to delete a previously defined liquid thanks to the button;

deletion of a liquid will be a soft removal; following a new re-enter of the same liquid previously used and deleted, the software will show the previous properties of the liquid;

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 CLONE – it allows to duplicate a previously defined liquid thanks to the button;

following a tap over this button the software will automatically display the keyboard in order to define the liquid name; the Clone operation will provide to automatically create the same active lot of the starting liquid as well as all the methods associations and reference value of the active lot of the starting liquid.

The LOTS section lists, in the alphabetical order, the previously defined lots associated to the selected liquid in the Liquids section. Each lot is characterized by:

 LOT – lot number of the selected liquid;  EXPIRATION DATE – expiration date of the selected liquid;  ACTIVE – check used in order to define the active lot; no more than one lot can be the

active one; please note the changing the active lot will imply the usage in the instrument of the method target values associated to the new lot.

In this list, if the number of liquids is equal or greater than 20, a search field will be displayed; the string will be searched in any part of the lots of the list; it will be possible

to remove the filter using the button at the right of the filter.

Furthermore, with reference to this section, the user can:

 ADD – it allows to add a new lot thanks to the button; following a tap over this

button the software will automatically display the keyboard in order to define the lot number; after having inserted the new lot of the liquid, the addition of a new lot will imply the automatic creation of the methods previously associated to the active lot with the target values set to 0;

 DELETE – it allows to delete a previously defined lot thanks to the button; deletion

of a liquid will be a soft removal; following a new re-enter of the same liquid previously used and deleted, the software will show the previous properties of the lot;

 CLONE – it allows to duplicate a previously defined lot thanks to the button;

following a tap over this button the software will automatically display the keyboard in order to define the liquid lot; the Clone operation will provide to automatically create the same methods associations with the same target values of the starting lot.

The TARGET VALUES section lists, in the alphabetical order, the previously associated methods to the selected lot in the Lot section of the selected liquid in the Liquids section. The user can define as PRE-DILUTED the selected lot: thanks to this option the predilution of a method will not be applied to the control.

Each target value is characterized by:

 METHOD NAME – name of the method associated to the selected lot of the selected

liquid;

 MEASUREMENT UNIT – not editable field, the measurement unit used for the method;

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 MIN – minimum acceptable value of the selected lot of the control; the minimum and

the maximum values will be automatically calculated if the user fills the mean and the standard deviation fields;

 MAX – maximum acceptable value of the selected lot of the control; the minimum and

the maximum values will be automatically calculated if the user fills the mean and the standard deviation fields;

 MEAN – mean value of the selected lot of the control; the mean and the standard

deviation values will be automatically calculated if the user fills the minimum and the maximum fields;

 STANDARD DEVIATION – standard deviation of the selected lot of the control; the mean

and the standard deviation values will be automatically calculated if the user fills the minimum and the maximum fields;