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/ 266
OPERATOR MANUAL
BT 3000 PLUS
cod. MO-04444-05-ING
SOFTWARE VERSION 8
Rev.0; 04/10/ 2004
ce
This product confomms to the safety requirements of the Councl| Directives
SUTOEEC of 27 October 1996 (European Panament) regarding the I-Vito
Deannostc Medical Devices. This deetve Is im accordance withthe Article 2,
Paragraph 2 ofthe Diectve B9/336/EEC, which ceases to apoly to the products
complying withthe resent recive. Refer to Paragraph 7, Ace No tof he IEC
Official Gazete No. L391 of Dec. 1808
Io conlorms to Halon Regultos Cet EN GHO10.0} end Cl EN 1820-4
(EMC).
Tho conformity is attested when tho equipments installed
in accordance wih the condians outined 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 - BT3000 PLUS - operator manual
SECTION I: GENERAL INFORMATION
CHAPTER A
4. INTRODUCTION
2, BASIC OPERATING PRINCIPLES OF THE ANALYZER
3. SYMBOLS: explanation of the used or applied symbols
4, BRIEF DESCRIPTION OF THE SYSTEM
4.1. Front view of the analyzer
4.2. Rear Panel Controls and Connectors
4.3. Modules
CHAPTER B
4, INSTALLATION
4.4. Unpacking the analyzer
41.2. Installation
4.3. Setting up the instrument
1.3.4. Turning on the instrument for the first time
1.3.2. Preliminary checks
CHAPTER C
4. FUNCTIONS
1.1. Description of the Program Menu
41.2. Operating principles
2.1. Computations
1
1.2.2. Applied mathematical functions
1.2.3. Initial computation
1.2.4, Optimization techniques for Clinical Chemistry
1.2.5. Methods Description
41.3. Analyses Programming
1.3.1. Creating a New Code
1.3.2. Relation Tests
Primary Analytical Parameters
Check Parameters
Secondary Analytical Parameters
Automatic re-runs
4, Controls
5, Calibrations
8. Creating Profiles
7. Creating the Current Analyses’ Tray
CHAPTER D
4. PERFORMANCE AND LIMITS.
CHAPTER E
1. OPERATING PROCEDURE
4.4. Turning on procedure
41.2. Reagents: insertion and removal
1.3, Running Standard and Controls (on demand or timed)
4.4. Samples
1.5, Work Lists
4.6. Turning off procedure
1.7. Access password
Index BT3000 PLUS Rev.0, Soft Vor. 8
Page: I of 4
12
16 INDEX - BT3000 PLUS - operator anual
CHAPTER F
4. QUALITY CONTROLS
1.4. Controls - Insertinglmodifying controls
4.2. Displaying and processing by date
1.3, Displaying and processing by lot pairs: Juden graph
4.3.1. Westgard Graph
4.3.2. Daily Chart Graph
4.4, Additional Functions
2. POPULATION
2.4, Analysis Selection (How to run a Query)
2.2. Principal statistics formulas used in Population module
2.3. Diagrams
2.4, Inserting external analyses
2.5. Other menu functions
3. PATIENTS’ ARCHIVE
3.1. Selection (How to run a Query)
3.2. Patient's report
3.3. Printing Reports
3.4, Other menu functions
CHAPTER G
4. DISPLAYING AND PRINTING RESULTS Page: 2
4.1. Results per patient Page: 2
1.2. Results per test Page: 4
1:3. Displaying real-time data Page: 5
1.4. Reaction Graphs Page: 6
1.5. Flags List Page: 7
CHAPTER H
4. ANALYZER TECHNICAL FUNCTIONS
4.1. Service Functions Page: 2
4.1.1. Analyzer Utilities Page: 2
1.1.2, Mechanical Calibrations Page: 3
1.2. Diagnostic Functions Page: 5
2. ANALYZER SETUP Page: 7
CHAPTER |
1. BARCODE AND RELATED FUNCTIONS Page: 2
2. USING THE BARCODE Page: 2
2.1. Barcode on Samples Page: 2
2.2. Barcode on Reagents Page: 4
CHAPTER K
4.VACUUM PUMP SYSTEM INSTALLATIONIOPERATION
41.1. Funetional characteristics Page: 2
1.2, System control functions Page: 3
113. Waste container (external) Page: 3
41.4, Installation and operation Page: 4
1.5. Maintenance and care Page: 4
1.6. Trouble-shooting Page: 4
41.7. Spare parts for maintenance Page 5
2. VACUUM PUMP SYSTEM PIN 662.0788 & BYPRODUCTS Page: 6
OBSOLETE - (No longer in production) o
2.1. Introduction Page: 6
2.2. Technical description vacuum pump Page: 7
Inder BTS000 PLUS Rew0, Soft Ver. 8 Page: 2of'4 INDEX - BT3000 PLUS - operator manual
2.3. Principles of operation
2.4. Vacuum gauge
2.5. Vacuum level regulator
2.6. Hydrophobic filter
2.7. Warnings
2.8. Technical Specifications
2.9. Caution! Shipping retainer - Vacuum pump system
2.40. Installation
2.41. Quick start-up
2.42. Care and maintenance
2.43. Fuse replacement mains power inlet module
2.14. Filter replacement
2.45, Peristaltic pump cartridge replacement
2.46. Trouble-shooting guide
2.47. Cleaning of the hydrophobic filter
2.48. User serviceable spare parts
CHAPTER L
4.1SE MODULE
4.4. Introduction
4.2. Parameters
41.3, Programming Standards and Controls
41.4. Replacing and Installing Electrodes
41.5. Preliminary steps before starting the system
41.6. Calibration procedure
4.7. Measuring unknown samples
41.8, Precautions for ISE Module usage
4.9. Suggestions for performance maintenance
4.40. Troubleshoo!
CHAPTER M
4. WARNINGS AND PRECAUTIONS
4.4. Potential risks during operation and maintenance
1.2. Interferences and actions to be avoided
1.3. Waste disposal
1.4, Safe disposal of the unusable instrument
CHAPTER N
4, MAINTENANCE AND CARE
4.4. Preventive maintenance and Extra Wash
4.2. Replacing tubing and accessories
41.3. Additional Maintenances
41.4. Cleaning the Instrument
2, MALFUNCTIONS.
2.4. Troubleshooting
2.2. Screen messages
Screen messages - Causes and remedies
CHAPTER O
4. TECHNICAL SPECIFICATONS
Index BT3000 PLUS Rev 0, Soft Ver. 8
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SECTION II: SUPPLEMENTARY INFORMATIONS
CHAPTER 1
4, ABBREVIATED OPERATING INSTRUCTIONS
4.4. Turning on and preliminary procedures
1.2. Inserting Reagents in Clinical Chemistry and ISE
1.3, Analytical calibrations and Controls
1.4, Entering Patients and Work Lists
1.5, Running Tests
1.6. Displaying and Printing Results
4.7. Turning off the analyzer
CHAPTER 2
2. WARRANTY CONDITIONS
CHAPTER 3
3. ORDERING INFORMATION
3.1. General terms and conditions for sale
3.2. Consumables for BT3000 PLUS
3.3. ISE Module consumables
CHAPTER 4
4, SOFTWARE
4.4, Serial Communication between BT3000 PLUS and Host Computer
4.2. Variable communication protocol
4.2.1, Serial communication test programs
CHAPTER 5
5. INSTALLATION OF THE OPERATING SYSTEM
5.4. Preliminary phase
5.2. Setup of the Operating System
5.3.Completing the Installation
5.4.Settings of the Operating System
5.5. Installation of the BT3000 PLUS Operating Program
5.6. Upgrading the BT3000 PLUS software
CHAPTER 6
6. TECHNICAL ASSISTANCE
CHAPTER 7
7. BIBLIOGRAPHY OF ALLIED SUBJECTS
CHAPTER &
8. LIST OF APPLICATIVE METHODOLOGIES
Inder BT3000 PLUS Rew0, Soft Ver.8 Page: 40f4
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BONN
2
14
19 OPERATOR MANUAL
BT3000 PLUS
SECTION I: GENERAL INFORMATION
CHAPTER A
1. INTRODUCTION Page:
2. BASIC OPERATING PRINCIPLES OF THE ANALYZER Page:
3. SYMBOLS: explanation of the used or applied symbols Page:
4. BRIEF DESCRIPTION OF THE SYSTEM Page:
4.1, Front view of the analyzer Page:
4.2. Rear Panel Controls and Connectors Page:
4.3. Modules Page:
IMPORTANT NOTICE
The introduction of access passwords has
been rendered mandatory since 2004 for
safeguarding sensitive data (refer to
CHAPTER E, paragraph 1.7.).
Biotecnica Instruments S.p.A.
Via Licenza, 18
00156 Rome - ITALY
Section] — Chapter A Description Index BT3000 P
Revd Sofi Ver 8
WORON
oo 1. INTRODUCTION
The BT3000 PLUS is an automatic analyzer for Clinical Chemistry and immunoturbidimetry,
represents the technological evolution of the T.A.R.GA. line (“Technology Advanced
Random Generation Analyzer’), manufactured by Biotecnica Instruments S.p.A. Rome,
Italy.
The BT3000 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.
* Besides clinical chemistry and immunochemistry tests. it is equipped for ions determination
for Na°, K*, CI, (CO2 upon request) with ion selective electrodes (ISE. Module, “ion
Selective Electrodes")
+ The analytical throughput is 330 tests/h for clinical chemistry, 205 tests/h for the ISE
Module including CO2 without I.S.&. module
+ 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),
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 reffigerated 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 — ChapterA System Description BT3000 PLUS Rev.0, Sofi Ver. 8 Page 2of 11 2. BASIC OPERATING PRINCIPLES OF THE ANALYZER
‘The BT3000 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/lo
p= incieent ight radiation intensity
1 = transmitted light radiation intensity
The absorbance, A, (or extinction, E) is defined as:
A= log (1/T) = log Wo
+ The Lambert-Beer law states the relation between absorbance, concentration of a
compound absorbing light and sample thickness.
Azecd
= molar extinction cosfficient of the compound abssorbing light at a certain (A) wavelength,
¢ = 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 BT3000 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 to give at the end the concentration of the compound into the sample.
The ISE (lon Selective Electrodes) module is a device dedicated to the determination in the
samples of the electrolytes: K”, Na’, CI, plus a channel for an optional CO; electrode (see
chapter L). This device is defined as “ion selective” as the used electrodes react with the
corresponding ions in accordance with the following Nemst law:
E=£)+RT/nF log aM”
aM” = Mion activity
E = potential in Vott
‘onstant (H” electrode redox semi-reaction std potential)
R= gas constant
F = Faraday’s constant
T = temperature expressed in Kelvin degrees
n= on charge
The average life of the electrodes is approx one year for sodium and reference; approx
three months for potassium, and approximately six months for chloride and carbon dioxide.
However, the electrodes’ life is dependent upon the number of sample runs and the routine
maintenance procedures outlined in this manual
Section! Chapter System Description BTS000 PLUS Rev, Soft Ver.§ Page Sof 11 3. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS
As the BT3000 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.
@ Ihr 5MQ
Conductivity: < 1pS/em?
pH: 64
Residual lons: < tug/l
Section Chapter 8 Unpacking & Installation
873000 PLUS
Rev), Soft Ver. 8 Page 100f 10 OPERATOR MANUAL
BT 3000 PLUS
SECTION |: GENERAL INFORMATION
CHAPTER C
1, FUNCTIONS
1.1. Description of the Program Menu
1.2. Operating Principles
2.1. Computations
. Applied mathematical functions
. Initial computation
. Optimization techniques for Clinical Chemistry
.5. Methods Description
Analyses Programming
1. Creating a New Code
. Relation Tests
. Primary Analytical Parameters
.4. Check Parameters
5. Secondary Analytical Parameters
6. Automatic re-runs
Controls
Calibrations
Cc
Cc
1.
2.
2.
2.
2.
3.
3,
3.
3.
3.
3.
eating Profiles
1.
1.
1.
1.
1.3
3.
1.
1.
1.
1.
1.
1.
4.
5.
6.
7. Creating the Current Analyses’ Tray
1.
1:
1.
1.
Biotecnica Instruments S.p.A.
Via Licenza, 18
00156 Rome - ITALY
Section! Chapier © Functions - Analyses Prog. = Cirls~Calib. Index BT3000 PLUS
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Rev.0, Soft Ver
BONNNNNASsaaa
HIVSaAkK Sous HZ AoeVAAN 1, FUNCTIONS
1.1, DESCRIPTION OF THE PROGRAM MENU
As already described in the Chapter A, the BT3000 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 & drug abuse, reading of potassium, sodium and
chloride (carbon dioxide upon request) with indirect ISE method ("lon Selective Electrodes")
(see Chapter. L)
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
Patients) Tests Analyzer Utility Ex and Batch mode.
Insert Routine/STAT cirsp «Run all pending patients»: Restarts the work list
after an interruption
«Repetition for analyses»: Selects the repetition
Run all pending patients Cris by analyses upon operator's request.
«Clear Patient List»: Deletes the entire
Repetition for analyses Ctrlt8 memorized patients list. The analyzer will request
confirmation before deleting.
Insert Batch cre
lear Patient List
Figure 1
Section I Chapter C Functions - Analyses Prog. -Cxrle-Calib, BT3000 PLUS Rev.0, Soft Ver. 8 Page 2 of 32 “Tests Menu” (Fig. 2)
SESE «Tests’ parameters (All Tests)»: It is used
Anabzer—Utiily — Edemal Programs for programming and memorizing tests.
Tests’ parameters (Al Tests) snitectisa «Analyses’ parameters (Only In Tray)»: It
provides direct access to the analyses on the
4 rameters (Only In Tr: shitsctiet
Bnanses parameters ni Tr9) current reagents’ tray.
ee er ShitectieT «Create current tray»: This item is used to
Inset profes shitectisp create the list of analyses’ in the current
= reagents tray.
Bun StandardsiConivals ShiCrrR — ingert profiles»: See paragraph 1.6
Export Data “Creating Profiles”
ImnportData
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).
“Analyzer Menu” (Fig. 3)
nn | «Analyzer’s utilities»: Provides access to the service
‘anavzer f Uity.Edemaipt procedures of the analyzer.
«Mechanical Calibrations»: For making adjustments to
mechanical devices.
Nechanical alioratons «Diagnostic»: The technical assistance personnel mainly use
this function (see Chapter H).
Anatyzer's utities
Diagnostic >
Figure 3
“Utility Menu” (Fig. 4)
MNENNENNNE «Archive Datay: This command stores the processed patients’
{gully Extamal Programs data into the patients’ archive.
sche Data «View reaction’s curves»: This command displays on a graph the
Yewrssctonsares | reaction’s curves of tests, with print capability
ew Resuts for éraises | «View results for Analyses»: Displays results for test.
«Setup Analyzer»: It is used to define some system parameters.
ee ee This command is disabled during analyzer operation. Refer to
seep "Setup Analyzer" in Chapter H, paragraph 2
superd ecbity (ogo | «Sleep»: This command sets the analyzer to a standby mode,
during which the cuvettes are washed and the monitor displays the
screensaver. Press any key to exit this mode, then a reset will occur
and the analyzer will be immediately ready to operate. This option is
Log Fee >| useful when the analyzer is not being used for a while, but it must
Figure 4 be kept on to resume work immediately.
Stutoown
Section! Chapter © Funotions Analyses Prog. ~Cirls-Calib. BTS000 PLUS Reu0, Soft Ver. Page 3 of 32 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. At the expiry of
programmed time and date the analyzer will exit the sleep 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 warmup time the analyzer will be
ready to operate.
«Shut-Downp: To tum 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 tum off leaving only the reagent
refrigeration chamber turned on. Press the ON/OFF button on the rear panel to tum 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
(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
«Log Files»: A memory location in which all the operations performed by the analyzer are
stored. This function is divided in two parts: the first part memorizes the type and the
number of tests performed; 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)
Eenral = The functions in this menu are outlined in the Chapter F.
Quality Control
Population
Patient Archive
Fig. 5
Two buttons "<" & ">" have been introduced (on
the title bar) in the screens of standards and
controls analysis parameter insertion. These
buttons allow for moving to previous or
Drei | successive analyses without returning to the
initial page
Section! — Chapter C Functions - Analyses Prog. -Ciris-Calib. BT3000 PLUS Rev.0, Soft Ver. 8 Page 4 of 32 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 AA = 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 (max 3)
With subtraction of the Blank reagent.
Kinetics
* Linear regression computation
«ABS = (straight line coefficient) x 60 sec
Fixed Time
ABS = A ABS (last reading — first reading)
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
Seotion! Chapter © Funotions ~Analyses Prog. ~Cirls-Calib. BTS000 PLUS Reu0, Soft Ver8 Page S of 32 Sample-Blank (B)
ABS =
ast reading of the second phase — last reading of the first phase
End Point 2 Points
If readings are more than 3:
+ L1=First reading
+ L2=Mean value of the last 3 readings
If readings are more than 2:
+ L1=First reading
+ L2=Mean value of the last 2 readings
Otherwise:
+ L1=First reading
+ L2=Last reading
ABS =L2-L1
Sample-Blank
Blank: RI+R2
1® phase: R1+ Serum
2" phase: R2
‘Computation: (Reading 2" phase - Reading 1*' phase) - blank
Sample-Blank
Blank R2
1° cuvette Ri + serum
2” cuvette: R2 + serum
‘Computation: (Reading 2” cuvette - Reading 1°' cuvette) — blank
End Point Starter
Dynamic: As normal End Point with serum starter
1® phase: Only reagent (R1 or R1+R2)
2 phase: Serum
Computation: Reading 2" phase — Reading 1* phase
Absolute End Point
This method is identical to the End Point but without subtraction of the Blank reagent.
.
COMPUTING CONCENTRATION VALUE
nr
In
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 Far = External Dilution Factor
Section I Chapter C Functions - Analyses Prog. -Cxrle-Calib, BT3000 PLUS Rev.0, Soft Ver. 8 Page 6 of 32 Dynamic Blank Check
If Dynamic Blank is present and test is either a Kinetic, or a Fixed Time, then’
* ABS = ABS - Dynamic Blank Value
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: Cone = ABS x Factor
© Othenvise the concentration is extrapolated from the standard’s curve, where:
Fnr__ : Internal Factor
ABS : Test ABS
Cone : Final concentration
1.2.2. APPLIED MATHEMATICAL FUNCTIONS
+ Correlation Coefficient
where:
Number of readings
Number of reading (i)
Times
Readings
ras
* Linear Regression
Section! Chapter © Funotions Analyses Prog. ~Cirls-Calib. BTS000 PLUS Reu0, Soft Ver8 Page 7 of 32 where
Angular coefficient for the line
Final point for the line
Number of readings
Number of reading (i)
Times
Readings
ra-spz
¢ Distance point-line
-MX-9
where
Angular coefficient for the line
Final point for the line
Point Abscissa
Point Ordinate
M
Q
x
Y
¢ Distance between two points
X-x,
y My; —yo)t
where’
X Abscissa
Y — : Ordinate
Xo First Point Abscissa
x; | Second Point Abscissa
Yo First Point Ordinate
Mt Second Point Ordinate
Mathematical Functions for Clinical Chemistry
+ VOLUMETRIC FACTOR (USED IN SAMPLE BLANK A TESTS}
vS +R,
WS +R, +R,
where:
K Volumetric factor
vS —: Serum volume
vRi_: First reagent volume
vR2 _: Second reagent volume
Section I Chapter C Functions - Analyses Prog. -Cxrle-Calib, BT3000 PLUS Rev.0, Soft Ver. 8 Page 8 of 32 |.S.E. Module Functions
*# COMPUTING THE SLOPE
(ny,
where:
S — :Slope
i Electrodes
BSF: Base Line Factor
mV, : mV High Standard
mV: mV Low Standard
BL, : Base Line High Standard
BLi_ : Base Line Low Standard
Cn: High Standard Concentration
Cc Low Standard Concentration
¢ COMPUTING THE RESULT
Cone =| Cs, + BSF wl
where:
s Slope
i Electrode
BSF: Base Line Factor
mV: mV Electrode
mVs; : mV Low Standard
BL : Base Line Electrode
Bis, : Base Line Low Standard
Csp : Low Standard Concentration
1.2.3. INITIAL COMPUTATION
BSF
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
where:
Z Zeroing with water
F, _: First Filter’s Value
F, : Second Filter’s Value
Fz,_; First Filter’s Zero-Value
Fz2 : Second Filter’s Zero-Value
Op : Optical path
Of =F.C.C.
Section! — Chapter © Funotions ~ Analyses Prog, ~ Cirls«Calib
BT3000 PLUS Rev.0, Sofi Ver. 8 Page 90f 32 ¢ LS.E. Module
reading from a single electrode
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 (To), then the ABS value for P1 must be extracted with
the following procedure:
with N<3
4. Compute the Regression line y = mX+q from the reading points
2. Search for the point on the line at To
with N23
4. Compute Best-Fit curve coefficients from the reading points
2. Search for the point on the line at To
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. IfCCis<0.99:
NN=N/3
Compute linear regression and store m and q
Compute the first most distant point from the line y = mX+q
Trace the point on the line
NN=NN-1
INN is > 0 go back to step (2)
PeReNa
where
€C 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 Chapter C Fimetions - Analyses Prog. -Crls Cali BT3000 PLUS Rev.0, Soft Vor. § Page 10 of 32 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.
Cone. in sample = Factor x (A3 - Reagent Blank)
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 (AA) 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
Cone. In Sample = Factor x (A3- A2) (A3 - A2) = aA
Section! Chapter C Funetions - Analyses Prog. -Ctris- Cali, BT3000 PLUS Rev.0, Soft Ver.8 Page 11 of 32 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 (AA/min,). This value is then multiplied by the factor to compute the concentration of the
analyte in the sample.
Cone. in Sample = Factor (A3 - A2) (A3 - A2) = AA/min.
Initial Rate (ILR.)
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:
Cone. in sample = Factor x (AA/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:
Cone. in sample = Factor x [A2 - (A1 x k)]
42
Al
R148 R2
Section Chapter C Fumetions - Analyses Prog. -Crls Cali BTS000 PLUS Rev.0, Soft Vor. § Page 12 of 32 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:
Cone. in sample = Factor x (A2 - A1)
a2
Ries 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:
Cone. in Sample = Factor x (A3- A1)
al aa
cere REBEATON
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:
Cone. in Sample = Factor x final A
Section Chapter C— Funetions - Analyses Prog. - Cirle Cali, BT3000 PLUS Rev.0, Soft Ver.8 Page 13 of 32 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 mi, 80 mi, 20 ml and 10 mi)
and in case of double reagent, the different size bottles are coupled together (e.g. 80+10, 10+20,
50+50, 10+10, ete.)
The “End Point”, “Fixed Time”, “Kinetic” and “LR.” methods allow, both with single and double
reagent, the use of a special feature called Serum Starter. Normally, during test runs, the same
preparation arm samples single or double reagents plus sample. By using the Serum Starter
function, the reagents are placed into the cuvette by the main preparation arm and the sample is
placed separately by the secondary arm. 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 Fived Time
Kinetic - LR. Single Ri Ri+SaTest
Only Read Single Ri =
End Point - Fixed Time
Kinetic - LR. Double Ri+Ta+R2#Tb R1+S+Ta+R2+ Took
End Point Fixed Time
Kinetic -LR. Double RI+R2+ To RI+RUS+ TROL
‘Sample Blank (A) RieS+Ta > Li+R2+ TDs 12
Sample Blank (A-b) Double Rite ‘Sample Blank (L2-L4)
‘Sample Blank (B) Double a RivS+TasLi R2+S+Ts12
Sample Blank (8-5) Sample Blank (L2-L4)
Ta and Tb = Incubation times for R1 and R2, L = Reading
SERUM STARTER SAMPLING PROCEDURE
Method Reagent | Blank Reagent Dynamic
End Point- Fixed Time
Kinetle -LR. Single + 8.5. RI Ri+T+SaTssb
Baron Figs [oonessa | aiewemen |__Aietrenaewesrtead
End Point- Fixed Time
Kinetic - LR. Double + 8.5. Ri+R2+Tr RI+R2+Tr+S+TsL
S.S. = Serum Starter, Tr = Delay Time for R1 and R2, Ts = Serum Incubation Time,
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 (AA) and concentration’s value computation
Kinetic Reagents reading check. Data detection during programmed reading time,
determination of the absorbance delta per minute (AM/min.), processing of the linear
regression and computation of the concentration’s value.
Initial Rate Reagents reading check. Data detection during programmed reading time,
determination of the absorbance delta per minute (AAImin.), processing of the linear
regression and computation of the concentrations value.
Section Chapter C Fimetions - Analyses Prog. ~Crls Cali BT3000 PLUS Rev.0, Soft Vor. § Page 14 of 32 ‘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 (AA) between first and second phase and
concentration’s value computation.
‘Sample Blank (A-b)
Sample Blank (B)
Blank Reagent (R1+R2); first chase (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
(AA) between first and second phase and concentration’s value computation.
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 (AA) 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 (AA) 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
2points datum in incubation time and the last datum in reading time), absorbance delta
determination (4A) and concentration's value computation
End Point Without Blank Reagent (reading only with reference to H;0). Final reaction data
iscigte detection (at the end of programmed time for reading) and concentration’s value
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 ul 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 "Reading only" method uses only
a single reagent, and the “Sample Blank” (A) & (B) methods require exclusively double reagent
methodologies.
Section! — Chapter
Functions - Analyses Prog. ~Civls-Calib, BTSO00 PLUS Rev, Soft Ver.8 Page 13 of 32 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.
©8©0005080 ©
=| as
Bheleteleis| o| |{Sielsielsie) es)
Fig. 6 Fig. 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°t in the
Eunction 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**". The test
type, defines whether the programmed test is a Clinical Chemistry, an ISE. (if enabled, refer
to Chapter L) 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 Chapter C Fumetions - Analyses Prog. ~Crls Cali BT3000 PLUS Rev.0, Soft Vor. § Page 16 of 32 1.3.2. Relation tests
Fig. 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”.
Fig. 9
In the parameters window (fig. 9) enter the following information:
“Name”: complete test name
“4** Unit": measurement unit. Clicking on the “2 Unit” itis possible to enter a secondary
unit, with its conversion factor (the analyzer will multiply the 1° 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! — Chapter C Funetions - Analyses Prog. -Ctris- Cali, BT3000 PLUS Rev.0, Soft Ver.8 Page 17 of 32 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.a. 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 = 900mI [(urine CRE x urine ml 24/n)(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
P Soo
ud i
