O.M._14.0_BT1000_BT1500_BT2000 Plus_BT3000_Plus_BT3500.pdf

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OPERATOR MANUAL P/N: MO04444-00ING SOFTWARE VERSION 14.0 Rev. 0, 10/2009

This manual is valid for the following BT analyzers: BT1000, BT1500, BT2000 Plus, BT3000 Plus, BT3500. The differences among the analyzers are highlighted where necessary.

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

IMPORTANT NOTICE ON THE USE OF THE UPS DEVICE ATTENTION! BIOTECNICA INSTRUMENTS ANALYZERS MUST OPERATE ONLY IF CONNECTED TO AN UPS DEVICE. BIOTECNICA WILL NOT BE RESPONSIBLE FOR ANY DAMAGE TO THE ANALYZER OR INJURY TO PERSONS IF THE ANALYZERS ARE OPERATED WITHOUT THE PROPER CONNECTION TO THE UPS DEVICE OR WITHOUT THE UPS ITSELF.

INDEX – Operator Manual SECTION I: GENERAL INFORMATION CHAPTER A 1. 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

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2 3 4 9 9 11 13

CHAPTER B 1. INSTALLATION 1.1. Unpacking the Analyzer 1.2. Installation 1.3. Starting the instrument 1.3.1. Turning on the instrument for the first time 1.3.2. Preliminary checks

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2 2 4 8 8 9

CHAPTER C 1. FUNCTIONS 1.1. Description of the Program Menu 1.2. Operating Principles 1.2.1. Computations 1.2.2. Applied mathematical functions 1.2.3. Initial computation 1.2.4. Optimization techniques for Clinical Chemistry 1.2.5. Methods Description 1.3. Analyses Programming 1.3.1. Creating a New Code 1.3.2. Relation Tests 1.3.3. Primary Analytical Parameters 1.3.4. Check Parameters 1.3.5. Secondary Analytical Parameters 1.3.6. Automatic re-runs 1.4. Controls 1.5. Calibrations 1.6. Creating Profiles 1.7. Creating the Current Analyses’ Tray

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2 2 5 5 7 9 9 10 15 15 16 17 23 24 27 28 29 34 35

CHAPTER D 1. PERFORMANCE AND LIMITS

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2

INDEX

Page 1 of 6

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

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2 2 2 5 7 13 17 18

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

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2 2 4 6 7 9 10 11 12 16 18 19 21 23 25 27 29

CHAPTER G 1. DISPLAYING AND PRINTING RESULTS 1.1. Results per Patient 1.2. Results per Test 1.3. Displaying Real-Time data 1.4. Reaction graphs 1.5. Flags list 1.6. Sorting results in real time

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2 3 8 9 11 13 14

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

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2 2 2 4 6 10

INDEX

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INDEX – Operator Manual CHAPTER I 1. BARCODE AND RELATED FUNCTIONS 2. USING THE BARCODE 2.1. Barcode on Samples 2.2. Reagent Barcode

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2 2 2 5

CHAPTER K 1. VACUUM PUMP SYSTEM INSTALLATION/OPERATION 1.1. Functional characteristics 1.2. System control functions 1.3. Waste container (external) 1.4. Installation & operation 1.5. Maintenance and care 1.6. Trouble-shooting 1.7. Spare parts for maintenance

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2 2 3 3 4 4 4 5

1. ISE MODULE 1.1. Introduction 1.1.1. Contents of the wooden crates: I.S.E. 1.1.2. Applied Mathematical Functions 1.2. Performance And Limits 1.3. I.S.E. Wash and system shut down 1.4. Mechanical Calibrations: I.S.E. Arm 2. Operating the I.S.E. Module 2.1. Parameters 2.2. Programming Standards and Controls 2.3. Replacing and Installing Electrodes 2.4. Preliminary steps before starting the system 2.5. Calibration procedure 2.6. Measuring unknown samples 3. Precautions, maintenance and Troubleshooting 3.1 Precautions for ISE Module usage 3.2. Suggestions for performance maintenance 3.2.1. I.S.E. Maintenance 3.3. Troubleshooting 4. Returning The Analyzer To The Tech. Assistance Service 5. I.S.E. Module Consumables

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2 2 3 3 4 5 6 7 7 10 13 14 15 17 18 18 19 20 22 26

CHAPTER M 1. WARNINGS AND PRECAUTIONS 1.1. Potential risks during operation and maintenance 1.2. Warnings and precautions 1.3. Waste disposal 1.4. Returning the analyzer to the T.A.S. 1.4.1. Operating Analyzer

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2 2 3 6 6 6

CHAPTER L

INDEX

Page 3 of 6

INDEX – Operator Manual 1.4.2. Not Operating Analyzer 1.5. Analyzer safe disposal 1.6. Electric and electronic devices disposal

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7 8 9

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

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2 2 3 3 5 5 6 7 8 8 9 10 12 14

CHAPTER O 1. TECHNICAL SPECIFICATONS

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2

CHAPTER 1 1. ABBREVIATED OPERATING INSTRUCTIONS 1.1. Turning on and preliminary procedures 1.2. Inserting Reagents for Clinical Chemistry 1.3. Analytical calibrations and Controls 1.4. Entering Patients and Work Lists 1.5. Running Tests 1.6. Displaying and Printing Results 1.7. Turning off the analyzer

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2 3 6 7 10 14 15 19

CHAPTER 2 2. WARRANTY CONDITIONS • Notes from the manufacturer • Parts/Instruments Return Authorization

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2 3 4

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2 2 3

SECTION II: SUPPLEMENTARY INFORMATION

CHAPTER 3 3. ORDERING INFORMATION 3.1. GENERAL TERMS AND CONDITIONS FOR SALE 3.2. Consumables for the analyzer INDEX

Page 4 of 6

INDEX – Operator Manual CHAPTER 4 4. SOFTWARE EXTENSION: Serial communication analyzer Host Computer 4.1. General 4.2. Patient transmission to analyzer 4.3. Results reception 4.4. Calculation of check-sum 4.5. Wiring diagram of interface cable 4.6. Variable communication protocol 4.7. Serial communication test programs 4.7.1. Program Comunica.exe 4.7.2. Program BTPLUS.exe

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2 2 3 4 5 6 17 17 17

CHAPTER 5 5. INSTALLATION OF THE OPERATING SYSTEM 5.1. 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 analyzer Program 5.6. Upgrading the analyzer software

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2 2 5 9 11 15 16

CHAPTER 6 6. TECHNICAL ASSISTANCE

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2

CHAPTER 7 7. BIBLIOGRAPHY OF ALLIED SUBJECTS

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CHAPTER 8 8. LIST OF APPLICABLE METHODOLOGIES

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INDEX

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INDEX – Operator Manual ATTENTION: USE OF THE ANALYZER INTERNAL COMPUTER – DOES NOT APPLY TO BT1500 The computer box of BT analyzers is designed for long-term security and reliability and is virtually maintenance-free as long as the user does not install any thirdparty 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 harddisk 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

Page 6 of 6

OPERATOR MANUAL

SECTION I: GENERAL INFORMATION CHAPTER A 1. 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

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2 3 4 9 9 11 13

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: All pictures in this manual are referred to the BT3000 Plus. Figures may be different for the other analyzers.

Biotecnica Instruments S.p.A. Via Licenza, 18 00156 Rome – ITALY

Section I

Chapter A

System Description

Page

1

of 11

1. INTRODUCTION This instrument is an automatic analyzer for Clinical Chemistry and Immunoturbidimetry, it 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 analyzer 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, the BT3000 Plus and BT3500 are equipped for ions determination with the I.S.E. Module (Ion Selective Electrodes). 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 for the reagent tray in use, including the relation tests. During analyzer operation, the refrigerated reagents chamber (not available in the BT1000) ensures a longer stability of the products in use. The positive barcode identification of reagents position (not available in the BT1000), reduces the 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 (not available in the BT1000). 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

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2. BASIC OPERATING PRINCIPLES OF THE ANALYZER The automatic analyzer is 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 analyzer 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. The ISE (Ion Selective Electrodes) module, where available, is a device dedicated to the determination in the samples of the electrolytes (see chapter L). This device is defined as ion selective as the used electrodes react with the corresponding ions in accordance with the following Nernst law: +

E = E0 + RT/nF log aM+

+

aM = M ion activity E = potential in Volt E0 = constant (H+ electrode redox semi-reaction std potential) R = gas constant F = Faraday’s constant T = temperature expressed in Kelvin degrees n = ion charge

The electrodes life is dependent upon the number of sample runs and the routine maintenance procedures outlined in this manual. Section I

Chapter A

System Description

Page

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of 14

3. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS As the 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: 2 1

3 4 5 6 10

7

8

9

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 Program code: operative program software 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 (not available in the BT1000)

⑩ Operating Pressure Indicator, Ambient Temperature (RT), Cuvette Temperature (CT)

Section I

Chapter A

System Description

Page

4

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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 14

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

Section I

Chapter A

Refrigerator disabled

System Description

Page

6

of 14

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.

* Not all symbols are listed here. These are only some examples.

Section I

Chapter A

System Description

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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

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8

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4. BRIEF DESCRIPTION OF THE SYSTEM 4.1. FRONT VIEW OF THE ANALYZER BT3000Plus & BT3500 2

8

1

6

7 3

5 4 10 11

9

Figure 2

1 ON/OFF BUTTON FOR COMPUTER 2 LCD DISPLAY 3 REFRIGERATED REAGENT COMPARTMENT 4 SAMPLES TRAY 5 SAMPLING ARM FOR CLINICAL CHEMISTRY 6 SAMPLING ARM ISE 7 ISE MODULE 8 FLUIDIC CIRCUIT AND READING STATION 9 PUSH-PULL HANDGRIPS 10 ISE FUNNEL 11 DILUENT BOTTLE

Section I

Chapter A

System Description

Page

9

of 14

BT1000, BT1500 & BT2000 Plus

2

1 5

6 8

3 4

7

Fig. 3

5

6

8

3 4

7

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 HANDGRIPS 8. DILUENT BOTTLE

Section I

Chapter A

System Description

Page

10

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

Rear Panel Fig. 4 IMPORTANT NOTICE: The illustrated connectors on the Computer Box (Fig. 4 & Fig. 5) 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. 5 Section I

Chapter A

System Description

Page

11

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Connectors of BT1500 rear panel

Section I

Chapter A

System Description

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12

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4.3. MODULES The BT analyzers are constructed of a one-piece stainless steel structure. The injectionmolded body (in Baydur®) is placed on the chassis to cover the instrument. The following pictures show the modular composition of the instruments. Each module has its own specific function. BT1000, BT1500 & BT2000 Plus Modules definition •

COMPUTER BOX: it is not present in the BT1500. 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 WASTE

H2O COMPUTER

SERUM

REAGENT

REAGENT BAR-CODE

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

SAMPLE BAR-CODE

Modules Arrangement BT1000, BT1500 & BT2000 Plus

Section I

Chapter A

System Description

Page

13

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BT3000 Plus & BT3500 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 electrodes, the washing wells and the control electronics. ISE MODULE: consists of the electrodes panel, hydraulic path and the electronics. SAMPLING ARM (two): is composed of a two-axes based mechanical system accommodating sampling needle head with built-in electronics including correct position sensor (Encoder).

Modules Arrangement BT3000 Plus & BT3500

Section I

Chapter A

System Description

Page

14

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OPERATOR MANUAL

SECTION I: GENERAL INFORMATION CHAPTER B 1. INSTALLATION 1.1. Unpacking the Analyzer 1.2. Installation 1.3. Starting the instrument 1.3.1. Turning on the instrument for the first time 1.3.2. Preliminary checks

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NOTE: All pictures in this manual are referred to the BT3000 Plus. Figures may be different for the other analyzers.

Biotecnica Instruments S.p.A. Via Licenza, 18 00156 Rome – ITALY Section I

Chapter B

Unpacking & Installation

Page

1

of 9

2 2 4 8 8 9

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 at 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 (two handgrips for BT1000, BT1500 and BT2000 Plus) 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

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Verification Of the contents of the wooden crates Verify upon receipt of the analyzer system that all parts are present and intact when opening the wooden crates and packaging. Please use Mod. 05_28spr, which is included in the shipment. This document is specific for each analyzer and lists in detail which items are present in the packages. The analyzer and accessories are contained in wooden boxes adequate for the shipment.

♦ 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.

Section I

Chapter B

Unpacking & Installation

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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 and is large enough for its dimensions (refer to Chapter O, 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. For moving the analyzer at least two persons are necessary. NOTE: All the components, when present, 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). Attention: always verify the shipment check list Mod. 05_28spr, especially for what concerns accessories and peripherals, as not all analyzer's models are supplied with all accessories/peripherals. The following instructions are referred to the analyzers supplied with all accessories and peripherals. In case your analyzer is not supplied with complete equipment, please ignore the instructions related to the accessory/peripheral which is not present. BT1500: as far as this analyzer has an external computer, please refer to its instructions for peripherals and electrical connections. The analyzer must be connected to the PC via the USB port located on the left side of the rear panel. 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

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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.

ON-OFF

FUSE

TO THE MAIN POWER ON-OFF ANALYZER

PRINTER POWER

TO ANALYZER TO 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.

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PRINTER: Printer rear view. TO POWER

Fig. 5 USB PORT

Refer to Figure 5 for connections. Connect the USB/USB cable to the printer USB port and to one of the USB ports on the rear side of the analyzer. Connect at the same way the power cord, from the printer to one of the power connectors on the analyzer's rear panel (see figure 2). FLUIDIC CONNECTIONS The external fluidic manifold (Figure 6 – BT1000, BT1500 & BT2000 Plus) 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

Figure 6 (BT1000, BT1500 & BT2000 PLUS) 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

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For BT3000 Plus and BT3500, the transparent, black, and blue tubes are fitted with quick-connects having built-in shut-off valves, which in case of disconnection prevents liquid spillage. 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 upper connector, identified by a white flange. Its other end goes to the external water container. The black tube for cuvettes waste fluid must be connected to the middle connector, identified by a black flange. Its other end goes directly into the second input connector of the vacuum pump. The blue tube must be connected to the lowest connector with blue flange on the fluidic manifold. Its other end goes directly into the first input connector of the vacuum pump system. For more info refer to Chapter K – Vacuum Pump.

Figure 6a

WARNING 1) Do not use the internal vacuum pump system with any other fluid source except the 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

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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, where available. To properly turn on the analyzer system, press once the green push-button placed on the front panel (Fig. 8). For what concerns the BT1500, verify first that the external PC is connected to the analyzer via USB, then turn the PC on and load the analyzer operative program. 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 & USB

Start button

Figure 8 Section I

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Figure 9

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

Verify that there is sufficient washing solution 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.

Daily

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

Daily

Zeroing of the photometer

Twice a day

Wash the cuvettes with the proper solution Extra wash of the cuvettes with acid solution Wash I.S.E. module with proper solution

NOTES

A reminder message will appear 20 min after start up and then after 6 hours.

Daily

Before turning off

Weekly

When turning off

Daily

When turning off

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

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OPERATOR MANUAL

SECTION I: GENERAL INFORMATION CHAPTER C 1. FUNCTIONS 1.1. Description of the Program Menu 1.2. Operating Principles 1.2.1. Computations 1.2.2. Applied mathematical functions 1.2.3. Initial computation 1.2.4. Optimization techniques for Clinical Chemistry 1.2.5. Methods Description 1.3. Analyses Programming 1.3.1. Creating a New Code 1.3.2. Relation Tests 1.3.3. Primary Analytical Parameters 1.3.4. Check Parameters 1.3.5. Secondary Analytical Parameters 1.3.6. Automatic re-runs 1.4. Controls 1.5. Calibrations 1.6. Creating Profiles 1.7. Creating the Current Analyses’ Tray

Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page: Page:

NOTE: All pictures in this manual are referred to the BT3000 Plus. Figures may be different for the other analyzers.

Biotecnica Instruments S.p.A. Via Licenza, 18 00156 Rome – ITALY Section I

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2 2 5 5 7 9 9 10 15 15 16 17 23 24 27 28 29 34 35

1. FUNCTIONS 1.1. DESCRIPTION OF THE PROGRAM MENU As already described in the Chapter A, the BT instruments are clinical chemistry automated analyzers for 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, drugs abuse and reading of electrolytes (where available, see Chap. 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 main menu contains 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 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

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Tests Menu

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: is used to create the analyses lists (profiles) which can be used for programming patients.

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 analytical parameters. There are two available options: Back-up (for exporting all the analyses) and Single Test (exports a selection of single tests). Import Data Copies the above-mentioned parameters from a floppy disk or from any other location into the analyzer memory. There are two available options: Restore (will import all parameters) and Single test (imports the exported single tests). The function is allowed only if modify parameters password is given. NOTE: when a back-up is imported, all data in the global and current analyses trays will be overwritten. 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

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

Figure 4 Section I

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 resume work immediately. Chapter C

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Note: the analyzer switches automatically to the 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 software 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, click on the left or right mouse button and press the Exit button on the window that appears. The system will reset and after approximately 20 minutes warm-up time the analyzer will be ready to operate (refer to Chapter E, paragraph 1.6.). 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 off procedures. He will be invited to place the solutions when needed and to ensure the 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

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

Figure 5

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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

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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: 1st phase: 2nd phase: Computation:

R1 + R2 R1 + Serum R2 (Last Reading 2nd phase –Last Reading 1st phase) – blank

Sample-Blank B-b Blank:

R2 R1 + serum R2 + serum (Last Reading 2nd cuvette –Last Reading 1st cuvette) – blank

1st cuvette: 2nd cuvette: Computation:

End Point Starter Dynamic:

1st phase: 2nd phase: Computation:

As normal End Point with serum starter Only reagent (R1 or R1+R2) Serum 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

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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

CC =

i

1

n

∑ (L

i

− T )( Li − L)

− L)

n

2

1

where: n i T L

∑ (T

i

− T )2

1

: Number of readings : Number of reading (i) : Times : Readings

♦ Linear Regression n

n

∑ ( L ) ∑ (T ) 2

n

M=

∑ (T L ) − n i

i

1

i

1

n

1

n n

n

∑ (T ) i

1

2



(∑ Ti ) 2 1

n

n ⎛ ∑1 Li ⎜⎜ n ∑1 Li − ∑ (Ti Li ) − n ⎜ 1 n n ⎜ ⎝ Q= M n

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where: M Q n i T L

: Angular coefficient for the line : Final point for the line : Number of readings : Number of reading (i) : Times : Readings

♦ Distance point-line

D =| Y − MX − Q | where: M Q X Y

: Angular coefficient for the line : Final point for the line : Point Abscissa : Point Ordinate

♦ Distance between two points Y=

where: X Y x0 x1 y0 y1

X − x0 ( y1 − y 0 ) + y1 x1 − x0

: X axis : Y axis : First Point X Axis : Second Point X Axis : First Point Y Axis : Second Point Y Axis

MATHEMATICAL FUNCTIONS FOR CLINICAL CHEMISTRY

♦ Volumetric factor (used in sample blank A tests) K= where:

K vS vR1 vR2

vS + vR1 vS + vR1 + vR2

: Volumetric factor : Serum volume : First reagent volume : Second reagent volume

♦ I.S.E. Module Functions, see chapter L, par. 1.1.2.

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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 F2 − Fz2 ⎟⎠ ⎝ V = Op Of where:

Z F1 F2 Fz1 Fz2 Op Of

: Zeroing with water : First Filter’s Value : Second Filter’s Value : First Filter’s Zero-Value : Second Filter’s Zero-Value : Optical path : 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

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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 TIME

READING 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) A1

DELAY TIME

Section I

A2

INCUBATION TIME

A3

READING TIME

Chapter C

(A3 - A2) = ∆A A1

DELAY TIME

A2

INCUBATION TIME

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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

DELAY TIME

A2

INCUBATION TIME

A3

READING TIME

A1

DELAY TIME

A2

INCUBATION TIME

A3

READING 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

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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

DELAY TIME

A2 A3

INCUBATION TIME

READING 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

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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 Reagent Blank Reagent

Method End Point - Fixed Time Kinetic - I.R. Only Read End Point - Fixed Time Kinetic - I.R. End Point - Fixed Time Kinetic - I.R. Sample Blank (A) Sample Blank (A-b) Sample Blank (B) Sample Blank (B-b)

Dynamic

Single

R1

R1 + S ⇒Ta ⇒L

Single

R1

S⇒ L

Double

R1 + Ta + R2 + Tb

R1 +S + Ta + R2 + Tb ⇒ L

Double

R1 + R2 + Tb

Double

R1 + R2

Double

R2

R1 + R2+ S + Tb ⇒ L R1 +S + Ta ⇒ L1+ R2 + Tb ⇒ L2 Sample Blank (L2 –L1) R1 +S + Ta ⇒ L1 R2 +S + Tb ⇒ L2 Sample Blank (L2 –L1)

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

SERUM STARTER SAMPLING PROCEDURE Reagent Blank Reagent Dynamic

Method End Point - Fixed Time Kinetic - I.R. End Point - Fixed Time Kinetic - I.R. End Point - Fixed Time Kinetic - I.R.

Single + S.S.

R1

R1 + Tr + S ⇒Ts ⇒ L

Double + S.S.

R1 + Tr + R2 + Tr

R1 + Tr + R2 + Tr + S + Ts ⇒ L

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.

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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 * (End-Point)

Reagent blank. Final reaction data detection (at the end of programmed time for reading) and concentration’s value computation.

End Point 2 points

Reagent’s reading check. Data detection during programmed reaction time (first 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 detection (at the end of programmed time for reading) and concentration’s value computation. However the Blank is read to verify the reagent.

End Point Absolute

* 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.

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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, an I.S.E. (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).

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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

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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.

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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

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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: a third degree polynomial function is used. It has a very good approximation, but sometimes it may show anomalies

-

Cubic spline: the typical cubic interpolation is used. There is a good connection between subsequent point couples. Approximation is perfect on single points, but is 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).

-

Minimum squares: a second or third degree polynomial interpolation is used. It gives the best approximation to the minimum squares. It is a very simple curve, but sometimes may be distant from the standard points.

-

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).

-

Semi-log: a second degree curve is used, which is function of the concentration logarithm, and gives the best approximation to the standard points minimum squares. It is asymptotical on the last point, has no flex points and well approximates the standard points. It may be used for highly non linear processes.

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

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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 there are some limits for the final solution (reagent + sample) as well as for sample or reagents. See Table 1 at the end of this paragraph. 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

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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 (see Table 1). Dilution: In this screen, two fields are available, Pre-Dilution 1: (predilution ratio) and PostDilution 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 method. Otherwise enter 1, and no predilution will be performed. Post-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 (see Table 1). Dilution: The programming of fields (text boxes) for Pre-Dilution 1: and Post-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

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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 approx 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.

Indicative volumes

Min / Max Sample Vol. µl Min / Max Reagent Vol. µl Min / Max volume in cuvette µl Max diluter volume µl Min / Max reaction (reag + sample) µl

BT1000 BT2000 Plus BT3000 Plus 1 / 100 1 / 470 280 / 700 470 300 / 700

BT1500 BT3500 0.8 / 100 0.8 / 300 180 / 400 300 180 / 400

Table 1

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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. In case of reagent out of limit, the blank will be repeated every time the test is performed in a run. 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 InitialRate. 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 InitialRate. 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-oflinearity 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

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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 1⁄4 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. Section I

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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. 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) Every: 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.

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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, (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 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.

OTHER COMMANDS IN THE PARAMETERS PAGE Save: saves and exits from the window. Print: prints parameters. Cancel: exits without saving.

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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 rerunning, 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 "
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