ELLIPSE

User Manual

Via E. Barsanti 17/A

00012 Guidonia – ROME (ITALY)
www.ams-analyzers.com
 CONFIGURATION SHEET

CHAPTER DESCRIPTION REVISION

INDEX TABLE OF CONTENTS 02

01 INSTALLATION 02

02 GENERAL DESCRIPTION 02

03 SOFTWARE DESCRIPTION 02

04 DAILY ROUTINE 01

05 METHODOLOGY 01

06 CALIBRATION CURVES 01

07 MAINTENANCE 02

08 FORMULAS AND CALCULATION MODELS 01

09 ERROR SIGNALING AND TROUBLESHOOTING 02

10 HOST COMMUNICATION 01

11 PACKING LIST 01

12 DIAGNOSTIC PROGRAM 02

Ellipse User Manual Rev.02 19 October 2005 Page 1

 INDEX

TABLE OF CONTENTS

Chapter 01 INSTALLATION

Chapter 02 GENERAL DESCRIPTION

Chapter 03 SOFTWARE DESCRIPTION

Chapter 04 DAILY ROUTINE

Chapter 05 METHODOLOGY

Chapter 06 CALIBRATION CURVES

Chapter 07 MAINTENANCE

Chapter 08 FORMULAS AND CALCULATION MODELS

Chapter 09 ERROR SIGNALING AND TROUBLESHOOTING

Chapter 10 HOST COMMUNICATION

Chapter 11 PACKING LIST

Chapter 12 DIAGNOSTIC PROGRAM

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 Chapter 01 - INSTALLATION

CHAPTER 01 - INSTALLATION

INDEX

1.1 UNPACKING .......................................................................................................................... 2

1.2 INSTALLATION..................................................................................................................... 4

1.2.1 INSTALLATION SITE SPECIFICATIONS........................................................................... 4

1.2.2 ELECTRIC CURRENT REQUIREMENTS ........................................................................... 4

1.2.3 CONNECTION OF THE ACCESSORIES ............................................................................. 5

1.2.3.1 POWER SUPPLY .................................................................................................................... 5

1.2.3.2 COMPUTER - INSTRUMENT CONNECTION .................................................................... 6

1.2.3.3 HYDRAULIC CONNECTIONS …....……………………………………………………….6

1.2.4 ATTENTION .......................................................................................................................... 6

1.2.5 SYMBOLS ............................................................................................................................. 7

1.2.6 REGULATORY COMPLIANCE.......................................................................................... 8

1.2.7 LIMITATION OF USE........................................................................................................... 8

1.2.8 BARCODE READER............................................................................................................. 8

1.2.9 WARRANTY ……...……………………………………………………………...…………8

1.2.10 CONSUMABLES AND ACCESSORIES PARTS LIST OUT OF WARRANTY…………9

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 Chapter 01 - INSTALLATION

1.1 UNPACKING

The ELLIPSE is packed and delivered in two separate wooden crates: one contains the analyzer itself
and the other the computer, along with its accessories. In the event that the order does not include the
PC component, the packing and delivery will involve one wooden crate plus a corrugated cardboard
box. The packing has been expressly studied and designed to insure maximum protection of the
contents during shipping and handling. It is therefore extremely important that the crate(s)/box be
carefully examined upon delivery in order to ascertain their integrity. Special attention should be
dedicated to examining the color of the “Shock Watch” glued to the crates, which must show the color
‘white’. A ‘red’ “Shock Watch” indicates that the crate(s) have experienced some sort of ‘shock’
during handling, transport and/or delivery. This fact must be noted by the courier on the delivery note,
as must any and all visible external damage (for example: holes, dents, rips or tears, water marks, etc.)
evident at the moment of delivery. This will simplify matters in the event of any future claims for
damages.

Upon arrival of the crate(s)/box, take out the

delivery note and make sure that all the items ELLIPSE
on the packing list are included in the crates S/N

and are undamaged. Make sure the series P/N

number on the delivery note/packing list 100 ÷ 230Vac 47 ÷ 63Hz 300W
corresponds to that impressed on the plate on Analyzer

the left side of the instrument. Medical

System Rome-Italy

Open the crate(s)/box from the top and very

carefully take out:
- the instrument;
- the computer and accessories.

MAKE SURE THAT THE UNPACKING IS CARRIED OUT BY TWO PEOPLE.

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 Chapter 01 - INSTALLATION

Do not discard the delivery crate(s)/box or the packing material until the correct functioning of the
instrument has been ascertained.
Remove all the items from the crate(s)/box very carefully.
Before connecting the "Ellipse", remove the protective packing material placed under the sampling
arm and under the wash station group.

Warning: in the event that it is necessary to repack any or all of the delivered item(s), the following
procedures must be carefully followed:

Reposition the protective packing material under the sampling arm and under the wash station
group.

Tape down (using masking tape if possible) the cover of the samples and reagents housing, the
front panels, and the samples and reagents racks.

Remove the probe from the sampling arm and place it inside a primary tube. Then cap the tube
and tape the cap down.

Be very careful to not bend the wash station cannulas when repositioning the protective packing
material.

Fill the empty spaces around the accessories packed in the crate using “pluriballs” or other
suitable packing material.

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 Chapter 01 - INSTALLATION

1.2 INSTALLATION
The ELLIPSE must only be installed by a qualified technician who has been authorised and trained to
do so. During its installation the system will be checked once again to ensure correct functioning. The
persons who are required to operate the ELLIPSE system must have received the adequate training.
This should also include the "know-how" of the normal maintenance for the instrument. A description
of the maintenance will be found in Chapter 7 of this manual.

ELLIPSE is a complex system, and it is therefore extremely important that it is correctly installed in
order to fully guarantee fine performance. If the installation and use directions, given in this manual,
are not correctly followed and/or safety indications are not respected, AMS cannot guarantee correct
functioning of the instrument. Apart from this, the safety of the operator could be placed at risk.

1.2.1 INSTALLATION SITE SPECIFICATIONS

Ascertain that the ELLIPSE system is not exposed to direct sunlight, draughts, dust or strong magnetic
fields. In addition, please take note of the following conditions required for the location of the
installation:

USE In covered and dry place

DEGREE OF POLLUTION 2
INSULATION CLASS I
INSTALLATION CATEGORY II
TEMPERATURE Between 18°- 30°C
HUMIDITY 20% ÷ 85%
ALTITUDE Max 3000 m
Shelf or table with a minimum surface of 75 x 60 cm stable
LOCATION and free of vibration
Leave a minimum distance of 10 cm around the instrument to
VENTILATION permit air circulation. Make sure that the front and rear holes
are not blocked by any object

1.2.2 ELECTRIC CURRENT REQUIREMENTS

The power voltages to which the instrument is adapted are indicated on the left-hand side
(see fig. 1). It must be plugged into a plug of the correct voltage.

VOLTAGE 100÷ 230 Vac 47/63 Hz ± 10%

FUSES 6.3 A /T - 5 x 20

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 Chapter 01 - INSTALLATION

NOTE: IT IS ADVISABLE TO MAINTAIN THE MAXIMUM STABILITY OF THE ELECTRICAL CURRENT IN THE
LABORATORY. WHERE THIS IS NOT POSSIBLE OR ASCERTAINABLE, USE OF THE FOLLOWING
SUPPLEMENTARY DEVICES IS RECOMMENDED:

ELECTRONIC STABILIZER
Used to stabilise the electric voltage in the laboratory. Any stabiliser with a power potential
greater than 0.5 KW, currently available on the market, can be used.

NO-BREAK MODULE UPS - (Uninterrupted Power Supply)

This module provides two important functions:
- stabilises the main-line power
- supplies current to the instrument in case of a main-line power failure.

1.2.3 CONNECTION OF THE ACCESSORIES

1.2.3.1 POWER SUPPLY

Fig. 1 – Plug (use the feeder cable supplied with the instrument).
The sticker below the plug in indicates the power supply voltage and the values of the fuses.

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 Chapter 01 - INSTALLATION

1.2.3.2 COMPUTER - INSTRUMENT CONNECTION

The instrument and the Personal Computer are connected by one serial RS232 standard cable
(Cod. 9-35-0055-01), which provides the hardware support for the communication.

1.2.3.3 HYDRAULIC CONNECTIONS

The instrument uses Cleaning solution and distilled water for reaction cuvettes cleaning; it uses Rinse
solution for sampling probe cleaning and cuvette blank determination (WBL). A second Rinse
hydraulic line is used for cuvettes quality control checking after washing.
For connecting said solution there are four inlet on the instrument left side identified by roman
numbers as here below specified:

• I Rinse solution (green color)

• II Rinse solution (yellow color)
• III Distilled water (blue color)
• IV Cleaning solution (red color)

The waste hydraulic lines are located on the instrument right side
Further information can be taken on the Hydraulic diagram (SI 16 00571 01 Service manual -chapter
04).

1.2.4 ATTENTION

The following label is found at the rear of the instrument.

CAUTION
TO PREVENT ELECTRIC SHOCK
DO NOT REMOVE BACK PANEL.
NO USER-SERVICEABLE PARTS INSIDE.
REFER SERVING TO QUALIFIED
SERVICE PERSONNEL

NOTE: THE REAR PANELS OF THE INSTRUMENT MUST NEVER BE OPENED WITHOUT HAVING FIRST
SWITCHED THE INSTRUMENT OFF AND DISCONNECTED THE ELECTRICITY CABLE.

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 Chapter 01 - INSTALLATION

THE MAINTENANCE AND CLEANING PROCEDURES FOUND IN CHAPTER 07 OF THIS MANUAL MUST BE
RESPECTED AT ALL TIMES.
REMEMBER TO FOLLOW THE DECONTAMINATION PROCEDURE WHEN REQUIRED
BEFORE INSTRUMENT MAINTENANCE OPERATION (SEE CHAPTER 07).

1.2.5 SYMBOLS

ATTENTION: READ THE INSTRUCTIONS IN THE USER MANUAL

TERMINAL OF TOTAL MASS PROTECTION (CONDUCTOR)

BIOLOGICAL HAZARD
(LOCATED NEAR THE REACTION PLATE AREA)
Carefully manipulate all the consumables and the wastes produced during the
analysis routines. Use appropriate protective garment. Disposal of wastes must
be done in compliance with applicable regulation. It is recommended to
periodically check the level in the waste container, in order to avoid overflow.

INDICATES THE BOTTLES CONNECTION

I RINSE SOLUTION
II RINSE SOLUTION
III DISTILLED WATER
IV CLEANING SOLUTION

STAND-BY BUTTON

BUZZER FORCE OFF BUTTON

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 Chapter 01 - INSTALLATION

BARCODE READER BUTTON

1.2.6 REGULATORY COMPLIANCE

The ELLIPSE instrument complies with:

• European Directive 98/79/CE for In Vitro Diagnostic Devices

1.2.7 LIMITATION OF USE

The ELLIPSE can not be used by blind operators because the user interface with the system requires a
monitor.
Furthermore the ELLIPSE must be used with particular caution by color blind operators because the
graphic interface displays different colors with different meaning.

1.2.8 BARCODE READER

A bar code reader can be optionally installed on the ELLIPSE. The barcode reader has a laser micro-
scanner classified as Class II laser device. It is compliant with applicable safety regulations.

WARNING TURN OFF ALWAYS THE INSTRUMENT before removal of those panels and
covers that protect from any interference and/or exposure to the laser beam active during sample
identification.

1.2.9 WARRANTY

AMS guarantees the substitution of all defective components and/or materials for a period of time not
above of fourteen months starting from the date of invoicing. Saying warranty, as well as Technical
Assistance, generally is intended furnished as net ex factory Rome.

This warranty does not include consumable and instrument parts in contact with liquids. All
components not covered by the warranty are reported in the table on the next page.

Besides warranty does not cover damage caused by:

- improper use of the ELLIPSE instrument (or however not according to the Producer or Seller
instructions)
- bad transport
- insufficient (or missing) preventive maintenance by the User
In particular any damages due to the transport must be immediately reported to the carrier when he
delivers.

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 Chapter 01 - INSTALLATION

1.2.10 CONSUMABLES AND ACCESSORIES PARTS LIST OUT OF WARRANTY

Quantity
Description Type Code
(Pieces)
Reagents containers 35 ml 12 C101-00190-00
Reagents containers 6 ml 12 C101-00191-00
Samples cups 0.8 ml 1000 AS650002
Short samples cups 1 ml 1000 AS650100
Adapter for short samples cups 1 9-01-0609-00
Reaction sectors 6 C101-00217-00
Washing solution bottle 2 lt 1 9-35-0041-00
Bottle level sensor 1 9-05-0078-00
Tubing Kit for peristaltic pump 2 65-01835-00
Tubing Kit – complete 1 65-01836-00
Cleaning solution 250 ml 2 ASRN0020
Rinse solution 50 ml 1 ASRN0021
Sampling probe (internal needle) 1 05-00707-00
Complete Sampling probe 1 10-00703-00
Drying Pad 1 01-01920-00
Halogen Lamp (6 V - 10 W) 1 9-35-0016-00
Interferential filters Kit (Stablife) 1 65-02017-00
Fuse 6,3 A-T 5x20 10 C132-01238-08
Inlet/outlet fitting for Rinse & Clean conts 1 01-01224-00
Cuvettes protection cover 1 05-01249-00
Reagent protection cover 1 10-00584-00
Reagent plate 1 10-00585-00
Samples rack 1 05-01829-00
Washing station, first or second cannulas (A) 1 05-01633-00
Washing station, third cannula (B) 1 05-01633-01
Washing station, fourth cannula (C) 1 05-01638-00
Washing station, fifth cannula without pad (D) 1 05-01919-00
Diluter Micro-Pump 1 05-01710-40
Air Micro-Pump (µP 6) 1 05-01711-20
Micro-Pump (µP 2 ÷5) 1 05-01826-16
Predilution rack 1 05-01735-00
Solenoid Valve –2 way 1 9-35-0035-00
Solenoid Valve –3 way 1 9-35-0036-00

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 Chapter 02 - GENERAL DESCRIPTION

CHAPTER 02 – GENERAL DESCRIPTION

INDEX

2.1 INTENDED USE AND SYSTEM DESCRIPTION........................................................... 2

2.2 ANALYSES CYCLE .......................................................................................................... 3
2.2.1 REACTION PLATE ........................................................................................................... 3
2.2.2 REACTION PLATE CYCLE ............................................................................................. 3
2.2.3 SAMPLING ARM - OPERATIONAL SEQUENCE ......................................................... 4
2.2.4 SAMPLING SYSTEM........................................................................................................ 5
2.2.5 WASH STATION ............................................................................................................... 6
2.2.6 WASH STATION CYCLE ................................................................................................. 6
2.3 TECHNICAL-OPERATIVE SPECIFICATIONS............................................................... 7
2.3.1 SOFTWARE AND COMPUTER SPECIFICATIONS....................................................... 8
2.3.2 OPTIONAL MODULES ..................................................................................................... 9
2.3.3 DIMENSIONS, WEIGHT AND OPERATING ENVIRONMENT.................................... 9
2.3.4 INSTALLATION SPECIFICATIONS................................................................................ 9

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 Chapter 02 - GENERAL DESCRIPTION

2.1 INTENDED USE AND SYSTEM DESCRIPTION

The “Ellipse” is a random access, computer controlled, counter-top, clinical analysis instrument.
The system can perform 138 tests per hour and has a machine cycle of 26 seconds. Its execution
time ranges from a minimum of 18 seconds to a maximum of 1040, depending on the analysis
method chosen.
The first time the system is used for laboratory analyses, the operator must configure the system
based on the specific needs of that laboratory; i.e.: the chemistry parameters and the reagents racks,
along with the normal, calibrated and control values, must all be defined.
The “Ellipse” is an “OPEN” system that allows configuration with different reagents selected by
the customer in order to fit his needs.

NOTE:
In order to assure the analytical performances of the system “instrument + reagents”, it is
responsibility of the laboratory staff to use reagents, controls and calibrators validated on the
“Ellipse”, or in alternative, to qualify other reagents, controls and calibrators in compliance with
the applicable regulations.

The daily routine analyses will be carried out according to patient sample arrival in a sequential and
continuous, non-stop manner.
The work list is organized using a loading rack holding up to 8 patient samples. Rack loading is
non-stop.
The racks can accommodate test tubes or micro caps. The bar code for primary tubes and reagent
containers is an optional feature.
When the system, the analytical unit and the computer, is turned on the color-meter lamp is supplied
with low voltage power (1.2 volts), the sampling arm pre-heater remains turned off, while instead
the reaction plate heater, the reagents refrigerating unit (optional module) and the electronic
components are turned on.
In this phase, the "Stand-by" light, placed on the front panel, will flash until the reaction plate
reaches a temperature of 36° C. When this temperature is reached, the "Stand-by" light will stop
flashing and will remain constantly lit.
In the case of system failure or malfunction, the "Ready" light, situated on the front panel of the
instrument, will light up red.
In order to access the main program, double click on the "Analyzer" icon on the computer desktop.

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 Chapter 02 - GENERAL DESCRIPTION

The main menu - "System Monitor" - will appear.

Whenever any system function is launched, the color-meter lamp and the sampling arm pre-heater
will receive regular power.

2.2 ANALYSES CYCLE

2.2.1 REACTION PLATE

The reaction plate of the "Ellipse" system contains 6 disposable racks with 20 reaction cuvettes
each.
The racks can be removed individually.
The basic operating cycle of the reaction plate takes 26 seconds. This cycle includes: optic reading
of the cuvettes in incubation, aspiration and dispensing of the reagents and the samples by the arm,
along with the relative positioning of the plate.
The reactions take place at 37° C. This temperature is maintained constant by a controlled heating
unit placed under the reaction plate.

2.2.2 REACTION PLATE CYCLE

After reagents and samples have been placed in cuvette #1, the reaction plate will rotate 40
positions counter-clockwise, so as to bring the first cuvette to be analyzed in front of the color-
meter for reading with either one or two wavelengths, if required.
The plate will then, moving clockwise, carry out all the readings of any other prepared cuvettes.
After having effectuated all the readings, the plate will move counter-clockwise to its initial
position minus one cuvette, ready for a new dispensing.
In this manner, the reaction cuvettes move clockwise 1 - 2 - 3 - 4 for dispensing, washing and the
relative readings.

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 Chapter 02 - GENERAL DESCRIPTION

2.2.3 SAMPLING ARM - OPERATIONAL SEQUENCE

1. The sampling arm lifts up from the wash well and carries out a wash cycle;

2. The arm moves toward the specific reagent container, while the diluter aspirates an air bubble
to separate the rinse column from the reagent;

3. The arm lowers itself into the reagent, below the level indicated by the sensor, and aspirates the
required quantity of reagent. If the method requires a Rinse (used in order to reduce the
possibility of negative contamination between the water column and the reagent) an extra
amount of reagent (not used in the analysis) will be aspirated before the quantity of reagent
necessary for the analysis, along with another air bubble for their separation;

4. While the diluter aspirates a second air bubble, the arm rises and then lowers into the wash well
so that it can be washed externally, to minimize cross contamination;

5. The arm moves to the specified sample and aspirates a third air bubble;

6. Once the level sensor has indicated the presence of the liquid, the arm stops and aspirates the
sample;

7. The arm once again is raised, while the diluter aspirates a fourth air bubble to prevent sample
loss;

8. At this point, the arm returns to the wash well in order to clean the outside of the probe and
aspirates a fifth air bubble;

9. The arm moves to the reaction plate, dispenses, and mixes the reagent and sample in the
reaction cuvette for incubation and reading;

10. The arm returns to the wash well and carries out a probe wash cycle.

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 Chapter 02 - GENERAL DESCRIPTION

2.2.4 SAMPLING SYSTEM

Aspiration of Air

Aspiration of Reagent

Aspiration of Air
(To separate reagent from serum)

To wash well to clean the

probe

Aspiration of air

Aspiration of serum

Aspiration of air

To wash well to clean the

probe H2O

AIR
Aspiration of air RGT

AIR
Dispensing and mixing in AIR
cuvette
SERUM

AIR
To wash well for final
wash

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 Chapter 02 - GENERAL DESCRIPTION

2.2.5 WASH STATION

The reaction plate wash station is made up of a series of five small needles situated on one side of
the reaction plate. Said needles are opportunely connected to the valve and pump system for
emptying, washing and drying operations (please see the hydraulic diagram).

2.2.6 WASH STATION CYCLE

The wash station carries out its operations alternating upward and downward movement. In its
downward movement phase the needles are guided in such a manner as to carry out the following
operations:

• The first needle, using the central cannula, removes the reaction mix while the external cannula
dispenses, shower-like fashion, the wash solution; after that the external cannula dispenses
wash solution and then the liquid is aspirated from the central cannula;

• The second needle operates exactly like the first but uses distilled water instead;

• The third needle operates exactly like the first but dispenses rinse solution into the cuvette so
that an optics check can be performed (if the results are negative, the cuvette is discarded);

• The fourth needle aspirates the Rinse solution used for the optic check.

• The fifth needles dries the sides.

All these operations are part of the routine operation of the instrument. Every reaction cuvette is
washed at the end of each round of analysis.

The reusability (optical integrity) of each reaction cuvette is always tested before the next round of
analysis.

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 Chapter 02 - GENERAL DESCRIPTION

2.3 TECHNICAL-OPERATIVE SPECIFICATIONS

♦ Completely automatic, random access, computer
controlled, counter-top, non-stop loading clinical
DESCRIPTION
chemistry and immunoturbidimetric analysis
instrument

♦ End Point, Fixed Time, Kinetic, Bichromatic,

REACTION TYPES
Differential
TEST SELECTION MODES ♦ Selective, Batch, Profile, STAT

PRODUCTIVITY ♦ 138 tests per hour

OPERATING TEMPERATURE ♦ 37° C

♦ 24 removable containers (capacity 35 and 6 ml)
♦ Reagent plate cooling unit (Optional)
IN LINE REAGENTS
♦ 12 positions for Controls and Standards
♦ Positive Bar Code Reader (Optional)

♦ Primary tubes (diameter from 8 to 16 mm; height

SAMPLE CONTAINERS
up to 100 mm) cups from 1 to 4 ml

♦ 4 racks, each having 8 positions for non-stop

SAMPLE LOADING sample loading
♦ Positive Bar Code Reader (Optional)

MINIMUM REACTION ♦ 220 µl

VOLUME

MAXIMUM REACTION ♦ 550 µl

VOLUME
♦ A single mechanical arm performs all the sampling
operations and is equipped with:
SAMPLING ARM • A volume level sensor
• Pre-heating of the reagent(s) to 37 °C
• Automatic probe washing
♦ Integrated syringe-free module having the
following specifications:
• Sample volume: 2 µl ÷ 99 µl (1 µl incr.)
DILUTER • Reagent 1 volume: 3 µl ÷ 500 µl (1 µl incr.)
• Reagent 2 volume: 3 µl ÷ 330 µl (1 µl incr.)
• Reagent 3 volume: 3 µl ÷ 330 µl (1 µl incr.)

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 Chapter 02 - GENERAL DESCRIPTION

PRECISION ♦ CV < 1 % at 2 µl

READING SYSTEM ♦ Direct reading

♦ Photometer: double ray, interferential filters
♦ Wavelength: 8 narrow band – from 340 nm to 620
nm – interferential filters plus one available
OPTIC SYSTEM optional filter position
♦ Light source: 6V/10W halogen bulb
♦ Linearity range: up to 3,500 Abs
♦ Resolution: 0.0005 Abs
CUVETTE OPTIC LENGTH ♦ 6 mm

♦ Composed of five probes that empty, wash and dry

WASHING STATION
the reaction cuvettes.
♦6 individually replaceable racks with 20 cuvettes
REACTION PLATE each
♦Incubation temperature: 37°C

2.3.1 SOFTWARE AND COMPUTER SPECIFICATIONS

TYPE ♦ IBM Compatible
CPU ♦ Pentium IV 500 MHz, 512 Kb Cache or plus

♦ RAM 256 Mb or plus

MEMORY ♦ Hard Disk 20 Gb or plus
♦ Floppy Disk 3 1/2” 1.44 Mb
Colour SVGA 15’’ low radiation
MONITOR Resolution 800 x 600 pixels;
max number of colors 65536 (16 bit)
PRINTER ♦ 80 Columns impact graphic (EPSON LX 300)
KEYBOARD AND MOUSE ♦ PS2
♦ One Bi-directional RS 232C serial ports and one
INTERFACE
parallel (one second serial port for the Host link)
♦ Multitasking WINDOWS XP Home edition
SOFTWARE ♦ Italian, English, Chinese, Czech. Software to be released
AVAILABLE LANGUAGES soon in these languages: Russian, Portuguese, French,
Polish. Upon request it is possible to release the software
in other languages.

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 Chapter 02 - GENERAL DESCRIPTION

♦ Disable all the energy saving options

♦ Disable the screen saver
SETTINGS
♦ Select English “USA” as language, dot as decimal
symbol and date and time in Regional setting

NOTE: Even though the computers demonstrate the same technical and operative characteristics,
some of these could have different hardware installed.
This could cause problems for the Ellipse software when running tests (A message appears
indicating “Random” error or blocks the program).
Therefore, if the PC is bought separately/locally, it is highly recommended to test the system before
proceeding with the installation at customer laboratories.
Consequently, AMS denies any responsibility for software problems that are due to buying the
computer separately from the instrument.

2.3.2 OPTIONAL MODULES

♦ POSITIVE BAR CODE READER

2.3.3 DIMENSIONS, WEIGHT AND OPERATING ENVIRONMENT

♦Height: 53 cm
DIMENSIONS ♦Width: 57 cm
♦Length: 75 cm

WEIGHT ♦35 kilos

OPERATING ♦Temperature: 18 °C ÷ 30 °C
ENVIRONMENT ♦ Relative Humidity: 20% ÷ 85%

2.3.4 INSTALLATION SPECIFICATIONS

♦Input voltage: 100 ÷ 230 Vac

♦Input frequency: 47 ÷ 63 Hz
POWER SUPPLY ♦Power consumption:
♦300 W for the analysis unit
♦400 W for the work station

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 Chapter 02 - GENERAL DESCRIPTION

Warning: in order to assure proper instrument functioning, the manufacturer strongly advises the
use of a stable tension supply outlet (+/-10%). If it is not possible to guarantee said stability, the
manufacturer suggests the use of:

♦ UPS (Uninterrupted Power Supply)

♦ ELECTRONIC STABILIZER

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 Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE

CHAPTER 03 - DESCRIPTION OF INSTRUMENT

SOFTWARE
INDEX

3.1 SYSTEM MONITOR………………………………...……………..…………………….………..3

Warning Lights.................................................................................................................................... …….5
Legends ........................................................................................................................................................ 7
Status Line.................................................................................................................................................... 8
Menus available under System Monitor: ..................................................................................................... 9
Command Buttons………………………………………………………………………..……………....10
Check button .............................................................................................................................................. 11
Order button ............................................................................................................................................... 11
Print button................................................................................................................................................. 13
Graph button............................................................................................................................................... 13
Rerun button............................................................................................................................................... 14
Edit Results button ..................................................................................................................................... 15
Move to Archive button ............................................................................................................................. 16
Unload button............................................................................................................................................. 16
3.1.1 START WORK ................................................................................................................................ 17
Wash all cuvettes........................................................................................................................................ 17
Water Blank Level ..................................................................................................................................... 18
Calibration & Quality Control.................................................................................................................... 18
Work List ................................................................................................................................................... 19
Start Running ............................................................................................................................................. 19
3.2 CHECKS ........................................................................................................................................... 20
WBL........................................................................................................................................................... 21
Main Area.............................................................................................................................................. ….21
Reagent Volume......................................................................................................................................... 23
Main Area................................................................................................................................................... 23
Details Area……………………………………………………….……………………………………...24
Reagent Configuration ............................................................................................................................... 25
Predilution Rack......................................................................................................................................... 27
3.3 ROUTINE ......................................................................................................................................... 31
Work List Setup ......................................................................................................................................... 32
Unassigned Sample .................................................................................................................................... 33
Saving data for more than one patient........................................................................................................ 37
Deleting a Patient………………………………………………………………………………….……...37

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 Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE

Deleting a rack…………………………………………………………………….……………………...38
Result by Patient ........................................................................................................................................ 40
Printing Data .............................................................................................................................................. 43
Main Area................................................................................................................................................... 44
Precision check........................................................................................................................................... 46
Calibration & Quality Control Setup ......................................................................................................... 47
Calibration Programming........................................................................................................................... 49
Editing Calibration ..................................................................................................................................... 50
Calibration Results ..................................................................................................................................... 51
Quality Control Results.............................................................................................................................. 58
Quality Control Graphs .............................................................................................................................. 60
Receive from Host...................................................................................................................................... 61
3.4 ARCHIVE ......................................................................................................................................... 62
Patients ....................................................................................................................................................... 63
Main Area................................................................................................................................................... 63
Details Area................................................................................................................................................ 64
Calibration.................................................................................................................................................. 65
Main Area................................................................................................................................................... 66
Details Area................................................................................................................................................ 68
Backup........................................................................................................................................................ 69
Restore........................................................................................................................................................ 70
Tests Counter ............................................................................................................................................. 71
Event Log ................................................................................................................................................... 72
3.5 PARAMETERS ................................................................................................................................ 73
Inserting the Password ............................................................................................................................... 74
Profiles ....................................................................................................................................................... 75
Ratio ........................................................................................................................................................... 77
Standards .................................................................................................................................................... 82
Controls ...................................................................................................................................................... 87
Options ....................................................................................................................................................... 91
Print Order.................................................................................................................................................. 92
Report Options ........................................................................................................................................... 93
Password Setting ........................................................................................................................................ 94
3.6 HELP................................................................................................................................................. 96
Guide F1.................................................................................................................................................... 97
Software versions ....................................................................................................................................... 98
3.7 SHUT DOWN ................................................................................................................................... 99

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3.1 SYSTEM MONITOR

Warning Lights

Reagent tray
Operative
Buttons Operative
Sample tray Reaction tray Desk Top area
Buttons

View Data/Details Area

The system’s management software is extremely user-friendly and, moreover, allows maximum
flexibility in its use.

The operator can access the management software by simply turning on the instrument. If the last
instrument Shut Down was due to a Fatal Error or if the Analyzer is at the time turned off, the user
must double click on the Analyzer icon located on the computer Desk Top.

The user interface screen is subdivided into two main areas:

the Desk Top area
the View Data/Details Area

The Desk Top area is a graphic illustration of the instrument that allows the operator to easily
identify each single item and its status. It includes:

√ A reagent tray with twenty-four reagents and twelve Standards and Controls positions;
√ A Samples tray composed by four racks with eight positions each.

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√ A reaction tray composed by six racks with twenty cuvettes each.

View Data/Details Area

Located in the lower section of the System Monitor mask, the View Data/Details Area contains
precise, detailed information concerning the item selected (Cuvette, Samples, Reagents, Standards
and Controls).
It is possible to view data details regarding single items by clicking on them whenever the mouse
pointer turns into a question mark as it passes over that particular element.

• If the operator selects a given position on the Reaction Plate, by placing the mouse pointer
over the required item:
a table containing the WBL values of the cuvette selected (both the main channel and the
reference channel values) will be viewed. The Print button will also be activated.

• If the operator selects a given position on the Samples Rack, by placing the mouse pointer
over the required item:
a table listing the tests programmed to be run on that sample will appear in the lower
portion of the window and information regarding the sample itself (patient name, sample
ID, rack and position) will appear in the upper portion of the window.

• If the operator selects a given position on the Reagents Rack, by placing the mouse pointer
over the required item, the below-illustrated table will appear allowing the user to view
information regarding the selected Reagent.

• If the operator selects a given position on the Controls or Standards, by placing the mouse
pointer over the required item, the below-illustrated table will appear allowing the user to
view information regarding the selected Control or Standard.

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WARNING LIGHTS

There are two types of alarms:

• The first type is a brief visual text message, which appears in the lower, left-hand portion
of the screen, up to the operative buttons. It can inform the operator that either there is “no
instrument connection”, or the “cover is open”, or that a “remote link” is in operation.

• The second are Warning Buttons (located in the upper, right portion of the mask) and they
can be:

- either a “Warning” represented by a triangle that lights up yellow. If the operator clicks
on this button, it is possible to view in the Details Area those events which caused the
warning (e.g.: liquid(s) finished).

- or a “Fatal Error” represented by an X that lights up red. Whenever a fatal error is

signalled, only those readings that have already been carried out will be saved; those
operations being carried out at the time are interrupted (e.g.: incubation). After every
“Fatal Error”, the user must have the instrument carry out a Wash cuvette cycle. If the
operator clicks on this button, it is possible to view in the Details Area those events that
caused the warning (e.g.: temperature error).

At this point, it can be useful for the operator to consult Event Log, listed under the
Archive menu, where all instrument status information is memorized, in order to have
more information regarding the occurrence.

Operative Buttons “Actions”:

START (green triangle): allows the operator to access the Start Work mask
where it is possible to start the running of the various tests and of any other operation regarding
the instrument.

PAUSE: temporarily interrupts only the sampling process. It does not interrupt
incubation, nor the reading of already dispensed samples. To restart, press START.

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STOP: halts instrument functioning - the sampled tests are lost.

Operative Buttons “Racks Replacement”:

Change cuvettes: allows the operator to change cuvettes rack. Clicking on it, the
following dialog box will automatically open and rack selection to be replaced can be done
clicking on the pull-down menu from 1 to 6.
Clicking on “OK” the instrument pass to the Priming and then in Stand-By condition while the
reaction plate turns up to bring the selected position in front of the operator to allow the cuvette
rack replacement.
Click on “OK” into the message that appears after reaction plate positioning to confirm the
happened replacement.

Cuvettes rack can be changed only when the instrument is not performing any operation or
procedure. In such condition, the button is made disable.
Whenever one or more cuvettes illustrated in the Reaction Plate are coloured Red, it is because the
instrument cannot perform the required readings on them due to the fact that they are not perfectly
transparent, or rather; their transparency is below the minimum or above the maximum limit
acceptable to the instrument program. If the operator wishes to view the filter readings, he/she can
do so from within the Details Area.

Whenever a cuvettes rack is inserted for the first time in the Reaction Plate, it is indicated in red
under System Monitor because the instrument does not have that data necessary for the
mathematical equations needed to calculate test results. Therefore, it is necessary to carry out a
WBL for that cuvettes rack (auto-zeroing) in order to be able to use it.

Load Sample/s: allows the operator to load samples rack. Clicking on it, the following
dialog box will automatically open and rack selection to be replaced can be done on the pull-down
menu, among those programmed, in the reported position A, or B, or C or D, defined by the
instrument.

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Clicking on “OK”, the sample plate turns up to bring the selected position in front of the operator,
to allow the sample rack loading.
Click on “OK” into the message that appears after sample plate positioning to confirm the
happened loading.
Samples rack can be loaded at any time, even if the instrument is in running condition.
In this case, pushing the loading operative button, the instrument pass from the Running to the
Pausing and then to the Pause condition, to allow the selected rack loading.

Click on “OK” into the message that appears after sample plate positioning to confirm the
happened loading; click on the START button and confirm pushing OK in order to restart the
running.

Load Reagents: allows the operator to load reagents. The button is able in Running
condition only. Clicking on it, the following dialog box will automatically open and ALL
selection to load reagents can be done on the pull-down menu.
Clicking on “OK” the instrument pass from the Running to the Pausing and then to the Pause
condition the allow the refill of one or more then one used reagents, or one new reagent
configuration loading.
Click on “OK” into the message that appears after reagent plate positioning to confirm the
happened loading; click on the START button and confirm pushing OK in order to restart the
running.

LEGENDS

There are three legends and one symbol to be found under System Monitor and they are the
following:

• A Legend regarding the colours associated with certain visual text messages
concerning reagent and sample status: (upper right)

Reag./Samples:

White (absent)
Sky blue (present)
Yellow (in use)
Green (completed)

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Magenta (low level)

Red (error - no sample or reagent)

• A legend regarding the various types of reagent bottles having different volume
capacities, that can be selected for use by the operator (medium right)

white 35 ml
sky blue 6 ml
magenta 6 ml
blu 6 ml

• A legend regarding the various types of test-tubes having different volume capacities,
that can be selected for use by the operator (lower right)

white (short – approximately 1 ml)

sky blue (conic– approximately 2 ml)
magenta (primary tube)

By clicking on “Options” under the “Parameters” menu, the operator can select the reagent
bottle to be used by default. The reagent code will be written in the colour of the bottle that
contains that reagent.

• A symbol regarding STAT

Samples having this symbol will be processed first of all the other programmed
and loaded samples.

STATUS LINE

The Status Line, lower left, contains information regarding the functioning condition of the
instrument. Said information allows the operator to follow and check the status of instrument
operation.

Stand By

Stop

Washing

Running WBL

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Running

Pause

Pausing

Safe

Priming

Moreover, in the Status Line, are reported the following information:

Icon indicating a fault sample reading executed by the Bar Code reader.

If the operator places the mouse pointer on this icon, it is possible to view the Firmware
version.

MENUS AVAILABLE UNDER SYSTEM MONITOR:

⇒ Monitor

⇒ Checks

⇒ Routine

⇒ Archive

⇒ Parameters

⇒ Help

⇒ Shut Down

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COMMAND BUTTONS

The Command Buttons are automatically activated as needed and have the following functions:

Make validated the results of a given Test (Check button);

Reorder the viewed data (Order button);

Print the viewed data (Print button);

View an absorbance graph (Graph button);

Repeat an already run test (Rerun button);

Modify the results of a test (Edit button)

Save and File results in the Archive (Move to Database button);

Send the data to the remote computer (Unload button)

The various icons are activated in accordance with the mask being used. It is possible to recognize
an inactive button by its opaque colouring or by the fact that it cannot be viewed. If the user places
the mouse pointer over an icon, a visual text message will appear describing the corresponding
function.

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CHECK BUTTON

Working within the Patient Results window and within the Test Results window (even under
System Monitor), the operator has the possibility to verify, select and confirm the results of the
tests by using the Check button located on the Desk Top. By selecting, from the offered list, a row
containing a result deemed correct (e.g.: the same test repeated for the same patient), the operator
can, by clicking on this command, make the selected test “valid”. The system will automatically
show the examined data in bold print, in order to make it more readily visible to the user.

ORDER BUTTON

Whenever the operator looks over the results of any one of the various operations carried out,
he/she may find it necessary to Re-order that list in a manner judged by him/her to be simpler and
more useful. This procedure is described in the following paragraph. The Order command can be
applied to the visualization of the various results listed here below:

Patients Results;
Test Results;
Quality Control Results;
Archive – Patients;
Archive – Calibration;
Tests Counter.

This re-ordering can be requested via the Order button located on the Desk Top, and can be
viewed (or rather, is activated) only during the visualization of those lists whose contents can be
re-ordered.

Re-ordering can also be requested directly from the area involved, by clicking on the small
triangle symbol that appears in the field heading. After clicking on the symbol, the user need only
select to have an alphanumerical order either ascending or descending.

How to Re-order

In order to carry out a re-ordering of viewed data, the operator must first select a row from the
required list and then click on the above-described Order button. The below-illustrated mask will
automatically open, allowing the user to select from the offered options and perform the operation.

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The Order Data mask contains: a “Keys” area where the operator can select which field(s) in the
List he/she wants to re-order; options concerning which type of Order is to be effectuated; another
” Sort Key List” area where those field(s) to be re-ordered, selected from the Key area, are listed;
plus the various buttons necessary for carrying out the procedures.

The operator must first click on the name of that field, within the “Keys” area,
which is to be re-ordered and then click on “Set”. The selected field will automatically be listed in
the “Sort Key List” area, ready to be re-ordered.

Once a given field (or fields) has been selected from the “Key” area and is
listed in the “Re-order List” area, the operator can change his/her mind and decide to delete one or
more fields from this list to be re-ordered. He/she need only click on the required field and then
click on “Remove”. The Remove button is activated only after at least one field has been selected
from the “Key” area.
For each individual field that is to be re-ordered the operator can choose from two Order options,
Ascending or Descending, located between the “Key” area and the “Re-order List” area.

After all the above-described selections have been made, the operator need
simply click on “OK” to have the instrument carry out the Order procedure. The Order Data
mask will automatically close and the List will now be viewed according to the order requested by
the user. To annul the operation and exit the Order Data mask, click on “Exit”.

Following are two examples, which could be useful for a better understanding of the above-
described procedure and also helpful in carrying out the Re-order operation.

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The two illustrations provided below are ordered according to two different criteria. The
“Position” (Pos) has been selected in the first illustration and an “Ascending” order has been
designated.

The second illustration, instead, exemplifies the selection of the “Sample ID” and the designation
of a “Descending” order.

PRINT BUTTON

In order to print the data viewed in a given mask, the operator must first select those rows that are
to be printed and then click on the “Print” button, located on the Desk Top.

GRAPH BUTTON

In order to view the reaction graph, or rather, the Graph of the Optical Densities obtained and the
reading times expected (as given under Methods) for the result selected, the user need simply
select the row in the Details Area containing the results he/she is interested in and then either
double click on it with the mouse or click on the “Graph” button located on the Desk Top.
This Graph button is activated only when the Details Area contains at least one row of data.

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Exit To exit the Graph mask, click on “Exit”.

RERUN BUTTON

Whenever it is deemed necessary to rerun a test (e.g.: the sample appears too concentrated, the
quantity of reagent seems insufficient, etc.), the operator can do so by using this “Rerun”
procedure – the relative button is located on the Desk Top.
Select the required row and then click on “Rerun”. The previously illustrated window will
automatically appear within which the operator can reprogram the required test. In order to carry
out the operation, the relative command, under the Start Work mask must be activated. All those
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fields, which may be of help to the user in the reprogramming of the test, can be viewed in this
mask. Among them:

Item Selected: indicates the name of the Test the operator has selected to be rerun, if only one
type of test has been selected. If more than one type of test has been selected, the window will
show “Multiple Selection”;

Total Selection: allows the operator to view the total number of reruns requested for the required
Test(s);

Dilution Ratio: allows the operator to decide, using a pull-down menu, the dilution ratio for that
test. This is possible only when one single type of test has been selected to be rerun, and not when
the operator has requested a Multiple Selection rerunning or when the sample volume permits to
do so (Sample volume more than four microliters).

By clicking on “OK”, the operator confirms the operation. Clicking on Exit, instead, annuls the
selection, as well as the operation.

EDIT RESULTS BUTTON

This button allows the operator to edit the results of the tests performed. To perform this
operation, first select the required row from the Details Area and click on the Edit button located
on the Desk Top. The below-illustrated window will open, containing two buttons: “OK” and
“Exit”.

Insert the new value for the test result and click on OK. The new value will automatically be
registered and will appear in the Results field of the relative test. At the same time, the Flags
column will show an E in the relative field (see the illustration below), indicating an Edit (see
Result Flags).

The window’s Exit button allows the operator to annul the editing operation.

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MOVE TO ARCHIVE BUTTON

The results of all those operations carried out under Start Work can be recorded and saved, along
with the patient data contained in the “Work List”, in a Archive. First, select the record to be saved
in the Archive from the Main Area and then click on “Move”, located on the Desk Top. The
following window will automatically come up:

This window contains a pull-down menu in the field labeled “Results to move” where the
operator can choose to save either the individual records selected from the Main Area or an entire
Rack. To confirm the move, click on “OK” and the selected data will automatically be moved and
thereby recorded in the Archive.
The Exit button annuls the move and the operation.

Data can be moved to the Archive only if the patient has been assigned tests and the tests have
been performed (and therefore have results). If the operator tries to confirm, “OK”, the movement
of data to the Archive when no results or tests are available for that patient, the program will
automatically annul the operation and the user will be informed via a visual text information
message to that effect.

The centred portion of this window contains the number of records moved, deleted or pending for
both Patients and Results. All this saved and filed data (“moved” data) can be consulted under
Archive – Patients.

UNLOAD BUTTON

This command makes it possible to activate data transmission to the Host. To carry out this
Transmission, select one or more rows from the Main Area of the Result by Patient window in
the Routine menu and then click on “Unload button” (located on the Desk Top only if Host
Connection selection has been made active in the Option Menu). In order to view this command
(not automatically shown on the Desk Top), the operator must have selected at least one record
under Patient Results.
The program will guide the operator during the data transmission, via a series of visual text
messages.

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3.1.1 START WORK

The START WORK button (green triangle) allows the operator to open the Start Work
window where he/she can select, as needed, the below-illustrated operations:

Wash all cuvettes

“Wash all Cuvettes” is the first option offered. Here, the user can select which cuvettes rack
contained in the Reaction Plate is to be washed. To do so, the operator must select, from the field’s
pull-down menu, one of the following: All, Rack 1, Rack 2, Rack 3, Rack 4, rack 5, Rack 6. If
he/she selects All, the programme will automatically wash all the cuvettes in the Reaction Plate,
while remain selections permit washing of the selected rack only.
Whenever this option is highlighted in red and is accompanied by a visual text information
message, viewed at the bottom of the Start Work mask, it means that the instrument is in the
condition to warrant cuvette washing. Therefore, the programme notifies the user to this effect and
suggests that said operation (“Wash all Cuvettes”) be carried out before performing any other
operation.

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WATER BLANK LEVEL

The second option, “WBL”, allows the user to activate a pull-down menu where he/she can
choose those cuvettes racks to be subjected to a water blank level reading, auto-zeroing. The
options offered are the following: All, Rack 1, Rack 2, Rack 3, Rack 4, rack 5, Rack 6.
All carry out WBL readings on all the cuvettes racks contained in the Reaction Plate, while remain
selections permit WBL readings on the selected rack only.

The WBL operation (auto-zeroing of the cuvettes) must be carried out daily, before running the
Work List tests. Each cuvette is filled with approximately 400 micro-liters of Rinse solution and
read for all the wavelengths of the eight filters. These readings are fundamental to determining
cuvette quality and for instrument auto-zeroing, necessary for subsequent numeric calculations.
The user can view the obtained WBL readings in the “Water Blank Level” mask.
The resulting WBL values will be used by the system to calculate the concentration of the tested
analita.
The reading system (Photometer) reads light intensity that passes through photodiodes. The
analogical values expressed in millivolt read by the photodiodes are then digitally
transformed into logical data expressed in “Counts” from 0 to 65553.
As we know from Lambert/Beer law, the relationship between transmittance (Ratio between
incident light Io and transmitted light I) and absorbance is an inverse logarithmic type. In
order to obtain a linear data, proportional to the concentration of the Analita tested, the
following mathematic algorithmic is used:

- Log (I / Io) = - Log [counts(1) / counts(2)] = Abs = Σ * C * r

Where:
counts(1) = reaction reading (I)

counts(2) = cuvette containing water reading (WBL = Io)

Abs = Absorbance (optical density)

Σ = absorbivity or Coefficient of molar extinction

C = concentration

r = Optical path length

The absorbance data given in the reaction reading (see reaction graph) contains the offset value
(about 100 counts).
Possible signal variation due to the lamp or to the filters (Thermical drift) are automatically
compensated by the readings taken from the reference channel.

CALIBRATION & QUALITY CONTROL

This third option makes it possible to calibrate the methods. In order to activate this option, it is
not only necessary to select the relative field, but also to request at least one Sample Blank (RBL)
execution in the Calibration & Quality Control function under the Routine menu.

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WORK LIST
The fourth option allows the operator to activate the work lists previously programmed.
There are four positions available for the Samples racks, identified by the “A”, “B”, “C” e “D”
characters.
By selecting the Work List option, the positions containing the previously programmed and loaded
samples rack are activate. After selection, samples racks are shown in the System Monitor in the
dedicated area. Here, the rack number is also available by assuming the colour corresponding to
the size of the liquid container. The samples are shown in sky blue colour if they are still to be run;
in yellow if they are in process and in green if they have been completed.

Note: A sample position will remain yellow coloured until all its programmed tests are completed.

Clicking on the rack number of each active position, a pull-down menu will be shown, where the
user can disable the selected rack by clicking on Nothing (when the machine is not in running). So
that, by pushing the start button, the samples will not be sampled, even if still shown on the
System Monitor.
While tests are in process, the reaction mixture in the reading will be shown on the System
monitor by changing the concerned cuvettes colour: from black to grey.

START RUNNING

To activate the carrying out of the option selected, click on “OK”. Note that the “Parameters”
menu is blocked (inactivated by the instrument itself) during the carrying out of any and all
operations. This is done in order to protect those masks that contain fields where, if the contents
were edited, the results of the operations could be compromised. When said operations have been
completed, the Parameters menu will automatically be reactivated. This reactivation can also be
obtained by clicking on “Stop” or “Pause”.

Exit

By clicking on “Exit”, the operator can exit the Start Work menu without carrying out any
operation.

N. B.:
The instrument program will carry out any automatic rerunning of the tests without the need for
the operator to intervene.
Further rerunning can be requested only after testing has been completed and preferably before
rack replacement.

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3.2 CHECKS

“Checks” includes the entire set of masks which allow the operator to access and
activate functions, as well as view a series of data, both useful and necessary for correctly
preparing the instrument for routine operation.
Each set of data, grouped according to information category, has its own dedicated mask.
Following is a list of these masks:

Water Blank Level: contains a graphic illustration of the results of all the WBLs run as quality
control on each of the 120 cuvettes.

Reagent Volume: contains an organized view of all that data set-up in the “Reagent
Configuration” mask, along with the calibration programming data (CTRL and STD).

Reagent Configuration: a necessary preliminary step before performing any analytical testing. In
this mask, the operator can assign the positions of the reagent liquids and also, if desired, that of
the controls, from among those set aside within the instrument specifically for this purpose.

Predilution: this mask contains all that data regarding the positions dedicated to sample
predilution as set-up in the “Reagent Configuration” mask.

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WBL

To access the Water Blank Level mask, first select the Checks Menu and then, from the options
listed, click on Water Blank Level.
The window that opens graphically illustrates the results of the operations carried out when the
WBL option is selected under the Start Work mask.

The values of the WBL are used in the mathematical operations for calculating test results and for
performing quality control checks on the 120 cuvettes (e.g. when checking transparency).
This window is divided into two sections, a Main Area and a Details Area, in order to facilitate
user access and comprehension.

The mask also contains buttons, which allow the operator to move on to other applications or
procedures.

MAIN AREA
The main area of the WBL mask contains a histogram of the WBL results on a scale ranging
between 28,000 and 63,000 counts.
By consulting this chart, the operator can immediately evaluate the status of the cuvettes within
this reference interval.
The histogram indicates the WBL values as explained below:

➜ The initial WBL measurement value is indicated in grey line;

➜ The penultimate WBL measurement value is indicated in matt yellow;
➜ The last WBL measurement value obtained is indicated in bright yellow.

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PLEASE NOTE 1: the difference between the penultimate and the last WBL readings are
illustrated by the different colouring of the histogram bar (a reduction in the counts value), or by
the presence of a vertical line on the bar coloured bright yellow (an increase in the counts value).

PLEASE NOTE 2: the bar is coloured yellow for WBL values falling within the tolerance range
(28,000 – 63,000 counts). If one or more of the reported values is out-of-range, a red line will
appear next to the number of the cuvette whose reading(s) is/are out-of-range.

In the Details Area, the operator can view the Archive information regarding readings for all eight
wavelengths and for each cuvette. The Main Area will, therefore, contain only that information
regarding the reading with the Optical filter set at 340 nm, while the Details Area will show the
values relative to all the positions of the photometer filter wheel.

The Main Area’s heading contains the following fields:

Cuv.: in addition to identifying the row, this heading also indicates the number of the Cuvette to
which the thereafter-reported values (in the following fields) refer. Whenever the cuvette is judged
to be “bad”, this number will be shown in red.

D. Rel.: refers to the difference between the value of the last WBL carried out and that of the
previous one.

D. Abs.: refers to the difference between the value of the last WBL carried out and that of the first
carried out.

Initial Date: indicates the date the first WBL was carried out.

The obtained values, subdivided according to filter (fields F0 to F9), are reported in the Details
Area.

Whenever the operator selects a given row from the Main Area, the Details Area will
automatically show more specific itemized data, in chronological order, regarding the values
obtained for the cuvette indicated by that selected row.

In the column regarding the “Date” field, the row containing “Ref” values report the values
obtained using the Optical reference channel.
All the data in the various fields will be shown in red in the Details Area, whenever the cuvette(s)
selected from the Main Area is/are judged “bad”.

Details Area

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This mask allows the operator to print the information herein contained. This is made possible via
the use of the command buttons located under System Monitor (please see the section regarding
the Command Buttons).

REAGENT VOLUME
To access the Reagent Volume mask, first select the Checks Menu and then, from the options
listed, click on “Reagent Volume”.
This mask gathers and suitably organizes all that data set-up in the Reagent Configuration mask
and in the Calibration Programming mask. In addition to the reagents contained in the reagent
housing, this mask also allows the operator to view data regarding standards and controls assigned
to the calibration procedure. This window is divided into two sections, a Main Area and a Details
Area, in order to facilitate user access and comprehension.

The Main Area is located in the upper portion of the screen and contains generalized information.

The Details Area is located in the lower portion of the screen and contains more specific, itemized
information.

MAIN AREA
Following is an illustration of the Main Area window as seen by the operator. This window
contains, in addition to those fields to be described in this paragraph, buttons that allow the user to
move on to other applications or carry out other procedures.

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The fields, that will be herein described, are the following:

Position: allows the operator to view the position occupied in the reagents rack; there are 24
positions available;

Type: indicates the type of liquid tested;

Name: indicates the reference acronym for that liquid;

Cup/Bottle Type: allows the operator to view the format of the container to be used for the liquid
indicated. There are two bottle types configurable on the instrument, which can be chosen
according to user needs. They are:
• 35 ml;
• 6 ml;

Residual Volume (ml): quantity of reagent left in the container and available for use in other
analyses (this information is automatically updated as each test is carried out). The amount is
expressed in millilitres and is a decimal figure.

DETAILS AREA

The Details Area is located in the lower portion of the screen – above is an illustration as seen by
the user. This area allows the operator to view the specific details regarding the particular liquid
selected in the upper portion of the window (i.e. in the Main Area). A description of the more
important fields follows:

Type: indicates the type of liquid tested;

Name: indicates the full name of the liquid being tested;
Predil. Ratio/Volume (ul): if the indicated liquid is a diluent, this field expresses the predilution
ratio set-up. Otherwise, it allows the operator to view the volume of reagent necessary for each
reaction;
Rinse (ul): quantity of liquid used to avoid an intermixing (i.e. cross-contamination) of the
reagents;
Residual Volume (ml): quantity of reagent left in the container and available for use in other
analyses (this information is automatically updated as each test is carried out). The amount is
expressed in milliliters and is a decimal figure.

Whenever the operator selects a Control from the Main Area, the Details Area will show the
Name, Lot Number, and Expiration Date of said Control.

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If, instead, the operator selects a Standard from the Main Area window, the Details Area will
view the Type of STD, the Name, the Lot Number, the Expiration Date, the number of Points,
and the relative Diluent.

Whenever the level of any Reagent drops below its “reserve level”:

➜ the position of that reagent under System Monitor will be shown coloured magenta;

The “reserve levels” are as follow:

• 5,7 ml for the 35 ml capacity container;

• 1,8 ml for the 6 ml capacity container;

Whenever the Reagent ends:

➜ the position of that reagent under System Monitor will be shown coloured red;
➜ it will be given an hearing warning message;

The operator can print the data visualized in this mask by using the command button located
under System Monitor (please see the section regarding the Command Buttons).

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REAGENT CONFIGURATION

To access the Reagent Configuration mask, first select the Checks Menu and then, from the
options listed, click on Reagent Configuration.

This function allows the operator to configure the reagents on the instrument.
The central area of the screen illustrates the reagent tray (including standards and controls), the
samples and predilution racks.

The lower left area of this mask dedicated to the reagents, the operator can view the legend of
those colours corresponding to the various sizes (capacities) of the reagent containers.

The right-hand area of the mask contains an enlarged illustration of the positioning of the
standards and controls. Those controls already configured on the instrument are listed below this
enlargement (please see the following paragraph dedicated to programming the controls).

A control can be activated or deactivated by simply clicking on its corresponding “box”. The
instrument will automatically assign an activated control to the first available, free, position in the
STD/CTRL rack. The operator can also, if he/she so desires, change the position of a given
control, moving it to another free position in the same standards and controls rack, or to one in the
reagents positions. Using the mouse – “Drag & Drop”, carries out this move.

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PREDILUTION RACK
In the left-hand portion of the screen, below “Reagents”, the operator can view the following:

by clicking on the pull-down menu, the user can select a number from 0 to 2.
These numbers indicate the racks dedicated to the predilution of the samples and are as follows:

0 no predilution rack will be set-up;

1 the sample plate position D will be dedicated to the

predilution rack P1;

2 the sample plate position D and C will be dedicated to the

predilution rack P2 and P1 respectively;

Methods List

This frame allows the user to view all the tests without predilution if no
prediluition rack will be set-up or all the tests with and without predilution if
predilution rack will be set-up.
These tests are listed in alphabetical order.

The selection of a given test immediately determines the automatic

placement, in that area reserved for reagents, of the diluents and the
reagents necessary for correctly carrying out that specific test. The
reagents are placed in the first position available within the reagents tray. However the operator
can change their position, if he/she so wishes, by using the mouse to move them via the Drag &
Drop function.

The name of the Reagent positioned in the rack will be shown in the colour that indicates its
container format. The relative legend can be viewed in a chart located below the Reagents Racks.
In order to change the format of the reagent container, the operator must first point the mouse
towards the name of that particular reagent and then right click. This will automatically open a
dialog box where the operator can select the type of container desired
In the lower portion of the screen, the user can view:

• Reagent Tray(s) Configuration

This section allows the operator to select from a pull-down menu, one of the eight
programmed reagents plates. The user can program up to 8 (eight) different reagent
configurations. Moreover, it is also possible to rename a given configuration, substituting its
current name with a new one, using the keyboard and then confirming the change by clicking
on OK. The user can at any time view the reagent configuration the instrument is using under
System Monitor.

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The “OK” button allows the operator to save the change(s) made and
confirm the configuration of the selected reagent(s).

Warning: if the operator enters the Reagents Configuration window once the Calibration has
been programmed, he/she will view the following message:

CALIBRATION PENDING!

It’s not possible to change the Reagent Configuration.

Retry later or delete Calibration.

In order to make any changes, the operator must first wait until the calibration has been either
carried out or eliminated from the programming.
If the name of the reagent has been changed in the Methods window, it will also be eliminated
from within the reagents configurations. System Monitor will therefore no longer show the name
of the configuration in use, but will instead indicate “INVALID”.

If the operator enters the Reagents window, he/she will view the following message:

CONFIGURATION NOT VALID!

Methods definition has been changed.

Select a new Reagent Tray Configuration and
Check its methods.

It is the operator’s responsibility at this point to either insert the modified test in the reagents
configurations and confirm the change by clicking on “OK”, or to not do so.

Exit
The “Exit” button allows the operator to close the Reagents Configuration mask
and to return to the main mask – System Monitor – without saving any operated changes or
modifications.

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Predilution

In order to access the Predilution mask, first select the Checks Menu and then, from the options
listed, click on Predilution View.

This window contains all that data regarding the pre-diluted samples carried out in their appointed
positions and activated under reagents configuration.

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The fields to be considered are the following:

Position = position assigned to the diluted sample in the samples rack and in the
predilution rack.
The numbering goes by 101 to 132 for the samples rack and by 201 to 250
for the predilution rack positions.

Sample Type = allows the operator to view the type of diluted sample (Serum / Urine)

Sample ID name = indicates ID code of the sample and patient name

Predilution Ratio = indicates the predilution ratio of the sample as set-up in the
corresponding method

This mask allows the operator to print the information herein contained.
This can be done by using the command button located in System Monitor (please see the section
regarding the Command Buttons).

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3.3 ROUTINE

The term Routine includes all those masks which are used both for programming the
Patients and for the Calibration of the relative Tests. This heading also includes all those paragraphs which
can help the operator better and more easily check the results of the performed operations.

Work List Setup: this mask is necessary for programming all those operations involving the
patients and their respective tests;

Result by Patient: here the operator can view the personal data of the patients as set-up in the
Work List programming mask and, if so desired, also the results of the programmed
tests. The user can also request a print-out of the report(s) and of the work list(s);

Result by Test: here the operator can view, in addition to the patient data as set in the Work List
programming mask, all that data specifically regarding the tests carried out;

Calibration and Q. C. Setup: this is a necessary and preliminary first step to be carried out before
any calibration. Here, the operator requests that the instrument carry out the RBL, the
calibration and the controls for each individual method in the configuration;

Calibration Results: here the user can view the results obtained regarding the “Calibration” and all
other related data;

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Quality Control Results: here the operator can view all the data regarding the controls carried out
on the tests;

Receive from Host: this command makes it possible to receive data from the Host regarding the
Patients and the Tests to be carried out (only if Host Connection selection has been
made active in the Option Menu).

WORK LIST SETUP

To access the Work List mask, the operator must first select Routine from the Menu and then,
from the options offered, click on Work List. The Work List window, illustrated above, allows the
operator to insert data regarding the patients and their respective Tests.

This programming phase is necessary before being able to load samples rack and to go on to the
“Start Work” window.

The Work List mask is organized in the following manner:

• An area located on the left-hand side of the screen, dedicated to the selection of the Racks and
to the positioning of the Samples in these Racks;

• An area located in the central, right-hand part of the screen, dedicated to personal data
regarding the patient, to the Methods, to the Profiles, and to the relative Ratios;

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• An area located in the lower portion of the screen that contains those buttons necessary for the
various management operations regarding the mask.

Positioning of the samples in the racks

Positions

The “Positions” field is located in the area dedicated to Rack selection, as

illustrated here to the left. There is a scroll bar which allows the user to view
all the available Racks, numbered from 1 to 99.

Within this area, those Racks which are available for sample assignment will be coloured grey, while those
that have already been assigned at least one programmed sample are coloured yellow. The number of that
particular Rack taken into consideration by the operator is highlighted in green, as illustrated here above. If
the rack number is coloured red, it means that testing is being run on the sample therein contained. In this
case, it is not possible to cancel the samples or the rack itself. However, the operator can add samples to be
run if there are still positions left free.

Cup Set-up
Once the Rack has been selected, the operator can view in the
“Positions” area (as seen here to the left) the CUPS for each of the
Rack’s 8 positions, represented by the first column of numbers. Each cup
has its own SID (Sample IDentification number) as set-up in the Samples
card (in the central area) and this SID can be viewed in the second
column of numbers.
For each position selected, the operator can view the Sample’s
corresponding personal data in the central area of the Samples card; and
the relative associated Methods, in the right area of the Methods card.

UNASSIGNED SAMPLE
The SIDS of samples which have been programmed and sent to
the Work List via the Host Link, but have not, as of yet, been
physically assigned to a specific Rack, will be viewed in the
“Unassigned Samples” field, illustrated here to the left. Within
this field, the operator can move a SID from here in the Rack and
viceversa, via the mouse using the Drag & Drop function.
Furthermore, this area allows the operator to use the Bar Code Module (please see the section:
Options) to manually program the samples without worrying about assigning them to a certain
position, as position assignment will be carried out by the instrument via a reading of the Bar Code.
The operator will automatically be notified through a visual text information message whenever this
function is active. The user can view this message in the that part of the screen located above the
command buttons in the System Monitor screen.

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Patient Personal Data

Sample
Personal data regarding the Patient and data regarding the corresponding sample are included in this
card. The following information can be viewed:

Type: a pull down menu containing a list of sample type options - Serum, Urine, Control – from
which the operator can choose. (Please see the ‘Controls in the Racks’ paragraph for
information regarding the choice of Control). Once the sample type has been set-up, i.e. said
selection saved, it can no longer be changed. At this point it will appear coloured dark grey.

Sample ID: required field – the Sample Identification Code can be made up of a Maximum of 15
letters or digits and will be assigned to only one of the accepted samples. If the SID is numerical, it
is set-up by the instrument program and is progressive. The operator can change the SID, but should
pay special attention as duplicate SIDs are not allowed. Said SID can be modified by the operator up
until the moment in which it is saved, at which point it can no longer be changed and will appear
coloured dark grey.

Patient ID; required field – Patient Identification Code. It is an unequivocal reference code,
unique to that individual patient. PIDs can be modified by the user up until the moment in which
they are saved, at which point they can no longer be changed and will appear coloured dark grey.
Seeing as how a given Patient can be tested more than once, different SIDs can be assigned to the
same PID. (Glycemic Curve):

Last Name: the patient’s last name (family name/surname);

First Name: the patient’s first name (given name);

Sex: this required field contains a pull-down menu offering two possible choices – male or female,
for the sex of the patient. During sample running, it is not possible to modify this choice and the
field will therefore appear coloured dark grey;

Birthdate: patient’s date of birth. This data can be inserted using the program’s calendar, accessible
by pressing F4 or by double clicking with the mouse. In case of patient’s date of birth absence,
regarding the reference range, patient will be consider as Adult. During sample running, it is not
possible to modify this choice and the field will therefore appear coloured dark grey;

Admis. Date: date of admission of the patient. This data can be inserted using the program calendar,
accessible by first selecting Admis. Date, then F4 or by double clicking with the mouse;
Diluted Ratio: indicates the dilution ratio of an already pre-diluted sample. Leaving he predefined
value of “1” unaltered, means that the sample is undiluted.

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Choosing “2” means that the sample is diluted manually by the operator in a 1 to 2 ratio. If “2” is
selected, the final result of the test run on that sample will be automatically multiplied by 2. During
sample running, it is not possible to modify this choice and the field will therefore appear coloured
dark grey;
The following include more detailed information:
Diagnosis: description of a possible pathology;
Location: department or ward;
Address: patient’s street address;
City: name of the city where the patient resides;
State: name of the state (or country) where the patient resides;
ZIP: Postal Zip Code
Notes: here the operator can insert any information deemed important or useful
STAT: indicates that the sample is urgent and will be executed as first before all other programmed
and loaded samples. After STAT sampling the analyzer will continue with other samples without
any further operation by the user.
Stat samples can be loaded on any of samples rack either on a free or busy position. In the latter
case, the previously loaded sample must be removed and re-programmed.

Methods

The Methods window (central area of the window –illustrated here above) contains a list of the test
acronyms that have been previously programmed under the Methods mask.
The tests in the Methods list are listed in alphabetical order and priority is given to those contained
in the reagents configuration currently in use by the instrument.
The acronyms are coloured either blue or grey as an indication of whether their relative reagents
have already been or not yet been programmed under the Reagents configuration currently in use.
Blue indicates that the reagents have already been programmed; grey, that they have not yet been
programmed. Click on the small boxes located beside the test acronyms to “check” the relative
methods for that patient being programmed in the Sample card.
The methods written in blue will be run when the sample rack is loaded and the relative Work List
is activated under the “Start Work” mask, while those highlighted in grey will remain set-up, but
will not be run until their relative reagents have been configured.
These tests will appear coloured dark grey when the instrument is in the process of carrying them
out or whenever they have already been run. It is not possible to modify or change the Test
assignment regarding Tests already carried out or those being run.

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Profiles / Ratios Areas

Located below the Methods List, this area includes the two, here-illustrated, frames.
These frames contain those tests which have been previously memorized (saved) under the
respective Profiles and Ratios programming masks.

Whenever a profile is selected in the Profiles Area, all those tests which are included in that Profile,
as set-up in the Methods list and necessary for carrying out that particular Profile, will be
automatically selected and a check mark ( ) will appear in the small adjacent box.

If the operator selects a Ratio which is listed under the Ratios area, a check mark ( ) will appear in
the small adjacent box and all those tests which are included in that Ratio will be automatically
selected and a check mark ( ) will appear in the small adjacent box of the methods window.

Already Assigned Sample ID

Select the required Rack (“Positions” area) and a position within the Rack. Fill out
the “Sample” card – the Patient ID is mandatory and therefore must be inserted – and mark
(‘check’) the relative methods in the Methods card. If the operator selects an unassigned position,
the instrument will propose the first available Sample ID to the user to be inserted in the “Sample”
card. If an already assigned position is selected by the user, then the operator must be careful when
choosing the SID, so as to not assign one already in use.
To confirm, click on “Save”, which will be activated only after a Sample ID and a Method have
been selected. If, by mistake, an already assigned Sample ID is set-up, the following dialog
box/visual text information message will appear:

Confirm by clicking on “OK”, change the SID and then click on “Save” once again.

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If, instead, the operator tries to save data without having first selected at least one Method, then the
following dialog box/visual text information message will appear:

Confirm by clicking on “OK”, select one or more Methods, and then click on “Save” once again.

Once the operator has clicked on “Save”, the “Positions” card will automatically be updated and
another, different Sample ID, available for a subsequent sample, will be proposed for the next
sample.

SAVING DATA FOR MORE THAN ONE PATIENT

To save data that is the same for more than one patient at a time, or rather, for
more than one patient all having the same methods programmed, use the “Save for…” button. The
selection process is the same as that used for a single patient. Click on “Save for…” instead of on
“Save”.
The following dialog box will appear:

Insert the number of patients for whom data is to be recorded, remaining within the Maximum
number position of the 99 samples racks. If the number inserted is greater than the number of
positions left free in a Rack, the program will assign the patients to the next Rack. Click on “OK”
to confirm and complete the operation. Click on “Exit” to cancel the operation

DELETING A PATIENT

Select the Rack and the position of the Sample ID to be deleted in the
“Positions” card. Then click on “Delete Sample” (this option is not activated if the operator
chooses a sample contained in the rack that the instrument is running at the time).

The following visual text information message/dialog box will appear:

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Click on “Yes” to confirm the deletion of the Sample; click on “No” to annul the request and exit.

DELETING A RACK

To delete all the samples contained in a given rack, select the Rack from the
“Positions” pull-down menu, then click on “Delete Rack” (this option is not activated if the
operator chooses a rack that the instrument is running at the time). The following visual text
information message/dialog box will appear:

Click on “Yes” to confirm the deletion of the Rack; click on

“No” to annul the request and exit.

Exit
To Exit the Work List mask and return to the System Monitor main screen, click
on “Exit”.

Controls in the Samples Racks

A Control in the Samples Rack can be programmed under the Work List mask. To access the Work
List mask, the operator must first select Routine from the Menu and then, from the options offered,
click on Work List.
This mask allows the operator not only to set-up the Controls, but also to program the patients and
their respective Tests (as described in the section dedicated to the Work List). When opened, the
mask will appear, structure-wise, as illustrated in the section dedicated to the Work List.
Whenever this mask is used for programming a Control, it will appear structurally identical to that
illustrated under the Work List section but certain fields will be deactivated. Therefore, the mask
will appear to the user as pictured below:

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Following is a more detailed description of the sections of the mask necessary for programming
Controls:
An area in the left-hand portion of the mask dedicated to the selection of the Racks and the
positioning of the Controls in the Racks;
An area in the central, right-hand portion of the mask dedicated to setting-up the Control and
the relative Methods;
An area in the bottom portion of the mask containing those buttons necessary for the various
management operations concerning the mask.
All the fields contained in the above-described areas maintain the same structure and function as
reported in the Samples Programming description (Work List).

Programming a Control

Select the required Rack (“Positions” area) and a position in that Rack for the Control. From the
Type field’s pull-down menu (central area of the mask, as illustrated here to the right), click on
“Control” and the above-illustrated mask will automatically appear.

Fill out the “Sample” card – the Patient ID must be here-inserted as it is mandatory data – then
click on “Name” (n. b.: in this particular case, the “Name” field allows the user to open a pull-down
menu listing the various controls). Select the required Control.

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The program will automatically view in the Methods card only those methods that in the
programming of the Control were assigned to the selected control and are currently configured in
the Reagents Plate.

The operator must, at this point, “Check” (√), in the Methods card, all those Tests that he/she wishes
to set-up the control on. It is not possible to select a Profile or insert a Ratio in the programming of a
Control. In fact, the two areas dedicated to these tests are not activated.

If the operator selects an unassigned position, the program will automatically propose the first
available Sample ID to the user to be inserted in the Sample Card. If an already assigned position is
selected by the user, then the operator must be careful when choosing the Sample ID, so as to not
assign one already in use.

To confirm, click on “Save”, which will be activated only after a Method has been selected.

If the operator wishes to save the data inserted for carrying out Control(s), or delete an entire Rack
or a single sample, he/she must use the buttons located in the lower portion of the mask. These
operations are described in detail in the Work List section.

RESULT BY PATIENT
To access the Result by Patient mask, first select the Routine Menu and then, from the options
listed, click on Result by Patient.
This mask allows to the operator the report(s) print-out and the Work List print-out for sample racks
preparation.
Furthermore in this mask are showed all that data regarding the patients as inserted in the Work
List Programming mask and also more specific data concerning the tests carried out or to be
executed.
This is provided in two areas:

a Main Area located in the upper portion of the mask - below is an illustration. This mask
contains all the pertinent fields needed by the operator in order to correctly identify the
sample.

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The window contains the following fields:

! :indicates STAT sample

Rack/Pos: indicates the Rack number and position in the rack used for that sample;

Type: indicated the type of sample used;

Sample Dilution: indicates the Dilution ratio used for the serum;

Sample ID: allows the operator to view the sample identification number;

Patient ID: allows the operator to view the patient identification number;

This section also contains specific personal data regarding the patient, such as that shown in the
fields entitled: Name, Sex, Birth date (please see the section: Work List).

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Reorder the viewed data (Order button);

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- Print the selected data – reports/work list (Print button);

- Repeat the selected samples (Rerun button);

- File the selected samples in the Archive (Move to Database button);

- Send the data to the remote computer (Unload button)

(Please see the section: Command Buttons)

a Details Area located in the lower portion of the mask. Below is an illustration of this
Details Area which contains specific, itemized information regarding each of the fields
contained in the Main Area.

Whenever a row in the Main Area is selected by the operator, the relative Details Area will
automatically appear providing all that specific data concerning the row selected.

Herein will be shown: the Tests performed, the Pre-dilution, the Dilution, the Result, the Unit of
Measurement used, and the Normal Values for that test.

Special attention should be paid to that column entitled Flags, as it lists any errors encountered
during operation. Whenever an error occurs, all those fields regarding that test are automatically
shown coloured red. In this case, a small red square (‚) appears in the Flags field. If the operator
passes over this symbol with the mouse, a visual text message will appear indicating the name of
the error encountered. In this window, as in many others, errors are signaled using letters which
stand for the type of error encountered – as reported in Result Flags description.

The last column in this Details Area is the Date column which gives the date the test was either
carried out or edited. If the test has not as of yet been carried out (pending), then this field will show
the date and exact time that the sample was accepted.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

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- Make validated the results of selected data (Check button);

- Reorder the viewed data (Order button);

- Print the selected data – reports/work list (Print button);

- Repeat the selected tests (Rerun button);

- Modify the results of the selected test (Edit button)

(Please see the section: Command Buttons)

PRINTING DATA

In order to print the data viewed in this mask, the operator must first select the row or rows
to be printed and then click on the Print button located on the Desk Top. The below- illustrated
dialog box will appear, asking if the operator wishes to print reports or work list. Work list print-out
can be useful to the operator in order to prepare the sample racks.

If the operator clicks on “YES”, only the report of the selected row(s) will be printed; if instead
he/she clicks on “NO”, the entire list of the selected patients will be printed for sample racks
preparation. Clicking on “Cancel” will annul the Print request. Likewise, the “Cancel” button that
appears during printing allows the operator to stop the printing process even while it is underway.

Result by Test
To access the Result by test mask, first select the Routine Menu and then, from the options listed,
click on Result by Test. The above-cited List will automatically be opened for viewing.

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This mask allows the operator to view all that data regarding the patients as inserted in the Work
List Programming mask and more specific data concerning the tests carried out. Said information is
provided in a single “Main Area” which contains all the pertinent fields.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Make validated the results of selected data (Check button);

- Reorder the viewed data (Order button);

- Print the selected data (Print button);

- View the absorbance graph of the selected test (Graph button);

- Repeat the selected tests (Rerun button);

- Modify the results of the selected test (Edit button).

(Please see the section: Command Buttons)

MAIN AREA
Located in the upper portion of the mask and illustrated below, this section contains all that data
regarding the carrying out of the samples testing.

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The following fields of the above-illustrated window are worthy of mention:

! :indicates STAT sample

Pos.: indicates the Rack number and position in the rack used for that sample;

Type: indicated the type of sample used;

Sample Dilution: indicates the Dilution ratio of the sample;

Sample ID: indicates the Sample Identification number (please see the section: Work List);

Name: indicates the name of the patient whose sample is being tested;

Test: indicates the name of the method(s) applied;

Test Dil.: provides the operator with information regarding the dilution of the sample for that
specific test (e.g.: 1:5 rerunning with dilution);

Results: indicates the obtained result(s);

Unit: indicates the unit of measurement used;

Flags: this field allows the operator to view if any errors occurred during operation.

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Whenever an error occurs, all those fields regarding that test are automatically shown colored red.
In this case, a small red square (‚) appears in the Flags field. If the operator passes over this symbol
with the mouse, a visual text message will appear indicating the full name of the error encountered.
In this window, as in many others, errors are signaled using letters which stand for the type of error
encountered – as reported in Result Flags description.

PRECISION CHECK
This mask allows the operator to check exactly how precise the results of a given test(s) are along
with their level of precision. To carry out this check, the operator must first select, in the Main Area,
the row(s) to be checked and right click with the mouse. (If the operator selects more than one row
for the Precision Check and these rows contain different tests, the check will be performed only on
the first test selected and any other of the same type test contained in the other rows selected; all
dissimilar test types will be automatically ignored.) At this point, the system will automatically
activate the visualization of the “Precision” command. Clicking on this button will open the below-
illustrated “Precision Check” window.

The “Precision Check” window contains the following useful information:

Test Name: indicates the name of the test to be checked. In the example window, the name of the
test is bib;
Total Tests: indicates how many tests of the indicated test-name are included in the rows the
operator has selected to be checked. In this example window, there are 32 bib tests to be checked;
Mean: indicates the mean value of the results of the 32 tests checked;
STD Deviation and CV%: indicate the Standard Deviation and Coefficient of Variation of the
checked tests.

To exit the “Precision Check” window, click on Exit.

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CALIBRATION & QUALITY CONTROL SETUP

In order to guarantee that the instrument provide reliable test results, correct and precise calibration
must be performed. This operation is carried out, for those tests for which it is required, and it must
necessarily be carried out by the operator whenever the instrument is first installed. Calibration can
then be either periodic or whenever required by factors external to the instrument itself, such as
reagent substitution. It may also be necessary to repeat calibration in the event that an instrument
part, concerning the analytical module, is replaced (photometer lamp, dilutor module, etc.)

Prior to any calibration, it is mandatory that both controls and standards for the relative methods
be correctly programmed.
To access the Calibration & Quality Control Setup mask, first select the Routine Menu and
then, from the options listed, click on “Calibration & Quality Control Setup”.

The above-illustrated window includes a central area dedicated to the selection of those tests for
which the operator can request an RBL, a calibration and/or a controls running.

The first column reports, in alphabetical order, the methods programmed in the currently-in-use reagents
configuration. The other columns concern the following fields:

Run: automatically checked (“√”) whenever either the RBL or the calibration is expired. This field
can be activated or deactivated (checked “√” or “un-checked”) by the operator;

RBL: automatically checked (“√”) whenever the RBL must be run for the first time, or when it is
expired;

RBL Expiration: number of days left before the RBL expires. For example: a “6” indicates that the
RBL is valid for another six days. Furthermore, the RBL is automatically scheduled to be run at the
end of said period. A “–3” indicates that the RBL expired three days ago. If the RBL has already
expired (past its expiration date), this number will be a negative number and will be shown in red. A
small, red square (‚) will be viewed next to this negative number.

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Placing the mouse pointer over this symbol will cause a visual text message to appear informing the
user of the date that the RBL is programmed to be run. Please note that the operator can decide the
RBL validity period by setting said value in the “RBL stability (# of days)” field in the “Methods”
mask;

Calibrators: this column contains the name of the Standard preceded by a number in parenthesis
indicating the relative number of points (in the case of a Master Standard, this number is preceded
by a % symbol, as reported in Standard), or by the symbol “-” if there are no Standards to calibrate.
Whenever a Standard is selected, both the Run and the RBL fields are automatically checked (“√”).
However, they can be “un-checked” by the operator if he/she does not wish to have the calibration
run on these two fields. The number and the name of the Standard are shown in Blue, if they are
still to be calibrated, or in Black if already assigned to calibration;

Warning: expired standard will not be shown.

Calibration Expiration: number of days left before the Calibration expires. For example: a “10”
indicates that the calibration is valid for another ten days. Furthermore, the calibration is
automatically scheduled to be run at the end of said period. A “–5” indicates that the calibration
expired five days ago. If the calibration has already expired (past its expiration date), this number
will be a negative number and will be shown in red. A small, red square (‚) will be viewed next to
this negative number. Placing the mouse pointer over this symbol will cause a visual text message
to appear informing the user of the date that the calibration is programmed to be run;

Please note that the operator can decide, for each test, a calibration validity period by setting said
value in the “Calibration Stability (# of days)” field in the “Methods” mask.

Controls: a check mark will automatically appear for those controls programmed in the currently-
in-use reagents configuration. This field can be activated or deactivated (checked “√” or “un-
checked”) by the operator.

Warning: expired Controls will not be shown.

An “Assign/Check” button is located in the lower portion of the mask. This allows
the operator to assign positions to the Standards and the Controls in the Calibration
rack.

Calibration Request

Whenever the operator clicks on Assign/Check, a Calibration Request

visual text message will appear within this same area informing the user of the number of
operations already assigned.

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In the left-hand portion of the calibration programming mask, the

operator can view the rack containing the standards and controls, whose positions will be assigned
using the Assign/Check button. The rack has 12 positions; the 12th is by instrument specifications
reserved for distilled water to be used for carrying out the RBL. The running of the controls can be
confirmed by the operator by either checking or not the relative boxes.

Controls in the Reagents Racks

Here reported to the left is an illustration of the area of the mask where
the Controls inserted in the calibration and positioned in the reagents
tray under reagents programming, can be viewed by the operator.

Automatic rerunning of the Controls

This paragraph is dedicated to those Controls which the user wishes to rerun after a given interval.
A continuous rerunning of a Control can be useful whenever relatively unstable or extremely
sensitive solutions are tested. In these cases the operator may find it useful to run a given control at
determined intervals in order to verify the reliability of the results.

The automatic rerunning of the controls must be programmed in the Methods Programming mask
under the Parameters menu.

The system automatically processes the Control whenever the latter has been calibrated, into the
used Reagent Configuration, and the method being run requires that particular Control.
A rerunning of the Control will be automatic every time the system runs a test belonging to a
control which is listed as expired.

CALIBRATION PROGRAMMING
To correctly carry out this procedure, first make sure that the automatic selection of the items in the
Calibration table has been carried out correctly. Make any necessary changes and then click on
“Assign/Check”. This activates that procedure which assigns the position of the Standards and the
Controls in the Calibration rack.

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When the assign procedure is successful, the following visual text message will appear informing
the user of the number of operations programmed.

Warning! It is not possible to carry out this “Assign” procedure for already assigned Standards
or for expired calibrators. If Standards having dilutions are assigned to calibration, the operator
must first make sure that there is enough liquid, in terms of volume, to carry out the operation set-
up. He/she must also ascertain that the concentration percentage of the Master Standards is not too
low with respect to the predilution volumes set-up in the Methods programming mask. If either of
these two situations occurs, the program will inform the operator using a visual text message
coloured red when he/she attempts to assign Standards to calibration. Moreover, no procedure will
be carried out for that Standard.

The Master Standards occupy only a single position, regardless of the points contained, while the
Standards occupy all those positions previously declared in the programming mask.

To confirm calibration, click on “OK”. This button is activated only after positions
have been assigned. Clicking on “OK” automatically closes the viewed window.

If the operator returns to the Calibration mask, after having confirmed the above-explained
operation by clicking on “OK”, the following visual text information message will appear:
CALIBRATION PENDING! – informing the user that a programmed calibration already exists.
At this point, the names of the Standards and of the Controls in the Calibration rack and in the
Calibration table are no longer coloured blue, but rather they appear coloured black to attest to the
fact that they have already been programmed.

The operator can, if he/she so desires, print a list of those items assigned to calibration. To do so,
first select those items to be printed from the Reagents Volume List in the Checks menu, and then
proceed as for any other Print request.

EDITING CALIBRATION

Even after having programmed a calibration, it is still possible to add RBL,

Standards and Controls not previously requested – as long as there are still free
positions left in the STD/CTRL Positions rack. However, it is not possible to
remove elements from an already programmed calibration. It is only possible to
completely cancel the entire already programmed calibration by using the “Delete
Pending” button, which is activated only when there is a calibration pending

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If the operator clicks on this button, the following visual text message will appear:

If the operator clicks on “Yes”, the cancellation of the pending calibration(s) is confirmed, and the
calibration is no longer valid. By clicking on “No” the operator can annul his/her request to cancel
any pending calibration.

The “Exit” button allows the operator to close the Calibration and Quality
Control programming mask and to return to the main mask: System Monitor.

CALIBRATION RESULTS
To access the Calibration Results mask, first select the Routine Menu and then, from the options
listed, click on Calibration Results.

The operator can here – please see the Calibration Results mask illustrated below – view the results
of the calibration and all the pertinent associated data. This window is divided into two sections, a
Main Area and a Details Area, in order to facilitate user access and comprehension.

• the Main Area is located in the upper portion of the screen and contains all the fields regarding
calibration results;

• the Details Area is located in the lower portion of the screen and contains specific, itemized
information regarding the calibration data of the individual test.

This mask also contains buttons which allow the user to move on to other applications or carry out
other procedures.

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Main Area

The following fields are included in this window:

Test Name: indicates the name of the method;

RBL Days: indicates the number of days since the last RBL was carried out. A small symbol - (■)
– indicates the presence of a message to be read by the operator. This visual text message can be
accessed by pointing the mouse at said symbol (please see the section: Calibration – RBL
Expiration);

Flags: informs the operator if any errors occurred during the running of the RBL. In this section
the Flags field is viewed twice more, indicating if the error has occurred during the running of the
Standard and/or during the reading of the controls. Whenever an error occurs, all those fields
regarding that item are automatically shown coloured red. In this case, errors are signalled using
letters which stand for the type of error encountered – as reported in Result Flags description;

D: indicates, by using either the number 1 or 2, the first or second row of data referring to either
differential or bichromatic methods;

Abs: here the user can view the optical density values obtained for the RBL. The Abs field is
shown a second time in this mask in order to report the optical density values obtained from the
standards. In the event of replicates (from 2 to 4) the program will automatically calculate the
average of the valid readings and in case of 3 or 4 replicates will eliminate the reading furthest from
the average. The mean value obtained will then be reported in this field. The absorbance values of
the replicates can be viewed in the Details area where the operator can also consult the graph;

Rate: represents reagent mobility during the reaction time expressed in absorbance;

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STD days: indicates the number of days since the last calibration was carried out. A small symbol -
(■) – indicates calibration execution date, pointing the mouse at said symbol (please see the section:
Calibration – STD Expiration);

Refer.: indicates the concentration of the Standard utilized (in the event of multi-point calibration,
more than one reference value will appear);

CV %: indicates the coefficient of variation percentage among replicates of the standard considered
valid with respect to the mean;

Factor: indicates the calibration factor;

Result: indicates the results obtained for the control;

Mean: indicates the mean value of the control;

Reference: indicates the range considered normal for that control.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures.

- Print the selected data (Print button);

- Modify the results of the Optical density of the standard (Edit button).

(Please see the section: Command Buttons).

Details Area

Located in the lower portion of the mask, the Details Area can be viewed by the operator as
illustrated above. If there are RBLs, Standards or Controls programmed for calibration and already
being carried out, they can be viewed at the beginning of this area and are highlighted by a yellow
background.
Once calibration has been carried out, this area allows the operator to view the details of the results
regarding the method selected in the Main Area. The most important fields are the following:

Type: indicates the type of operation requested (RBL, STD or Control);

Pos.: indicates the position occupied within the STD/CTRL rack;

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Name: indicates the name of the standard or control;

Lot: indicates the lot number assigned to that standard or control;

Abs: indicates the Optical density obtained;

Ref/Res.: indicates the results obtained for the control or the reference value for the standards;

Unit: indicates the measurement unit used for that method;

Factor: indicates the calibration factor;

Flags: this field allows the operator to view if any errors occurred during operation (please see the
Result Flags description). Whenever an error occurs a character with a small red square (■) appear
in the Flags field. If the operator passes over this symbol with the mouse, a visual text message will
appear indicating the full name of the error encountered;

Date: allows the operator to view the date in which the RBL/STD/CTR was carried out;

Time: allows the operator to view the exact time the RBL/STD/CTR was carried out.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Print the selected data (Print button);

- View the absorbance graph of the selected test (Graph button);

- Repeat the selected tests (Rerun button).

(Please see the section: Command Buttons).

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Calibration Curve

This window graphically illustrates the results of those operations carried out under the “Start
Work” mask, after clicking on the “Calibration” option.

To access the Edit Calibration Curve mask, select the required Standard
(containing results) from the Main Area of the Calibration Results list and click on the Edit
button, located on the Desk Top.

This mask contains a graphic illustration of the results of the Calibration operations plus those fields
that allow the user to view the mathematical procedure used for calculating the results of the
calibration curve. The Name of the Standard and the Date in which the calibration was carried out
can be viewed in the heading of the mask.

This window is divided into two sections, a Main Area and a Details Area, in order to facilitate
user access and comprehension. This mask also contains, in the lower portion of the window,
buttons which allow the user to carry out the necessary procedures.

Main Area
The Main Area of this mask is dedicated to a Graph of the indicated standard. The information
provided in this area is organized in such a manner as to be easily accessible and user friendly.
Furthermore, it provides the operator with all that data necessary for a proper understanding of the
calibration process underway. Here, the user can view a graphic representation of the Curve,
including all its readings, regarding the Standard selected in the Calibration Results mask. The
equation used for calculating the data is provided at the top-center of the Graph. The ordinate axis
shows data regarding Optical Density; and the abscissa, data concerning Concentration.

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Details Area

Located in the lower area of this same mask, the Details Area contains a table in the left-hand
portion, reporting data necessary for viewing the graph in the Main Area. For each point declared
for that given Standard, said table contains the values of the following items, organized in columns:

Reference: indicates the reference value of the concentration as set-up by the user for that Standard
in the Standards mask;

O.D. (abs): provides the value of the read Optical Density;

CV %: indicates the coefficient of variation percentage among replicates of the standards

considered valid with respect to the mean;

Flags: this field allows the operator to view if any errors occurred during calibration. Errors are
signaled using letters which stand for the type of error encountered – as reported in Result Flags
description;

Recalculated: indicates the new value obtained with relation to the type of calculation algorithm;

% Error: allows the user to view the % of error found. Or rather, it indicates, in percentage form,
the gap between the value set-up by the operator in the Reference field and that given in the
Recalculated field;

Absolute Error: indicates the absolute error obtained between the value set-up by the operator in
the Reference field and that shown in the Recalculated field;

• The following fields are listed, to the right of the above-described table:

Calculation Model: this field contains a pull-down menu offering the various calculation types
available for the Standard;

Factor: this field is activated only for test that have been declared against factor;

STD. Dev.: contains values that indicate the deviation of the curve with respect to the points of that
Standard (lower values mean best Calculation Model);

Absorbance: the operator can insert in this field an Optical Density value in order to verify and
check the concentration that would be obtained based on the curve had using the Recalculate
button;

Recalculate: this button allows the operator to edit the calibration data obtained;

Result (mg/l): shows the result of a new recalculation. This value will be represented by a red circle
in the graph illustrated in the Main Area.

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Recalculating the concentration

If, after calibration, the operator believes that anomalies may have occurred or
Recalculate
that the calculation model previously set-up in the Methods mask does not
truly satisfy the reaction, he/she can have the instrument perform a new
calculation on the concentration of the Standard.

The user can, in this mask, based on the points contained in the Standard, insert values in the O. D.
(abs) field; select a calculation model deemed appropriate from the Calculation Model pull-down
menu and insert, if the selected calculation so requires, values in the other fields of the Details Area.
Please note that this will automatically cause the program to signal an E in the Flags field.

The Factor field is activated only for those methods defined against-factor in the Calculation
Model field. Here, the user should insert those values needed for calculating the concentration.

Once the Factor calculation has been selected and the data saved, it is no longer possible to change
the model. This is because when the data is saved, all the points the Standard curve not involved in
the calculation operation are automatically zeroed. Click on Recalculate, located in the lower-left
portion of the mask under the table, to run the concentration calculation.

If the data inserted in the fields are not correct, as can happen in the O. D. (abs) field, and the
resulting curve is different from the considered Standard, the program will automatically allow the
operator to view, in the graph illustrated in the Main Area, those points of the Standard which do
not coincide with the entire curve. Moreover, the following visual text message will appear in the
upper portion of the mask:
“CALCULATION ERROR”

Deleting a point from a Standard

Delete
Delete To delete a point in a Standard curve, first select the required point from the table
containing all the points of the Standards curve and then click on “Delete”, located
in the lower portion of the mask, in that area dedicated to the various buttons. The
instrument will automatically open a visual text message dialog box requesting
confirmation of the delete procedure. If the user clicks on “Yes”, the point will be
deleted from the Standard curve. If he/she clicks on “No”, the delete procedure will
be annulled.

Save
Save In order to memorize and, therefore, utilize the settings programmed in this mask, the
user must click on “Save”, located in the lower portion of the mask.

Printing Data

The operator can print the graph and the data contained in the Calibration Curve
Print
mask by clicking on the “Print” button. This button is deactivated while editing is
being carried out, but is automatically reactivated once the edited data has been
memorized by clicking on “Save”.

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QUALITY CONTROL RESULTS

To access the Quality Control Results mask, first select the Routine Menu and then, from the
options listed, click on “Quality Control Results”.

This mask allows the operator to view all that data regarding the methods and their relative controls
in order to make sure that all relative constraints have been satisfied and necessary conditions met
(e.g.: that each test have at least one control).
This Quality Control Results mask is divided into two sections, a Main Area and a Details Area,
in order to facilitate user access and comprehension:
• the Main Area is located in the upper portion of the screen;
• the Details Area is located in the lower portion of the screen.

Main Area

The above-illustrated window contains, from left to right, the following fields:
Test Name: the name of the method (its acronym);
Control Name: the name of the control regarding that particular test;
Lot: indicates the Lot Number of the control;
Ref. Min.: indicates the minimum reference value;
Ref. Max.: indicates the maximum reference value;
Unit: indicates the unit of measurement used;
Exp. Date: indicates the expiration date of the control (please see the section: Controls –
Programming).
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The mask also contains buttons which allow the operator to move on to other applications.

Details Area

Whenever a row in the Main Area is selected by the operator, the relative Details Area will
automatically appear, providing all that specific data concerning the row selected.

The following fields are contained herein:

Type: the acronym “CTRL” (control) is listed here;

Pos.: indicates the position occupied by that control;

Flags: this field allows the operator to view if any errors occurred during operation (please see the
Result Flags description). Whenever an error occurs a character with a small red square (■) appear
in the Flags field. If the operator passes over this symbol with the mouse, a visual text message will
appear indicating the full name of the error encountered;

Optical Density, Concentration, and Unit are also listed, followed by Date and Time: each
column contains information relative to that heading selected.
This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Print the selected data (Print button);

- View the absorbance graph of the selected test (Graph button).

(Please see the section: Command Buttons)

Deleting (a) Control(s)

The operator can, if he/she so desires, delete the results of the Quality Control. First, select the
result to be deleted and then right click with the mouse.

The menu, “Delete the Selected Control(s)”, here-

illustrated to the left, will automatically appear. Clicking
on this option will immediately cause the program to
delete all those controls selected in the Details Area.

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QUALITY CONTROL GRAPHS

The Quality Control Graphs mask allows the operator to view two graphs. Following is
an illustration of the two:

The first concerns the Graph of the Optical Density relative to the reading times for results
contained in the rows of the Details Area. The user need simply select the row in the Details Area
containing the results he/she is interested in and then either double click with the mouse or click on
the “Graph” button located on the Desk Top.
This Graph button is activated only when the Details Area contains at least one row of data.

To exit the graph and return to the Quality Control Results mask, click on “Exit”.

The second graph – following is an illustration – reports, in the uppermost area, the name of the
Control, the name of the Test and the month in which it was carried out.
The operator must first select the required row in the Main Area and at least two rows in the
Details Area, and then click on the “Graph” button located on the Desk Top.

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On the left-hand side of the Graph, the operator can view the standard deviations (from –3SD to
+3SD) and on the right-hand side, their relative concentration value.
A red line represents the mean value obtained with respect to the expected mean value.
At the bottom of the Graph, the user can read the total number of controls viewed, the mean
concentration value, the standard deviation and the coefficient of variation percentage obtained.

The operator can print the graph by clicking on the “Print” button located in the lower, left-hand
corner of the mask.
Please note that the graph is monthly and therefore, the print-out will be month by month.

To close the graph mask, click on “Exit”, located in the lower, right-hand corner of the mask.

RECEIVE FROM HOST

The last item on the Routine Menu is “Receive from Host”.
This command allows the operator to activate and receive data transmission from the Host.
However, this item is not automatically viewed under this Menu. In order to view said item, the user
must first select the “Host Connection” option inside the Options mask.
To activate data transmission, click on the above-cited command: the connection is automatic.
For further information regarding data transmission, see the paragraph entitled Host –
Communication.

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3.4 ARCHIVE

The term Archive indicates the entire set of all those masks which provide the
operator with a complete and total overview, necessary for managing both the exams and their
results. These masks allow the user to view all the filed data and also describe simply, yet
thoroughly, both the “Backup” and “Restore” operations. These two operations can be used only
with this program – they are not compatible with any other analyzer.

Each set of data, specific to its own topic, has its own mask. Following is a list of the included
masks:
Patients: this mask includes the results of those tests run on the patient samples as set-up in the
programming mask Work List and contained in the Archive;

Calibration: here the operator can view all the calibrations run;

Backup: this mask is necessary in order to be able to make a copy of the Patients onto a floppy
disk. Here, the user can select those results to be copied;

Restore: allows the user to replace data back into the Archive from a floppy disk;

Tests Counter: allows the operator to view the total number of tests carried out, subdivided into
groups (RBL, STD, CTRL and Samples);

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Event Log: this mask records any and all anomalous events involving instrument status.

PATIENTS
To access the Patients mask (illustrated below), select Archive from the Menu and then click on
“Patients”. The following window will automatically open:

This mask allows the operator to search for Patients in the “Archive – Patients” mask by inserting
the relevant search criteria data into the given fields.

For example: if the user inserts as the search criteria data in the “from date” and the “to date”
fields, the program will pull up and view in the Work List, all those patients contained in the
Archive and filed between those two dates.

To confirm a selection criterion, click on OK. To annul the selection and request that no operation
be carried out, click on Exit.

This mask allows the operator to view the results of the tests run along with personal data regarding
the patients as inserted in the Work List programming mask and contained in the Archive -
Patients. The results of the operations, together with data regarding the samples of those patients
inserted in the Work List are here-given into two sections, a Main Area and a Details Area, in order
to facilitate user access and comprehension.
• the Main Area is located in the upper portion of the screen and contains all the fields regarding
patient data and a description of the sample;
• the Details Area is located in the lower portion of the screen and is dedicated to more specific,
itemized information, in particular to the results of the given operation.

MAIN AREA
Located in the upper portion of the mask, below is an illustration of the Main Area window as seen
by the operator:

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Following is a list and relative description of those fields contained in this area of the mask:

Rack and Cup: indicates the number of the Rack and the position in that Rack of the given sample;

Type: indicates the type of sample used;

Sample Dilution: allows the operator to view the predilution ratio;

Sample ID: indicates the sample’s identification number;

Patient ID: indicates the patient’s identification number;

Name: allows the operator to view the name of the patient;

Sex and Birth date : indicates the sex and date of birth of the patient.
This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Reorder the viewed data (Order button);

- Print the selected data – reports/work list (Print button);

(Please see the section: Command Buttons)

DETAILS AREA
Located in the lower portion of the mask, the Details Area contains specific, itemized information
regarding the row selected in the Main Area. Below is an illustration:

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Following is a list and relative description of those field contained in this area of the mask:

Test: indicates the name of the test carried out;

Predilution and Dilution: indicate the predilution and the dilution ratio of the involved sample;

Results: allows the operator to view the results obtained;

Unit: indicates the measurement unit used for that test, as set-up in the methods parameters;

Normal Values: allows the operator to view the normal range of values for the performed test;

Flags: this field allows the operator to view if any errors occurred during operation (please see the
Result Flags description). Whenever an error occurs a character with a small red square (■) appear
in the Flags field. If the operator passes over this symbol with the mouse, a visual text message will
appear indicating the full name of the error encountered;

Date: indicates the date and exact time of day in which the test was run.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Reorder the viewed data (Order button);

- Print the selected data (Print button);

- View the absorbance graph of the selected test (Graph button);

(Please see the section: Command Buttons)

CALIBRATION
To access the Calibration mask (illustrated below), select Archive from the Menu and then click
on Calibration. The following window will automatically open:

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This mask allows the operator to insert date and then request that the program search for a
Calibration previously carried out.

For example: if the user inserts as the search criteria data in the “from date” and the “to date”
fields, the program will pull up and view all the calibrations contained in the Archive –
Calibration List filed between those two dates.
To confirm a selection criterion, click on OK. To annul the selection and request that no operation
be carried out, click on Exit.

This Archive – Calibration window allows the operator to view the results of the procedures
previously carried out and programmed in the Calibration preparation mask.
The results of the operations and filed data are here given.

The Calibration window is divided into two sections, a Main Area and a Details Area, in order to
facilitate user access and comprehension.

• the Main Area is located in the upper portion of the screen and contain all the fields regarding
calibration.

• the Details Area is located in the lower portion of the screen and contains specific, itemized
information.

MAIN AREA
Located in the upper portion of the mask, below is an illustration of the Main Area window as seen
by the operator.

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Following is an explanation of the contained fields:

Test: indicates the name of the test carried out;

Total: indicates the total number of tests run for the Calibration procedure and for the Analyzer
check, as filed in the Archive;

RBL: allows the user to view the number of RBLs carried out for each test and filed in the Archive;

Std: indicates the number of Standards run for each test and filed in the Archive;

Ctrl: allows the operator to view the number of Controls run for each test and filed in the Archive;

First Date and Last Date: indicates the time-window relative to the data contained in the database,
for each test.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Reorder the viewed data (Order button);

- Print the selected data (Print button);

(Please see the section: Command Buttons.)

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DETAILS AREA
Located in the lower portion of the mask, the Details Area contains specific, itemized information
regarding each of the fields selected in the Main Area.

Following is an explanation of the contained fields:

Type: indicates the type of item considered;

Pos: indicates the position occupied by that item within the rack dedicated to calibration;

Name: allows the operator to view the name of that item;

Lot: indicates the lot number assigned to that item;

Abs: indicates the Optical density measured;

Ref./Res.: gives the reference value for the standards and the result obtained for the controls;

Unit: indicates the measurement unit used;

Factor: indicates the factor resulting from the calibration procedure regarding that given test;

Flags: this field allows the operator to view if any errors occurred during operation (please see the
Result Flags description). Whenever an error occurs a character with a small red square (■) appear
in the Flags field. If the operator passes over this symbol with the mouse, a visual text message will
appear indicating the full name of the error encountered;

Date: indicates the date in which the operation was carried out.

Time: indicates the time in which the operation was carried out.

This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Reorder the viewed data (Order button);

- Print the selected data (Print button);

- View the absorbance graph of the selected test (Graph button);

(Please see the section: Command Buttons)

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BACKUP

To access the Backup mask, select Archive from the Menu, and then, from the options listed, click
on Backup. This mask, as illustrated here above, allows the operator to make a copy of the data
contained in the Archive. Said data is copied onto a floppy disk and can be saved for future
reference or reinserted in (re-copied back into) the Archive at a later date (please see the Archive –
Restore description).
The Backup mask is quite simple – a detailed description follows:

Month to backup: a pull-down menu containing a list of all the months of the year – data is
organized by the program under monthly headings and is therefore filed, stored and shown, when
requested, in this manner. By selecting a given month, the operator can view all that data pertaining
to that requested time interval.

Automatic Deletion: this is a “check” ( ) field. If the operator clicks on and therefore “checks”
( ) this field, the program will automatically delete/cancel the data from the Archive at the same
time it carries out the Backup procedure - i.e.: copies it onto the floppy.
The central area of this mask contains the fields that allow the operator to view the total number of
patients and results which have been copied onto the floppy. If the Auto Delete field has been
activated (“checked” – “ ”), this area will also indicate the total number of results eliminated.
The mask also contains two buttons for performing the following two operations.

Performing Backup
OK Select the month containing those results to be copied from the pull-down menu:
Month to backup. If the user wishes to eliminate these results from the Archive at the same time
they are copied onto the floppy, he/she need only click on the Automatic Delete window thereby
“checking” ( ) the relative field. At this point, click on “OK”, located in the lower, left-hand
corner of the window.
The user can monitor the Backup operation via a series of visual text messages provided by the
program regarding the copying of the data onto the floppy. In addition, these messages also serve as
a guide to the user.

ExitEXIT To exit the Backup mask and return to the System Monitor main screen, click on
“Exit”.

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RESTORE

To access the Restore mask, select Archive from

the Menu, and then, from the options listed, click on Restore. This mask, as illustrated here above,
allows the operator to recopy data back into the Archive. Said data are copied from the floppy, that

was previously used for performing a Backup, and are hereby reinserted into the program (under
Work List - Setup) where they can be accessed for reference and/or for performing various other
operations.
The Restore mask is quite similar to the Backup mask – a detailed description of the included
fields follows:

Read Disk

The upper, right-hand corner of this mask has a field where the user can view the data contained on
the floppy. This field is activated by clicking on Read Disk, located in the upper, left-hand corner
of the mask. Doing so opens a pull-down menu where the operator can choose the required month.
At this point the user can select the month and thereby view all the data contained in the floppy
regarding that selected time frame.
The central area of this mask contains those fields that allow the operator to view the total number
of patients and results which have been copied back from the floppy into the Archive - Patients. The
mask also contains two buttons for performing the following two operations.

Performing Restore
Read Disk
Use the Read Disk command to view all the data contained within the floppy. The contents of the
disk will automatically be viewed in the upper portion of the screen. Using the pull-down menu,
select the month that contains the required data that the operator wishes to recopy back into the
system’s Archive.

Clicking on “OK” will automatically cause the restore operation to be performed.

This button is located in the lower, left-hand portion of the mask.

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The user can monitor the Restore operation via a series of visual text messages provided by the
program regarding the copying of the data from the floppy back into the Archive. In addition, these
messages also serve as a guide to the user.

EXIT To exit the Restore mask and return to the System Monitor main screen, click on
“Exit”.

TESTS COUNTER

To access the Tests Counter mask, select Archive from the Menu and then, from the options listed,
click on Tests Counter.
The Tests Counter mask, as illustrated above, provides the user with information regarding all the
various operations. It presents the sum of all those tests carried out in the various operations.
Following is a description of the included fields.

Test: allows the operator to view the acronym used for the Test carried out;

Total: indicates how many times that particular test was carried out, in the various operations;

RBL: indicates how many RBLs (Reagent Blanks) were carried out for that specific test;

Std: allows the user to view the total number of Standards carried out for that particular test;

Ctrl: allows the user to view the total number of Controls carried out for that particular test;

Sample: indicates the number of unknown Samples carried out for that particular test;

First Date and Last Date: allow the operator to view the dates on which that particular test was
first and last run.

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This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedures:

- Reorder the viewed data (Order button);

- Print the selected data (Print button);

(Please see the section: Command Buttons).

EVENT LOG

To access the Event Log mask, select Archive from the Menu and then, from the options listed,
click on “Event Log”.

This window logs all those events/occurrences judged to be anomalies which are encountered
during instrument operation. Said anomalies can be either:

• Warning! – identified by a yellow triangle

• Fatal Error! – identified by a red ics (X) sign

This mask also contains the following fields:

A: allows the operator to view the type of anomaly encountered;

Description: provides the user with a brief description of the anomaly recorded;

Date: indicates date and exact time of the registered event.

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This mask also contains buttons which allow the user to move on to other applications or carry out
the following procedure:

- Print the selected data (Print button)

(Please see the section: Command Buttons).

3.5 PARAMETERS

The term Parameters indicates that mask in which system configuration is carried
out. Each set of parameters regarding a specific operation to be performed will have its own
programming mask where the operator can carry out a guided set-up. The Parameters Menu is
protected by a Password and cannot be viewed without its insertion.

It is not possible to access the Parameters Menu masks while the instrument is in operation.

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This is a self-protect mechanism aimed at avoiding any conflicts which may occur as a result of
changes made regarding parameters involved in the on-going operation and/or its results. Therefore,
the Parameters Menu is inactivated and effectively blocked during instrument test running.
Instructions follow:

INSERTING THE PASSWORD

Whenever Parameters is selected, the below illustrated Password mask will open. This mask
allows the operator to protect the programming masks from unauthorized viewing and/or
manipulation which could risk the integrity of the work carried out.

In order to view the various elements

contained under the Parameters Menu,
the user must correctly digit the valid
Password within the provided field
(maximum 10 letters – no numbers or
other symbols are allowed).

At this point, the user must click on

“OK”. The system will automatically close the Password mask and open a pull-down menu
containing the various included elements.

N. B.: the valid Password must be inserted in order to be able to access and/or insert
programming data within the individual masks which make up the Parameters Menu.

This mask contains the following fields:

Methods: indicates the screen where the methods along with their relative parameters are defined.
For further, more detailed information, please see Chapter 05 – Methods.

Profiles: this mask is dedicated to setting up the Profiles and the relative tests that they include;

Ratio: this mask concerns setting up the Ratios and their respective parameters;

Standards: the standards, along with the relative tests, are programmed in this screen;

Controls: this mask allows the user to program the controls and their relative tests;

Options: this mask allows the operator to define the system’s defaults options;

Print Order: this mask makes it possible for the user to decide the order in which the results of the
various analyses will be printed out, regardless of the order in which the tests were carried out;

Report Options: this mask is where the user can define the Header Text of the Report Print-out and
the error symbols that will be used therein;

Password Setting: this mask is necessary in order to be able to modify the current password.
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PROFILES

To access the Profiles mask, select Parameters from the Menu, insert the current password, and
then, from the options offered, click on “Profiles”.

This function makes it possible to program test profiles (predetermined groups of tests that are
programmed to be carried out together). There is no numerical limit to the number of profiles that
the user can define.

The left-hand area of this mask contains a list of all the already programmed and saved Profiles.
Whenever a Profile is selected from this area, the operator will view, in the central portion of the
window, the list of all the tests said Profile includes.

The central section of this mask is dedicated to the selection of the tests. Here, the operator can
view, in alphabetical order, all programmed tests and checked ( ) that are already part of existing
Profiles.

The lower portion of the screen includes those operative buttons necessary for carrying out the
following operations:

Adding a New Profile

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To create a new Profile, click on “Add Profile”. The following dialog box will automatically open.

Save Digit the name of the new Profile in the space provided for a Maximum of 12
characters. Confirm the operation by clicking on OK. The new Profile will now be viewed listed
along with the other pre-existing Profiles in the left-hand portion of the window. Select with check
( ) the tests to be included in the new profile and the click on “Save” to memorize the new data
and complete the programming operation.

Adding or Removing test(s) from a Profile

Save To edit the list of Tests which make up a Profile, select the required Profile from the
“Profiles” List. At this point, the Tests List will appear, allowing the operator to view all those tests
that are available; and among these, all those tests which currently make up the selected Profile will
appear checked ( ). Please see the illustration below:

The user, at this stage, need simply click on a yet, unchecked Test to check ( ) it and thereby
include it in the selected Profile, or click on an already checked Test, to uncheck it and thereby
remove it from the selected Profile. Click on “Save” to memorize and save the changes made.

Eliminating a Profile

Whenever the operator wishes to eliminate an entire Profile, he/she must first
select the required Profile from the Profiles List in the left-hand portion of the window, and then
click on “Delete Profile”. The following visual text warning message will appear:

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Click on “Yes” to confirm the elimination of the named Profile or on

“No” to annul the request and the operation.

Exit

EXIT To exit the Profiles mask and return to the main mask, System Monitor, click on
“Exit”.

RATIO

To access the Ratio Definition mask, select Parameters from the Menu, insert the current
password, and then, from the options offered, click on “Ratio”.

The mask that opens is dedicated to the programming of the Ratios and their respective parameters.
This function makes it possible for the operator to obtain more detailed information regarding the
mathematical calculations carried out, having available to him/her the results of the individual tests.
Said mask is divided into three areas:

• the section located in the upper portion of the mask contains the following fields:

Description: indicates the full name of the programmed ratio. This field can contain a Maximum
of 20 characters.

Unit: indicates the unit used for representing the values of the ratio;

Decimals: indicates how many decimal places are to be included in the ratio values, as reported in
the “Reference Values” Table and in the Print-out of the Patient’s Test Results. Said selection can

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be effectuated from the field’s pull-down menu (as illustrated here-below), by selecting from a
Minimum of 0 to a Maximum of 3;

LIS Code: indicates the acronym (maximum 6 characters) used for the serial data transmission of
the test;

Reference Range: in this same area, to the right, there is also a “Reference Range” table where
the reference values regarding the tests are given. They are divided into the following categories:
Low, Normal, High, according to the sex and age of the subject. Following is an illustration:

The values which are inserted for Male subjects are automatically entered into the Female and
Child category areas as predefined values. However, the operator can choose other values for these
two categories and insert them into the appropriate spaces provided by selecting that area and
inserting the desired values.

• The section that is located in the lower, left-hand portion of the mask is dedicated to the
calculation ratio and contains the following fields:

Calculation Model: indicates the operation set-up for test calculation as selected from the field’s
pull-down menu. This menu automatically appears whenever this field is selected and offers the
user five options. The operator can choose an operation containing: 2 elements, identified by the
letters A and B; 3 elements, identified by the letters A, B and C; or 4 elements, identified by the
letters A, B, C and D.

Expression: allows the user to view the programmed ratios. Please note that in this field the letters
viewed in the Calculation Model field are not seen and in their place the operator will find the LIS
Code of the selected Tests,

Other fields, regarding calculation of the tests, listed here-below, are indicated by the letters A, B, C
and D.

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These letters in fact, refer to the elements selected in the Calculation Model and include
multiplicative coefficient and the name of the test set-up for the calculation.

Whenever the user selects one of the four fields described in order to be able to set-up a test, upon
clicking, a pull-down menu will automatically open containing the names of the tests which can be
selected.

If no test has been selected for that field, this field is not activated and will appear coloured light
grey – the other activated fields will appear coloured blue.

• the section located in the lower, right-hand portion of the mask contains a list of the
programmed ratios and includes the operative buttons necessary for carrying out the
following operations:

Programming a new Ratio

Programming a new ratio includes declaring its name, using an acronym, and also defining it by
setting-up all the data relative to this new test.

Currently, there are five equations available for defining a mathematical relation between two or
more analyses. They are:

1. aX – bY
2. aX / bY
3. aX / (bY – cZ)
4. (aX + bY) – (cZ + dW)
5. aX – bY – (cZ / dW)

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These equations can be applied to many analytical relations. Following are some examples:

BUN/CRE RATIO aX / bY 1xBUN / 1xCRE

ALBUMIN/GLOBULIN RATIO aX / (bY – cZ) 1xALB / (1xPRO – 1xALB)
GLOBULIN aX – bY 1xPRO – 1xALB
INDIRECT BILIRUBIN aX – bY 1xBIT – 1xBID
LDL CHOLESTEROL aX – bY – (cZ/dW) 1xCHO–[(1xHDL–(0.2TRI)]
RISK INDEX aX / bY 1xCHO / 1xHDL
NON-PROSTATIC PHOSPHATASE aX – bY 1xACP – ACP Inhibit
AST/ALT RATIO aX / bY 1xAST / 1xALT
DIBUCAINE aX – bY – (cZ/dW) 100-0-(100DIB/CHE)
% HbA1C aX / bY 100 HbA1C/ HB

Adding a new Ratio

Click on “Add” in the Ratio Definition mask. The following New Test dialog
box window will automatically open:

The operator must digit, in the space provided, the name (an acronym) of the new ratio making sure
to use a maximum of 6 characters.
The user must be careful to not insert an acronym which is already in use, or rather, one which
corresponds to another listed test. If the acronym is already in use, when the operator clicks on
“OK”, the following visual text information message will appear:

At this point the user must: click on “OK”, change the name to be assigned to the new test and then
click once again on “OK”. At this point the new name will be accepted.

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Defining a Ratio
Save In order to correctly program a new test, the user must insert the settings for the
parameters in the fields of the previously discussed sections of the Ratio Definition mask. These
parameters can all be subsequently edited – with the exception of the acronym, which will remain
as set-up here.
Insert settings into those fields necessary; both in the case of a new method and in the event of
editing for already programmed tests. To memorize the data inserted, click on “Save”.

Deleting a Ratio

First select the required ratio from the list of Ratio in the Ratio Definition mask, and then click on
“Delete”. The following warning message dialog box will appear:

Click on “Yes” to confirm the elimination, or on “No” to cancel the Delete procedure and exit this
operation.

Printing Ratio
Print
First select the required ratio from the list of Ratio in the Ratio Definition window,
and then click on “Print”.

Exiting the Ratio Definition Mask

EXIT To exit the Ratio Definition mask and return to the main mask, System Monitor,
click on “Exit”.

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STANDARDS

To access the Calibrators mask, first select Parameters from the Menu, insert the current
password, and then, from the options offered, click on “Standards”.

This window is used to program the standards and their relative tests. It is divided into the
following three sections:

• an area located in the left-hand portion of the screen containing a list of the already
programmed Standards, provided in alphabetical order. Whenever the operator selects a standard
from the list, the tests therein contained along with their relative values will be viewed.

• an area located in the central portion of the screen, dedicated to setting-up the standards and
to the values of the individual tests. The upper portion of this area contains the following required
fields:

Lot Number: allows the user to view the Lot number of each individual standard;

Expiration Date: allows the user to view the expiration date set for the Standard.

Warning! Once the standard has expired, it will no longer be viewed.

Predilution: if this field is not activated, it means that the calibration curve is ready and diluted
according to the dilution ratio of the method. If this field is activated, it means that the calibration
curve is ready and undiluted – the instrument will apply to the standard the same dilution ratio as
that of the method (if there is one). For Master Standard, please see Chapter 06 – Multipoint
Calibration.

Diluent: Indicates the diluent type used

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The lower-most area of this section is dedicated to a table of the tests contained in the standards.
The rows in the table provide information regarding the various methods; while the columns
indicate the reference values.

• The lower area of the screen is dedicated to mask management. It is made up of the
operative buttons necessary for carrying out the required operations:

Inserting a new Standard

Inserting a standard includes both Adding a New Standard (declaring its name using an acronym)
and Defining the Standard by setting-up all the data relative to this New Standard to be Added.

Adding a New Standard

Click on “Add STD” in the Calibrators mask. The following Add Calibration
dialog box window will automatically open

where the operator must digit, in the spaces provided, the following information:

Name: the name of the new Standard (maximum 12 characters);

Lot Number: the lot number of the Standard (maximum 8 characters);

Expiration Date: the expiration date for the new Standard. When this mask first opens, this field
will contain the current date. However, the user can open a calendar by pressing F4 or double
clicking with the mouse, or can simply edit the date by digiting a new date in the place of that one
given. Warning! Once the standard has expired (i.e. after its programmed expiration date), it
will no longer be viewed.

Points: here, operator must specify the number of calibration points of the Standard – a value
between a Minimum of 1 and a Maximum of 8;

Master: the user must check ( ) this field in order to specify that the calibration points are
automatically produced by the system itself based on the Master Standard.
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To confirm the data set-up and therefore the adding of the New Standard, the user must click on
“OK” located in the Add New Standard mask. At this point, the new standard can be viewed
along with all the other, already programmed standards, in the standards list. Clicking on “Exit”
allows the operator to annul the entire operation.

Warning! The data set-up and inserted in this mask for the purpose of adding a new Standard
cannot be edited or modified in any way. To change any data, the user must necessarily eliminate
(delete) the required Standard.

Defining a Standard

Save

In order to correctly program a new Standard, the user must define both the tests (Please see the
section “Adding a Test or Tests”, further along in this text), and the concentrations relative to each
single point.

To memorize the data inserted regarding new Standards, or in the event of editing data for already
programmed Standards, click on “Save”.

If the below-illustrated visual text information message appears, it means that the “Save” button has
been clicked on without any editing of the already set-up data.

The user need only confirm, by clicking on “OK”.

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Deleting a Standard

First select the required standard from the list of Standards in the left-hand part of the
“Calibrators” mask, and then click on “Delete STD”.
The following warning message dialog box will appear:

Click on “Yes” to confirm the elimination or on “No” to cancel the Delete procedure.

Adding a Test or Tests to a Standard

First select the name of the Standard from the List of Standards in the Calibrators mask. Then click
on “Add Test(s)”. The below-illustrated Add Test(s) window will automatically open. This
window contains all those tests available for that particular Standard and not defined against-
factor. The methods shown are appropriate for the type of Standard selected; or rather: if the
Standard is a 1 point standard, only those tests defined as against-standard will be listed. If the
Standard required has 2 points, then the list will contain all those methods defined as Cubic, PtP,
etc. – or rather; multipoint calculations. Select the required test, confirm the selection by clicking on
OK, and the method will automatically be inserted in the Standard. Clicking on Exit, allows the
user to annul the operation. At this point, the Calibrators mask will view the added test(s), and the
operator must now insert the number of Replicates, the relevant CV % and in the Ref. 1 column,
(Ref.n for multipoint Standards), the known concentration value.

Whenever a test or tests are added to an existing Standard, this window will contain a list of only
those tests which are not already included in that Standard.

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Deleting a Test or Tests from a Standard

First select the name(s) of the Standard(s) from the List of Standards in the Calibrators mask. Then
click on “Delete Test(s)”. The following Delete Test(s) window will automatically open
containing a list of all those tests included in that Standard:

Select the test(s) ( ) to be eliminated and then confirm the operation by clicking on “OK”; or click
on “Exit” to annul the Delete procedure.

Exit

EXIT

To exit the Calibrators mask and return to the main mask, System Monitor, click on “Exit”.

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CONTROLS

To access the Controls mask, select Parameters from the Menu, insert the current password, and
then, from the options offered, click on “Controls”.

This window allows the operator to program the controls along with their relative tests. It is made
up of:
• an area located on the left-land side of the mask where the user can view the list of
programmed Controls, provided in alphabetical order.
Whenever the operator selects a control from the list, the tests therein contained will be viewed
in the central area of this window;

• an area located in the central portion of the mask, whose upper section is dedicated to
data that identifies the control, contained in the following required fields:

Lot Number – here the user can view the Lot Number of each individual control;

Expiration Date – here the operator can view the expiration date of the controls. Warning! Once
the control has expired (i.e. after its programmed expiration date), it will no longer be viewed in the
calibration programming mask

• an area located in the central portion of the mask, whose lower section provides the
operator with a table of the tests contained in the selected control. Each row in the table
refers to a given test; while the columns indicate the following data:

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Minimum Value: the minimum value that is considered acceptable for that control;
Maximum Value: the maximum value that is considered acceptable for that control:
Mean and SD: the mean value and the Standard Deviation regarding the range of acceptable
values, as defined by the Minimum and Maximum values inserted for that control.

• an area in the lower portion of the mask made up of those buttons necessary for mask
management operations.

Adding a New Control or Controls

To create a new Control(s), click on “Add CTRL”. The following dialog box will automatically
open containing the below-listed fields in which the user must insert the required data.

Name: Digit, in the space provided, a short name for the New Control, having a maximum of 12
characters;
Lot Number: Specify the Control’s lot number, using a maximum of 8 characters;
Expiration Date: Insert in the field the expiration date of the new Control. When this mask first
opens, this field will contain the current date. However, the user can open a calendar by pressing F4
or double clicking with the mouse, or can simply edit the date by digiting a new date in the place of
that one given.
To confirm the data set-up and therefore the adding of the New Control, the user must click on
“OK” located within the Add Control mask. At this point, the new control can be viewed along
with all the other, already programmed ones, in the dedicated list. Clicking on “Exit” allows the
operator to annul the operation.
Warning! The data set-up and inserted in this mask for the purpose of adding a new Control cannot
be edited or modified in any way. To change any data, the user must necessarily eliminate (delete)
the required Control.

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Adding a Test or Tests to a Control

First select the name of the Control from the List of Controls. Then click on
“Add Test(s)”.

The below-illustrated “Add Test(s)” window will automatically open. This window contains all
those tests not already contained in that Control. If the control is a New Control, then this window
will contain a list of all the methods; seeing as how no test has, as of yet, been inserted in the new
control.

Select the required test ( ) and confirm the selection by clicking on “OK”. The
method will automatically be inserted in the list of tests for that Control.

EXIT The operator can annul the operation by clicking on Exit.

The Controls mask will now view the added test, along with the relative columns in which data
regarding the acceptable range values of the control must be inserted.

To memorize the data inserted, or in the event of editing data for already programmed Controls,
click on “Save”.

If the below-illustrated visual text information message appears, it means that the “Save” button has
been clicked on without any editing of the already set-up data.

The user need only confirm, by clicking on “OK”.

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Deleting a Control

First select the required control from the list of Controls, and then click on “Delete CTRL”. The
following warning message dialog box will appear:

Click on “Yes” to confirm the elimination.

Click on “No” to annul the Delete procedure.

Deleting a Test or Tests from a Control

To eliminate a test from a Control, first click on “Delete Test(s)”.

The following Delete Test(s) window will automatically open containing a list of all those tests
included in that Control.

Select the test ( ) to be eliminated and then confirm the operation by clicking on “OK”. Clicking
on Exit annuls the delete operation.

Exit

EXIT To exit the Controls mask and return to the main mask, System Monitor, click on
“Exit”.

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OPTIONS

To access the Options mask, select Parameters from the Menu, insert the current password, and
then, from the options offered, click on “Options”.

The Options mask allows the operator to define a series of default parameters for the analyzer, as
described below:

Age Limit – Child/Adult: the operator can insert in this field an age limit for defining a patient as
either an Adult or a Child. This age limit will be used by the program when the normal values range
is assigned;

Bar Code Module: this field must be “checked” ( ), whenever the user wishes to insert samples
using the Bar Code;

ISE Module: to be defined;

Host Connection: this option allows the operator to connect to the Host. Whenever the command is
selected, the user can view on the System Monitor and in the Instrument Routine Menu those
commands necessary for Receiving and Transmitting data;

Setting of the Reagent and sample containers

Configuration 1 - Select A – Generic into the Reagent Bottle kit field.

Sample: allows the user to set the type of samples containers. It contains a pull-down menu where
the operator can choose either: Short, Conical or Primary;

Short = Short cup P/N 650100 must be loaded on sample cup Rack P/N 05-01829-00.

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Conical = Conical cup P/N 01-01739-00 (next introduction) can be loaded on sample cup Rack P/N
05-01829 and on the Primary tube sample Rack (Universal) P/N 05-00586-00.

Primary = Primary tube can be loaded on the Primary tube sample Rack (Universal) P/N 05-
00586-00 and in case of poor sample, Conical cup P/N 01-01739-00 can be loaded.
In this configuration, the needle aspiration course has been reduced in order to permit Conical cup
P/N 01-01739-00 (next introduction) safe using. Needle aspirates up to 26 mm from the primary
tube button.

Reagent: allows the operator to declare the de-fault type of container to be used for the reagents.
This field contains a pull-down menu, offering the operator the choice of either 35 ml or 6 ml sizes;

Configuration 2 - Select B – Dedicated into the Reagent Bottle kit field.

Sample: allows the user to declare the type of container to be used for the samples. It contains a
pull-down menu where the operator can choose either: Short, Conical or Primary;

Short = Short cup P/N 650100 must be loaded on the Primary tube sample Rack (Universal) P/N
05-00586-00 using adapter P/N 9-01-0609-00

Conical = Short cup P/N 650100 must be loaded on the Primary tube sample Rack (Universal) P/N
05-00586-00 using adapter P/N 9-01-0609-00

Primary = Primary tube can be loaded on the Primary tube sample Rack (Universal) P/N 05-
00586-00.
With this configuration, the needle aspirates up to 12 mm from the primary tube button.

Reagent: allows the operator to declare the de-fault type of container to be used for the reagents.
This field contains a pull-down menu, offering the operator the choice of either 35 ml or 6 ml sizes;

Each liquid container size corresponds to a different colour. For further information, please see the
legend provided under System Monitor;

Log Full System Actions: it makes it possible to record, in dedicated files, all those system
operations useful for identifying the cause of the problem, whenever unidentifiable instrument
errors occur. This field is “checked” ( ) always, it can be made not active for one run only.

Automatic Data Deletion (days): this field makes it possible for the operator to define for how
long the following data must be retained in memory: Water Blank Levels, Quality Control and
the Event Log table. The user must simply insert, in the corresponding field, the number of days for
which said data must be kept in the system memory – after which the data will be automatically
deleted;

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Memorizing the Operations Carried Out

In order to memorize and, therefore, utilize the settings programmed in this mask,
the user must click on “OK”, located in the lower portion of the mask.

Exit

EXIT To exit the Options masks and return to System Monitor, click on “Exit”, located in
the lower right-hand portion of the mask.

PRINT ORDER

To access the Print Order mask, select Parameters from the Menu, insert the current password,
and then, from the options offered, click on “Print Order”.

This window allows the operator to decide in what order the tests are to be printed for the final
report, regardless of the order in which they were carried out.

A Methods (Test) Print Order list is located in the central area of this window. Here the operator
can view all those tests to be placed in whatever order is deemed appropriate. Those buttons useful
for the various operations are located in the lower portion of the window.
The tests included in the list are given using the same acronym as that used in the “Methods List”
field in the “Methods” mask, where they were previously set-up.

Setting-up the Test Print Order

The operator can choose the criteria to be used when deciding the order in which
to print the tests – selecting either to print them according to test type or functionality. To do so,

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he/she must simply use the “Drag and Drop” function of the mouse to position the tests in the order
he/she wishes them to be printed, and then click on “OK” to memorize the data.

Exit

EXIT To exit the Print Order mask and return to System Monitor, click on “Exit”.

REPORT OPTIONS

To access the “Report Options” mask, select “Parameter” from the menu and then, from the
options offered, click on “Report Options”. This mask allows the operator to define the header
report and symbols that will indicate errors on the report print-out.

This mask contains:

• A Header Text area located in the upper portion of the mask, where up to 800 characters can be
inserted;

• A lower area containing a Warning message on the right and on the left the flags list with the
following fields:

Group: allows the operator to view the group to which that Flag belongs. Each group has its own
symbol, which indicates the exact type of Flag (See Chapter 09 – TROUBLE SHOOTING GUIDE
AND LIST OF ALARMS);

Flag Description: this field allows the user to see the name set-up for that type of error;

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Symbol: this field contains either a character or a symbol indicating one or more errors. The
characters or symbols set-up, have will be those used in the report print-out, or rather, they will
substitute the character used to declare that error in the report print-out (See Chapter 09 –
TROUBLE SHOOTING GUIDE AND LIST OF ALARMS);

The right-hand portion of this section contains an area dedicated to the visual text “Warning!”
message. The operator should always consult this message before undertaking any further action
that might compromise the reliability of the test result(s).

• Two Operation buttons located in the lower, right-hand portion of the mask.

Setting-up the Report

To set-up the header text within the space provided – Header Text – click on this
area and type in the desired text, making sure to not exceed the 800-character Maximum.
If the user wishes to edit the character used to indicate a given Flag, he/she need only select the
Symbol field of the relative Flag and insert the new character.
To make sure that both the text and any new symbols are memorized by the program and
subsequently used for the print-out of the report, click on OK, located in the lower, right-hand
corner of the mask. “OK” is activated only after the information contained in this mask has been
edited in some way.

Exit
EXIT

To exit the Report Options mask and return to the main mask, System Monitor, click on “Exit”.

PASSWORD SETTING
To access the Password Setting mask, select Parameters from the Menu, insert the current
password, and then, click on Password Setting.

The Password Setting mask, as illustrated below, allows the operator to change the Password
currently in use.

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In order to edit the current Password, the user must insert, in the New Password field, a new code
having a Maximum of 10 alphanumerical characters.

Digit the new code (new Password) in the Confirm New Password field and
then click on “Change”. This button is activated only when the exact same code has been inserted
in both the New Password field and the Confirm New Password field. If the operation has been
carried out correctly, and is therefore successful, the program will notify the user via a visual text
information message. The Exit button can be used to annul the operation at any time.

3.6 HELP

This function allows the user to access the system’s on-line Guide “Help”.
Here, the operator can view the list of revisions regarding the installed software components.

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GUIDE F1

To access the Guide F1 mask, select “Help” from the Menu and then, from the options listed, click
on Guide F1. The on-line “Guide F1” can also be accessed directly from any screen by pressing the
F1 key on the keyboard.

This mask contains an information manual whose aim is to assist the user in learning how to operate
the system. Individual topics can be selected by either clicking directly on the highlighted key
words, or from the three tabs marked “Contents”, “Index”, “Search” – briefly explained as follows:

Contents: allows the user to view the contents of the guide;

Index: allows the user to view the index of the key words (please see the screen);
Search: presents another screen to be used for searching within the guide.

The window on the right-hand side of the screen allows the operator to view the text explaining the
topic selected.

To exit the on-line Guide F1 and return to the preceding screen, click on the “X” located in the
upper, right-hand corner of the screen.

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INFO SOFTWARE VERSIONS

To access the Info mask, select “Help” from the Menu and then, from the options listed, click on
Info.

This window allows the user to view the list of the revisions of all the software components, that are
installed in the system the operator is using.

Exit

EXIT To close this window, exit the Info mask and return to the main mask, System
Monitor, click on Exit.

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3.7 SHUT DOWN

In order to exit the programme, the operator must first allow the instrument to
complete all the still running operations (System in Stand By).

The “Shut Down” command that allows the user to close the programme and the software is
located on the instrument Desk Top.

Clicking on this command causes the following visual text dialog box to appear after a few seconds:

Clicking on “Yes” will cause the programme to close and the system to shut down. The operation
takes a few seconds. Conversely, clicking on “No”, will annul the request and no system shut down
will occur.
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 Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE

Whenever the Shut Down procedure is launched, the Cuvette Plate normally viewed in the System
Monitor window, will change into a clock figure (please see the illustration) whose hands move
counter-clockwise, marking the closure of the programme.

Complete Shut Down will occur within a maximum of four minutes.

Once Shut Down is completed, the instrument can either be turned off or left on – in stand-by –
ready to be reactivated for another work cycle.

During Stand-by, the instrument will maintain the following conditions:

• heating of the Reaction Plate;

• reduced power (voltage) to the photometer Lamp.

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 Chapter 04 - DAILY ROUTINE

CHAPTER 04 – DAILY ROUTINE

INDICE

4.1 DAILY ROUTINE……………………………………………………………………….2

4.2 STAND-BY FUNCTION…………………………………………………………….…..3

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 Chapter 04 - DAILY ROUTINE

In this chapter the main operations are resumed for the correct execution of the analytical routine
on the Ellipse.

4.1 DAILY ROUTINE

The operations listed below, have to be carried out in sequential order:

⇒ Switch on the analytical module of the ELLIPSE, the computer and the peripheral equipment
(e.g. the printer)
⇒ Wait until the work-temperature has been reached and stabilized

In the mean time:

⇒ Control the liquid level in the bottles: H2O distilled, Rinse and Cleaning Solutions
⇒ Control the liquid level in the waste bottles, empty them if necessary
⇒ If the ELLIPSE has remained unused for more than 24 hours (e.g. during the weekend), run a
cuvette wash cycle by pressing the designated key in the "Start Work" mask
⇒ Run the "autozero" of the cuvette WBL(Water Base Line) by pressing the designated key in
the "Start Work" mask
⇒ Verify the reagents configuration in the "System Monitor", if modifications need to be made,
enter into the function, "Reagent Tray Configuration" (under the "Checks” menu)
⇒ Check reagent supply levels (See Reagent Volumes mask under the "Checks” menu)
⇒ Verify the correct positioning of the Standard and Controls
⇒ Verify the validity of the current calibration by running the controls. If necessary, carry out a
new calibration in the program "Calibration & C.Q." (under the “Routine” menù).
⇒ Program the routine by introducing the patients data and the requested analysis (under the
“WorkList” window)

OPERATIONAL:
⇒ Place the sample cup/tubes in the dedicated racks
⇒ Push the relevant button on the System monitor mask to loading the samples racks on the
instrument
⇒ Click on Start key in the System Monitor screen (green arrow), then in the Start Work mask,
active the “Work List” function by pressing the designated key
⇒ Run the routine by clicking the “OK” key in the “Start Work” window

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 Chapter 04 - DAILY ROUTINE

⇒ Check the results (shown on the video); evaluate them and decide (if necessary), to request the
re-run or edit of a specific analysis
⇒ Transmit the results to the Host Computer (if the ELLIPSE is integrated into the Laboratory
Information System)
⇒ Print out the tests results
⇒ Transfer the completed samples into the archive
⇒ When the work has finished, click on the Shutdown key to exiting from the ELLIPSE
program and switch off the Computer and Peripheral Equipment
⇒ Switch off the analytical module or leave it in Stand-by.
⇒ Always remove all the cups/tubes used and, if necessary, remove the reagent tray for
refrigeration

On the following page the flow chart indicates the sequential operations that need to be done to
insure that the daily routine will be carried out correctly.

4.2 STAND-BY FUNCTION

In the eventuality that the laboratory needs to process the samples throughout the span of the
entire day (small batches taken outside of the normal routine, Stat, etc.), it is opportune to keep the
system in a "Stand-by" condition. This condition reduces the time required for the reaction plate
temperature stabilisation after the switching off and the switching on of the Analyzer.

During Stand-by, the main functions of the instrument are kept active (temperature of reaction
plate, low voltage supply of the photometric lamp). Thus, immediate process of samples that have
arrived unexpectedly, is possible.

The instrument enters the Stand-by status when:

- the analytical module is switched on but the computer is switched off
- the analytical module and the computer are still switched on, but the ELLIPSE program is
closed.

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DAILY ANALYTICAL ROUTINE OPERATIONS

LIQUID SUPPLY

CUVETTE WASHING

CARRYING OUT OF WBL

(Water Base Line)

REAGENT
CONFIGURATION

REAGENT SUPPLY

VERIFICATION OF CALIBRATION
VALIDITY

NO
?

CARRYING OUT YES

OF CALIBRATION

CALIBRATION
RESULTS

NO
YES
?

PATIENT ENTRY

START ROUTINE

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 Chapter 05 - METHODOLOGY

CHAPTER 05 - METHODOLOGY

INDICE

REFERENCE RANGE……………………….……………………………………….3
REACTION PARAMETERS .......................................................................................4
MEASURE PARAMETERS ........................................................................................6

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 Chapter 05 - METHODOLOGY

This function enables the user to define the methodology parameters to be used for test execution.
It is possible to memorize an unlimited number of methods.

The window displays a series of parameters divided in the following three areas:

(top left side)

Description = Test’s long name

Unit = Choose unit of measure (mg/dl, U/l, …)

Decimals = Number of decimal places expressed in the results and patient

report. Selection can be done by positioning the mouse in the field and
choosing from 0 to 3 inside the pull down menu showed

Lis Code = Laboratory Information System; communication code used between

the instrument and the Host Computer. (This code applies only if the
instrument has been inserted in the Laboratory Information System).

Unit Factor = conversion factor for the unit of measure

Slope = default value imposed at 1

Intercept = default value imposed at 0

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NOTE: the values of Slope and Intercept permit the user to establish a correlation between
instruments and/or different methods. To evaluate the correlation between different
instruments, it is necessary to calculate the linear regression.

Ellipse

Intercept Slope

Instrument X

(top right)

REFERENCE RANGE

Low Values = Lower range reference values differentiated for men, women and
children. Each patient category gives three values defined according
to the parameters set for the normal values: Low Alert, Very Low,
Low.

Normal Values = Normal range reference values differentiated for men, women and
children.

High Values = Upper range reference values differentiated for men, women and
children. Each patient category gives three values defined according
to the parameters set for the normal values: High, Very High, High
Alert.

Rerun = Option to repeat test automatically with indications given regarding

any eventually requested sample dilutions or increase. The dilution or
increase ratios are differentiated according to the value field for which
the rerun was requested; Furthermore, any anomaly found regarding
congruity between the imposed serum/urine volume and the separated
part that is to be sampled (based upon the dilution ratio requested) will
be flagged. (For example, 3 µl of the sample cannot be divided by
five because there is not enough sample material).
The Rerun option requires the automatic repetition of the tests whose
results are out of the Normal Values range.

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 Chapter 05 - METHODOLOGY

(on the center left)

REACTION PARAMETERS

Reaction Type = Defines the type of calculation (End Point, Fixed Time, Kinetic,
Differentiated)

Direction =Defines the direction of the reaction: (assorbancy increment =

direction Up) or (absorbancy decrease = direction Down). If the user
does not want this control, he should select the option “None”.

E.P. Limit (abs) = The value placed in this field indicates the limit, expressed in
absorbancy, within which the reaction is considered stable (See
Chapter 08). If the value is equal to or higher than the limit, it will
automatically be flagged. This specific parameter is applicable only
when using the “End Point” methodologies.

Depl. Limit (abs) = Absorbancy limit below or above which, (according to the direction
of the reaction), no reaction must go. Indicates exhaustion of the
substrate. Such situation will automatically be flagged. This specific
parameter is applicable only when using the “Kinetics and Initial
Rate” methodologies.

First Limit (abs) = This function checks the reaction stability (see Chap. 08). If the
check has a negative result, the test will be flagged. This specific
parameter is applicable only when using the “Fixed Time”
methodologies.

Linear Factor = This value regards a check on the stability of the “First Limit”
reactions. This specific parameter:
- is applicable only when using the “Initial Rate” methodologies
- depends on the reading time
- is statistically calculated

Fit = The value introduced into this field indicate the limit of variation of
the reading points compared to the calculated regression line, and
within which the reaction is considered stable. If the value is outside
of this parameter, even by only one reading point, it will be flagged.
This specific parameter is applicable only when using the “Kinetics”
methodologies.

RBL Execution: = This field permits to define RBL request, from 0 (never) to 4

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RBL Max CV %: = The value introduced into this field indicate the maximum
acceptable coefficient of variation percentage (CV%) among the
replicates.

RBL Min – Max (abs) = Minimum and maximum values inserted for the RBL

(central right)

Predilution = This column of the chart indicates the diluent used, the Lot Number
and the requested predilution ratio (The following ratios are possible:
1:1 – 1:2 – 1:3 – 1:4 – 1:5 – 1:10 – 1:15 – 1:20 – 1:25).

S+R1 = This column of the chart shows the reagent code that has been used,
the batch number, the reagent, rinse and sample volumes expressed in
µl.
The Rinse solution is aspirated in order to rinse the tube (see Chapter
02) before the reagent aspiration. The Rinse solution is not dispensed
in the reaction cuvette.

Reag.2 = This column of the chart shows, for those methods that require a
second reagent, the 2nd reagent’s addition time, code, batch number,
and the volume required expressed in µl.

Reag.3 = same conditions that apply to Reagent 2 (see above)

Wash = This column of the chart shows the washing solution code that has
been used. The Washing solution is aspirated in order to further rinse
the probe before the reagent aspiration.

Incubation = Incubation time given in seconds, starting from the moment of the
last reagent’s addition (1°, 2° or 3° reagent, depending on which
method is used).

Read = The total time needed to perform the reading; it is expressed in

seconds. For kinetics methods, the reading time must be selected
inside the pull-down menu from the timing reporting the symbol (*);
the readings start from time T0 that coincides with that of adding the
reagent R1 and the sample in the reaction cuvette; the next readings
are taken after the incubation period and are repeated every 13, 26, 39,
52 or 65 seconds with relation to the relevant selection (see table nr 1
in the chapter 08 – Formulas and calculation models). The End point
methods reading coincides with the end of the Incubation period, and
therefore a zero value appears in the Read field.

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 Chapter 05 - METHODOLOGY

Filter 1 (nm) = Primary filter; the following filters are available: 340 – 380 – 405 –
492 – 510 – 546 – 578 – 620

Filter 2 (nm) = Secondary filters; The choices are the same as those given above.

Bichr. Factor = Bichromatic Factor; allows the user to correlate the sample
absorbancy read with the secondary filter (Filter 2) to the primary
filter (Filter 1).

(on the lower left)

MEASURE PARAMETERS

Measure Model = method’s mathematic calculation model being executed (Factor,

Standard, Point to Point, Quadratic, Cubic, Quadratic 5 Points,
Reverse Cubic, Log Logit 2 parameters, Log Logit 3 parameters)

Factor = Calibration factor

Sample blank = This selection permits to the system to subtract the absorbance value
of the sample (matrix effect).
This specific parameter is applicable only when using the “End Point”
methodologies.

Lin. Limit low = The lower limit for reagent linearity, expressed in concentration.
This value is reported in the Low Alert field of the chart “Reference
Range” (the table located at the top right).

High = The upper limit for reagent linearity, expressed in concentration.

This value is reported in the High Alert field of the chart “Reference
Range” (the table located at the top right).

Rerun when Over = Option to repeat the test if the results are out of the linearity limits
(if the results are superior to the High value). The dilution ratio is
selected by using the menu options available when the user places the
mouse on the field; it is possible to choose one of the following
ratios: 1:1 – 1:2 – 1:3 – 1:4 – 1:5 – 1:10 – 1:15.

RBL stability (days) = Instrument’s Reagent stability, expressed in days. In other words, it
is the number of days that the RBL is considered valid. After this
period of time, the instrument indicates that it is necessary to perform
a new RBL, highlighting in red the date that the RBL has expired.

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Calibr. stability (days) = The number of days that the calibration is considered valid. After
this period of time, the instrument indicates that it is necessary to
perform a new calibration, highlighting in red the date that the
calibration has expired.

Dynamic Controls (min) = A request to perform quality control during the routine analysis, at
specified time intervals (of 15 minutes and multiples of 15 minutes);
It is possible to position the control bottle in a free position of the
reagent rack because this operation requires a higher consumption of
the controls compared to the normal calibration operations.

(on the bottom right)

Method List = Lists the configurated methods; By choosing a method the

corresponding parameters automatically appear.

Save = Saves the method and visualized parameters; This button is pushed
to either confirm the changes made, or after the initial programming
has been done.

Add = Used to insert a new method.

⇒ A new window “New Test” requests the user to insert the name of
the new test (from 1 to 6 characters max)
⇒ push OK
⇒ insert the parameters
⇒ push Save

Delete = deletes the visualized methods. The user is asked to confirm the
execution of the Delete command before continuing.

Print = Prints the page with the parameters of the selected method.
Backup = Used to copy all the methods on the floppy disk
Restore = Used to restore all the methods from the floppy disk
Exit = Returns to System Monitor.

For each selected Method, the disabled fields are highlighted opaque gray. The values of the
enabled fields are given in black figures.

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 Chapter 06 - CALIBRATION CURVES

CHAPTER 06 – CALIBRATION CURVES

INDICE

6.1 CALIBRATION CURVE ..............................................................................................….4

6.2 EXAMPLE OF HOW TO PREPARE A CURVE………………………………………..6

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 Chapter 06 - CALIBRATION CURVES

Multipoint calibration is used for all non-linear type methods.

Multipoint calibration requires the carrying out of more than one standard; each standard is one
point on the calibration curve (for a maximum of 8 points).

As far as the calibration curve itself is concerned, it is necessary to further distinguish whether or
not the method, in addition to being non-linear, requires a predilution of the sample (please see
Methods Parameters) and if the standard is a Master Standard.

Method not requiring Predilution

If the considered method does not require predilution, then the following two situations are
possible:

A Ready-to-Use Curve: all the points of the calibration curve are available in the calibration rack
(or rather, the same number of cups of undiluted standard are available and loaded as there are
points on the calibration curve). The system carries out the calibration curve of the loaded
calibrators.

Master Standard: the calibration rack contains only the Master Standard cup. In this case, before
carrying out the calibration of the method, the instrument system prepares the single points which
make up the calibration curve, starting from the Master Standard.
The instrument itself does the preparation and, after having determined the single points of the
calibration curve in the predilution rack, in accordance with the concentration percentage setup in
the programming of the standard, it then goes on to carry out the calibration test on the prepared
points.

Method requiring Predilution

If the considered method does require predilution, then the following situations are possible:

Ready-to-Use Calibration curve (Calibrators), undiluted-type.

Master Standard field not selected and Predilution field selected:

All of the points of the calibration curve are available in the calibration rack (or rather, the same
number of cups of undiluted standard are available and loaded as there are points on the calibration
curve). The instrument treats the standards as if they were samples and carries out the dilution of
the standard in a predilution cup according to the dilution ratio of that method. It prepares as many
cups of pre-diluted standard as there are calibration points setup in the programming of that
standard and then goes on to carry out the calibration test on the points prepared.

Ready-to-Use Calibration curve (Calibrators), diluted-type.

Master Standard and Predilution field not selected:

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All of the points of the calibration curve are available in the calibration rack (or rather, the same
number of cups of diluted standard are available and loaded as there are points on the calibration
curve).
The instrument treats the standards differently from the samples. In fact, in order to carry out the
standard, it does not dilute the standard, as setup in the method, as the standard is already diluted.
The system then performs the calibration test on the available points.

Master Standard – Undiluted

Master Standard and Predilution field selected:

Only the cup containing the Master Standard is available in the calibration rack. Before carrying out
the calibration of the pre-diluted method, the system prepares the individual points of the calibration
curve, starting from the Master Standard.
The instrument itself does the preparation and, after having determined the single points of the
calibration curve in the predilution rack, in accordance with the concentration percentage setup in
the programming of the standard, it then carries out a new dilution of the standard in a new
predilution cup, in accordance with the dilution ratio of the method.
The instrument then prepares as many cups of pre-diluted standard as there are calibration points
setup in the programming of that standard, with the exception of any eventual 0% and/or 100%
concentration, and then goes on to carry out the calibration test on the points prepared.
The instrument treats the standards exactly as if they were samples.

Master Standard – Undiluted

Master Standard field selected and Predilution field not selected:

Only the cup containing the Master Standard is available in the calibration rack. The system
prepares the individual points of the calibration curve, starting from the Master Standard.
The instrument itself does the preparation and, after having determined the single points of the
calibration curve in the predilution rack, in accordance with the concentration percentage setup in
the programming of the standard and with the dilution ratio of the method, it then goes on to carry
out the calibration test on the prepared points. The instrument treats the standards differently from
how it treats the samples.
This type of preparation is defined as OPTIMIZED, in so far as it makes it possible to use a
minimum quantity of the Master Standard.

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6.1 CALIBRATION CURVE

Immunoturbidimetric methods require multiple-point type calibration because the reaction curves
are not linear and do not respect “Lambert and Beer’s” law .

The types of reactions used are: END POINT, FIXED TIME and KINETIC (mono and bi-reagent).

The relationship between the concentrations of the standards and the optical density readings is not
linear and, therefore, must be resolved using the following mathematical algorithms:

POINT TO POINT Y = bX + a

2
SQUARED Y = cX + bX + a

SQUARED - HAVING
4 3 2
5 COEFFICIENTS Y = eX + dX + cX + bX + a

3 2
CUBIC Y = dX + cX + bX + a

3 2
INVERSE CUBIC 1/Y = d(1/X) + c(1/X) + b(1/X) + a

LINEAR LOG LOGIT Log Y = bLog | X / (K - X) | + a

3 2
CUBIC LOG LOGIT Log Y = dLog |X/(K - X)| + cLog |X/(K - X)| + bLog |X/(K - X)| + a

Where: a, b, c, d, e represent the coefficients of the curve

Y represents the concentration of the standard

X represents the optical density of the standard

K represents the optical density of the standard at 0

concentration

POINT TO POINT

(Y = bX + a)

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This type of calculation algorithm does not make it possible to have a true calibration curve, but
rather a series of straight lines which unite the various points representing the concentration of the
standards. In fact, the above equation represents a straight line passing between two (standard)
concentrations, having its own angular co-efficient (b) and intercept (a).

The example below clearly illustrates the differences between a Point to Point mathematical
solution and a cubic calculation model.

0.8
3 2
y = 3E -06 x - 0 .00 06x + 0.035 4x - 9E -0 5
0.7
y = 0.0025x + 0.6
y = 0.005x + 0.5
0.6
ABSORBANCES

y = 0.015x + 0.2
0.5

0.4 y = 0.02x + 0.1

0.3

0.2
y = 0.0299x + 0.001
0.1

0
0 10 20 30 40 50 60 70

C O N C E N T R A T IO N S

The equation to the third degree (here represented by the continuous line) makes it possible to
create a true calibration curve, in so far as it is the most accurate interpolation among the calibration
points.

The other equation (here represented by the dotted line) expresses the linearization of two adjacent
standards. In fact, each straight line has its own angular co-efficient and intercept.

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6.2 EXAMPLE OF HOW TO PREPARE A CURVE

In order to prepare a calibration curve, the operator must first select “Standard” from the
“Parameters” menu.

If the required standard is not included in the list of calibrators, preceed as follows in order to setup
a new calibrator on the instrument:

⇒ press “Add STD”

⇒ insert in the window that opens (see below): the name of the calibrator to be added; the number
of calibration points (maximum eight); and, where applicable, indicate whether or not it is a
Master Standard.

IMPORTANT! The Lot Number and the expiration date are required data. They MUST
necessarily be inserted in this window.

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⇒ press OK to return to the previous screen

⇒ select the Predilution option, if needed (please see above-given indications)

IMPORTANT! The name of the diluent must be indicated always for Standard Master, whether
the Predilution field is optioned, or not.

The diluent of the calibrator can either be the same one used to dilute the samples (i.e. coincides
with that indicated in the method) or it can be a different one. If it is the same, the diluent will be
assigned to a position in the reagents rack during the reagents configuration programming phase; if
it is different, the instrument software will assign, the last free position available on the reagent rack
and its name will appear in “System Monitor”, but only when calibration is requested.

⇒ press “Add Tests” to select those tests to be calibrated using that standard

⇒ select the tests to be added and press OK

⇒ insert the concentration value of the standard (reference value) in the “Conc.” field

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⇒ define the concentration percentages for each single point of the curve by selecting from among
the available percentages listed in the Ref. field column. The values given in concentration and
corresponding to the percentages defined can be viewed by positioning the mouse over the red
dot inside the “Ref” field window.

N.B.: the percentages inserted must be in either increasing or decreasing order.

If the Calibration Curve is of the Ready-to-Use type (pre-prepared standards for the various
points), the operator must insert in the “Ref” field, the concentration value of the standards.

⇒ Once the programming has been completed, press “Save” and then “Exit”

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⇒ Access the “Calibration and Q. C.” function from the “Routine” menu

⇒ Request calibration and then press “Assign/Check”

⇒ Position the Standards and the Controls following the indications as shown on the screen (See
the above-illustrated window. Please note that further, more detailed information is available
under the Reagents Volume function which can be found in the Preparation menu)

⇒ Press “OK”

⇒ Press “Start Work” (rgeen button) under “System Monitor”

⇒ After having placed the Reagent(s), Diluent(s), and the predilution cups in their respective
positions, select calibration under the “Start Work” window and then press OK.

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CHAPTER 07
- MAINTENANCE -

INDEX

7. MAINTENANCE……………………………………………………………………......2
7.1 PREVENTIVE MAINTENANCE……………………………………………………....2
7.2 LIST OF PARTS SUBJECT TO WEAR AND USAGE………………………………..4
7.3 SAMPLING PROBE - CLEANING PROCEDURE………………………………...….5
7.4 WASH STATION CANNULAS - CLEANING PROCEDURE..…………..………......5
7.5 WASH SOLUTION BOTTLES - CLEANING……………………………..…………..6
7.5.1 WASH SOLUTION BOTTLES - CLEANING PROCEDURE…………………...……6
7.6 TIP WASHING ………...…………………………………………………………….....7
7.6.1 TIP - CLEANING PROCEDURE………………………………………………..…..….7
7.6.2 PROCEDURE FOR REPLACING THE TIP…………………………………………...9
7.7 HYDRAULIC CIRCUIT WASHING ………...…………………………..….…….….10
7.7.1 HYDRAULIC CIRCUIT - CLEANING PROCEDURE…….…………………….…..10
7.8 CHANGING THE PERISTALTIC PUMP TUBES…………….…………………..…11
7.8.1 PROCEDURE FOR REPLACING THE PERISTALTIC PUMP TUBES………..…...11
7.9 CHANGING THE PHOTOMETER LAMP………...……………………………….. .12
7.9.1 PROCEDURE FOR REPLACING THE PHOTOMETER LAMP……...……….….. .12
7.10 CHANGING THE REACTION CUVETTES………………………….………...….. .13
7.10.1 PROCEDURE FOR REPLACING THE REACTION CUVETTES………..…………13
7.11 CHANGING THE TUBES KIT………………………………………………………..15
7.11.1 PROCEDURE FOR REPLACING THE TUBES KIT…………………..………...…..15
7.12 TABLE C – LIST OF THOSE MAINTENANCE PROCEDURES THAT CAN BE
PERFORMED BY THE USER AND/OR BY THE MAINTENANCE
TECHNICIAN…………………………………………….........................……………16
7.13 DECONTAMINATION PROCEDURE……………………………………………….18

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7 MAINTENANCE

This chapter contains all those routine operations, which concern instrument maintenance. Said
procedures, listed and described below, should be carefully and scrupulously followed in order to
guarantee the manufacturer’s specifications and the perfect working order of the instrument over
time.

7.1 PREVENTIVE MAINTENANCE

MAINTENANCE SCHEDULE

Table A, illustrated below, lists all those procedures to be carried out by the user/operator and the
relative frequency schedule. Strict adherence to said schedule will guarantee the optimal operative
efficiency of the instrument.

TABLE A – MAINTENANCE SCHEDULE

FREQUENCY PROCEDURE NOTES

DAILY – Before launching Check the levels of all the wash
See Table B
“Start Work” solutions (Rinse, Water and Cleaning)
DAILY – Before launching Check the levels of Reagents,
See Table B
“Start Work” Standards and Controls
DAILY – Before launching Check the levels of the Waste Bottles
“Start Work” and, if necessary, empty them
See the User’s Manual,
DAILY – Before launching
Carry out a WBL cycle Chapter 03– Description
“Start Work”
of Instrument Software
Clean the Sampling Probe using either
DAILY – After Shutdown See Procedure 7.3
paper towelling or gauze

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TABLE B – MAINTENANCE SCHEDULE

FREQUENCY PROCEDURE NOTES

Clean the Wash Station’s four
EVERY TWO WEEKS See Procedure 7.4
cannulas
Clean the wash solution bottles
EVERY TWO WEEKS See Procedure 7.5
(Rinse, Water and Cleaning)
ONCE A MONTH Clean the Tip See Procedure 7.6

ONCE A MONTH Clean the Hydraulic Circuit See Procedure 7.7

EVERY THREE MONTHS Change the Reaction Cuvettes See Procedure 7.10

EVERY SIX MONTHS Change the Peristaltic Pump Tubes See Procedure 7.8

EVERY SIX MONTHS Change the Tip See Procedure 7.6

ONCE A YEAR Change all the tubes (Tube Kit) See Procedure 7.11
EVERY 2000 HOURS Change the Photometer lamp See Procedure 7.9

• N. B.: the above-described maintenance schedule refers to that situation in which the
workload of the Analyzer is approximately 500 tests per day. The interval frequency
may vary according to the individual instrument’s daily workload.

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7.2 LIST OF PARTS SUBJECT TO WEAR AND USAGE

Quantity
Description Type Code
Pieces
Reagents containers 35 ml 12 C101-00190-00
Reagents containers 6 ml 12 C101-00191-00
Samples cups 0.8 ml 1000 AS650002
Short samples cups 1 ml 1000 AS650100
Adapter for short samples cups 1 9-01-0609-00
Reaction sectors 6 C101-00217-00
Washing solution bottle 2 lt 1 9-35-0041-00
Bottle level sensor 1 9-05-0078-00
Tubing Kit for peristaltic pump 2 65-01835-00
Tubing Kit – complete 1 65-01836-00
Cleaning solution 250 ml 2 ASRN0020
Rinse solution 50 ml 1 ASRN0021
Sampling probe (internal needle) 1 05-00707-00
Complete Sampling probe 1 10-00703-00
Drying Pad 1 01-01920-00
Halogen Lamp (6 V - 10 W) 1 9-35-0016-00
Interferential filters Kit 1 9-65-0029-00
Fuse 6,3 A-T 5x20 10 C130-01238-08
Inlet/outlet fitting for Rinse & Clean conts 1 01-01224-00
Cuvettes protection cover 1 05-01249-00
Reagent protection cover 1 10-00584-00
Reagent plate 1 10-00585-00
Samples rack 1 05-01829-00
Washing station, first or second cannulas (A) 1 05-01633-00
Washing station, third cannula (B) 1 05-01633-01
Washing station, fourth cannula (C) 1 05-01638-00
Washing station, fifth cannula without pad (D) 1 05-01919-00
Diluter Micro-Pump 1 05-01710-40
Air Micro-Pump (µP 6) 1 05-01711-20
Micro-Pump (µP 2 ÷5) 1 05-01826-16
Predilution rack 1 05-01735-00
Solenoid Valve –2 way 1 9-35-0035-00
Solenoid Valve –3 way 1 9-35-0036-00

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7.3 SAMPLING PROBE – CLEANING PROCEDURE

1) Turn off the Analyzer

2) Use only lint-free paper towelling or gauze

3) Dampen the gauze or paper towelling with distilled water and clean the outside of the
sampling probe. Wipe the probe from the top downwards only! This is to avoid that
any bits of cloth, paper or lint fibres accidentally enter the probe itself.

4) The manufacturer suggests that once weekly the above-described cleaning procedure
be performed using, instead of only simple distilled water, a 5% sodium hypochlorite
solution to dampen the gauze and then be repeated using distilled water.

7.4 WASH STATION CANNULAS – CLEANING PROCEDURE

1) Turn off the Analyzer.

2) Place a sheet of paper under the wash station cannulas in order to keep any extraneous
material from accidentally falling into the cuvettes.

3) Use only lint-free paper towelling or gauze.

4) Dampen the gauze or paper towelling with distilled water and clean the outside of the
cannulas. Wipe the cannulas from the top downwards only! This is to avoid that any
bits of cloth, paper or lint fibres accidentally enter the cannulas themselves.

5) The manufacturer suggests that once weekly the above-described cleaning procedure
be performed using, instead of only simple distilled water, a 5% sodium hypochlorite
solution to dampen the gauze and then be repeated using distilled water.

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7.5 WASH SOLUTION BOTTLES – CLEANING

During normal use and over time, mold and dust can build up inside the wash solution bottles.
For this reason, it is extremely important that they be periodically washed. Said cleaning must be
thorough and meticulous in order to insure that every trace of mold or residue be removed.

How often the bottles must be cleaned depends on their use and on the quality of the distilled water
used in that particular laboratory. However, the manufacturer recommends thorough washing at least
once every two weeks.

It is extremely important that the user not underestimate the risks associated with mold and dust
particles. They are to be regarded as a serious hazard as they can be the cause of instrument
malfunction.

The wash solution bottles are located on the right side of the analyzer.

7.5.1 WASH SOLUTION BOTTLES - CLEANING PROCEDURE

1) Turn off the Analyzer.

2) Pull the level sensor connectors out from the bottle caps.

3) Take the caps off the bottles and empty them.

4) Fill each bottle with a 5% sodium hypochlorite solution.

5) Clean the inside of each bottle using a bottlebrush in order to remove all traces of mold
and/or residue.

6) Leave the sodium hypochlorite solution stand in the bottles for at least ten minutes.

7) Empty the bottles, rinse them repeatedly and well with tap water, and then twice more
using distilled water.

8) Dry the bottles.

9) Fill the bottles with their proper solutions.

10) Replace the bottles in their respective housings.

11) Close the bottles and reconnect the level sensors.

12) Carry out two ‘Wash Cuvettes’ cycles and two ‘WBL’ cycles. Check system efficiency
by comparing the WBL values and the test results obtained against the laboratory’s
quality control values.

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7.6 TIP WASHING

The Tip is used to dry the cuvettes after they have been washed. This drying process is carried out via
aspiration and therefore, over time, the Tip will necessarily absorb various contaminating particles.
The manufacturer suggests that the Tip be replaced every six months. Said frequency may vary
depending on the workload of the individual laboratory and the operating conditions/environment of
the single instrument.
The Tip must be washed regularly in order to guarantee proper functioning and must be replaced with
a new Tip as necessary.

7.6.1 TIP - CLEANING PROCEDURE

1. Turn off the Analyzer.
2. Unscrew the fastening screw and remove the Washing station protective cover (Fig. 1).
3. Remove the top cover of the washing station unscrewing the four fastening screws (Fig. 2).
4. Remove the cannula that contains the Tip (the 5th cannula) and the spring (Fig. 3).
5. Disconnect the aspiration tube (Fig. 4).
6. Once the cannula has been removed, immerge it in a 5% solution of sodium hypochlorite for at
least 15 minutes (Fig. 5).
7. Attach a 10 ml syringe to the cannula and aspirate and dispense the hypochlorite solution
through the cannula (and the Tip) until the latter is completely clean (Fig. 6). This aspirating
and dispensing forces the liquid through the Tip fibers in both directions
8. Once the Tip is clean, repeat the aspirating and dispensing cycle 10 more times using distilled
water, then disconnect the syringe.
9. Re-connect the aspiration tube to the cannula (Fig. 7).
10. Re-position the cannula in its housing being careful to not kink the aspiration tube
11. Re-position the spring on the cannula’s cylindrical axel.
12. Re-position the top cover of the washing station, making sure that the cylindrical tops of the
cannulas fit into the corresponding holes on it.
13. Manually move the wash station downwards and centre the tip with the cuvette turning it.
14. Remount the Washing station protective cover (Fig. 1).

Washing Station
protective cover

Fig.1 Instrument Top view

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Spring

Fastening screw 5th cannula

Fig. 2 Fig. 3

Aspiration tube

Fig. 4 Fig. 5
Sodium hypochlorite

Connect the syringe to the cannula

Fig. 6 Fig. 7

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7.6.2 PROCEDURE FOR REPLACING THE TIP

1. Turn off the Analyzer.

2. Unscrew the fastening screw and remove the Washing station protective cover (Fig. 1).
3. Remove the top cover of the washing station unscrewing the four fastening screws
(Fig. 2).
4. Remove the cannula that contains the Tip (the 5th cannula) and the spring (Fig. 3).
5. Disconnect the aspiration tube (Fig. 4), remove the used Tip and replace it with a new one. Press
lightly to push the new Tip into place – be careful to not press too hard as this could deform the
Tip (Fig. 8).
6. Insert the cannula containing the new Tip into a cuvette, pushing it down inside until it takes on
the shape of the inside of the cuvette (Fig. 9).
7. Remove the cuvette, connect the aspiration tube to the cannula and reposition the cannula back
into its proper housing in the wash station. Be careful to not kink the aspiration tube while doing
so.
8. Reposition the spring in its proper housing. Remount the wash station coverlid making sure that
the cylindrical tops of the cannulas fit into the corresponding holes on the wash station coverlid.
9. Manually move the wash station downwards and centre the tip with the cuvette turning it.
10. Remount the Washing station protective cover (Fig. 1).

Push the new Tip into the cuvette

Pull to remove the used Tip

Fig. 8 Fig. 9

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7.7 HYDRAULIC CIRCUIT WASHING

During normal use and over time, mold and dust can build up inside the wash bottles and can have a
negative effect on the hydraulic circuit, compromising the correct functioning of the micro-pump and
valves. This, in turn, can lead to inefficiency in the sampling probe and cuvette washing system.

For this reason, it is extremely important that the hydraulic circuit be periodically washed. Said
cleaning must be thorough and meticulous in order to assure that every trace of mold or residue be
removed.

How often the hydraulic circuit must be washed depends on the operating conditions/environment of
the single instrument and the quality of the distilled water used in that particular laboratory. The
manufacturer recommends thorough washing at least once a month.

It is extremely important that the user not underestimate the risks associated with mold and dust
particles. They are to be regarded as a serious hazard as they can be the cause of instrument
malfunction.

The hydraulic circuit input cannulas are located inside the bottles on the left side of the Analyzer.

7.7.1 HYDRAULIC CIRCUIT - CLEANING PROCEDURE

1) Turn on the Analyzer.

2) Prepare a bottle containing 500 ml of a 5% sodium hypochlorite solution

3) Insert the four aspiration cannulas, located inside the liquids bottles, into the bottle containing
the sodium hypochlorite solution.

4) Have the instrument carry out a ‘WBL’ cycle and then a ‘Wash cuvettes’ cycle.

5) Wait for fifteen minutes. Clean and dry the four cannulas and then insert them into a bottle
containing distilled water.

6) Have the instrument carry out a ‘WBL’ cycle and then a ‘Wash cuvettes’ cycle.

7) Insert the four aspiration cannulas back into their respective bottles. Said bottles should have,
in the meantime, been cleaned and filled with a fresh supply of the required solution.

8) Have the instrument carry out a ‘WBL’ cycle and then a ‘Wash cuvettes’ cycle. Check system
efficiency by comparing the WBL values and the test results obtained against the laboratory’s
quality control values.

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7.8 CHANGING THE PERISTALTIC PUMP TUBES

The manufacturer recommends that the Peristaltic Pump tubes be replaced every six months. Said
frequency may vary depending on the workload of the individual laboratory. The quality and
reliability of these tubes is fundamental to a correct emptying of the cuvettes.

7.8.1 PROCEDURE FOR REPLACING THE PERISTALTIC PUMP TUBES

1. Open the panel located on the right side of the instrument pushing down the looking door (Fig. 1).
2. Unhook the hinged guide by pushing the pin toward to the left (Fig. 2).
3. Pull the tubes off their relative nipples and substitute with new ones (Fig. 2).
4. After having unlooked the hinged guide, disconnect the tubes from their nipples
5. Remount, repeating the above steps, 4 through 2, in reverse order. Turn clock wise the peristaltic
pump rotor, in manual way, in order to be sure that tubes are right positioned inside the guide.

Tubes to be replaced
Looking door Pin

Hinged guide lock

Peristaltic Pump Rotor Nipples

Fig. 1 Instrument right side Fig. 2 Peristaltic Pump Assembly

6. Turn on the Analyzer and wait until the instrument has reached its proper operating temperature.
7. Have the instrument carry out a ‘Wash cuvettes’ cycle and then a ‘WBL’ cycle. Check system
efficiency by comparing the WBL values and the test results obtained against the laboratory’s
quality control values.

8. Make sure that there is no leakage and then close back the panel.

• Always use original replacement parts; never lubricate the peristaltic pump roller bearings.
• After prolonged instrument inactivity: verify the efficiency of the peristaltic pump tubes.

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Please note: if the instrument is not able to completely empty the washing well, check the condition
of the tube and make sure that there are not obstruction into the hydraulic lines.

7.9 CHANGING THE PHOTOMETER LAMP

The manufacturer suggests that the lamp be replaced after approximately 2000 hours of use.
Figure 2 illustrates the photometer lamp, its support base and its power supply wires. There is a small
hole on the lamp base useful for its mechanical alignment. The lamp is mounted on the photometer,
which is located on the left-hand side of the reaction plate.

7.9.1 PROCEDURE FOR REPLACING THE PHOTOMETER LAMP

1) Turn off the Analyzer.
2) Remove the front panel unscrewing the four anchored screws (Fig. 1).
3) Disconnect the power supply wires from the Lamp Regulator Board by loosening the clamp
screws on the M1 connector (Fig. 2).
4) Unscrew the lamp’s fastening screw and remove the lamp from its housing (Fig. 2)
5) Replace the old lamp with a new one making sure that the pin is correctly inserted in the
alignment hole (Fig. 2). Remount the assembly by repeating the above steps 4 through 1 in
inverse order.
6) Turn the Analyzer on and wait until the instrument has reached its proper operating
temperature.
7) Have the instrument carry out a ‘WBL’ cycle. Check system efficiency by comparing the WBL
values and the test results obtained against the laboratory’s quality control values.

Anchored screw

Fig. 1 Instrument front view

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Halogen Lamp

Lamp's fastening screw

M1 Connector

Fig. 2 Photometer

WARNING! DO NOT TOUCH THE GLASS PART OF THE LAMP WITH YOUR FINGERS!
IF NECESSARY, USE A CLEAN CLOTH TO REMOVE DUST, OR ALCOHOL TO REMOVE MORE
STUBBORN DIRT.

7.10 CHANGING THE REACTION CUVETTES

Over time and through normal use the perfect transparency of the cuvettes diminishes. This less-than-
perfect transparency has a negative impact on the quality of the optical readings. The manufacturer
suggests that the cuvettes be replaced after three months of use. The cuvettes racks are located inside
the reaction plate.
7.10.1 PROCEDURE FOR REPLACING THE REACTION CUVETTES
1. Turn on the Analyzer and wait until the instrument has reached its proper operating
temperature.

2. Click on the change cuvettes rack button , located under the work program (Please see
Chapter 03 – Description of Instrument Software).

3. A pull-down menu will appear. Click on the rack number 1 and then on OK, in order to have
the selected rack accessible (Fig. 1)

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Reaction Rack cover

Fig. 1

4. Remove the reaction rack cover from its housing (Fig. 1).
5. Turn the two locking pins making free the reaction rack.

6. Remove the reaction rack from its housing and replace it with a new one (Fig. 2).
7. Make sure to reinsert the new rack VERTICALLY. Turn the two locking pins in order to fix
the rack. Be especially careful to not touch the external surface of the cuvettes dedicated to
photometric reading.
8. Repeat the procedure from point 2 to 7 in order to replace the reaction racks from 2 to 6.
9. Have the instrument carry out a ‘WBL’ cycle. Check system efficiency by comparing the WBL
values and the test results obtained against the laboratory’s quality control values.

Reaction Rack

Fig. 2

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locking pin

Fig. 3

7.11 CHANGING THE TUBES KIT

Over time and through normal use, the tubes become worn.
The manufacturer suggests that the tubes be replaced at least once a year. These tubes are located
inside the instrument to link the Washing Station, the Peristaltic Pump and the Washing Well to the
Washing Pump Assembly.

7.11.1 PROCEDURE FOR REPLACING THE TUBES KIT

1. Turn off the Analyzer.

2. Unscrew the four screws to remove the panel located on the rear side of the instrument to
access the washing pump assembly (Fig. 1 and Fig 2).
3. Replace the tubes following the indications provided in the hydraulic diagram (SI-
00571-01).
4. Turn on the Analyzer and wait until the instrument has reached its proper operating
temperature.
5. Have the instrument carry out a ‘Wash cuvettes’ cycle and then a ‘WBL’ cycle. Make sure that
there is no leakage.
6. Check system efficiency by comparing the WBL values and the test results obtained against the
laboratory’s quality control values.

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Fig. 1 Instrument rear view

Fig.2 Pumps module

7.12 TABLE C – LIST OF THOSE MAINTENANCE PROCEDURES THAT

CAN BE PERFORMED BY THE USER AND/OR BY THE
MAINTENANCE TECHNICIAN

EFFECTUATED
PROCEDURE FREQUENCY (*)
BY
CLEANING THE SAMPLING PROBE DAILY OPERATOR

CLEANING THE FOUR WASH STATION EVERY TWO

OPERATOR
CANNULAS WEEKS

CLEANING THE WASH SOLUTION EVERY TWO

OPERATOR
BOTTLES WEEKS
EVERY THREE
REPLACING REACTION CUVETTES OPERATOR
MONTHS
CLEANING THE TIP ONCE A MONTH OPERATOR
REPLACING THE TIP AS NEEDED OPERATOR
AS NEEDED
ALIGNING AND ADJUSTMENT OF THE
SAMPLING ARM (e.g.: after replacing OPERATOR
any mechanical
(Std&Ctr/Reagents/Samples/Dispensing)
part)

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 Chapter 07 - MAINTENANCE

REPLACING THE PERISTALTIC PUMP EVERY SIX

OPERATOR
TUBES MONTHS
AFTER 2000
REPLACING THE PHOTOMETER BULB OPERATOR
HOURS OF USE

REPLACING THE SAMPLING PROBE AS NEEDED OPERATOR

CLEANING THE HYDRAULIC CIRCUIT AS NEEDED OPERATOR

MAINTENANCE
REPLACING THE TUBES (Tubes Kit) ONCE A YEAR
TECH

REPLACING THE PRE-HEATER AND THE MAINTENANCE

AS NEEDED
SENSOR LEVEL TECH
MECHANICAL ALIGNMENT OF THE MAINTENANCE
AS NEEDED
SAMPLING ARM TECH
REPLACING OR ADJUSTING THE OPTIC MAINTENANCE
AS NEEDED
SENSORS TECH
MAINTENANCE
REPLACING THE BELT AS NEEDED
TECH
MAINTENANCE
REPLACING A MOTOR AS NEEDED
TECH
ALIGNING THE WASH STATION/REACTION MAINTENANCE
AS NEEDED
PLATE TECH
ALIGNING THE REACTION OR REAGENT MAINTENANCE
AS NEEDED
OR SAMPLE PLATE TECH

MAINTENANCE
REPLACING THE PHOTOMETER AS NEEDED
TECH

MAINTENANCE
ADJUSTING THE PHOTOMETER AS NEEDED
TECH
REPLACING THE ELECTRONIC
MAINTENANCE
BOARDS/CARDS AND THE MECHANICAL AS NEEDED
TECH
MODULES

N. B.: the above-indicated frequency intervals may vary according to the individual instrument’s
daily workload.

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7.13 DECONTAMINATION PROCEDURE

Before replacing any instrument parts, repairing any defective items or performing any instrument
maintenance procedure(s), the operator or maintenance technician must carry out the below-
described decontamination procedure of the instrument part(s) involved in the operation(s).
This procedure can be performed on:
the entire Analyzer
those part(s) of the instrument subject to possible contamination

Material necessary

- an ESOFENOL solution diluted to 6% (60 cc in one liter of distilled water). ESOFENOL is

an antibacterial and antiviral substance.
- Rubber gloves
- Mask
- Lab coat

External surfaces and individual parts

Spray the solution all over the instrument, paying particular attention to wetting:
- the sampling arm
- the reaction plate (including the cuvettes)
- the reagent and standard and control plate
- the sample plate (including the racks)
- the instrument chassis
Allow the solution to stand for approximately 30 minutes
Wipe the solution off the instrument and the various components using a sponge dampened
with distilled water

Carry out a decontamination of the internal hydraulic circuit.

Hydraulic circuit (Entire Instrument)

Fill a container with a 5% sodium hypochlorite solution.

Disconnect the three silicon aspiration tubes from the nipples on the caps of their respective
tanks.
Immerge all three tubes into the container filled with the 5% sodium hypochlorite solution and
have the instrument carry out two ‘Wash cuvettes’ cycles and then two ‘WBL’ cycles.
Remove the three tubes from the 5% sodium hypochlorite solution and immerge them in another
container containing the instrument Rinse Solution.
Have the instrument carry out one ‘Wash cuvettes’ cycle and then one ‘WBL’ cycle.
Reconnect the three aspiration tubes to the nipples on their respective tanks.

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CHAPTER 08
FORMULAS AND CALCULATION MODELS

INDEX

8.1 END POINT METHODOLOGY - SINGLE REAGENT............................................................ 2

8.2 END POINT METHODOLOGY - SINGLE REAGENT........................................................... 4

8.3 “END POINT LIMIT” CONCEPT .............................................................................................. 5

8.4 “RGT RATE” CONCEPT............................................................................................................ 6

8.5 END POINT METHODOLOGY - TWO REAGENTS.............................................................. 7

8.6 END POINT METHODOLOGY - TWO REAGENTS.............................................................. 9

8.7 SAMPLE BLANK CORRECTION......................................................................................... 11

8.8 FIXED TIME OR INITIAL RATE METHODOLOGY........................................................... 15

8.9 FIRST LIMIT CONCEPT......................................................................................................... 17

8.10 FIXED TIME OR INITIAL RATE METHODOLOGY –...................................................... 18

8.11 DEPLETION LIMIT CONCEPT WITH FIXED THERSHOLD......................................... 20

8.12 DEPLETION LIMIT CONCEPT............................................................................................ 21

8.13 KINETICS METHODOLOGY............................................................................................... 24

8.14 TIMING OF THE KINETIC REACTIONS ........................................................................... 26

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This chapter describes the mathematical models and the formulas used to define the results of the
analyses carried out with the Ellipse instrument.

The three principal groups of analysis are:

- End Point Mono and Bi Reagent, Monochromatic and Bichromatic

- Fixed Time or Initial Rate Mono and Bi Reagent, Monochromatic and Bichromatic
- Kinetics Mono and Bi Reagent, Monochromatic and Bichromatic

The same “Final Result” formula is used for each analysis group:

Final Result = (Analytical Result x Unit Conversion Factor) x Slope + Intercept

The Slope and Intercept parameters refer to the conventional formula Y = aX + b where:

Y = results of the reference instrument

X = results of the Ellipse instrument
a = slope
b = intercept

reporting the Y values (reference instrument) in ordinate and X (Ellipse system) in abscissa.

8.1 END POINT METHODOLOGY - SINGLE REAGENT

Monochromatic, Without Sample Blank

This methodology is used to determine the substrate concentrations.

For each "End Point" test, the system carries out three readings expressed in optical density,
respectively at times T0, T1-13" and T1.

These readings and times are both displayed on the Reaction Graph. In order to visualize the graph,
select the relevant test and then click on the button “Graph” (the graph also appears by clicking
twice the selected test).

The Analytical Result is obtained using the Abs (T1) RBL value, that is taken during the calibration
phase as the first reading point, and Abs (T1) taken during the analysis phase as the second reading
point.

The T0 reading is not used for this method type.

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Absorbance Add
(Abs) Sample/Std+Rgt
Abs (T1)

RBL

T0 Time
T1-13” T1
INCUBATION

STD Concentration
Analytical Result = CF x [Abs (T1) - RBL] CF = _______________
Abs STD (T1) - RBL
Where:

T1 - T0 = Incubation time (1032" max)

RBL = Reagent Base Line value taken at time (T1) during the calibration phase and
displayed in the calibration results window. This value is used as the first reading
point to produce the Analytical Result.

Abs (T1) = Reading carried out at the end of the incubation period and used as the second
reading point to produce the Analytical Result.

Furthermore, an absorbance reading is also carried out at time T1 - 13". It is used to check the reaction
stability (End Point Limit).

ABBREVIATIONS:

STD = Standard
CF = Calibration Factor
RBL = Reagent Base Line
Example:

GLU
CF = 295
Res 91 RBL = 0.0251

Abs Time Analytical Result = CF x [Abs (T1) - RBL]

0.236 0 (T0)
0.3319 317 (T1 -13") Analytical Result = 295 x (0.3336 - 0.0251) = 91
0.3336 330 (T1)

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8.2 END POINT METHODOLOGY - SINGLE REAGENT

Monochromatic, With Sample Blank

For each "End Point" test, the system carries out three readings expressed in optical density,
respectively at time T0, T1-13" and T1.

These readings and times are both displayed on the Reaction Graph. In order to visualize the graph,
select the relevant test and then click on the button “Graph” (the graph also appears by clicking
twice the selected test).

The Analytical Result is obtained using the optical density readings at times T0 and T1 respectively
as the first and second reading points.

• Attention: In the event of a fast reaction where the first reading point value taken (Abs (T0) is
significantly higher with respect to the RBL value detected during the calibration phase, it is not
possible to use this type of methodology.

Absorbance Add
(Abs) Sample/Std+Rgt
Abs (T1)

Abs (T0)

Time
T0 T1-13” T1
INCUBATION

STD Concentration
Analytical Result = CF x [Abs (T1) - Abs (T0)] CF = ____________________
Abs (T1)STD - Abs (T0)

Where:

T1 - T0 = Incubation time (1032" max)

Abs (T0) = the reading expressed in absorbance carried out immediately after the reagent and
sample have been dispensed. This value is used as the first reading point to produce
the Analytical Result.

Abs (T1) = the reading expressed in absorbance carried out at the end of the incubation time
and used as the second reading point to produce the Analytical Result.

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Furthermore, an absorbance reading is also carried out at time T1 - 13". It is used to check the
reaction stability "End Point Limit".

ABBREVIATIONS:

STD = Standard
CF = Calibration Factor
RBL = Reagent Base Line

Example: CF = 295

GLU
Analytical Result = CF x [Abs (T1) - Abs (T0)]
Res 91

Abs Time
0.237 0 (T0) Analytical Result = 295 x (0.5454 - 0.237) = 91
0.5442 317 (T1 -13")
0.5454 330 (T1)

8.3 “END POINT LIMIT” CONCEPT

The end point limit is a check performed by the analyzer to verify the reaction stability and determine
the validity of the result obtained.

An acceptability value (expressed in absorbance) is inserted by the operator into the End Point field
in the method parameters (See Chapter 05 - Methodology in the present manual).

A low acceptability value increases the severity of the control, while a high value reduces the same.

Result’s acceptability conditions:

Abs (T1) - Abs (T1 - 13") < End Point Limit

Absorbance Add Sample/Std+ Rgt

(Abs)
Confidence
limit

Time
T1 – 13" T1

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∆Abs = Abs (T1) - Abs (T1 - 13") = 0.3336 - 0.3319 = 0.0017 < End Point Limit

The following example shows how the end point limit value is calculated:

Calibration factor obtained = 300

By maintaining an uncertainty of 1 mg as acceptable, it follows:

1 mg
The value to be inserted in the End Point Limit box, represents in
________ = 0.003
absorbance, the uncertainty that may exist between Abs (T1) and Abs
300 (T1 - 13")

In the analysis phase, tests in which the following ratio is verified:

Abs (T1) - Abs (T1 - 13") > 0.003 (End Point Limit)

the results will be flagged "A" .

8.4 “RGT RATE” CONCEPT

The Reagent Rate represents in terms of absorbance, the reagent’s mobility during the reaction.

Absorbance
(Abs)

RGT Rate
RBL

T0 T1 Time

The RGT Rate value is automatically evaluated in the calibration phase and displayed in the
Calibration results mask. The RGT Rate value is not displayed in End Point methods because it is
already enclosed in the RBL value. In the End Point Methods with two reagents, the RGT Rate value
measured is used for the analytical result calculation only when the Sample Blank correction is
actively selected. The RGT Rate correction could be positive or negative according to the direction
of the reaction (Up or Down).

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8.5 END POINT METHODOLOGY - TWO REAGENTS

Monochromatic, Without Sample Blank

For each "End Point" test that uses two reagents, the system carries out four readings expressed in
optical density, respectively at time T0, T1- 8" , T2-13" and T2.

These readings and times are both displayed on the Reaction Graph. In order to visualize the graph,
select the relevant test and then click on the button “Graph” (the graph also appears by clicking
twice the selected test).

The T0 reading is not used for this method type. The system obtains the Analytical result by using the
Abs (T2) RBL value, detected during the calibration phase, as the first reading point and Abs (T2)
value taken during the analysis phase as the second reading point.

Add Sample/Std+ Rgt 1 Add Rgt 2

Absorbance
( Abs)

RBL

Time
T0 T1 T2 - 13" T2

INCUBATION R1 INCUBATION R2

Analytical Result = CF x [Abs (T2) – RBL]

STD Concentration
CF = _______________
[Abs STD (T2) – RBL]

Where:

T1 - T0 = Incubation time Reagent 1

T2 - T1 = Incubation time Reagent 2
(The total time must be < 1040")

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RBL = Reagent Base Line value taken at time (T2) during the calibration phase and
displayed in the calibration results window. This value is used as the first reading
point to produce the Analytical Result.

Abs (T2) = reading expressed in absorbance carried out at the end of the incubation time R2
(T2) and used to produce the Analytical Result.

Furthermore an absorbance reading is also carried out at time T2 - 13". It is used to check the reaction
stability "End Point Limit".

ABBREVIATIONS:
STD = Standard
CF = Calibration Factor
RBL = Reagent Base Line

Example:

CA2

Res 11.9
CF = 27.78
RBL = 0.3416
Abs Time
0.3037 0 (T0) Analytical Result = CF x [Abs (T2) - RBL]
0.3133 18 (T1 - 8")
0.7711 330 (T2 - 13")
0.7700 343 (T2)

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8.6 END POINT METHODOLOGY - TWO REAGENTS

Monochromatic, With Sample Blank

For each "End Point" test that uses two reagents, the system carries out four readings expressed in
optical density, respectively at the time T0, T1- 8" , T2-13" and T2.

These readings and times are both displayed on the Reaction Graph. In order to visualize the graph,
select the relevant test and then click on the button “Graph” (the graph also appears by clicking
twice the selected test).

The Analytical Result is obtained by the system using the Abs T1 - 8" value as the first reading point
and Abs (T2) value as the second reading point, described in the chart below.

• Attention: This methodology type can be used as an automatic sample blank correction. In fact,
the first reading point T1 - 8" corresponds to the absorbance value “Rgt1+Sample” in the reaction
cuvette. In order to obtain a correct reading at the time T1 - 8" , the minimum Rgt1+ Sample
volume must be ≥ 220 µL.

Add Sample/Std+ Rgt1 Add R2

Absorbance
( Abs)

RBL

Time
T0 T1-8 " T1 T2 -13" T2

INCUBATION R1 INCUBATION R2

Analytical Result = CF x {[Abs T2 – (Abs T1 – 8" x VCF)] ± RGT Rate}

STD Concentration
CF = _____________________________________
[Abs T2 – (Abs T1 – 8" x VCF)] ± RGT Rate

Where:

T1 - T0 = Incubation time R1
T2 - T1 = Incubation time R2

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Abs (T1 - 8") = reading, expressed in absorbance, taken 8 seconds before the end of the Incubation
time R1. This reading is used as the first reading point to produce the Analytical
Result.

Abs (T2) = reading, expressed in absorbance, taken at the end of the incubation time R2 and
used to produce the Analytical Result.

VCF = Volume Correction Factors. This factor is automatically calculated by the system
and is introduced to compensate for the dilution ratio introduced with the addition
of the second reagent.

RGT RATE = reading, expressed in absorbance, of the reagents’s mobility during the reaction.
This value is automatically calculated during the phase of calibration and is
reported in the “Calibration Results” window.

Furthermore an absorbance reading is also carried out at time T2 - 13". It is used to check the reaction
stability "End Point Limit".

ABBREVIATIONS:
STD = Standard
CF = Calibration Factor
VCF = Volumetric correction factor
RGT Rate = Reagent rate
V1 = Total volume of reagent1 + sample. It must be ≥ 220 ml
V2 = Total volume of reagent1, plus sample, plus reagent 2

Example:

DBIL CF = 85.47
RGT Rate = 0.0036
Res 3.0

Abs Time V1 R1 + Sample

0.1187 0 (T0) VCF = =
0.1336 18 (T1 - 8") V2 R1 + Sample + R2
0.1662 330 (T2 - 13")
0.1681 343 (T2) 300 + 12
VCF = = 0.9689
300 + 12 + 10

Analytical Result = CF x { [Abs T2 - (Abs T1- 8" x VCF)] ± RGT Rate }

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8.7 SAMPLE BLANK CORRECTION

In the End Point monoreagent methodology where the absorbance of the sample itself can affect the
analytical result, it is necessary to evaluate the Sample Blank. This correction can be done by
choosing one of the following according to the specific need:

• Sample blank (on line correction)

• Differential (absolute correction)

• Bichromatic (partial correction)

SAMPLE BLANK

This option performs the calculation of the "Sample Blank" on line, without using the differential or
bichromatic type methodologies.
This correction will be considered in the Analytical Result only if the “Sample Blank” field located
on the method parameters (See Chapter 05 - Methodology in the present manual).
This kind of correction must be considered valid only for slow developing reactions (monoreagent).
As the basis for the calculation, a reading is taken at time T0, immediately after the dispensing of the
sample in the reagent, neglecting the value of the RBL (the value of the RBL is not taken in
consideration for the calculation of the final result).
In two reagent reactions, a reading is taken at time T1 – 8” and used as the basis for the calculation of
the final result.

DIFFERENTIAL

This type of methodological approach is used for the resolution of the problems posed by the
"Sample Blank", and is always usable. Most importantly, it is decisively the most valid approach.
The operative disadvantages due to this type of methodology are the following:

• A double system cycle (one for the "Sample Blank" and one for the reaction).
• Use of two cuvettes (one for the "Sample Blank" and one for the reaction which are read on the
same wave-length.)
• Double Consumption of the sample volume.

Absorbance Add
( Abs) Sample + Rgt
Abs (T1)

∆ Reaction Variation

Abs (T0)
AbsSB
∆ Sample Blank
AbsSB (T0)
Time
T0 T1

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Analytical Result = CF x { [∆ ABS (reaction) - ∆ ABS(Sample blank)] }

Analytical Result = CF x { [Abs (T1) - Abs (T0) ] - [AbsSB (T1) - AbsSB (T0) ] }

STD Concentration
CF = ________________________________________
{ [Abs (T1) - Abs (T0) ] - [AbsSB (T1) - AbsSB (T0) ] }

BICHROMATIC

This type of methodology is applicable to the End Point reactions, which require a reading of the
"Sample Blank". The correction that will carry onto the matrix, is not absolute, but relative.

The Bichromatism use requires the following selections:

• A secondary wavelength (filter 2) useful for the evaluation of the absorbance due only to the
biological liquid’s properties (turbidity, ittera, hemolyses).
• A bichromatic correction factor.

Absorbance
Add
Sample + Rgt
Abs F1 (T1)

∆ Reaction filter 1

Abs F1 (T0)
AbsF2 (T1)
∆ Reaction filter 2
AbsF2 (T0)
Time
T0 T1

Analytical Result =CF x {[∆ Abs(Reaction filter 1)]-[Bic.Fact. x ∆ Abs(Reaction filter 2)]}

Analytical Result =CF x {[Abs F1 (T1) - Abs F1 (T0) ] - [Bic.Fact. x[AbsF2 (T1) - AbsF2 (T0) ]]}

STD Concentration
CF = ______________________________________________
{ [Abs F1 (T1) - Abs F1 (T0) ] - [Bic.Fact. x[AbsF2 (T1) - AbsF2 (T0) ]]}

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N.B. As the absorbance spectrum of the interferential substance is varied (turbidity, ittera or
hemolyses), the choice of the second wavelength will be in function of the interferential
substance that is meant to be corrected.

The secondary filter choice is made with the following criteria:

1. Significant indication of the interferent absorbance to be taken in consideration
2. Minimum evaluation in terms of chromogene absorbance

The possibility to make this choice is supplied by observation of the absorbance spectrum of the
chromogene by the interferential substances, using a scansion spectrophotometer.
If it is not possible to use a spectrophotometer, an alternative can be found by coupling the following
historical indications:

For all the NADH dependent reactions (End Point, Kinetics), ascendant or descendant, resort is
made to a prevailing correction of turbidity:

F1 = 340 F2 = 380

For all the reactions read at 405 nm with substrate equivalent to Paranitrophenol, Paranitroaniline
etc. ascendant or descendant, a prevailing correction of the ittera is performed:

F1 = 405 F2 = 492 (460/500)

For all the reactions having TRINDER indicators, a prevailing correction of the emulsion
(hemolyses) is performed:

F1 = 510 F2 = 578 (560/580)

For all the reactions, a prevailing correction of the turbidity with a filter is performed:

F2 = 620 (600/700)

Examples:

Prot. Tot F1 = 546 F2 = 620

Calcium F1 = 578 F2 = 620

Bil. Tot. F1 = 546 F2 = 620

Etc. etc.

For the calculation of the bichromatic correction factor, please refer to the example on the following
page.

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EXAMPLE OF THE CALCULATION OF THE BICHROMATIC CORRECTION FACTOR

The example illustrated below presupposes the use of a primary filter at 620 nm and a correction of
the matrix with a filter at 510 nm.

END POINT
Absorbancies/Times Chart

RBL SAMPLE
620 nm
OPTICAL DENSITY TIMES OPTICAL DENSITY TIMES
0.0015 B620 0 0.0495 A620 0
0.0015 174 0.267 174
0.0015 187 0.268 187
510 nm
1 1
0.001 B 510 187 0.174 A 510 187

Increase of the absorbance due to the reaction (Rgt + Smp) at 620 nm equal to:

A620 - B620 = 0.0495 - 0.0015 = 0.048

Increase of the absorbance due to the reaction (Rgt + Smp) at 510 nm equal to:
1 1
A 510 -B 510 = 0.174 - 0.001 = 0.173

0.048 (∆Abs 620 nm)

BICHROMATIC FACTOR = __________________________ = 0.277
0.173 (∆Abs 510 nm)

The combination of the Absorbance and Time are both displayed on the Reaction Graph. In order to
visualize the graph, select the relevant test and then click on the button “Graph” (the graph also
appears by clicking twice the selected test).

The Abs values of the samples, should have been taken from several different numbers “n” of
matrixes, in order to obtain an average that is as representative as possible.

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8.8 FIXED TIME OR INITIAL RATE METHODOLOGY

Single Reagent, Monochromatic

This methodology type does not need of any correction referring to the possible interference due to
the sample (matrix), since the results are calculated with variations of absorbance (∆ Abs), and not
with absolute values of absorbance.

For each "Fixed Time" test single reagent, the system carries out five readings expressed in optical
density, respectively at the times T0, T1-13" , T1, T2-13" and T2.

These readings and times are both displayed on the Reaction Graph. In order to visualize the graph,
select the relevant test and then click on the button “Graph” (the graph also appears by clicking
twice the selected test).

The Analytical result is obtained by the system using the ∆Abs obtained between Abs(T1) value as
first reading point and Abs (T2) value as second reading point as described in the following formula:

Absorbance
(Abs) Add Sample/Std+ Rgt

Abs (T2) Sample

or Standard

Abs (T1) Sample

or Standard

Abs (T2) Reagent

Abs (T1) Reagent

T0 T1 -13" T1 T2 -13" T2
Time

STD Concentration
Analytical Result = CF x (∆Abs Sample ± RGT Rate) CF =
∆Abs Standard ± RGT Rate

Where:

T1 - T0 = Incubation Time

T2 - T1 = Reading time

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∆Abs Standard = the value expressed in absorbance variation detected between the end and the
beginning of the reading time (Abs T2 - Abs T1). This value is taken during the
calibration phase and it is memorized in the calibration results screen. It is used to
determine the calibration factor which will be used to produce the Analytical
Result.

∆Abs Sample = the value expressed in absorbance variation detected between the end and the
beginning of the reading time (Abs T2 - Abs T1). This value is taken during the
analysis phase and it is used to produce the Analytical Result.

RGT RATE = The reagent rate is the mobility of the reagent it self during the reaction express in
Absorbance (Abs T2 Reagent - Abs T1 Reagent). This value is automatically calculated during the
calibration phase and it is memorized in the calibration results window. The RGT Rate correction
could be positive or negative according to the direction of the reaction (Up or Down).

Furthermore, two absorbance variations are also carried out between time T2 and T2 - 13" and
between T1 and T1 - 13 ". These absorbance variations are used to check the reaction stability "First
Limit".

ABBREVIATIONS:

STD = Standard
CF = Calibration Factor

Example:

CF = 5.00
CREAT RGT Rate = 0.015

Ris 1.46

Abs Time
0.2362 0 (T0)
0.2451 5 (T1 - 13")
0.3732 18 (T1 )
0.6047 83 (T2 - 13")
0.6796 96 (T2)

Analytical Result = CF x [(Abs SMP T2 - Abs SMP T1) - (Abs RGT T2 - Abs RGT T1)]

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8.9 FIRST LIMIT CONCEPT

This is a control of the reaction stability, where:

∆Abs1 = Abs (T1) - Abs (T1 -13")

∆Abs2 = Abs (T2) - Abs (T2 - 13")

In case the following formula is not satisfied

∆Abs1 - Lin Fact x ∆Abs2 < First Limit

the result of the test carried out will be accompanied by the “A” flag.

Add Sample/Std+ Rgt

Absorbance
( Abs)

∆Abs2
∆Abs1

Time
T0 T1 -13" T1 T2 -13" T2

INCUBATION READING

HOW CALCULATE THE FIRST LIMIT AND THE LINEAR FACTOR

1) Initially increase the First Limit Value (e.g.: First Limit Value = 1 indicates absorbance
differences equal to 1000, for which there will be no flag)
2) Launch routine
5 samples low pathological level
5 samples normal level
5 samples high pathological level
3) Select the graph of the reactions, and evaluate the two partial deltas (∆Abs1, ∆Abs2) sample by
sample.
4) Calculate the average for the three sample series for the ∆Abs1 and ∆Abs2 values.
∆Abs1
The ratio _________________ = Linear Factor
∆Abs2
This factor permits the correlation of the two absorbancies for the "First Limit" control.
The effective value of the First Limit to be inserted into the methodology, will be established by the
operator according to the same criteria followed for the End Point Limit, that is in function to the
severity of the desired control. Elevated values of Abs reduce the efficiency of the control.

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

8.10 FIXED TIME OR INITIAL RATE METHODOLOGY –

TWO REAGENTS Monochromatic

This methodology type does not need of any correction with reference to the possible interference
due to the sample (matrix), since the results are calculated with variations of absorbance (∆ Abs), and
not with absolute values of absorbance.
For each "Fixed Time" test two reagents, the system carries out six readings expressed in optical
density, respectively at times T0, T1, T2-13" , T2, T3-13" and T3.

These readings and times are both displayed on the Reaction Graph. In order to visualize the graph,
select the relevant test and then click on the button “Graph” (the graph also appears by clicking
twice the selected test).

The system gets the Analytical result by using the ∆Abs obtained between Abs(T2) value as the first
reading point and Abs (T3) value as the second reading point as described in the following formula:

Absorbance Add Sample/Std+ Rgt 1

(Abs)

Abs (T2) Sample

or Standard
Add Rgt 2

Abs (T1) Sample

or Standard

Abs (T2)
Reagent

Abs (T1)
Reagent
T0 T1 T2 -13" T 2 T3 -13" T3 Time

INCUBATION R1 INCUBATION R2 READING

STD Concentration
Analytical Result = FC x (∆Abs Sample ± RGT Rate) CF =
∆Abs Standard ± RGT Rate

Where:

T1 - T0 = Incubation Time R1

T2 - T1 = Incubation Time R2

T3 - T2 = Reading time

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

∆Abs Standard = the value expressed in absorbance variation detected between the end and the
beginning of the reading time (Abs T3 - Abs T2). This value is taken during the
calibration phase and it is memorized in the calibration results screen. It is used to
determine the calibration factor which will be used to produce the Analytical
Result.

∆Abs Sample = the value expressed in absorbance variation detected between the end and the
beginning of the reading time (Abs T3 - Abs T2). This value is taken during the
analysis phase and it is used to produce the Analytical Result.

RGT RATE = the reagent rate is the mobility of the reagent itself during the reaction Absorbance
(Abs T3 Reagent - Abs T2 Reagent). This value is automatically calculated during
the calibration phase and it is displayed in the calibration results window. The RGT
Rate correction could be positive or negative according to the direction of the
reaction (Up or Down).

Furthermore, two absorbance variations are also carried out between times T3 and T3 - 13" and
between T2 and T2 - 13 ". These absorbance variations are used to check the reaction stability "First
Limit".

ABBREVIATIONS:

STD = Standard
CF = Calibration Factor

Example:

CRE AT 2RGT CF = 33
RGT Rate = 0.0089
Ris 0.90

Abs Time
0.2852 0 (T0)
0.2868 18 (T1 )
0.5577 31 (T2 - 13")
0.5738 44 (T2)
0.5991 109 (T3 - 13")
0.6100 122 (T3)

Analytical Result = CF x [(Abs T3 - Abs T2) ± RGT Rate]

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

8.11 DEPLETION LIMIT CONCEPT WITH FIXED THRESHOLD

This is a control parameter for the reaction. If the initial reaction happens quickly, it can exhaust the
substrate, and needs to be checked to avoid errors. This parameter refers to absolute values of
absorbance, meaning that it can be applied on Initial Rate and Kinetic methods only.
These values must never be reached during the entire analytical process for either the positive
reactions (UP) or the negative ones (Down) as specified in the method parameters.

When the direction of the reaction is positive (UP), and the absorbance values detected at the
beginning and at the end of the reading time are greater than the value inserted into the field “Dep.
Lim” in the method parameters (See Chapter 05 - Methodology in the present manual),
the results will be two asterisks accompanied by a flag “A”.
When the direction of the reaction is negative (DOWN), and the absorbance values detected at the
beginning and at the end of the reading time are less than the value inserted into the field “Dep. Lim”
in the method parameters (See Chapter 05 - Methodology in the present manual),
the results will be two asterisks accompanied by a flag “A”.

POSITIVE REACTIONS (UP)

Absorbance
( Abs) FLAG “A”

Depletion Limit

Abs (T1)

NO FLAG
Abs (T0)

T0 T1
Time
INCUBATION READING

NEGATIVE REACTION (DOWN)

Absorbance
( Abs)

Abs (T0)
NO FLAG

Abs (T1)

Depletion Limit
FLAG “A”
Time
T0 T1
INCUBATION READING

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

8.12 DEPLETION LIMIT CONCEPT

With Bichromatic Correction Factor (Variable Threshold)

Bichromatic readings have several advantages amongst which surely the most interesting is the
possibility to consider the matrix effect in the kinetic reactions, with the aim of compensating for the
value of the "Depletion Limit" (see previous page).

Taking once again the graph on the previous page into consideration:

Absorbance Absorbance

DL DL

Matrix
Effect

Time Time

The value of the Depletion Limit (DL) is expressed in the absolute value. Considering the
introduction of a sample with a particular matrix, which creates a rising of the reaction curve, (graph
at right) one has a lower DL value, that is consequently erroneously flagged next to the Analytical
results that will be two asterisks.

With the bichromatic correction it is possible to measure the amount of interference created by the
matrix effect on the basic reaction. This amount will be taken into account for modifying the DL
value, as illustrated below:

Absorbance

B
λ1

λ2 A

Time

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

The correct Depletion Limit value is represented by the following formula:

DL (corrected) = DL(in method) + BCF

Where:

Segment A = represents the absorbance value of the matrix wave-length λ2.

Segment B = represents the absorbance value of the matrix wave-length λ1.

BCF = represents the Bichromatic Correction Factor.

The Bichromatic Correction Factor (BCF) is a numerical factor which permits evaluation of the
matrix value at the wave-length λ1 by means of a reading taken at the wave-length λ2. The BCF is
given by the ratio between the reading on λ1 and the reading on λ2:

Segment B
BCF =
Segment A

Corrections to the Depletion Limit (DL) are carried out automatically by the Ellipse software
programme which controls both of the methods UP and DOWN, with their combinations.

In order to become active the automatic correction of the variable threshold for Depletion Limit
control, the user needs to:

to activate in the method parameters (See Chapter 05 - Methodology in the present manual) the
option of correction by selecting the secondary filter
calculate the Bichromatic Correction Factor (BCF) as illustrated on the following page.

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

Example of the Bichromatic Correction Factor (BCF) with Kinetic Reactions Calculation, in
order to obtain the correction of the Depletion Limit (DL)

The BCF is calculated only once, per instrument, per method and per filter used. One proceeds for
the mean statistic of the differences in absorbance provoked by a number "n" of samples (at least 30
with low activity), in comparison with the reagent blank in use, and read at two wave-lengths.

The following example expresses the type of calculation to be carried out with the absorbance values
of the reaction graphs displayed on the screen.

KINETICS
Absorbances/Times Chart

REAGENT BLANK (RBL) SAMPLE BLANK(Smp + Rgt)

λ1 = 340µm
Abs Times Abs Times

1.2991 RBL340 0 1.7251 Smp340 0

1.2981 174 1.5445 174

1.2984 187 1.5152 187
1.2979 200 1.4867 200
1.2982 213 1.4600 213
1.2987 226 1.4317 226
1.2985 239 1.4032 239
1.2993 252 1.3763 252
1.2991 265 1.3488 265
λ2 = 380µm

0.1988 RBL380 0.5719 Smp380

Increase of absorbance due to the Sample reaction (Rgt + Smp) at 340 nm equal to:

Smp Blk340 - RBL340 = 1.7251 - 1.2991 = 0.4260

Increase of absorbance due to the reaction (Rgt + Smp) at 380 nm equal to:

Smp Blk380 - RBL380 = 0.5719 - 0.1988 = 0.3731

0.426 (∆Abs 340 nm)

BICHROMATIC CORRECTION FACTOR = ___________________ = 1.1417
0.3731 (∆Abs 380 nm)

Note: The absorbance values used in the calculation are representative of the absorbance mean of
30 samples.

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

8.13 KINETICS METHODOLOGY

This methodology type is used to determine the enzyme activity. Its does not need any correction due
to possible sample (matrix) interference, since the results are calculated with variations of absorbance
per minute (∆ Abs x min), and not with absolute absorbance values. For that the analytical result is
computed as follows:

Analytical Result = CF x (∆Abs Sample x min ± RGT Rate)

Analytical Result = CF x (Slope Sample ± slope RGT Rate)

The calibration factor for calculate the enzyme activity is directly correlated to the following
parameters:

temperature
optical path length
ratio dilution reagent-serum
co-efficient of the molar extinction of the co-enzyme detector
reading time

Follows the general formula for the determination of the calibration factor for enzyme activity
calculation:

Vt
Calibration Factor = ____________________
Vs x O.T. x ε
Where:

Vt = Sample volume + Reagent volume

Vs = Sample volume

(*) For Vt and Vs it is necessary to use an identical unit of measure, for example: ml or l

O.T. = Optical path length (cm).

ε = Molar extinction coefficient at the specified wave-length λ

For each "Kinetic" test, the system carries out a number of readings expressed in optical density,
respectively at time T0, and “n” reading between T1 to T2 (a number of readings from four to eight as
indicated on the next table nr 1) according to the incubation and reading time defined in the method
parameters (See Chapter 05 - Methodology in the present manual).

All the reading points taken during the reading time (from T1 to T2) are used by a linear regression
algorithm to calculate the slope of a theoretical straight line. This slope (∆Abs x min) is used to
produce the Analytical result.

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 Chapter 08 - FORMULAS AND CALCULATION MODELS

NEGATIVE KINETIC REACTION

Absorbance Add Sample/Std+ Rgt

( Abs)

Abs (T1)

Abs (T2)

T0 T1 T2 Time

INCUBATION READING

STD Concentration
Analytical Result = CF x SLOPE CF = x 60
∆Abs STD (T2 – T1)
Where:
T1 - T0 = Incubation Time
T2 - T1 = Reading time
SLOPE = (∆Abs x min.) used to produce the Analytical Result. The slope that best
approximates the reading points detected between the beginning and the end of the
reading time, using a criteria of minimum squares.
ABBREVIATIONS:
STD = Standard
CF = Calibration Factor
FIT = Linear correlation coefficient. Represents a control parameter for Kinetic reactions.
Indicates the addition of the mean square errors, normalized to the variance, related to all the reading
points detected during the reading time. If the detected value is more than the number inserted into
the specific field FIT on the method parameters (See Capter 05 - Methodology in the present
manual), the result is flagged "A".

GOT/AST Example:
Ris 35
FIT 0.980 CF = 1746
FIT = 1
Abs Time Incubation time = 122"
1.5598 3 (T0) Reading time = 91 "
1.5180 122 (T1)
1.5110 135 Analytical Result = CF x SLOPE
1.5061 148
1.4995 161 Analytical Result = CF x (Abs T1 - Abs T2) x 60 / 91
1.4930 174
1.4878 187
1.4827 200
1.4762 213 (T2)

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8.14 TIMING OF THE KINETIC REACTIONS

Incub Max RT NrR Incub RT NrR Incub RT NrR Incub RT NrR Incub RT Nr
Max Max Max Max R
Reading every 13 " Reading every 26 " Reading every 39 " Reading every 52 " Reading every 65 "
988 39 4

975 52 5

962 65 6

949 78 7

936 91 8
923 104 5

897 130 6

871 156 7

845 182 8
832 195 6

793 234 7
767 260 6

754 273 8
715 312 7
702 325 6

663 364 8
637 390 7

572 455 8

TAB. N° 1

Where:
Inc Max = Maximum Incubation time (including eventual reagent incubation time)
RT = Reading time inserted in the method parameter
Nr R = Number of readings carried out by the Ellipse to calculate the slope
The above table shows the combinations of the maximum incubation time with the reading time
programmed in the method parameters. The minimum incubation time is 5 seconds. The reading time
is selected inside a pull down menu in the method programming mask (See Chapter 05 -
Methodology in the present manual). Selectable reading times can be from 39 seconds minimum to
455 seconds maximum and they are accompanied by an asterisk.
With regards to the selected reading time, the system will carry out all the readings needed for slope
calculation, from four to a maximum of eight, every 13, 26, 39, 52 or 65 seconds as showed in the
above table.

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 Chapter 09 - ERROR SIGNALING AND TROUBLESHOOTING

CHAPTER 09 - ERROR SIGNALING AND

TROUBLESHOOTING

INDEX

9.1 ERROR SIGNALING…………………………………………………………………………..……..2

9.1.1 SYSTEM ERRORS ..........................................................................................................2

9.1.2 RESULT FLAG………...………………………………………………………………..3

9.1.3 DESCRIPTION OF RESULT FLAGS..............................................................................3

9.2 TROUBLESHOOTING GUIDE .......................................................................................6

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 Chapter 09 - ERROR SIGNALING AND TROUBLESHOOTING

9.1 ERROR SIGNALING

This chapter is dedicated to a description of the error signalling which may occur during the
programming or carrying out of the various operations. Error signals can be divided into the
following two groups:
➢ System Errors
➢ Result Flags

9.1.1 SYSTEM ERRORS

Whenever a system error is detected, it is signalled via the activation of the below-listed warning
lights/buttons:
➢ Warning Light: a triangle-shape located in the upper, right-hand portion of the System Monitor
screen. It lights up yellow when activated.
If this yellow triangle does light up, the operator need simply click on it to access the relative visual
text warning message indicating the cause of the signalled anomaly (said window will open in that
area dedicated to viewing data).
Following is a list of possible visual text “Warning!” messages:
• Liquid Alarm I (Rinse Solution)
• Liquid Alarm II (Distilled Water)
• Liquid Alarm III (Cleaning Solution)
• Liquid Alarm IV (Optional Solution)
• Temperature Out-of-Range
• Host Serial Port cannot be opened
➢ Fatal Error: an “X”-shape located in the upper, right-hand portion of the System Monitor mask.
It lights up red when activated.
If this red “X” lights up, the operator need simply click on it to access the relative visual text
message explaining the cause of the Fatal Error (said window will open in that area of the mask
dedicated to viewing data).
Following is a list of possible Fatal Error visual text messages:
• Horizontal Arm Error
• Sample Tray Error
• Filter Error
• ADC Error – Sample Channel
• ADC Error – Reference Channel
• Reaction Tray Position Error
• Plate Error (Home sensor not found)
• Vertical Arm error
• Reagent Tray Error
• Wash System Error
• Diluter Error
• Interlock Open while Instrument is running
• Macro send Error
• Overflow Rx Buffer Micro
• Time out Error (Generic error)
• Invalid command error
• Invalid parameter error

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 Chapter 09 - ERROR SIGNALING AND TROUBLESHOOTING

• Check sum error

9.1.2 RESULT FLAGS

Result Flags are categorized under the following group headings, Each group is identified by a
symbol, as listed here-below:

X PHYSICAL ERRORS

R CONCENTRATION ERRORS

C CALIBRATION ERRORS

A OPTIC DENSITY ERRORS

E RESULTS EDITED MANUALLY

? PROGRAMMING ERRORS

Every Result Flag, signalling an error, is accompanied by a symbol representing the group it is part
of. The operator need only click on the small red square ( ) next to the Result Flag symbol to access
the visual text message explaining the cause(s) of the signalled error.
In the central column of the following tables, the user will find those symbols which signal the type
of error encounter, as used in the print-out of the final report. These symbols can be modified by the
operator, in the Parameters section, under print options.

WARNING! The use of the Error Symbols in the print-out of the results (inclusion and/or
exclusion) IS UNDER THE DIRECT AND SOLE RESPONSIBILITY OF THE USER

9.1.3 DESCRIPTION OF RESULT FLAGS

X Physical Errors

Temperature Error: T Reaction temperature (Reaction Plate) is out-of-

range.
No Sample S Either no sample or sample serum quantity
below minimum or above maximum level for
the declared container.

No Reagent: R Either no reagent or reagent level below

minimum or above maximum level for the
declared container.

No Rack: * No Rack present during sampling.

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R Concentration Errors

Very Low and Very High: L-H Flags determined by test results out-of-range as
setup in the Methods.

Low Alert and High Alert: A Flags determined by test results out-of-range as
setup in the Methods.

Low and High Linearity Limit: G Flags determined by test results out-of-range as

Calculation Error: C Concentration calculation error due to

foreseeable causes (Asymptote).

C Calibration Errors

RBL missing: * No Reagent Blank Level.

Calibration missing: * No Standard or no Calibration curve.

STD Replicate insufficient: * Insufficient number of valid Standard Replicates.

STD Replicate outside CV%: * Coefficient of Variation Percentage in the Standard

Replicates over the set value.

Invalid Calibration: * Calibration curve not valid – either because it is not

monotonic or because the Fit is above the set value.

A Optic Density Errors

Inversion: I Reaction direction not in line with that set-up.

End Point Limit: P Values over the limits setup in the Methods
Parameters

Depletion Limit: D Values over the limits setup in the Methods Parameters.

First Limit: * Values over the limits setup in the Methods Parameters.

FIT: F Values over the limits setup in the Methods Parameters.

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 Chapter 09 - ERROR SIGNALING AND TROUBLESHOOTING

RBL out-of-range: * Reagent Blank Levels outside the range Setup.

Sample outside Standard: # Sample absorbance outside the calibration curve.

E Results Edited Manually

Results Edited: E This symbol automatically appears whenever the
operator has manually modified the obtained results.
This operation annuls all the symbols indicating errors
which, in this case, will not be viewed.

? Programming Errors
All those software errors which are deemed unforeseeable are indicated using this symbol.

Result Asterisks
In the event that the following situations and/or error conditions occur, the system will notify the
user via a visualization of two asterisks (**) in the Results field:

PHYSICAL ERRORS
1 – very little or no sample
2 – very little or no reagent
3 – no rack

CONCENTRATION ERRORS
4 – calculation error
5 – signalling depletion limit

PROGRAMMING ERROR
6 – all cases

In the following situations and/or error conditions, the results field will contain a “0”:

1 – if the result is less than zero

2 – if the result is equal to zero

OPTIC DENSITY ERRORS

3 – Flag signalling inversion

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 Chapter 09 - ERROR SIGNALING AND TROUBLESHOOTING

9.2 TROUBLESHOOTING GUIDE

PROBLEM ➢ POSSIBLE CAUSE SOLUTION

Repeatability of results insufficient ➢ Sample Probe dirty
Clean the Sample Probe as described in Chapter 07
Maintenance

➢ Hydraulic leak and/or air bubble in the hydraulic circuit

(sampling)
Check Sample Probe fit
Check the fit of the hydraulic tubes and their connection:
if necessary, substitute the tubes and/or adjust their
connections/fittings

➢ Wash solution is contaminated. If the wash solution

contains contaminating particles (e.g.: mold, dust, lint), these
micro-particles can cause errors during the WBL running.
Change the wash solution
Clean the Wash Solution Bottle(s) and carry out the
Hydraulic Circuit wash procedure as described in
Chapter 07 – Maintenance

➢ Deterioration of the Reagent(s)

Substitute the bad reagent(s)

➢ Reaction cuvettes not dried correctly after being washed

Check the Tip used to dry the cuvettes after washing to
make sure it is in good working condition. If necessary,
clean the Tip or change it, following the procedure
described in Chapter 07 – Maintenance

➢ Light bulb not stable

Light bulb nearing the end of its 2000-hour life cycle
duration, or premature deterioration. In both cases,
change the light bulb following the substitution
procedure described in Chapter 07 – Maintenance.
Insufficient volume/quantity of the ➢ This type of problem could happen either when the
various Rinse, Cleaning and
instrument is first turned on due to a lack of liquid in one or
Distilled Water solutions.
more bottles, or during test running whenever the involved
liquid has been finished
Refill the required bottle. If the instrument is running
tests, it will automatically Pause. Wait until sampling is
suspended, then refill the involved bottle with the
required liquid (Rinse/Cleaning/ Distilled Water). Press
Start to continue running the rest of the programmed
tests. This operation will not adversely affect the already
run tests.

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 Chapter 10 – Host Communication

CHAPTER 10 – HOST COMMUNICATION

INDEX

10.1 COMMUNICATION WITH THE HOST COMPUTER ....................................................... 2

10.1.1 COMMUNICATION PARAMETERS .................................................................................. 2

10.2 PROTOCOL SPECIFICATION ............................................................................................. 3

HEADER RECORD (H)...................................................................................................................... 4

PATIENT RECORD (P)...................................................................................................................... 5

TEST ORDER RECORD (O).............................................................................................................. 8

RESULTS RECORD (R)................................................................................................................... 10

MESSAGE TERMINATOR RECORD (L) ...................................................................................... 12

REQUEST INFORMATION RECORD (Q):.................................................................................... 13

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 Chapter 10 – Host Communication

10.1 COMMUNICATION WITH THE HOST COMPUTER

The Ellipse can be connected to a host computer for the purpose of facilitating results print-out and
patient management.

In order to enable communication between the Ellipse and the host computer, select the Host Link
field under Options in the Parameters menu.

To activate communication between the Ellipse and the host computer, select Host–Tx (please see
the software description in Chapter 03 of this User’s Guide)

10.1.1 COMMUNICATION PARAMETERS

The Ellipse is linked to the managing computer using an RS-232C serial connector having the
following specifications:

o Transmission method : Asynchronous, half duplex

o Baud Rate : 9600 Bit/sec.
o Data bits: : 8
o Parity : None
o Stop bit : 1
o Connector : 9 pin type D (male output from the Ellipse)

1-CF(DCD)
(DSR)CC-6
2-BB(RD)
(RTS)CA-7
3-BA(TD)
(CTS)CB-8
4-CD(DTR)
(RI)CE-9
5-AB(GND)

Serial connector

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 Chapter 10 – Host Communication

10.2 PROTOCOL SPECIFICATIONS

This part of Help (Protocol Specifications) contains information for the laboratory computer and
analyzer. This exchange of data follows specific ASTM protocols:

E 1381-95 Standard Specification for Low-Level Protocol to Transfer Messages between

Clinical Laboratory Instruments and Computer Systems;
E 1394-97 Standard Specification for Transferring Information between Clinical Instruments
and Computer Systems.

ASTM uses a number of different terms to indicate the way it groups data.

• Field: an individual piece of data often referred to as a data field or a data element.

• Record: a number of logically related data fields grouped together to form one part of a
complete message.

• Repeat field: a data field of the same type as the one immediately preceding it. A delimiter
separates one instance of a repeat field from the next.

• Component field: part of data field that might contain more than one piece of data.

The default communication configuration for the Analyzer is the following: "9600,N, 8,1".

ASTM uses record types that are common and familiar to all laboratory personnel. It uses the
following record types:

• Header Record (H): contains identifying information about the sending station,
conventions that the device uses for field recognition, and the date and time of send station
transmission.

• Patient Record (P): contains patient information and identification number.

• Test Order Record (O): contains information about the assay or requests themselves and
includes other data.

• Result Record (R): contains information about the outcome of individual tests for an
individual patient and follows a sample program record. The results contain the actual
measurements derived from the test and a comparison of the individual result to certain
ranges specified as norms for the laboratory.

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 Chapter 10 – Host Communication

• Message Terminator Record (L): although the ASTM protocol supports three additional
record types - a Request for Information Record, a Scientific Record and a Manufacturer's
Information Record - the Analyzer is not implementing these in the first release and will
ignore them.

• Request Information Record (Q): is used by either clinical instruments or computer

systems for a remote request for information from its reciprocal system.

The instrument does not send or accept comment records.

Header Record (H)

Field Field Title Down Up Max Description and Valid Values
Load Load Len

1 Record Type R A 1 This is a required field that contains an

ID “H” identifying it as a header record.

2 Delimiters I A 4 The Analyzer System uses only the four

default values shown here. Delimiters may
not be duplicated. The field delimiter
follows the escape character to separate
the delimiter specification from a
subsequent field in the header record.
Using default values, the first six
characters of the header record will appear
using the following characters:
H I\^&I
Field Delimiter I
Repeat Delimiter \
Component Delimiter ^
Escape Delimiter &
3 Message I N
Control ID
4 Access I N
Password
5 Sender Name I A 10 ‘SHAnalyzer’: This is the name of the
or ID device that is sending the data.
6 Sender Street I N
Address
7 Reserved Field I N
8 Sender Tel. I N
Number

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 Chapter 10 – Host Communication

9 Characteristics I N
of Sender
10 Receiver ID I N

11 Comments or I N
Special
Instructions
12 Processing I N
13 ASTM Version I N
No.
14 Date and Time I A 14 Date and Time of transmission: formatted
as YYYYMMDDHHMMSS. For
example: 3:35 PM on March 1, 1995
would be represented using the following
characters:
19950301153500.
Legend: R Required D Down Load
O Optional U Up Load
I Ignored N Never
A Always S Sometimes

Example Header Record Layouts (H)

Download

Host H I \ ^ I I I HOST I I I I I I I I I19950301153500<CR>

Upload

Analyzer System H | \ ^ & | | | SHAnalyzer | | | | | | | | | 19950301154000<CR>

Patient Record (P)

Field Field Title Down Up Max Description and Valid Values
Load Load Len

1 Record Type ID R A 1 This is a required field that

contains a “P” identifying it as a
patient record.
2 Sequence Number R A 3 This field starts with a “1” for the
patient and is incremented by 1 for
each additional patient within the
transmission.
3 Practice Assigned R A 15 This field can be assigned by the
Patient ID instrument with no corresponding
download.

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 Chapter 10 – Host Communication

4 Laboratory I N
Assigned
Patient ID
5 Patient ID No. 3 I N

6 Patient Name O S 36 This field has two components:

• Last Name (up to 20
characters)
• First Name (up to 15
characters).
7 Mother's Maiden I N
Name
8 Birth Date O S 8 Formatted as YYYYMMDD: For
example, a birth date of December
1, 1980 would be represented as:
19801201
9 Patient Sex R A 1 The valid values are:
• M for Male
• F for Female

10 Patient Race/Ethnic I N The Analyzer System will ignore

Origin this field at launch.
11 Patient Address O S 60 For Analyzer, this is a four-
component field:
• Address (25 characters)
• City (25 characters)
• State (2 characters e.g.:
NY, IT)
• Zip (5 characters)
12 Reserved Field I N

13 Patient Tel Number I N

14 Attending Physician I N
ID
15 Special Field 1 I N

16 Special Field 2 I N

17 Patient Height I N

18 Patient Weight I N

19 Patient Known or I N
Suspected Diagnosis

20 Patient Active I N
Medications
21 Patient's Diet I N

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 Chapter 10 – Host Communication

22 Practice Field No. 1 I N

23 Practice Field No. 2 I N

24 Admission Date and O S 8 Admission date only.

Discharge Date (if Formatted as YYYYMMDD.
desired)

25 Admission Status I N

26 Location O S 20

27 Nature of I N
Alternative
Diagnostic Code
and classifiers
28 Alternative I N
Diagnostic Code
and classification
29 Patient Religion I N

30 Marital Status I N
31 Isolation Status I N

32 Language I N
33 Hospital Service I N

34 Hospital Institution I N

35 Dosage Category I N

Legend: R Required D Down Load

O Optional U Up Load
I Ignored N Never
A Always S Sometimes

Example Patient Record (P)

Download

Host P | 1 | B108K | | | MW5910^Smith | | 19861002 | M | | Park Avenue^New

York^NY^10002 | | | | | | | | | | | | | 20020923 | | Hematology | | | | | | | | | |

Analyzer P | 1 | B108K | | | MW5910^Smith | | 19861002 | M | | Park Avenue^New

System York^NY^10002 | | | | | | | | | | | | | 20020923 | | Hematology | | | | | | | | |

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 Chapter 10 – Host Communication

Test Order Record (O)

Field Field Title Down Up Max Description and Valid
Load Load Length Values

1 Record Type R A 1 This is required field that

ID contains an “O” identifying it
as an order

2 Sequence R A 3 This field starts with “1” for

Number the first Test Order Record
and is incremented by 1 for
each additional Test Order
Record within the record.
This will be reset to “1”
whenever another patient
record is transmitted.

3 Specimen ID R A 15 Although the operator can

manually edit this field at
any time, the value of this
field is usually assigned by
the laboratory computer
before down loading. The
Analyzer uses and reports its
results based on the assigned
specimen ID.

4 Instrument I N
Specimen ID

5 Universal I N 9 This is a four-component

Test ID field:
I N • Universal Test ID
Code (not used)
I N • Universal Test ID
Name (not used)
R A
• Universal Test ID
Type (not used)
• Manufacturer's or
local code (6
characters):
This is the code defined in
the Analyzer.

6 Priority I N
7 Request I N
Ordered
Date/Time

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 Chapter 10 – Host Communication

8 Specimen I N
Collected
Date/Time
9 Collection I N
End Time
10 Collection I N
Volume/Units
11 Collector ID I N

12 Action Code I N

13 Danger Code I N

14 Relevant I N
Clinical Info.
15 Date/Time I N
Specimen
Received
16 Specimen R A 1 This is a numeric field
Type indicating the type of
specimen:
The Imm. System uses the
following ASCII characters:
0= Serum
1= Urine
17 Ordering I N
Physician
18 Physician I N
Tel. Number
19 User Field I N
No. 1
20 User Field I N
No. 2
21 Lab Field No. I N
1
22 Lab Field No. I N
2
23 Date /Time I N
Result
Reported Last
or Modified

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 Chapter 10 – Host Communication

24 Instrument I N
Charge
25 Instrument I N
Section ID
26 Record Type I A 1 The field indicates the
direction of the transmission:
O - Down Loading
F - Up Loading
27 Reserved I N
Field
28 Location or I N
Ward of
Specimen
Collection
29 Nosocomial I N
Infection Flag
30 Specimen I N
Service
31 Specimen I N
Institution
Legend: R Required D Down Load
O Optional U Up Load
I Ignored N Never
A Always S Sometimes

Example Test Order Record Layouts (O)

Download

Host O | 1 | AR102 | | ^^^GLU | | | | | | | | | | | 0 | | | | | | | | | | O | | | | |

Analyzer System O | 1 | AR102 | | ^^^GLU | | | | | | | | | | | 0 | | | | | | | | | | F | | | | |

Results Record (R)

Field Field Title Down Up Max
Load Load
Len
1 Record Type ID A 1 This is a required field that contains an
“R” identifying it as a Results Record.

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 Chapter 10 – Host Communication

2 Sequence A 3 This field starts with “1” for the first

Number result and is incremented by 1 for each
additional result within the record.
This will be reset to “1” when the results
from another test order record are
transmitted to the laboratory computer.
3 Universal Test ID I N This is a four-component field:
• Universal Test ID Code (not used)
I N • Universal Test ID Name (not
used)
I N 9 • Universal Test ID Type (not used)
• Local Manufacturer's or local code
A
R (6 characters) this is the code
defined in the Analyzer.

4 Data or A 10 ‘Data’ is a 10-character, floating point

Measurement field that includes the decimal point. The
value number of precision point digits will vary
according to the test and is configurable
on the Analyzer.
5 Units of Measure A 6 This is a field for up to 6 characters that
the operator defines for analytic
measurement.
6 Reference A 21 This field has two components; one
Ranges giving the lower limit and the other the
upper limit of the range. The format for
this field is N^N.
7 Result Abnormal A 2 This field indicates the normal status of
Flags the result. The following codes are valid
values:
L - Below Low normal
H - Above High normal
LL - Below Panic normal
HH - Above Panic normal
< - Below absolute low (under linearity)
> - Above absolute high (over linearity)
N - Normal
A - Abnormal
E – Edited

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 Chapter 10 – Host Communication

8 Nature of N
Abnormality
Testing
9 Result Status A 1 The Imm. System currently implements
only two valid values:
F - final results;
V - operator verified/approved result.
10 Date of Change N
in Instrument
Normative
Values or Units
11 Operator ID N

12 Date/Time Test N
Started
13 Date/Time Test A 14 Date and Time of test completion:
Completed formatted as YYYYMMDDHHMMSS.

14 Instrument ID N

Legend: R Required D Down Load

O Optional U Up Load
I Ignored N Never
A Always S Sometimes

Example Result Record Layouts (R)

Upload

Analyzer System R | 1 | ^^^GLU | 70.97 | UL | 70^105 | N | | F | | | | 20020923114302 |

Message Terminator Record (L)

Field Field Title Down Up Max Description and Valid Values
Load Load
Len
1 Record Type R A 1 This is a required field that contains an
ID “L” identifying it as an Message
Terminator Record.
2 Sequence R A 1 For a message terminator, this message
Number should always be “1”.
3 Termination R A 1 This indicates the cause of termination.
Code The following codes are valid values for

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 Chapter 10 – Host Communication

the Analyzer :
Null or N-normal termination

Legend: R Required D Down Load

O Optional U Up Load
I Ignored N Never
A Always S Sometimes

Example Message Terminator Record Layout (L)

Host LI1IN

Analyzer System LI1IN

Request Information Record (Q):

Field Field Title Down Up Max Description and Valid Values
Load Load Len

1 Record Type ID A 1 This is a required field that contains a

“Q” identifying it as a request.

2 Sequence Number A 1 It is always “1”.

3 Starting Range ID A 31 This field can either be:

Number
"ALL" - to mean all demographics
and tests being ordered should be sent
to the instrument at this time,
or can have two components:
• Computer system patient ID
No. (up to 15 characters);
• Computer system specimen
ID No. (up to 15 characters).
4 Ending Range ID N
Number
5 Universal Test ID N
6 Nature of Request N
Time Limits
7 Beginning Request N
Results Date and
Time
8 Ending Request N
Results Date and
Time

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 Chapter 10 – Host Communication

9 Requesting N
Physician Name
10 Requesting N
Physician
Telephone
Number
11 User Field No. 1 N
12 User Field No. 2 N
13 Request A 1 It is always "O" (requesting test
Information Status orders and demographics only).
Codes

Example Request Information Record Layouts (Q)

Download To

Analyzer System H | \^& | | | SHAnalyzer | | | | | | | | | 20020927100402

Q | 1 | ALL | | | | | | | | | | O
L|1|N

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 Chapter 11 - PACKING LIST

CHAPTER 11 – PACKING LIST

CUSTOMER - __________________________ NATION - ________________________ DATE – ______________

Packing: Wooden Box N°1 Size: cm 65x80x77 Gross weight: 58 Kg Net weight : 35 Kg
Carton Box N°2 : cm 60x40x25 : 5 Kg : 4 Kg

INSTRUMENT
Ref. Code Description Q.ty Box OK
N°
01 16-00571-..... CLINICAL CHEMISTRY ANALYZER ELLIPSE - S/N ……….. 1 1
02 70-01832-00 ELLIPSE SOFTWARE – Rev. …………………. 1 2
ACCESSORIES
Ref. Code Description Q.ty Box N°
03 AS620005 POWER CORD 1 2
04 32-01238-08 FUSE 6,3A-T 5x20 2 2
05 9-35-0055-01 INTERCONNECTING CABLE (5 m) 1 2
06 9-05-0078-00 RESERVOIR LEVEL SENSOR 4 2
07 9-35-0041-00 BOTTLE 2 Lt. 4 2
08 50-01831-00 BOTTLES INTERCONNECTING CABLE 1 2
09 01-00217-00 REACTION RACKS 6 2
10 AS650100/1 PACK OF 200 SAMPLE CUPS (1 mL) 1 2
11 9-01-0609-00 ADAPTOR FOR SAMPLE CUPS 5 2
12 650002/1 PACK OF 200 SAMPLE CUPS (0.8 mL) 1 2
13 ASRN0020 CLEANING SOLUTION (2 x 250 ml) 1 2
14 ASRN0021 RINSE SOLUTION (50 ml) 1 2
15 01-00190-00 PACK REAGENT CONTAINER 35 ml 12 2
16 01-00191-00 PACK REAGENT CONTAINER 6 ml 12 2
17 90-01891-00 REAGENT CONTAINER SCREW CAP 24 2
18 AS070096 SCREWDRIVER 1 2
19 10-00586-00 PRIMARY TUBE SAMPLE RACK 4 2
20 05-01829-00 SAMPLE CUP RACK 4 2
21 55-01548-00 SPECIAL KEY FOR PROBE TIGHTENING 1 2
22 90-01862-00 USER MANUAL 1 2

List Rev. 02

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 Chapter 12 – DIAGNOSTIC PROGRAM

CHAPTER 12
- DIAGNOSTIC PROGRAM -
INDEX

12 DIAGNOSTIC PROGRAM 3
12.1 STATUS BAR 6
12.2 TEST FOLDER 7
12.3 “ARM” FOLDER 8
12.3.1 VERTICAL COMMAND AREA 9
12.3.2 HORIZONTAL COMMAND AREA 9
12.3.3 STATUS COMMAND AREA 10
12.3.4 ARM SETTING COMMAND AREA 10
12.4 “DILUTER” FOLDER 11
12.4.1 OPERATIONS AREA 12
12.4.2 SENSOR STATE AREA 12
12.4.3 USER AREA 12
12.4.4 STATUS COMMAND AREA 12
12.5 “OPTIC” FOLDER 13
12.5.1 OPERATIONS AREA 13
12.5.2 SENSOR STATE AREA 14
12.5.3 FILTERS AREA 14
12.5.4 DIGITAL CONVERSION AREA 14
12.5.5 STATUS COMMAND AREA 14
12.6 “PLATE” FOLDER 15
12.6.1 OPERATIONS AREA 15
12.6.2 MOTOR ON/OFF AREA 16
12.6.3 STATUS COMMAND AREA 16

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.7 “TEMPERATURES” FOLDER 17

12.7.1 TEMPERATURES AREA 17
12.7.2 OFFSET AREA 18
12.7.3 TEMPERATURE TEST AREA 18
12.7.4 STATUS COMMAND AREA 19
12.8 “WASH” FOLDER 19
12.8.1 OPERATIONS AREA 20
12.8.2 TEST AREA 20
12.8.3 STATUS COMMAND AREA 20
12.9 “USER” FOLDER 21
12.9.1 USER TEST MICRO AREA 21
12.9.2 STATUS COMMAND AREA 22
12.10 “MISCELLANEOUS” FOLDER 22
12.10.1 GENERAL RESET AREA 23
12.10.2 LOG RAW DATA AREA 23
12.10.3 CONTINUOUS TEST RUN 23
12.10.4 STATUS COMMAND AREA 24
12.11 “GLOBAL SETTING” FOLDER 24
12.12 “MACRO SETTING” FOLDER 25
12.13 “CONFIGURATION” FOLDER 26

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 Chapter 12 – DIAGNOSTIC PROGRAM

12 DIAGNOSTIC PROGRAM

The diagnostic program enables the operator to perform a complete check of each of the Ellipse module
functions.
This program has a folder structure, with each folder containing functions pertaining to the specific
module. To launch the program the operator has to click with the left side of the mouse, on the
Diagnostic area located on the lower right side of the screen of the System Monitor (Fig.1).
The Ellipse must be in the stand-by state to access this area.

Fig. 1

Click Here
Once the program starts, the following screen appears (Fig. 2)
Fig. 2

Test
Folders

Optical Sensor
Status
Status Bar

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 Chapter 12 – DIAGNOSTIC PROGRAM

The diagnostic program is subdivided into three distinct areas: test folders, optical sensor status,
status bar. The last two areas are present on every diagnostic window.
The three areas enable the operator to verify multiple functions as specified below:

Test Folders: checks the functionality of the Ellipse’ various sub-systems; The individual
functions are illustrated later on.

Optical Sensor Status: visualizes the sensor status that controls the Sampling Arm, the Diluter, the
Washing Station, the Optical filter wheel, the Reaction plate, the Sample plate, the Reagent plate and
the Cover Lock, as well as the Liquid Reservoir Alarm, the Front panel button and the Level Sensor
Test (Fig. 3)
Fig. 3

Furthermore, there are three types of unused fields for future use: Leak for Arm, Washing Station and
Plate. While the program is running, the fields given in the figure can be either of two distinct colors,
red or green.

The fields:

• Vertical Arm’s Optical Switch (O.S.)

• Horizontal Arm’s Optical Switch (O.S.)
• Diluter’s Optical Switch (O.S.)
• Wash Station’s Optical Switch (O.S.)
• Filter Wheel’s Optical Switch (O.S.)
• Reaction Plate’s Optical Switch (O.S.)
• Sample Plate’s Optical Switch (O.S.)

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 Chapter 12 – DIAGNOSTIC PROGRAM

• Reagent Plate’s Optical Switch (O.S.)

turn green when the specific device is in the home position, and turn red when not in the home position.

The field
• Cover Lock

turns green when the cover is closed, and turns red when open.

The fields:
• Arm Leak Alarm (Arm Leaking)
• Wash Station Leak Alarm (Wash Station Leaking)
• Plate Leak Alarm (Reaction Plate Leaking)

turn green when there is no leaking, and red when there is.

The following six fields signal the alarms for the bottles containing the washings liquids and waste
materials:
• Waste1 Liquid Reservoir Alarm
• Waste2 Liquid Reservoir Alarm

turning green when the liquid level is not excessive, and red when the waste bottle indicated by the
alarm is almost full.

• Liquid 1 Liquid Reservoir Alarm

• Liquid 2 Liquid Reservoir Alarm
• Liquid 3 Liquid Reservoir Alarm
• Liquid 4 Liquid Reservoir Alarm

turning green if the liquid level is above the predetermined minimum limit, and red if the liquid
quantity is below the predetermined minimum level (the bottle is almost empty).

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 Chapter 12 – DIAGNOSTIC PROGRAM

The following fields signal the state of the button on the Ellipse’s operator panel:

• Al.Res. Front Panel Button

• St-By Front Panel Button
• Ready Front Panel Button

turning green when the button is not pushed in, and red if it is.

The field
• Test ON

It is green fixed; if pushed, on the right of it will be showed a red drop that becomes temporarily green
when the liquid is detected.

12.1 STATUS BAR

Monitors the instrument’s status (Fig.4).

Fig. 4

Time
Firmware Rel.
Al. Res Status Indicator Date
Instrument Status
Ready Status Indicator

Start/Stop Diagnostics

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.2 TEST FOLDER

The following is a summary of each individual test folder’s function.

The Ellipse’s diagnostic program is subdivided into 10 folders:

Arm: the adjustment of the arm position can be checked and carried out;

Diluter: checks if the diluter is functioning correctly;

Optic: checks if the optical block is functioning correctly;

Plate: checks if the reaction, samples and reagents plates are functioning correctly;

Temperature: checks the temperature of the pre-heater and reaction plate;

Wash: checks if the wash station is functioning correctly;

User: checks if the user functions are working properly;

Miscellaneous: performs general checks;

Macro Setting: the operator can identify which macros have been loaded;

Configuration: Through the use of a password, only qualified technical personal can adjust

certain parameters (This file is not accessible to the Laboratory operator).

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.3 “ARM” FOLDER

Warning: the improper use of the functions described in this folder can damage the sampling probe.

The Arm File is subdivided into four areas:

♦ VERTICAL
♦ HORIZONTAL
♦ STATUS COMMAND
♦ ARM SETTING

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.3.1 VERTICAL COMMAND AREA

(5 commands)

Home: Brings the arm vertically to a home position;

Down Well: Brings the arm’s axis “z” to the height of the well;
Up: Raises the arm tenths of a millimeter as preset in the square found immediately
on the right, with relation to the previous Down movement;
the box becomes active when the arm is positioned on a sample, a reagent, a
standard or a cuvette.
Down: Lowers the arm tenths of a millimeter as pre-determined by the square found
immediately on the right; the box becomes active when the arm is positioned on
a sample, a reagent, a standard or a cuvette.

Go Level: Brings the probe to either the reagent level, the sample or the standard and reads
the level. Before giving this command, it is necessary to set the parameter for the
probe’s maximum lowering level in the max area (mm);

12.3.2 HORIZONTAL COMMAND AREA

(5 commands)

Back to wash well: Brings the arm back to the home position;
Go Reag.: Brings the arm to the reagent position specified in the sheet menu next to the
command;
Go Sample: Brings the arm to the sample position specified in the sheet menu next to the
command;
Go Std.: Brings the arm to the standard/control position specified in the sheet menu next
to the command;
Go Disp.: Brings the arm to the dispense position;

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.3.3 STATUS COMMAND AREA

Send: Visualizes the commands sent from the program to the instrument hardware;
Receive: Visualizes the answers of the instrument’s hardware to the commands sent by the
program;
Sensor State: Indicates the sensor status relative to the arm’s vertical axis, the internal arm and
the external arm.

12.3.4 ARM SETTING COMMAND AREA

(5 commands)
Step: Visualizes the number of steps.
+: Performs the counter-clockwise rotation of the arm (to adjust the position);
-: Performs the clockwise rotation of the arm (to adjust the position);
Save: Saves the adjustment data;
Reset: Completely resets the Arm

In this area the boxes can be activated when the arm is positioned on a sample, a reagent, a standard or
a control or a cuvette.

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.4 “DILUTER” FOLDER

The Diluter Folder is subdivided into four areas:

♦ OPERATIONS
♦ SENSOR STATE
♦ USER
♦ STATUS COMMAND

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.4.1 OPERATIONS AREA

(3 commands)
Home: Brings the diluter to the Home position;
Asp: Aspirates the micro-litres as predetermined in the ul. box (may be set manually
through + and – or by using the cursor located immediately above);
Disp.: Distributes the micro-litres as predetermined in the ul. box (may be set manually
through + and – or by using the cursor located immediately above);

12.4.2 SENSOR STATE AREA

In the Sensor State area the diluter sensor status is indicated.

12.4.3 USER AREA

(1 command)
Probe Wash Test: Activates and deactivates the probe wash system

12.4.4 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument hardware;
Receive: Visualizes the instrument hardware’s response to the commands sent by the
program.

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12.5 “OPTIC” FOLDER

The Optic folder is subdivided into five areas:

♦ OPERATIONS
♦ SENSOR STATUS
♦ FILTERS
♦ DIGITAL CONVERSION
♦ STATUS COMMAND

12.5.1 OPERATIONS AREA

(2 commands)
Lamp ON: Turns on the Optic Lamp;
Lamp OFF: Turns off the Optic Lamp;

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.5.2 SENSOR STATE AREA

This area indicates the status of the wheel filters.

12.5.3 FILTERS AREA

(10 commands)
Reset : Positions the wheel filters in home position (dark);
340 nm: Positions filter n° 1 in front of the reading sensor;
380 nm: Positions filter n° 2 in front of the reading sensor;
405 nm: Positions filter n° 3 in front of the reading sensor;;
492 nm: Positions filter n° 4 in front of the reading sensor;
510 nm: Positions filter n° 5 in front of the reading sensor;
546 nm: Positions filter n° 6 in front of the reading sensor;
577 nm: Positions filter n° 7 in front of the reading sensor;
620 nm: Positions filter n° 8 in front of the reading sensor;
Spare: Positions filter n° 9 in front of the reading sensor (Optional);

12.5.4 DIGITAL CONVERSION AREA

(2 commands)
START/STOP Sample Channel Conversion: Performs an analogical/digital conversion of the
principal channel;

START/STOP Reference Channel Conversion: Performs an analogical/digital conversion of the

reference channel;
12.5.5 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument hardware;

Receive: Visualizes the instrument hardware’s response to the commands sent by the
program.

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12.6 “PLATE” FOLDER

The Plate Folder is subdivided into three areas:

♦ OPERATIONS
♦ ALL MOTORS ON/OFF
♦ STATUS COMMAND

12.6.1 OPERATIONS AREA

Reaction Plate area:

(3 commands)
To Disp.: Automatically positions the cuvette, indicated on the sheet menu aside, under the
dispensing position

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 Chapter 12 – DIAGNOSTIC PROGRAM

To Optic: Automatically positions the cuvette, indicated on the sheet menu aside, in front
of the colorimeter

Reset: Performs the reset of the reaction plate by positioning the # 1 cuvette in the
dispensing position

Sample Plate area:

(2 commands)
To Asp.: Automatically brings sample, indicated on the sheet menu aside, under the
aspiration position
Reset: Performs the reset of the sample plate by positioning the # 1 sample in the
aspiration position

Reagent Plate:
(2 commands)
To Asp.: Automatically brings reagent, indicated on the sheet menu aside, under the
aspiration position
Reset: Performs the reset of the sample plate by positioning the # 1 reagent in the
aspiration position

12.6.2 ALL MOTORS ON/OFF AREA

(1 command)
ALL Motors ON/OFF: Engages/Disengages the motors to allow a manual movement of the modules
(Sampling Arm; Reaction, Reagents and samples Plates, Washing Station, Filter Wheel and Peristaltic
Pump).

12.6.3 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument hardware;
Receive: Visualizes the instrument hardware’s response to the commands received from
the program.

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12.7 “TEMPERATURES” FOLDER

The Temperature Folder is subdivided into three areas:

Temperatures
Offset
Status Command

12.7.1 TEMPERATURES AREA

(4 commands)
Temp. Test Run: To enter in the Temperature Test folder
Plate: Performs a temperature reading in the reaction plate compartment;
Arm: Performs a temperature reading in the arm’s pre-heater.
Calib. Sensor: To carry out the calibration procedure of the thermometric probe included
in the kit P/N 55-01204-00, as illustrated in Chapter Six “Settings and
Adjustments”.

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.7.2 OFFSET AREA

(2 commands)
To correlate the thermometric probe included in the kit P/N 55-01204-00 with another reference
thermometric probe.

Service probe: The offset value that has been previously inserted and the temperature value
read by the thermometric probe appear in the closed fields.

Cursor: To enter the offset value ± 3 C°. The offset value will be zero after exiting
from the folder.

12.7.3 TEMPERATURE TEST AREA

(3 commands)
START: To perform the test check and to regulate the temperature of the preheater and of the
reaction plate by using the kit P/N 55-01204-00, as illustrated in Chapter 6 “Setting
and Adjustments”.
The number of sample cycles are predefined, whereas the reagent and sample
positions for test execution can be selected by the operator.

Service Probe: the field in which the temperature of the service probe appears.

WASH: To run a wash cycle on the cuvettes used for testing.

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 Chapter 12 – DIAGNOSTIC PROGRAM

EXIT: To exit from the Temperature Test box and to run a wash cycle on the cuvettes if
they have been used.

12.7.4 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument hardware;
Receive: Visualizes the instrument hardware’s response to the commands sent by the program.

12.8 “WASH” FOLDER

The Wash folder is subdivided into three areas:

♦ OPERATIONS
♦ TEST
♦ STATUS COMMAND

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 Chapter 12 – DIAGNOSTIC PROGRAM

12.8.1 OPERATIONS AREA

(2 commands)
Home: Brings the washing device to the Home position;
Down: Makes the washing device go down to the washing position.

12.8.2 TEST AREA

(5 commands)
Test P5 + E.V. 5: Performs switching on of the E.V. 5 solenoid valve and turns on the P5 pump
and automatically switching off the E.V. 5 solenoid valve and turns off the P5
pump after a period of four seconds
Test P5: It turns on the µP5 pump and automatically turns it off after a period of four
seconds.
Test P6–Cuvette Dry:It turns on the µP6 pump and automatically turns it off after a period of four
seconds.
Peristaltic Pump: It turns on the peristaltic pump and automatically turns it off after one second.

Washing Cycle: It performs the functional check of the Washing Station , as illustrated in
Chapter Six “Settings and Adjustments”.

12.8.3 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument hardware;
Receive: Visualizes the instrument hardware’s response to the commands sent by the
program.

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12.9 “USER” FOLDER

The User Folder is subdivided into two areas:

♦ USER TEST MICRO

♦ STATUS COMMAND

12.9.1 USER TEST MICRO AREA

(3 commands)
Alarms ON: Turns on and off the Alarms indicator lamp;
Ready ON: Turns on and off the READY indicator lamp;
Test BUZZER: Performs a complete operational test of the buzzer;

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12.9.2 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument

hardware;
Receive: Visualizes the instrument hardware’s response to the commands sent
by the program.

12.10 “MISCELLANEOUS” FOLDER

The Miscellaneous folder is subdivided into four areas:

- General Reset
- Log Raw data
- Continuous Test Run
- Status Command

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12.10.1 GENERAL RESET AREA

(1 command)
Reset: Performs the resetting of the general system.

12.10.2 LOG RAW DATA AREA

(1 command)
Enable: To save a copy of the files for the technical diagnosis if the instrument
malfunctions. The files are memorized in the folder “Log” inside the folder
“Analyzer”.

12.10.3 CONTINUOUS TEST RUN

(1 command)
Start Test: Performs an automatic test during which the modules (Sampling Arm, Reaction
plate, Washing Station and Photometer) are moved to all the different positions.

The correct modules positioning is also automatically verified and showed on the following table:

To stop the test push on the “Exit Test” key

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12.10.4 STATUS COMMAND AREA

Send: Visualizes the commands sent by the program to the instrument hardware
Receive: Visualizes the instrument hardware’s response to the commands.

12.11 “GLOBAL SETTING” FOLDER

The Global Setting Folder is for next application.

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12.12 “MACRO SETTING” FOLDER

This folder allows the user to read the macro present in the Ellipse.
To read the macro follow the below procedure:
⇒ Select from the menu sheet “Read Macro” the number of relevant macro;
⇒ Click with the left side of the mouse on the Read area;
⇒ If the Macro requested exists, the information will appear in the designated area.

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12.13 “CONFIGURATION” FOLDER

This folder may be accessed only by qualified technical assistant.

It is necessary for the technical assistant to insert a password to access this folder.

The Configuration Folder is subdivided into four areas:

• Gap
• Backlash Dil.
• Heater
• Wash. Well level Test

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Gap: defines the volume, in µL, of the air bubble that separates the Rinse (the liquid column into the
sampling arm tube) from the sampled reagent; this volume must be set in the range from 10 to 24
(Standard value 16).
For the correct setting of the gap volume it is necessary to apply the procedure of BIB (Precision
check of the Analytical plate) and BIC (Volume precision check of the Sampling line).

If BIC’s CV values should exceed the limit specified below, the GAP has to be increased by
steps of 2 µL (starting from 10 µL) until obtaining the expected BIC’s CV value

Precision check of the Analytical plate BIB

Prepare two series of 32 samples each by using a diluted solution of K2Cr2O7 (obtained from 4
gr/l concentrated solution diluted 1:100 with Rinse solution (distilled water + 1000 µL/litre of Brij))
Use the same solution as samples and reagent
Program a new method with the following parameters:
Method name: BIB
Type: End Point
Sample volume K2Cr2O7 0,04 gr/l 3 µL
Reagent volume K2Cr2O7 0,04 gr/l 300 µL
Rinse volume 20 µL
Filter: 340 nm
Incubation time: 116 sec
Calculation factor: 1000

BIB Procedure
1. Select conical cup in Options
2. Program the BIB method using the above parameters and configure a reagent rack containing it
3. Enter in the calibration screen and select RBL for BIB method.
4. Put the Rinse solution as reagent and standard (fourteenth position of the Crt/Std rack) and Start
the Calibration

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5. Program 64 BIB; fill 32 conical samples cup with K2Cr2O7 0,04 gr/l
6. Load the samples racks into the Analyzer at positions 1 and 2
7. Substitute the Rinse Solution with K2Cr2O7 0,04 gr/l in the reagent rack
8. Start the Analyzer. At the end of the last sampling, move the samples racks to positions 3 and 4.

The mean of the reading obtained from each of the 32 sample series must fall within 360 ÷ 400.
The coefficient of variation (CV %) must be lower than 0.7 % for each series of 32 samples.

Precision check of the Sampling volume BIC

Prepare two series of 32 samples each by using K2Cr2O7 4 gr/l (concentrated)
Use the same solution for both samples and reagent
Program a new method with the following parameters:
Method name: BIC
Type: End Point
Sample volume K2Cr2O7 4 gr/l 3 µL
Reagent volume RINSE Solution (distilled water + 1000 µL/litre of Brij) 300 µL
Filter: 340 nm
Incubation time: 116 sec
Calculation factor: 1000

BIC Procedure
1. Program the BIC method using the above parameters and configure a reagent rack
2. Enter in the Calibration screen and select RBL for BIC method.
3. Put the Rinse Solution as reagent and Standard (fourteenth position of the Crt/Std rack) and
Start the Calibration
4. Program 64 BIC ; fill 32 conical samples cup with K2Cr2O7 4 gr/l (concentrated)
5. Load the samples racks into the Analyzer at positions 1 and 2
6. Start the Analyzer. At the end of the last sampling, move the sample racks to positions 3 and 4.

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The mean of the readings obtained from each of the 32 sample series must fall between 350 ÷ 450.
The coefficient of variation (CV %) must be lower than 1.6 % for each series of 32 samples

If BIC’s CV values should exceed the limit specified above, the GAP has to be increased by steps
of 2 µL (starting from 10 µL) until obtaining the expected BIC’s CV value

Backlash Dil.: Allows to recover the sampling imprecision generated by the motor when it inverts
its rotation; the setting is expressed in µL and obtained by using the following
procedure:

1. Enter in the Diagnostic Arm folder menu and make the Sampling Arm “Reset”
2. Enter in the Diluter folder, press the “HOME” button and then Push “PROBE WASH TEST”
button three times in order to fill the hydraulic sampling line
3. Remove the plastic cover of the sample racks vane and take out the samples racks
4. Enter in the ARM folder and push the “GO” button in order to move the probe to sample
position # 1
5. Put a sample cup containing distilled water (about 1ml) under the sampling probe
6. Enter in the DILUTER folder and aspirate 300 µL of distilled water from the cup
7. Remove the sample cup containing distilled water
8. Select 1 µL to dispense and press the “Disp” key repeatedly until water appears on the tip of the
probe.
9. Substract 1 from the number of times you pressed the “Disp” key. The obtained number has to be
introduced as BACKLASH value
10. Push the Save button to memorize the inserted data
11. Push the Reset button into the ARM folder
12. Close the Diagnostic program by clicking on the Diagnostic button

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Heater: to adjust the preheater and reaction plate temperatures;

Wash. Well level Test: By clicking on the “Run Test” button the system performs an automatic
verification and adjustment cycle for the liquid level in the washing well.
A number appears in the box “Level” that corresponds to the rotation time
of the rinse pump in milliseconds, that is necessary to maintain the correct
liquid level in the washing well.
The functioning range is between 350 and 700 milliseconds. If the
washing well is not sufficiently filled, a message appears to warn the user
to check the hydraulic line.
If the value taken during the test is different from the previous one, it is
necessary to click on “Save” in order to save the new data.

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