OPERATOR MANUAL

BT 1000 & BT2000 PLUS

P/N: MO04840-02ING

SOFTWARE VERSION 11.2

Rev. 0, 09/2008

This product conforms to the safety requirements of the Council Directives

98/79/EEC of 27 October 1998 (European Parliament) regarding the In-Vitro
Diagnostic Medical Devices. This directive is in accordance with the Article 2,
Paragraph 2 of the Directive 89/336/EEC, which ceases to apply to the products
complying with the present directive. Refer to Paragraph 7, Article No.1 of the IEC
Official Gazette No. L331 of Dec. 1998.
It also conforms to Italian Regulations CEI EN 61010-01 and CEI EN 61326-1 (EMC).
The conformity is attested when the equipment is installed
in accordance with the conditions outlined in the manual

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
Tel. +39-06-4112316
Fax +39-06-4103079
E-mail: [email protected] Website: www.biotecnica.it
 INDEX – BT2000 PLUS BT1000– Operator Manual
SECTION I: GENERAL INFORMATION

CHAPTER A
1. INTRODUCTION Page: 2
2. BASIC OPERATING PRINCIPLES OF THE ANALYZER Page: 3
3. SYMBOLS: explanation of the used or applied symbols Page: 3
4. BRIEF DESCRIPTION OF THE SYSTEM Page: 9
4.1. Front view of the analyzer Page: 9
4.2. Rear Panel Controls and Connectors Page: 10
4.3. Modules Page: 11

CHAPTER B
1. INSTALLATION Page: 2
1.1. Unpacking the Analyzer Page: 2
1.2. Installation Page: 4
1.3. Starting the instrument Page: 8
1.3.1. Turning on the instrument for the first time Page: 8
1.3.2. Preliminary checks Page: 10

CHAPTER C
1. FUNCTIONS Page: 2
1.1. Description of the Program Menu Page: 2
1.2. Operating Principles Page: 5
1.2.1. Computations Page: 5
1.2.2. Applied mathematical functions Page: 7
1.2.3. Initial computation Page: 9
1.2.4. Optimization techniques for Clinical Chemistry Page: 9
1.2.5. Methods Description Page: 10
1.3. Analyses Programming Page: 15
1.3.1. Creating a New Code Page: 15
1.3.2. Relation Tests Page: 16
1.3.3. Primary Analytical Parameters Page: 17
1.3.4. Check Parameters Page: 24
1.3.5. Secondary Analytical Parameters Page: 25
1.3.6. Automatic re-runs Page: 28
1.4. Controls Page: 29
1.5. Calibrations Page: 30
1.6. Creating Profiles Page: 35
1.7. Creating the Current Analyses’ Tray Page: 36

CHAPTER D
1. PERFORMANCE AND LIMITS Page: 2

INDEX BT2000 PLUS – BT1000 Page 1 of 5

 INDEX – BT2000 PLUS BT1000– Operator Manual
CHAPTER E
1. OPERATING PROCEDURE Page: 2
1.1. Turning on procedure Page: 2
1.2. Reagents: insertion and removal Page: 2
1.3. Running Standard & Controls (on command or timed) Page: 4
1.4. Samples Page: 6
1.5. Work Lists Page: 12
1.6. Turning off procedure Page: 16
1.7. Access Password Page: 17

CHAPTER F
1. QUALITY CONTROLS Page: 2
1.1. Inserting/modifying controls Page: 2
1.2. Data management Page: 4
1.3. Displaying and processing by lot pairs: Juden graph Page: 6
1.3.1. Westgard Graph Page: 7
1.3.2. Daily Chart Page: 9
1.4. Additional Functions Page: 10
2. POPULATION Page: 11
2.1. Analysis Selection (How to run a Query) Page: 12
2.2. Principal statistics formulas used in Population module Page: 16
2.3. Inserting external analyses Page: 18
2.4. Other menu functions Page: 19
3. PATIENTS’ ARCHIVE Page: 21
3.1. Selection (How to run a Query) Page: 23
3.2. Patients’ report Page: 25
3.3. Printing Reports Page: 27
3.4. Other menu functions Page: 29

CHAPTER G
1. DISPLAYING AND PRINTING RESULTS Page: 2
1.1. Results per Patient Page: 3
1.2. Results per Test Page 7
1.3. Displaying Real-Time data Page: 8
1.4. Reaction graphs Page: 10
1.5. Flags list Page: 12

CHAPTER H
1. ANALYZER TECHNICAL FUNCTIONS Page: 2
1.1. Service Functions Page: 2
1.1.1. Analyzer Utilities Page: 2
1.1.2. Mechanical Calibrations Page: 4
1.2. Diagnostic Functions Page: 6
2. ANALYZER SETUP Page: 9

INDEX BT2000 PLUS – BT1000 Page 2 of 5

 INDEX – BT2000 PLUS BT1000– Operator Manual
CHAPTER I
1. BARCODE AND RELATED FUNCTIONS Page: 2
2. USING THE BARCODE Page: 2
2.1. Barcode on Samples Page: 2
2.2. Reagent Barcode Page: 5

CHAPTER M
1. WARNINGS AND PRECAUTIONS Page: 2
1.1. Potential risks during operation and maintenance Page: 2
1.2. Warnings and precautions Page: 3
1.3. Waste disposal Page: 6
1.4. Returning the analyzer to the T.A.S. Page: 6
1.4.1. Operating Analyzer Page: 6
1.4.2. Not Operating Analyzer Page: 7
1.5. Analyzer safe disposal Page: 8
1.6. Electric and electronic devices disposal Page: 9

CHAPTER N
1. MAINTENANCE AND CARE Page: 2
1.1. Preventive maintenance and Extra Wash Page: 2
1.2. Replacing tubing and accessories Page: 3
1.2.1. Clinical Chemistry Page: 3
1.2.2. Extra wash cuvettes Page: 5
1.2.3. Photometric lamp Page: 5
1.2.4. Dilutors’ piston o-ring Page: 6
1.3. Cleaning the instrument Page: 7
2. MALFUNCTIONS Page: 8
2.1. Troubleshooting Page: 8
2.2. Screen messages Page: 9
2.2.1. Screen messages - Causes and remedies Page: 9
2.2.2. Messages requiring technical assistance Page: 10
2.2.3. Optical system verification messages Page: 13
CHAPTER O
1. TECHNICAL SPECIFICATONS Page: 2

INDEX BT2000 PLUS – BT1000 Page 3 of 5

 INDEX – BT2000 PLUS BT1000– Operator Manual
SECTION II: SUPPLEMENTARY INFORMATION

CHAPTER 1
1. ABBREVIATED OPERATING INSTRUCTIONS Page: 2
1.1. Turning on and preliminary procedures Page: 3
1.2. Inserting Reagents for Clinical Chemistry Page: 6
1.3. Analytical calibrations and Controls Page: 7
1.4. Entering Patients and Work Lists Page: 10
1.5. Running Tests Page: 14
1.6. Displaying and Printing Results Page: 15
1.7. Turning off the analyzer Page: 19

CHAPTER 2
2. WARRANTY CONDITIONS Page: 2
• Notes from the manufacturer Page: 3
• Parts/Instruments Return Authorization Page: 4

CHAPTER 3
3. ORDERING INFORMATION Page: 2
3.1. GENERAL TERMS AND CONDITIONS FOR SALE Page 2
3.2. Consumables for BT2000 PLUS Page: 3

CHAPTER 4
4. SOFTWARE EXTENSION:
Page: 2
Serial communication BT2000 PLUS <-> Host Computer
4.1. General Page: 2
4.2. Patient transmission to BT2000 PLUS Page: 2
4.3. Results reception Page: 3
4.4. Calculation of check-sum Page: 4
4.5. Wiring diagram of interface cable Page: 5
4.6. Variable communication protocol Page: 6
4.7. Serial communication test programs Page: 17
4.7.1. Program Comunica.exe Page: 17
4.7.2. Program BTPLUS.exe Page: 17

CHAPTER 5
5. INSTALLATION OF THE OPERATING SYSTEM Page: 2
5.1. Preliminary Phase Page: 2
5.2. Setup of the Operating System Page: 6
5.3. Completing the installation Page: 12
5.4. Settings of the Operating System Page: 14
5.5. Installation of BT2000 PLUS Program Page: 19
5.6. Upgrading the BT2000 PLUS software Page: 21

INDEX BT2000 PLUS – BT1000 Page 4 of 5

 INDEX – BT2000 PLUS BT1000– Operator Manual
CHAPTER 6
6. TECHNICAL ASSISTANCE Page: 2

CHAPTER 7
7. BIBLIOGRAPHY OF ALLIED SUBJECTS Page: 2

CHAPTER 8
8. LIST OF APPLICABLE METHODOLOGIES Page: 2

ATTENTION: USE OF THE BT2000 PLUS (AND DERIVATES) INTERNAL

COMPUTER

The computer box of analyzer BT2000 PLUS and by-products is designed for long-
term security and reliability and is virtually maintenance-free as long as the user
does not install any third-party application programs. If these applications are
installed, then they may damage the operating system registry and may also
cause disastrous consequence for the computer's hard-drive. Biotecnica
Instruments S.p.A. will not be responsible for any damage to the analyzer, its
software and data in the hard-disk in case of improper use of the PC box. This
includes also: installation of external programs, not properly secure net
connections (intranet and internet) and the use of disks without the necessary
verification for viruses presence. Biotecnica Instruments S.p.A. will not be
responsible for any damage caused by non authorized third parties who may open
and alter the PC box configuration.

INDEX BT2000 PLUS – BT1000 Page 5 of 5

 OPERATOR MANUAL
BT 1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER A
1. INTRODUCTION Page: 2
2. BASIC OPERATING PRINCIPLES OF THE ANALYZER Page: 3
3. SYMBOLS: explanation of the used or applied symbols Page: 3
4. BRIEF DESCRIPTION OF THE SYSTEM Page: 9
4.1. Front view of the analyzer Page: 9
4.2. Rear Panel Controls and Connectors Page: 10
4.3. Modules Page: 11

IMPORTANT NOTICE
The introduction of access passwords has been
rendered mandatory since 2004 for safeguarding
sensitive data (refer to CHAPTER E, paragraph 1.7.).

NOTE:
This manual is valid for both BT1000 and BT
2000PLUS. The following components are not
installed on the BT1000:
a) Reagent refrigerator
b) Barcode
c) Touchscreen

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter A System Description Page 1 of 11

1. INTRODUCTION
The BT2000 PLUS is an automatic analyzer for Clinical Chemistry and Immunoturbidimetry,
represents the technological evolution of the T.A.R.G.A. line (“Technology Advanced
Random Generation Analyzer”), manufactured by Biotecnica Instruments S.p.A. Rome,
Italy.
The BT2000 PLUS software is based upon Windows 2000 NT® (Fig. 1). It is easy to learn
and offers the operator (thanks to its selective random access) the maximum flexibility in
the acquisition and performing of ROUTINE and URGENT (“STAT”, “Single Test Actual
Time”) tests on serum, plasma and urine.
Designed for continuous use (24 hours non-stop), the analyzer can perform STANDARDS’
CALIBRATION and QUALITY CONTROLS upon operator’s request or at programmed time
intervals.
An AUTODIAGNOSTIC FUNCTION is built into the operative software, continuously
monitors the analyzer system for correct operation.

The analytical throughput of BT2000 PLUS is up to 250 tests/h and (up to 200 tests/hour for
BT 1000) for clinical chemistry.
The methods used are: End Point, Fixed Time, Kinetic, Initial-Rate (I.R.), Sample Blank
type A and B, Only Read, End Point 2 points, Sample Blank (A-b), Sample Blank (B-
b),Absolute End Point and End Point Starter. It is possible to store up to 500 different
test codes, plus “Relation Tests” with no limit. In the stored analyses list the operator can
generate customized test codes sequence of reagent plate in use, including the relation
tests.
During analyzer operation, the refrigerated reagents chamber ensures a longer stability of
the products in use.
The positive barcode identification of reagents position, eliminates any possible error during
the positioning of bottles.
It is possible to perform repetitions (“Re-run”) upon operator's request or automatically
(pathological results).
In case of hyperactive results, the test repetition can be performed with automatic dilution of
the sample, as programmed in the parameters page. It is also possible to run tests on
already diluted samples, thanks to the automatic data processing function.
Random positioning of samples and positive barcode identification. The bar-code feature
and the connection to the Host Computer allow the system to be fully automated.
An internal software manages the QUALITY CONTROL (statistics of control sera and
population) and PATIENTS’ ARCHIVE with data display and printouts.

Figure 1
Section I Chapter A System Description Page 2 of 11
2. BASIC OPERATING PRINCIPLES OF THE ANALYZER
The BT2000 PLUS is an automatic analyzer based upon the spectrophotometry principles.
The light absorption laws rule the performance of spectrophotometers.
The amount of light radiation that passes through a homogeneous absorbing medium is
defined as transmittance, T, where:
T = I / I0
I0 = incident light radiation intensity
I = transmitted light radiation intensity
The absorbance, A, (or extinction, E) is defined as:
A = log (1/T) = log I0/I
The Lambert-Beer law states the relation between absorbance, concentration of a
compound absorbing light and sample thickness:
A=εcd
ε = molar extinction coefficient of the compound absorbing light at a certain (λ) wavelength.
c = molar concentration of the compound absorbing light
d = optical path of the radiation into the solution
The absorbing spectrum of a compound is represented by a graph where the absorbed light
(= absorbance) is related with the wavelength. For a colored solution, the graph will show
one or more absorbance peaks. These may be in the visible part of the spectrum (400-700
nm) as in the ultraviolet (200-400 nm) region.
The BT2000 PLUS uses a photometric system specially designed by the R&D Dept. of the
Biotecnica Instruments S.p.A.
A light beam is sent through a cuvette that contains the solution that has to be read. The
exiting light beam is transmitted to a photometer containing 10 interference filters of
different wavelengths. The signal is amplified and then processed by the specific
electronics and by the computer. The program then makes all the necessary calculations
and controls, so that it can finally present the concentration of the compound in the sample
and the any irregularities found in the reaction.
The general principle upon which the photometry in clinical chemistry is based is the
following: the increasing or the decreasing of the color intensity in a specific solution is
proportional to the searched compound concentration. Generally speaking, when a sample
is added to a specific reagent, it starts a reaction carried out by specific enzymes or
substrates. This reaction causes the increasing (or decreasing) of the solution color inside
the cuvette. During the reaction process, the instrument “reads” it by means of its
absorbance. The final data processing is done with reference to a calibration or a
theoretical factor, so as to give at the end the concentration of the compound into the
sample.

3. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS

As the BT2000 PLUS analyzer software is based upon Windows, it uses the Windows style, icons,
quick commands, function keys and curtain-shaped menus.
Every screen has its own icons and specific menus that will be described hereafter. The full
meaning of each command will be explained in the corresponding chapters.
At the start-up, the program will display the following main window:

Section I Chapter A System Description Page 3 of 11

 1
2

5 3

8 9 10

① Main menu: each menu generates other commands and/or options

② & ③ Direct access icons: selecting each icon the relative command is directly
activated
④ Software version: operative program version
⑤ Access level: is the access level of the operator: it is password dependent
⑥ Vertical Bar - Commands: Direct access to function commands
⑦ Messages bar: clicking here opens a window showing the messages received
by the program
⑧ Errors bar: by clicking here a window is opened showing the errors occurred
during the work session
⑨ Refrigerator Status Indicator
⑩ Operating Pressure Indicator, Ambient Temperature (RT), Cuvette
Temperature (CT)

Section I Chapter A System Description Page 4 of 11

 SERVICE ICONS BAR

Reset Analyzer (F5)

Stand-by Analyzer (F6)

Displays the Volumes’ Status; Used to Insert/Remove Reagents (F10)

Password (F7)

Status Analyzer (F2)

Printer Setup (F4)

Help on line (F1)

FUNCTION ICONS BAR

1 - To Insert New Codes, Parameters, Standards and Controls for all Analyses

2 - To Create the On-Line Reagents’ Tray

3 - To Insert Parameters/ Standard and Controls for the On-Line Reagents

4 - To Insert/Modify Profiles

5 - To Insert Routine - View Programmed or In-Run Patients

6 - To Insert Batch

Section I Chapter A System Description Page 5 of 11

 7 - To Run Standards

8 - To Run Controls

9 - Analyzer’s Utilities

10 - Mechanical Calibrations

11 - a) Results Listed per Patient b) Results per test in real time

12 - No Results

13 - Reaction Graphs

14 - Turning off the System

Simply positioning the cursor on the icons the “hint” will appear (where available), showing a brief
description of the icon function. This is followed (when available) by the function key between
brackets, which allows for the same function or command as the icon. For example, the hint “Reset
(F5)” means that the function key F5 has the same function of the icon. In the same way, in each
menu are shown (when available) the quick commands (e.g. “Insert Batch” (Ctrl+B) means that the
same function is activated by typing simultaneously on the keyboard the keys “Ctrl” and “B”).

GENERAL ICONS

Cancel (aborts the programming and closes the window)

Save (saves the program and closes the window)

Print (prints the window's contents, i.e. parameters, graphs etc.)

Reduces the window to the upper bar where the analyzer's name appears.

An icon representing refrigeration system operation has been added to the status bar in the main
menu. The "Refrigerator disabled" state may be necessary if the operator decides not to use the
refrigerator for reactions or after a refrigeration operating error generated by the system.

Refrigerator enabled Refrigerator disabled

Section I Chapter A System Description Page 6 of 11

 IVD SYMBOLS: PRINTED PACKAGING ITEMS

Caution, consult instructions for use

In vitro Diagnostic Medical Device

Catalog number

Manufacturer

Lot number or Batch code

Storage temperature

Expiry date

Biological hazard

Risk symbols

CE Logo (Directive 98/79/CE)

Electrical and electronical devices: collect and dispose separately.

Section I Chapter A System Description Page 7 of 11

 SYMBOLS APPLIED ON THE ANALYZER
A compilation of the main nameplate and warning symbols used for the IEC standards
based on Table 1 of IEC 61010-1 Second Edition.

Direct current

Alternating current

Both direct and alternating current

Earth (ground) Terminal

Protective earth conductor terminal

Frame or chassis (ground) terminal

Equipotentiality

ON (Main supply)

OFF (Main supply)

Equipment protected by double insulation or reinforced insulation

Caution, risk of electric shock

(black on yellow background)

Caution, refer to accompanying documents

(black on yellow background)

Section I Chapter A System Description Page 8 of 11

4. BRIEF DESCRIPTION OF THE SYSTEM

4.1. FRONT VIEW OF THE ANALYZER

5 1

Fig. 2

1 ON/OFF BUTTON FOR COMPUTER

2 LCD DISPLAY
3 REFRIGERATED REAGENT COMPARTMENT
4 SAMPLES TRAY
5 SAMPLING ARM FOR CLINICAL CHEMISTRY
6 FLUIDIC CIRCUIT AND READING STATION
7 INTEGRAL HANDGRIPS
8. DILUENT BOTTLE

Section I Chapter A System Description Page 9 of 11

4.2. REAR PANEL CONTROLS AND CONNECTORS
Computer Box
See Fig. 4

Rear Panel
Fig. 3
IMPORTANT NOTICE:
The illustrated connectors on the Computer Box (Fig. 3 & Fig. 4) may not be the exact representation
due to possible design modifications without notice during the life of this manual. For correct
configuration of the computer panel, please check the panel of Computer Box on the analyzer rear
panel.

Connectors, Computer Box

Fig. 4

Section I Chapter A System Description Page 10 of 11

4.3. MODULES
The BT2000 PLUS analyzer is constructed of a one-piece stainless steel structure. The
injection-molded body (in Baydur®) is placed on the chassis to cover the instrument.
Fig. 5 shows the modular composition of the instrument. Each module has its own specific
function.
Modules definition
• COMPUTER BOX: consists of LCD Monitor, Touch screen, Main board, Power Supply and
peripheral devices.
• READING STATION MODULE: comprises cuvette plate, photometer, diluter, reading unit,
washing station, H2O reservoir and electronics.
• POWER SUPPLY MODULE: houses the main power supply of the analyzer.
• REAGENT TRAY MODULE: is composed of the rotating reagent's tray, the refrigeration
chamber, the bar-code reader and the electronics.
• SAMPLE TRAY MODULE: is composed of the rotating samples tray, the bar-code reader, the
sample tube sensors, the washing wells and the control electronics.
• SAMPLING ARM: is composed of a two-axes based mechanical system accommodating
sampling needle head with built-in electronics including correct position sensor (Encoder).

POWER SUPPLY DILUTER (READING STATION)

NEEDLE
WASTE

PHOTOMETER
CUVETTE
H2O WASTE

COMPUTER

MODULES:
SERUM 1 – COMPUTER BOX
REAGENT 2 – READING STATION
3 – POWER SUPPLY
4 – REAGENT MODULE
5 – SERUM MODULE
6 – SAMPLING ARM

REAGENT BAR-CODE SERUM BAR-CODE

Only on BT2000 PLUS) (Only on BT2000 PLUS)

Modules Arrangement
Fig. 5

Section I Chapter A System Description Page 11 of 11

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER B
1. INSTALLATION Page: 2
1.1. Unpacking the Analyzer Page: 2
1.2. Installation Page: 4
1.3. Starting the instrument Page: 8
1.3.1. Turning on the instrument for the first time Page: 8
1.3.2. Preliminary checks Page: 10

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter B Unpacking & Installation Page 1 of 10

1. INSTALLATION

1.1. UNPACKING INSTRUCTIONS

♦ Unpacking the analyzer and the accessories
The crates can be easily opened by applying the lever action, with a large screwdriver, to
remove all the spring clips on the base of the crate as shown in the Figure 1. Carefully
remove the upper covering. Remove the analyzer and place it on a stable vibration-free
surface. Carefully unpack all the accessories and place them in a protected place. Store the
empty wooden crate in a safe place for future use.

CAUTION
The analyzer is provided with four integral handgrips located on the left and right
sides of the base frame. To lift or move the instrument from one location to another,
always use the handgrips. ATTENTION: two persons are necessary to move the
analyzer.

Arrow Pointing
Upwards

Base

Spring Clip

Figure 1

Section I Chapter B Unpacking & Installation Page 2 of 10

♦ Verification Of the contents of the wooden crates
Verify upon receipt of the BT2000 PLUS analyzer system that all parts are present and
intact when opening the wooden crates and packaging. In the basic package, the BT2000
PLUS analyzer system is provided with the following items in the checklist:

Contents of the large wooden crate:

Qty Description OK
1 ANALYZER
1 USER'S MANUAL
1 INSTALLATION DISK
1 WINDOWS SOFTWARE DISK
1 KEYBOARD DRIVER
1 UPS DRIVER
1 MB DRIVER
1 PRINTER DRIVER

Contents of the small wooden crate - accessories and peripherals:

Qty Description OK
1 WASTE PROBE, H2O INTAKE TUBE
1 1 UPS UNIT 1100VA (P/N 330.2132), 1 POWER CORDSET (P/N
330.6391).
1 TRANSPARENT OVERFLOW TUBE 50cm LONG
1 CORDLESS KEYBOARD & MOUSE (P/N 662.2057)
1 PRINTER (P/N 330.2172)
1 SURFACTANT CONC. 2x50 ml (P/N 392)
1 WASHING SOLUTION FOR CUVETTE 1 liter (P/N 393)
1 FUNNEL CAP OPENER, TOOL (90-05201-01)
2 FUSES 250 VOLT, 8A T (P/N 330.6342B)
1 QUARTZ HALOGEN LAMP 12V, 35W, 9° (P/N 330.9321)
1 ANNUAL MAINTENANCE KIT (662.2001)
1 CLEANING TOOL FOR SAMPLING NEEDLE (662.0629A)
2 CUBITAINER 10 LITERS WITH BOX (P/N 662.1010)
1 WASHING PISTON GRIP SLEEVE, TOOL (662.1025)
1,000 TRANSP. SAMPLE CUPS 2ml (667.1040)
50 REAGENT CONTAINER 50 ml (667.1084)
25 REAGENT CONTAINER 20 ml (667.1085)
25 REAGENT CONTAINER 10 ml (667.1086)
2 10 ml TUBES (667.1081)

Section I Chapter B Unpacking & Installation Page 3 of 10

♦ Verifying eventual damages occurred during shipment
It is highly recommended to accurately verify the instrument and its accessories for any
damages that could have occurred during shipment. In case there is a damage or missing
items then please fill out all the sections of the Mod. 05-35a in this manual in the SECTION
II, CHAPTER 2 “WARRANTY CONDITIONS”. Send it to your nearest sales/service office
or directly to Biotecnica Instruments S.p.A. Rome, Italy. After appropriate evaluation,
Biotecnica or its branch office will provide the best solution to the problem.

1.2. INSTALLATION
The analyzer must be placed on a stable vibration-free-surface, level table or cart. It should
be easily accessible to the operator to load samples, consumables, reagents, etc. Ensure
that the table can bear the instrument’s weight (approx 70 Kg) and is large enough for its
dimensions (refer to Chapter M, paragraph 1. “Technical Specifications”). Avoid exposure to
direct light, heat, air streams and draught. The instrument’s left, right and rear sides must
be left free (min. 20 cm from the wall) to ensure the produced heat dispersion and easy
tubes and cables connection. Room temperature must not exceed 32°C. We recommend
placing on the same table the analyzer and its peripherals (max allowed distance: 1.5 m).
The printer can be placed in any location, always taking into consideration the paper feed,
the connections with the instrument and the power supply needs. It is very important to
place the analyzer away from strong electromagnetic fields, such as centrifuges, electric
motors, big refrigerators, X-ray instruments, etc.
The table must be near a wall outlet with earthing and differential switch (life-saving)
The analyzer refrigerator produces water condensation in the reagent chamber. This is
important for cooling the reagents in the bottles. In case of too much condensation, wipe it
off with a clothe without drying it completely (never do this operation with the analyzer on).
The instrument can be leveled by means of the four adjustable feet, to ensure the good
drainage of the condensation.
CAUTION
The analyzer is provided with handgrips located on the left and right sides of the
base frame. To lift or move the instrument from one location to another, always use
the handgrips.

NOTE:
All the components shown in the following figures may undergo modifications over the time.
Therefore, it is recommended to verify them accurately prior to any repair or installation
(refer to eventual specific manuals included).

ELECTRICAL CONNECTIONS
Connect main power cable from the instrument to the UPS and connect the latter to the
main wall outlet (Figure 2). Power circuit should respect current laws and have a good
earth connection.

Section I Chapter B Unpacking & Installation Page 4 of 10

The printer and peripheral devices should be connected to the appropriate accessory power
connectors on the analyzer rear panel (adjacent to main power inlet). See Figure 2.

FUSE

PRINTER POWER
ON-OFF ANALYZER

FROM UPS

Figure 2
CONNECTING MOUSE AND KEYBOARD
Keyboard and mouse are cordless, and work by radio transmission. The receiver with PS/2
adapter should be plugged into the appropriate port on the rear panel.
The receiver has two cables with colored connectors that should be plugged into the
respective ports of the same color. They are generally violet for keyboard and green for
mouse (Figure 3).
Receiver, mouse and keyboard should be already tuned. If not, then observe the following
procedure:
Turn on the analyzer, after program loading (system boot) is finished, press "connect"
button on the receiver, and then press "connect "button" on mouse. Next, press "connect"
button on receiver again and press connect button on keyboard (rear). Refer to Figure 4.
Connect buttons are generally located on the rear and can be pressed with the tip of the
pen or pencil. Test mouse and keyboard and eventually repeat the tuning operation starting
from the receiver. These devices need tuning only once.

Section I Chapter B Unpacking & Installation Page 5 of 10

 from BT
2000 PLUS
from BT
2000 PLUS

Fig. 5
PRINTER:
Refer to Figure 5 for connections.

FLUIDIC CONNECTIONS

The external fluidic manifold (Figure 6) located at the bottom left of the rear panel has three
connectors dedicated to H2O intake, discharge of waste fluids, and a connector for
transparent fluid overflow tube. A transparent tube supplies double distilled water from the
external container. The waste probe tube discharges the analyzer waste (flowing from an
internal vacuum pump) to the external waste container. In addition, the tubes are fitted with
quick-connects having built-in shut-off valves, which in case of disconnection prevents
liquid spillage.
Overflow Tube

Fisher connector
Waste Probe

Waste
Probe H2O Intake

Fig. 6

The transparent tube (double distilled H2O plus Surface Active Agent i.e. tensioactive -
1ml every liter of water, ratio 1/1000) must be connected to the right connector (H2O
Intake). Its other end goes to the external water container. Connect the liquid level detector
cable (Fisher connector) and the drain tube of the waste probe to the middle connector
(Waste Probe). Insert the waste probe in authorized external waste container (Fig. 7).

Section I Chapter B Unpacking & Installation Page 6 of 10

WARNING
1) Do not use the internal vacuum pump system with any other fluid source except the BT2000 PLUS
analyzer. The unauthorized use may result in serious injury to the user and permanent damage to
the vacuum pump system.

DRAIN TUBE CONNECTOR

Fisher Connector
LEVEL SENSOR

RED LED

WASTE PROBE (P/N 07-05165-01)

Figure 7

Section I Chapter B Unpacking & Installation Page 7 of 10

1.3. STARTING THE INSTRUMENT

1.3.1. TURNING ON THE INSTRUMENT FOR THE FIRST TIME

Turning on procedure for the first time:
1) Turn on the UPS device as described in the appropriate supplied manual.
2) Power on the printer (refer to the specific manual enclosed).
3) To switch on the analyzer, use the main power switch on the rear panel of the instrument. This
button activates only the refrigerating system for the reagents. To properly turn on the analyzer
system, momentarily press the push-button under the Floppy Disk display (Fig. 8).
CAUTION
Do not press this push-button during analyzer operation, because when pressed it stops the
instrument, leaving only the refrigerating system on (refer to Paragraph 1.6., Chapter E,
"Turning off procedure").
The start-up process includes the loading of the operating system (bootstrap) into the memory.
At the end of the boot (loading of the operating system), the instrument activates all the devices
and performs mechanical, hydraulic and electronic checks. The hydraulic check is represented
by a graphical page "Auto Diagnostic" (Fig. 9) where the different phases of tests in progress
are displayed sequentially. At the end of each test a message “Passed” or “Not Passed”
appears. If all the tests had positive outcome (Passed) then this page automatically disappears.
If one of the tests was followed by a message “Not Passed” then this indicates that the
particular device is not functioning properly. This means that the instrument is not in the
condition to perform analytic tests. By performing a manual reset (F5), the instrument will repeat
the auto-diagnostic cycles in an infinite loop until the problem has been resolved.
4) Once turning on procedure has completed (lasting few minutes), wait for the system to warm up.
During warm-up phase the temperature indicator flashes on the bottom right of the display until
the appropriate temperature is reached. The instrument reaches the steady state after
approximately 20 minutes.
5) After turning on the system, there is an access password requirement. Refer to Chapter E,
paragraph 1.7. ACCESS PASSWORD regarding the utilization of the password.
6) Prime the hydraulic circuit using the commands outlined in Chapter H, paragraph 1.1. “Service
Functions” (“Dilutor prime”, “Wash with water”).

DVD-ROM

FLOPPY
DISK

POWER BUTTON
COMPUTER

Fig. 8

Section I Chapter B Unpacking & Installation Page 8 of 10

 Fig. 9

Section I Chapter B Unpacking & Installation Page 9 of 10

1.3.2. PRELIMINARY CHECKS
Before using the analyzer, it is recommended to perform the preliminary checks outlined
below. Some of these checks should be performed daily and others are periodically.

DESCRIPTIVE TABLE

OPERATIVE CONTROL PERIODICITY NOTES

Verify that there is sufficient washing solution Daily

in the external tank for the needs of the
working day. The washing solution is
prepared by adding to double distilled
H2O the Surface Active Agent –
tensioactive - 1ml per liter of water (i.e.
ratio 1:1000). See technical specifications
regarding double distilled water below.

Check that the waste containers are empty Daily

or that they are of sufficient capacity for at
least containing washing solution
corresponding to the daily waste liquid
volume.

A reminder message will

Zeroing of the photometer Twice a day appear 20 min after start up
and then after 6 hours.

Wash the cuvettes with the proper solution Daily Before turning off
Extra wash of the cuvettes with acid solution Weekly When turning off

DOUBLE DISTILLED WATER SPECIFICATIONS:

Resistivity: > 5 M Ω/m
Conductivity: < 1µS/cm
pH: 6,4
Residual Ions: < 1µg/l

Section I Chapter B Unpacking & Installation Page 10 of 10

 OPERATOR MANUAL
BT 1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER C
1. FUNCTIONS Page: 2
1.1. Description of the Program Menu Page: 2
1.2. Operating Principles Page: 5
1.2.1. Computations Page: 5
1.2.2. Applied mathematical functions Page: 7
1.2.3. Initial computation Page: 9
1.2.4. Optimization techniques for Clinical Chemistry Page: 9
1.2.5. Methods Description Page: 10
1.3. Analyses Programming Page: 15
1.3.1. Creating a New Code Page: 15
1.3.2. Relation Tests Page: 16
1.3.3. Primary Analytical Parameters Page: 17
1.3.4. Check Parameters Page: 24
1.3.5. Secondary Analytical Parameters Page: 25
1.3.6. Automatic re-runs Page: 28
1.4. Controls Page: 29
1.5. Calibrations Page: 30
1.6. Creating Profiles Page: 35
1.7. Creating the Current Analyses’ Tray Page: 36

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 1 of 35

1. FUNCTIONS
1.1. DESCRIPTION OF THE PROGRAM MENU
As already described in the Chapter A, the BT2000 PLUS is a clinical chemistry automated
analyzer for programming and performing tests in Routine (programming per patient), Batch
(samples per test) and STATs on serum, plasma and urine. The single samples are always
accessed in random mode.
Besides the clinical chemistry, it is possible to perform turbidimetry tests (immunochemistry)
for specific Proteins, pharmaceuticals and drug abuse.
Once the program is loaded, the main page appears, where it is possible to enter all the
menus. These are available in two variants: the horizontal and the vertical menu bars.
Moreover, there is the icon bar that can be used for a rapid access to the most frequently
used commands (refer to Chapter A, paragraph 3.).
The analyzer provides access to the operating commands in the following three different
ways:
Menus
Shortcuts
Icons
Menu: move the cursor on the selected command and click once to access the function.
Shortcuts: the shortcut is a particular combination of the keys: "Ctrl or Alt + one letter of
the function’s name" (ex. "Ctrl+P" or "Alt+A"). It gives a direct access to the requested
command. The Shortcuts are available for the menu items in "Patients" and "Tests".
These are always enabled, except for the external programs, the diagnostic page, and the
parameters’ programming pages or in case of errors’ notification.
Icons: it is the symbolic representation of a given function. Move the mouse cursor on the
desired icon and confirm by a single click to access the function.
The menus contain five items: "Patients", "Tests", "Analyzer", "Utility" and "External
programs".
Each item has a sub-menu that provides access to additional commands, some of which
can also be selected through combination of keys corresponding to the desired shortcut.

"Patients Menu" (Fig. 1)

"Insert Routine/STAT", "Insert Batch": these items
are used to enter samples for Routine/STAT and Batch
mode.
"Run all pending patients": Restarts the work list
after an interruption.
"Repetition for analyses": Selects the repetition by
analyses upon operator's request.
"Clear Patient List": Deletes the entire memorized
patients list. The analyzer will request confirmation
before deleting.
Figure 1

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 2 of 35

"Tests Menu" (Fig. 2)
"Tests’ parameters (All Tests)": It is used for
programming and memorizing tests.
"Analyses’ parameters (Only In Tray)": It
provides direct access to the analyses on the
current reagents’ tray.
"Create current tray": This item is used to
create the list of analyses’ in the current reagents
tray.
"Insert profiles": See paragraph 1.6. "Creating
Profiles".

Figure 2
"Run Standards/Controls": Activates the procedure for running standard/controls.
"Export Data": Copies onto a floppy disk or any other desired location, the above-
mentioned parameters. There are two available options: "Back-up" (for exporting all the
analyses) and "Single Test" (exports the single tests).
"Import Data" Copies the above-mentioned parameters from a floppy disk or from any
other location. There are two available options: "Restore" (will import all parameters) and
"Single test" (imports single tests).
NOTE: when a single parameter is imported, it will be placed in the Global list of
analyses. The operator will have then to correctly place it in the Current tray.

"Analyzer Menu" (Fig. 3)

"Analyzer’s utilities": Provides access to the service
procedures of the analyzer.
"Mechanical Calibrations": For making adjustments to
mechanical devices.
"Diagnostic": The technical assistance personnel mainly use
this function (see Chapter H).

Figure 3

"Utility Menu" (Fig. 4)

"Archive Data": This command stores the processed patients’ data
into the patients’ archive.
"View reaction’s curves": This command displays on a graph the
reaction’s curves of tests, with print capability.
"View results for Analyses": Displays results for test.
"Setup Analyzer": It is used to define some system parameters.
This command is disabled during analyzer operation. Refer to
"Setup Analyzer" in Chapter H, paragraph 2.
"Sleep": This command sets the analyzer to a standby mode,
during which the cuvettes are washed and the monitor displays the
screensaver. Press the button at the center of the display to exit
from the sleep mode. A reset will occur and the analyzer will be
immediately ready to operate. This option is useful when the
analyzer is not being used for a while, but it must be kept on to
Figure 4 resume work immediately.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 3 of 35

Note: The analyzer switches automatically to standby mode when left unused for more than
thirty minutes.
"Suspend activity (Log-Off)": This command is used for programming the power on of the
analyzer on a specific date and hour. A small window will appear on the monitor where the
restart time and date can be set. After the programming is confirmed, a guided procedure
will lead to the system’s washing procedure and afterwards the analyzer will suspend its
activity. The system will be off except for the reagent refrigeration chamber. Approx 30 min.
before the programmed turning on time, the lamp and the cuvettes’ Peltier will be
reactivated. At the expiry of programmed time and date the analyzer will exit the suspend
mode by performing a system reset. To resume the analyzer activity before the
programmed time, press any key. The system will reset and after approximately 20 minutes
warm-up time the analyzer will be ready to operate.
"Shut-Down": To turn off the analyzer, it is important to observe the shutdown procedure
(refer to Chapter E, paragraph 1.6.). The program, through a guided procedure, will perform
the shutdown wash, and then the computer will turn off leaving only the reagent
refrigeration chamber turned on. Press the ON/OFF button on the rear panel to turn also
the refrigerator off.
Note: The analyzer’s program will guide the operator through screen messages in the
analyzer turning on and turning off procedures. He will be invited to place the solutions
when needed and to ensure correct execution of washing procedures. In case the washing
procedures are not performed during shutdown, then at the next restarting of the analyzer
(and before any sample run) the system will display a message inviting the operator to
perform the required washings. Bear in mind that it is not possible to ensure data precision
and accuracy if the normal washing and maintenance procedures are not observed.
"RS232": This command is active only when the serial communication is enabled (see
"Analyzer Setup", Chapter H, paragraph 2). It allows the analyzer to send data to the host
computer, upon operator’s request.
When the serial port is active, two more commands will appear: Accept result to be sent
and Delete result to be sent. The first one will send the results to the Host computer, the
second will delete the results waiting to be send.
"Log Files": gives access to the files where the operations performed by the analyzer are
stored. This function is divided in two parts: the first part memorizes the performed
operations; the second stores the errors and the incorrect procedures. This read-only area
is very important for the Technical Assistance/service personnel.

"External Programs" Menu (Fig. 5)

The functions in this menu are outlined in the Chapter F.

Figure 5

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 4 of 35

1.2. OPERATING PRINCIPLES
Generally, adding a sample to its reagent determines a chemical reaction (involving
enzymes and/or substrates) whose effect is to increase (or decrease) the color and thus the
optical density of the solution in the cuvette. As the reaction proceeds, it is "read" by the
analyzer in terms of "absorbance" ("A" or "Abs" for absorbance).
As every analyte has its own reagent with its proper characteristics; therefore it becomes
necessary to use different methodologies (preparation and reading) based upon different
wavelengths for each test. Many tests are based on similar principles, hence they will have
in common the method and the wavelength, but not necessarily the incubation and reading
times.
To obtain the concentration of an analyte in a sample, the analyzer multiplies the
absorbance (or the absorbance delta ∆A = absorbance variation) developed by that sample
reaction with a multiplication factor.
Besides some analyses for which a theoretical factor is used, usually the factor is
calculated during a calibration. During the calibration the analyzer reads the reaction
obtained with a known concentration sample called "standard". The factor is calculated by
dividing the known concentration value by the absorbance read for the standard.
For the non-linear analyses (e.g. immunoturbidimetric tests) it is necessary to create an
interpolation curve by means of several standards at different concentrations.

1.2.1. COMPUTATIONS
♦ COMPUTING ABSORBANCE ("ABS")
End Point
ABS = Mean value of the last points in reading time- second phase - (max 3)
With subtraction of the Blank reagent.
Kinetics
• Linear regression computation
• ABS = (straight line coefficient) x 60 sec
Fixed Time
ABS = ∆ ABS (last reading in second phase – first reading in second phase)
Initial-Rate
• Linear regression computation
• ABS = Straight line coefficient
In case test is unstable:
• Linear regression computation
• Elimination of 49% of the most distant points from the straight line
• ABS re-computation
Sample-Blank (A)
ABS = Last reading of the second phase – last reading of the first phase x K*
* K = Volumetric factor

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 5 of 35

Sample-Blank (B)
ABS = Last reading of the second phase – last reading of the first phase
End Point 2 Points
If readings are > 3:
• L1 = First reading in incubation time (phase 1)
• L2 = mean value of last three readings (phase 2)

If readings are > 2:

• L1 = First reading in incubation time (phase 1)
• L2 = mean value of last two readings (phase 2)

In the other cases:

• L1 = First reading in incubation time (phase 1)
• L2 = Last reading (phase 2)

ABS = L2 - L1

Sample-Blank A-b
Blank: R1 + R2
1st phase: R1 + Serum
2nd phase: R2
Computation: (Last Reading 2nd phase –Last Reading 1st phase) – blank

Sample-Blank B-b
Blank: R2
1st cuvette: R1 + serum
2nd cuvette: R2 + serum
Computation: (Last Reading 2nd cuvette –Last Reading 1st cuvette) – blank

End Point Starter

Dynamic: As normal End Point with serum starter
1st phase: Only reagent (R1 or R1+R2)
2nd phase: Serum
Computation: Last Reading 2nd phase –Last Reading 1st phase

Absolute End Point

This method is identical to the End Point but without subtraction of the Blank reagent.

♦ COMPUTING CONCENTRATION VALUE

Fnr
• If the External Dilution Factor is less than or equal to 1 then Fnr = 1
• In other cases Fnr = External Dilution Factor
• If sample is run with dilution then Fnr = External Dilution Factor
Dynamic Blank Check
If Dynamic Blank is present and test is either a Kinetic, or a Fixed Time, then:
• ABS = ABS – Dynamic Blank Value

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 6 of 35

If Dynamic Blank is not present and test is an End Point, then:
• ABS = ABS – Blank Value
ABS = ABS x Fnr
• If the factor is used, then: Conc = ABS x Factor
• Otherwise the concentration is extrapolated from the standard’s curve, where:
Fnr : Internal Factor
ABS : Test ABS
Conc : Final concentration

1.2.2. APPLIED MATHEMATICAL FUNCTIONS

♦ Correlation Coefficient

∑ (T
n
− T )( Li − L)
CC = 1 i
n n

∑ (L
1
i − L) 2
∑ (T
1
i − T )2

where:
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings

♦ Linear Regression
n n

n ∑ ( L ) ∑ (T ) i
2
i
2

∑ (T L ) − n
i i
1
n
1
n
M= 1
n

n 2 (∑ Ti ) 2
∑ (T )
1
i − 1
n

n
⎛ n n
⎞
∑1 Li ⎜⎜ n ∑1 Li ∑ T ⎟⎟ i
− ∑ (Ti Li ) − n 1

n ⎜ 1 n n ⎟
⎜ ⎟
Q= ⎝ ⎠
M

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 7 of 35

where:
M : Angular coefficient for the line
Q : Final point for the line
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings
♦ Distance point-line
D =| Y − MX − Q |

where:
M : Angular coefficient for the line
Q : Final point for the line
X : Point Abscissa
Y : Point Ordinate
♦ Distance between two points
X − x0
Y= ( y1 − y 0 ) + y1
x1 − x0

where:
X : X axis
Y : Y axis
x0 : First Point X Axis
x1 : Second Point X Axis
y0 : First Point Y Axis
y1 : Second Point Y Axis

Mathematical Functions for Clinical Chemistry

♦ VOLUMETRIC FACTOR (USED IN SAMPLE BLANK A TESTS)
vS + vR1
K=
vS + vR1 + vR2
where:
K : Volumetric factor
vS : Serum volume
vR1 : First reagent volume
vR2 : Second reagent volume

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 8 of 35

1.2.3. INITIAL COMPUTATION
The initial computation is important for transforming the microprocessor data into
compatible data for the program to generate the single absorbance value, which will be
used afterwards for the final absorbance computation.
♦ Clinical Chemistry
⎛ F − Fz1 ⎞
Z − Log ⎜⎜ 1 ⎟⎟ − Op
⎝ F2 − Fz 2 ⎠
V=
Of
where:
Z : Zeroing with water
F1 : First Filter’s Value
F2 : Second Filter’s Value
Fz1 : First Filter’s Zero-Value
Fz2 : Second Filter’s Zero-Value
Op : Optical path
Of : F.C.C.

1.2.4. OPTIMIZATION TECHNIQUES FOR CLINICAL CHEMISTRY

♦ Searching for the right reading point (for Fixed Time test):
If the point (P1) is not read exactly at (T0), then the ABS value for P1 must be extracted with
the following procedure:
with N < 3
1. Compute the Regression line y = mX+q from the reading points
2. Search for the point on the line at T0
with N ≥3
1. Compute Best-Fit curve coefficients from the reading points
2. Search for the point on the line at T0
N = number of points during reading time
♦ Normalization of reading data (elimination of erroneous readings)
(for Kinetics and Initial-Rate tests):
If more than two points are obtained during reading time, then:
a. If CC is > 0.99, the procedure stops
b. If CC is ≤ 0.99:
1. NN = N / 3
2. Compute linear regression and store m and q
3. Compute the first most distant point from the line y = mX+q
4. Trace the point on the line
5. NN = NN – 1
6. If NN is > 0 go back to step (2)
where:
CC : Correlation Coefficient
N : Number of points during reading time
NN : Number of points to be traced
m : Angular coefficient for the line
q : Known line coefficient

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 9 of 35

1.2.5. METHODS DESCRIPTION
End Point
Once the sample has been added to its reagent, a reaction occurs first causing a variation in the
solution’s color i.e. the absorbance (usually during incubation time), followed by a phase in which
the reaction’s color is stable, defined as "plateau".
Generally, the absorbance value (A) is read from the first point after the incubation time. This value
is then multiplied by the factor computed during calibration, to obtain the concentration of the
analyte in the sample.
Conc. in sample = Factor x (A3 - Reagent Blank)

A2 A3

A1

DELAY TIME INCUBATION READING

TIME TIME

Absolute End Point

This method is identical to the End Point but without subtraction of the Reagent Blank.

Fixed Time
In this type of reaction, there is an increase (or decrease) of the absorbance during both
incubation’s and reading’s phases. However, the slope of the line may not be the same during the
two phases. The reaction graph displayed to the user is not always linear, but can also appear as
piecewise linear. This is because the graph is obtained by the union of the read points that may not
be aligned. A regression line is calculated during both incubation’s and reading’s phases. These
provide the user with information about the correct evolution of the reaction. During reading time,
the absorbance delta (∆A) is also computed, which is used for calculating the final concentration for
the analyte in the sample.
It may happen, due to a physical delay, that the instrument does not respect the timing and that
tests are read at a different final time from the one set in the parameters. In this case the analyzer
performs one more reading, traces the regression line between the last two points, moves to the
exact reading time and derives the correct absorbance value from it.
Concentration is calculated by multiplying the absorbance delta (during reading time) by the factor
obtained from the calibration:
Conc. In Sample = Factor x (A3 - A2) (A3 - A2) = ∆A

A1 A2 A3 A1 A2 A3

INCUBATION DELAY TIME INCUBATION READING TIME

DELAY TIME READING TIME
TIME TIME

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 10 of 35

Kinetics
This kind of reaction is very similar to the previous one, with the difference that the reaction and the
graph derive both from the computation of two regression lines: one for the incubation phase and
the other for the reading phase. These two lines are often the same if the reaction has a good
quality. The regression line for the reading phase is then scaled to minutes to compute absorbance
delta (∆A/min.). This value is then multiplied by the factor to compute the concentration of the
analyte in the sample:
Conc. in Sample = Factor (A3 - A2) (A3 - A2) = ∆A/min.

A1 A2 A3 A1 A2 A3

DELAY TIME INCUBATION READING TIME DELAY TIME INCUBATION READING TIME
TIME TIME

Initial Rate (I.R.)

This type of reaction is very similar to the kinetic one. If the initial phase is stable, then it behaves
exactly like a kinetic reaction. If the initial phase in unstable, the regression line is computed by
eliminating the points outlying it from 49% to 100%. Thus, the calculation is identical to the one for
kinetic reaction:
Conc. in sample = Factor x (∆A/min)

Sample Blank (A)

This method is used whenever it is required to eliminate the photometric interference of the sample
(for example turbid sera) from the reaction. These are double-reagent End Point reactions. The
reaction and the computation are performed during two distinct phases: in the first phase (sample
blank) the reaction between the first reagent and the sample (R1+S) takes place, while in the
second phase the second reagent is added to R1+S (R1+S+R2). The final absorbance used for
computing the concentration of the analyte is obtained from the difference in absorbance between
the two phases:
Conc. in sample = Factor x [A2 - (A1 x k)]

A2

A1

R1+S R2

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 11 of 35

Sample Blank (B)
This kind of reaction is very similar to the previous one. The reaction always occurs in two phases:
in the first phase (sample blank) the analyzer reads the final absorbance (A1) of the reaction
between the first reagent and the sample (R1+S), in the second phase it reads the final absorbance
(A2) of the reaction between the second reagent and the sample (R2+S). The two reactions are
distinct and separate, and the sampling in the two phases takes place in two different reading
cuvettes. The final absorbance used for computing is obtained from the difference between the two
phases:
Conc. in sample = Factor x (A2 - A1)

A1
A2

R1+S R2+S

End Point 2 Points

This method (only for single reagent tests) is used whenever it is required to eliminate from the
reaction the interference due to the sample. The absorbance of the first reading in incubation phase
is subtracted from the final absorbance:
Conc. in Sample = Factor x (A3 - A1)

A1 A2 A3

DELAY TIME INCUBATION READING TIME

TIME

Only Read
This method is used to read in End Point solely the sample, with a reagent blank. It can be used to
read an already prepared (manually) solution. The factor for the computation can be either derived
from calibration or set by the user:
Conc. in Sample = Factor x final A

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 12 of 35

For all the methods, except for Only Read, it is possible to work with one or two reagents.
These reagents can be ready to use or concentrated (in this case the analyzer provides automatic
dilution). The reagents can be placed in bottles of different volumes (50 ml, 20 ml and 10 ml) and in
case of double reagent, the different size bottles are coupled together (e.g. 50 + 50, 50 + 20, 50 +
10, etc.).

The "End Point", "Fixed Time", "Kinetic" and "I.R." methods allow, both with single and double
reagent, the use of a special feature called Serum Starter. Normally, during test runs, the arm
samples single or double reagents plus sample. By using the Serum Starter function, the reagents
are placed into the cuvette first and then the sample is placed separately. In this way, the reagents
can incubate in the cuvette for the programmed time, before the sample is added which starts the
reaction.

The sampling dynamics of the above-mentioned methods are tabulated as follows:

NORMAL SAMPLING PROCEDURE
Method Reagent Blank Reagent Dynamic
End Point - Fixed Time
Kinetic - I.R. Single R1 R1 + S ⇒Ta ⇒L
Only Read Single R1 S⇒ L
End Point - Fixed Time
Kinetic - I.R. Double R1 + Ta + R2 + Tb R1 +S + Ta + R2 + Tb ⇒ L
End Point - Fixed Time
Kinetic - I.R. Double R1 + R2 + Tb R1 + R2+ S + Tb ⇒ L
Sample Blank (A) R1 +S + Ta ⇒ L1+ R2 + Tb ⇒ L2
Double R1 + R2
Sample Blank (A-b) Sample Blank (L2 –L1)
Sample Blank (B) R1 +S + Ta ⇒ L1 R2 +S + Tb ⇒ L2
Double R2
Sample Blank (B-b) Sample Blank (L2 –L1)

Ta and Tb = Incubation times for R1 and R2, L = Reading

SERUM STARTER SAMPLING PROCEDURE

Method Reagent Blank Reagent Dynamic
End Point - Fixed Time
Kinetic - I.R. Single + S.S. R1 R1 + Tr + S ⇒Ts ⇒ L
End Point - Fixed Time
Kinetic - I.R. Double + S.S. R1 + Tr + R2 + Tr R1 + Tr + R2 + Tr + S + Ts ⇒ L
End Point - Fixed Time
Kinetic - I.R. Double + S.S. R1 + R2 + Tr R1 + R2 + Tr + S + Ts ⇒ L

S.S. = Serum Starter, Tr = Delay Time for R1 and R2, Ts = Serum Incubation Time, L = Reading

The way the Reagent Blank and the Reaction’s Dynamics are used is tabulated below:
End Point Reagent blank. Final reaction datum detection (at the end of programmed time for
incubation and reading) and concentration’s value computation.
Fixed Time Reagent’s reading check. Data detection during programmed reading time, absorbance
delta determination (∆A) and concentration’s value computation.
Kinetic Reagent’s reading check. Data detection during programmed reading time,
determination of the absorbance delta per minute (∆A/min.), processing of the linear
regression and computation of the concentration's value.
Initial Rate Reagent’s reading check. Data detection during programmed reading time,
determination of the absorbance delta per minute (∆A/min.), processing of the linear
regression and computation of the concentration’s value.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 13 of 35

 Sample Blank (A) Reagents’ reading only for check (R1+R2); first phase (sample blank) with reagent 1
and sample (data detection at the end of incubation time 1), second phase
(analysis) adding reagent 2 (data detection at the end of incubation time 2),
absorbance delta determination (∆A) between first and second phase and
concentration’s value computation.
Sample Blank (A-b) Blank Reagent (R1+R2); first phase (sample blank) with reagent 1 and sample (data
detection at the end of incubation time 1), second phase (analysis) adding reagent 2
(data detection at the end of incubation time 2), absorbance delta determination
(∆A) between first and second phase and concentration’s value computation.
Sample Blank (B) Reagent’s reading only for check with R2 (Working Reagent); first phase (sample
blank) with reagent 1 and sample (data detection at the end of incubation time 1),
second phase (analysis) with reagent 2 and sample (data detection at the end of
incubation time 2), absorbance delta determination (∆A) between first and second
phase and concentration’s value computation.
Sample Blank (B-b) Blank Reagent with R2 (Working Reagent); first phase (sample blank) with reagent
1 and sample (data detection at the end of incubation time 1), second phase
(analysis) with reagent 2 and sample (data detection at the end of incubation time
2), absorbance delta determination (∆A) between first and second phase and
concentration’s value computation.
Only Read * Reagent blank. Final reaction data detection (at the end of programmed time for
(End-Point) reading) and concentration’s value computation.
End Point Reagent’s reading check. Data detection during programmed reaction time (first
2 points datum in incubation time and the last datum in reading time), absorbance delta
determination (∆A) and concentration’s value computation.
Without Blank Reagent (reading only with reference to H2O). Final reaction data
End Point
detection (at the end of programmed time for reading) and concentration’s value
Absolute
computation. However the Blank is read to verify the reagent.

* During "Only Read" (End-Point) analyses, the analyzer uses the reactive just to prepare the
reagent blank. The analysis’ procedure requires then to sample at least 300 µl from the final solution
in the sample cups and pour it into the cuvettes for the reading phase. Only single reagent use is
allowed.
For the "End Point", "Kinetic", "Fixed Time", "Initial-Rate" and "End-Point 2 Point" methods it
is possible to use single and double reagent methodologies. The "Only read" method uses only a
single reagent, and the "Sample Blank" (A) & (B) methods require exclusively double reagent
methodologies.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 14 of 35

1.3. ANALYSIS PROGRAMMING
The analyzer can store virtually endless analysis codes (with parameters). There are two
different codes’ lists: a "global" (All Tests) list where all programmed codes are stored, and
an "on-line reagents tray" (Current Tray) list, where only the codes for the analyses that
have their reagent in the tray are stored. Patients, standards and controls can be
programmed and performed only for the on-line list.

Figure 6 Figure 7
The analysis programming page can be accessed from the main menu ("Tests") or from
the specific icon that gives direct access (see Chapter A, paragraph 3., icon n°1 in the
Function Icons Bar) (Fig. 6).
To set out new analyses it is necessary first to create the code (this function is enabled only
in the "All Tests") and then to assign the parameters, the standards and the controls
(these are enabled also in the "Current Tray"). To perform any test it is necessary to move
its code from the "All Tests" to the "Current Tray" by using the command "Modify
Current Tray" (Function Icons Bar, icon n°2). Once the Current Tray is created, it will be
possible to assign a position to each reagent bottle.

1.3.1. CREATING A NEW CODE

Open the analysis programming page and select "New Code". Enter the test’s code and
select the "Test Type" among the options showed by clicking on the button"u". The test
type, defines whether the programmed test is a Clinical Chemistry, or a relation test
(mathematical computation, refer to paragraph 1.3.2. "Relation tests"). Use the button
Save to memorize the test, or press Cancel to exit and abort programming. Any code can
be deleted with "Clear Code" or modified with "Rename". Once a code is set, it is possible
to program the analytical parameters (see paragraph 1.3.3. and the following).

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 15 of 35

1.3.2. RELATION TESTS

Figure 8
Once the code has been created for the relation test (as shown in Fig. 8), it is possible to
program its general parameters and the related mathematical function. In the analyses list
click on the code (the check symbol will be displayed), then select "Parameters".

Figure 9
In the parameters window (fig. 9) enter the following information:
"Name": complete test name
"1st Unit": measurement unit. Clicking on the "2nd Unit" it is possible to enter a secondary
unit, with its conversion factor (the analyzer will multiply the 1st unit by the given factor).
"Supplementary Factor": The result of the mathematical function will be multiplied also by
this value. This is simply an additional calculation offered by the analyzer.
"Normal Range": insert the min. and max. values of the normal range for male, female and
child.
"Decimals": it is possible to choose the number of decimals after the point. Leaving the
"Automatic" option the analyzer will follow this principle (floating point):
for values like 0.XXX three decimals
for values up to 9.XX two decimals
for values up to 99.X one decimal
for values over 100 no decimals
To enter the mathematical function select "Function"
Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 16 of 35
 Fig. 10.a Fig. 10.b

A window divided in two parts will be displayed: one for the calculator and one for the
analyses list (current tray), Fig. 10. The mathematical function can be composed of simple
values and operations or can recall sample results acquired by the analyzer (serum and
urine) on other tests (complex function). To enter a simple mathematical function avail
yourself of the calculator. To enter a complex function, select the code of the test to be
inserted into the function. A small field will appear, where it is possible to select between
serum or urine results for that test. Then complete the function with the needed operations.
To create more complex functions (involving more than one test’s result) it is advisable to
use the parenthesis as for all normal mathematical functions. Ex. For the creatinine
clearance with urine/24h = 900ml [(urine CRE x urine ml 24/h)/(serum CRE x 1440)] the
formula would be: ( [CRE&U] * 900) / ([CRE&S] * 1440).
The button "Test Function" (Fig. 10.b) is used for checking the relation test result from the
analyzer, based on values given to the tests involved in the function. This option is useful
for verifying the correct use of values and parenthesis in the formula.
The other options (Figure 9) available are:
"Save": saves and exits from the window.
"Print": prints parameters.
"Cancel": exits without saving.
Note. The relation tests can be inserted into the available analyses’ list for the current tray,
even if they have no determined reagent position (refer to paragraph 1.7. "Modify Current
Tray"). The result for a relation test can be returned only if both the test itself and all the
other analyses involved in the function are present in the current reagent tray.

1.3.3. PRIMARY ANALYTICAL PARAMETERS

From the page All Tests or Current Tray select the desired test code, then move mouse
cursor over "Parameters" and click to confirm.
In the displayed page, the analytical parameters for the chosen test are shown: they are
divided into "Primary Parameters", "Secondary Parameters" and "Check Parameters".
By clicking on the > or < buttons it will be possible to go to the next or previous test
parameters.

The first screen shows "Primary Parameters", to display the other screens click on the
corresponding tags.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 17 of 35

"Primary Parameters"
"Code": The code of the selected
analysis is shown in the text-box. It
is not possible to write in this field.
"Bar-Code": It is possible to
assign a numerical code for
positive barcode identification. It
enables (if activated in the "Setup
Analyzer") bar-code scanning to
correctly identify the bottle during
reagent’s insertion phase.

Figure 11

"Test methodology": In this field the reaction principle used for the test can be specified
(for example: Jaffè, IFCC, etc.). This option is useful when recalling the tests from the
QUALITY CONTROL archive, in accordance with different principles, during the function
"Data Processing".

"Method": This parameter defines the main methodology for the analysis. To program
move the cursor over "6" and select the chosen method. The available methods are
detailed in paragraph 1.2.5. of this chapter.

Figure 12
"Kind of process": defines the kind of test’s calibration: "linear", "with factor" or "with
curve". The following choices are available:
Available Methods (Fig.13)

End Point
Kinetic
Fixed Time
Initial-Rate (I.R.)
Sample Blank type (A)
Sample Blank type (B)
Only Read
End Point 2 Points
Sample Blank (A-b)
Sample Blank (B-b)
End Point Starter
Absolute End Point
Figure 13
Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 18 of 35
"linear": This function is used for linear reactions, it requires analytical test calibration to
process computing factor.
"with factor": It is used for linear reactions whenever the computing factor is known.
"with curve": Non-linear tests, distinguished by:
Polynomial: It is used for non-linear tests. Here an almost perfect cubic approximation
curve is generated, which lacks infinite approximations on too distant points.
Cubic spline: It is used for non-linear reactions. A cubic interpolation is created for solving
the problems of polynomial curve in some particular cases; the approximation is zero on
the points, not flex point free.
Log-logit 4 and Log-logit 5: It is a logarithmic approximation on four or five points, used
for non-linear tests.
Multi-point: Linear interpolating function for several standard concentrations (max 6). It
mathematically extrapolates data that are out of calibration’s limit.
Minimum squares: Used in non-linear reactions. A minimum squares approximation is
created for solving the problems of polynomial & spline curves in some particular cases
and is flex point free.
Line for two points: Used for linear reactions. It requires analytic calibration of the test.
Processes the passing line for two different concentrations. Represents FACTOR (SLOPE)
and INTERCEPT (SHIFT).

"FILTER": The operator can select the desired filter value for the "1st Filter" and the "2nd
Filter" (reference filter) from the available filter wavelengths: 340, 380, 405, 436, 480, 510,
546, 578, 630, 700 nm (Figures 14 and 15).
For the tests in bichromatism, click on the "1st Filter" and select the desired filter value
from the cascading window and then go to "2nd Filter" and select the desired filter value
from its cascading window (1st position has empty field).
For the tests in monochromatism, select the desired filter value in the "1st Filter"
cascading window. Since the second filter is not used in this test, therefore select the first
position (empty field) in the cascading window of "2nd Filter". In this case the analyzer will
use a "reference filter" only to stabilize the readings.

Figure 14 Figure 15
"Reaction direction": select the kind of absorbance variation to be checked during
reaction. The following choices are available:
(h) "Increasing"
(h) "Decreasing"
(h) "None"
Selecting "None" excludes the possibility of controlling the reaction direction, and in
addition no control is performed on the flags of ABS Limit and out of range reagents. This
function is useful when testing new methods.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 19 of 35

Select correct option so that the parameters later described: "Final ABS", "Initial ABS"
and "Reagent Limit" have the necessary reference with reaction progress.
"Reagents": click on this button to select the reagents’ parameters (Fig. 16).
The user can enter the following information:
"Number of reagents": Enter the number of reagents the methodology requires, max. 2.
Use up/down arrow keys "v" or move the cursor directly on the box and enter the value.
Insert the volume of each reagent by selecting the corresponding table (Reagent #1 &
Reagent #2, see Fig. 16) in accordance with number of reagents programmed.

Figure 16
"Volume µl": enter the reaction volumes for each reagent expressed in µl selecting the
corresponding tag (Reagent #1 and Reagent #2, see Fig. 16). Always bear in mind that the
minimum volume for the final solution (reagent + sample) is 280 µl, while the maximum allowable
volume is 700 µl.
"Concentrated": this field refers to concentrated reagents. If ready-to-use reagents are used this
option should be disabled. If the program for volume of the "Concentrated" is enabled, then insert
in the "Volume µl" text box, the volume of the concentrated reagent that the analyzer will withdraw
for sampling, select the type of diluent to be used: if double distilled water "Dilution with water" or
dedicated diluent "Dilution with solution". Write in the apposite field "µl Diluent" the volume of
diluent to be added to the concentrated reagent. For example: for a dilution ratio of 1:3 write 100µl
for the concentrated reagent and 200µl for the diluent. The dedicated diluent is considered by the
analyzer as a further reagent and will therefore take a position of its own in the reagents’ tray. If the
diluent is the distilled water, the analyzer will take it from the main reservoir.
"Sample": clicking on the button will open the window where sampling parameters for "Serum" and
"Urine" can be programmed (Fig. 17 and 18). The "Serum" card is displayed first. To move
between the "Serum" and "Urine" cards, click on the desired tag. The user can enter the following
information:

Figure 17 Figure 18

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 20 of 35

Serum Parameters (Fig. 17)
"Name": Enter the complete name. The text written in this field will be used also to identify the test
in the report printouts.
"Serum µl": Sample volume expressed in µl (100 µl max).
"Dilution": In this screen, two fields are available, "Pre-Dilution 1:" (predilution ratio) and
"Dilution 1:" (ratio of dilution repetitions). Maximum pre-dilution limit is 1/250. In case both ratios
are set, the user can work within this limit, or in case a higher limit is necessary then an external
dilution must be performed (refer to chapter E, paragraph 1.4. "Samples").
"Pre-Dilution 1:": Set sample’s pre-dilution ratio only if required by the methodic otherwise enter 1
for not to predilute.
"Dilution 1:": Set the sample’s dilution ratio to be used for automatic repetitions of tests, which
during the determination have either Max ABS Delta or Final ABS or Test Limit values out of the
programmed limits (see ensuing "Control Parameters"). The user can then set an adequate
dilution ratio in order to bring the reaction into linearity limits.

Urine Parameters (Fig. 18)

"Name": enter the complete name
"Urine µl": sample volume expressed in µl (100 µl max).
"Dilution": The programming of fields (text boxes) for "Pre-Dilution 1:" and "Dilution 1:", is
identical to the above-mentioned Serum Parameters.
ATTENTION: for analyses on urine samples, it is recommended to read the "Note on urine
parameters" at the end of paragraph 1.3.5. Secondary Parameters.

NOTE: for diluting serum samples the analyzer will use the diluent (saline solution) while for
urine samples, the analyzer will use bi-distilled water.

"Times": this command allows setting of incubation and reading times. Move the mouse cursor
over "Times" command and click to confirm; a form appears on a side of the screen with
programmable fields (Fig. 19). The user can then enter the following information:

Figure 19

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 21 of 35

"Sample Starter": This parameter, if enabled, allows separate dispensation between sample and
reagent. This parameter can be used only for double reagents applications. See also par. 1.2.5.
METHODS DESCRIPTION and the note at the end of this paragraph. To enable click on this box to
confirm.
"Delay Time": Parameter expressed in seconds preceding the incubation time, and it indicates a
time gap available for the solution in the cuvette to become stable. During delay time no reading is
performed (different from the incubation time) and it is useful in tests with "0" incubation time.
"Incubation Time": This parameter expressed in seconds, indicates incubation time for the
analysis (reagent and samples dispensed in the cuvettes) as required by the methodology. The
possible values range from 0 to 999 seconds. For double-reagent methods, it is possible to enter
different incubation times for the first and second reagent originating in different sampling dynamics.
During incubation time the analyzer performs reading for capturing in advance the reactions that are
out of linearity range (see later "Check Parameters").
"Reading Time": The user must enter the reading time (following the incubation time) in seconds,
keeping in mind that the analyzer performs a reading every 10 seconds. The possible values range
from 0 to 990 s.

Notes on the serum starter

When the serum starter is not activated the analyzer dispenses reagents and sample with different
dynamics based on the programming:
Single-reagents: it takes the reagent and serum and dispenses both in the cuvette
Double-reagents: it takes the first reagent and serum and dispenses both in the cuvette; then it
takes the second reagent and distributes it in the same cuvette. If the incubation time of the first
reactive is zero, it takes both reagents and serum and dispenses everything together in the cuvette.
The method with the serum starter makes it possible instead to take the two reagents (even at
different times) and dispense the serum in the cuvette last.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 22 of 35

1.3.4. CHECK PARAMETERS

Figure 20 Figure 21
Select the "Check Parameters" table (Fig. 20 and 21). To set a given parameter, move the cursor
on its corresponding textbox and click to confirm.
The user can enter the following information:
"Reagent limit (mABS)": this parameter indicates the limit absorbance (ABS) value that is
acceptable for the reagent (maximum for increasing reactions, minimum for decreasing ones) and it
is expressed in mABS. If reagent’s absorbance is beyond this limit, the analyzer will check the
results with "O" flag (Reactive out of limit). This parameter allows monitoring reagents quality as
well as checking any variation from the specific techniques. The parameter is identical for the serum
and urine.
Note:
This control has the highest priority on all the other check flags and inhibits the automatic
repetition functions.
"Curve Acceptance (%)": C.C. = Correlation Coefficient. This is only applicable to kinetic type test
(fixed time, kinetic and initial rate). The programmable values range from 0% to 100%. This
parameter is identical for both serum and urine and indicates the acceptability limit for any data
instability that is detected during programmed reading time. If this value is exceeded, the final result
will be checked with a "±" flag (Unstable Sample – C.C.% greater than assigned value).
"Test limit (Conc)": This parameter is used in all methodologies and it allows verification of the
final concentration of the analyses. It represents a threshold value beyond which the analyzer
detects an out-of-linearity condition (hyperactivity). With "Re-run hyperactive" check enabled (refer
to paragraph 1.3.6. "Automatic re-runs"), the analyzer will automatically re-run the test, diluting the
sample as programmed in the serum parameters, in order to bring the reaction into linearity range.
The final result is automatically multiplied by the dilution factor and will be checked with "I" flag (=
Hyperactive Sample – out of Test Limit-).
"Initial ABS (mABS)": This parameter is used only for the methods "Kinetics", "Fixed Time" and
"Initial-Rate". It is expressed in mABS and defines the limit for the total absorbance (reagent +
serum) expected for this test. The first reading of the incubation phase is compared with this value.
If the read value is greater than the parameter, the analyzer will consider that as a possible
interference of serum in the reaction (for example: lipemic serum), thus marking the final result with
"~" flag (= Serum Interference).
"Final ABS (mABS)": this parameter is used only for the methods "Kinetics", "Fixed Time" and
"Initial-Rate". It is the last reading of the reaction expressed in mABS; it indicates the limit (upper
limit for increasing analyses, lower limit for decreasing ones) beyond which the analyzer detects an
out-of-linearity test (hyperactivity). With "Re-run hyperactive" check enabled (refer to paragraph
1.3.6. "Automatic Re-runs"), the analyzer will automatically re-run the test diluting the sample
(refer to Chapter E, paragraph 1.4. "Samples") in order to bring the reaction into linearity range.
The final result is automatically multiplied by the dilution factor and will be checked with "A" flag (=
Hyperactive Sample – out of final ABS Limit-).

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 23 of 35

"Max ABS Delta" (mABS): This parameter expressed in mABS is used in all the methods, except
"Only Read". It represents the maximum Delta (∆) for the reaction detected during incubation
phase. Test is considered out of linearity when this value is surpassed. The analyzer verifies the
reaction process during the incubation phase for all the methods. The reaction is prolonged for a
period equivalent to 60 seconds for the methods "Kinetics", "Fixed Time" and "Initial-Rate".
For the methods in "End Point", (End point, End Point 2 point, End Point Starter, Absolute End
Point, Absolute End Point, Sample Blank A and B, Sample Blank A-b, and Sample Blank B-b),
the reaction is prolonged for a period equivalent to ¼ of the incubation time but never less than 20
seconds. The assigned Max ABS Delta is compared with the one calculated at the end of 60
seconds or one-fourth the incubation time, based on the type of test.
With the "Re-run hyperactive" check enabled (refer to paragraph 1.3.6. "Automatic Re-runs"),
the analyzer will automatically re-run the test by pre-diluting the sample (see. "Samples") in order
to reenter the reaction into linearity range. The final result is automatically multiplied by the dilution
factor and will be checked with "d" flag (= Hyperactive Sample – out of Max ABS Delta-).
"Check Prozone" (mABS): this parameter checks the ABS variation tendency during all processing
time of the test. In case of inversion it is likely to be in a Prozone situation. The final result will be
checked with "C" flag. This parameter is used for all methods, except for "Only read" and indicates
the maximum allowable inversion in the reaction (expressed in mABS). If the prozone flag is
activated in a sample, this will be repeated as if it was a hyperactive, if the repetition of hyperactives
is enabled. In addition, for an inverse curve flag, the analyzer will also test the prozone.
"Re-run serum and Re-run urine": these commands are used to enable automatic repetitions, for
more information see paragraph 1.3.6 of this chapter.
Note. The parameters "Test limit", "Initial ABS", "Final ABS", "Max ABS Delta" and "Check
Prozone" are different for serum and urine (see Fig. 19 and 20).

1.3.5. SECONDARY ANALYTICAL PARAMETERS

Figure 22
After selecting the "Secondary Parameters" (Figure 22) to program click inside the
desired parameter textbox and confirm.
The user can enter the following information:
"1st Unit": Enter the measurement unit in this field. Click on the "2nd Unit" to enable it for the
second unit of measurement. Instantly a new textbox will appear where the operator can type in the
second unit of measurement and the conversion factor between the two units. In case of two units of
measurements, the test value is expressed in two results. In the analytical calibrations the "1st
Unit" of measurement is used.
1St Unit (Urine): by selecting Urine it is possible to enter a specific unit of measurement and then
the conversion factor between the unit of measurement expressed in serum and that expressed in
urine.
N.B.: always remember that the calibrations are made with the parameters assigned to
serum, so this should be taken into account for urine analyses.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 24 of 35

The Factor field is only for urine and represents a multiplication factor. All the information must be
entered in this field, which allows the analyzer to convert the serum units of measurement into those
for urine, to convert the diuresis units of measurement and possibly compensate the different
volume of urine compared to serum (see the note at the end of the paragraph).
"Dynamic Blank": If the parameter is enabled, then the analyzer quantifies and memorizes the
photometric drift of the reagent blank by processing only the reagent as sample. After the
determination of the Reagent Delta ABS, this value is then subtracted from the Sample ABS value.
The value of Reagent Delta ABS is then visualized in the "STANDARD" page adjacent to the
absolute value of the reagent. The dynamic blank is only available for the Fixed Time, Kinetics and
Sample Blank A tests.
"Number of needle washes": With this command the user can set the number of washings to be
performed after the dispensing of the reagent used for the test. Normally one washing is sufficient,
however in case of highly contaminating tests more washings will be necessary. To set washing
numbers (maximum 9 washings) in accordance with the contaminating force of the used product,
press the up/down arrow keys "v" or move the mouse cursor inside the dedicated box and enter
directly the value.
"Additional washes": allows the operator to enter two additional special washes into the sampling
dynamics. These additional washes may be useful when contamination between reagents is found.
The two solutions used are a base to be put in position 24 of the reagent plate and an acid to put in
position 23. The additional wash may be for just the sampling needle (check Only needle) or it can
be for needle and cuvette. In both cases it is possible to select the additional wash to be performed
with one (check "Only one wash") or with two solutions: an acid and a base. The needle and
cuvette wash will take place before dispensing the test. The normal water washing of the cuvette will
still take place, it will then be washed with the (or both) additional solution and then rinsed again
with water. In case of double reagents, the needle first wash will take place simultaneously to the
cuvette wash.
If there is no additional solution in the reagent bottle, the test result will be marked with the "W" flag
and the testing of the single analysis will be aborted.

"Reagent Blank Timing": This parameter is used for automatic determination of the ABS value for
the reagent. Select, among available choices present in the "Reagent Blank" timing list (see Fig.
22), one of the following:
(h) "Every run": The absorbance determination for the reagent will be performed at every
work start-up.
(h) "Every day": The absorbance determination for the reagent will be performed once a
working day (when the first working list of day is started).
(h) "up Hour": The absorbance determination for the reagent will be performed at the time
intervals as programmed into the "Hour" and "Minute" boxes. For example, setting "02"
hour and "00" minutes, determination will be performed every two hours. To set the value,
press "v" or move the mouse cursor inside the dedicated box and enter directly the value.
"Decimals": If this parameter is used with the "Custom", then it sets the number of decimal places
that should be used to represent numerical results of the tests. Alternatively, if the decimal places
are not programmed "Automatic", then the analyzer automatically sets the number of decimal
places in accordance with "floating point" algorithm.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 25 of 35

"Instrumental Factor": This function introduces a constant correction of the final data of the
executed test. It may be used for making adjustments to test data obtained from analytical methods
or different type of instruments. Calculation: final result = value x instrumental factor
"Shift": This function introduces a constant quantitative correction of final test data. It may be used
for making adjustments to test data obtained through analytical methods or instruments of different
types. Calculation: final result = value + shift.

NOTE: When the following parameters are used at the same time: Instrumental factor and Shift (in
secondary analytical parameters), External dilution factor and Urine 24/h (in the patient’s data), the
calculation made by the analyzer will be as follows:
[(test result x External factor x Instrumental factor) + Shift] x Urine 24/h

ATTENTION: if the calculation of the result (with instrumental factor and shift) gives a value less
than zero, <NC> (not calculable) will be displayed instead of the result and the associated flag will
be M: Error in the parameters (instrumental factor and shift): By opportunely correcting the
instrumental factor and shift parameters and running the calculation again (with the Correction
function chap. G par. 1.1) it is possible to convert the <NC> result to a valid number.

NOTE ON THE URINE PARAMETERS

The analyzer always uses the parameters assigned to the serum when it runs the calibrations. It is
necessary to bear this in mind when programming analyses on urine.
For tests dedicated solely to urine, it is advisable to program the serum parameters identically to
those for urine. In this way the test calibration will be consistent with the urine parameters. For
running the tests, urine can be regularly selected as sample, which will allow the use of all the fields
assigned to it, both in the parameters and in patient entry (e.g. diuresis).
For tests on serum and urine, since the calibration is made on the serum parameters, it is
necessary to take into account all the factors, which permit aligning the serum parameters to the
urine ones.
a) Unit of measurement: if the unit for serum is mg/dl and the one for urine must be g/l, the factor
will be: 100
b) Sample volume: if the serum volume is 3µl, and that of the urine is 30µl, the factor will be 0.1*
The total conversion factor for cases a) & b) will be given by 100 x 0.1 = 10
These factors all go together in the Factor field relative to the first urine unit of measurement.
Diuresis: The diuresis field does not have a unit of measurement for greater flexibility, however, to
avoid additional calculations, it is advisable to enter the diuresis volume already in the urine units of
measurement.

* The factor will be around 0.1, since the exact relation is given by the relation of volumetric factors,
however the relation vol. S / vol. U can be used as a good guideline.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 26 of 35

1.3.6. Automatic Re-Runs
The commands "Re-run Serum" and "Re-run Urine" are available (automatic repetition
parameters for hyperactive or pathological tests) in the "Check Parameters" table.
To set, move the mouse cursor over the desired command and click to confirm. The following
functions are available in the displayed table:
"Normal range": Min. Max. M: ⎫
Min. Max. F: ⎬ normal reference values (min. and max.)
Min. Max. C: ⎭ for male (M), female (F) and children (C).
"Re-run hyperactive": It allows automatic re-run for a hyperactive result, with dilution or not of the
sample, according to the implemented programming (see par. 1.3.3.). Check the box to confirm and
enable. The Profile (see below) is automatically enabled when selected.
"Re-run pathological": it allows automatic re-run for a pathological test, without sample dilution.
Check the box to confirm and enable. The "Panic range" box appears; similar to the "Normal
range", it allows programming the limits beyond which the analyzer performs test re-run. Values in
the "Panic range" can be different from those in the "Normal range" tests.
"Profile": it is available when automatic (hyperactive/pathological) re-run option is enabled and it
allows automatic execution of analyses to be associated to programmed test. To set, move the
mouse cursor over "Profile" command and click to confirm. The available analyses list will then
appear, select the tests to be associated and store with "Save" command. The analyzer will
automatically execute the profile associated to the hyperactive or pathological test.
For non-linear tests, the following fields will also appear:
Re-run out of curve "above": allows automatic re-running of the samples with an absorbance
above the calibration curve by applying the same dilution relation required for hyperactive samples.
The sample outside the curve is marked with the flag ">" if it is still outside the curve after re-
running, the flag will be ">>".
Re-run out of curve "below": allows automatic re-running of samples with an absorbance below
the calibration curve. In this case the analyzer applies a different relation between the serum and
reactive in order to make the absorbance return within the curve limit. The sample outside the curve
is marked with the flag "<" if it is still outside the curve after re-running, the flag will be "<<".

GENERAL CONSIDERATIONS ON TEST LIMIT, REACTION LIMIT AND MAX DELTA

ABS
These three parameters are used to monitor a likely hyperactive situation in a sample, whether it is
serum or urine. With automatic hyperactive samples re-run option enabled, the analyzer produces
two results: the first value indicates the specific parameter that has been passed (for example, if
Reaction Limit has been passed, the "A" flag is displayed), while the second one indicates what
has been detected after repetition. In case the automatic sample’s re-run has not been sufficient to
restore the reaction within programmed limits, the user can insert a manually pre-diluted sample.
For this purpose, a field called "Dilution Factor" has been added to the patient entry page. During
check-in or sample’s re-run phase, it is possible to set a pre-dilution parameter that will be used by
the analyzer when calculating final result. For manually pre-diluted samples, if the result is
hyperactive, this will be checked with the appropriate flag, but test won’t be automatically re-run.

Note:
Reporting the first and second result when automatically re-running pathological and
hyperactive tests: in case of automatic re-run of hyperactive and pathological tests, the analyzer
displays and prints in real time a compressed report. The report shows the results obtained from the
first and second determination naming them first and second result. However, one should bear in
mind that in the patients archive only the second result is stored, the one obtained after the
repetition. If printing is set in real time in "report" format (see Setup Chapter H, par. 2), the printed
result will only be the second one, just like for the patient archives printing.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 27 of 35

1.4. CONTROLS
In the pages "All Tests" and "Current Tray" select desired test code then move the mouse
cursor to the command "Controls" and click to confirm. The parameters for the desired test
are contained in the displayed page.
The controls are divided into "Known" and "Unknown", where it is possible to program
three levels for each one subdivided in tables:
"Known": Level 1, 2, 3
"Unknown": Level 1, 2, 3

Figure 23 Figure 24
The first displayed tables are "Level 1" for "Known" and "Unknown" controls. To select
move onto the desired tag title and click to confirm (Fig. 23).
"Known": To program move the cursor over desired boxes and confirm. Enter "Lot name
or number", theoretical value, and low & high limits. Enter "Sample position", already set
to controls in the section "Setup Analyzer" included in the inner ring of samples’ tray.
"Unknown": Enter "Lot name or number" and "Sample position". Reserved positions are
those already set in the program "Setup Analyzer", which are shared with known ones.
"Timed re-run": With this program it is possible to set automatic controls run for a selected
analysis. For each control it is possible to enter the time of automatic execution. Move over
"Timed re-run" field and check the box.
It is possible to enter intervals of days and hours for automatic controls run (Fig. 24):
"upon Date" (daily interval): Select the function and set interval days, then enter test
running time (for example 1 08,30 means every day at 08,30 or in any case at start up).
"upon Hour" (hour interval): Select the function and set the desired interval, hours and
minutes.
Every day or when the preset time expires, the analyzer will automatically alert the user that
there are controls to be run. If reagents and controls are present, then the user can directly
confirm to execute the tests.
"View used positions": This command displays the test disposition.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 28 of 35

1.5. CALIBRATIONS
Programming
The analytical calibrations that can be run by the analyzer are divided as follows:
Linear and Non Linear
Selection occurs during the programming of the analytical test parameters (refer to paragraph 1.3.3.
"Primary Analytical Parameters" and the following) and can be executed on user’s request or
automatically.
In the pages "All Tests" and "Current Tray" select desired test code then move the mouse cursor
to the command "Standard" and click to confirm. The parameters of calibration, execution and
verification of the preselected test are shown in the displayed page.
Always bear in mind that the serum parameters will be used for the calibrations, regardless of the
sample that is going to be used.

Analyses With Factor

Calibration executed by the analyzer is not required for these tests, but a theoretical factor for
calculation needs to be entered. This is a parameter to convert the absorbance values (ABS),
determined by the analyzer, in final concentration values. A box appears where it is possible to
enter a known factor value, declared in the method, while the reagent ABS value detected by the
analyzer is represented at the same time.

Analyses with Linear Calibration

In this type of test the analyzer executes a calibration with a known concentration standard. Based
on the absorbance values detected for the standard, the analyzer calculates the factor, which will be
used to convert the absorbance values (ABS) of samples to final concentration values. After each
new calibration the analyzer calculates and updates the factor. Alternatively, it is possible to directly
enter a known value in the Factor field.
The following parameters also need to be set.

Range Limit – Minimum and Maximum: in order to

verify the validity of the calibration, enter the minimum
and maximum limits that the calculated factor must be
within. After an out of range value, a warning is given
and the previously memorized factor is not changed. If
known concentration and absorbance values are
available, it is possible to mathematically process the
factor using the Calculation function key.

Figure 25

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 29 of 35

 NOTE:
The used calibrators or standards must be placed in the positions assigned on the sample tray
(bear in mind that the numbering is programmed in the Analyzer Setup program, par. 2, chap.
H). In linear analysis it is possible to use up to 4 different standard concentrations or execute up
to a maximum of 4 repetitions on a single point. It is possible to program the same positions for
various analyses if a multi-calibrator is used.

Programming re-runs on a single point (see Fig. 25)

By entering 1 in the Number of samples box, the N. replicates box automatically appears.
Enter the number of replicates to be executed, up to a maximum of four.
A programming box appears for the position and value of the standard concentration, plus other
boxes which cannot be programmed related to replicates, for a total equal to the desired number
of replicates. The values in the ABS boxes are automatically updated during the calibration
phase. If known they can be entered by the operator. With this type of programming, the analyzer
will execute a maximum of four samplings from the same sample cup, then calculate a factor for
each sampling and update the calculation factor using the mean of factors obtained for the
replicates.

Programming multiple standards (see Fig. 26)

Enter the number of standards to be used in the Number of samples box (maximum of 4). The
programming boxes for the positions and concentration values of the standards are automatically
displayed in the same quantity. The values in the ABS boxes are automatically updated during
the calibration phase, if known they can be entered by the operator. With this type of
programming, the analyzer will execute a maximum of four samplings of the standard from
separate cups with different concentrations, then calculate a factor for each standard and update
the calculation factor using the mean of factors obtained for the replicates.

Figure 26

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 30 of 35

Max Var. (%) (Maximum percentage variation): calibration verification parameter. It represents
the acceptable difference (in percentage) among the factors calculated if various standards are
used or if replicates are executed on a single point. After a variation above the programmed limit,
a warning is given and the previously memorized factor is not changed.

Reagent ABS: each time a reagent blank is executed for the analysis, the measured value is
updated in this window. If Dynamic blank is enabled (subtraction of the reagent photometric
variation, see par. 1.3.3. Primary Analytical Parameters and following paragraphs) the
measured reagent ABS value is displayed, plus the variation determined during reading of the
blank.
% from last Calibration: parameter which checks the percentage between the executed and
previous calibration. It compares the determined factor with the memorized one. After a variation
above the programmed limit, a warning is given and the previously memorized factor is not
changed.
View used positions: opens a single box to represent the position of tests in relation to the
sample tray.
Enable Auto Adjust: this parameter enables or disables automatic modification of the tests
results if another calibration is executed when running patients. The user must be enabled to the
access level (by password) to modify this parameter.
Last standardization: display box for the date and time of the last test calibration (with positive
result). By double clicking on the box it is possible to view the data of the previous positive
calibration, this can be re-loaded with the Reset command if desired.
Timed re-run: parameter used to program automatic calibration execution. Once the
programmed standardization time has elapsed, the analyzer sends a warning message and if the
reagents and standards are present, calibration can be directly executed. Enter the
standardization time by enabling the check and program the intervals in days and hours:
By Date: select the function for programming the interval days, then indicate the test
execution hour (e.g. 1 08.30 means every day at 8:30 or each time the analyzer is turned on).
By Hour: select the function and program the desired time interval, in hours and minutes.
Print: command for printing the programmed parameters.
Save: command for memorizing and exiting.
Cancel: program for exiting without memorizing changes.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 31 of 35

Analyses with Non Linear calibration (see fig. 27)

Non Linear analyses require from 3 to 6 standards. If the process type is Multi Point the number to
enter in the Number of Samples box varies from a minimum of 2 to a maximum of 6. In the
analyses with Log logit 4 & 5 curve, programming is the same by the required positions are 4 and
5, respectively.
Select the number of standards to be used to construct the curve. The fields for entering the position
and concentration of the various standards appear automatically. The values in the ABS boxes are
automatically updated during the calibration phase, if known they can be entered by the operator.
Programming is similar to that for analyses with factor, but here automatic standard dilution is also
available.
To use the standard pre-dilution function program the positions of the standards and enter the
calibrator concentration (the most concentrated point of the curve) at the first pre-selected position.
Then click on the Automatic Dilution box. Three new fields will open:

Figure 27
Dilution: sets the dilution relation. The analyzer will automatically calculate and update the scalar
concentrations starting from the highest concentration value already present in the fields.
Place the cup with entire standard on the sample tray in the assigned position, plus a number of
empty cups equal to the subsequent standards. The serial dilutions used to build the curve will be
prepared in these cups.
Dilution with solution: used to select whether to dilute the sample with physiological solution
(located in the specific test tube to the right of the I.S.E. arm) or with bidistilled water taken from the
external tank.
Use Zero Point: used to automatically reset the concentration of the lowest point of the curve to
zero. During the predilution phase of the standards the analyzer will dispense the pre-selected
diluent (physiological or water) in this position.

For all the tests with calibration curve, the analyzer will warn the operator if samples (patients) have
results above or below the calibration curve with a flag (below curve "<" and above curve ">") next
to the result. It is possible to select automatic re-running for samples outside the curve in the control
parameters (see par. 1.3.6 Automatic repetitions). When the absorbance of the least concentrated
point of the calibration curve (or point with 0.0 concentration) is negative, it will be automatically set
to zero, in order to prevent false results, for example concentrations with a minus sign.
It is possible to normalize the memorized calibration curves, using a single calibration point (see
below).
Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 32 of 35
Normalization procedure for memorized calibration curves

Check Re-calibration on single point to enable. In the Calibration point box enter the number of
the position occupied by the calibrator selected during construction of the previous curve and enter
the new position desired for placing it in the Sample position box. Once reading of the standard
has been completed, the analyzer checks the percentage offset obtained from the memorized
datum, it then reprocesses and mathematically changes the remaining ABS values of the standards
that are already part of the curve thus normalizing the entire calibration.

The fields Reagent mABS, % from last calibration, View used positions, Enable auto adjust,
Last standardization, Timed re-run, Print, Save and Cancel have the same programming and
functions described for linear calibrations.

Use serum Pre-dilution: if in the sample primary parameters (par. 1.3.3.) a pre-dilution ratio has
been set, it is possible to perform the standards pre-dilution with the same ratio as for the sample.

Graph: command for displaying the interpolation graph of the memorized curve. The curve and data
are represented on the graph display page.

NOTE ON TIMED RE-RUN

Timed re-runs of controls or standards may expire while the analyzer is in the standby phase. In this
case the expirations will be automatically delayed by 10 minutes.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 33 of 35

1.6. CREATING PROFILES

Figure 28
Figure 29

INSERT/MODIFY PROFILES: this function creates/modifies analyses groups, useful when

checking-in patients. It can be accessed from "Tests" menu or from the specific icon that
allows direct access (Figure 28).
It is possible to delete, update and print an already existing profile.

Creating a profile: click over "New" button: the "Profile Name" textbox will appear. Enter
the name for the profile and click on "Analyses": this will open a window where it will be
possible to select the analyses for the profile. Click "Save" to store the selected analyses
(Fig. 29). It is possible to enter in the "Code for Bar-Code" field a numerical code. The
analyzer, when reading the bar-code labels of Patients, will recognize it. This code is used
for completely computerized acquisition of the analyses assigned to the patient.
To update an existing profile, select it from the list and click on "Modify", and then proceed
as outlined previously. To delete an existing profile, select its name and press "Erase",
confirmation is requested prior to erasing.

Attention: during the patient acquisition, only the analyses present on the tray are
displayed for each profile.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 34 of 35

1.7. CREATING THE CURRENT ANALYSES TRAY

Figure 30

The function "Create/Modify current reagents' tray" creates the list for the reagents
placed on the tray. It can be accessed from the "Tests" main menu or from the specific
icon that allows direct access.
Into the window (Fig. 30) the "All tests" list ("Available") is displayed and adjacent to it ("In
Tray") the tests for the current tray are listed.
To create the reagents’ tray list, select one or more (CTRL+mouse for multiple selections)
tests from the left window then transfer them with arrow commands " " (move single test or
selection) or " " (move all available tests).
To remove from the current tray list select and transfer codes with commands " " (single or
selection) or " " (all available). Once tests are transferred, the analyzer automatically
assigns the positions and the type of bottles, but the user can modify both according to his
needs.
To modify, select the desired test in "In Tray list" and then move the cursor in "Position #"
textbox. Now enter directly the number or use up/down arrow keys "v" to scroll. Bottle size
can be selected by checking "hLarge" or "hSmall". There is also a field for selecting the
volume of available bottles.
In case of "Double Reagents" or "Concentrated", to be diluted with solution, positions
and bottles’ type are displayed for each product. It is possible to use the same reagent
position for several analyses.
The creation of the current reagents list is automatic when the Bar-Code option is enabled
(refer to Chapter I).
The Relation Tests can be entered in the analyses tray. They are placed at end of the
generated list and no physical position is assigned to them.
"Save": Memorizes data and exits.
"Exit": To leave (exit) the program without saving.
"Print": To print data in the current tray.

Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 35 of 35

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER D
1. PERFORMANCE AND LIMITS Page: 2

NOTE:
This manual is valid for both BT1000 and BT
2000PLUS. The following components are not installed
on the BT1000:
a) Reagent refrigerator
b) Barcode
c) Touchscreen

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter D Performance and Limits Page 1 of 3

1. PERFORMANCE AND LIMITS

PERFORMANCE
Operating Mode “Random access”
Methods Tests for Clinical Chemistry and Immune-Chemistry
Test Mode Routine, Batch, Emergencies (STAT), Profiles
Tests on line 48 refrigerated reagents + Relation Tests
Tests in memory 500 single- or double- reagent + unlimited Relation Tests
Test Reruns Automatic or on demand
Calibrations and Controls Automatic or on demand
Automatic Profiles Automatic execution of related profiles or on demand
Measurement Direct reading of 25 cuvettes (made of special optical glass)
Samples Tray Capacity 52 positions for Samples & STATs, 26 for Standards and Controls
Bar code scanner 2 separate scanners for positive identification of samples & reagents

TIME REQUIRED TO REACH STEADY STATE

Ambient conditions (Analyzer): 21°C R.T., 33% RH
Time required for the analyzer to completely reach steady state: 20 minutes
Ambient conditions (Refrigeration Chamber): 21°C R.T., 33% RH
Time required for the refrigerated bottles to completely reach steady state: Approx. 2 hours
CLINICAL CHEMISTRY (BT2000 PLUS)
Sampling cycle: 14.5 seconds
Analytical throughput: Up to 250 tests/hour (single reagent)
CLINICAL CHEMISTRY (BT 1000)
Sampling cycle: 18 seconds
Analytical throughput: Up to 200 tests/hour (single reagent)
CUVETTE OPERATING TEMPERATURE
Programmable Temperatures: Room Temperature, 30°C, 32 °C, or 37 °C
Precision ± 0,2°C - Accuracy ± 0,2°C
Temperature Monitoring Device based on Peltier Effect
REAGENT CHAMBER TEMPERATURE
Nominal Temperature: ~11°C (between 5ºC and 15ºC approx.: depending upon the Setup setting)
Temperature Monitoring Device based on Peltier Effect
OPERATING AMBIENT TEMPERATURE
18 °C to 32 °C, 10% to 90% RH, Non condensating

PHOTOMETER
Optical System Solid state photometry, (patented by Biotecnica Instruments S.p.A.)
Detectors 10 silicon photodiodes for UV/Visible +1 reference channel
PRECISION AND ACCURACY
Spectral response: 340, 380, 405, 436, 480, 510, 546 578, 630, 700 nm
Bandwidth: ± 5 nm max
Photometric precision: ± 1% from 0 to 2.000 O.D., ± 2.5% at 2.400 O.D.
Photometric sensitivity: ± 0.001 ABS
Drift: ± 0.005 ABS/h (steady state)
Light path: 7 mm
Light source (Photometer): Reflectorized Halogen dichroic lamp, 12 VDC, 35 Watts
Life hours: Approximately 2000 hours
NOTE: For optimal result the lamp can be used for about 1,500 hours. The long-term use will result in the gradual
deterioration of the UV emission.

Section I Chapter D Performance and Limits Page 2 of 3

DILUTER - TECHNICAL SPECIFICATIONS
Diluters Type: Biotecnica Diluter Module
Max Volume: 470 µl
Linearity: ± 0.1% (full scale)
Accuracy at 3 µl: ± 3%
Accuracy from 10 to 470 µl: ± 1%
Reproducibility: ± 0.7% at 3 µl ± 0.6% > 3µl
Life Expectancy: 3 million operating cycles
Maintenance: every 300.000 operating cycles (O-ring seal replacement)

VOLUMES
WORKING SOLUTIONS
Clinical Chemistry
Reaction Volume: 280 µl min. to 700 µl max. (double reagent)
Sample Volume: 1 to 100 µl

RESIDUAL VOLUMES FOR REAGENT BOTTLES

50 ml BOTTLES: Approx 1.5 ml
20 ml BOTTLES: Approx 0.6 ml
10 ml BOTTLES: Approx 0.6 ml

RUNNING TIMES FOR “UTILITY” (approximate)

Wash & Fill Up: 270 seconds (approximately)
Wash H2O: 180 seconds (approximately)
Zeroing: 420 seconds (approximately)
F.C.C.: 900 seconds (approximately)
Extra wash cuvette: 540 seconds (approximately)
Wash Shut Down: 12 minutes (approximately)

WASHES VOLUMES
Clinical Chemistry Washes
H2O single wash of cuvette: 5 ml (approximately)
H2O Single wash of Needle: 2 ml (approximately)
Consumption per test: 7 ml (approximately)

H2O for zeroing: 250 ml (approximately)

H2O total wash of cuvette: 170 ml (approximately)
Extra wash of cuvettes: approx. 170 ml H2O + 13 ml Cuvette Washing Solution

Operating Limits
The instrument cannot guarantee the preceding performance specs in the following conditions:
1) Ambient conditions beyond the specified range.
2) Use of non-conformant clinical chemistry products such as washing solution, distilled water, and etc.
3) Maintenance schedule and expiry date ignored.
4) Use of non-original spare parts and consumables.
The manufacturer does not guarantee the correct instrument. Incase of implementation of unanticipated
methodologies. Consult your nearest sales/service office or factory for the use of different methodologies.

Section I Chapter D Performance and Limits Page 3 of 3

 OPERATOR MANUAL
BT 1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER E
1. OPERATING PROCEDURE Page: 2
1.1. Turning on procedure Page: 2
1.2. Reagents: insertion and removal Page: 2
1.3. Running Standard & Controls (on command or timed) Page: 4
1.4. Samples Page: 6
1.5. Work Lists Page: 12
1.6. Turning off procedure Page: 16
1.7. Access Password Page: 17

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter E Operating Procedure Page 1 of 19

1. OPERATING PROCEDURE

1.1. TURNING ON PROCEDURE

Turn on the analyzer by pressing on/off switch on the rear panel (refer to Chapter B,
paragraph 1.3. "Starting the instrument". This operation turns on only the refrigerating
system for the reagents. To properly turn on the analyzer, momentarily press the
pushbutton located below the LCD display (Chapter B, Figure 11). Remember that if the
same pushbutton is pressed again, it turns off the analyzer. Turning off the program in this
way may permanently damage it. After this initial phase of power on, it will be necessary to
enter the password (see paragraph 1.7. ACCESS PASSWORD in this chapter). After the
turning on procedure (lasting approx. 1 minute), allow the analyzer to warm-up. The
instrument is ready for use after about 20 minutes, when the temperature in the cuvettes
tray has reached the proper value and the photometric lamp is stable. At this point the
analyzer will require a zeroing of the photometer. It is advisable to execute the photometer
zeroing every time it is requested by the analyzer i.e. every six hours.
It is not advisable to keep the analyzer "ON" for more than one month as this may
cause problems with Windows internal counters.

1.2. REAGENTS: INSERTION AND REMOVAL

Figure 1
This function is accessed either by pressing F10 key or by clicking on the specific icon. It
helps the user to correctly position the reagent bottles, as programmed in the current tray.
The reagent tray is divided into three sectors, identified by the letters A, B and C. Each
sector has 8 positions. The screen displays the representation of 8+8 bottles (Figure 1).
The analysis codes of large bottles are displayed on the lower positions, while the upper
positions indicate the codes used for small bottles including the volume status for the
sample diluent.
The symbols "+" or "XXX<2" can be displayed inside the code boxes (fields). The symbol
"+" indicates that the position is used for many analyses, while the symbol "XXX<2"
indicates the position of second bottle pertaining to the double-reagent analyses.
In the field "SECTOR" the belonging group is shown, and the default choice is "A". To
change group click on the left and right hand buttons

Section I Chapter E Operating Procedure Page 2 of 19

ATTENTION: FOR THE USER SAFETY, NEVER ATTEMPT TO OPEN THE SAMPLES AND
REAGENTS COVERS WITHOUT USING THE PROPER SOFTWARE-GUIDED PROCEDURE.

Insert / remove reagent: to insert or remove the reagent bottles

Right-click over analysis code. A combo box asks the user to choose between "Insert
bottle" or "Remove Bottle". After the choice has been made, the analyzer will correctly
position the tray to match with the arrow at the base of the tray itself. The verification of fluid
volume contained in the bottle is associated with the insertion procedure. With the barcode
option enabled, identification is correctly achieved through the automatic scan of the
barcode on the inserted bottle. The same function can be performed on command, by
activating the "Scan bottle" command, near the insertion and removal commands.
NOTE: when using the "Remove" option, no functional control is performed: the
existing volume and test code are not removed.
In case the bar-code on reagents is enabled, when removing a reagent with the
"Remove" function, the analyzer will perform a scan of the position to verify that the
reagent has been removed. When closing the View volumes status window, the
analyzer will perform a second verification scanning and then will move the removed
test code from the on-line tray to the global list.

"Check volumes"
This option checks, on user’s demand, the volume contained in all the bottles that are
placed on the tray. Click with mouse on this command to confirm.
"Scan all bottles"
Enabled only when barcode option is on. It automatically performs the correct identification
of all bottles’ positions. Move cursor to this command and click.
"Print"
Performs a printout of the reagents status, with volumes and positions.
"Volume’s information"
By clicking on the each analysis code, the volume of the reagent contained in the bottle is
displayed as well as the number of tests that can be performed with it (Figure 2). For
various tests in the same position, they will be listed individually. The count of the
executable tests is made by single analysis, as if it was present alone in that given position.
The Real samples field refers to the maximum number of samples which can be executed
for the test when one of the reagents has a lower volume than the other. In this case the
reagent with the lower volume determines the maximum number of samples that can really
be executed.

Figure 2

Section I Chapter E Operating Procedure Page 3 of 19

1.3. RUNNING STANDARDS & CONTROLS (ON DEMAND OR TIMED)

Figure 3 Figure 4
The "Run Standards" and "Run Controls" functions are available from the "Tests" main
menu or through the specific icons that allow direct access.
The displayed analysis codes belong to the list generated in the "Current tray" list. Only
codes with programming, even if incomplete, are displayed on the controls page. In this
case the un-programmed levels will be displayed, even if not enabled. The entire list of tests
present in the current tray is displayed for the standards (with the exception of relation
tests).
RUNNING STANDARDS
Standards’ calibration can be run either on command or automatically at pre-determined
time intervals (refer to Chapter C, paragraph 1.5. "Calibrations"). Both choices can
coexist. The commands are "Immediate Standards" and "Timed Standards (Fig. 3).
"Immediate Standards": Once the button is clicked a list of codes appears, select the
desired tests and run by pressing "Run". With "Select All" or "Deselect All" commands, it
is possible to select or deselect the whole list. A message will ask the user whether the
calibration standards are already present in the tray or not. If the samples are already
present, click "Yes" and calibration procedure will automatically start. Otherwise, if
calibration samples aren’t already placed on the tray, click "No"; in this case a procedure will
guide the user through samples’ insertion. By clicking over sample’s position, the tray moves
itself to accommodate cup’s insertion. Once the necessary cups have been inserted, it is
possible to run the calibration.

"Timed Standards": Only the codes with programmed times are enabled. After selection of tests,
the calibrations can be run. In this case, the interval of the automatic calibration starts when tests
are run. In case the calibrations aren’t run, then the time count of calibration’s interval starts from
the moment the selection was made. Once the automatic calibration time has elapsed a message
appears on the screen asking the operator if the tests need to be run. If the standards and reagents
are on the tray answer yes. At this point the automatic calibration time restarts.
If the message is not answered or a negative answer is given, the calibration time count starts
again. The previous calibration remains in the memory. If the timing expires while the analyzer is in
standby, it will be automatically moved 10 minutes forward.

Section I Chapter E Operating Procedure Page 4 of 19

Running Controls
Controls Sera can be run on command or automatically, according to programmed time
intervals (refer to Chapter C, paragraph 1.4. "Controls"). The two modes can coexist.
Commands are "Immediate Controls" and "Timed Controls" (Fig. 4).
"Immediate Controls":
Clicking this button generates a list of codes. With "Select All" or "Deselect All"
commands, it is possible to select or deselect the whole list.
The single levels for each type of control can be selected
at the same time for all the tests present, by clicking on
the relative button, which will change color from dark
green to light green.
Select the desired tests and run by pressing "Run".
A message will ask the user whether the control samples are already present in the tray or
not. If samples are already present, click "Yes" and run will automatically start. Otherwise,
if controls samples aren’t already placed on the tray, click "No"; in this case a guided
procedure is presented for samples’ insertion. By clicking over sample’s position, the tray
moves itself to accommodate cup’s insertion. After the insertion of necessary cups, run the
controls.
"Timer-driven Controls":
Only the codes with programmed times are enabled.
When the listed tests are selected the controls can be executed, in this case the automatic
execution time interval starts from when the test begins, if the controls are not executed the
execution time count starts from when the selection is carried out. When the automatic
execution time has elapsed a message appears on the screen asking the operator if the
tests need to be executed. If the operator answers yes, it checks for the presence of the
controls and reagents and starts the tray.
If the message is not answered or a negative answer is given, the control time count starts
again. If the timing expires while the analyzer is in standby, it will be automatically moved
10 minutes forward.

Standards, Controls and Patients Run

The analyzer allows the associated running of standards, controls and patients. The
standards can be processed before, during or after patients’ run. These three options
provide the analyzer with maximum operating flexibility.
To run the calibrations during the patients determinations, proceed as described above.
The analyzer will calculate the factors for the calibrations being run and update the result
page in real time (by patient). If no errors occur in the calibrations, the results of the next
patients will be calculated with the new factors at the end of the calibrations. The results of
the patients before the calibrations will be calculated with the previous factors. When
finished working it is possible to recalculate all the results based on the last executed
calibration, again if there have not been any errors. This function is available on the result
page in real time for patients (see Ch. G, par. 1. Displaying and printing results).
Press the Correction button and select the correction with standard. This way all the
results will be recalculated based on the last calibration.
NOTE:
In case of analytical errors during calibrations, the analyzer displays the error type
and conserves the previous validated calibrations in the analyzer memory.

Section I Chapter E Operating Procedure Page 5 of 19

1.4. SAMPLES

Entering Samples (Routine, STAT, Controls and Batch)

Samples can be entered with "Insert Routine/STAT" or with "Insert Batch". These can be
accessed from "Patients" main menu or from dedicated icons. Select "Exit" to leave the
program. The represented analyses codes pertain to the list generated in the "Create
current tray".
Insert Routine/STAT: The following options are available in this page "Global Insert/View
Patients" (Figure 5):

Figure 5
NOTE:
Point the cursor on the desired option and click to confirm.

Section I Chapter E Operating Procedure Page 6 of 19

"Re-run": allows tests which have been run and not archived to be re-run (repetitions) on
user’s demand.
"Routine": Default display of Patient positions.
"STAT": Displays STAT (Single Test in Actual Time, i.e. urgent positions) positions.
"Control": Displays Control positions.
"Standard": Displays Calibrators positions.
"New Entry": Enables data entry procedure for Routine, STAT and Controls.
"Extra Patients": Displays the list of patients with no assigned position. Patients selected
in the work-list may be moved here ("Options" menu, "Send to extra patients" command)
and then back.
"Exit": To leave program
New Entry Routine:
After the selection of "Routine" followed by confirmation through command "New Entry",
the patients acquisition frame is displayed (Figure 6). The programmed patient can be
executed immediately or saved for later use. The programming fields and the functions are
outlined below:

Duplicate Patient

Figure 6A

Figure 6
"Group": Select the group (Man, Woman, Child) for correct reference with normal values
range.
"Type": It is default set to "Serum". The sample type (Serum or Urines) is selected here. If
"Urine" is selected, then the volume of diuresis (in the 24h) is requested. This is required
for processing data acquired with automatic calculation on 24 hours. If this processing is not
required then leave the value at zero "0".
"Assigned Group" ("Routine" or "CTRL Routine"): The default setting is "Routine". It is
used for selecting the category (Patient or Control Serum) during sample programming.
Selecting "CTRL Routine" the type ("Known" or "Unknown") and levels (Level 1, 2, 3)
must be specified.
Section I Chapter E Operating Procedure Page 7 of 19
NOTE:
With this type of acquisition, the controls belonging to the stored Q.C. will use the
positions assigned to routine patients, not the dedicated ones.

"Position": Displays the first free position from the available positions. To modify this field
use horizontal arrows "⇐ ⇒" or type in the desired position. Do not modify to accept.
"Code": It is the identification number assigned by the user to the patient. The user can
also enter the code of a patient saved in the work list, even if in execution. In this case, a
message asks the user to confirm patient’s data cloning. In case of affirmative response, all
the data relevant to the patient is instantly displayed and is linked to the current position.
The cloning of a patient’s code allows the user to obtain one report in case different
samples are used. If this option is not used, then separate reports are obtained.
"Duplicate patient": By clicking on the icon, it is possible to create a worklist with the same
profile (Autobatch) or else a list with sequential codes. When the patients are entered
using the duplication method, their codes may be assigned by the analyzer, or it may be a
progressive number. In the case of progressive number, the operator must enter the first
code to be used.
"Surname", "Name": Enter patient’s personal data.
"Draw Date": System date is automatically displayed. To modify, move mouse cursor on
textbox, click and edit.
"Note": Additional information to be added to the report.
"External Dilution Factor": By default set to "1". It allows analysis determination on
externally diluted samples. Enter in this field the external dilution factor ratio used in sample
preparation. Final result is multiplied by the inserted ratio.
CAUTION!
IN THIS CASE THE PRE AND POST DILUTION FACTORS OF TEST PARAMETERS
WILL NOT BE TAKEN INTO CONSIDERATION.

NOTE:
If a hyper-activity parameter value is surpassed (indicated by an appropriate flag)
during determinations of externally diluted samples, the "Automatic Re-run" is not
performed.

"Test": Generates the Analysis List. Select each analysis to be performed on the sample.

Section I Chapter E Operating Procedure Page 8 of 19

Profiles, Select/Deselect Tests

"Profile": The stored "Profiles" list (Fig. 7) is displayed through this command (refer to
Chapter. C, paragraph 1.6. "Creating Profiles"). Two acquisition modes are available. The
first one requires a double-click on profile’s name. The second mode, after choosing the
profile with one click, requires confirmation by activating "Select".
The analyses programmed in this way can be modified. To add or remove tests, it is
necessary to enter in the screen "Select tests" and confirm by clicking on the textboxes.
With "Deselect", it is possible to delete an already selected profile.

Figure 7
"Delete": Cancels the programmed patient or the analyses of an already programmed (and
saved) patient. Confirmation is requested.

"Save": Saves patient’s data and the associated analyses. With this command test
execution is delayed.

NOTE:
In the routine programming, it is possible to acquire a greater number of patients
than the available number of positions in samples’ tray. All the patients acquired with
no associated position are saved and displayed in the extra patients list and can be
transferred to the main list on user’s demand (refer to paragraph 1.5. "Work Lists").

"Run": This command immediately starts the execution of the programmed patient. The
sample plate adjusts itself to match the position assigned to the patient, and a blinking red
LED indicates the position for inserting cup or primary tube. If patient code is missing or no
analyses have been selected then this command cannot be activated.

Section I Chapter E Operating Procedure Page 9 of 19

New Entry/STAT:
After the selection of "STAT" followed by confirmation through "New Entry", the STAT
acquisition frame is displayed (Figure 8). Bear in mind that the tray positions reserved for
emergencies are the ones assigned in the "Analyzer Setup" (Chapter H, paragraph 2.).
An appropriate screen message alerts the user when a wrong position number is entered.
Patients acquired as "STAT" can be saved as described in "Routine", but if sent for
execution, they are analyzed immediately with highest priority.
All the acquired patients with no assigned position are saved and displayed in the
temporary list "Extra Patients (STAT)", from where they can be transferred back to the
work-list on user’s demand (refer to paragraph 1.5. "Work Lists").

Figure 8

New Entry/Controls:
Once the icon "Controls" is selected, the list of control positions is displayed (Fig. 9).
Controls acquisition frame is displayed by activating "New Entry" command or with aclick
on a given position. A window identical to the one displayed in "Routine" appears but
without the patient fields. Bear in mind that the tray positions reserved for controls are the
ones assigned in the "Analyzer Setup" (Chapter H, paragraph 2.). An appropriate screen
message alerts the user when a wrong position number is entered. Patients acquired as
"Controls" can be saved as described in "Routine", and are executed afterwards. All the
acquired controls without assigned position are saved and displayed in the temporary list
"Extra Patients (Control)", from where they can be transferred on user’s demand (refer to
paragraph 1.5. "Work Lists").

Figure 9

Section I Chapter E Operating Procedure Page 10 of 19

Insert Batch:
In this page (Figure 10) select the desired analysis code and associate sample positions
with it. Analysis list and routine numerations are displayed.The "Select" command (located
next to the tray positions) automatically enables all the positions entered in the fields
"From" and "To", and the "Deselect" disables them all. Click on the check boxes to
enable or disable a test. After entering one or more analysis code, enable test runand start
working phase by pressing "Run". The enabled sera positions are highlighted in red, while
the analyses codes in blue. Press "Exit" to terminate and leave.
This check-in procedure is simplified as it doesn’t require patients data entry and doesn’t
make any distinction between serum and urine. In the report, A progressive numerical
identification is automatically assigned to the report, for example Batch # xx.
NOTE:
Even if the programming is based on analyses, the analyzer processing is always
patient selective.

ATTENTION: when programming a batch, it is necessary to be sure that all the selected
positions are free and not already programmed in the routine work-list. When "Run" is
selected, the analyzer will ask confirm that the positions are free.
"Are you sure that the selected positions are all available?"
Answering "Yes", the batch will be run, answering "No", the run will be aborted in order to
allow the operator to verify if the positions in the routine work-list are available or not.
If the operator runs a batch in which some of the selected positions are not available, the
analyzer will skip on those positions and will keep the already programmed patients (in the
same status these were before running the batch). The positions of the batch that have
been skipped will not be considered at all, as if these were not programmed from the
beginning.

Figure 10

Section I Chapter E Operating Procedure Page 11 of 19

1.5. WORK LISTS

Figure 11
The Work Lists can be accessed through the menu "Patients" → "Insert Routine/STAT" or
directly using its proper icon. The screen displays the "Current Tray (Routine)" in the center
and the "Extra Patients (Routine)" on the right. During the working phase, it may be useful
to display also the "Re-run" worklist.
Click on the "Routine", "STAT", "Control" and "Standard" buttons to view the
corresponding work lists. For "Control" and "STAT", as for the patients, the screen displays
the "Current Tray (Routine)"list and the "Extra Patients (Routine)" list. It is possible to run
controls and calibrators even during the determination of patients. Thework-lists show the
position number and test code: the samples being run are marked in red, the free positions
in green, the samples which are programmed but in Stand By are marked in blue. If there is
a lack of serum or reagent in the Performed Patients List they are marked in yellow. The
patient codes have Italics characters for cloned samples and are underlined for
determinations and repetitions. The characters are yellow for data being processed. The
samples located in the Extra Patients List are graphically indicated in blue.
Work Lists are used to display the entered patients’ codes or to verify the samples’ state on
the tray (Fig. 11)

Routine Tray List:

Inside this list it is possible to view in real-time the actual situation. The user, by clicking on
an active position, enables the Registry situation with information on selected code and
analyses. It is possible to modify if the sample is not being run. It is possible to enter new
data by justclicking on a vacant position. During tray processing, as the samples are
analyzed, the positions that were previously occupied become vacant (green).

Section I Chapter E Operating Procedure Page 12 of 19

"Options": The "Options" menu is available in the "Current Tray" (Routine, STAT and
Controls). It displays the following commands (Figure 12):

"Send to extra patients": The selected patients are removed

from current samples tray list for placement on "Extra Patients
List". Selection can be done by checking the appropriate boxes.
Use "Select All" to select the whole list and "Deselect All" to
deselect.

"Print": Prints the partial (for selected items) or total samples

list.

"Select All": Automatically selects the whole list.

"Deselect All": Automatically deselects the whole list.

"Run": Work start command. If single patients or the whole list is

selected, a message asks if the samples have been inserted. If the answer is affirmative,
the analyzer automatically starts processing. In case of a negative answer, a guided
procedure will assist the user to insert the samples. Confirming with cursor on the
corresponding line performs the selection of the sample to be inserted. After the insertion of
all the samples, activate "Run".

"Delete": Removes selected or all the patients. Confirmation is required.

NOTE:
In case the serum barcode is enabled in the "Options" menu, then two additional
commands are automatically added (Controls are excluded). The two commands are
"Scan Tray" and "Scan Tray and Run". Both commands allow further selection: "All"
and "Single Position".

"Scan tray": Allows positive identification and saves present samples on the tray. It is
subdivided into the following two functions:
"All": The tray performs a rotation scan to make a positive identification, and saves
all the samples (codes) in the sera tray.
"Single Position": Allows positive identification and saving of only one single code.
The analyzer requests the desired position and the tray accordingly positions itself
for sample’s insertion. Makes one rotation for reading the present code.

"Scan tray and run": Performs reading rotation as before, but runs the tests immediately.

NOTE:
In patients’ bar-code printing protocols it is possible to add "Profile Number", which
provides total automation in patient acquisition (refer to Chapter C, paragraph 1.6.
"Creating Profiles" and Chapter I, paragraph 1. "Bar-code and related functions").
During bar-code reading, the analyzer provides a list of likely errors that occurred. In
this case the reading can be repeated by re-activating the command.

Section I Chapter E Operating Procedure Page 13 of 19

"Extra Patients": It displays the acquired patients that haven't been inserted in the run list.
The user by clicking on an active position enables Registry Situation with selected code and
analyses information. It is possible to modify it.
"Options": The "Options" menu allows the following functions:
"Send to Current Tray": The selected patients are removed from "Extra Patients List"
for placement on current samples tray list. The patients will be placed in the free
positions starting from the first available. Use Select all or Deselect all commands to
select or deselect the whole list. It is also possible to "drag and drop" single patients to
the current tray in any available position.
"Print": Prints the selected or total samples list.
"Delete": Removes selected or all the patients. Confirmation is required.
"Performed Patients List": This list displays the codes and positions for the completed
patients that are available for repetition. The user, by double-clicking on an active code,
enables patient’s information page with assigned analyses and relevant results, while by
clicking on a given analysis code, the reaction graph is presented. To re-run, the desired
patient code must be transferred to Current Tray List and then run again. Confirm with a
single click on the position number, confirmation is requested before transferring. If the
answer is positive, then the screen "Select Repetition Position" is displayed. If available
the previously used position is shown otherwise the first vacant position is presented,
modify if necessary. Once the position is confirmed or modified, Registry Situation with
related analysis is presented. Deselect the analysis that should not be repeated, add
new tests if needed. Once programming has been terminated confirm with command
"Run" to run the sample or "Save" for memorizing.

NOTE:
Confirmation is requested in all the patients’ work lists, to perform Codes Transfer
Commands. The analyzer verifies the availability of positions in the samples tray list
and eventually prompts the user about the impossibility to complete the task.

"Standards List":
Activation of "Standard" button displays a list (Fig. 13) of Calibrator Positions "Current
Tray (Standards)". This list is in a read-only format.

Figure 13

Section I Chapter E Operating Procedure Page 14 of 19

"Global Insert/View patients"
The "Functions" menu in the "Global Insert/View patients" (fig 14) bar provides access to
the following commands:

Figure 14
♦ "Run All Pending Patients":
A sole command for running the already acquired patients and the partially processed
patients (because of an interruption during tests execution). The analyzer will continue to
process suspended patients. Confirmation is required.
♦ "Repetition for Analyses":
This command re-runs test for samples. First the selection of the desired analyses codes is
required and then the confirmation. The analyzer automatically searches for the samples
which had already undergone determination of selected analytes, and performs the newly
assigned work list and then updates patient reports with new data obtained from the
repetition.
♦ "RS 232":
This function is used for transferring data from the analyzer to the host computer. Data
transfer can be automatic if enabled in the Setup. If it is not enabled, then the data transfer
occurs on user’s request through the command "Accept Result to be sent". Confirmation
is required. The function "Delete Result to be sent" allows deletion of the data to be sent
to the host computer; confirmation is required (see also Chapter H, paragraph 2. "Analyzer
Setup").
♦ "Clear Patients’ List":
This command allows deletion of the previously acquired patients list. Confirmation is
required. It deletes the whole list.

Section I Chapter E Operating Procedure Page 15 of 19

1.6. TURNING OFF PROCEDURE
To turn off the instrument, the "SHUT DOWN" procedure must be performed. In this way
the instrument is definitely turned off, except for the refrigerator for the reagents. The shut
down procedure proposes the wash of the cuvettes with appropriate washing solution
before turning off. The analyzer indicates the position where the detergent should be
inserted (see also Chapter. C, paragraph 1.1.).
NOTE: if cuvettes are not properly washed at the shut-down, at the following start up
the analyzer will ask for the cuvettes extra wash (with acid solution). Performing the
normal cuvettes wash (with the cuvettes washing solution) will not prevent the
analyzer from warning again that the extra wash is needed.
Conditions are:
a. If no test has been performed before the shut-down, at the following start-up of the program, no wash
message will appear.
b. If no test has been performed before the shut-down and the shut-down wash has been started but it did
not complete correctly, then at the following start-up of the program, the analyzer will warn the operator that
the preceding wash was not correctly completed.
c. If tests have been performed and the shut-down wash was not performed, at the following start-up of the
program, the analyzer will ask for the Extra wash cuvettes and will warn the operator that the preceding
wash was not correctly completed.
NOTES:
1) Having performed a test: it means having performed either a single test with reagents and sample or any
procedure involving colored solutions, such as the FCC.
2) The analyzer asks for the Extra wash cuvettes as it does not know how long the solutions were left inside
the cuvettes before washing them.

The analyzer provides two other modes for interrupting its operation:
1) "SLEEP-MODE"
This mode can be manually activated, or it starts automatically when the instrument is left
inactive for more than 30 minutes. The Sleep-Mode automatically performs the wash and
fill up of the cuvettes with bi-distilled water and remains idle (waiting for user’s commands
for immediate operation).
2) "LOG-OFF"
The "Log-Off" mode represents a partial turning off of the analyzer. It disables some
devices: halogen lamp of the photometer, cuvettes thermostat and drive motors. This mode
is used for energy saving.
The Log-Off mode is utilized for programming automatic turning on at a desired date and
time. The instrument will remain in a stand-by condition and it will automatically turn on 30
minutes before the programmed time. The turning on in anticipation allows the analyzer to
reach steady state thus allowing immediate operation at the programmed time.
To exit ahead of time from a suspended activity, press a key on the keyboard and press the
Exit button on the window that appears. However, in this case it is necessary to wait for the
devices to become operational.

NOTE
It is not advisable to keep the analyzer "ON" for more than one month as this may
cause problems with Windows internal counters.

CAUTION!
If the "SHUT DOWN" procedure has not been observed, then do not ever stop the
analyzer by turning off the main switch. This may cause irreparable loss of data in
the archives and damages to the operative program.

Section I Chapter E Operating Procedure Page 16 of 19

1.7. ACCESS PASSWORD

To comply with the European law on privacy (processing of sensitive data) enacted with
Italian Legislative Decree no. 196 of 30/6/2003 passwords have been implemented for the
analyzer. This makes it possible to keep a record of the activity of each authorized operator.

To have access to the analyzer program, a sequence of USERNAME and PASSWORD

needs to be entered.

When the analyzer is installed or first used, the Administrator or lab manager must assign
each operator with a Username and password combination, associated with his own access
level to the program.

The first window that appears is dedicated to the Administrator (a manager who takes care
of archiving as well as password management of the users who have access to the
analyzer).

The Administrator needs to enter the following in the Username field: ADMIN
The Administrator needs to enter the following in the Password field: Administrator

Figure 15

After pressing the Logon button, a window will open where the Administrator enters his new
personal password.

Figure 16

The Administrator password does not have an expiration date, while those assigned to
operators need to be renewed every three months.

Section I Chapter E Operating Procedure Page 17 of 19

Do not forget the Username and Password sequence. If this happens, the Administrator will
have to delete the operator profile and create a new one. If the Administrator forgets his
own password, it will be necessary to delete the entire list of passwords using an external
special program. If necessary, submit a request to the Technical Assistance Service.
Once access to the password entry page is obtained, the Administrator must assign each
operator with his Username and Password combination. Press on New User. A window
opens for typing the Username and password and confirming the password. Next, the
Administrator needs to assign the access level allowed for the individual operator.

Figure 17

Each level allows access to normal analyzer operations (acquisition and running of patient
lists, Calibrations, Q.C. program and Population, etc.) plus some specific functions that
would otherwise not be available. Access to the patient archive is allowed by putting a
check in the specific box.
Level 0: Normal user
Level 1: Correction of results with standard
Correction of results with factor
Changing of results in patient archive
Standard: Auto Adjust
Standard: Calculation (calculation of the factor for manually entered abs)
Level 2: Changing of clinical chemical parameters
Changing of relation test parameters
Importing of parameters with "Restore" function
Importing of parameters with "Single test" function
Level 3: User with access to instrument diagnostics

Section I Chapter E Operating Procedure Page 18 of 19

To be able to allow a user to have an access level other than 0 it is necessary to know the
system password that allows access to the same level. This is requested after selecting a
level.
The system passwords can be changed in the analyzer Setup. Access is only allowed to
the third level.
ATTENTION: if the new system passwords are forgotten, it is necessary to format the
hard disk and reinstall the program. In this case any unsaved data will be lost.
Biotecnica shall not be held liable for system passwords that are changed by the
user.

NOTE: the users password MUST be at least of eight characters. It is advisable to use
alpha-numeric passwords. Avoid using 8-times repeated characters such as
YYYYYYYY or 33333333.
It is advisable to test the password every time a new password is programmed.

Section I Chapter E Operating Procedure Page 19 of 19

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER F
1. QUALITY CONTROLS Page: 2
1.1. Inserting/modifying controls Page: 2
1.2. Data management Page: 4
1.3. Displaying and processing by lot pairs: Juden graph Page: 6
1.3.1. Westgard Graph Page: 7
1.3.2. Daily Chart Page: 9
1.4. Additional Functions Page: 10
2. POPULATION Page: 11
2.1. Analysis Selection (How to run a Query) Page: 12
2.2. Principal statistics formulas used in Population module Page: 16
2.3. Inserting external analyses Page: 18
2.4. Other menu functions Page: 19
3. PATIENTS’ ARCHIVE Page: 21
3.1. Selection (How to run a Query) Page: 23
3.2. Patient’s report Page: 25
3.3. Printing Reports Page: 27
3.4. Other menu functions Page: 29

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter F Q.C. - Population - Patient's Archive Page 1 of 29

1. QUALITY CONTROLS

This is an external program used to enter, change and process quality controls. The
program can process data from the analyzer (controls run in routine or dedicated positions)
and from other instruments (with the Insert / Modify Data function).

NB: due to the large dimensions that the archive can reach, it is advisable to run a
backup at regular intervals, even monthly.
It is advisable to use the “Export Data” function in the FILE menu to export the
archive in CSV or Fixed length format (see par 2.4 OTHER MENU FUNCTIONS).
Once the archive is saved into a different location, please delete the internal archive
to avoid the archive itself to crash.

The program is composed of three separate

sections:
♦ Insert/Modify controls
♦ Data Management
♦ Juden graph
plus some Additional functions

Figure 1

1.1. INSERTING/MODIFYING CONTROLS

It makes possible to process data obtained externally at the analyzer. It requests a series
of information used to statistically process the inserted values. Press the Insert Modify
Data button.

Figure 2

Section I Chapter F Q.C. - Population - Patient's Archive Page 2 of 29

To enter a new name in the Analyses, Lot and Method field, click on the
button

To confirm and close the window, press MEMORIZE.

Analyses: insert a name for analysis or select one from the existing list.
Lot: insert the lot number or select one from the existing list.
Method: insert a method or select one from the existing list.
Type: select if the control is a known or unknown type.
Level: select the level to assign to the values.
The press the Memorize Lot button: a window will open for inserting the central control
value and relative acceptability range.
After providing all the necessary data for unequivocal identification of the control data, the
values can be inserted by pressing the Memorize button. The date and time proposed by
the analyzer can be changed if necessary.
Once data insertion is finished, close the window in figure 2. At this point statistical
processing of the data becomes available.
Data inserted manually will be managed exactly like the data from the analyzer (control
execution).

Section I Chapter F Q.C. - Population - Patient's Archive Page 3 of 29

1.2. DATA MANAGEMENT
Used to display and process data.

Figure 3
To obtain data processing it is necessary to provide the analyzer will all the information
related to the control: Analysis, Lot, Method, Control type – Known/Unknown – and
Level.
If the All option is left in the Lot and Method fields, the search will be done for all the lots
and all the methods relative to the test selected in the Analyses field. In this condition the
Range and Westgard Decision values will not be displayed (fig. 3a).

Figure 3a

Section I Chapter F Q.C. - Population - Patient's Archive Page 4 of 29

Data searches can be run for a single date (Daily) or for an interval of dates (Total).

It is possible to select All data for both the Daily Q.C.

and for the Total. In this case no additional range will
be requested to further narrow the search field.

If only data for a precise time period in a work day

are going to be processed, it is possible to disable
the check on the All data field. At this point the
analyzer proposes a date and time range. Enter the
values within which to run the search.

If data for a precise time period in days are going to

be processed, it is possible to disable the check on
the All data field. At this point the analyzer proposes
a start and end date for the search. Enter the values
within which to run the search.

Make all the selections necessary for processing the data, then press the Search button.
The results will be displayed as shown in figure 3. The data are ordered by date and time.
Out of range controls are indicated with an asterisk.
To delete a record, it must be first selected with the left mouse button, then it can be deleted
by pressing the right mouse button. This is possible only if the search is Daily and not Total.

When the search is run on unknown controls the range and Westgard classes are not
displayed.
Deleting data: see fig. 3 and 3a. After having performed a daily query, it is possible to
delete one or more control values. To delete a control, first highlight it, then right click on it
and confirm.

Section I Chapter F Q.C. - Population - Patient's Archive Page 5 of 29

1.3. DISPLAYING & PROCESSING BY LOT PAIRS: JUDEN GRAPH

After selecting the key parameters "Analyses", "Lot", "Method", “Type”

(“Known/Unknown”) and “Level”, data processing and visualization is performed. The
controls are ordered by date and only in case of known controls the "Out of limit" condition
is indicated. Refer to Figure 4.
This function relates two different levels for the same lot displaying distribution of controls
within the limits of lots.

Figure 4
By clicking over a value plotted on the graph, the information relating the pair of values will
be displayed.

Section I Chapter F Q.C. - Population - Patient's Archive Page 6 of 29

1.3.1. Westgard Graph

The "Westgard graph" provides a global vision of a given lot by plotting data on a diagram
having the origin at "0" line representing the actual mean (not the theoretical value) of the
same lot and as division values such as Mean±1S ±4S (see Westgard table in Figure 5). All
data within the given range will be displayed with a green triangle while the out of range
data will be plotted using red squares.

Figure 5
By clicking the mouse over a given value in the graph, its information will be displayed (fig.
6). Click on the “Print” button to print the graph.

Figure 6

Section I Chapter F Q.C. - Population - Patient's Archive Page 7 of 29

"Westgard's Decision"
It is a procedure for classifying values of a "Known" lot taken into consideration for
processing.
Mean: mean between the maximum and minimum lot value
S: (Maximum lot value – Minimum lot value) / 8
The following procedure is observed for classification:

Class A (1-2S): One result exceeds Mean by +/- 2S.

Class B (1-3S): One result exceeds Mean by +/- 3S.

Class C (2-2S): Two consecutive results exceed mean by 2S in the same direction.

Class D (R-4S): Difference between two consecutive results is higher than 4S and at
least one result exceeds mean by +/- 2S.

Class E (4-1S): Four consecutive results exceed mean by more than 1S in the same
direction and at least one result exceeds mean by +/-2S.

Class F (10x): Ten consecutive results are all in the same direction of the mean value
and at least one result exceeds the mean by +/- 2S.

Classes are controlled from F to A. The classes are mutually exclusive, that is, if a given
value is mapped to one class then it can't be part of another class.

Example:
2 E classes means that 5 consecutive results exceed Mean by more than 1S in the same
direction and at least one result exceeds mean by +/-2S; alternatively two groups of 4
consecutive results exceed the mean by more than 1S in the same direction and at least
one result exceeds mean by +/-2S.

Section I Chapter F Q.C. - Population - Patient's Archive Page 8 of 29

1.3.2. Daily Chart Graph
The "Daily Chart graph" provides a global vision of a given lot, plotting data on a diagram
having the origin represented by the actual mean (not by the theoretical value) of the same
lot and as divisions values such as Mean+Standard Deviation*1, Mean+Standard
Deviation*2 to Mean+Standard Deviation*4. In addition the red dashed lines indicate the
upper and lower limits of the lot. All data within the range will be represented by a green
triangle, while the out of range data will be plotted using red squares.

Figure 7
By clicking the mouse over a given value in the graphic, its information will be displayed.
Click “Print” to print the graph.

Figure 8

Section I Chapter F Q.C. - Population - Patient's Archive Page 9 of 29

1.4. ADDITIONAL FUNCTIONS

Figure 9 Figure 10
The FUNCTIONS menu contains the following:
“Export Data”: Saves memorized quality controls by selecting a particular "Method”,
“Analyses”, “Lot”, and “Date”. If "All" is selected in the above-mentioned fields then all
controls will be memorized. Refer to Figure 10. It is also possible to export the QC data in
CSV (comma separated values) or Fixed length formats, compatible both with Word or
Excel kind applicatives.
NOTE: the use of this function is very important to have constantly updated archives
in a hard disk different from the analyzer’s.
Once the *.csv or *.txt file has been created, it can be opened with Excel or Word.
First open the appropriate program (both programs will open both kind of files, but
the easier way is to use Excel for *.csv and Word for *.txt files). Then select “Open
file” and in the “open” window, select in the field “File of type”: “all files - *.*”. Click
twice on the file you want to open.
“Import Data”: Overwrites the actual stored data with the imported data. CAUTION: It is
not possible to restore overwritten data.
“Delete Data”: it is possible to delete records in the archive by “Date”, “Method”,
“Analyses”, “Lot” or erase the whole archive (Figure 9). CAUTION: It is not possible to
restore deleted data in the previous "Delete Data" command.
- Reindex Data-Base: function used to reorder the Quality Controls archive.
- Close: closes the Q.C. program.

The DATA menu contains the functions explained in the paragraphs above.

Figure 11
The PREFERENCE menu (fig. 11) contains the following:
External archive: used to view and print the quality controls memorized on the hard disk or
on a floppy disk. A window opens where the position for opening the archive can be
selected.
Printer Setup: used to set up the printer (heading, footnotes, etc.)

Section I Chapter F Q.C. - Population - Patient's Archive Page 10 of 29

2. POPULATION

Figure 12
The Population module manages and displays graphs as well as data, and computes
statistics on data of all the analyses performed by the instrument.
N.B.: due to the large dimensions that the archive can reach, it is advisable to run a
backup at regular intervals, even monthly. It is advisable to use the “Export Data”
function in the FILE menu to export the archive in CSV or Fixed length format (see
par 2.4 OTHER MENU FUNCTIONS). Once the archive is saved into a different
location, please delete the internal archive to avoid the archive itself to crash.
The main functions are:
Display and data acquisition from updated analyses file.
Update internal archives.
Generate dynamic query that allows to sort and display data by analysis, analytical
method, results’ range, group, type and date.
Statistical operations: display number of run tests, mean calculation, standard deviation,
variation & correlation coefficients, variance, deviance, angular coefficient and known
term of the minimum square line.
Display data graphs: Trender (data with fitting line), L. Jennings, histograms with base
zero and statistical (mean value represents the base).
Printout of total and partial data, graphs, and statistics.

Moreover the program has the following built-in secondary functions:

Total and partial “Back-Up” and “Restore” (selected by date and/or group and/or type
and/or method and/or by results’ range) functions.
Total “Restore” function appends (adds) data to the existing archive.
Printer setup.
Deletion of the whole population archive.
Addition of external tests for storing in the memory results belonging to different
analyses than those performed by the analyzer: these results will be saved in the
archive thus allowing data display and statistics generation.

Section I Chapter F Q.C. - Population - Patient's Archive Page 11 of 29

2.1. ANALYSIS SELECTION (How to run a Query)

Figure 13
To perform any query it is necessary to select an analysis from the “Select Analysis” list
(Fig. 13). Once selected all existing methods associated to the analysis (“Select Method”)
are displayed. It is possible to select among the available methods by clicking on the check
box. One can simultaneously enable the search for one or more groups "Group" (Man,
Woman, Child) or Test Type (Serum, Urine, Relation). Moreover it is possible to limit
search within two dates (Date range) or according to a given data range (Results range).
Once the all query criteria have been selected, press the Search button to display the data
and statistics referred to it (Fig. 14). This page shows the statistical processing for the
query. They are also present on the pages for graphic processing (Diagrams)

The statistical data presented for

the query include:
Number of selected records
Mean
Standard Deviation
Variation coefficient
Variance
Deviance
Correlation coefficient
Median
Minimum result
Maximum result

Figure 14
The query data can be printed (Print Preview) in three different formats:

- Only values
- Only statistics
- Values and statistics
Once the selection is made the print preview page opens. To print, press the printer icon.

Section I Chapter F Q.C. - Population - Patient's Archive Page 12 of 29

By pressing on the Diagrams button, a series of possible graphics processing is proposed
for the executed query (Fig 15).

Figure 15
By clicking on one of the keys related to diagrams it is possible to view one of the graphs
listed below.

In all available diagrams, by double-clicking the

mouse on a given plotted point, information about
its coordinates (position and value) is shown.
The specific criteria used for the query are also
described, if present.

Data Sequence Graph

Figure 16
By clicking on “Data Sequence” (Fig.16) key, the data sequence is displayed.

Section I Chapter F Q.C. - Population - Patient's Archive Page 13 of 29

Trender Graph

Figure 17
By clicking on Trender button, data sequence is displayed together with its related minimum
square line (Fig. 17); in the lower part of the graph the equation for the line is shown.

L. Jennings Graph

Figure 18

By clicking on "L. Jennings" button, L. Jennings graph is displayed for the selected data
(Fig. 18).

Section I Chapter F Q.C. - Population - Patient's Archive Page 14 of 29

Histogram Graph
By clicking on Histogram button, the histogram for the selected data is displayed (Fig. 19).

Figure 19

Statistic Histogram Graph

Figure 20

By clicking on Statistic Histogram button, the histogram for the selected data with respect
to the mean value is displayed. (Fig. 20).

Section I Chapter F Q.C. - Population - Patient's Archive Page 15 of 29

2.2. PRINCIPAL STATISTICS FORMULAS USED IN POPULATION

♦ Mean:

X: X1 ..Xn selected elements; being “n” the number of elements:

X1 + X2 + … + Xn
X=
n

♦ Standard Deviation:
SD: is a quantity that measures the spread of data across its mean value. If data is mostly
located near the mean SD assumes a small value, otherwise a large value indicates large
data spread.
n

DS =
Σ (Xi – X)
i=1
2

n-1

♦ Variation coefficient:
CV%: is computed as the ratio between mean square error and arithmetic mean. CV% is a
relative quantity and independent from the measurement unit used.

DS*100
CV=
X

♦ Minimum square line y = ax + b

Where:

Σ XY-nΣxΣy
a=
Σ X2 - n(ΣX)2
b= ΣY-aΣx
♦ Correlation Coefficient:

Σ[(Y-Y)*(X-X)]
CC =
Σ(X-X)*(Y-Y)
♦ Variance:

[ X* X]
ΣΧ2 - Σ nΣ
V=
n-1

♦ Deviance:
2
(Σ X)
D =Σ X2 - n

Section I Chapter F Q.C. - Population - Patient's Archive Page 16 of 29

Median:
The Median for an ordered ser of data is the central value or the arithmetic mean of the two
central values, depending on the fact that the number of elements in the set be odd or
even. In particular the median for N odd elements, is the X[(N+1)/2]th element.
Example.: given the following 9 elements set
1, 2, 2, 17, 21, 34, 34, 34, 67

Median = [X (N+2)]/2 = X[(9+1)/2] = X[5] = 21

median is 21, the fifth element.

The median for N even elements, is the { X(N/2) +X[(N+2)/2] }/2 element.
Ex.: be given the following 8 elements set
1, 2, 12, 24, 26, 45, 45, 46
{X[4]+X[5]}/2 = (24+26)/2 = 25
median is 25.

By comparing the median and the arithmatical mean, one can assume the existence of a
measurement error or an asymmetry in the distribution function, in case these two
quantities differ greatly.

Section I Chapter F Q.C. - Population - Patient's Archive Page 17 of 29

2.3. INSERTING EXTERNAL ANALYSES

Press on the New Record in the Utility menu.

Figure 21
It is possible to store in the analyzer’s memory results of other analyses not performed by
the analyzer. These data will be saved into the archive and it will be possible to display
statistics as well as analyses results.
The input screen (Fig. 21) shows the following fields:
“Analysis Name”, “Analytical Method”, “Result”, “Date”, “Group” and “Test Type”.
To insert a series of consecutive values for the new analysis, the results field should be
programmed last. Then enter the results by pressing “Enter” on the keyboard (or the
Accept button) to confirm each value.
By pressing the Exit key the external analysis insertion window closes and the entered data
become available for statistical processing.
Data entry is case sensitive, meaning that an analysis name written in capital letters (YOU)
is different from the one written in lower case letters (you) and is different from the one
written with initial upper case letter (You).

Section I Chapter F Q.C. - Population - Patient's Archive Page 18 of 29

2.4. OTHER MENU FUNCTIONS
The main menu contains three items, each of which has different commands. The most
useful are also displayed in the navigation bar (Fig. 22)

Figure 22
FILE MENU
Backup: creates a backup copy of the executed query. The backup
copy can be saved on a floppy disk or the hard disk.
Restore Backup: used to restore the backup copy to its original
position.
Export Data: this function allows exporting data in CSV (comma
separated values) or Fixed length formats, compatible both with Word
or Excel kind applicatives.

Section I Chapter F Q.C. - Population - Patient's Archive Page 19 of 29

It is possible to export the whole archive (select All archive) or a query. To export a single
query, it is first necessary to perform the query and then to click on the Export data option.
NOTE: the use of this function is very important to have constantly updated archives
in a hard disk different from the analyzer’s.
Once the *.csv or *.txt file has been created, it can be opened with Excel or Word. First open the
appropriate program (both programs will open both kind of files, but the easier way is to use Excel for
*.csv and Word for *.txt files). Then select “Open file” and in the “open” window, select in the field
“File of type”: “all files - *.*”. Click twice on the file you want to open.

Exit: exits the application.

UTILITY MENU
Insert new Record: see the paragraph above (par. 2.3
and fig. 21)
Setup: opens the printer setup window (see also Ch. H
Analyzer Setup, par. 2)
Format floppy disk: used to format a floppy disk.
Report with grayed lines: used to select whether to
print the reports in “easy reading” format. Easy reading
printing contains light gray lines alternated with lines
the color of the paper.

DELETING MENU
Delete Record(s) selected: it is possible to highlight several values in a query by holding
down the CTRL key while selecting various results
with the mouse cursor. These values can be
deleted with this command.
Delete analysis data: deletes all the data related
to the selected analysis and executed query.
Selected analysis data that is not part of the query
will be preserved.
Delete all archives: completely deletes the population archives.

Section I Chapter F Q.C. - Population - Patient's Archive Page 20 of 29

3. PATIENTS ARCHIVE
The “Patients Archive” module displays patients’ information and allows report printing.
N.B.: due to the large dimensions that the archive can reach, it is advisable to run a
backup at regular intervals, even monthly.
It is advisable to use the “Export Data” function in the FILE menu to export the
archive in CSV or Fixed length format (see par 2.4 OTHER MENU FUNCTIONS). Once
the archive is saved into a different location, please delete the internal archive to
avoid the archive itself to crash.
An automatic maintenance has been added to the Patients Archive in order to avoid
archive crash due to data overload. At periodical intervals, depending on the size of the
Archive, the following maintenance message will appear.

In case of Archive crash, it

will be possible to restore one
of the automatically
performed backups.

Go to the External Programs menu, and select Restore Patients

Archive.

The following window will appear. Select the file date you wish
to restore and click on the Restore button. Pay careful attention:
overwritten data can not be restored.

Section I Chapter F Q.C. - Population - Patient's Archive Page 21 of 29

PATIENTS ARCHIVE

Figure 23
Its main features are:

♦ Displaying as well as data acquisition from updated analysis file.

♦ Innternal archives update.
♦ Internal and external archives display.
♦ Modifying values;
♦ Dynamic query that allows sorting, ordering and displaying data by date range, code,
patient’s name/surname,.
The program also contains other complementary functions:
♦ Archive backup;
♦ Printer set-up
♦ Deleting analysis file, query or the entire archive
♦ Floppy disk formatting

Section I Chapter F Q.C. - Population - Patient's Archive Page 22 of 29

3.1. SELECTION (How to run a Query)

Figure 24
To run a query it is possible to specify various query criteria (Fig. 24) such as:
♦ Tests date range;
♦ Analysis code range;
♦ Name;
♦ Surname;
♦ Arrangement by code, surname, test date.

“Select all” is displayed by default in the fields. In this case, by pressing the Search button
all the data present in the archive will be displayed.
Patients will be ordered by Test Date as long as the operator does not want to order by
Code or Surname.

Section I Chapter F Q.C. - Population - Patient's Archive Page 23 of 29

Choose date:
Clicking on the icon next to the editing window "Choose Date" for selection of tests date, it
is possible to select the desired date range for search (query). It is possible to select the
initial and final date with simple clicks in the window (shown at the left). Click on “exit” to
save and close the frame. Press ESC to abort.

Choose code
It is possible to enter the information regarding the search range for desired analyses codes
by clicking on the icon (hand) next to "Choose Codes". The search is case sensitive,
meaning that the system distinguishes the capital letters (Upper case letters) from the small
letters (lower case letters).
Clicking on the button "Accept" will save the values entered in the editing fields "Insert Initial
Code" and "Insert Final Code". Pressing of "Cancel" will cancel the operation of the codes
selection.

Choose Name/Surname
Click on the “hand” icon corresponding to "Choose Name" or "Choose Surname" to open
the "Name Selection" window for searching by name or surname. Write name or surname in
the dedicated field and click “Accept” to save the search or click "Cancel" to abort the
operation. The search is case sensitive.

Once the search criteria have been fixed, click on Search button. The patients’ data page
will be displayed as in fig. 24.

Section I Chapter F Q.C. - Population - Patient's Archive Page 24 of 29

3.2. PATIENTS REPORT
By clicking with the right button of the mouse on one of the records (Fig. 25) it is possible to
select one of the functions described below.

Figure 25
View Analyses: this can also be accessed with a double click and is used to display the
information related to the selected patient (Fig. 26)
Info Record: displays the position of the selected record inside the executed query.
Quick Print: immediately prints the report for the selected patient.

View Analyses

Figure 26
With the keys Previous and Next it is possible to scroll the entire patients list.
Send to RS232: sends the results to the Host Computer (when enabled)
Print Preview: opens the print preview of the patient’s report.

In addition to the list of "Analysis" of selected code, the following informations are displayed:
name, surname, test date, group, measurement unit, flags (an asterix identifies tests with
flags; see flag page below), Min - Max range, and notes.

Section I Chapter F Q.C. - Population - Patient's Archive Page 25 of 29

There is a possibility to change the analysis results by right-clicking with mouse on the
relative line and selecting the option "Modify Value” (fig. 27). In the first field the "Old Value"
of the result is shown, while in the second field "New Value" it is possible to insert the
modified result. In case a wrong value is entered, then a screen message will alert the user
to repeat the operation. Please pay careful attention to the correct entry of the decimal
separator.

Figure 27

N.B.: the possibility of accessing the Patients’ Archive module and modifying the
analysis values is controlled by password and thus only accessible to authorized
personnel.
See also Chapter E, Paragraph 1.7 Access Password.

It is also possible to view the

analysis flags by selecting the View
flags option (Fig. 27) or with a
double click on the analysis line (Fig.
28).

For more information on the

meaning of the flags see Chapter G,
paragraph 1.5.

Figure 28
Section I Chapter F Q.C. - Population - Patient's Archive Page 26 of 29
3.3. PRINTING REPORTS
The Print All button in figure 24 is used for quick access to a print window with some
options.

Complete Report (with preview): this option will allow

printing of all patients’ reports matching with the search
criteria. A printing preview will be displayed.
The operator will start the actual printing of reports by for
single patient.
Complete Report (Quick print): this option will allow
printing of all patients’ reports matching with the search
criteria. Printing is immediate, with no preview.
Records Selected (Quick print): if only one or a few
patients are selected, it will be possible from here to print
only these reports
These three kinds of printings will produce reports as
shown in Fig. 29.

Figure 29
In this kind of printout, all patient data are shown, followed by the analyses list with
analytical method, result (with flags) and normal range.

Section I Chapter F Q.C. - Population - Patient's Archive Page 27 of 29

Compress Report, will produce a different kind of report, where only analyses are listed,
with no reference to the pertinent patient. A printing preview will be displayed (Fig. 30).

Figure 30
There is another type of printing by test option in the main window of the Patient Archive
(Fig. 24):

Test Report: from here it is possible to select one of the available tests and to print the
corresponding results (Fig. 31 and 32)

Select the test, move it into the Analysis

Selected field with > and click on Print
preview

Figure 31

All results matching with the

search criteria are displayed.

Figure 32
Section I Chapter F Q.C. - Population - Patient's Archive Page 28 of 29
3.4. OTHER MENU FUNCTIONS

Other menus are available with relative command in the

main page of the Patient Archive (Fig. 23), some of these
are also present in the navigation bar.

FILE
Load Date and Code: used to load the date for the test
execution dates and patients codes so that they are
available in the query criteria “scroll-box” (par. 3.1.).
Export Data: has the same function as in the Population
archive: see par 2.4 OTHER MENU FUNCTIONS
Exit: is used to close the Patients Archive program.

UTILITY
SetUp: opens the printer setup.
Backup: creates a backup copy of the selected search,
without deleting files from the HD. To create the backup it is
necessary to first perform a search, then select a location
for the backup files.
View External Archive: click on this button, select the
location where the backup files are and then press the
search button to view data.
View Internal Archive: press this button to go back to the
internal archive after having viewed an external backup file.
Format Floppy: it is used to format a floppy disk.
Report with grayed lines: used to select whether to print
the reports in “easy reading” format. Easy reading printing
contains light gray lines alternated with lines the color of the
paper.

DELETE
Delete Records Selected: Allows deletion of only the
randomly selected records.
Delete All Search: it deletes the whole performed search.
Delete All Archive: it deletes the whole archive.

SEND TO RS232
Send Records Selected: sends randomly selected records
to the host computer.
Send All Search: sends the whole performed search to the
host computer.

Section I Chapter F Q.C. - Population - Patient's Archive Page 29 of 29

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER G
1. DISPLAYING AND PRINTING RESULTS Page: 2
1.1. Results per Patient Page: 3
1.2. Results per Test Page 7
1.3. Displaying Real-Time data Page: 8
1.4. Reaction graphs Page: 10
1.5. Flags list Page: 12

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter G Displaying and Printing Results Page 1 of 12

1. DISPLAYING AND PRINTING RESULTS
The representation of the test results can be accessed through the specific icons (Fig. 1) for
the two available options: “View results for sample” (results will be displayed for patient)
and “View results in real time” (results will be displayed as the single tests are read).

View results for sample

View results in real time

Figure 1

By clicking on the icon for View results for sample the operator has the possibility of
viewing the results by sample or by test (Fig. 2).

Figure. 2
In the first case the patient data are displayed together with all the analyses run on that
sample. In the second case the results of performed tests are displayed, grouped by
analysis.

<NC> WRITTEN INSTEAD OF THE RESULT

The paragraphs below (for example see fig. 4 or fig. 8) display the result pages in real time.
It is possible to read <NC> “not calculable” in place of the value. This refers to values that
cannot be calculated for one of the following reasons:
- no serum
- no reagent
- no washing solution
- no diluent
- incorrect parameters
- expired reagent
- inverse curve
<NC> results can normally be archived (only in the patient archive) with the other results
(see Ch. H, par. 2. Analyzer Setup) or they can be stored in the work lists to let the operator
re-run the sample as soon as possible. In this case, the patient with the <NC> result will be
regularly archived and a copy will be left in the work lists.
<NC> only appears on the result page in real time, it will be replaced by a series of dots
“….” in the patient archive.

Section I Chapter G Displaying and Printing Results Page 2 of 12

1.1. RESULTS PER PATIENT

Figure 3
The "Patient’s" data display page is shown in Figure 3. It can be accessed through
the specific icon (Fig. 1).
In this area information related to calibrations is represented, like the values of calculated
factors or any types of errors that occurred during execution.
If there is no data the page appears blank. A color code makes it possible to quickly identify
the information:
- red text: presence of flags in at least one test of the sample
- blue text: controls
- green text: calibrations
- black text: no anomaly in the test or the entire sample
It is a brief representation of data and allows visualization of results of patient in execution
as the tasks for the single patients are completed.
Once the results are archived, the information present in this page will no longer be
available.
The following information are displayed for each sample:

a) Sample Position (#XX) Progressive number from 01 to 52 for Routine and STAT.
Progressive number from 01 to 26 for STD and CTRL.

Section I Chapter G Displaying and Printing Results Page 3 of 12

b) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
It is automatically assigned for CTRL, but can be assigned by the
user during input. The relevant group level is also indicated (see
Chapter F, paragraph 1. “Quality Controls”).

c) Surname, Name Patient’s personal data.

d) Sample Type The relationship of Sample to one of the groups: Routine, STAT,
CTRL or STD is indicated between brackets.

e) Results The results of test attributed to patients are represented with:

- full name of the analysis

- execution method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets – see also par. 1.5)
For automatic re-runs the values of the first and second
determination are represented.

INFO FLAGS
In both types of result displays (per patient and in real time) an Info Flags button is
available on the upper right.

It provides access to a page where the flags are listed, with a short explanation of the
meaning of each one (Fig. 4).

Section I Chapter G Displaying and Printing Results Page 4 of 12

 Figure 4
ADDITIONAL COMMANDS
The following commands are available in the data display page (fig. 3):

PRINT: Print command. It allows two options: Normal print-out (will print the pages as they
are displayed i.e. samples will be printed sequentially) or Printout for sample (will print one
single patient for each page). However, this is not a print-out in report format.

Figure 5
A print preview will be displayed (Fig. 5) where it is possible to select which and how many
pages to print.
Section I Chapter G Displaying and Printing Results Page 5 of 12
SORT: Data sorting command. This function is enabled only at the end of working session.
The real-time data are displayed in random order as the analyzer returns them. The "Sort"
command allows sorting based in the following criteria, in this order: date, time, position on
the tray. The controls are placed last and the calibrations first.
ADJUST: Data re-reprocessing command. This function is enabled only at the end of
working sessions. For patients re-run manually only the last result will be recalculated. The
correction is made starting with the absorbance memorized for the single test.
Two types of data re-processing are possible. The first allows
application of a percentage correction in increase or decrease.
The second uses the last valid calibration as reference.

When recalculating the percentage or

Correction factor (Fig. 6) a window is
presented for selecting the test to
recalculate, then by pressing the Adjust
button, a mask appears for inserting the
recalculation percentage (increase or
decrease) and the type of sample to apply it
to (routine, STAT and/or control). The
maximum percentage allowed (both
increase and decease) is 50%. By clicking
on Accept the analyzer will make the
adjustment.

Figure 6

In the correction With standard the analyzer runs the recalculation starting from the
absorbance memorized for the test, thus the various analytical parameters and the last
valid calibration are taken into consideration. In this case, if the instrumental factor and shift
have been set in the analytical parameters, they will be used in calculating the new value.
N.B.: If a recalculation result returns a value of 1,000,000 or higher, <NC>, not calculable
will be shown instead of the result. If the returned result is negative, the M flag will be
assigned: error in the parameters (instrumental factor and shift).
NB: In the correction With standard, Relation Tests results will not be recalculated.
The E flag (recalculated value) will be assigned to all tests that undergo recalculation.
Use of the correction functions is only for operators authorized with a specific password
(see chap. E, par. 1.7 Access Password).
ARCHIVE DATA saves all the data present on the page on the hard disk. After archiving,
the data will be available, based on type, in the three external programs: Quality Control,
Population and Patient archive. Archive data also includes the deletion of the data from the
visualization pages (per patients and in real time) as well as reaction graphs. Therefore, it is
a good idea to print any pertinent graphs before archiving data.
DELETE RESULTS deletes all the data from the visualization pages (per patients and in
real time) as well as the page of reaction graphs. The data cannot be recovered.
EXIT: closes the page and returns to the main program, without modifying the data.

Section I Chapter G Displaying and Printing Results Page 6 of 12

1.2. RESULTS PER TEST

Figure 7
After the termination of programmed task, the results can be viewed per Test. The test
Results display page is shown in Figure 7.
The following information is displayed for each single test:
a) Code and test name: The displayed code is the same read on the list of tests,
while the full name between parenthesis is the one
assigned by the operator in the analytical parameters
(chap. C, par. 1.3.3.).
b) Sample Position (# XX): Progressive number from 01 to 52 for Routine and STAT.
Progressive number from 01 to 26 for STD and CTRL.
c) Sample Code: For patients (Routine and STAT) it is assigned during
check-in.
For STD and Batch it is assigned automatically.
d) Results: The results of test attributed to patients are represented
with:
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flag (between brackets – see also par. 1.5)

Section I Chapter G Displaying and Printing Results Page 7 of 12

The following commands are available in the results display page:

PRINT: used to print the contents of the window. This is not a print-out in “report” format. A
print preview will be displayed (Fig. 6) where it is possible to select which and how many
pages to print.
EXIT: closes the page and returns to the main program, without modifying the data.

PRINT-OUTS IN REPORT FORMAT

From the visualization pages mentioned in this chapter it is not possible to obtain print-outs
for patients in report format. For more information on these type of print-outs, see chap. F
par. 1.6 and chap. H, par. 2.).

1.3. DISPLAYING REAL-TIME DATA

Figure 8

This page can be accessed through the specific icon (fig. 1). The data shown (Figure 8)
refer to the results obtained by the analyzer in real time, i.e. as the tests are completed. For
this reason the results of tests with a shorter incubation and reading time may appear first
even if they belong to later patients. The results are not sorted in any way, not per patient,
not for type of test. When no data is present this page is empty.
The data display is synthetic.

Section I Chapter G Displaying and Printing Results Page 8 of 12

Once the results are archived, the information present in this page will no longer be
available. The results of tests associated to flags are shown in red.
The following information are displayed for each single test:
a) Sample Position (#XX) Progressive Number from 01 to 52 for Routine and STAT.
Progressive Number from 01 to 26 for STD and CTRL.
b) Sample code For patients (Routine and STAT) it is assigned at input.
It is automatically assigned to STD and Batch.
It is automatically assigned to CTRLs, but the operator
can give it during input. The group pertinence is indicated.
(see Chapter F, paragraph 1. “Quality Controls”).
c) Date and time: The date and time the test was run is between
parenthesis.
d) Results: The results of test attributed to tests are represented with:

- name of the analysis

- execution method
- result
- unit of measurement
- absorbance read (between parentheses)
- range of normal values
- any flags (between brackets – see also par. 1.5)
For automatic re-runs the values of the first and second
determination are represented.
A window is also available on this page (Info flag – see par. 1.1.) with information relative
to the flags associated to the results. The Print and Exit buttons are also present, their
functions have already been described in the previous paragraph.

Section I Chapter G Displaying and Printing Results Page 9 of 12

1.4. REACTION GRAPHS
This function can be accessed through the specific icon. It is used for displaying and
eventually printing the graphs of the analyses. The page that opens displays the first
available graph.
IMPORTANT: The graphic pages are available only after test runs and prior to data archival
(par. 1.1.).

Graphs are divided into two parts by two dashed orthogonal axes. On the left part there is
the incubation time graph, while on the right there is the reading time graph (Fig. 9).
On the right of the window, there are two frames containing the information concerning the
absorbance determined during the two phases (incubation and reading times), Each
division in the Time axis is approx 10secs.

Figure 9

The following information is reported on the graph page (Fig. 9).

Conc: shows the test result.

CC%: shows the correlation coefficient compared to the test
regression rate.
ABS Value: shows the test absorbance value.
Phase1: corresponds to the incubation phase for almost all the
tests, with the exception of tests in two phases (such as sample
blank). It shows the absorbance data detected by the analyzer
during the test: start, end, minimum and maximum absorbance
and the delta between the start and end absorbance.
Phase 2: corresponds to the reading phase or the second phase.
The rest of the information is the same as phase 1.

N.B.: The absorbance values read per single point in each phase
are shown at the bottom, under the graph. This data can be exported into a file by pressing
the Export Values button.

Section I Chapter G Displaying and Printing Results Page 10 of 12

 Using the up/down hand keys the user scrolls through different patients, while
using left/right arrow keys, the different graphs for a single patient are shown
(Figure 9).

By selecting an identification code, among the available in the “Skip

to code” field, it is possible to go directly to the single patient.

Print: used to print the displayed graph.

By accepting to print also thee data, all
the absorbances corresponding to the
reading points will be printed, otherwise
only the information in the first part of
the graph will be printed.

<- Absorbances of single points.

EXIT: closes the page and returns to the main program.

Section I Chapter G Displaying and Printing Results Page 11 of 12

1.5. FLAGS LIST
The analyzer uses flag symbols to properly check analyses result. These symbols are
printed adjacent to the result.
The following priority exists for the flags indicating hyperactivity:
I (Test Limit),
A (Reaction Limit)
d (Max ABS Delta)
The flags and their meanings are tabulated below:
FLAG MEANING
+ Pathological above range
- Pathological below range
I Hyperactive sample (Test Limit exceeded)
d Hyperactive sample (Max. ABS Delta surpassed)
A Hyperactive sample (Reaction Limit exceeded)
O Reagent Out of Limit
! Inverse Reaction
S Serum missing
R Reagent missing
r Dilution reagent missing (for diluting samples)
~ Serum interference
P Errors in Parameters
± Unstable sample (C.C. % greater than assigned value)
> Sample above Calibration curve
>> Sample above Calibration curve after repetition
< Sample below Calibration curve
<< Sample below Calibration curve after repetition
No Error: result to be accepted
? Impossible to calculate Relation Test, due to missing data (no Serum or Reagent)
X Error in Relation Test (negative result)
C Probable Prozone Effect (Prozone Check value exceeded)
T Result processing impossible: analysis is not resident on the tray
N Reagent expired - result set to 0 (zero), if the barcode is used
E The test result has been recalculated
M Error in the parameters (instrumental factor and shift)
W Either one or both of the additional washing solutions is missing

Note:
During report printing from patients’ archive, all flags are replaced by the generic
symbol ’ (asterisk).

In the patients archive active flags will be highlighted in red and will have the check in the
corresponding box.

Section I Chapter G Displaying and Printing Results Page 12 of 12

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATIONS

CHAPTER H
1. ANALYZER TECHNICAL FUNCTIONS Page: 2
1.1. Service Functions Page: 2
1.1.1. Analyzer Utilities Page: 2
1.1.2. Mechanical Calibrations Page: 4
1.2. Diagnostic Functions Page: 6
2. ANALYZER SETUP Page: 9

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter H Analyzer Technical Functions/Setup Page 1 of 14

1. ANALYZER TECHNICAL FUNCTIONS

1.1. SERVICE FUNCTIONS

The analyzer has dedicated commands to allow Service and Diagnostic operations. The
Service functions are divided into Analyzer Utilities and Mechanical Calibrations.
These functions are accessed from Analyzer’s main menu or through the appropriate direct
access icons.

The commands are available in the form of buttons. To access a function just push a
button.
The Exit button on both pages closes the window and saves any settings.
The Analyzer Utilities include items (FCC Calculation, Lamp Setup, Temperature Test and
Empty Fluidics) normally dedicated to technical assistance personnel. These functions
should not be used unless they have been suggested by qualified personnel. Just like for
the other parts of the program or analyzer, these functions must be used according to the
intended use established by the manufacturer, failure to do so will result in warranty
invalidation.

1.1.1. Analyzer Utilities

Direct Access Icon

Figure 1

To activate any of the following commands click on the corresponding button (Figure 1):
Wash with water: washes, with the washing solution (bidistilled water and surface active
agent) the cuvettes and leaves them filled with water. This function is recommended when
a work session has ended and the analyzer is not going to be used again immediately.
However, after 20 minutes of inactivity, the analyzer goes into standby and automatically
washes the cuvettes.

Section I Chapter H Analyzer Technical Functions/Setup Page 2 of 14

Wash cuvettes: is used for complete washing of the hydraulic circuit and reading cuvettes.
Once the command is given, a message appears asking to insert the bottle (50 ml)
containing the dedicated washing solution (code 393) in position n° 24. This function must
be run daily when the analyzer is shut off (using the guided shut down procedure) or at the
end of the day if the analyzer is not shut off.
Extra wash cuvettes: is used for complete washing of the hydraulic circuit and reading
cuvettes with a special solution. Once the command is given, a message appears asking to
insert the bottle (50 ml) with the special washing solution (code 393E) in position n° 23. This
wash is run with an acid solution and is necessary at least once a week or if the analyzer
returns inconsistent results for no apparent reason. This wash will reset the Diagnostic
page maintenance counter.
Dilutor prime: Performs a filling-up cycle with distilled water of the hydraulic circuit and
sampling system.
Zeroing on water: Performs photometer zeroing with distilled water. This procedure can be
performed either on request or automatically. In this second case, when the zeroing time
has elapsed the analyzer will propose a message on the screen requesting zeroing.
When the analyzer is first turned on each day, it waits for the reaching of the steady state
(stabilization of the Peltier temperature and lamp), then it requests the photometer zeroing.
It is important to remember that zeroing is necessary to avoid any drift of the photometer
zero.
Check volumes: The analyzer checks the volumes of reagents present in the reagent tray.
These volumes are updated in the corresponding window Reagents status for the
reagents insertion procedure (F10 key).
Volumes calibration: used to allow the analyzer to create references used as a basis for
determining the volume of reagents in the bottles and serum holder cups. A screen
message invites to insert a large bottle fitted with a small bottle 10 ml (both empty) into the
position number 1 of the reagents tray. It then asks to insert an empty sample cup into
position #1 of the sample plate. These are automatically and gradually filled up with distilled
water according to an internal procedure.
F.C.C. calculation: This procedure is for calculating the optical correction factor for the
reading cuvettes. A screen message invites to insert a bottle with appropriate solution into
the position #24 of the reagents tray. Generally a solution of Potassium Bichromate with
absorbance around 0,500 Abs (read at 340 - 700nm) is used. The analyzer guides the user
through the procedure. This function is password protected.
It is performed only when one or more cuvettes are replaced or after a thorough service is
performed on the instrument computer (e.g. hard disk substitution) where correction factors
may be lost.
Lamp Setup: this function is only necessary after the photometric lamp has been changed.
It is used to align the new lamp to preset internal values. It also carries out photometer
zeroing at the same time. It is advisable that only technical assistance personnel use this
function.
Temperature test: Verifies thermostatic temperature of the reading cuvettes plate. For a
correct measurement it is important that the thermometer of low temperature absorbance
(miniature probe tip) is used. The measurement cuvette should be filled with 300 to 400µl of
distilled water. It is also important that the measurements are takenapproximately 20
minutes after the instrument has reached the steady state.

Section I Chapter H Analyzer Technical Functions/Setup Page 3 of 14

Empty Fluidics: This command completely empties the fluidic circuit. It is to be used
exclusively as preliminary operation for maintenance or eventual moving of the instrument.

NOTE: if one of the analyzer functions is active, remember not to make modifications in the
Setup program. This will cause a reset of the analyzer thus terminating the activated
function.

1.1.2. Mechanical Calibrations

This function allows mechanical centering and adjustments for the different positions of the
sampling arm, cuvettes plate, sample plate and reagents tray. Bear in mind that the
analyzers are already factory-calibrated and a new adjustment is seldom necessary. To
perform calibrations, move the mouse cursor on the desired function and click to confirm:
the [-] Dec. and [+] Inc. command keys will be enabled on the screen, which determine the
movement of the selected object either clockwise or counterclockwise, step by step. The [*]
Test key lowers and lifts the sampling needle or the wash piston to check centering.
NOTE:
It is highly recommended to calibrate the trays (Sample/Reagent/Cuvette) first and then the
positions of sampling arm. In addition the sampling needle must be centered on the
required positions.

Direct Access Icon

Figure 2

The Calibrations menu is subdivided into two columns: Clinical Chemistry Arm and Tray
as shown in Figure 2. The following commands are available:

Section I Chapter H Analyzer Technical Functions/Setup Page 4 of 14

 TRAY
Sample tray: centers the tray so that the arm is centered on the first
position of the serum tray.
Reagents tray: It is recommended to insert a large reagent bottle matched
with small bottle into position #4 prior to the calibration. By activating this
command the reagents tray moves and puts position #4 below the hole for
the first reagent. Center the bottle for the first reagent in this position. It is
suggested to check also the position for the second reagent.
Cuvettes tray: The washing piston must be centered on the cuvette. Check
correct centering through the piston up/down movement using the
command (*) Test.

CLINICAL CHEMISTRY ARM

Washing position: Arm remains on the washing position upon which it must be centered.
Arm on 1st ring: The sampling arm moves to position #1 of the 1st ring (outer circle). Insert
an empty cup into the tray to better observe theposition. Center the sampling needle on the
cup using the needle lower function [*] Test to better visualize the position.
Arm on 2nd ring: The sampling arm moves to position #27 of the 2nd ring.
Arm on 3rd ring: The sampling arm moves to position #1 of the 3rd ring.
Arm on 4th ring: The sampling arm moves to position #14 of the 4thring.
1st reagent: the sampling arm moves to the appropriate hole on the instrument’s top for
accessing 1 st reagent. Before starting the calibration a big bottle matched with a small one
must be inserted in position n° 4. Center the sampling needle on the neck of the bottle.
2nd reagent: The sampling arm moves to the position for the second reagent corresponding
to the appropriate hole for accessing small reagent bottle on the instrument’s top. It is
recommended to calibrate the reagent tray prior to calibrating the sampling arm.
Cuvettes position: The sampling arm moves over cuvettes tray. The sampling needle
must be centered on the cuvette.

Section I Chapter H Analyzer Technical Functions/Setup Page 5 of 14

1.2. DIAGNOSTIC FUNCTIONS
Diagnostic pages are accessible only from Analyzer’s main menu (Fig. 3). The Diagnostic
functions are partially reserved for approved service personnel only. Therefore the access
to some of the functions is password protected.
It contains the following options: Show F.C.C., Show Optical Transmission, Show
Diagnostic and General Diagnostic.

Figure 3

Show F.C.C.: It shows the optical correction factor calculated for all the reading cuvettes.
For each cuvette, the mABS and the F.C.C. values (Figure 4) are reported. It also indicates
the cuvettes with correction factor exceeding the preset limits (± 3%). It is possible to print
this page.

Figure 4

Section I Chapter H Analyzer Technical Functions/Setup Page 6 of 14

 Show Optical Transmission: After each photometric zeroing,
it indicates the percentage transparency of the cuvettes. The
cuvettes with poor transparency are highlighted (Figure 5). If
the optical transmission of a cuvette falls below a specific
percentage (40% less than the mean of the calculated O.T.),
the analyzer will eliminate it and will work with one less
cuvette. If it becomes necessary to eliminate four or more
cuvettes, the analyzer generates an alarm and will not allow
work to continue. It is possible to continue to work with three
damaged cuvettes.
Optical transmission of the cuvettes tends to decrease due to a
series of factors, including lamp performance, opaque cuvettes
etc.

Figure 5

Show Diagnostic: it shows the status of the various parts of the system that should be
replaced regularly. This page shows the consumable parts, life cycles, remaining cycles
and the possible replacement date (Figure 6). When at the analyzer start up, the message
There are the following obligations in diagnostic, appears, it means that the indicated
item has to be replaced or an action has to be undertaken. In the Show Diagnostic page
there will be one or more red lines corresponding to the parts needing replacement (refer to
Chapter N). Once the required maintenance has been performed, reset the internal
counters of the analyzer, by clicking on the single voice described in the table on the right
side.

Figure 6
Based on how the analyzer is used, the cycles may come to an end before the dates or vice
versa. However, the maintenance requested by the analyzer should be carried out, even if
the actual workload has been light. This guarantees perfect operation of the analyzer. If the
analyzer has not been used for some time, it is advisable to replace the tube kits and
possibly the seals, since they can deteriorate even if not used.

ATTENTION: the maintenance page shown in figure 6 is only an example. Check the
consumable parts mentioned above, the cycles and replacement dates on the
analyzer. Bear in mind that the replacement dates indicated on the maintenance page
are a guideline as they are calculated on an average work day that may not reflect the
needs of each lab.
Section I Chapter H Analyzer Technical Functions/Setup Page 7 of 14
General Diagnostic: This function is reserved for the Technical Assistance personnel for
diagnosing problems that cause analyzer malfunction. There is free access to most of this
program. However, the use of this program without the proper supervision of approved
technical personnel, is under user's responsibility. Therefore it is highly recommended that
the operator is assisted by the specialized technical personnel when using this program.
This page verifies the operation of the following devices and the operating phases:
1) Photometer stability and operation.
2) Hydraulic functions: sampling, washing, and emptying of cuvettes.
3) Barcode operation and programming.
4) Stress program.

The Diagnostic page has four menus.

Utility: contains the same items previously explained

at the beginning of the paragraph, plus the Exit
command to close the diagnostic program.

Load external programs and Flash microcontroller

programmation are options dedicated to the
Technical Assistance personnel, and may not appear
at all in the menu.

Photometer: is used to check the sampling and the readings

executed by the photometer.
Select filters: used to select the filters for executing the
reading.
Sampling: used to select whether to run a normal sampling or
to use the serum as starter.
Cuvette: used to empty or fill a cuvette as selected by the
operator. It runs a wash and fill cycle for the cuvettes.
Reading: used for reading the zero on filters, zeroing on water and reading (in mV and
mAbs) of the contents of the cuvettes.

Mechanics: the items in this menu are not

available. All the commands are only available
with third level access (Technical Assistance).
Only read barcode on reagent and serum is
available to operators.

Export / Import Mechanical Calibrations: the

calibrations in the Diagnostic section can now be
exported into a support different from the floppy.

Section I Chapter H Analyzer Technical Functions/Setup Page 8 of 14

2. ANALYZER SETUP
This command is used for entering additional information on the various controls of the
system. It can be accessed through the Utility ⇒ Setup Analyzer in the main menu. It is
disabled during working sessions of the analyzer.
NOTE: if one of the analyzer functions is active, remember not to make modifications
in the Setup program. This will cause a reset of the analyzer thus terminating the
activated function.
By clicking on the Setup Analyzer command a screen displays various programmable
items. Point the cursor on the desired title and click to confirm. After setup is done, click
Save to save changes or Cancel to leave the program without saving (bear in mind that
setup is an external program and must be closed once changes are made). It is highly
recommended that operations in the setup program are performed by specialized
personnel. It is advisable to keep track of the modifications made to the setup and the
effects they can have on analyzer operation to avoid problems later on.

LANGUAGE: on this page (Figure 7) it is possible to select the language (for example
English or Italian) from those available).

Figure 7

If there are no languages on the list they need to be installed. To view all the available
languages, insert the installation disk of the operating program in the CD reader, then press
the Browse the Folder button and browse the disk contents until finding the Language
folder and click on OK (fig. 7a).

The Setup program will load the languages in an internal

directory of the analyzer, then it will be possible to select the
desired language from those available in the scroll box.

Figure 7a

Section I Chapter H Analyzer Technical Functions/Setup Page 9 of 14

SYSTEM: In this page it is possible to modify the following options (Figure 8):

Figure 8

Icons: It enables or disables the displaying of the icons on top of the screen.
Navigation Bar: It enables or disables the displaying of the navigation bar on the left side
of the screen.
Voice: it enables or disables vocal function (vocal messages). By clicking on the icon a
mask appears for selecting and controlling the audio (reproduction speed and volume).
Use European Menu: If disabled, it changes the menu bar as well as the operating
functions from European mode to the ones exclusively dedicated to USA mode.
NOTE: The USA operating modes are not outlined in the present manual.
Print-out real time results with color: When enabled, the real time print-out will be in
colors, otherwise it will be in black and white. Bear in mind that in this way, the identification
at glance of results associated to flags in printouts is lost, as they are normally printed in
red.
Print-out real time results with final report: When enabled, it provides test results per
patient in real time print-out in report format. However, remember that if it is necessary to
execute a re-run, a new print-out would be obtained. This option may be costly in terms of
paper and may cause confusion as there may be several reports printed for the same
sample.
Archive the results with <NC> instead of the value: used to archive all the results,
including those marked as not calculable in the Patient Archive. If this is not enabled, the
results marked with <NC> will not be archived and they will be left on the work list to allow
for re-running them (see Ch. G, par. 1. and Ch. F, par. 3.2.)
Add to extra patient list: during the patient programming phase in Routine, it is possible to
have the analyzer memorize the patients directly on the extra patients list, instead of the
normal work list (see Ch. E, par. 1.5. Work lists). This option is divided into: If not empty
and In any case. In the first case, the patients are saved in the additional list only if it
contains at least one other patient. In any case: the patients are saved directly on the extra
patients list.
N.B.: The patients are transferred to the extra patients list only if the acquisition is via the
New Entry button, and not by clicking directly on a free position on the sample tray (see
Ch. E, par. 1.4.).
This option may be useful in cases where all patients are being programmed, before
actually receiving the samples. As the samples are received the patients are moved from
the extra patients list to the routine list and the work is started.

Section I Chapter H Analyzer Technical Functions/Setup Page 10 of 14

PRINTER HEADER/FOOTER: Customizes the printouts generated by the analyzer in the
Patient Archive, Population and Quality Control Utilities (Figure 9). Two editable fields
are displayed for programming of HEADER & FOOTER. Characters can be formatted (B for
bold, U for underline, I for italic) as needed. Text format, font type, size and text color are
also available. To print a test page click Test button.

Figure 9

BAR-CODE: Enables bar-code scanning option (Figure 10). Confirm Present to enable it
or Not Present to disable it. With bar-code enabled, further options are: On Samples and
On Reagents (or just one of the two).

Figure 10

Setup Bar-code on Samples: This function customizes the contents of the patient code
reported on the bar-coded label.

Dimension Sample Code: This field is used to define the number of characters dedicated
to the patient code. If set to zero, the code length is variable (codes with a number of
characters between 1 and 13 are accepted automatically). If as an example 10 is entered,
then the patient code must have ten characters.
Use a digit for Serum/Urine: If enabled it is possible to use one character to automatically
identify the type of sample (Serum/Urine) undergoing test.
Use one or two digits for profile number: When enabled it is possible to use one or two
characters to identify automatically the profile number assigned during profiles
programming (refer to Chapter C, paragraph 1.6., Creating Profiles).

Section I Chapter H Analyzer Technical Functions/Setup Page 11 of 14

SERIAL: Enables RS232 serial port to communicate with host computer (Figure 11).

Figure 11

Check Present to enable or Not Present to disable. Once the serial port is enabled, the
Parameters functions with the fields COM Number, Baud-Rate, and Hand-Shake are
enabled too.
COM Number: Sets the serial port number (for example COM 1, COM 2 etc.)
Baud-Rate: Sets data transmission speed between the analyzer and the host computer.
Click u to view all the possible transmission speeds. To select, click on the desired value.
Hand-Shake: Enables Data Flow Control to be used during data transmission. Click u to
view the available options. To select, click on the desired option.
Protocol: it is possible to use the internal communication protocol or a variable protocol.
When choosing the variable protocol, it will be possible to set the protocol options by
clicking on the dedicated icon. Only expert operators should set the variable protocol (see
Chapter 4, Section II, paragraph 4.2).
All results must be sent automatically (without validation): When this option is enabled,
all results from the analyzer are sent automatically and immediately to the host computer. If
the option is not enabled, then the operator decides when to send the data (see Chapter C,
paragraph 1.1. Description of the program Menu). Analyzer will display the following
options for sending patients to the host computer: accept results to be sent or delete results
to be sent (see Chapter. E, paragraph 1.5. WORK LISTS).
Send the results with <NC> instead of the value: by selecting this option the non-
calculable results will also be sent to the Host Computer, if the option is not enabled the
<NC> results will not be sent to the Host Computer and will be deleted. In this case the
<NC> results that are not archived and are on the work lists can be run again by the
analyzer and if there are valid results, they will then be sent to the Host computer.

Section I Chapter H Analyzer Technical Functions/Setup Page 12 of 14

WORKING TEMPERATURE: Sets working temperature for reading cuvettes and activates
the refrigerator for the reagents. Click to select the desired temperature among the
available (Figure 12).

Figure 12

• Room Temperature
• 30°C
• 32°C
• 37°C
By selecting Room temperature bear in mind that when this is very high the temperature of
the solution in the cuvettes will be high as well. The same thing is true even if the selected
temperature is 37°C, but the room temperature is 40°C, for example. The heating elements
of the cuvette tray are able to heat but not cool if the room temperature is higher than the
programmed temperature.
Enable Reagent Refrigerator: If not selected, it excludes the reagent refrigeration.

SAMPLES’ TRAY: Customizes samples’ tray (Figure 13). Here it is possible to change the
number of positions dedicated to the samples of Routine, STAT, Standards and Controls.

Figure 13

Routine and STAT positions are included in the two outermost rings with progressive
numeration from 1 to 52. Standard and Controls positions are in the innermost rings with
progressive numeration from 1 to 26. It is not possible to exclude one typology to
advantage of the other one. The minimum number of assignable positions is 1 for the
Routine, STAT and Standards; and 3 for the controls.

Section I Chapter H Analyzer Technical Functions/Setup Page 13 of 14

Click up/down arrows to increase/decrease the number of dedicated positions, or write the
desired number into the textbox. The analyzer will automatically upgrade the positions for
the second item of the pair every time the first one is changed.

PASSWORDS: on this page (Figure 14) it is possible to insert new passwords instead of
the internal system ones. It is not advisable to change these passwords, since if they are
forgotten or lost it will no longer be possible to access the system.

Figure 14

ATTENTION: when writing any of the passwords in one of the three appropriate field, it is
necessary to confirm it by pressing Enter. This will also enable the following writing field. If
the procedure is correct, the analyzer will display a message confirming that the password
has been changed.

Section I Chapter H Analyzer Technical Functions/Setup Page 14 of 14

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER I
1. BARCODE AND RELATED FUNCTIONS Page: 2
2. USING THE BARCODE Page: 2
2.1. Barcode on Samples Page: 2
2.2. Reagent Barcode Page: 5

NOTE:
This manual is valid for both BT1000 and BT
2000PLUS. The following components are not
installed on the BT1000:
a) Reagent refrigerator
b) Barcode
c) Touchscreen

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter I Barcode and Related Functions Page 1 of 5

1. BAR-CODE AND RELATED FUNCTIONS
The software for the BT2000 Plus allows independent enabling (and disabling) for bar-code
scanning on Samples and Reagents (refer to Chapter H, paragraph 2. “Analyzer Setup”).
The enabling of barcode scanning on samples visualizes specific commands in the program
(refer to Chapter E, paragraph 1.5. “Work Lists”).
The BT2000 PLUS uses as format a numeric code of max 13 digits (for example EAN 13).
If the used format has a lesser digits, then the information space is reduced in the labels
printing protocol. In fact it is not possible to add profiles number, serum and urine
identification and besides the number of available characters for patient code are also
reduced.

2. USING THE BAR-CODE

2.1. BARCODE ON SAMPLES

Entering Patients
Tests to be run can be acquired from the Host Computer, from those stored after manual
input (refer to Chapter E, paragraph 1.4. “Samples”) and through barcode scanning using
the "Profile" utility (refer to Chapter C, paragraph 1.6. “Creating Profiles”).
Manual programming: the patient is programmed manually (code and analyses), then his
position on the sample tray is checked by barcode reading. In this case the samples can be
inserted randomly on the tray, since the barcode reader will assign the position on the tray
to the patient corresponding to each code read which has the same ID code.
Programming via Host Computer: The patient is programmed (code and analyses) on the
Host Computer and transferred to the analyzer. The position on the sample tray is checked
by barcode reading as described above.
Programming with Profiles function: this can be used with manual programming and
programming via Host Computer. In this case when the barcode is created, the desired
profile code also needs to be inserted (already assigned as described in chap. C, par. 1.6.
Create Profiles). When the barcode is read the profile is automatically assigned to the read
code. Once the patients are acquired it is possible to add or remove analyses. The samples
can be randomly inserted in the sample tray and the barcode reader will assign the position.
Entering patients with and without bar-code on the same tray
Patients with barcode and those without can be run together. Patients without barcode must
be inserted exactly into the positions assigned during programming. Patients with bar-code
can be freely placed in any of the free position with no need to respect the assigned
position number.

Section I Chapter I Barcode and Related Functions Page 2 of 5

 Bar-code Notes and Example
The bar-code on samples length and meaning can be programmed in the Setup program at
the bar-code page.
The maximum number of digits that can be assigned to a sample is 15, depending also
from the type of bar-code used.
See the following examples.

EXAMPLE 1
Patient ID# of digits: 10 With one digit for serum or urine: no With two digits for profile: no
1234567890
PRINTED CODE: 1234567890 TOTAL 10 CHARACTERS

EXAMPLE 2
Patient ID# of digits: 10 With one digit for serum or urine: yes With two digits for profile: no
1234567890 1
PRINTED CODE: 12345678901 TOTAL 11 CHARACTERS

EXAMPLE 3
Patient ID# of digits: 10 With one digit for serum or urine: yes With two digits for profile: yes
1234567890 1 99
PRINTED CODE: 1234567890199 TOTAL 13 CHARACTERS

If in the Setup the number of digits for the patient ID is set to 15 and the printed code is of
10 characters, the analyzer will consider as ID# the 10 printed numbers.
If in the Setup the number of digits for the patient ID is set to 13 and the printed code is of
10 characters, the analyzer will consider as ID# the 10 printed numbers.
If in the Setup the number of digits for the patient ID is set to 13 (serum/urine digit and
profile number are active) and the printed code is of 13 characters, the analyzer will not
consider the digits for serum/urine and for profile number as it is expecting the patient ID to
be of 13 digits. The patient ID always has the priority on the following numbers.

EAN13
If the bar-code used is an EAN13, the sample bar-code can be programmed as follows.
NOTE: with the EAN13 there are some limitations: the first number must not be 0; the
actual number of digits is 12 as the last digit is the checksum X (automatically created).

EXAMPLE 1
Patient ID# of digits: 12 With one digit for serum or urine: no With two digits for profile: no
123456789012
PRINTED CODE: 123456789012X TOTAL 13 CHARACTERS

EXAMPLE 2
Patient ID# of digits: 11 With one digit for serum or urine: yes With two digits for profile: no
12345678901 0
PRINTED CODE: 12345678901X TOTAL 13 CHARACTERS

EXAMPLE 3
Patient ID# of digits: 9 With one digit for serum or urine: yes With two digits for profile: yes
123456789 1 99
PRINTED CODE: 123456789199X TOTAL 13 CHARACTERS

Section I Chapter I Barcode and Related Functions Page 3 of 5

ANOMALIES IN BARCODE READING
There are some cases where the analyzer automatically makes modifications to the work
lists acquired by barcode.
- two identical barcodes are read in two different positions: the analyzer deletes both
codes since it has no way of knowing which one is incorrect. Thus, new programming
becomes necessary.
- a patient without a barcode and one with a barcode are found in the same position:
when the barcode is read the analyzer detects a sample with a barcode in a position where
another patient was programmed without a barcode. The sample with barcode remains in
the assigned position, while the patient without barcode is moved to the additional list (see
chap. E, par. 1.5. Work lists).

Additional Information regarding types of barcodes:

The barcode scanner located inside the analyzer has ha the possibility of memorizing from
one to six different codes in its flash ram memory.
At present the following codes are default set in the flash ram memory of the barcode
scanner module:
Ean13, Code39, Codabar, Interleave 2 of 5 (6); Interleave 2 of 5 (8); Interleave 2 of 5
(10).
The scanner automatically detects the presence of one of the preceding codes on the
barcode label.

Other codes can be programmed upon request. They are available in blocks of six and are
uploaded by floppy disk.
Some of these codes available upon request include:
2/5 INTERLEAVED, CODE 39, CODE 39 FULL ASCII, CODABAR, CODE 128, EAN 128,
CODE 93, PLESSEY, PHARMACODE, ALL EAN/UPC, EAN 13, EAN 8, UPC A, UPC E,
EAN 13 ADDON 2, EAN 8 ADDON 2, UPC A ADDON 2, UPC E ADDON 2, EAN 13
ADDON 5, EAN 8 ADDON 5, UPC A ADDON 5, UPC E ADDON 5, EAN/UPC w/o ADDON,
EAN/UPC ADDON 2, EAN/UPC ADDON 5, EAN/UPC ADDON N

Suggested dimensions for the labels:

Although the analyzer is equipped with a high quality barcode scanner, the labels of
improper dimensions or defective labels may not be read. For correct readings the barcode
label should be properly centered on the tube and should have a height between 2 cm and
3.7 cm. The barcode on the label should be completely visible after the tube has been
inserted into the sample plate. It must not be partially covered on the top and the bottom. If
the tube is partially covered by barcode, then the tube must be positioned in such a way
that the barcode is facing outwards of the sample plate.

Section I Chapter I Barcode and Related Functions Page 4 of 5

2.2 REAGENT BARCODE
The main objective of the reagent bottle barcode is the positive identification of the bottle to
avoid position error. Moreover, upon request, a special program makes it possible to “close”
the analyzer making it possible to use just reagents with barcode, introducing a series of
additional controls.
However the barcode can be used only with specific labels produced by the manufacturer
of the reagents.
At the installation of the instrument can be configured in the following three different modes
of operation, in agreement between the manufacturer of the analyzer, the reagent supplier
and the client:
1) Use of reagent bottles without barcode, independent use.
2) Use of reagent bottles with barcode (analysis code), only for positive identification
of the bottle.
3) Use of reagent bottles with complex barcode, use of reagents bound by
purchasing agreement.
This mode allows for a barcode with customized reading key. The instrument
doesn't accept bottles having unknown and incoherent barcode labels, thus
preventing the execution of the tests. The applied algorithm provides for: analysis
code, bottle type, test type (single or double), reagent lot and expiration date. The
improper modification of any one of these parameters invalidates its applicability.
There is also a built-in prevention against refilling of previously identified bottle.
NOTE:
Exclusively the Director General of the company manufacturing the analyzer releases
additional information.

“Check volumes”
This command allows measurement of the volume of the reagent bottles (refer to Chapter
E, paragraph 1.2. “Reagents: insertion and removal”). With reagent barcode enabled, it
is also possible to check the actual position of all the bottles in tray.
At the end of the reagent scanning, the analyzer sorts codes disposition and provides a list
of all the errors found during reading phase. In case of detected anomalies, the procedure
can be repeated once the problems have been solved. Every time a new reagent bottle is
inserted, the analyzer will read the inserted codes.
When removing a reagent with the "Remove" function, the analyzer will perform a scan of
the position to verify that the reagent has been removed. When closing the View volumes
status window, the analyzer will perform a second verification scanning and then will move
the removed test code from the on-line tray to the global list (see also Cap. E, page 3).

Section I Chapter I Barcode and Related Functions Page 5 of 5

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER M
1. WARNINGS AND PRECAUTIONS Page: 2
1.1. Potential risks during operation and maintenance Page: 2
1.2. Warnings and precautions Page: 3
1.3. Waste disposal Page: 6
1.4. Returning the analyzer to the T.A.S. Page: 6
1.4.1. Operating Analyzer Page: 6
1.4.2. Not Operating Analyzer Page: 7
1.5. Analyzer safe disposal Page: 8
1.6. Electric and electronic devices disposal Page: 9

ATTENTION: USE OF THE BT2000 PLUS (AND DERIVATES) INTERNAL COMPUTER

The computer box of analyzer BT2000 PLUS and by-products is designed for long-term
security and reliability and is virtually maintenance-free as long as the user does not
install any third-party application programs. If these applications are installed, then they
may damage the operating system registry and may also cause disastrous consequence
for the computer's hard-drive. Biotecnica Instruments S.p.A. will not be responsible for
any damage to the analyzer, its software and data in the hard-disk in case of improper
use of the PC box. This includes also: installation of external programs, not properly
secure net connections (intranet and internet) and the use of disks without the necessary
verification for viruses presence. Biotecnica Instruments S.p.A. will not be responsible for
any damage caused by non authorized third parties who may open and alter the PC box
configuration.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter M Warnings & Precautions Page 1 of 9

1. WARNINGS AND PRECAUTIONS

1.1. POTENTIAL RISKS DURING OPERATION AND MAINTENANCE

USE
Although the BT2000 PLUS analyzer system uses high performance components, which
provide a high degree of safety, it is essential that the user takes the usual precautions to
safeguard himself and to ensure a safe working environment.
Biotecnica Instruments S.p.A. only guarantees the workmanship and materials of its
products. It is the duty of the user to take care of safe operation and no amount of
warnings can take place of such care.
As regards the moving parts in the analyzer, these have been appropriately protected to
avoid any potential risks to the user, and for proper instrument operation and safety.
However, it is highly recommended to exercise extreme care during analyzer operation
and especially when working close to the devices.
To avoid accidental contamination, use suitable guards and/or personal protection, such
as overall and gloves. When handling reagents, it is advisable to observe good
laboratory practice (GLP) rules.
Chemicals, serum samples and reagents must be handled with extreme caution. Patient
samples may be biologically hazardous. The reagents or any other substances that may
enter in contact with samples should be treated in the same way as samples themselves.
The materials of human origin, such as control sera, are tested for the detection of
HbsAg, anti-HCV anti-HIV-1 anti-HIV–2 antibodies. Even if the result is negative, as
no known analytical method can exclude any infection’s risk with certainty
therefore these materials must be considered as potentially infective and thus
must be handled with extreme caution. The reagents and any other substance
entering in contact with samples must be treated in the same way. The reagents must be
manipulated (before, during and after the use) by qualified personnel familiar with their
characteristics in order to safeguard the user as well as the quality of the reagent itself.

MAINTENANCE
• It is of extreme importance that the instrument is fully turned off and the power cord
unplugged from the wall outlet to safely perform any maintenance or service
procedure.
• During maintenance procedures (see "Chapter L, “Maintenance“), the safety and
warning precautions must be observed as outlined in the preceding paragraph.
• The exterior of the analyzer casing may be cleaned periodically to remove dust
grease and other contamination. It is not necessary to clean the inside. Use soft cloth
dampened with a mild solution of detergent with water.
• The owner shall be responsible for maintenance of the analyzer. Wear or damage
caused by lack of normal maintenance or by misuse of the analyzer shall not be
considered as defective workmanship and material.

Section I Chapter M Warnings & Precautions Page 2 of 9

1.2. WARNINGS AND PRECAUTIONS
The following warnings will aid the user to provide adequate safeguards to assure
safe trouble-free performance:
1. BEFORE OPERATING THIS SYSTEM, BE SURE TO READ THE OPERATOR MANUAL
THOROUGHLY AND CAREFULLY. AFTERWARDS, KEEP IT HANDY FOR FUTURE
REFERENCE.
2. TAKE SPECIAL CARE TO FOLLOW THE WARNINGS AND CAUTIONS INDICATED ON
THE SYSTEM REAR PANEL AS WELL AS IN THE OPERATOR MANUAL.
3. SYSTEM’S USE SHOULD BE RESTRICTED TO LAB’S QUALIFIED PERSONNEL ONLY.
4. SLOTS AND OPENINGS IN THE CASE, BACK PANEL, AND BOTTOM ARE PROVIDED
FOR VENTILATION. THIS ENSURES RELIABLE OPERATION OF THE SYSTEM AND
TO PROTECT IT FROM OVERHEATING. DO NOT BLOCK OR COVER THESE
OPENINGS.
5. BEFORE USING THE SYSTEM, CHECK THAT THE VOLTAGE ON THE REAR PANEL
LABEL MATCHES THE LOCAL LINE VOLTAGE.
6. TO GUARANTEE SAFETY THE SYSTEM MUST BE PROPERLY GROUNDED. THE
WIRES IN THE MAINS POWER CORDSET ARE COLORED IN ACCORDANCE WITH
THE FOLLOWING CODES:
GREEN AND YELLOW: EARTH
BLUE: NEUTRAL
BROWN: LIVE
IN CASE OF DOUBTS CONTACT THE NEAREST QUALIFIED ELECTRICIAN.
7. REPLACE FUSE AS MARKED (see Chapter L, "Maintenance"). PRIOR TO THE
REMOVAL OF ANY FUSE, TURN POWER OFF AND UNPLUG THE CORDSET FROM
THE WALL.
8. UNDER NO CIRCUMSTANCES IS THIS INSTRUMENT CASE TO BE OPENED. THIS
INSTRUMENT IS NOT USER SERVICEABLE. DANGEROUS HIGH VOLTAGES INSIDE
THIS INSTRUMENT CASE. IN EVENT OF DIFFICULTY, PLEASE NOTIFY YOUR
DEALER FOR PROMPT SERVICE.
9. FOR OPERATING SAFETY, DO NOT INSTALL THE SYSTEM IN A LOCATION WHERE
IT WILL BE EXPOSED TO HEATING EQUIPMENT OR RADIATORS, DIRECT SUN
LIGHT, OR ANY OTHER SOURCE OF EXTREMELY HIGH TEMPERATURES.
10. DO NOT OPERATE THE SYSTEM IN THE PRESENCE OF FLAMMABLE FLUIDS OR
GASEOUS ATMOSPHERE, DISINFECTING AGENTS, CLEANING AGENTS, ETC., DUE
TO POSSIBLE FIRE OR EXPLOSION.
11. DO NOT KINK, BEND, LAY OBJECT ON, OR OTHERWISE DAMAGE OR RESTRICT
CABLES AND TUBES.
12. BE SURE THAT THE POWER SWITCH ON THE BACK PANEL OF SYSTEM IS OFF
WHEN PLUGGING IN, OR REMOVING THE POWER CORDSET FROM A WALL
OUTLET.
13. TURN OFF THE MAINS POWER SWITCH ON THE REAR PANEL WHENEVER THE
SYSTEM IS NOT IN USE. THIS PREVENTS DAMAGES DUE TO SURGE IN THE MAINS
POWER.

Section I Chapter M Warnings & Precautions Page 3 of 9

14. DO NOT ATTEMPT TO ALTER THE SHAPE OF ANY PART OF THE SYSTEM.
15. IF THE SYSTEM IS NOT OPERATING PROPERLY AND THE TROUBLE-SHOOTING
SECTION (refer to Chapter L, “Maintenance”) DOES NOT PROVIDE A SATISFACTORY
SOLUTION TO THE PROBLEM, THEN DO NOT USE THE SYSTEM UNTIL THE
DEFECTS ARE REMEDIED.
16. INSPECT ALL ACCESSORIES AND SYSTEM CORDS. DO NOT USE IF DAMAGE CAN
BE SEEN SUCH AS CUT INSULATION OR OUTER COVERING, FRAYED OR BROKEN
WIRES, CORRODED OR BROKEN CONNECTORS ETC.
17. TO REDUCE THE RISK OF FIRE OR ELECTRIC SHOCK, DO NOT ALLOW FLUIDS OR
ANY FOREIGN OBJECT TO ENTER THE SYSTEM. WIPE OFF SPILLS IMMEDIATELY.
18. DO NOT USE BENZENE, THINNER, ANY KIND OF SOLVENTS, OR ABRASIVE
DETERGENTS TO CLEAN THE CASE. CLEAN WITH SOFT DUSTING CLOTH
DAMPENED WITH DISTILLED WATER. IF NECESSARY USE ONLY NEUTRAL
DETERGENT.
19. DO NOT STICK OBJECTS OF ANY KIND INTO THE SYSTEM THROUGH BACK PANEL
OR CASE SLOTS AS THEY MAY TOUCH DANGEROUS VOLTAGE POINTS OR SHORT
OUT PARTS THAT COULD RESULT IN FIRE OR ELECTRIC SHOCK.
20. INSTALL THE SYSTEM IN SUCH A WAY THAT ADEQUATE VENTILATION IS
PROVIDED ALL AROUND TO PROPERLY DISSIPATE THE HEAT.
21. USE ONLY ORIGINAL BIOTECNICA’S TUBING REPLACEMENTS. DO NOT USE
CONVENTIONAL TUBING. THIS WILL CAUSE MALFUNCTION OF THE SYSTEM.
22. MAKE SURE ALL FLUID LINES ARE FREE OF KINKS, NICKS, SHARP BENDS,
PUNCTURES, OR OCCLUSIONS BEFORE INSTALLING ON SYSTEM.
23. DO NOT TWIST THE PERISTALTIC PUMP TUBING WHEN PLACING IN THE RACEWAY
OF THE PUMP ROLLER.
24. RELEASE THE PERISTALTIC PUMP TUBING WHENEVER THE SYSTEM IS UNUSED
FOR A PERIOD OF TIME LONGER THAN 36 HOURS.
25. IF IT IS NOT BE USED FOR SOME TIME, THE PINCH-VALVES TUBING SHOULD BE
RELEASED.
CAUTION
THE HYDRAULIC CIRCUIT SHOULD BE FULLY DISCHARGED AND THE WATER RESERVOIR
DISCONNECTED FROM THE CIRCUIT PRIOR TO RELEASING THE TUBES FROM THE PINCH
VALVES. IF THESE STEPS ARE NOT TAKEN, SERIOUS DAMAGE MAY BE CAUSED TO THE
ANALYZER.
26. THE HALOGEN LAMP MUST BE REPLACED SOME MINUTES AFTER THE
INSTRUMENT HAS BEEN TURNED OFF AND POWER CORD UNPLUGGED (refer to
Chapter L, “Maintenance”).
27. ALWAYS ALLOW THE BURNT OUT LAMP TO COOL DOWN BEFORE HANDLING OR
ATTEMPTING REPLACEMENT.
28. NEVER TOUCH THE LAMP OR THE REFLECTOR WITH BARE FINGERS. USE A RAG
WHEN CHANGING.
29. IF THE LAMP IS TOUCHED INADVERTENTLY DURING INSTALLATION, CLEAN THE
LAMP OR REFLECTOR WITH ALCOHOL AND DRY WITH A CLEAN, SOFT CLOTH
BEFORE BURNING. CONTAMINATION OF THE LAMP OR REFLECTOR MAY REDUCE
LAMP PERFORMANCE.

Section I Chapter M Warnings & Precautions Page 4 of 9

30. THIS LAMP (WHEN LIT) EMITS UV (ULTRAVIOLET) RADIATION. PROLONGED
EXPOSURE TO THIS LAMP MAY CAUSE SKIN AND EYE IRRITATION.
31. THE ANALYZER SYSTEM MUST NOT BE DISMANTLED OR REPAIRED BY ANYONE
WHO HAS NOT BEEN QUALIFIED BY THE MANUFACTURER. INCORRECT WORK
MAY CAUSE FIRE OR IRREPARABLE DAMAGE TO THE SYSTEM.
32. DO NOT OVERLOAD ACCESSORIES POWER OUTLETS AND EXTENSION CORDS AS
THIS CAN RESULT IN FIRE OR ELECTRIC SHOCK.
33. DO NOT PLACE THE SYSTEM ON AN UNSTABLE CART, STAND, OR TABLE; THE
SYSTEM MAY FALL, CAUSING SERIOUS INJURY TO USER, AND SERIOUS DAMAGE
TO THE APPLIANCE. PLACE THE SYSTEM ON A STABLE, VIBRATION-FREE, LEVEL
TABLE OR CART.
34. USE ONLY SECURE POWER SOURCE TO PROTECT THE ANALYZER SYSTEM
AGAINST POWER SURGES. DISCONNECT TEMPORARILY THE ANALYZER POWER
CORD FROM THE WALL OUTLET IN CASE OF BAD ATMOSPHERIC CONDITIONS.
35. DO NOT OIL ANY PART OF THE SYSTEM.
36. EMPTY WASTE CONTAINERS WHENEVER THEY ARE FULL. ENSURE THAT THE
CONTAINER LIDS ARE SCREWED ON TIGHTLY TO PREVENT LEAKAGE OR
DISPERSION INTO THE ENVIRONMENT.
37. THE SAFE DISPOSAL OF THE ANALYZER WASTE MATERIAL WITH MINIMAL
ENVIRONMENTAL IMPACT IS THE RESPONSIBILITY OF THE USER AND WILL HAVE
TO MEET THE LOCAL LAWS AND DISPOSITIONS.
38. DO NOT ATTEMPT TO REMOVE ANY PANELS OR COVERINGS OF THE ANALYZER
SYSTEM WHILE THE SYSTEM IS IN OPERATION.
39. AFTER OPERATION/SERVICING, COVER THE SYSTEM WITH A PROTECTIVE
PLASTIC OR CLOTH SHEET.
40. DO NOT USE SOFTWARE DISKS OF UNKNOWN ORIGIN IN THE ANALYZER
COMPUTER AS THEY MAY INTRODUCE VIRUSES.
41. DO NOT USE THE COMPUTER OF THE ANALYZER FOR ANY OTHER PURPOSE THAN
THE ONE FOR WHICH IT IS DESIGNED FOR.
42. BE PARTICULARLY CAUTIOUS THAT NO PARTS OF YOUR BODY (e.g. FINGERS
HAIR, ETC.) OR LOOSE OBJECTS (e.g. CABLES, TUBING, ETC.) CAN BE TRAPPED
BY ANY MOVING OR ROTATING PARTS (e.g. SAMPLING ARM, PLATES, WASHER
MODULE, PUMP ROLLERS ETC.) OF THE ANALYZER SYSTEM.

NOTE:
a) The careful observation of the proceeding warnings should result in a long and
satisfactory performance. If the above-mentioned notices are not fully observed, then any
form of warranty is no longer valid and Biotecnica Instruments S.p.A. will not be
responsible for any subsequent damage or loss. (see Section II, 2 “Warranty
Conditions”).
b) The information in this manual is based upon the hardware and software currently in use.
Biotecnica Instruments S.p.A. reserves the right to make software and hardware changes
or improvements for product enhancement without notice and without imposing any
obligation upon itself to install these changes or improvements on its products
previously manufactured.

Section I Chapter M Warnings & Precautions Page 5 of 9

1.3. WASTE DISPOSAL
• To ensure environment health and safety, it is recommended not to discard the used
consumables, waste liquids or disposable maintenance kits into the environment.
• Insure that the disposal of waste material is done according to all applicable laws
and regulations.

1.4. RETURNING THE ANALYZER TO THE TECHNICAL ASSISTANCE

SERVICE
The Technical Service Assistance (S.A.T.) may intervene locally, at the Lab, or at
Biotecnica Instruments S.p.A. for analyzers returned for repair.
In both cases it is necessary to decontaminate the analyzer and its parts to protect the
health of technical assistance employees.
To decontaminate the analyzer follow the procedure below, bearing in mind that any part of
the analyzer may come into contact, even accidentally, with potentially infected samples:
therefore set up adequate protection using the necessary individual protection devices.
Be very careful of any splashing of residual decontaminant when disconnecting the various
tubes or touching the various parts of the hydraulic system, after decontamination.
The procedure described below is not considered to be complete and any other action
taken by the Lab to ensure the safety of Biotecnica’s technicians is appreciated.

1.4.1. Operating Analyzer

1. Remove all the consumable parts, still present, from the analyzer (sample cups, test
tubes, reagent bottles etc.).
2. Put a suitable decontaminant (e.g. HCl 1N hydrochloric acid diluted at 3%) in a
reagent bottle and place it in position no. 24.
3. Start a cuvette (Analyzer Utilities menu – Wash cuvettes) wash cycle.
4. Wait five minutes after the wash has finished and then remove the decontaminant
bottle from the reagent tray.
5. Run a normal wash cycle with water (Analyzer Utilities – Wash with water).
6. Empty the hydraulic circuit (from the Analyzer Utilities menu - Empty fluidics).
7. Shut down the analyzer.
8. Clean off the entire sample tray with decontaminant and a clean cloth, as well as its
housing and all the accessible surfaces of the analyzer.
For assistance at the Lab: in addition to the above, disconnect the waste tube from the
instrument and clean an area with decontaminant which is large enough for the
Technician to work.

Section I Chapter M Warnings & Precautions Page 6 of 9

 For shipping the analyzer to Biotecnica:
In addition to the instructions in points 1 to 8 above, carry out the following:
1. Disconnect the waste tube from the instrument.
2. Disconnect the water tube from the instrument, wind it up and put it in a bag.
3. Push the sampling needle all the way into its wash well.
4. Put the cuvette and serum cover trays back in their places.
5. Make sure that all moveable parts are secured tightly.
6. Decontaminate the vacuum system discharge probe by soaking it for five minutes in
HCl 1N diluted at 3%.
7. Wind up the waste tube and put it in a tightly shut bag.
8. Pack up the peripheral devices and analyzer in their original packing.

1.4.2. Not Operating Analyzer

1. Remove all the consumable parts, still present, from the analyzer (sample cups, test
tubes, reagent bottles etc.).
2. Clean off the entire sample tray with decontaminant (hydrochloric acid HCl 1N
diluted at 3%) and a clean cloth, as well as its housing and all the accessible
surfaces of the analyzer.
3. Unscrew the sampling needle from its arm and soak it for five minutes in
decontaminant and then rinse it with water and put it aside or screw it back into
place.
4. Decontaminate the vacuum system discharge probe by soaking it for five minutes in
HCl 1N diluted at 3%.
5. Make sure the cuvettes are empty and then fill them manually with the
decontaminant solution. After five minutes remove the solution and replace it with
bidistilled water.
For assistance at the Lab: in addition to the above, disconnect the waste tube from the
instrument and clean an area with decontaminant which is large enough for the
Technician to work.
For shipping the analyzer to Biotecnica:
In addition to the instructions in points 1 to 5 above, carry out the following:
1. Disconnect the waste tubes from the instrument.
2. Disconnect the water tube from the instrument, wind it up and put it in a bag.
3. Push the decontaminated sampling needle all the way into its wash well.
4. Put the cuvette and serum cover trays back in their places.
5. Make sure that all moveable parts are secured tightly.
6. Wind up the decontaminated waste tube and put it in a tightly shut bag.
7. Make sure the cuvettes are empty.
8. Make sure there is no residual liquid in the hydraulic circuit or any other part of the
instrument.
9. Pack up the peripheral devices and analyzer in their original packing.

Section I Chapter M Warnings & Precautions Page 7 of 9

1.5. ANALYZER SAFE DISPOSAL
When the instrument is no longer useable or needs to be decommissioned, follow the
procedure below, bearing in mind that any part of the analyzer may come into contact, even
accidentally, with potentially infected samples: therefore set up adequate protection using
the necessary individual protection devices.
Be very careful of any splashing of residual decontaminant when disconnecting the various
tubes or touching the various parts of the hydraulic system, after decontamination.
1. Remove all the consumable parts, still present, from the analyzer (sample cups, test
tubes, reagent bottles etc.).
2. Empty the hydraulic circuit (from the Analyzer Utilities menu: empty fluidics).
3. Remove the water tube from the external container and put it in a container with at
least one liter of suitable disinfectant or decontaminant (e.g. hydrochloric acid HCl
1N diluted at 3%). Put disinfectant in a bottle in position 24 of the reagent tray.
4. Fill the hydraulic circuit again by running a reset and a series of prime of the clinical
chemical diluter.
5. Run a wash of the cuvettes (from the Analyzer Utilities menu - Wash with water)
6. Wait five minutes. Remove the disinfectant from the container and replace it with
water. Put the water tube back in the container which has just been filled.
7. Run a wash of the cuvettes again, and then empty the hydraulic circuit again.
8. Shut down the analyzer.
9. Remove all the cords connecting the UPS to the mains and peripheral devices from
the analyzer.
10. Remove all the cables connecting the peripheral devices (keyboard, mouse, wireless
connector, printer and UPS).
11. Carefully clean off the entire sample tray with decontaminant (hydrochloric acid HCl
1N diluted at 3%) and a clean cloth, as well as its housing and all the accessible
surfaces of the analyzer.
12. Carefully clean the peripheral devices using a clean cloth and a disinfectant.
13. Remove the waste tube from the analyzer.
14. Remove the vacuum system discharge probe and soak it for five minutes in
disinfectant (HCl 1N diluted at 3%). Then rinse it in water.
15. Remove all the tubes which are part of the washing, distribution and sampling
hydraulic circuit.
16. Sort the material from decommissioning the instrument so that they can be recycled
or disposed of as special waste in accordance with local laws.

If the analyzer is going to be returned to the Distributor, make sure all the removal parts of
the system are bagged and separated after decontamination so that they can be disposed
of as special waste.

Section I Chapter M Warnings & Precautions Page 8 of 9

1.6. ELECTRIC AND ELECTRONIC DEVICES DISPOSAL
ATTENTION:
Waste Electrical and Electronic Equipment, called WEEE must be disposed of in
accordance with Italian Legislative Decree no. 151 of 25 July 2005:
“Implementation of EC directives 95/2002, 96/2002 and 108/2003, related to the
reduction of hazardous substances in electrical and electronic equipment as well as
waste disposal” published in the Italian Official Gazette no. 175 of 29-7-2005- Ordinary
Supplement no. 135.
The points below provide some instructions related to disposal of WEEE, however we
recommend consulting the aforesaid Legislative Decree for additional information.
1. WEEE must not be disposed of as urban waste, it must be recycled.
2. Municipalities guarantee operation, access and suitability for recycling systems for
WEEE, so that end users and distributors can return to collection centers all waste
produced within their territories, at no cost.
3. WEEE can be returned to the distributor when new equipment is purchased, without
prejudice the provisions of Legislative Decree 151/05.
4. The distributor has the obligation to take the WEEE, however pick up may be
refused when there is a risk of contamination of personnel assigned to this job.
5. The presence of hazardous substances in electrical and electronic equipment
requires separate disposal due to the potential effects on the environment and
humans. Improper use of the same equipment or its parts may be potentially
hazardous.
6. The symbol that indicate separate disposal of electrical and electronic equipment is a
trash container on wheels with a cross over it as indicated below: the symbol is
printed in a visible, readable and indelible manner

Editor’s note: The picture is only for the purposes of example: see the printed version in the Italian
Official Gazette no. 175 of 29-7-2005

7. Legislative Decree 151/05 includes a list of fines for illegal disposal of WEEE.

NOTE:
The manufacturer shall not be held liable for any failure to comply with
regulations regarded to delivery of the instrument to third parties. Check the
pertinent lists at specialized waster disposal centers.

Section I Chapter M Warnings & Precautions Page 9 of 9

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION I: GENERAL INFORMATON

CHAPTER N
1. MAINTENANCE AND CARE Page: 2
1.1. Preventive maintenance and Extra Wash Page: 2
1.2. Replacing tubing and accessories Page: 3
1.2.1. Clinical Chemistry Page: 3
1.2.2. Extra wash cuvettes Page: 5
1.2.3. Photometric lamp Page: 5
1.2.4. Dilutors’ piston o-ring Page: 6
1.3. Cleaning the instrument Page: 7
2. MALFUNCTIONS Page: 8
2.1. Troubleshooting Page: 8
2.2. Screen messages Page: 9
2.2.1. Screen messages - Causes and remedies Page: 9
2.2.2. Messages requiring technical assistance Page: 10
2.2.3. Optical system verification messages Page: 13

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter N Maintenance & Troubleshooting Page 1 of 13

1. MAINTENANCE AND CARE

1.1. PREVENTIVE MAINTENANCE AND EXTRA WASH

EXTRA WASH
This function is similar to the daily one but run with a stronger detergent. This operation is requested
by the instrument on a weekly basis. See paragraph 1.2.3. The extra wash helps guarantee
efficiency and long life for the reading cuvette.

Exercise extreme care to ensure that the system is regularly provided with proper maintenance
and care to avoid any problems and malfunctions, which can potentially generate erroneous
results. This will give longest life at lowest overall cost.
The maintenance is normally performed at regular intervals or whenever the operating
conditions dictate it. The analyzer stores the number of run tests and a built-in maintenance
software automatically alerts the operator through on-screen messages whenever any part
needs attention or replacement. Failure to follow proper maintenance and replacement
procedures may result in system malfunction.
The software programmed maintenance does not exonerate the user from neglecting any
unexpected problems.
For the reasons just mentioned, we recommend that the operator follows the suggestions below:
The following simple steps serve as practical guidelines in establishing your care and
maintenance program:
1) Replace the worn out component soon after the on-screen message from the maintenance
software has been displayed (Figure 1 “Show Diagnostic”). To access this function refer to
chapter H.
2) Any consumable part showing signs of wear or damage should be immediately replaced,
even if the appropriate on-screen message is not already displayed.
3) Use only original Biotecnica parts. Do not replace defective parts with non-original parts as
this will cause malfunctioning of the analyzer. In case of any doubt, contact the Biotecnica
Instruments S.p.A. or nearest service center.
4) Use only bi-distilled water for the washes performed during working phases.
5) Use only Biotecnica Instruments S.p.A. approved wash solution for the routine washing
procedures and at the end of working session.
6) During routine maintenance, exercise extreme caution to avoid any contamination. When
replacing tubing, needle, or handling waste container etc. accidental contact with potentially
contaminating liquid is possible. For individual safety, use suitable protective garments, such
as overalls and gloves (refer to Chapter K, paragraph 1.1. “Potential risks during use and
maintenance”).

The components that are most subject

to wear are the fluidic tubing used in
the valves, the peristaltic pump
cartridges and the photometric lamp.
The hydraulic circuit items, not
mentioned in the maintenance table,
should be considered as non-
consumable and should be replaced
only by the qualified technical
personal during service.
Figure 1

Section I Chapter N Maintenance & Troubleshooting Page 2 of 13

1.2. REPLACING TUBING AND ACCESSORIES
CAUTION:
a) Completely empty hydraulic circuit, using the program outlined in the Chapter H,
paragraph 1.1., “Empty Fluidics” and wait until this operation terminates.
b) Always make sure that the mains power switch on the instrument is turned off and
the power cord is unplugged from the wall outlet before performing any
maintenance procedure.
The following figures show the position and indication of components to be replaced.
The maintenance kits include what is needed for maintaining the Clinical Chemical part
(Reading station).

See paragraph 1.2.1.

See paragraph 1.2.2.
See paragraph 1.2.3.
See paragraph 1.2.4.

1.2.1. Clinical Chemistry (Annual Maintenance Kit code 662.2001)

- Peristaltic pump cartridge (ref. 4 fig 2): remove both ends of the peristaltic pump tubing
from the diluter manifold. Squeeze the locking catches and remove the defective cartridge.
Place the new cartridge on the drive shaft and gently press to snap-fit. Carefully attach the
pump tubing to both fittings in the diluter manifold.
- Tube for valves (ref. 1 fig 2): detach valve tube and discard it. Carefully attach ends of no-
pinch valve tubing to appropriate fittings (Figure 2).
- Aspiration tube for washing module (ref. 2 fig 2): detach defective tube and replace with
new aspiration tube.
- H2O tube for washing module (ref. 3 fig 2): remove and discard the old tubing. It is
possible that a small quantity of distilled water will flow out of the water reservoir.
Immediately dry it after the tube replacement. Carefully attach the ends to the valve and to
the appropriate fittings of the water reservoir and the washer.
- Tubular filter for water container (263 µ) (ref. 5 fig 2): maintenance includes annual
replacement (or if the filter is completely clogged).
- Sampling arm: maintenance of the sampling arm includes annual replacement (or if the
device does not work correctly) of the sampling needle (ref. 6 fig 2). To replace the needle,
loosen and remove retaining nut with needle from the needle holder. Clean or substitute
with new needle. Then gently push in needle into the needle holder until fully seated and
screw it gently back into the needle holder.

Note: the reading cuvettes are also part of the reading station, but they do not need to be
replaced unless it is impossible to wash them correctly or they break. If they need to be
replaced contact the Technical Assistance Service.

Section I Chapter N Maintenance & Troubleshooting Page 3 of 13

The annual maintenance kit corresponds to the “Tube and Peristaltic Pump Kit” on the
Diagnostic page (fig. 1)

1 3

6
Figure 2

ANNUAL MAINTENANCE KIT (P/N. 662.2001)

ITEM QTY DESCRIPTION
1 2 Diluter/Valve Tube
2 1 Aspiration Tube for Washing Module
3 1 H2O Tube for Washing Module
4 1 Peristaltic Pump Cartridge
5 1 Tubular Filter for Water Container
6 1 Sampling Needle

Section I Chapter N Maintenance & Troubleshooting Page 4 of 13

1.2.2. Extra Wash Cuvettes (solution code 393E)
This is requested by the analyzer on a weekly basis.
Insert a bottle with washing solution code 393E in position 23 as indicated in the
message and activate the command.
It is highly advisable to run this operation any time the efficiency of the cuvettes is
questionable. A progressive accumulation of contaminants in the cuvettes may lead to
serious release problems when running tests.

Analyzer Utilities menu

Figure 3

1.2.3. Photometric Lamp (code 11-05255-01)

The analyzer controls the Halogen lamp condition, and it should be replaced every 1500
hours or when there is a faulty operation. The analyzer verifies lamp efficiency and stability,
and alerts the user through appropriate messages in case of fault.
Precautions for handling the halogen lamp:
• Turn off power and remove the power cord from the wall outlet before servicing.
The replacement of the Halogen lamp can be done by the removal of the rear panel,
or by sliding the transparent shutter on the front panel and then removing the access
cover from the deck Figure 4.
• Always allow the burnt out lamp to cool down.
• Never touch the reflector or the lamp with bare fingers. Use a rag when changing.
• If the lamp is touched inadvertently during installation, clean the lamp or reflector
with alcohol and dry with a clean, soft cloth before burning. Contamination of the
lamp or reflector may reduce lamp performance.
• It is recommended to initially burn the new lamp for about 30 minutes before
analyzer operation.
• Release the lamp assembly by gently sliding downwards and remove the burnt
out lamp.
• Insert a new halogen lamp fully into the socket. It is recommended to slightly
press both of the lamp retaining spring clips before fitting the lamp.
• Slide the lamp assembly onto the light cone and orient the lamp socket in the
vertical position as shown in the Figure 4

Section I Chapter N Maintenance & Troubleshooting Page 5 of 13

 •

Figure 4

1.2.4. Dilutors’ Piston o-ring

The dilutor o-ring (clinical chemical dilutor) needs to be replaced annually. Since this
replacement operation is very difficult it is advisable to ask for intervention from the
Technical assistance service.

Figure 5

Code Description
Dilutor piston o-ring kit
11-05283-01
(contains what is necessary for one dilutor)

Section I Chapter N Maintenance & Troubleshooting Page 6 of 13

1.3. CLEANING OF THE INSTRUMENT
It is a Good Laboratory Practice (GLP) to maintain the instrument in optimal operating
conditions. The instrument should be fully turned off and the power cord unplugged from
the wall outlet prior to performing any cleaning procedure.
The exterior of the analyzer casing may be cleaned periodically to remove dust, grease and
other contamination. Use soft dusting cloth dampened with distilled water or a mild solution
of detergent with water. Do not use alcohol, solvents, or abrasives.
Use appropriate soft lint less cloth or tissues for LCD Display cleaning. Clean gently and
avoid excessive rubbing to prevent damage to the LCD surface. Do not use any liquid that
may damage the invisible matrix of the touch screen.
Protective gloves and laboratory coats/gowns should be worn to prevent contamination
when cleaning the inside of the reagent chamber or serum plate chamber because of liquid
contaminants. Use appropriate disinfectant for the thorough cleaning and elimination of
biological residues.
Clean the cuvettes thoroughly with approved washing solution.
Immediately eliminate any traces of serum drops or liquid contaminants using appropriate
disinfectant to avoid difficulties associated with removal of dry and tenacious
contaminations.
Handle cuvettes with protective gloves.

Section I Chapter N Maintenance & Troubleshooting Page 7 of 13

2. MALFUNCTIONS

2.1. TROUBLESHOOTING
The risk of encountering system malfunctions is very low if the routine care and
maintenance procedure (outlined in the previous chapter) and the instructions in the
operating manual are strictly observed. Refer to the troubleshooting guide below and the
subsequent text regarding symptoms and corrective actions.

SYMPTOMS CORRECTIVE ACTIONS

Verify that the UPS group is turned on, the electrical cables
are correctly connected and check the fuses. If fuses need
replacement then observe the following procedure:
1) Turn off the instrument by pressing the main switch on
The instrument or one of its the rear panel and unplug power cord.
2) Extract the fuse-holder (located above the main switch on
peripheral devices does not the rear panel) by gently opening the latch with a tool.
turn on Discard the old fuses and replace with new fuses, which
match the selected voltage rating indicated on the rear
panel label. Insert the fuse-holder into the compartment
and push until its latch snaps back into the position (see
Figure 3, Chapter B).
Sampling imprecision due to dirt in the dilutor:
Results are invalid or cannot 1) Disconnect dilutor tubes
2) Remove the two mounting screws on the
be reproduced due to residues transparent dilutor chamber and clean the piston with soft
in the dilutor. lint less cloth dampened with alcohol. Rinse the chamber
and reassemble. Connect the tubes to appropriate ports.
Sampling imprecision due to the presence of air in the
hydraulic circuit. Probably caused by the clogged tubular filter
in the external water container:
Check, replace Filter if necessary (ref. 5 Fig. 2).
Sampling imprecision due to deteriorated tube in the dilutor
valve:
Inspect and replace Tube (ref. 1 Fig. 2).
Sampling imprecision due to reagent or sample residues in
the sampling tube or in the needle:
− Inspect and replace Peristaltic Pump Cartridge (ref. 4
Results are invalid or cannot Fig. 2).
be reproduced due to air in the − Check and replace the Sampling Needle (ref. 6 Fig. 2).
sampling system. − Check and replace the Sampling Tube. To be replaced
by qualified service technician only.
Sampling imprecision due to reagent or sample residues on
the external surface of the needle, with consequent
contamination during preparation:
Remove Needle and clean externally using gauze soaked
with alcohol (ref. 6 Fig. 2).
Check the efficiency of built-in devices for needle
cleaning. In case of vacuum pump malfunction or if there
are any obstructions in the cleaning devices, contact
immediately the nearest Biotecnica sales/service office.
Vacuum pump malfunction or occluded washing piston.
Results are imprecise due to − In case of vacuum pump malfunction or if there are any
insufficient cleaning or drying obstructions in the washing piston, contact immediately
the nearest Biotecnica sales/service office.
of the reading cuvettes. NOTE:
Check sampling/washing hydraulic circuit for leaks,

Section I Chapter N Maintenance & Troubleshooting Page 8 of 13

 which may affect system performance.
Invalid results or results Defective or burnt-out lamp.
Inspect and replace the lamp, refer to par. 1.2.3 in this
cannot be reproduced. chapter.
Invalid results or results
Perform all maintenance procedures and check all possible
cannot be reproduced without causes described earlier in this chapter.
any evident reason.

2.2. SCREEN MESSAGES

2.2.1. Screen Messages - Causes And Remedies

The BT2000 PLUS software has a built in Auto-diagnostic function, which is enabled during
normal working sessions. This function allows verification of any system malfunction or
lacking of any solution necessary for running the tests.
In presence of any system malfunction, an appropriate message is displayed on the screen
indicating the type of error and the suggested solution. The system stops until the causes of
error are eliminated and then the operation can be resumed from where it stopped.
When anything necessary for test run is lacking (for example reagent or sample) an
appropriate message is displayed on the screen, sampling procedure for the missing
element is interrupted while the analyzer continues with the next working phases.

The error “SAMPLE IS MISSING” is displayed when

SAMPLE IS MISSING the analyzer detects the absence of sample through
a built-in liquid sensor. It is subdivided into NO
NO ROUTINE #XX ROUTINE, NO STAT, NO STANDARD, NO CONTROL.
NO STAT #XX After this message the sampling of the missing sample
NO STANDARD #XX is interrupted. It is possible to run remaining tests using
the rerun commands (Chapter E, paragraph 1.5) after
NO CONTROL #XX
the problem is solved.
The error “REAGENT IS MISSING” is displayed when
REAGENT IS MISSING the analyzer detects the absence of reagent needed
for test run. After this message the sampling of the
NO REAGENT XXX missing reagent is interrupted. It is possible to run
remaining tests using the rerun commands (Chapter E,
POSITION XX
paragraph 1.5) after the problem is solved.
The error message “NO SAMPLE DILUENT” is
displayed when the analyzer detects the absence of
sample diluent solution. The testing of samples to be
NO SAMPLE DILUENT prediluted is interrupted. To solve the problem add
fresh diluent solution and re-run the sample (Chapter
E, paragraph 1.5).

This message appears when the vacuum pump inside

the analyzer has lost efficiency and the vacuum level
VACUUM SYSTEM: is below -40 millibar. It is possible to continue the tests
if the vacuum level is -35 millibar and by setting the
minimum threshold in the setup to -20 millibar. If the
problem persists contact nearest sales service
- WARNING – department.
After resolving the problem, the analyzer can be
LOW PRESSURE restarted and continue testing from where it stopped.
The message "-WARNING- LOW PRESSURE" may
Section I Chapter N Maintenance & Troubleshooting Page 9 of 13
 also appear when waste liquid container is full. Empty
or replace it.
The message “No Water …” appears when washing
water does not reach the analyzer because the external
water container is empty or defective loading pump.
When this message is displayed, the sampling
procedure for programmed tests is stopped. Fill the
- WARNING - external water container to continue the tests. Check,
NO WATER replace if necessary, the tubular filter on the intake tube
inside the water tank (par. 1.2.1. and ref. 5 Fig. 2). The
analyzer will start working from where it stopped (see
Chapter E, paragraph 1.5.). If the error message
persists, because of defective loading pump, contact the
approved technical assistance.
The message “Extra wash” is displayed during normal
THERE ARE THE working sessions seven days after the last Extra wash
FOLLOWING was performed. Execute an Extra wash procedure. This
message does not stop test execution, but it is not
OBLIGATIONS IN possible to guarantee correct results if an effective Extra
DIAGNOSTIC: Wash is not performed. The extra wash message is
EXTRA WASH displayed also if the analyzer is turned off without
washing the cuvettes with the correct daily procedure.

Section I Chapter N Maintenance & Troubleshooting Page 10 of 13

2.2.2. Screen Messages Requiring Technical Assistance

SCREEN MESSAGE CAUSES & REMEDIES

This message stops the execution of programmed
tests. The message “ERROR RESETTING SAMPLE
TRAY” is generated by an incorrect home position of
ERROR RESETTING the sample tray. This error can be caused either by an
SAMPLE TRAY absence of sample tray, or defective position sensor.
In case of a wrong positioning or absence of sample
tray, correctly position the sample tray in its chamber
and then press “F5” (“Reset”) key to restore correct
analyzer operation. In case of defective position
sensor contact qualified technical assistance to solve
the problem.

This message stops the execution of programmed

tests. The message “ERROR RESETTING
REAGENT TRAY” is activated by an incorrect zero
positioning of the reagent tray. This error can be
ERROR RESETTING caused either by an incorrect placement of reagents
REAGENT TRAY tray into the analyzer or by a defective position
sensor. Verify and correctly place the reagents tray
and then press “F5” (“Reset”) key to restore correct
analyzer operation. In case of defective position
sensor contact qualified technical assistance to solve
the problem.

This message stops the execution of programmed

tests. The message “ERROR RESETTING
DILUTOR” is generated by an incorrect zero
positioning of the dilutor piston. This error can be
ERROR RESETTING caused either by an excessive piston friction or a
DILUTOR defective position sensor. In the event of friction it is
sufficient to disassemble and clean the piston with a
soft cloth dampened with alcohol, reassemble and
then press “F5” (“Reset”) key to restore correct
analyzer operation. In case of defective position
sensor contact approved technical assistance to solve
the problem.

This message stops the execution of programmed

tests. The message is generated by a position sensor
ERROR RESETTING error of the cuvette tray. Press “F5” (“Reset”) key to
CUVETTE TRAY try to restore the correct operation of the analyzer. If
this does not solve the problem, then it will be
necessary the to contact approved technical
assistance.

Section I Chapter N Maintenance & Troubleshooting Page 11 of 13

 SCREEN MESSAGE CAUSES & REMEDIES
This message stops the execution of programmed
ERROR RESETTING ARM tests. The message “ERROR RESETTING ARM
ARM (HORIZONTAL) (HORIZONTAL)…” is generated by a defective
position sensor of the arm. Press “F5” (“Reset”) key
to restore the correct analyzer operation. If the
ERROR RESETTING I.S.E. problem persists, then contact approved technical
ARM (HORIZONTAL) assistance.

This message stops the execution of programmed

tests. The message “ERROR RESETTING ARM
ERROR RESETTING ARM (VERTICAL)” is generated by an error during
(VERTICAL) up/down motion the sampling needle. This error may
be caused by a deformed needle, obstructions (i.e.
improper placing of the reagent bottles) or a defective
ERROR RESETTING ARM position sensor. If the needle is deformed, replace it.
I.S.E. (VERTICAL) As regards obstructions, just place the bottles
correctly. Afterwards press “F5” (“Reset”) key to
restore correct analyzer operation. In case of
defective position sensor, contact approved technical
assistance.

This message stops the execution of programmed

tests. A defective position sensor of the washer
ERROR RESETTING module generates the message "ERROR
WASHING STATION RESETTING WASHING STATION". Press “F5”
(“Reset”) key to restore correct analyzer operation. If
the message persists, contact approved technical
assistance.

The message “Impossible to reset analyzer” indicates

a system error. It does not allow the continuing of
IMPOSSIBLE TO RESET working phases. Restart the system computer by
ANALYZER pressing the start button located under the LCD
screen. If the message persists, contact approved
technical assistance.

The message “Synch error” indicates a system

error. It does not allow the continuing of working
SYNCH ERROR phases. Restart the system computer by pressing the
start button located under the LCD screen. If the
message persists, contact approved technical
assistance.

The message “System blocked” indicates a total

SYSTEM BLOCKED blockage of the system. Restart the system computer
CALL ASSISTANCE by pressing the start button located under the LCD
screen. If the message persists, contact approved
technical assistance.

Section I Chapter N Maintenance & Troubleshooting Page 12 of 13

2.2.3. Optical System Verification Messages

ERROR MESSAGE CAUSES & REMEDIES

The message “LAMP PROBABLY OFF” is displayed
after a photometric zeroing, when the analyzer detects
that the optical system has a lower efficiency than the
minimum value stored. When this message is
- WARNING - displayed it is not possible to continue sampling tests.
LAMP PROBABLY OFF Replace photometric lamp (see par. 1.2.3 in this
chapter) and perform Photometric Zeroing (refer to
Chapter H paragraph 1.1.1.). In case the error
message still persists, contact approved technical
assistance.
The message “LAMP EXHAUSTED” is displayed
after a photometric zeroing, when the analyzer detects
that the optical system has at 340nm a lower
efficiency than the minimum value stored. The
- WARNING - sampling tests are not stopped after this message. It
is necessary to replace the lamp (see par. 1.2.3 in this
LAMP PROBABLY chapter) and repeat the “Photometer zeroing”
EXHAUSTED command (refer to Chapter H paragraph 1.1.1.). If
after observing these steps, the message no longer
appears, then it is possible to continue testing.
In case the error message still persists, contact
approved technical assistance.
The message “ERROR IN OPTICAL GROUP” is
ERROR IN OPTICAL displayed after resetting the analyzer and indicates an
optical group malfunction. Contact approved technical
GROUP assistance.
The message “CUVETTES TRANSMISSION OUT
OF LIMITS” is displayed after a photometric zeroing,
when the analyzer detects optically unusable
cuvettes. After this message the unused cuvettes (up
CUVETTES to a max. of three) are rejected by the analyzer that
TRANSMISSION continues to work with the remaining ones. An “Extra
OUT OF LIMITS wash” should be run followed by a new “Photometer
zeroing”.
If more than three cuvettes are unused operation is
stopped and intervention of the specialized technical
personnel is required.

IMPORTANT NOTICE:
The above-mentioned messages are only a partial representation of all the possible
warnings that the analyzer may output to the user. In case of any messages that are
not covered here or are not clear, please contact Technical Assistance Dept. at
Biotecnica Instruments S.p.A.

Section I Chapter N Maintenance & Troubleshooting Page 13 of 13

 OPERATOR MANUAL
BT1000 & BT2000PLUS

SECTION I: GENERAL INFORMATION

CHAPTER O
1. TECHNICAL SPECIFICATONS Page: 2

NOTE:
This manual is valid for both BT1000 and BT
2000PLUS. The following components are not installed
on the BT1000:
a) Reagent refrigerator
b) Barcode
c) Touchscreen

NOTE:
Specifications are subject to change without notice

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section I Chapter O Technical Specifications Page 1 of 4

1. TECHNICAL SPECIFICATIONS
PERFORMANCE
Operating Mode: “Random access”
Methods: Tests for Clinical Chemistry and Immune-Chemistry
Test Mode: Routine, Batch, Emergencies (STAT), Profiles
Tests on line: 48 refrigerated reagents + Relation Tests
Tests in memory: 500 single or double- reagent + unlimited Relation Tests
Test Re-runs: automatic or on demand
Calibrations and Controls: automatic or on demand
Automatic Profiles: automatic execution of related profiles or on demand
Measurement: direct reading of 25 cuvettes in optical glass
Quality Control: 3 known levels and 3 unknown levels
Remote diagnostic: Via Modem (optional)
Maintenance: Automatic program
Sample Tray Capacity: 78 total positions; 52 positions for Samples & STAT, 26 for Standard and
Controls
Sampling arm: 1 for Serum and Reagents
Bar code scanner: 2 distinct barcode scanners for positive identification of samples and reagents
TIME REQUIRED TO REACH STEADY STATE
Ambient conditions: 21 °C R.T., 33% RH
Time required for the analyzer to reach steady state: 20 min.
Ambient conditions: 21 °C R.T., 33% RH
Time required for refrigerated bottles to reach steady state: approximately 2 hours
CLINICAL CHEMISTRY (BT2000 PLUS)
Sampling Cycle: 14.5 seconds
Analytical throughput: Up to 250 tests/hour single reagent
CLINICAL CHEMISTRY (BT 1000)
Sampling Cycle: 18 seconds
Analytical throughput: Up to 200 tests/hour single reagent
CUVETTE OPERATING TEMPERATURE
Programmable Temperatures: room temperature, 30°C, 32 °C, or 37 °C
Precision ± 0,2°C - Accuracy ± 0,2°C
Temperature Monitoring Device based on Peltier Effect
REAGENT CHAMBER TEMPERATURE
Nominal Temperature: Between 5°C and 15°C Approx. (depending upon the setting)
Temperature Monitoring Device based on Peltier Effect
OPERATING AMBIENT TEMPERATURE
18 °C to 32 °C, 10% to 90% RH, Non condensating

DIMENSIONS AND WEIGHT NOTE: weight and dimensions shown are approximate
Instrument: Kg 85 (188 lb)
Packaged Instrument: Kg 105 (232 lb)
Accessories: Kg 25 (55 lb)
Packaged Accessories: Kg 45 (99 lb)
Instrument’s Dimensions: L = 78 cm (31") D = 58 cm (23") H = 68 cm (27")
Packaged Instrument’s Dimensions: L = 120 cm (47") D = 72 cm (29") H = 97 cm (38")
Packaged Accessories’ Dimensions: L = 70 cm (28") D = 70 cm (28") H = 55 cm (22")

ANALYZER POWER REQUIREMENTS

Universal Input: 100 / 240 V~, 50-60 Hz
Power: 370 Watts (BT1000: 250W)
PFC Unit (Power Factor Correction) included.

Section I Chapter O Technical Specifications Page 2 of 4

PRINTER POWER REQUIREMENTS
Universal Input: 100 / 240 V~, 50-60 Hz
Power: 50 Watts
UPS (optional):
Input: 220 V~, 50-60 Hz (110 V~ on request)
Output: 220 V~, 50-60 Hz (110 V~ on request)
Power: 1100 VA (710 Watts)

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The BT2000 PLUS instrument has passed all tests related to Electromagnetic Compatibility (EMC),
and "Safety requirements for electrical equipment for measurement, control, and laboratory use"
performed by the OCE Lab (EMC & Electrical Safety Compliance Test Laboratory), Ministry of
Communication - Italy accredited EMC certification body, No. 051 of 21 October 1998. Certificate's
documentation is available on request. The BT2000 PLUS is in conformity with the following
normative/standards:
EN 61326: EMC
EN 61010-1: ELECTRICAL SAFETY

PHOTOMETER

Optical System: Solid state photometry, (patented by Biotecnica Instruments S.p.A.)

Detectors: 10 UV/VIS photodiodes + reference channel
PRECISION AND ACCURACY
Spectral Response: 340, 380, 405, 436, 480, 510, 546 578, 630, 700 nm
Bandwidth: ± 5 nm max (The 700 nm is a Long Pass filter)
Photometric precision: ± 1% from 0 to 2.000 O.D., ± 2.5% at 2-3 O.D.
Photometric Sensitivity: ± 0.001 ABS
Drift: ± 0.005 ABS/h (steady state)
Optical path: 7 mm
Photometric Lamp: Tungsten Halogen Lamp with Dichroic Reflector
Beam Angle: 9º
Power: 35 Watts
Input voltage: 12 VDC
Avg Rated Life: Approximately 2000 hours
NOTE: For optimal result the lamp can be used for about 1,500 hours. The long-term use will result in the
gradual deterioration of the UV emission.
Diluter Type: Biotecnica Diluter
TECHNICAL SPECIFICATIONS
Max Volume: 470 µl
Linearity F.S.: ± 0.1%
Accuracy at 3 µl: ± 3%
Accuracy (Full Scale): ± 0.1%
Reproducibility: ± 0.7% at 3 µl; ± 0.6% at >3 µl
Average Life: 3 million operating cycles
Maintenance: Every 300,000 operating cycles (O-ring seal replacement)

Section I Chapter O Technical Specifications Page 3 of 4

VOLUMES
WORKING SOLUTIONS
Clinical Chemistry
Reaction Volume: 280 µl minimum; 700 µl max. (double reagent)
Sample Volume: from1 to 100 µl
RESIDUAL VOLUMES OF REAGENTS BOTTLES
NEW SERIES
50 ml BOTTLES: 1.5 ml
20 ml BOTTLES: 0.6 ml
10 ml BOTTLES: 0.6 ml

“UTILITY” EXECUTION TIMES

Wash & Fill Up: 270 seconds (approximately)
Wash H2O: 180 seconds (approximately)
Zeroing: 420 seconds (approximately)
F.C.C.: 900 seconds (approximately)
Extra Wash Cuvette: 540 seconds (approximately)
Wash Shut Down: 12 minutes (approximately)

WASH VOLUMES
Clinical Chemistry Washes:
H2O Single Wash of Cuvette: 5 ml (approximately)
H2O Single Wash of Needle: 2 ml (approximately)
Consumption per test: 7 ml (approximately)

H2O for Zeroing: 250 ml (approximately)

H2O Total Wash of Cuvette: 170 ml (approximately)
Extra Wash of Cuvettes: approx. 170 ml H2O + 13 ml Cuvettes Washing Solution

DATA MANAGEMENT
Computer > Pentium M > 1.6 GHz or more, IBM compatible
DVD/CD Rom Player > 16X
Hard disk >40 Gb
Floppy Disk Drive: 1,44 Mb
Monitor: LCD Display Module TFT 12” with integrated touchscreen
Interface: Serial Ports RS232C + USB PORTS
Printer: Ink-jet Color IBM compatible or other
Mouse & keyboard: Cordless, IBM compatible
External Modem: Optional
Error Messages: Visible (Vocal optional)
Software: Microsoft Windows 2000® PRO (Licensed)

NOTE:
1 As regards the technical specifications for the system "instrumentation + reagent" used in the applications
of kit, these are the responsibility of kit’s manufacturer and will be stated in the applications (refer to the
instructions accompanying the kits).
2 The analyzer BT PLUS does not require (after sales) any routine electrical or mechanical readjustments.
There are mechanical and electronic adjustments performed by the manufacturer (Biotecnica Instruments
S.p.A.) during assembly and quality controls. These adjustments may be performed again in case required
by a particular technical service and in any case are at the discretion of the authorized technical personnel
only. However, It is highly recommended to check the system periodically to prevent any faults or
malfunction of the analyzer.

Section I Chapter O Technical Specifications Page 4 of 4

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 1
1. ABBREVIATED OPERATING INSTRUCTIONS Page: 2
1.1. Turning on and preliminary procedures Page: 3
1.2. Inserting Reagents for Clinical Chemistry Page: 6
1.3. Analytical calibrations and Controls Page: 7
1.4. Entering Patients and Work Lists Page: 10
1.5. Running Tests Page: 14
1.6. Displaying and Printing Results Page: 15
1.7. Turning off the analyzer Page: 19

FOREWORD
This quick guide gives a global view of the system operation by outlining
the sequence of fundamental operating phases. It is highly
recommended to carefully read the whole manual in order to have a
deeper knowledge of each argument.

ATTENTION: USE OF THE BT2000 PLUS (AND DERIVATES) INTERNAL COMPUTER

The computer box of analyzer BT2000 PLUS and by-products is designed for long-term
security and reliability and is virtually maintenance-free as long as the user does not install
any third-party application programs. If these applications are installed, then they may
damage the operating system registry and may also cause disastrous consequence for the
computer's hard-drive. Biotecnica Instruments S.p.A. will not be responsible for any
damage to the analyzer, its software and data in the hard-disk in case of improper use of
the PC box. This includes also: installation of external programs, not properly secure net
connections (intranet and internet) and the use of disks without the necessary verification
for viruses presence. Biotecnica Instruments S.p.A. will not be responsible for any damage
caused by non authorized third parties who may open and alter the PC box configuration.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section II Chapter 1 Abbreviated Operating Instructions Page 1 of 19

1. ABBREVIATED OPERATING INSTRUCTIONS

The BT2000 PLUS is an automatic analyzer for clinical chemistry and immunochemistry analyses.
The analyzer can be divided into the following two distinct operative parts:
a) Sampling Unit: It prepares for tests the samples and single or double reagent.
b) Reading Unit: Cuvette plate with integral automatic washing system.

SYMBOLS
As the BT2000 PLUS analyzer software runs under Windows, it uses the same philosophy with
windows, icons, quick commands, function keys and curtain-shaped menus.
Every window has its own icons and specific menus that will be described hereafter. The full
meaning of each command will be explained in the corresponding chapters.
At the start-up the program will display the following main window:

1
2

5 3

8 9 10

① Main menu: each menu generates other commands and/or options

② & ③ Direct access icons: selecting each icon the relative command is directly activated
④ Software version: operative program version
⑤ Access level: is the access level of the operator: it is password dependent
⑥ Vertical Bar - Commands: Direct access to function commands
⑦ Messages bar: clicking here opens a window showing the messages received by the
program
⑧ Errors bar: by clicking here a window is opened showing the errors occurred during the
work session
⑨ Refrigerator Status Indicator
⑩ Operating Pressure Indicator, Ambient Temperature (RT), Cuvette Temperature (CT)

Section II Chapter 1 Abbreviated Operating Instructions Page 2 of 19

1.1. TURNING ON AND PRELIMINARY PROCEDURES
Turning on procedure for the first time:
1) Turn on the UPS device as described in the appropriate supplied manual.
2) Power on the printer (refer to the specific manual enclosed).
3) To switch on the analyzer, use the main power switch on the rear panel of the instrument. This
button activates only the refrigerating system for the reagents. To properly turn on the analyzer
system, momentarily press the push-button under the Floppy Disk display (Fig. 1).
CAUTION
Do not press this push-button during analyzer operation, because when pressed it stops the
instrument, leaving only the refrigerating system on (refer to Paragraph 1.6., Chapter E, "Turning
off procedure").
4) Once turning on procedure has completed (lasting few minutes), wait for the system to warm up.
During warm-up phase the temperature indicator flashes on the bottom right of the display until
the appropriate temperature is reached. The instrument reaches the steady state after
approximately 20 minutes.

DVD-ROM

FLOPPY
DISK

POWER BUTTON
COMPUTER

Fig. 1

5) Verify the presence of the washing liquid (at least for the daily needs). It consists of bi-distilled
H2O plus surfactant (1ml/l of water - ratio 1/1000).
6) Verify that waste liquid containers are empty or at least have the capacity to contain the quantity
of liquid produced during the working day.
NOTE:
It is important to observe steps 5) and 6) to ensure a continuous operation of the analyzer without
interruptions.

Direct Access Icon

Fig. 2

Run a dilutor prime by the command “Dilutor prime” (Fig. 2).

Run a wash by the command “Wash with water”.

Section II Chapter 1 Abbreviated Operating Instructions Page 3 of 19

 SERVICE ICONS BAR

Reset Analyzer (F5)

Stand-by Analyzer (F6)

Displays the Volumes’ Status; Used to Insert/Remove Reagents (F10)

Password (F7)

Status Analyzer (F2)

Printer Setup (F4)

Help on line (F1)

FUNCTION ICONS BAR

1 - To Insert New Codes, Parameters, Standards and Controls for all Analyses

2 - To Create the On-Line Reagents’ Tray

3 - To Insert Parameters/ Standard and Controls for the On-Line Reagents

4 - To Insert/Modify Profiles

5 - To Insert Routine - View Programmed or In-Run Patients

6 - To Insert Batch

Section II Chapter 1 Abbreviated Operating Instructions Page 4 of 19

 7 - To Run Standards

8 - To Run Controls

9 - Analyzer’s Utilities

10 - Mechanical Calibrations

11 - a) Results Listed per Patient b) Results per test in real time

12 - No Results

13 - Reaction Graphs

14 - Turning off the System

Simply positioning the cursor on the icons the “hint” will appear (where available), showing a brief
description of the icon function. This is followed (when available) by the function key between
brackets, which allows for the same function or command as the icon. For example, the hint “Reset
(F5)” means that the function key F5 has the same function of the icon. In the same way, in each
menu are shown (when available) the quick commands (e.g. “Insert Batch” (Ctrl+B) means that the
same function is activated by typing simultaneously on the keyboard the keys “Ctrl” and “B”).

GENERAL ICONS

Cancel (aborts the programming and closes the window)

Save (saves the program and closes the window)

Print (prints the window's contents, i.e. parameters, graphs etc.)

Reduces the window to the upper bar where the analyzer's name appears.

An icon representing refrigeration system operation has been added to the status bar in the main
menu. The "Refrigerator disabled" state may be necessary if the operator decides not to use the
refrigerator for reactions or after a refrigeration operating error generated by the system.

Refrigerator enabled Refrigerator disabled

Section II Chapter 1 Abbreviated Operating Instructions Page 5 of 19

1.2. INSERTING REAGENTS FOR CLINICAL CHEMISTRY

Figure 3
This function is accessed either by pressing F10 key or by clicking on the specific icon. It
helps the user to correctly position the reagent bottles, as programmed in the current tray.
The reagent tray is divided into three sectors, identified by the letters A, B and C. Each
sector has 8 positions. The screen displays the representation of 8+8 bottles (Figure 3).
The analysis codes of large bottles are displayed on the lower positions, while the upper
positions indicate the codes used for small bottles including the volume status for the
sample diluent.
Insert / remove reagent: to insert or remove the reagent bottles
Right-click over analysis code. A combo box asks the user to choose between "Insert
bottle" or "Remove Bottle". After the choice has been made, the analyzer will correctly
position the tray to match with the arrow at the base of the tray itself. The verification of fluid
volume contained in the bottle is associated with the insertion procedure. With the barcode
option enabled, identification is correctly achieved through the automatic scan of the
barcode on the inserted bottle. The same function can be performed on command, by
activating the “Scan bottle” command, near the insertion and removal commands.

NOTE: when using the “Remove” option, no functional control is performed: the
existing volume and test code are not removed.

Fig. 4 Fig. 5

Section II Chapter 1 Abbreviated Operating Instructions Page 6 of 19

1.3. ANALYTICAL CALIBRATIONS AND CONTROLS
CALIBRATIONS
The analytical calibrations that can be run by the analyzer are divided as follows: With Factor,
Linear and Non Linear. The selection occurs during the programming of the analytical test
parameters (refer to Chapter C, paragraph 1.3.3. “Primary Analytical Parameters”) and can be
executed on user’s request or automatically.
Linear and With factor analyses
“Factor”: This parameter converts absorbance (ABS)
values detected by the analyzer into final concentration
values. When a theoretical factor is used (i.e. “With
Factor” methodologies), enter in this field the known
factor. The analyzer, when calibrating, calculates and
updates the factor value.
“Range limit”: In order to verify calibration’s validity,
enter the "Minimum" and "Maximum" range in which the
factor must be included. If an out-of-limit factor is
detected, a message informs the user and the
previously stored value is not modified.
Calibrators or standards used must be placed into
dedicated positions on the samples’ tray. It is possible
to use up to 4 different standard concentrations or run
up to 4 repetitions on a single title (and position) in the
linear analyses.

Figure 6

Programming replicates on a single title

Enter “1” into the “Number of samples”, then enter the “N. replicates” (up to 4 max). Select the
actual position (“Pos.”) on the tray for the replicated standard and then the concentration
(“Conc.”). The values are automatically updated in the “ABS” boxes during the calibration and the
factor will be automatically calculated.
Programming several standards
Enter the number of standards to be used in the “Number
of samples” textbox. Enter the actual positions (“Pos.”)
on the tray for each standard and then the concentrations
(“Conc.”). The values are automatically updated in the
"ABS" boxes during the calibration and the factor will be
automatically calculated.

Calibration parameters
“Max Var. (%)” (Maximum percentage variation): This
parameter is for verifying percentage variation. It
represents the acceptable difference between the ABS
values calculated for the different calibration points, in
case more calibrators are used or repetitions are
performed on a single title. When an out-of-limit variation
occurs, a message informs the user and the calibration
will not be stored (the previous positive calibration will
remain in memory).

Figure 7
Section II Chapter 1 Abbreviated Operating Instructions Page 7 of 19
“Reagent mABS”: It is a read-only field and it is updated every time the blank reagent is
performed.

“% from last calibration”: It is a percentage check made between current and previous calibration.
It compares the newly determined ABS with already stored data. If the programmed limit is
surpassed, then a message informs the user and the previous positive calibration will remain intact
in memory.

“Automatic adjust”: It is a password-protected parameter that enables or disables automatic

modification of test results in case of an additional calibration run during patients’ execution.

“Last Standardization”: This field displays date and time for the last stored positive calibration. By
double-clicking over the date textbox it is possible to display the previous calibration parameters.

“Save”: This command saves data and then closes the window.

Non Linear analyses: These tests require from 3 to 6 standards. Enter the number of standards to
be used in the “Number of Samples” field. Enter the actual positions (“Pos.”) on the tray for each
standard and then the related concentrations (“Conc.”). The values are automatically updated
during calibration into the “ABS” boxes.

To use standards pre-dilution function, enable the “Automatic Dilution”. It is then possible to
select whether dilution must be performed with water or physiological solution (“Dilution with
solution”). In the “Dilution” field enter the required dilution ratio. If automatic dilution is not
required, then appropriate concentration of the corresponding standard must be entered in the each
concentration field.

“Graph”: This command displays the graph of the stored interpolation curve. In the graphic display
page, data and curve are displayed together and can be printed.

Normalization procedure for the stored calibration curve

Figure 8

Enable with check “Re-calibrating on single point”, then enter in the “Calibration point”, the
position number (corresponding to the “Number” field) occupied by the desired calibrator during the
plotting of previous curve. Then enter in the “Sample position”, the position on the tray where it
should be placed. After determination, the analyzer calculates the percentage offset for the current
result from the stored value, then reprocesses and mathematically updates the remaining ABS
values of standards already pertaining to the curve, thus normalizing the whole calibration.

Section II Chapter 1 Abbreviated Operating Instructions Page 8 of 19

CONTROLS
The controls are divided into “Known” and “Unknown”, where it is possible to program three
levels for each one subdivided in tables:
“Known”: Level 1, 2, 3
“Unknown”: Level 1, 2, 3

Figure 9 Figure 10
“Known”: Enter lot name or number, mean value, and min & max limits. Enter tray’s position,
already set to controls in the section “Setup Analyzer” included in the inner ring of samples’ tray.
“Unknown”: Enter lot name or number and tray’s positions. Reserved positions are those already
set in the program “Setup Analyzer”, which are shared with known ones.

RUNNING STANDARDS AND CONTROLS

The functions “Run Standards” and “Run Controls” can be accessed from “Tests” main menu or
through the specific icons that allow direct access (Fig. 11 and 12).
The displayed analysis codes pertain to the list generated in the “Current tray”. To run standards
and controls, select the desired tests and then click on the “Run” button. To leave program press
"Exit".

Run Standards Run Controls

Direct access icon Direct access icon

Figure 11 Figure 12

Section II Chapter 1 Abbreviated Operating Instructions Page 9 of 19

1.4. ENTERING PATIENTS AND WORK LISTS
Entering Samples (Routine, STAT, Controls and Batch)
Samples can be entered with “Insert Routine/STAT” or with “Insert Batch”. These can be
accessed from “Patients” main menu or through appropriate direct access icons. Select "Exit" to
leave the program. The represented analyses codes pertain to the list generated in the "Create
current tray".
Entering Patients: The options outlined below are available in this page "Global Insert/View
Patients" (Figure 13). Point the cursor on the desired option and click to confirm. To leave program
press "Exit".

Direct access icon

Figure 13

“Re-run”: allows tests re-run (repetitions) on user’s demand.

“Routine”: Default displays of Patient positions

“STAT”: Displays STAT (Single Test in Actual Time, i.e. urgent positions) positions.

“Control”: Displays Control positions.

“Standard”: Displays Calibrator positions.

“New Entry”: Displays window for entering data of Routine, STAT and Control samples.

“Extra Patients”: Displays the list of patients with no assigned position. Patients selected in the
work-list may be moved here (“Options” menu, “Send to extra patients” command) and then back.

"Exit": To leave program

Section II Chapter 1 Abbreviated Operating Instructions Page 10 of 19

Example of entering samples
New Entry Routine:

Figure 14

After the selection of "Routine" followed by confirmation through command "New Entry", the
patients acquisition frame is displayed (Figure 14). The programmed patient can be executed
immediately or saved for later use. The programming fields and the functions are outlined below:
“Code”: It is the identification number assigned by the user to the patient. It is possible to assign an
already given code thus creating a clone of the patient. The cloning of a patient's code allows the
user to obtain one report in case different samples are used. If this option is not used, then separate
reports are obtained.
It is also possible to create multiple duplicates of the same patient, where the codes will be
automatically assigned and identified by the name “Autobatch”. These will have individual reports.
“Surname”, “Name”: Enter patient’s personal data.
“Date”: enter the test date.
“Notes”: enter additional notes.
“External Dilution Factor”: By default set to “1”. It allows analysis determination on externally
diluted samples. Enter in this field the external dilution factor ratio used in sample preparation. Final
result is multiplied by the inserted external dilution factor.
“Group”: Select the group (Man, Woman, Child) for correct reference with normal values range.
“Type”: It is default set to “Serum”. The sample type (Serum or Urines) is selected here. If “Urine”
is selected, then the volume of diuresis is requested.
“Assigned Group” (“Routine” or “CTRL Routine”): The default setting is “Routine”. It is used
for selecting the category (Patient or Control Serum) during sample programming. Selecting “CTRL
Routine” the type (“Known” or “Unknown”) and levels (Level 1, 2, 3) must be specified.

Section II Chapter 1 Abbreviated Operating Instructions Page 11 of 19

“Position”: Displays the assigned position on the sample tray.
“Test”: Generates the Analysis List. Select each analysis to be performed on the sample.
“Profile”: Select the desired profile among the available. The analyses programmed in this way can
be modified. To add or remove tests, it is necessary to enter in the screen "Select tests" and confirm
by clicking on the textboxes. With “Deselect” it is possible to delete an already selected profile.
“Save”: Saves patient’s data and the associated analyses. With this command test execution is
delayed.
NOTE:
In the routine programming, it is possible to acquire a greater number of patients than the
available number of positions in samples’ tray. All the patients acquired with no associated
position are saved and displayed in the extra patients list and can be transferred to the main
list on user’s demand (refer to paragraph 1.5. “Work Lists”).
“Run”: This command immediately starts the execution of the programmed patient. The sample
plate adjusts itself to match the position assigned to the patient, and a blinking red LED indicates
the position for inserting cup or primary tube.

Entering samples in Batch

Direct access icon

Figure 15
Batch Entry: Click test code, then click each desired position (selected positions are highlighted in
red). Finally click on the checkbox by the code to activate the programmed batch. Select the “Run”
button to perform the patients. Refer to Figure 15.

Section II Chapter 1 Abbreviated Operating Instructions Page 12 of 19

Work Lists

Figure 16
Work Lists (Figure 16) are used to display the patient codes or to verify the status of the samples in
the tray together with the situation of Routines, STAT, Controls and Calibrators. The Work Lists can
be accessed through the menu "Patients" → "Insert Routine/STAT" or using its direct access icon.
The screen displays the “Current Tray (Routine)” in the center and the “Extra Patients (Routine)”
on the right. During the working phase, the "Re-run" is also shown.
Click on the STAT, Controls and Standard buttons to view their worklists. For each the
Current Tray and the Extra Patients lists will be displayed. It is possible to perform patients
while running calibrations.

Section II Chapter 1 Abbreviated Operating Instructions Page 13 of 19

1.5. RUNNING TESTS
Once the data has been entered, insert the samples into the tray (Figure 17) and then place the
tray into the analyzer (Figure 18).

Figure 17 Figure 18

“Options”:
The “Options” menu is available in the "Current Tray" (Routine, STAT and Controls). It displays the
following commands:

“Send to extra patients”:

The selected patients are removed from current samples tray list for
placement on "Extra Patients List". Selection can be done by checking the
appropriate boxes.
“Print”:
Prints the partial (for selected items) or total samples list.
“Select All”:
Automatically selects the whole list.
“Deselect All”:
Automatically deselects the whole list.
“Run”: Work start command. If single patients or the whole list are selected,
a message asks if the samples have been inserted. If the answer is affirmative, the analyzer
automatically starts processing. In case of a negative answer, a guided procedure will assist the
user to insert the samples. The selection of the sample to be inserted is performed by confirming
with cursor on the corresponding line. Use “Select All” to select the whole list and “Deselect All”
to deselect it but in this case confirmation is required. After the insertion of all the samples, activate
"Run"
“Delete”: Removes selected or all the patients. Confirmation is required.

Section II Chapter 1 Abbreviated Operating Instructions Page 14 of 19

1.6. DISPLAYING AND PRINTING RESULTS
Displaying Patients Results
The representation of the test results can be accessed through the specific icon (shown
on the right) for the two available options: “View results for sample” (results will be
displayed for patient) and “View results for test” (results will be displayed for test).

Figure 19
The "Patient’s" data display page is shown in Figure 19. It can be accessed through the
specific icon (shown on the right). It is a brief representation of data and allows
visualization of results of patient in execution as the tasks for the single patients are
completed. Once the results are archived, the information present in this page will no longer be
available.
In this area information related to calibrations is represented, such as the values of calculated
factors or any types of errors that occurred during execution.
If there is no data the page appears blank. A color code makes it possible to quickly identify the
information:
- red text: presence of flags in at least one test of the sample
- blue text: controls
- green text: calibrations
- black text: no anomaly in the test or the entire sample
The following information is displayed for each sample:

a) Sample Position (#XX) Progressive number from 01 to 52 for Routine and STAT.
Progressive number from 01 to 26 for STD and CTRL.

Section II Chapter 1 Abbreviated Operating Instructions Page 15 of 19

b) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
It is automatically assigned for CTRL, but can be assigned by the user
during input. The relevant group level is also indicated (see Chapter F,
paragraph 1. “Quality Controls”).

c) Surname, Name Patient’s personal data.

d) Sample Type The relationship of Sample to one of the groups: Routine, STAT, CTRL
or STD is indicated between brackets.

e) Results The results of test attributed to patients are represented with:

- full name of the analysis

- method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)
For automatic re-runs the values of the first and second determination
are represented.

The following commands are available in the data display page:

“Print”: Print command. If enabled, it prints the entire contents of the data display page. However,
this is not a print-out in report format.
“Sort”: Data sorting command. This function is enabled only at the end of working session. The
real-time data are displayed in test execution order. The "Sort" command allows sorting based in the
following criteria, in this order: date, time, position on tray. The controls are places last and the
calibrations first.
“Adjust”: Data re-reprocessing command. This function is enabled only at the end of working
sessions. For patients re-run manually only the last result will be recalculated. The correction is
made starting with the absorbance memorized for the single test.
After confirming the command and selection of the desired analysis, two data re-processing modes
are available. The first mode allows a positive or negative percentage correction and the second
mode uses the latest valid calibration
“Archive Data”: This command saves data into the patients archive.
“Delete Results”: deletes all the data from the visualization pages (per patients and in real time) as
well as the page of reaction graphs.
“Exit”: Exits from data display page.

INFO FLAGS
In both types of result displays (per patient and in real time) an Info Flags button is available on the
upper right.
It provides access to a page where the flags are located, with a short explanation of the meaning of
each one.

Section II Chapter 1 Abbreviated Operating Instructions Page 16 of 19

RESULTS PER TEST

Figure 20
After the termination of programmed task, the results can be viewed per "Test". The test Results
display page is shown in Figure 20. Test results with flags are highlighted in red.
The following information is displayed for each single test:

a) Code and test name: The displayed code is the same read on the list of tests, while
the full name between parentheses is the one assigned by the
operator in the analytical parameters (chap. C, par. 1.3.3.).
b) Sample Position (# XX): Progressive number from 01 to 52 for Routine and STAT.
Progressive number from 01 to 26 for STD and CTRL.
c) Sample Code: For patients (Routine and STAT) it is assigned during check-in.
For STD and Batch it is assigned automatically.
d) Results: The results of test attributed to patients are represented with:
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)

The following commands are available in the results display page:

PRINT: used to print the contents of the window. This is not a print-out in “report” format. A
print preview will be displayed where it is possible to select which and how many pages to
print.
EXIT: closes the page and returns to the main program, without modifying the data.
Section II Chapter 1 Abbreviated Operating Instructions Page 17 of 19
DISPLAYING REAL-TIME DATA

Figure 21
The data shown refer to the results obtained by the analyzer in real time (fig. 21), i.e. as the tests
are completed. The results are not sorted in any way, not per patient, not for type of test.
The data display is synthetic. The results of tests associated to flags are shown in red.

Once the results are archived, the information present in this page will no longer be available.

The following information is displayed for each single test:

a) Sample Position (#XX) Progressive Number from 01 to 52 for Routine and STAT.
Progressive Number from 01 to 26 for STD and CTRL.
b) Sample code For patients (Routine and STAT) it is assigned at input.
It is automatically assigned to STD and Batch.
It is automatically assigned to CTRLs, but it can be given by the
operator during input. The group pertinence is indicated. (see
Chapter F, paragraph 1. “Quality Controls”).
c) Date and time: The date and time the test was run is between parenthesis.
d) Results: The results of test attributed to tests are represented with:
- name of the analysis
- execution method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)
For automatic re-runs the values of the first and second
determination are represented.

Section II Chapter 1 Abbreviated Operating Instructions Page 18 of 19

A window is also available on this page (Info flag) with information relative to the flags associated to
the results. The Print and Exit buttons are also present, their functions have already been described
in the previous paragraph.

1.7. TURNING OFF THE ANALYZER

To turn off the instrument, the "SHUT DOWN" procedure must be observed. In this way the
instrument is turned off, except for the reagent refrigerator. The shut down procedure proposes the
wash of the cuvettes with appropriate washing solutions before turning off. The analyzer indicates
the position where the detergent should be inserted for the cuvettes washing (see also Chapter. C,
paragraph 1.1.).

There are two additional modes for interrupting analyzer operation:

1) “SLEEP-MODE”
This mode can be manually activated, or it starts automatically when the instrument is left inactive
for more than 30 minutes. The Sleep-Mode automatically performs the wash and fill up of the
cuvettes with bi-distilled water and remains idle (waiting for user’s commands for immediate
operation).

2) “LOG-OFF”
The "Log-Off" mode represents a partial turning off of the analyzer. It disables some devices:
halogen lamp of the photometer, cuvettes thermostat and drive motors. This mode is used for
energy saving.
The Log-Off mode is utilized for programming automatic turning on at a desired date and time. The
instrument will remain in a stand-by condition and it will automatically turn on 30 minutes before the
programmed time. The turning on in anticipation (30 minutes before the programmed time) allows
the analyzer to reach steady state thus allowing immediate operation at the programmed time.
To exit ahead of time from a suspended activity, press a key on the keyboard and press the Exit
button on the window that appears. However, in this case it is necessary to wait for the devices to
become operational (around 20 minutes).

CAUTION!
a) Do not ever stop the analyzer by turning off the main switch prior to performing
the correct "SHUT DOWN" procedure.
b) Improper shutdown may cause loss of data and programs and will necessitate
reinstallation of the operating software.

Section II Chapter 1 Abbreviated Operating Instructions Page 19 of 19

 OPERATOR MANUAL
BT 1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 2
2. WARRANTY CONDITIONS Page: 2
• Notes from the manufacturer Page: 3
• Parts / Instruments Return Authorization Page: 4

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section II Chapter 2 Warranty Conditions Page 1 of 4

2. WARRANTY CONDITIONS

• Biotecnica Instruments S.p.A., after having accurately tested this analyzer,

guarantees the instrument for 1 (one) year starting from invoice or goods delivery.
• The warranty includes the repairing and the replacement for free of the faulty
parts due to wrong manufacturing. Warranty is not extended to the normally
consumable parts of the system.
• The warranty is not valid in case of improper use, negligence, improper or lack of
maintenance and cleaning, tampering or repairing by third parties not authorized
by Biotecnica Instruments S.p.A. and in any case when the cause cannot be
stated as original manufacturing fault.
• The costs of shipment and transport to Biotecnica Instruments S.p.A. for repair or
substitution, and the risks deriving from this is the responsibility of the buyer,
including all the costs of onsite technical service at client's location (transport,
board and lodging) as well.
• If the stated defects will result to be out of warranty limits, the buyer will pay repair
or replacement costs.
• Biotecnica Instruments S.p.A. is not responsible for any unforeseen technical
problem that might occur. If the requested technical assistance is outside the
terms of warranty a charge will me made to the customer as per current rates in
force.
• Biotecnica Instruments S.p.A. is an internationally known for its high quality
standards in production. Biotecnica Instruments S.p.A. is thus responsible for
providing to the customer clear and effective information for use of it's products,
including all the precautions and warnings for a secure and risk-free use.
• Service personnel must also refer to the warnings and cautions notices in this
manual. It is the duty of the service engineer of Biotecnica to instruct the
customer’s personnel to take all necessary precautions during repair and handling
of products.
• Biotecnica Instruments S.p.A. is not responsible for any damage that may be
caused directly or indirectly to persons or things due to a lack of observance of all
the warnings and cautions outlined in the user's manual, and concerning the
warnings and cautions during the different working phases of the instrument (see
chap. M). Direct, indirect, incidental, special, moral damages as well as other
damages of any type (including, with no limitation, those deriving from profit’s
loss, business interruption or information loss) cannot be ascribed to Biotecnica
Instruments S.p.A. even in the case in which the possibility of the event had been
explicitly stated.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
Tel. +39-06-4112316
Fax +39-06-4103079
E-mail: [email protected]
Web: www.biotecnica.it
Section II Chapter 2 Warranty Conditions Page 2 of 4
NOTES FROM THE MANUFACTURER
The Biotecnica Instruments S.p.A. reserves the right to revise this manual without
notice, for any reason. This includes but is not limited to, utilization of advance in
the state-of-the-art and changes thereof. Product enhancement resulting from our
continuing quality improvement effort may necessitate changes in specifications
without notice. This fact doesn’t oblige the company to inform its actual customers
because the information included in the present manual refers to state of the
product when shipped, thus no warranty about notification of future changes is
given.
The information contained in this manual is proprietary with "Biotecnica
Instruments S.p.A.". Reproduction of any part or whole may only be performed
with written permission from "Biotecnica Instruments S.p.A.".

Section II Chapter 2 Warranty Conditions Page 3 of 4

 Page 1 of 1

Mod.05-35a-ing Rev. 1
Parts / Instruments Return Authorization
DATE: ______/______/____

From:
To: Technical Assistance – Export Manager
Client information
Instrument model: Serial number:

Defective part
Part description:

Code: Serial number:

Bar-code number: Quantity:
Under warranty: Yes No Invoice number: Date:
Description of the problem:

Request for:
Repair Exchange Quotation Urgent

Name: Signature:

Biotecnica Instruments response

Return authorization number: / 200_ Date:

Approved: Yes No
Repair Exchange Destroy Quotation:
Note:

Approved by: Technical Assistance Dept. Signature:

Checked by: Quality Assurance Manager Signature:
NOTE: No parts or instruments will be accepted for repair or replacement without a Return Authorization number that can
be obtained from Biotecnica Instruments S.p.A. Fax this Return Authorization form to +39 06 410 3079 to the attention of
Technical Assistance/Export Manager, who will then evaluate and issue a Return Authorization number.

WARRANTY EXCTRACT: Biotecnica Instruments S.p.A. warrants its instruments to be free from defective parts and
workmanship for a period of one (1) year from the date of purchase. Liability under this warranty is expressly limited to
repair or replacement of defective parts at the option of Biotecnica Instruments S.p.A. This warranty does not cover the
results of misuse, accident or abuse of any parts of its instruments which have been repaired, tampered with or altered by
anyone other than personnel authorized by Biotecnica Instruments S.p.A. This warranty does not apply to fluid handling
devices, consumables or reagents.
Products returned to Biotecnica Instruments S.p.A. for repair or replacement shall be sent with transportation prepaid.
If found not to be defective under the terms of warranty, a charge will be made for repair or replacement and freight costs
will be at customer’s expense.

Section II Chapter 2 Warranty Conditions Page 4 of 4

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 3
3. ORDERING INFORMATION Page: 2
3.1. GENERAL TERMS AND CONDITIONS FOR SALE Page 2
3.2. Consumables for BT2000 PLUS Page: 3

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section II Chapter 3 Ordering Information Page 1 of 3

3. ORDERING INFORMATION
For technical or ordering assistance start with our convenient ordering check list located in
the ensuing paragraphs 3.2. and 3.3. For further assistance, don't hesitate to call the
Biotecnica Instruments S.p.A. or your local sales/representative office.
To obtain accessories/spare parts, address order or enquiry to your Biotecnica Instruments
S.p.A. sales/service representative or to Biotecnica Instruments S.p.A. and supply the
following Information:
a) Instrument Model and Serial Number
b) Quantity of parts desired
c) Part Number
d) Description
Biotecnica Instruments S.p.A.
Via Licenza, 18
00155 - Rome (ITALY)
Phone: +39 06 411 2316 Fax: +39 06 410 3079 E-mail: [email protected]
NOTE:
DUE TO IMPROVEMENTS IN DESIGN AND/OR SPECIFICATIONS, SOME PRODUCTS MAY DIFFER
SLIGHTLY FROM THE PREVIOUS DESCRIPTION.

3.1. GENERAL TERMS AND CONDITIONS FOR SALE

ORDERS: All telephone or written orders placed by the customer are considered a binding
contract created with the Company, when a written order acceptance has been sent by the
Company or the ordered goods have been shipped. For orders with a value over Euro
250,00, the goods including the packing cases are shipped carriage paid. All prices listed
exclude VAT and all similar taxes and the purchaser will be liable for such taxes if
applicable.
SHIPMENTS: In accordance with the general provisions of law, the goods are shipped at
the customer's risk even where shipped carriage free.
The goods with cold storage temperature between 2 - 8° are shipped at controlled
temperature.
CLAIMS: Any claims must be made within 10 days from the receipt of goods.
PAYMENT TERMS: The terms of payment indicated on the invoice are valid. In the event
of overdue account, interest and expenses will be applied as per the regulations introduced
by Italian Legislative Degree 231/2002 of 7 November 2002 implementing EC directive
35/2000 (official ECB rate plus the rate established annually by the Italian government).
JURISDICTION: For any judicial contest, legal venue for both parties is Rome (Italy).

For additional information please visit our website at the following URL:
www.biotecnica.it

Section II Chapter 3 Ordering Information Page 2 of 3

3.2. CONSUMABLES FOR BT2000 PLUS

PRODUCT PART NO. SIZE

Surfactant Concentrate 392 2x50 ml
Cuvettes washing solution 393 1 liter
Cuvettes’ extra wash solution 393E 2x100 ml
Fuse 8AT, 250 Volt (for Analyzer) 330.6342B 1
Power Cord (for analyzer) 330.6391 1
Power Cord (for peripheral devices) 330.6400 1
Peristaltic Pump Cartridge 330.9072 1
Halogen Lamp 12V/35W for Photometer 330.9321 1
Tubular Filter for H2O container 330.9614 1
Distilled Water container 5 lt Cubitainer 660.4002 1
Cleaning Tool for Arm Needle 662.0629A 1
Waste Container 10 lt Cubitainer 662.1010 1
Sampling Needle 662.1011 1
Annual Maintenance Kit 662.2001 1
Sample Cup 2 ml 667.1040 1 (min. 1000)
10 ml Test-tube 667.1081 1
Reagent Bottle 50 ml (white) 667.1084 1
Reagent Bottle 20 ml (white) 667.1085 1
Reagent Bottle 10 ml (white) 667.1086 1
Reagent bottle cap 667.1075 1

Section II Chapter 3 Ordering Information Page 3 of 3

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 4
4. SOFTWARE - Serial Communication:
Page: 2
BT2000 PLUS <-> Host Computer
4.1. General Page: 2
4.2. Patient transmission to BT2000 PLUS Page: 2
4.3. Results reception Page: 3
4.4. Calculation of check-sum Page: 4
4.5. Wiring diagram of interface cable Page: 5
4.6. Variable communication protocol Page: 6
4.7. Serial communication test programs Page: 17
4.7.1. Program Comunica.exe Page: 17
4.7.2. Program BTPLUS.exe Page: 17

Important Notice:
Any modification to the Variable Serial Protocol is restricted to qualified personnel only. The
Biotecnica Instruments S.p.A. guaranties the correct performance of the internal serial
protocol. The responsibility for any malfunction arising out of any modifications to the
scripts of the Variable Serial Protocol rests with the customer.

WARNING
This information regards the setting up of the barcode for sample tubes identification. The
reading of the sample barcode label has the same progression as patient code.
For example: Once a patient code of 15 characters has been entered, then a code of 8
characters followed by 7 empty spaces to reach the 15 characters is sent.
The code read on the barcode label must have the same sequence 8 + 7 for correct detection.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section II Chapter 4 Serial Communication Page 1 of 17

4. SOFTWARE - SERIAL COMMUNICATION:
BT2000 PLUS <-> HOST COMPUTER

4.1. GENERAL
The analyzer BT2000 PLUS allows bi-directional communication through RS 232C serial
connection with any host computer.
The particular feature of the dialog is that it is always the host computer, which initiates the
communication for either transmitting patient list or for receiving the results.
To initiate any communication the host computer will have to send to analyzer the character
STX (0x02) and expect the character ACK (0x06) as a response. At this point the host
computer will send data to the analyzer and terminate the communication by sending the
character EOT (0x04).
It is important to remember that any communication is followed by a response from the
analyzer.
It must be noted that if the parameter to be transmitted is shorter in length than the length
requirement of the communication protocol than a space must be added before or after. For
example the analysis have length 4, therefore to send a code GLY one must add a space
after to reach the length of 4 characters.

4.2. PATIENT TRANSMISSION TO BT2000 PLUS

► Start communication with sequence STX<->ACK.................
► Send patient code.................................................................. (15 characters)
► Send list type for patient insertion......................................... ("T" for Routine or "R" for STAT)
► Send type of serum............................................................... ("S" for Serum or "U" for Urine)
► Send if the patient is a clone................................................. ("Y" for Yes or "N" for No)
► Transmit position of cup........................................................ ("00" unknown)
► Send number of tests to be executed.................................... (from "01" to "99")
► Send codes of tests to be performed..................................... (4 characters)
► Send Check-Sum................................................................... (3 characters)
► Send end transmission character EOT..................................
► Wait for response from the analyzer...................................... (2 characters)

If the communication is successful then the analyzer responds with character "Y" followed
by a byte, which identifies the position where patient has been inserted. In case the
communication was unsuccessful, then the analyzer responds with "N" followed by a byte
identifying the type of error. The possible errors generated by the analyzer in response to
the invalid insertion of patient are as follows:

0x01 Check-Sum Error

0x02 Unknown Command
0x03 Routine/STAT field Error
0x04 Serum/Urine field Error
0x05 Clone Yes/No field Error
0x06 Cup position Error
0x07 Number of Analysis field Error

Section II Chapter 4 Serial Communication Page 2 of 17

 0x08 Wrong Number of Test
0x09 Position already in execution
0x0A Cloning impossible
0x0B Code duplicated
0x0C One or more analysis not present in the analyzer
0x0D One or more analysis not present in the current plate
0x0E Too many analysis for the patient
0x12 No patient to repeat
0x13 The serum field in the patient to be repeated is different from the
memorized one
0x14 Patient to be repeated, but the list is already full
0x15 Patient to be repeated, but the list is different
0x16 The assigned position is already in use
0x17 Already existing or performed patient, it is not a clone and belongs
to a supplementary (extra) list
0x18 Already performed patient, but no repetitions or clones are active

For example to send a patient with code 000000000000001, serum type and with analysis
GLY, BUN and CHO onto the STATS list, then one must send the following sequence of
characters (excluding initial sequence STX<->ACK):

000000000000001RSN0003GLU BUN CHO 134<EOT>

Where:

000000000000001............. Patient code

R........................................ Identifies STATS list
S........................................ Identifies the type of patient (in this case: Serum)
N........................................ Identifies that the patient is not a clone
00....................................... Unknown position (the analyzer will insert the patient in a
convenient position)
03....................................... Identifies the number of test to be executed.
GLY, BUN, CHO................. Test codes (observe the space after each code to reach the 4
characters limit)
134..................................... Identifies the Check-Sum
<EOT>............................... This character ends communication

4.3. RESULTS RECEPTION

There are three commands for receiving reports from the analyzer:
R.......... Reception of next available report
L.......... Reception of the last report sent (in case of reception problems)
A.......... Reception of the first available report (in case one desires to receive again all
the reports)
The commands R, L, and A require standard communication or the procedure STX<->ACK
and the character EOT to end communication.
As a response to one of these three commands the analyzer sends the requested report (if
Section II Chapter 4 Serial Communication Page 3 of 17
available) or the character NAK (0x15) if there is no report to be sent. It must be borne in
mind that after a run test the reports are not immediately available for transmission as these
need validation. To do this, go to Utility menu, RS232 and enable the option "Accept result
to be sent". This operation must always be performed after each run test or groups of run
test.
There is also an additional option for performing validation operation automatically. Go to
Setup of the analyzer (Menu Utility, Setup Analyzer), go to the Serial (fourth from the left)
and enable the option "All results must be sent automatically (without validate)" at the
bottom of the page.
In case of positive response to the request for a report the analyzer transmits:

Patient code........................ 15 characters

List type............................... "T" for Routine or "R" for STATS
Sample type........................ "S" for Serum or "U" for Urine
Number of reports.............. 3 characters

For each report:

Analysis code..................... 4 characters
Result.................................. 7 characters
Check-Sum......................... 3 characters
<EOT>

The following is an example of eventual response to the data sent in "Sending a patient to
BT2000 PLUS ":

000000000000001RS003GLU 000.000BUN 0010.10CHO 00100.0245<EOT>

Where:
000000000000001........ Patient code
R.................................... Identifies STATS list
S.................................... Identifies the type of patient (in this case: Serum)
003................................ Identifies numbers of reports
GLU................................ First test code
000.000......................... GLU test result
BUN.............................. Second test code
0010.10......................... BUN test result
CHO............................... Third test code
00100.0......................... CHO test result
245................................ Identifies the Check-Sum
<EOT>.......................... This character ends communication

4.4. CALCULATION OF CHECK-SUM

This procedure calculates a Control code in accordance with the transmitted or received
data. An algebraic sum of ASCII values of all the sent characters is executed. For example
the character "A" has ASCII value 65 - 0x41.
Consequently the module 256 of the found value is executed (balance of dividing the value
by 256). This is the Check-Sum to be sent.
Section II Chapter 4 Serial Communication Page 4 of 17
4.5. WIRING DIAGRAM OF INTERFACE CABLE

BT2000 PLUS

BT2000 PLUS

Section II Chapter 4 Serial Communication Page 5 of 17

4.6. VARIABLE COMMUNICATION PROTOCOL

Introduction
The variable serial protocol has been designed to provide the user with possibility to
personalize the transmitted and received data from the analyzer.
The user can transmit or receive in addition to preset data (patient code, analysis code,
results etc.), also the simple text strings and/or characters in order to meet the personal
requirements.
Not only the user can decide to send or receive numerical information (for example number
of tests) not as single byte but as a preset numerical string or vice versa.
For example the user can decide to receive something like:
"Initiate analysis data"
<Analysis data true and typical>
"End analysis data"

Where the phrases "Initiate analysis data" and "End analysis data" do not refer to any
preset data by the analyzer but serve only for monitoring communication process (can be
useful for inserting specific markers on those programs which obtain information from text
files).
It is obvious that the protocol of initiation and end of communication, the commands for the
request of report, and the analyzer responses in case of error or success remain identical to
the usual preset serial communication.
NOTE:
a) If a check-sum is omitted in a communication then the analyzer will not control it.
b) The following numbers have been used to represent the error codes relevant to
sending a patient to the analyzer as regards the parameters not part of the
standard serial communication:
0x0F Data (constant) sent to a TAG #Char, #String or #Stringn does not fall within the
possible values range
0x10 Data (variable) sent to a TAG #Char, #String or #Stringn is not valid
0x11 An analysis variable is outside the SET BEGIN/END relative to the analysis

Section II Chapter 4 Serial Communication Page 6 of 17

Notes regarding Scripts
A script is a text document. Each one of the single commands must each reside in a
different line and be complete. In other words a single command cannot be divided into
more lines.

Stringn ‘Name’|$10 -> Valid line

Stringn ‘Name’|$10 char ‘A’ -> Invalid line

Stringn ‘Name’ -> Invalid Command

|$10

An editor for writing, modifications, saving and compiling of one or more scripts is
accessible inside the program (setup function). In any case it is possible to write a script
with any text editor (DOS or Windows) like Notepad of Windows or the EDITOR of the DOS.
It is not possible to import documents written with UNIX as the characters used for going to
the next line are different from the ones used by the DOS or Windows.

CAUTION!
If one wants to use the script stored in a removable disk (for example floppy disk)
then it will be necessary to copy it on the hard disk.

TYPE OF DATA

Character: Identifies a single character, can pass as printable character (enclosed between single
apostrophes), as decimal ASCII value (followed by symbol $) or else hexadecimal ASCII
value (followed by 0x).
If for example we want to identify the character A (decimal value 65 or
hexadecimal value 41) then we can write 'A', $65 or 0x41.
String: Identifies a sequence of printable characters enclosed in single apostrophes, for example:
'this is a string'.

Comment: Identifies a portion of test (preceded by a character ; which will not be compiled but will
serve as note only for the programmer.

Variables: These are particular sequence of characters preceded by the symbol #, which will be
used by the program for storing internal information (patient code, analysis name and
etc.), refer to "TABLE 1 - TRANSMISSION/RECEPTION".
There are also variables for direct uses, which allow for identification of
any character below ASCII 32 (space) to facilitate the writing of the script
(for example, one can use the variable #EOT to identify the character $4),
see "TABLE 2 - INTERNAL VARIABLES".

Section II Chapter 4 Serial Communication Page 7 of 17

SCRIPT FUNCTIONS

String: Identifies a string of variable length ending with a particular character.

Syntax:
String <string>I<Terminator>

Where
<String> Transmit/receive string
<Terminator> End character

Note:
It is not possible to use the variables like parameter <Terminator>

Example:
String ‘Hello Word’|$0
String ‘My String’|’@’
String #Variable1|0x10

Stringn: Identifies a string of fixed length

Syntax:
Stringn <String>|<Length>

Where
<String> Transmit/receive string
<Length> String length

Note:
If the length of the text strings is less than the data length then a series of spaces will
be added on the right to reach the data preset length. In case the text string is longer
than the data length then the string end will be cut off to match the data length.

If the length of the numerical values is less than the data length then a series of
characters '0' will be added to the left to reach the preset data dimension. In case the
length of the numerical values string is longer than the data length then the string will
be truncated to match the data length.

It is not possible to use variables as parameter <Length>.

Example:
Stringn ‘Hello Word’|$40
Stringn #Variable1|0x10

Section II Chapter 4 Serial Communication Page 8 of 17

Char: Identifies a single character (or single byte)

Syntax:
Char <Character>

Example:
Char ‘H’
Char $20
Char 0x10
Char #STX

Set: Identifies the beginning and the end of the group of repetitive commands

Syntax

Set Begin<Name of group>

Begin repetitive group

Set End<Name of group>

End repetitive group

Note:
Actually the ANALYSESDATA is the unique SET present, which identifies the
analysis in transmission/reception.
Only one command SET BEGIN and one command SET END can be present in a
script.
A script must always contain the command SET.
The variable PATIENTNUMBERTEST must be present before the command SET.

Section II Chapter 4 Serial Communication Page 9 of 17

COMPILATION ERRORS
One or more errors due to incorrect script writing or the system error may show up during
compilation of a script. The compiler shows the error code, the description of error, and the
line where it has been detected.
The following table shows the error codes, description, and the possible causes:
Error Code Description Possible Causes
An invalid command has been inserted in the
1 Unknown command
commands of script.
A string as first parameter for String or Stringn
2 A string request
command has not been inserted.
A string like parameter <lunghezza - length> of
3 A number request
command Stringn has been inserted.
4 Invalid number format Inserted invalid decimal or hexadecimal number.
a) Inserted more than two parameters for
command String or Stringn.
5 Excessive data
b) Inserted more than one parameter for the
command Char or Set.
6 Invalid data A string for command Char has been inserted.
7 String Terminator Request The end (') character of a string not found.
a) Inserted less than two parameters for
command String or Stringn.
8 Too little data
b) No parameter inserted for command Char or
Set.
The string length for Stringn command is less than 0
9 Invalid String Length
or more than 128.
a) An empty string inserted for the command
10 Empty string String or Stringn.
b) Inserted a character identified as "
a) Tried to transfer an invalid variable in the list
of internal variables.
11 Unknown variable
b) Tried to use a transmission variable in the
script of reception or vice versa.
12 Damaged file Hard disk error. Contact Sales/Service.
Internal error. Probably damaged program. Reinstall
13 Unknown file the program. If the problem persists contact
sales/service.
a) The text SET BEGIN or SET END not written.
Incorrect identifier in the b) A different value from ANALYSEDATA
14
SET command transferred as <Group name> for the SET
command.
15 Damaged exit file Hard disk error. Contact sales/service.
16 SET command not closed The SET END not inserted in the script.
17 Too many SET commands More than one SET BEGIN command inserted.
18 SET command not found The SET BEGIN command not found in the script.
Incorrect variable for SET A different value from ANALYSEDATA transferred
19
command as <Group name> for the SET command.
Variable not found before The highlighted variable required in the script before
20
the SET command the SET BEGIN command.
The variable must be String The highlighted variable must be String type, not
21
type Char
An already occupied position on the plate has been
22 Already occupied position
entered
Patient exists but in different An already existing code (or already executed) on
23
lists the plate has been entered, but the list is different.
Patient executed but no An already processed code has been entered
24
repetition without indicating a repetition or a clone.

Section II Chapter 4 Serial Communication Page 10 of 17

 TABEL 1 – TRANSMISSION

The following variables are used for the transmission of a report from analyzer to the host
computer:
Variable Usage Type of valid data
PATIENTCODE Patient Code String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
PATIENTGROUP Group (1) String Character
PATIENTLISTTYPE List (2) String Character
PATIENTTYPE Method Type (3) String Character
PATIENTNOTE Descriptive Note String
PATIENTNUMBERTEST Number of Results String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
ANALYSENAME Analysis name String
ANALYSESTYPE Analysis Type (4) String Character
ANALYSESCONCENTRATION1 1st Concentration String
ANALYSESCONCENTRATION2 2nd Concentration String
ANALYSESFLAGS1 Flag 1st Result String
ANALYSESFLAGS2 Flag 2nd Result String
ANALYSESMINVALUE Minimum Value String
ANALYSESMAXVALUE Maximum Value String
ANALYSESUM1 1st Unit of Measurement String
ANALYSESUM2 2nd unit of measurement String
ANALYSESUMFACTOR Unit Factor String
ANALYSES2RESULT Does the 2nd result exists? (5) String Character
ANALYSESSERUMTYPE Method Type (3) String Character
ANALYSESURINE24H Urine in 24/h String
(1)
Identifies Male, Female or Child (Select one of these):
‘M’ : Male
‘F’ : Female
‘C’ : Child
(2)
Identifies Routine or STAT (Select one of these):
‘R’ : Routine
‘S’ : STAT
Transmitting patient from archive will always have identifier of Routine.
(3)
Identifies Serum or Urine (Select one of these):
‘S’ : Serum
‘U’ : Urine
(4)
Identifies Clinical Chemistry, or Relation Analysis (Select one of these):
‘C’ : Clinical Chemistry
‘R’ : Relation Analysis
(5)
Identifies if the 2nd result exists or not (Select one of these):
‘Y’ : 2nd result exists
‘N’ : 2nd result does not exist

• If only the final result is desired then always refer to variables pertaining to 2nd result.
• In case of the absence of 2nd result then its variables will have the same values of the 1st result.

Section II Chapter 4 Serial Communication Page 11 of 17

 TABLE 1 – RECEPTION

The following variables are used for reception of a patient by the analyzer:
Variable Usage Type of valid data
PATIENTCODE Patient Code String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
PATIENTLISTTYPE List (1) String Character
PATIENTGROUP Group (2) String Character
PATIENTTYPE Method Type (3) String Character
PATIENTURINE24H Urine in 24/h String
PATIENTNOTE Descriptive Note String
PATIENTISCONTROL If the patient is a control (4) String Character
PATIENTCONTROLKNOK If it is a known control (5) String Character
PATIENTCONTROLLEVEL Control Level (6) String Character
PATIENTCLONE If it is a clone (7) String Character
PATIENTCUPPOSITION Vial (Cup) position String Character
PATIENTNUMBERTEST Number of test String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
(1)
Identifies Routine or STAT (Select only one of these):
$0 : Routine
$1 : STAT
‘0’ : Routine
‘1’ : STAT
‘R’ : Routine
‘S’ : STAT
‘ROUTINE’ : Routine
‘STAT’ : STAT
(2)
Identifies Male, Female or Child (Select only one of these):
$0 : Male
$1 : Female
$2 : Child
‘0’ : Male
‘1’ : Female
‘2’ : Child
‘M’ : Male
‘F’ : Female
‘C’ : Child
‘MAN’ : Male
‘FEMALE’ : Female
‘CHILD’ : Child
(3)
Identifies Serum or Urine (Select only one of these):
$0 : SERUM
$1 : URINE
‘0’ : SERUM
‘1’ : URINE
‘S’ : SERUM
‘U’ : URINE
‘SERUM’ : SERUM
‘URINE’ : URINE

Section II Chapter 4 Serial Communication Page 12 of 17

(4)
Identifies a Control or a Sample (Select only one of these):

$0 : Sample
$1 : Control
‘0’ : Sample
‘1’ : Control
‘N’ : Sample
‘Y’ : Control
‘S’ : Sample
‘C’ : Control
‘NO’ : Sample
‘YES’ : Control
‘SAMPLE’ : Sample
‘CONTROL’ : Control
(5)
Identifies a Known or Unknown Control (Select only one of these):

$0 : Unknown
$1 : Known
‘0’ : Unknown
‘1’ : Known
‘N’ : Unknown
‘Y’ : Known
‘U’ : Unknown
‘K’ : Known
‘NO’ : Unknown
‘YES’ : Known
‘UNKNOW’ : Unknown
‘KNOW’ : Known
(6)
Identifies Control Level (Select only one of these):
$1 : Level 1
$2 : Level 2
$3 : Level 3
‘1’ : Level 1
‘2’ : Level 2
‘3’ : Level 3
‘L’ : Level 1
‘N’ : Level 2
‘A’ : Level 3
‘LOW’ : Level 1
‘NORMAL’ : Level 2
‘ABNORMAL’ : Level 3
(7)
Identifies if it is a Clone (Select only one of these):
$0 : Normal
$1 : Clone
‘0’ : Normal
‘1’ : Clone
‘N’ : Normal
‘Y’ : Clone
‘NOCLONE’ : Normal
‘CLONE’ : Clone

Section II Chapter 4 Serial Communication Page 13 of 17

 TABEL 2 – INTERNAL VARIABLES

Variables Decimal Hexadecimal

NUL $00 0x01
SOH $01 0x02
STX $02 0x03
ETX $03 0x04
EOT $04 0x05
ENQ $05 0x06
ACK $06 0x07
BEL $07 0x08
BS $08 0x09
TAB $09 0x0A
LF $10 0x0B
VF $11 0x0C
FF $12 0x0D
CR $13 0x0E
SO $14 0x0F
SI $15 0x10
DLE $16 0x11
DC1 $17 0x12
DC2 $18 0x13
DC3 $19 0x14
DC4 $20 0x15
NAK $21 0x16
SYN $22 0x17
ETB $23 0x18
CAN $24 0x19
EM $25 0x1A
SUB $26 0x1B
ESC $27 0x1C
FS $28 0x1D
GS $29 0x1E
RS $30 0x1F
US $31 0x20

Section II Chapter 4 Serial Communication Page 14 of 17

 SCRIPT EXAMPLES

The examples outlined here are the transformation in script of the standard routine of the
patient reception by the analyzer.

Stringn #PatientCode|$15
Char #PatientListType
Char #PatientType
Char #PatientClone
Stringn #PatientCupPosition|$2
Stringn #PatientNumberTest|$2

Set #BeginAnalysesData
Stringn #AnalysesCode|$4
Set #EndAnalysesData

Stringn #CheckSum|$3

The following are the details of the above Scripts:

Stringn #PatientCode|$15
Patient Code of fixed length equal to 15 characters

Char #PatientListType
Type of list (Routine/STAT) as single character

Char #PatientType
Serum type (Serum/Urine) as single character

Char #PatientClone
Identifies if the patient is or is not a clone (single character)

Stringn #PatientCupPosition|$2
Position of serum cup (string of fixed length equal to 2 characters)

Stringn #PatientNumberTest|$2
Number of tests to be executed (string of fixed length equal to 2 characters)

Set #BeginAnalysesData
Beginning of analysis codes

Stringn #AnalysesCode|$4
An analysis code of fixed length equal to 4 characters. It must be entered for each type of test
as per qty indicated in the #PatientNumberTest.

Set #EndAnalysesData
End of analysis codes

Stringn #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)

Section II Chapter 4 Serial Communication Page 15 of 17

 The following examples are the transformation in script of the standard routine for the
transmission of a report by the analyzer to the host computer:

Stringn #PatientCode|$15
Char #PatientType
stringn #PatientNumberTest|$3

Set #BeginAnalysesData
Stringn #AnalysesCode|$04
Stringn #AnalysesConcentration2|$7
Set #EndAnalysesData

Stringn #CheckSum|$3

The details of the above scripts are as follows:

Stringn #PatientCode|$15
Patient Code of fixed length equal to 15 characters

Char #PatientType
Serum type (Serum/Urine) as single character

stringn #PatientNumberTest|$3
Number of results to be sent (a string of fixed length equal to 3 characters)

Set #BeginAnalysesData
Beginning of zone repeated for the number of results to be sent (see #PatientNumberTest)

Stringn #AnalysesCode|$04
An analysis code of fixed length equal to 4 characters

Stringn #AnalysesConcentration2|$7
Concentration referred to the analysis code as per #AnalysesCode (a string of fixed length
equal to 7 characters)

Set #EndAnalysesData
End of zone repeated for the number of results to be sent

Stringn #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)

Section II Chapter 4 Serial Communication Page 16 of 17

4.7. SERIAL COMMUNICATION TEST PROGRAMS
4.7.1. Program COMUNICA.EXE:
It is a simple communication program for sending command characters to the analyzer and receive
any response.
At the start the only input to the program is the number of the communication port (from 1 to 4).
A blue screen divided into two sections is displayed. In the upper section the characters coming
from the analyzer are displayed, while the lower section displays the characters sent to the
analyzer.
The only special keys used are F1 to clear the screen and F10 for exiting the program.
The special characters (with values less than 32) are displayed in ASCII notations along with their
values.
For example the Character EOT - value 4 - will be shown as EOT (4).
To send a special character (with values less than 32 or higher than 124) it is necessary to keep
pressed the ALT key and simultaneously to write the value of the character to be sent using
numerical keys. For example to send EOT it is necessary to keep the ALT key pressed and
simultaneously enter the value 4 through the numerical key and then release the ALT key.

4.7.2. Program BTPLUS.EXE:

It is a simple communication program that simulates the host computer. At the start it is necessary
to identify the number of communication port (from 1 to 4) and the desired procedure (Transmission
or Reception).
In case the Transmission is selected the program will ask for patient code (from 1 to 15 characters),
the test number (from 1 to 9) and the relevant analysis code for each test (for example: BUN).
It is a good practice to use the same analysis codes, which the analyzer has memorized in the plate
actually in use, if otherwise then an error will result in the transmission phase.
Now the program will execute an initialization procedure of communication with the analyzer, will
send patient data and wait for the outcome of transmission.
At the end the screen will display the outcome of the operation or show the position number of the
plate where the patient has been inserted or explanation of error code sent by the instrument (for
example: Patient Code Duplicated).
If the Reception procedure is selected, then the program will begin initialization of communication
with analyzer, will ask for data of the next report ready for serial dispatch and show data of relevant
downloaded report.
If there are no reports to be received, then a relevant message will be displayed.
Every time the program waits for a response from the analyzer, in case of problem it is possible to
abort the current operation by simply pressing the Esc (Escape) key.
NOTE:
Both the programs must reside in the computer connected serially to the analyzer through appropriate cable
indicated in the Operators Manual.
The computer must be an IBM compatible equipped with DOS operative system: Windows 95, Windows 98, or
Windows 2000. The operating systems such as MAC, UNIX, Windows ME or XP are not supported.
Since the programs operate in DOS ambience, therefore in case the Windows operating system is used then it
will be necessary to open a DOS shell (the command Prompts of MS-DOS is found in the menu Programs,
Accessories - accessed through the Start button on the bottom left of the screen).
Both the programs use serial port with the following setups:

Baude-Rate....................... 9600
Stop-Bits........................... 1
Parity................................. None
Hand-shake...................... Hardware

IMPORTANT NOTICE: These two programs are in the installation disk under Utility folder.

Section II Chapter 4 Serial Communication Page 17 of 17

 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 5
5. INSTALLATION OF THE OPERATING SYSTEM Page: 2
5.1. Preliminary Phase Page: 2
5.2. Setup of the Operating System Page: 6
5.3. Completing the installation Page: 12
5.4. Settings of the Operating System Page: 14
5.5. Installation of BT2000 PLUS Program Page: 19
5.6. Upgrading the BT2000 PLUS software Page: 22

COMPUTER MAINTENANCE PROTOCOL

The computer box of analyzer BT2000 PLUS and by-
products is designed for long-term security and reliability
and is virtually maintenance-free as long as the user does
not install any third-party application programs. If these
applications are installed, then they may damage the
operating system registry and may also cause disastrous
consequence for a computer's hard-drive.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section II Chapter 5 Software: Installation & Upgrade Page 1 of 21

5. INSTALLATION OF THE OPERATING SYSTEM (OS)
CAUTION!
INSTALLATION OF THE OPERATING SYSTEM MUST BE DONE BY EXPERT PERSONNEL, AND
ONLY IN CASE THE OS HAS TO BE RE-INSTALLED EX-NOVO.
BEFORE STARTING ANY SOFTWARE INSTALLATION PROCEDURE, CONTACT THE AUTHORIZED
TECHNICAL PERSONNEL ONLY.

5.1. PRELIMINARY PHASE

1) Ensure that the BIOS has the following Boot configuration:
- Hard-Disk
- CD-ROM
- Drive A
2) Check that the mouse and the keyboard are properly connected.
3) Ensure that the following supplementary hardware has been correctly installed:
- Additional Serial
- Audio Card (optional)
- Network Interface Card (optional)
- Touch Screen
- Connecting cable between IBM & 552
4) Turn on the instrument and insert Windows 2000 disk in the CD-ROM drive
The following screen appears:

Press enter to initiate installation.

Section II Chapter 5 Software: Installation & Upgrade Page 2 of 21

Now the screen displays the end-user license agreement for Microsoft Windows:

Press "F8" (I agree) to accept it.

Windows displays the existing partition of the hard disk:

Press "ENTER" to use the default partition.

Section II Chapter 5 Software: Installation & Upgrade Page 3 of 21

Select "Format the partition using the FAT file system":

Press “ENTER” to continue.

Now the Setup formats the hard disk and this phase may last for a few minutes:

Section II Chapter 5 Software: Installation & Upgrade Page 4 of 21

Now the Setup copies files to the Windows 2000 installation folders in the hard disk and this
may take several minutes to complete:

At the end of preceding phase the system will restart (DO NOT REMOVE CD-ROM FROM
CD-ROM DRIVE).

Section II Chapter 5 Software: Installation & Upgrade Page 5 of 21

5.2. SETUP OF THE OPERATING SYSTEM
After the restart, the system displays the "Setup Wizard" which will guide the user during
Setup of the Operating System:

Click “NEXT” key to continue with Setup.

Now the Windows Setup detects the existing hardware and installs devices in the system.
This will take several minutes. In case the system halts (crash), that means some hardware
is not compatible with the system and/or the board utilized.

CAUTION
DO NOT INTERRUPT THIS OPERATION!!!

Section II Chapter 5 Software: Installation & Upgrade Page 6 of 21

Now the Setup asks for setting the correct date and time for the system. One may skip this
now and set the date & time later.

After making appropriate corrections, click “NEXT” key.

The Setup requests to enter Name of instrument and Organization:

Enter “bt plus” as "Name" and “biotecnica” as "Organizzazione".

Click “NEXT” key.

Section II Chapter 5 Software: Installation & Upgrade Page 7 of 21

Now type the Product Key of Windows (the Product Key is composed of 5 groups of 5 characters
each):

The 25 characters Product Key appears on the installation CD-ROM cover.

After typing the Product Key click “NEXT” key.
In case of incorrect Product Key entry, a message will alert the operator to enter the correct Product
Key.
Now provide the Administrator Password for your system:

In the field “Administrator Password” type “ENZO” and rewrite it in the field “Confirm
Password”.

Section II Chapter 5 Software: Installation & Upgrade Page 8 of 21

In case the board has a LAN (network) communication hardware, then the following
screens will be displayed:

Do not change the default parameters and click “NEXT” in both the screens.

Section II Chapter 5 Software: Installation & Upgrade Page 9 of 21

Now the Setup installs the Windows components and then completes the final set of tasks,
which may take several minutes:

Section II Chapter 5 Software: Installation & Upgrade Page 10 of 21

The second phase of the installation has been successfully completed. Remove CD from
the drive. Click "Finish" to restart the system:

Section II Chapter 5 Software: Installation & Upgrade Page 11 of 21

5.3. COMPLETING THE INSTALLATION
This is the most delicate phase of the whole process. If it is not performed correctly then it will be
necessary to repeat the whole installation procedure of the operating system.
A welcome message is displayed:

Click “NEXT” key.

Enter user name that will log on to the system (STRICTLY OBSERVE THESE INSTRUCTIONS).

Enter “Administrator” as “User Name”.

Enter "ENZO" as "Password", which was also used in the previous installation phase.
Confirm password by rewriting it.
Click “NEXT” to continue.

Section II Chapter 5 Software: Installation & Upgrade Page 12 of 21

The Windows installation has been completed. Click “Finish” to exit.

Section II Chapter 5 Software: Installation & Upgrade Page 13 of 21

5.4. SETTINGS OF THE OPERATING SYSTEM
Uncheck the box “Show this screen at startup” (at the bottom left of the screen) and click
"Exit" (at the bottom right of the screen).

Open Control Panel: Click “Start”, point to “Settings”, and click “Control Panel”.

Section II Chapter 5 Software: Installation & Upgrade Page 14 of 21

Double click on “Display” icon.

Select “Settings”:

Set “Screen area” to 800 by 600 pixels.

Section II Chapter 5 Software: Installation & Upgrade Page 15 of 21

Click “Yes” on the "Monitor Settings".

Go to “Screen Saver”:

Click “Power” (at the bottom right).

Section II Chapter 5 Software: Installation & Upgrade Page 16 of 21

Select the settings "Never" in “Turn off monitor” and “Turn off disks”:

Click “OK”.
If one desires to select a background picture go to "Background" page.

Select the desired background picture and set “Stretch” in the "Picture Display".
Click “OK”.

Section II Chapter 5 Software: Installation & Upgrade Page 17 of 21

If a question is asked then respond by clicking “Yes”:

The Operating System is now configured correctly and one may proceed to the installation
of the drivers of the peripheral devices (e.g. Additional Serial port, Touchscreen, and
printer).

CAUTION:
The supplementary drivers must be installed prior to installation of the BT3000 PLUS operating
program in the system.

THE PRINTER MUST BE INSTALLED BEFORE THE OPERATIVE

PROGRAM!
Open the Printers window (“Start” button, “Settings”, “Printers”) and
click on “New Printer”, then follow instructions. Otherwise, insert the
printer’s installation disk into the driver and follow the printer’s setup
instructions.

Section II Chapter 5 Software: Installation & Upgrade Page 18 of 21

5.5. INSTALLATION OF THE BT2000 PLUS OPERATING PROGRAM
Insert the CD-ROM containing the operating program of the BT2000 PLUS in the CD-ROM
drive.
The following screen appears:

Click “LAUNCH SETUP”.

Now the installation procedure begins, which will guide the user during operating program
installation.

Click “NEXT”.

Section II Chapter 5 Software: Installation & Upgrade Page 19 of 21

The installation procedure automatically checks the communication port (COM) used for
communication with the 552. In case the communication port not found (cable disconnected, no
processor, etc.), the following screen "Select communication port" will appear:

Here the operator will manually select the Com port used for communication (normally "Com4"
is utilized).
Select Com4 and click “Accept”. Now the installation of operating programs begins.
CAUTION:
DO NOT INTERRUPT THE ONGOING INSTALLATION, UNLESS FOR SERIOUS REASONS.

Section II Chapter 5 Software: Installation & Upgrade Page 20 of 21

After the termination of previous phase, a message "Setup has finished installing bt Plus on
your computer" will be displayed:
Click “Finish”.
Now a screen with various options for "End installation" (with restart or without restart of the
system) is displayed.
In case of the new installation, select "Yes, I want to restart my computer now" (first option).
Now the operating program has been installed correctly in the system.

5.6. UPGRADING THE BT2000 PLUS SOFTWARE

- Proceed with installation as for a new instrument.

Section II Chapter 5 Software: Installation & Upgrade Page 21 of 21

 OPERATOR MANUAL
BT 1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 6
6. TECHNICAL ASSISTANCE Page: 2

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY

Section II Chapter 6 Technical Assistance Page 1 of 2

6. TECHNICAL ASSISTANCE

In case of need for the Technical Assistance Service, before calling Biotecnica, please
make sure that the following information are available:

- analyzer model
- serial number
- program code (at the center of the main screen)
- analyzer configuration (printable from the External programs menu, with third level
password)

For operative and applications problems, make sure all possible information is available (in
addition to the above mentioned), such as:

- analytical parameters printout

- calibration parameters printout
- calibration results in RT printout
- calibration reaction graphs printout
- samples reaction graphs printout
- real time pages printout
- possible errors or messages from the analyzer printout

Please do not return any equipment orpart of the systemto Biotecnica before
discussing your problem with an authorized technical assistance representative or
Biotecnica own technical assistance. The Technical Assistance Service at
Biotecnica Instruments S.p.A. will provide a Return Authorization Number for the
Parts/Instruments Return Authorization module available in Section II, chapter 2.

Reference numbers for Biotecnica Instruments S.p.A. Technical Assistance

Service:

BIOTECNICA INSTRUMENTS S.p.A.

Via Licenza, 18
00156 – ROME
ITALY

℡ Tel. +39.06.4112316 ¬Fax +39.06.4103079

Technical Assistance E-mail [email protected]

Biotecnica E-mail [email protected]

à www.biotecnica.it
Section II Chapter 6 Technical Assistance Page 2 of 2
 OPERATOR MANUAL
BT1000 & BT2000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 7
7. BIBLIOGRAPHY OF ALLIED SUBJECTS Page: 2

NOTE:
The following bibliography is given to supplement this manual,
whose scope as an operator manual permits only the mention or
brief explanation of some subjects.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00155 Rome – ITALY

Section II Chapter 7 Bibliographical Reference Page 1 of 2

7. BIBLIOGRAPHY OF ALLIED SUBJECTS

♦ Burtis C.A., Ashwood E.R.: “Tietz Textbook of Clinical Chemistry” IInd Ed. W.B.
Saunders Company, 1994

♦ Press W.H., Flannery B.P., Teukolsky S.A., Vetterling W.T.: “Numerical Recipes” -
The Art Of Scientific Computing -, Cambridge Univ. Press, 1986

♦ EN 591 (1994): In vitro diagnostic systems – Requirements for user manuals for in
vitro diagnostic instruments for professional use (ital. UNI 96)

♦ EN 61010-1: Safety requirements for electrical equipment for measurement,

control and laboratory use – Part 1: General requirements (amendment to IEC
1010-1:1990 + A1:1992)

♦ EN 1658 (1996): Requirements for marking of in vitro diagnostic instruments

♦ Directive 98/79/EC on in vitro diagnostic medical devices (1998)

♦ EN 980:2002: Graphical symbols for use in the labelling of medical devices

♦ 2002/95/EC: Restriction of the use of certain hazardous substances in electrical

and electronic equipment

♦ 2002/96/EC: Waste electrical and electronic equipment (WEEE)

Section II Chapter 7 Bibliographical Reference Page 2 of 2

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