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Erbachem XL 600 Manual Operador
Erbachem XL 600 Manual Operador
Operator’s Manual
XL-600
Version III104.3 II
Contents
Contents ................................................................................................................................................................ i
Foreword ........................................................................................................................................................... vii
Document Conventions ...................................................................................................................................... ix
Abbreviations...................................................................................................................................................... xi
List of flags ....................................................................................................................................................... xiii
1. Overview of the Analyzer .............................................................................................. 错误!未定义书签。
1.1 An Introduction to the Clinical Chemistry Analyzer ......................................... 错误!未定义书签。
1.2 Features .................................................................................................................. 错误!未定义书签。
1.3 Technical Specifications ........................................................................................ 错误!未定义书签。
1.4 System Overview.................................................................................................... 错误!未定义书签。
1.4.1 Front Side of the Analyzer ............................................................................... 错误!未定义书签。
1.4.2 Rear Side of the Analyzer ................................................................................ 错误!未定义书签。
1.4.3 Left Side of the Analyzer ................................................................................. 错误!未定义书签。
1.4.4 Top View of the Analyzer ................................................................................ 错误!未定义书签。
2. Installation of the Analyzer .......................................................................................... 错误!未定义书签。
2.1 Receiving Instructions ........................................................................................... 错误!未定义书签。
2.2 Warranty Information .......................................................................................... 错误!未定义书签。
2.3 Unpacking of the Analyzer ................................................................................... 错误!未定义书签。
2.4 Packing List ............................................................................................................ 错误!未定义书签。
2.5 Installation.............................................................................................................. 错误!未定义书签。
2.5.1 Environmental conditions ................................................................................ 错误!未定义书签。
2.5.2 Space requirements .......................................................................................... 错误!未定义书签。
2.5.3 Electrical requirements and connections .......................................................... 错误!未定义书签。
2.6 Hydraulic Connections .......................................................................................... 错误!未定义书签。
2.7 Application Software Installation ........................................................................ 错误!未定义书签。
2.7.1 Uninstalling previous version of application software ..................................... 错误!未定义书签。
2.7.2 Installation process ........................................................................................... 错误!未定义书签。
2.7.3 Post installation process ................................................................................... 错误!未定义书签。
2.7.4 Running the application for the first time ........................................................ 错误!未定义书签。
2.7.5 Switching ON the analyzer .............................................................................. 错误!未定义书签。
2.7.6 Checks to be performed before running the analyzer ....................................... 错误!未定义书签。
2.7.7 Printer installation ............................................................................................ 错误!未定义书签。
2.7.8 In case of Spool32 error ................................................................................... 错误!未定义书签。
3. Function ........................................................................................................................ 错误!未定义书签。
3.1 Sample Handling System ...................................................................................... 错误!未定义书签。
3.1.1 Sample Tray (Primary Tubes and Bar-codes) .................................................. 错误!未定义书签。
3.1.2 Sampling Arm .................................................................................................. 错误!未定义书签。
3.1.3 Sample Syringe ................................................................................................ 错误!未定义书签。
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3.1.4 Sample Probe.................................................................................................... 错误!未定义书签。
3.1.5 Wash Station for Sample Probe........................................................................ 错误!未定义书签。
3.2 Reagent Handling System ..................................................................................... 错误!未定义书签。
3.2.1 Reagent Tray .................................................................................................... 错误!未定义书签。
3.2.2 Reagent Bottles (and Bar-codes) ...................................................................... 错误!未定义书签。
3.2.3 Reagent Arm .................................................................................................... 错误!未定义书签。
3.2.4 Reagent Probe .................................................................................................. 错误!未定义书签。
3.2.5 Reagent Syringe ............................................................................................... 错误!未定义书签。
3.3 Stirrer ..................................................................................................................... 错误!未定义书签。
3.4 Cuvette Rinsing Unit ............................................................................................. 错误!未定义书签。
3.5 Photometer (Flat Field Polychromator) and Reaction Tray.............................. 错误!未定义书签。
3.6 Measurement Flow Chart ..................................................................................... 错误!未定义书签。
4. Operation ....................................................................................................................... 错误!未定义书签。
4.1 Precautions during Operation .............................................................................. 错误!未定义书签。
4.2 Analyzer Start Up .................................................................................................. 错误!未定义书签。
4.3 The Main Screen of the Application Software .................................................... 错误!未定义书签。
4.3.1 Common buttons and mouse pointers .............................................................. 错误!未定义书签。
4.4 [Test Parameters] .................................................................................................. 错误!未定义书签。
4.4.1 {Test Code} ...................................................................................................... 错误!未定义书签。
4.4.2 {Test} ............................................................................................................... 错误!未定义书签。
4.4.3 {Report Name} ................................................................................................. 错误!未定义书签。
4.4.4 {Assay Type} ................................................................................................... 错误!未定义书签。
4.4.5 {Assay Points} ................................................................................................. 错误!未定义书签。
4.4.6 {Wavelength} ................................................................................................... 错误!未定义书签。
4.4.7 {Control Interval} ............................................................................................ 错误!未定义书签。
4.4.8 {Sample Replicates} ........................................................................................ 错误!未定义书签。
4.4.9 {Sample Volume Normal} ............................................................................... 错误!未定义书签。
4.4.10 {Sample Volume Decrease}........................................................................... 错误!未定义书签。
4.4.11 {Sample Volume Increase} ............................................................................ 错误!未定义书签。
4.4.12 {Standard Volume} ........................................................................................ 错误!未定义书签。
4.4.13 {R1/R2}.......................................................................................................... 错误!未定义书签。
4.4.14 {Multiple Positions} ....................................................................................... 错误!未定义书签。
4.4.15 {Reagent Stability} ........................................................................................ 错误!未定义书签。
4.4.16 {React. Abs Limit} ......................................................................................... 错误!未定义书签。
4.4.17 {Reaction Dir.}............................................................................................... 错误!未定义书签。
4.4.18 {Reagent ABS} .............................................................................................. 错误!未定义书签。
4.4.19 {Tech. Serum /Urine Limits} ......................................................................... 错误!未定义书签。
4.4.20 {Serum Panic Limit} ...................................................................................... 错误!未定义书签。
4.4.21 {Prozone Limit} ............................................................................................. 错误!未定义书签。
4.4.22 {Unit} ............................................................................................................. 错误!未定义书签。
4.4.23 {Decimal Point} ............................................................................................. 错误!未定义书签。
4.4.24 {Normal value serum} ................................................................................... 错误!未定义书签。
4.4.25 {Urine Values} ............................................................................................... 错误!未定义书签。
4.4.26 {AutoRerun} .................................................................................................. 错误!未定义书签。
4.4.27 {Y = aX + b} .................................................................................................. 错误!未定义书签。
4.4.28 Test Parameters sub-menus ............................................................................ 错误!未定义书签。
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4.4.29 [Test Parameters: TESTS]................................................................................... 错误!未定义书签。
4.4.30 [Test Parameters: Calib Table] ........................................................................... 错误!未定义书签。
4.4.31 [Test Parameters: Copy] ..................................................................................... 错误!未定义书签。
4.5 [Patient Entry] ....................................................................................................... 错误!未定义书签。
4.5.1 {Sample No.} ................................................................................................... 错误!未定义书签。
4.5.2 {Sample Pos} ................................................................................................... 错误!未定义书签。
4.5.3 {Patient ID} ...................................................................................................... 错误!未定义书签。
4.5.4 {Patient Name} ................................................................................................ 错误!未定义书签。
4.5.5 {Disk No.}........................................................................................................ 错误!未定义书签。
4.5.6 {Date} .............................................................................................................. 错误!未定义书签。
4.5.7 {Date of Birth} ................................................................................................. 错误!未定义书签。
4.5.8 {Sample Cup} .................................................................................................. 错误!未定义书签。
4.5.9 {Age} ............................................................................................................... 错误!未定义书签。
4.5.10 {Address} ....................................................................................................... 错误!未定义书签。
4.5.11 {Referred by} ................................................................................................. 错误!未定义书签。
4.5.12 {Drawn by/Analyst}....................................................................................... 错误!未定义书签。
4.5.13 {Sample Remarks} ......................................................................................... 错误!未定义书签。
4.5.14 {Patient Remarks} .......................................................................................... 错误!未定义书签。
4.5.15 {Location} ...................................................................................................... 错误!未定义书签。
4.5.16 {Draw date} ................................................................................................... 错误!未定义书签。
4.5.17 {Body Mass Index} ........................................................................................ 错误!未定义书签。
4.5.18 {Urine Volume} ............................................................................................. 错误!未定义书签。
4.5.19 {Sample type} ................................................................................................ 错误!未定义书签。
4.5.20 {Emergency} .................................................................................................. 错误!未定义书签。
4.5.21 {Category} ..................................................................................................... 错误!未定义书签。
4.5.22 {Bar-code} ..................................................................................................... 错误!未定义书签。
4.5.23 {Calculated Item}........................................................................................... 错误!未定义书签。
4.5.24 {Selected Test}............................................................................................... 错误!未定义书签。
4.5.25 [Patient Entry: TESTS] ...................................................................................... 错误!未定义书签。
4.5.26 [Patient Entry: Profile] ....................................................................................... 错误!未定义书签。
4.5.27 [Patient Entry: WorkList]................................................................................... 错误!未定义书签。
4.5.28 [Patient Entry: Clr Sched] .................................................................................. 错误!未定义书签。
4.5.29 [Patient Entry: Refresh]...................................................................................... 错误!未定义书签。
4.5.30 [Patient Entry: Del Disk].................................................................................... 错误!未定义书签。
4.6 [Reagents] ............................................................................................................... 错误!未定义书签。
4.7 [Standardisation] ................................................................................................... 错误!未定义书签。
4.7.1 [Standardisation: Positions] .................................................................................. 错误!未定义书签。
4.7.2 [Standardisation: Calib Table] .............................................................................. 错误!未定义书签。
4.7.3 [Standardisation: Controls] ................................................................................... 错误!未定义书签。
4.7.4 [Standardisation: WorkList] ................................................................................. 错误!未定义书签。
4.7.5 [Standardisation: Clr Sched] ................................................................................. 错误!未定义书签。
4.7.6 Steps for standardisation .................................................................................. 错误!未定义书签。
4.8 [Run Test] ............................................................................................................... 错误!未定义书签。
4.8.1 {Run Test: Reagent Bar-code Scan} ................................................................... 错误!未定义书签。
4.8.2 {Run Test: Reagent Level Scan} ........................................................................ 错误!未定义书签。
4.8.3 {Run Test: Sample Bar-code Scan} .................................................................... 错误!未定义书签。
4.8.4 [Run Test: Run status] ........................................................................................ 错误!未定义书签。
4.8.5 [Run Test: Run Status: Run Monitor] ..................................................................... 错误!未定义书签。
iii
4.9 Procedure for obtaining result printout .............................................................. 错误!未定义书签。
4.10 [Exit] ..................................................................................................................... 错误!未定义书签。
5. Quality Control .............................................................................................................. 错误!未定义书签。
5.1 [Quality Control] ................................................................................................... 错误!未定义书签。
5.2 [Quality Control: TESTS].......................................................................................... 错误!未定义书签。
5.3 [Quality Control: Daily QC] ...................................................................................... 错误!未定义书签。
5.4 [Quality Control: Monthly QC]................................................................................... 错误!未定义书签。
5.5 [Quality Control: Twin Plot] ..................................................................................... 错误!未定义书签。
5.6 [Quality Control: Control Data] ................................................................................ 错误!未定义书签。
5.7 [Quality Control: Reports] ........................................................................................ 错误!未定义书签。
5.7.1 [Indv Mon] ....................................................................................................... 错误!未定义书签。
5.7.2 [Indv List] ......................................................................................................... 错误!未定义书签。
5.7.3 [Cuml Mon] ...................................................................................................... 错误!未定义书签。
5.7.4 [Data Reprint] ................................................................................................... 错误!未定义书签。
5.8 Procedure to run a Control ................................................................................... 错误!未定义书签。
6. Previous Data ................................................................................................................ 错误!未定义书签。
6.1 [Previous Data] ...................................................................................................... 错误!未定义书签。
6.2 [Previous Data: Analyst/Location] ........................................................................... 错误!未定义书签。
6.3 [Previous Data: Backup] ............................................................................................ 错误!未定义书签。
6.3.1 {Previous Data: Backup: Test Parameters} ............................................................ 错误!未定义书签。
6.3.2 {Previous Data: Backup: Patients} ......................................................................... 错误!未定义书签。
6.3.3 {Previous Data: Backup: Standardisation} ............................................................. 错误!未定义书签。
6.3.4 {Previous Data: Backup: Control}.......................................................................... 错误!未定义书签。
6.3.5 {Previous Data: Backup: System Switch} .............................................................. 错误!未定义书签。
6.4 [Previous Data: Calculation Item] ............................................................................ 错误!未定义书签。
6.5 Procedure to Enter a Calculation Item ................................................................ 错误!未定义书签。
6.6 [Previous Data: Calibration Monitor] ...................................................................... 错误!未定义书签。
6.7 Procedure for modifying the calibration data ..................................................... 错误!未定义书签。
6.8 [Previous Data: Calibration Trace] .......................................................................... 错误!未定义书签。
6.9 [Previous Data: Cuvette Blank]................................................................................. 错误!未定义书签。
6.10 [Previous Data: Database Status] ........................................................................... 错误!未定义书签。
6.11 [Previous Data: Delete Data] ................................................................................... 错误!未定义书签。
6.12 [Previous Data: Doctors List] .................................................................................. 错误!未定义书签。
6.13 [Previous Data: Error Record] ............................................................................... 错误!未定义书签。
6.14 [Previous Data: Offline Entry] ................................................................................ 错误!未定义书签。
6.15 [Previous Data: Patient Report] ............................................................................. 错误!未定义书签。
6.16 [Previous Data: Pending List] ................................................................................. 错误!未定义书签。
6.17 [Previous Data: Print Test Parameters] ................................................................. 错误!未定义书签。
iv
6.18 [Previous Data: Reagent Status] ............................................................................. 错误!未定义书签。
6.19 [Previous Data: Recalculation] ............................................................................... 错误!未定义书签。
6.20 [Previous Data: Rerun List] .................................................................................... 错误!未定义书签。
6.21 [Previous Data: Result Backup].............................................................................. 错误!未定义书签。
6.22 [Previous Data: Result Reprint] ............................................................................. 错误!未定义书签。
6.23 [Previous Data: Serum Indices]............................................................................... 错误!未定义书签。
6.23 [Previous Data: Serum Indices]............................................................................... 错误!未定义书签。
6.24 [Previous Data: System Switch] .............................................................................. 错误!未定义书签。
6.25 [Previous Data: Test Statistics] ............................................................................... 错误!未定义书签。
6.26 [Previous Data: Time Course] ................................................................................ 错误!未定义书签。
7. Maintenance .................................................................................................................. 错误!未定义书签。
7.1 Maintenance and Analyzer Care .......................................................................... 错误!未定义书签。
7.2 [Service Check] ...................................................................................................... 错误!未定义书签。
7.3 [Maintenance] ........................................................................................................ 错误!未定义书签。
7.3.1 {Reset} ............................................................................................................. 错误!未定义书签。
7.3.2 {Photometer}.................................................................................................... 错误!未定义书签。
7.3.3 {Cuvette Rinse} ............................................................................................... 错误!未定义书签。
7.3.4 {Auto Wash} .................................................................................................... 错误!未定义书签。
7.3.5 {Water Save} ................................................................................................... 错误!未定义书签。
7.3.6 {ISE unit} ......................................................................................................... 错误!未定义书签。
7.4 In case of long shutdown ....................................................................................... 错误!未定义书签。
7.5. Troubleshooting .................................................................................................... 错误!未定义书签。
Index .................................................................................................................................. 错误!未定义书签。
A. Electrolyte Measurement by ISE ................................................................................. 错误!未定义书签。
A.1 Introduction to the ISE module ........................................................................... 错误!未定义书签。
A.2 Technical Specifications ....................................................................................... 错误!未定义书签。
A.3 ISE Measurement Theory .................................................................................... 错误!未定义书签。
A.4 Electrodes .............................................................................................................. 错误!未定义书签。
A.5 Reagents Used ....................................................................................................... 错误!未定义书签。
A.6 Installation ............................................................................................................. 错误!未定义书签。
A.7 Removal of Electrodes .......................................................................................... 错误!未定义书签。
A.8 Calibration and Sample Processing .................................................................... 错误!未定义书签。
A.9 ISE Test Scheduling .............................................................................................. 错误!未定义书签。
A.10 Operating Cycles ................................................................................................. 错误!未定义书签。
A.11 Maintenance Schedule ........................................................................................ 错误!未定义书签。
A.12 Shutdown Procedure .......................................................................................... 错误!未定义书签。
A.13 Error Codes ......................................................................................................... 错误!未定义书签。
v
A.14 Trouble-shooting Guide ..................................................................................... 错误!未定义书签。
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vii
Foreword
This manual is organized in a progressive sequence for easy study and reference. It is an instructional aid to
provide a reference for easy operation and general maintenance of this analyzer. The manual contains detailed
description of the analyzer features and specifications. It also contains principle of operation, function, and
general maintenance procedures. It is recommended that the operator reads this manual and becomes
thoroughly familiar with the contents before attempting analyzer operation. Use of the analyzer with proper
information will ensure quality test results and trouble free analyzer operation and performance.
Assumptions are made that before attempting operating the analyzer, the operator is familiar with the
operation of analyzer and has:
viii
ix
Document Conventions
This manual uses the following typographic conventions:
[Previous Data] Items inside square brackets refer to different screens. For example,
[Previous Data] refers to the screen obtained after clicking <Previous Data>
on the main menu.
[Test Parameters: Tests] Nested items separated by colon inside square brackets refer to a sub-screen.
For example, [Test Parameters: Tests] refers to the screen obtained after pressing
<Tests> on the [Test Parameters] screen. The parent screen referred to is put
in a smaller font and the screen in context is put in a normal font.
{Test Parameters: Unit} Nested items separated by colon inside curly braces indicate a field name on
a particular screen. For example, {Test Parameters: Unit} refers to {Unit} field
on the [Test Parameter] screen. The screen name is put in a smaller font and
the field referred to is put in a normal font.
GLU, ErbaPath Words that the operator is instructed to type or select appear in italicized
Arial font.
YES|NO Text in italicized Arial font separated by vertical bar(s) indicates a choice
between two or more items. You must choose one of the items. For example,
YES|NO means, you have to choose one of the YES and NO options.
R2 Volume Required Bold text enclosed in a text box indicates a warning or notice.
<Enter> Text enclosed between ‘<’ and ‘>’ signs refer to the names of keys and key
sequences such as <Enter> and <Ctrl+v>.
<Alt + v> A plus sign (+) between key names indicates a combination of keys. For
example <Alt + v> suggests you to hold down <Alt> key while pressing the
<v> key.
<Up/Down/Left/Right Individual direction keys are referred to by the direction of the arrow on the
Arrow> key top (Left Right, Up or Down). The phrase “arrow keys” is used when
describing these keys collectively.
<Backspace>, <Home> Other navigational keys are referred to by their specific names.
<Go Back>, <Modify> Specific names enclosed between “<” and “>” signs refer to application
software specific buttons.
C:\Analyzer\ParamFile.txt Paths and file names are given in mixed case in italics.
x
xi
Abbreviations
Throughout this manual, the following abbreviations have been used
ABS./abs. Absorbance
QC Quality control
R1 or RGT1 Reagent 1
R2 or RGT2 Reagent 2
SI Serum Indices
xii
xiii
List of flags
This flag is issued with a patient result to indicate a same rerun that took place due
#
to violation of Panic Limits
+/- 1SD This flag is issued with control serum result to indicate that the result is below or
above 1SD limit
+/- 2SD This flag is issued with control serum result to indicate that the result is below or
above 2SD limit
+/- 3SD This flag is issued with control serum result to indicate that the result is below or
above 3SD limit
AbsLim This flag can be issued with patient, calibrator and control result.
1) For increasing direction chemistries, this flag indicates that the reaction mixture
absorbance is higher than the programmed Reaction Absorbance Limit
2) For decreasing direction chemistries, this flag indicates that the reaction
mixture absorbance is lower than the programmed Reaction Absorbance Limit
If AutoRerun is set to YES, the patient sample is sent for a Decreased volume run.
CalA* This flag indicates that the Calibrant A for ISE module is absent or air bubble is
present in Calibrant A
Chk Calib This flag is issued with patient or control serum result and indicates that
something is wrong with the calibration and the calibration table needs to be
checked and corrected to calculate a result (e.g., number of standards provided for
multipoint calibration is less than 3)
Chk QCParam This flag is issued with control serum result and indicates that the target Mean and
SD values have not been defined in Quality Control screen for the control
D This flag is issued with patient results and indicates a Decreased volume run
D* This flag is issued with patient, calibrator and control results and indicates diluent
absent error.
H This flag is issued with patient result to indicate that the result is higher than the
programmed maximum reference value
I This flag is issued with patient results and indicates an Increased volume run
L This flag is issued with patient results and indicates that the result is lower than
the programmed minimum reference value
xiv
Lin.H This flag is issued with patient, calibrator and control results to indicate that the
upper limit of linearity of the reagent has been exceeded
1) For Rate chemistries, this flag indicates that the rate of reaction (ΔAbs/min) is
more than the programmed rate in Technical Limit Max
2) For endpoint chemistries, this flag indicates that the sample concentration is
higher than the concentration programmed in Technical Limit Max
If AutoRerun is set to YES, the patient sample is sent for a Decreased volume run
Lin.L This flag is issued with patient, calibrator and control results to indicate that the
lower limit of linearity of the reagent has been violated
1) For Rate chemistries, this flag indicates that the rate of reaction (ΔAbs/min) is
less than the programmed rate in Technical Limit Min
2) For endpoint chemistries, this flag indicates that the concentration is lower than
the concentration programmed in Technical Limit Min
If AutoRerun is set to YES, the patient sample is sent for an Increased volume run
MONO This flag is issued with patient result when, for the concerned test, the absorbances
of the calibrators are not changing monotonically with the concentration of the
calibrators in the calibration table
OutOfRange.H This flag is issued with patient and control serum results to indicate that the
absorbance of the sample is higher than the highest absorbance in the calibration
table. If AutoRerun is set to YES, the patient sample is sent for a Decreased
volume run for increasing direction chemistries and for an Increased volume run
for decreasing direction chemistries.
OutOfRange.L This flag is issued with patient and control serum results to indicate that the
absorbance of the sample is lower than the lowest blank absorbance in the
calibration table. If AutoRerun is set to YES, the patient sample is sent for an
Increased volume run for increasing direction chemistries and for a Decreased
volume run for decreasing direction chemistries.
P* This flag is issued with patient and control serum resuls to indicate that prozone
(antigen excess) has occurred. If AutoRerun is set to YES, the patient sample is
sent for a Decreased volume run
Panic.H This flag is issued with a serum sample result to indicate that the patient result is
higher than the programmed Serum Panic Limit Max. If AutoRerun is set to YES,
the sample is sent for a same rerun
Panic.L This flag is issued with a serum sample result to indicate that the patient result is
lower than the programmed Serum Panic Limit Min. If AutoRerun is set to YES,
the sample is sent for a same rerun
PD This flag is issued with patient, calibrator and control results to indicate that the
sample was prediluted
R1* This flag is issued with patient, calibrator and control results to indicate that the
volume of Reagent 1 is insufficient or Reagent 1 is not present.
R2* This flag is issued with patient, calibrator and control results to indicate that the
volume of Reagent 2 is insufficient or Reagent 2 is not present.
xv
RgtAbsMax This flag is issued with patient, calibrator and control results to indicate that
reagent absorbance is higher than the programmed Reagent Absorbance Max
RgtAbsMin This flag is issued with patient, calibrator and control results to indicate that
reagent absorbance is lower than the programmed Reagent Absorbance Min
S* This flag is issued with patient, calibrator and control results to indicate that the
volume of Sample is insufficient or Sample is not present
SYS!
This flag is issued with patient, calibrator and control results to indicates that there
was some problem with the transmission between the analyzer and PC which has
affected the result
xvi
xvii
Chapter 1
1. Overview of the Analyzer ................................................................................................................................ 3
1.1 An Introduction to the Clinical Chemistry Analyzer ........................................................................... 3
1.2 Features .................................................................................................................................................... 4
1.3 Technical Specifications .......................................................................................................................... 5
1.4 System Overview...................................................................................................................................... 6
1.4.1 Front Side of the Analyzer ................................................................................................................. 6
1.4.2 Rear Side of the Analyzer .................................................................................................................. 7
1.4.3 Left Side of the Analyzer ................................................................................................................... 7
1.4.4 Top View of the Analyzer .................................................................................................................. 8
2 Overview of the Analyzer
Overview of the Analyzer 3
Overview
1.1 An Introduction The Clinical Chemistry Analyzer is an open, fully automated, discrete, patient
to the Clinical prioritized, random access, computerized analyzer and intended for in vitro
Chemistry Analyzer quantitative determination of a wide range of analytes in various body fluids.
Once programmed, it is a truly walk-away system. The analyzer operation is very
user-friendly with minimum handling required from the operator. However, the
analyzer being a highly sophisticated system, it is of utmost importance that the
operator reads the instructions and becomes familiar with its functioning before
attempting any analyzer operation.
The working unit of the analyzer comprises a basic operating unit with an
intelligent photometer and sophisticated robotics combined with an operating
console and a central processing unit (CPU).
The operating unit of the analyzer includes the sample and reagent handling
systems. The sample handling system consists of a sample tray, sample arm,
sample syringe, and a wash station for the sample probe. The sample tray can hold
up to 50 routine samples, 20 standards, 2 blanks, 8 controls, and ISE (optional)
cleaning and calibrant solutions. Routine samples can be loaded in primary tubes
or sample cups. With (optional) bar-code unit, bar-coded primary tubes can be
directly kept on the sample tray. This provides positive sample identification and
minimizes the risk of biological hazards. The reagent handling system consists of
a reagent tray (with 50 positions), two reagent arms, reagent syringes and wash
station for the reagent probes. Reagent bottles are bar-coded (optional) and
available in 2 capacities i.e., 50 ml and 20 ml. A unique 5 ml reagent adaptor is
available which can be used for expensive reagents to avoid wastage. The mixer
unit and a 7-stage laundry complete the robotics of the analyzer.
The CPU consists of a Pentium-IV 1.7 GHz processor (or higher) with a 48 x CD
Drive, and minimum 256 MB memory. The application software can be installed
on computers with operating systems of Windows® 98, Windows® 2000, or
Windows® XP.
The application software is the final component that provides Intelligence to the
operating system. The software is comprehensive and complete with correction
formulas and auxiliary data storage for 10,000 test results.
Programming the analyzer is very simple. The analyzer provides various well-
structured options on screen that are aptly named such as Test Parameters, Patient
Entry, Quality Control, Reagents, Previous Data, Standardisation, Run Tests and
Service Check for easy programming. The operator can click the mouse or use the
(optional) touch-screen for selecting the desired options. The ‘pull-down’ options
provide the operator alternatives to select desired options. Upon completion of the
programming, the required samples and reagents can be loaded on the system to
start performing test runs. Results are printed on a printer attached to the CPU.
4 Overview of the Analyzer
1.2 Features Besides the aforementioned, the analyzer has the following unique hardware and
software features:
Overview
Overview
Analysis Speed 600 (with ISE) or 360 Biochemistry tests per hour
Display Resolution 800 x 600
Number of tests on Maximum 50 + 3 ISE options
board
Assay Modes 1-Point, 2-Point, Rate-A and Rate-B
Calibration Linear (two point and multipoint), Factorized, and
Non-linear multipoint
Sample (Tubes/Cups) Primary tubes of 5, 7 or 10 ml & sample cups
Sample Disk
Outer ring 50 routine patient samples
Inner ring 20 positions for standards/STAT, 2 blanks, 8
controls & 2 ISE solutions (optional)
Stat Sampling Total 25 positions (E1-E20 standard positions on
standard tray & E46-E50 on sample disk outer ring)
Bar-code Reader (Optional) For samples as well as reagents
Reagent Disk Cooled reagent disk with 50 positions
Outer ring 25 even numbered positions for 20 ml bottles
Inner ring 25 odd numbered positions for 50/20 ml bottles
Sample Volume (µl) 3-60 (adjustable in 0.1 µl step)
Reagent Volume (µl) R1: 75—300
R2: 0 or 10—300 (adjustable in 1 µl step)
Reaction Volume (µl) 250 (maximum reaction volume = 660 µl)
Programmable 95 photometric tests, 10 calculation items, serum
Parameters indices, 3 ISE (optional) tests Na, K, Cl.
Reagent Bottles 50 ml, 20 ml, and 5 ml tube adaptors
Photometry Optics Mono- and bi-chromatic measurement using
holographic diffraction grating
12 Wavelengths: 340, 376, 415, 450, 480, 505, 546,
570, 600, 660, 700 & 750 nm
Absorbance Range 0 – 3.2
Light Source Pre-aligned water cooled Halogen lamp (12V/20W)
Reaction Disk 60 permanent hard glass cuvettes
Auxiliary Data 10,000 results
Mains Supply 220 ± 5 V AC (or 110 ± 3 V AC, optional),
1100 VA, 50/60 Hz
Interface RS-232 C port for Bi-directional Communication
Dimensions
Analyzer 840 (W) x 610 (D) x 1100 (H) mm
Trolley 700 (W) x 670 (D) x 940 (H) mm
Floor Space 7.7 x 4.2 feet
Approximate Weight 150 kg (main unit with CPU)
6 Overview of the Analyzer
REAGENT-2 SYRINGE
REAGENT-1 SYRINGE
SAMPLE SYRINGE
Overview
ISE COVER POWER SUPPLY
RS232
NUMBER PLATE
DI. WASH
WATER BIO- WASTE
SOLUTION HAZARDS
WASTE
ON/OFF SWITCH
CRU
2 3 4 5
60 1 6
59
ISE 55
56
57
58 7
8
9
Stirrer
10
54
11
53
12
52
13
51
14
46 47 48 49 50
15 16
17 18 19 20
R1
Sample
44 45
21
43
22
42
23
41
24
25
40
26
39 27
38 28
29 30 37
36
31 32 33 34 35
4
43 45 2 6
41 47
50 8
49
39
44 10
42 46 48
48
1
40
37
50
46
12
38
S19
3
S18 S20
2
S1
35
S1
36
7
14
44
B1
S16
S2
ISE2
3 5 7 9
4
B2
R2
1
5
11
34
49
ISE1
S15
S3
C1
33
41 43 45 47
13
15 17 19 21
6
16
42
32
C8
C2
S14
S4
39
31
8
C7
S13
C3
S5
23
37
30
40
18
25
35
C6 27 29
C4
31 33
10
9
S12
S6
C5
29
28
S11
S7
20
38
S10
12
S9 S8
26
14
27
24
22
36
16
13
22
25 20 18
24
34
23 15
26
21 17 32
19 30 28
Installation
Check to see that the arrows on the sides of the packages are pointing up.
If the arrows do not point up, make a remark about this on the invoice
copy
• Visually inspect the outside of the package for rips, dents, or possible
shipping damage. Document any sign of damage on the bill of lading,
regardless of how insignificant it may appear. This is to protect your
interests
• Notify your service representative that the analyzer system and its
components have arrived
• Wait for your service representative to unpack the system and open the
packages
2.2 Warranty All analyzers are warranted against defective materials or workmanship for a
Information period of one year commencing from the date of the shipment of the analyzer.
This warranty does not cover any defect, malfunction, or damage due to :
2.3 Unpacking of the The analyzer is packed carefully to prevent any shipping damage. Upon arrival,
Analyzer inspect the packing according to the list and notify the carrier of any apparent
damage. Follow the steps described in the following paragraphs to install the
analyzer.
1. Remove the front panel of the wooden box by loosening the bolts. The
front panel on the wooden box is marked.
Installation
2. Remove the top and side panels of the wooden box as a whole section by
loosening bolts from back panel side.
3. Remove the four “Z” brackets, which are holding the analyzer on the
pallet.
4. Move the leveling bolt upwards so that the unit rests on the castor wheels.
5. Roll down the analyzer slowly from the pallet to the floor.
Installation of the Analyzer 5
Installation
Spigot for 20 liter. Water can 1 No.
Spigot for 20 liter. Waste can 1 No.
5 Bio-hazardous Waste Can (Empty) – 10 Liter. 1 No.
Nozzle & Cap – for Bio-hazardous waste.
6 Cleaning Solution Can (Empty) – 10 Liter. 1 No.
Cap For Cleaning solution. 1
7 Cuvettes (60 + 5 extra) 65 Nos.
8 Reagent Tray Assy. 1 No.
9 Reagent Tray Cover 1 No.
10 Sample Tray Assy. Disk –1 (1-50) with Standard Plate 1 No.
11 Main Unit to Computer Interface Cable 1 No.
12 Power Cord (15 A, 3 Pin Top) 1 No.
13 PVC Support For 20ml Reagent Bottle 25 Nos.
14 Sample Cups 500
Nos.
15* Reagent Bottles (20 ml.) With Caps. 50 Nos.
16* Reagent Bottles (50 ml.) With Caps. 50 Nos.
17* Reagent Bottles (20 ml.) With Caps and Bar code labels 25 Nos.
18* Reagent Bottles (50 ml.) With Caps and Bar code labels 25 Nos.
19 Test Tubes (5ml.) with bar-code labels (Optional) 5 Nos.
20 Test Tube Adapter 100
Nos.
21 5 ml. Reagent bottle Adapter 25 Nos.
22 Dia 4 X 6 Polyurethane Tube (for connecting DI water can) – 1000 mm 1 No.
23 Dia 4 X 6 Polyurethane Tube (for connecting Bio hazardous waste can) – 650 mm 1 No.
24 Dia 2 X 4 Silicon Tube With Counterweight (for connecting Cleaning solution can) – 1 No.
1100 mm
25 Dia.12 X 18 Silicon Pipe for Waste – 500mm. 1 No.
26* Dia 4 X 6 Polyurethane Tube (for connecting optional ISE outlet to Bio hazardous 1 No.
waste can) – 650 mm.
27* Sample tray assy. Disk-2 (51-100) with emergency plate 1 No.
28* Computer with mains cord (Sr. no. )
29* Keyboard (Sr. no. )
30* Mouse (Sr. no. )
31* Color monitor with cord (Sr. no. )
32* Printer with cord & cable (Sr. no. -- EPSON)
33* Computer Trolley 1 No.
34 Unit Installation Instruction Sheet 1 No.
35 Can Connection Diagram Sheet (with ISE / without ISE) 1 No.
36 Hydraulic diagram sheet 1 No.
*
: Optional (As per the customer requirement)
6 Installation of the Analyzer
2.5 Installation A proper installation location is very important for accurate functioning of the
analyzer. The user is advised to make sure that the environmental and electrical
conditions are met as recommended below to ensure accuracy and precision of the
analyzer, as well as to maintain a high level of safety for the operator. Please leave
a minimum of 0.5 meter space on the left and right sides, the rear, and top of the
analyzer for easy operation as well as maintenance and service.
Installation
conditions
• Analyzer should not be subjected to direct sunlight
• Installation site should be free from dust
• The installation site should be flat (zero gradient)
• The installation site floor construction should be able to support
approximately 150 kg
• Room Temperature should be 15 °C to 30 °C and the temperature
fluctuation during analysis should not be more than ±2 °C
• Maximum relative humidity allowed is 80% (non-condensing)
• If the temperature and humidity fluctuations are not within the specified
range, the analyzer cannot maintain data reliability
• The installation site should be well ventilated. However, the analyzer
should not be exposed to direct air flow from air conditioners
• The site should be free from significant vibration
• The analyzer should be kept away from strong electromagnetic sources
and electrical interferences
• It should be near the power source and should have minimum of 0.5 m.
space on all the five sides
• The CPU console should not be more that 15 meters away from the
Analyzer
2.5.3 Electrical
requirements and Voltage & Single phase continuous stabilized AC, 220 ± 5 Volts or 110 ±
connections Frequency 3 volts, 50/60 Hz.
Grounding Perfect grounding must be provided at power source with all
applicable local requirements (a Grounded 3 pin Power Plug
should be used).
Plug Points One 15 Amp outlet and three 5 Amp sockets should be
Installation
2.6 Hydraulic Unpack the accessory box. Four clearly marked Jerry cans have been provided for
Connections the liquids that need to be kept on the liquid platform on the rear side of the
instrument.
The de-ionized water should have resistivity more than 1 Mega Ohm cm (or
conductivity less than 1 µS/cm)
Preparation of cleaning solution: Fill the cleaning solution can with 10 liter of
DI water. Pour the concentrated cleaning solution (such as XL-Wash) into the can
to prepare a 1% detergent solution. Mix well before use.
Connect the tubes from analyzer to the Jerry cans as shown in the following figure
(Figure 2.1). Make sure to clean the cans periodically.
Installation of the Analyzer 9
Installation
ISE Cover
SERIAL NO PLATE
TUBING CONNECTIONS
2.7 Application The analyzer PC comes with preinstalled Analyzer Application Software. For any
Software Installation reason, if the software needs to be installed on another PC, the PC should meet the
following requirements:
2.7.1 Uninstalling To uninstall earlier version of application software, please follow these steps:
previous version of
application software ¾ Take a back up of the file c:\program files\xl600\xl.mdb (preferably in
some other directory)
¾ Click <Start> button on the task-bar menu
¾ Select Settings | Control Panel option
¾ In the Control Panel window, double click on Add/Remove Programs icon.
It will open Add/Remove Programs Properties window
¾ Select the installed version of application software from the
Install/Uninstall tab and click on the <Add/Remove> button
¾ A message "Are you sure you want to completely remove XL version
number & all its components?" is displayed. Click on <Yes> button to
proceed with the uninstallation procedure (or click <No> to abort the
uninstallation process)
¾ Another message will appear asking you whether all shared components
should be removed. Click <Remove All> button. A confirmation message
"You are about to remove all shared files that are no longer in use" is
displayed. Click <OK>
¾ Uninstallation process starts and after a while “Procedure Completed”
message is displayed to indicate completion of the uninstallation process
Installation of the Analyzer 11
2.7.2 Software Please follow these steps to install the application software:
installation process 1. Insert the application software CD in the CD drive of the analyzer PC.
2. The CD automatically starts to install the application software
3. If the application software installation screen does not appear, then click on
<Start> button on the task bar and select Run option. This will open run
panel. Click on <Browse> and select setup.exe file from the CD drive and
click on <Open>. Click on <OK> to start the installation process.
4. A welcome message will be displayed, click on <OK> and follow the
instructions displayed on the screen.
Installation
5. If version conflict message is displayed during the installation, click on
<No to all>.
6. After completion of the installation process, shutdown and restart the
computer.
2.7.3 Post installation Steps to be followed after installing the application software on a computer with
operations Windows XP Operating system
1. Right click on desktop and select Properties
2. Select Appearance
3. In “Windows & Button", choose “Windows Classic Style” and Click on
<Apply>
4. If you have installed 102 series software on a computer with Windows XP
Operating System
a. Search a folder named “Support” from the CD and copy XL.mdb
file into folder C:\Windows\System
b. After copying, right click on this file and click Properties and then
select option “Archive”
c. Click OK and you are ready to run the application software
2.7.4 Running the 1. Before starting the application software, make sure that the monitor display
application for the resolution is 800 x 600. Also, make sure that the in the Taskbar properties,
first time AutoHide option is ticked.
2. Start the application software. The application software can be started by
clicking on the software icon available in the Start Menu (the menu obtained
by clicking on <Start> button on the task bar
3. Enter the username, password provided
4. Click on <OK> to proceed
2.7.5 Switching ON The analyzer and the application software should be started one by one in either of
the analyzer the following orders:
1. Start the application software; wait for 15 seconds, then switch ON the
analyzer
2. Or switch ON the analyzer; wait for 1 minute, then start the application
software
12 Installation of the Analyzer
2.7.7 Printer Check for following points before using Application Software to generate
installation printouts
1. Check that printer driver is installed
2. Check that the cable between printer and the analyzer PC is connected
properly
3. There should be no paper jam or any other obstruction in the printer
4. Feed the paper to the printer and switch it ‘ON’
5. Print a test page to confirm correct printing
2.7.8 Setting correct Follow the following steps to set the printer font to Draft Condensed on Epson
font on Epson LX-300+ printer. This font setting is necessary for correct formatting of online
LX-300+ printer result printout in Compact mode (which can be set in the [Previous Data: System
Switch] screen in the {Online Print Format} option).
1. Turn the printer is ON.
2. Make sure that there are no pending print jobs. If some print jobs are
pending, feed appropriate paper in the printer and finish the pending print
jobs. Switch OFF and then switch ON the printer.
3. Locate the <Pause> button on the printer (this button can be identified by
a pointing hand and “3Sec” labels). Hold the <Pause> button down until
the orange Pause indicator starts blinking.
4. Press the <Font> button to change the fonts. The current font selection is
indicated by the combination of ON/OFF/blinking status of two green
indicators above the fonts list on the printer. Continue pressing the <Font>
button until the following indicator combination is reached: right green
indicator is blinking and the left green indicator is OFF. This combination
of green indicator status shows that the font has been set as Draft
Condensed.
5. Switch OFF the printer and after 5 seconds switch it ON. The Draft
Condensed font settings are saved.
2.7.9 In case of ¾ After getting a Spool32 error during run, do not opt to close the application.
Spool32 error Let the run be completed. After the run is over, close the application software
and restart the computer. Start the application software. The report of run
results can be seen in [Previous Data: Result Reprint] screen
Installation
9. Another window titled "Extract File" will open. Click <Browse> button
next to the "Restore From" field on this window.
10. Another window titled "Browse for folder" will open. Select CD drive,
select the folder named “Spool”, and press <OK> on this window.
11. Press <OK> on the "Extract File" window.
12. A window titled "Backup file" opens, press <OK> on this window. (If the
wizard asks permission to create a new folder press <Yes>). You will get
a confirmation "File has been successfully extracted" and you will be
asked whether to restart the computer. Select <NO>.
13. Repeat the steps from step 5 to 11 but this time in the step 6 select the file
c:\windows\system\spoolss.dll.
14. Close the "System File Checker" wizard by clicking on <Close>.
15. Restart the computer.
16. Search for *.tmp files from C:\Windows folder and delete them. There
would be some *.tmp files which will not be deleted.
17. Reinstall the printer driver.
18. Please check the cable connection from the PC to the printer. Check that
there is no paper jam or any other obstruction to the printer. Check the
printer by printing some other document. If it is working properly then
start the application.
14 Installation of the Analyzer
Installation
Chapter 3
3. Function .......................................................................................................................................................... 3
3.1 Sample Handling System ........................................................................................................................ 3
3.1.1 Sample Tray (Primary Tubes and Bar-codes) .................................................................................... 3
3.1.2 Sampling Arm .................................................................................................................................... 4
3.1.3 Sample Syringe .................................................................................................................................. 5
3.1.4 Sample Probe...................................................................................................................................... 5
3.1.5 Wash Station for Sample Probe.......................................................................................................... 6
3.2 Reagent Handling System ....................................................................................................................... 6
3.2.1 Reagent Tray ...................................................................................................................................... 6
3.2.2 Reagent Bottles (and Bar-codes) ........................................................................................................ 7
3.2.3 Reagent Arm ...................................................................................................................................... 7
3.2.4 Reagent Probe .................................................................................................................................... 7
3.2.5 Reagent Syringe ................................................................................................................................. 7
3.3 Stirrer ....................................................................................................................................................... 8
3.4 Cuvette Rinsing Unit ............................................................................................................................... 8
3.5 Photometer (Flat Field Polychromator) and Reaction Tray ............................................................. 10
3.6 Measurement Flow Chart ..................................................................................................................... 11
2 Function
Function 3
3. Function
3.1 Sample Handling Sample handling system of the analyzer consists of a sample tray, a sampling arm,
System a sample syringe, and a wash station for the sample probe.
The sample arm moves from its ‘home’ position (trough) to sample tray to aspirate
the sample and to the reaction tray to dispense the sample.
37 39
35 41
33
36 38
43
40
34
31
42
32
Function
45
44
29
30
S 14 S15 6
S1
S1 7
46
3 S1
47
8
28
S1
S1
27
E4 E5
E6
48
S19
S11
E3
26
B2 B1
49
E2
S20
25
S10
50
24
E1
S1
S9
C1
C4
C2
1
23
C3
22
S8
S2
2
S3
S7
S6
S4
20
S5
21
3
18
6
16
19
5
17 14
12 10
7
15
9
13 11
3.1.1 Sample Tray Sample Tray of the analyzer consists of two sections:
(Primary Tubes and
Bar-codes) The outer section (marked as 1 in Figure 3.1) is for placing the patient samples.
The outer section has 50 positions for patient samples. Position numbers 46-50
are also available for stat/emergency samples. Adapters are available for loading
primary tubes of different sizes. Primary tubes as well as cups could be placed in
the outer section. The positions are marked 1 to 50 on disk 1, 51 to 100 on disk 2
and so on.
The inner section (marked as 2 in Figure 3.1) is for placing blank, control,
stat/emergency samples, and standards/calibrators. It is a detachable tray mounted
on top of the routine/primary tube tray. On this tray, only cups can be placed in the
dedicated positions as marked on the disk. The outer ring of the standard tray
contains 20 Positions for Standards (marked S1 - S20). The inner ring contains
eight positions for Controls (marked C1 - C8), two separate positions for optional
ISE solution (marked ISE1-ISE2) and two positions for blanks (marked B1 - B2).
4 Function
3.1.2 Sampling Arm The sampling arm carries sample from the sample cup or tube placed on the
sample tray to the reaction cell or the (optional) ISE unit. The sample probe has
liquid sensing capability and alerts the operator of insufficient sample volumes in
the sample cup. The sample arm is also fitted with vertical obstruction detection
(VOD) system, which prevents the sample probe and arm from damage.
Function
3.1.3 Sample Syringe The sample syringe of the analyzer is positive displacement type and dispenses
volumes between 1 µl to 60 µl. Sample volumes can be incremented in 0.1 µl
steps. The sample syringe is located behind the front panel of the analyzer and
connected to the sample arm/probe using appropriate tubing.
Function
Figure 3. 3: Schematic diagram of the sample syringe
3.1.4 Sample Probe The sample probe aspirates the sample and dispenses it in the cuvette. It is coated
with Teflon from outside as well as inside to minimize any sample carry over.
3.1.5 Wash Station The sample probe is cleaned internally as well as externally. The wash station for
for Sample Probe the sample probe consists of a double arrangement. The first position is ‘Drain
Position’ (for internal cleaning of the probe) and the second position is ‘Trough
Position’ (position for external cleaning of the probe). After the sample probe has
dispensed sample into the cuvette, the sample arm moves to the wash station, i.e.,
drain position, dispenses the remaining sample along with 1.0 ml of De-ionized
Water in the drain. Then the arm moves to trough position and is cleaned with a
jet of D.I. Water.
Function
Drain Trough
Figure 3.5: Schematic diagram of the wash station of the sample probe
3.2 Reagent The Reagent handling system of the analyzer consists of the following
Handling System components: Reagent Tray, Reagent Arms, Reagent Probes, and Reagent
Syringes.
3.2.1 Reagent Tray The reagent tray is detachable and allows one to load up to 50 reagent bottles at
any time. The reagent tray is placed in the reagent compartment, which is cooled
to about 15 °C below the ambient temperature. A reagent tray cover is provided
which prevents evaporation of reagents and seals the cool temperature within.
6
4 18
2
20
7
31
4
33
1 3 5
22
35
2
49
37
47 39
45 43 41
24
50
26
48
28
46
30
44
32
42 34
40 38 36
3.2.2 Reagent Bottles The reagent bottles are available in two capacities: 20 ml and 50 ml. Both the
(and Bar-codes) bottles are graduated and the user can visualize the amount of reagent present in
each bottle. Special 5 ml adapters are also available to keep expensive reagents or
reagents in smaller volumes. A schematic of the two types of bottles provided with
the Analyzer, (20 ml and 50 ml) is shown below:
Function
Figure 3.7: Schematic diagram of the reagent bottles
All bottles are screw capped to prevent evaporation of reagents while not in use.
On the outer ring of the tray (even numbered positions), 20 ml bottles can be
placed. The inner ring (odd numbered positions) is available for the 50 ml bottles
as well as 20 ml bottles. Suitable boat supports are provided to accommodate 20
ml bottle on the inner ring. Bar-coded labels are affixed on the reagent containers
for identification by the bar-code reader (optional).
3.2.3 Reagent Arm Reagent Arms (R1 & R2) of the analyzer carry reagent from the reagent bottle to
the cuvettes. The probes mounted on the reagent arms aspirate the reagent from
the reagent container and dispense them in the cuvettes. The R1 arm is used for
aspirating and dispensing the first reagent and the R2 arm is used for aspirating
and dispensing of the second reagent. The design of the reagent arm is similar to
the sample arm (shown in Figure 3.2).
3.2.4 Reagent Probe The reagent probes of analyzer are mounted on the motor driven reagent arms,
which move from the reagent positions to the cuvette. The probes are equipped
with conductance based liquid level sensors. The construction of the probe is
similar to that of the sample probe. Reagent1 probe can be identified by black
sleeve and Reagent2 by yellow sleeve. Reagent1 and Reagent2 arms have black
and yellow dots respectively for differentiating the two.
3.2.5 Reagent The reagent syringes of analyzer are positive displacement type and are located
Syringe alongside the sample syringe. Both the syringes of Reagent 1 & Reagent 2 have a
maximum capacity of 500 µl each. Reagents (R1 & R2) can be programmed in
1µl steps to a maximum of 300 µl. The reagent syringes are connected to the
reagent arms by PTFE tubing.
8 Function
3.3 Stirrer The stirrer of analyzer consists of two paddles, which spin when the motor is
activated. This is a dual stirrer. Separate stirrers paddles are used to mix reagent 1
with sample and reagent 2 with sample + reagent1 mixture. This stirring action is
used for mixing the reaction mixture after addition of the sample to the reagent in
the cuvette and/or after addition of the second reagent. The stirrers are activated
from their ‘home’ position and move into the cuvettes. When the stirrers are in
contact with the reaction mixture (in the cuvette), they are activated and spun.
This ensures a thorough mixing of the solution. The schematic diagram of the
stirrer is shown below.
Function
3.4 Cuvette Rinsing The analyzer is equipped with a 7-stage laundry as shown in the figure 3.9.
Unit
DETERGENT DISPENSE
DETERGENT DISPENCE
DDIONISED
I WATER DISPENS
WATER E
DISPENCE
DRIER
DRYER
Step 1: Nozzle 1a aspirates the reaction mixture and nozzle 1d dispenses detergent
Function
solution in the cuvette.
Step 2: The reaction cuvette then moves by one position. Nozzle 2a aspirates the
cleaning solution and nozzle 2d dispenses de-ionized water in the cuvette.
Step 3: The reaction cuvette then moves by one position. Nozzle 3a aspirates the
cleaning solution and nozzle 3d dispenses de-ionized water in the cuvette.
Step 4: The reaction cuvette then moves by one position. Nozzle 4a aspirates the
cleaning solution and nozzle 4d dispenses de-ionized water in the cuvette.
Step 5: The reaction cuvette then moves by one position. Nozzle 5a aspirates the
cleaning solution and nozzle 5d dispenses de-ionized water in the cuvette.
Step 6:The reaction cuvette filled with de-ionized water moves to a vacant
position
Step 7: The reaction cuvette filled with de-ionized water moves and comes
between the lamp and the photometer. Here cuvette blank absorbance is measured.
This absorbance is subtracted from the reaction mixture absorbance.
Step 8: After the cuvette blank absorbance measurement, the water in the cuvette
is aspirated by the aspiration stage, i.e., nozzle 6a.
Step 9: At this step, the cuvette is completely dried with the help of the drier, i.e.,
nozzle 7a.
10 Function
3.5 Photometer (Flat The photometer used in the analyzer is different from the conventional filter wheel
Field Polychromator) type or array type.
and Reaction Tray
CONCAVE BHG
DETECTOR SURFACE
Function
This analyzer uses flat field polychromator for measuring the optical densities of
reaction mixtures. This polychromator is constructed with a concave grating
which is optimized for forming the image of the entrance slit on the photo detector
array and for dispersing light into its component wavelengths. This eliminates
several optical interferences and greatly improves the efficiency of the photometer.
The dispersed beam falls on the photo detector array of thirty-eight elements out
of which twelve are used with a narrow optical window. The second order
attenuation is achieved by deploying glass filters for near IR and UV regions. The
current generated by each element of the detector array is converted to voltage and
amplified by high input impedance and high gain operational amplifiers. These
amplified voltage signals are shielded and transmitted to a high precision Data
Acquisition System.
Function
1:40 10 Measure reaction absorbance 6:40 40 Measure reaction absorbance
1:50 11 Measure reaction absorbance 6:50 41 Measure reaction absorbance
2:00 12 Measure reaction absorbance 7:00 42 Measure reaction absorbance
2:10 13 Add Reagent2 + Stir + 7:10 43 Measure reaction absorbance
Measure reaction mixture
absorbance
2:20 14 Measure reaction absorbance 7:20 44 Measure reaction absorbance
2:30 15 Measure reaction absorbance 7:30 45 Measure reaction absorbance
2:40 16 Measure reaction absorbance 7:40 46 Measure reaction absorbance
2:50 17 Measure reaction absorbance 7:50 47 Measure reaction absorbance
3:00 18 Measure reaction absorbance 8:00 48 Measure reaction absorbance
3:10 19 Measure reaction absorbance 8:10 49 Measure reaction absorbance
3:20 20 Measure reaction absorbance 8:20 50 Measure reaction absorbance
3:30 21 Measure reaction absorbance 8:30 51 Measure reaction absorbance
(Absorbance measurement
ends)
3:40 22 Measure reaction absorbance 8:40 52 Empty cuvette contents + Add
detergent
3:50 23 Measure reaction absorbance 8:50 53 Empty cuvette contents + Add
DI water
4:00 24 Measure reaction absorbance 9:00 54 Empty cuvette contents + Add
DI water
4:10 25 Measure reaction absorbance 9:10 55 Empty cuvette contents + Add
DI water
4:20 26 Measure reaction absorbance 9:20 56 Empty cuvette contents + Add
DI water
4:30 27 Measure reaction absorbance 9:30 57
4:40 28 Measure reaction absorbance 9:40 58 Measure cuvette blank
absorbance
4:50 29 Measure reaction absorbance 9:50 59 Empty cuvette water
Chapter 4
4. Operation ......................................................................................................................................................... 3
4.1 Precautions during Operation ................................................................................................................ 3
4.2 Analyzer Start Up .................................................................................................................................... 3
4.3 The Main Screen of the Application Software ...................................................................................... 4
4.3.1 Common buttons and mouse pointers ................................................................................................ 4
4.4 [Test Parameters] .................................................................................................................................... 5
4.4.1 {Test Code} ........................................................................................................................................ 5
4.4.2 {Test} ................................................................................................................................................. 6
4.4.3 {Report Name}................................................................................................................................... 6
4.4.4 {Assay Type} ..................................................................................................................................... 6
4.4.5 {Assay Points} ................................................................................................................................... 9
4.4.6 {Wavelength} ................................................................................................................................... 10
4.4.7 {Control Interval} ............................................................................................................................ 11
4.4.8 {Sample Replicates} ........................................................................................................................ 11
4.4.9 {Sample Volume Normal} ............................................................................................................... 11
4.4.10 {Sample Volume Decrease}........................................................................................................... 12
4.4.11 {Sample Volume Increase} ............................................................................................................ 12
4.4.12 {Standard Volume} ........................................................................................................................ 13
4.4.13 {R1/R2}.......................................................................................................................................... 14
4.4.14 {Multiple Positions}....................................................................................................................... 15
4.4.15 {Reagent Stability} ........................................................................................................................ 16
4.4.16 {React. Abs Limit}......................................................................................................................... 17
4.4.17 {Reaction Dir.} .............................................................................................................................. 17
4.4.18 {Reagent ABS} .............................................................................................................................. 17
4.4.19 {Tech. Serum /Urine Limits} ......................................................................................................... 17
4.4.20 {Serum Panic Limit} ...................................................................................................................... 18
4.4.21 {Prozone Limit} ............................................................................................................................. 18
4.4.22 {Unit} ............................................................................................................................................. 19
4.4.23 {Decimal Point} ............................................................................................................................. 19
4.4.24 {Normal value serum} ................................................................................................................... 19
4.4.25 {Urine Values} ............................................................................................................................... 20
4.4.26 {AutoRerun} .................................................................................................................................. 20
4.4.27 {Y = aX + b} .................................................................................................................................. 20
4.4.28 Test Parameters sub-menus ............................................................................................................ 21
4.4.29 [Test Parameters: TESTS]................................................................................................................... 22
4.4.30 [Test Parameters: Calib Table] ........................................................................................................... 22
4.4.31 [Test Parameters: Copy] ..................................................................................................................... 34
4.5 [Patient Entry] ....................................................................................................................................... 34
4.5.1 {Sample No.} ................................................................................................................................... 35
4.5.2 {Sample Pos} ................................................................................................................................... 35
4.5.3 {Patient ID} ...................................................................................................................................... 36
4.5.4 {Patient Name} ................................................................................................................................ 36
4.5.5 {Disk No.}........................................................................................................................................ 36
4.5.6 {Date} .............................................................................................................................................. 36
4.5.7 {Date of Birth} ................................................................................................................................. 36
4.5.8 {Sample Cup} .................................................................................................................................. 36
4.5.9 {Age} ............................................................................................................................................... 36
4.5.10 {Address} ....................................................................................................................................... 37
4.5.11 {Referred by} ................................................................................................................................. 37
4.5.12 {Drawn by/Analyst}....................................................................................................................... 37
2 Operation
4. Operation
4.1 Precautions • Do not remove the reagent tray cover or introduce new reagent bottle
during Operation during the operation of the analyzer
• Avoid touching any of the probe arms during operation
• Do not place samples or reagent bottles on the analyzer platform.
• Do not place samples in the sample tray while it is rotating
4.2 Analyzer Start • Ensure that all the electrical connections are as per the installation
Up procedure
• Check and fill (if required) de-ionized water (NCCLS Type II or better)
and cleaning solution in the respective cans (clean the cans periodically)
• Switch ON the rear switch of the analyzer (with this switch the cooling
and (optional) ISE units are powered ON)
Operation
• Switch ON the switch on the side (with this the analyzer unit is powered
ON and all the arms and trays initialize)
• Switch ON the computer and start the analyzer application software (give
a gap of about 1 minute between switching ON the analyzer and starting
the application software)
• Remove any memory resident software (including anti-virus software)
from the Analyzer PC
• Fill the reagents or place fresh reagent bottles as required
• Shake the (optional) ISE Calibrant A bottle once
• Initialize or enter desired test parameters
• Perform AutoSpan after installation
4 Operation
4.3 The Main Screen The main screen of the application software is shown in figure below.
of the Application
Software
Analyzer
Operation
This screen has been referred to as the 'Main Menu Screen' throughout this manual.
On this screen, the following options are available to the user:
• Test Parameters
• Patient Entry
• Quality control
• Reagents
• Previous data
• Standardisation
• Service Check
• Maintenance
• Run Test
• Exit
The details of each of these sub menus follow in the next sections and chapters.
4.3.1 Common The common buttons of the application software are shown in the figure below.
buttons and mouse These buttons are available at the bottom of all screens apart from the Main Menu
pointers Screen.
A thick blue mouse pointer indicates the buttons that are available for clicking.
A hand shaped pointer indicates that by clicking the object you can obtain
more options/details. When you take the mouse pointer to <Go Back> button, it
changes to a thick black pointer to indicate that the button is available for
clicking.
Operation 5
4.4 [Test Parameters] This is the first sub-menu available on 'Main Menu Screen' of the software and can
be viewed by clicking on <Test Parameters> button on the Main Menu Screen.
The following screen is displayed once you click on <Test Parameters> button.
Operation
Figure 4.2: [Test Parameters] screen
The software can store test parameters for up to 99 assays in its memory.
<Previous>, <Next> buttons can be used to view the parameters of previous or
next assay respectively. Each assay is identified by a one to four letter code. To
add new test parameters, click on <Add> button and save the test parameters by
clicking on <Save> button. To modify any saved test parameters, click on
<Modify> button. After making the desired modifications, the changes can be
saved by clicking on <Save> button.
The user should define and check each of the test parameters on the display before
starting a run. The user should feed appropriate data as per reagent inserts. A
brief explanation of each of the fields available on the [Test Parameters] screen is
as given below.
4.4.1 {Test Code} This field is used to give a unique number between 1 and 99 to different assays.
This code is used as part of the bar code on the reagent bottles and is used to
identify a reagent bottle for the corresponding test. It is necessary to enter a
unique test code for each of the tests.
6 Operation
4.4.2 {Test} This pull-down field is used to select an already defined test for viewing as well as
to assign a 4-letter alphanumeric name to a newly added test for easy
identification. For example, GLU can be used to identify Glucose test parameters.
It is necessary to define this parameter and once defined it cannot be modified.
The test parameters can be viewed by selecting one of the test names on this pull-
down option. Alternatively, the user can also select test names by clicking on the
<Test> button on the screen and clicking on the appropriate test names. The
application software can have up to 99 tests in its memory.
4.4.3 {Report Name} This field is used to store the full name (25 characters maximum) of the test that
will appear in the patient report. Enter the full name for the assay. For example,
one can feed Aspartate Transaminase in this field (while AST will be entered
in {Test} field).
4.4.4 {Assay Type} Use this pull-down option to select the assay type among 1POINT, 2POINT,
RATE-A and RATE-B. It is recommended to use:
Operation
1POINT: The method is used for normal end-point assays using one or two
reagents where the final absorbance is used for concentration calculation. Mean of
the absorbances recorded between M2Start and M2End points is taken and this is
used for the calculation of the sample results.
ABS
Rgt2
ABS2=Final abs
Rgt1
Time
Figure 4.3: Schematic diagram of measurement by 1POINT assay
Operation 7
2POINT: This method is used for end-point analysis when a sample or reagent
blank is necessary. In this assay type, the initial absorbance (usually measured
after addition of the first reagent) is recorded and subtracted from the final
absorbance (which is usually measured after addition of the second reagent).
Necessary correction factors to correct the difference in mixture volume are taken
into account while subtracting the initial absorbance. The initial absorbance
recorded is the mean of the absorbances recorded between M1Start and M1End
and this absorbance is subtracted from the final absorbance, which is the mean of
the absorbances recorded between M2Start and M2End. This differential
absorbance is then used for calculation of sample concentration.
ABS
Rgt 1 Rgt 2
ABS2=Final abs.
Rgt2
ABS2
Rgt1 ABS1
ABS1
Operation
TIME
RATE-A: This method is used for kinetic/rate assays where the change in
absorbance per minute is used for result calculation. The slope (absorbance change
per minute) is obtained from the absorbances recorded between M2Start and
M2End using the least square linear regression method as per the following
formula:
⎡1 n ⎤
⎢ n ∑ (Ti Ai )⎥ − T A
ΔA / ΔT = ⎣ ⎦
i =1
⎡1 2 ⎤
( )
n
⎢ n ∑ Ti ⎥ − T
2
⎣ i −1 ⎦
Where, Ti is the time in minute and Ai is the absorbance, n is the number of points.
Rgt1
ABS ABS
Rgt2
ABS
ABS/MIN
TIME
RATE-B: This method is used for kinetic/rate assays where differential rate is
useful. The initial rate of change in absorbance per minute (usually obtained after
addition of the first reagent) is subtracted from the final rate of change of
absorbance per minute (usually obtained after addition of the second reagent).
Necessary correction factors to correct the difference in mixture volume are taken
into account while subtracting the initial rate of change in absorbance per minute.
The initial rate of absorbance change per minute is recorded between M1Start and
M1End using the least square regression method and is subtracted from the rate of
change in absorbance per minute recorded between M2Start and M2End using the
least square regression method explained in the section on RATE-A assay type.
Rgt1
ABS Rgt2
ABS
ABS
ABS2/min - ABS1/min
ABS1/min
ABS2/min
TIME
Operation
13 130 2 min 10 sec
14 140 2 min 20 sec
15 150 2 min 30 sec
16 160 2 min 40 sec
17 170 2 min 50 sec
18 180 3 min 00 sec
19 190 3 min 10 sec
20 200 3 min 20 sec
21 210 3 min 30 sec
22 220 3 min 40 sec
23 230 3 min 50 sec
24 240 4 min 00 sec
25 250 4 min 10 sec
26 260 4 min 20 sec
27 270 4 min 30 sec
28 280 4 min 40 sec
29 290 4 min 50 sec
30 300 5 min 00 sec
31 310 5 min 10 sec
32 320 5 min 20 sec
33 330 5 min 30 sec
34 340 5 min 40 sec
35 350 5 min 50 sec
36 360 6 min 00 sec
37 370 6 min 10 sec
38 380 6 min 20 sec
39 390 6 min 30 sec
40 400 6 min 40 sec
41 410 6 min 50 sec
42 420 7 min 00 sec
43 430 7 min 10 sec
44 440 7 min 20 sec
45 450 7 min 30 sec
46 460 7 min 40 sec
47 470 7 min 50 sec
48 480 8 min 00 sec
49 490 8 min 10 sec
50 500 8 min 20 sec
51 510 8 min 30 sec
10 Operation
M1Start and M1End: These assay points are used to select the time points for
measurement of initial absorbance for 2POINT and RATE-B assay types. This
absorbance serves as reagent or sample blank. This initial absorbance (or
absorbance change per minute) in these assays is subtracted from the final
absorbance (or absorbance change per minute) that is measured between M2Start
and M2End points. M1Start and M1End can have values from 1 to 51 for
2POINT and RATE-B assays.
M1End should always be equal to or more than M1Start. The difference between
M1End and M1Start should be at least three in case of RATE-B assay. In addition,
M1End has to be less than or equal to M2Start. For 1POINT and RATE-A assays,
M1Start and M1End should be programmed as "0".
specifies the incubation time point. Similarly, M2End is the time until when the
absorbance is recorded for the purpose of concentration calculation.
For 2POINT and RATE-B chemistries, M2Start has to be more than or equal to
M1End.
4.4.6 {Wavelength} This pull-down option is used to select appropriate primary and secondary
wavelengths for absorbance measurement. The measurement wavelengths are
selected from 12 fixed values provided. In case of bi-chromatic measurement, the
final absorbance is obtained by subtracting the absorbance at the secondary
wavelength from that at the primary wavelength. For monochromatic
measurements, enter ‘0’ for the secondary wavelength.
If bi-chromatic measurement is not desired, enter zero for the value of the
secondary wavelength.
Operation 11
4.4.7 {Control The Control Interval parameter enables the user to define number of samples after
Interval} which the control serum will run automatically. This interval can be selected
between 0 and 1000 by a pull-down option. For example: Control Interval = 30
means that control serum will be run after every 30th sample analyzed for that
chemistry.
If the Mean and SD values for the control of the corresponding tests are not
entered in [Quality Control] screen, a reminder is given to the user to enter these
values. The details of the Quality Control are given in the next chapter.
4.4.8 {Sample In this parameter, select the number of repeated sample measurements to be
Replicates} performed for any chemistry using the pull-down option. Repeated sample
measurements are usually used to check repeatability. All samples programmed
for this chemistry will be repeated for the programmed number of times. A value
from 1 to 20 can be selected in this parameter. For routine operation, this
parameter is programmed as '1'.
4.4.9 {Sample These fields enable the user to specify normal (or default) sample volumes of
Volume Normal} serum or urine. The fields are divided into three columns: Serum/Urine Sample,
Operation
Serum/Urine Postdiln, and Serum/Urine Diluent.
Enter an appropriate volume between 3 and 20 µl. The total volume of diluted
sample and reagents should be more than or equal to 200 µl. When sample is not
to be prediluted, user should enter zero in this field.
Enter a value between 140 and 300 µl. The total volume of sample and diluent for
predilution should be more than or equal to 200 µl. When no predilution of sample
is desired, this parameter should be defined as zero.
12 Operation
4.4.10 {Sample These fields are used to specify (lower than normal) sample volumes to carry out
Volume Decrease} an automatic rerun of the sample in case of a hyperactive sample or when the
Sample is requested as Decrease in the Patient Entry screen. The fields are
divided into three columns: Serum/Urine Sample, Serum/Urine Postdiln, and
Serum/Urine Diluent.
be aspirated from the dilution cuvette and dispensed into the reaction cuvette.
Enter an appropriate volume between 3 and 20 µl. The total volume of diluted
sample and reagents should be more than or equal to 200 µl. When sample is not
to be prediluted, user should enter zero in this field.
Enter a value between 140 and 300 µl. The total volume of sample and diluent for
predilution should be more than or equal to 200 µl. When no predilution of sample
is desired, this parameter should be defined as zero.
4.4.11 {Sample These fields are used to specify (higher than normal) sample volumes to carry out
Volume Increase} an automatic rerun of the sample in case of a sample with low reactivity or if the
sample is requested as Increase on the Patient Entry screen. The fields are
divided into three columns: Serum/Urine Sample, Serum/Urine Postdiln, and
Serum/Urine Diluent.
Enter an appropriate volume between 3 and 20 µl. The total volume of diluted
sample and reagents should be more than or equal to 200 µl. When sample is not
to be prediluted, user should enter zero in this field.
Enter a value between 140 and 300 µl. The total volume of sample and diluent for
predilution should be more than or equal to 200 µl. When no predilution of sample
is desired, this parameter should be defined as zero.
4.4.12 {Standard These fields enable the user to specify the standard/calibrator volumes to be used
Volume} for calibration. The fields are divided into three columns: Sample, Postdiln, and
Diluent.
Operation
Usually, the Standard Volume entries will be the same as Normal Serum Volume
entries. However, the Standard Volume entries could be different from Normal
Serum Volume entries when the calibrator is not to be diluted but the sample is to
be diluted. This happens usually for esoteric assays for which the standards
available is prediluted and do not require to be diluted, but the samples need to be
diluted.
For example, when the standard is prediluted but sample requires to be diluted 10
times, the standard volume entries might be like {15, 0, 0} and the normal sample
volume entries will be like {20, 15, 180}.
Enter an appropriate volume between 3 and 20 µl. The total volume of diluted
standard and reagents should be more than or equal to 200 µl. When standard is
not to be prediluted, user should enter zero in this field.
Enter a value between 140 and 300 µl. The total volume of standard and diluent
for predilution should be more than or equal to 200 µl. When no predilution of
standard is desired, this parameter should be defined as zero.
4.4.13 {R1/R2} These fields are used to define Volume, Position, Size, and Batch number of each
reagent being used for the analysis. Each analysis on analyzer can be performed
with a maximum of two reagents. Hence, two reagents, namely R1 and R2, can be
Operation
defined for each of the chemistries. Reagent 1 is added in the reaction cuvette
right in the first cycle while Reagent 2 is added in the 13th cycle. Sample is added
to the reaction cell in the 2nd cycle.
{R1/R2: Position}: Assign a position for the Reagent bottle for any chemistry. It is
not necessary to define a position if one is using bar-coded reagent bottles. There
are 50 pre-defined positions for reagent placement. In case R2 is not desired, the
user can define its position as zero. If one does not want to use an assay, both the
reagent positions can be programmed to be zero. It is possible to use multiple
positions for R1 reagent as explained in the following section.
If reagent bar code is used (optional), the reagent positions are automatically
identified by the test code on the bar-code label after reagent bar codes scan.
{R1/R2: Size}: This parameter represents the size of the bottle. Three types of
bottle sizes are possible – Large (50 ml), Small (20 ml), and Tube (5 ml). These
bottles can be selected as the L or S or T in the pull-down option. The even
positions in the reagent tray are meant only for the small bottles. The odd
positions in the reagent tray can be used for placing both the large and the small
bottles (with the adapter). The 5 ml reagent adapter tubes have to be placed in a
small or large bottle, which can be placed in any position.
Operation 15
4.4.14 {Multiple This option is for defining multiple positions for Reagent 1. Clicking on
Positions} <Multiple Positions> button in the [Test Parameters] screen, pops a sub-screen as
shown below:
Operation
Figure 4.7: [Test Parameters: Multiple Positions] screen
On this sub-screen, the main Reagent 1 position, volume and size is displayed on
top. Below that is a table where the operator can assign up to 10 additional
positions and bottle sizes, which he/she intends to use.
During the run, the reagent is at first taken from the lowest
position number assigned and not from the main position.
Later, when the reagent is over in the first position, the
analyzer automatically switches over to the position where
sufficient reagent is available until the last position.
Make sure to do a reagent volume scan before starting a run with tests that use
multiple positions for Reagent 1.
4.4.15 {Reagent This option is for defining parameters related to the stability of the reagents.
Stability} Clicking on <Reagent Stability> button in the [Test Parameters] screen pops a
sub-screen called “Reagent Stability Parameters” as shown below.
Operation
{Batch no.}: Use this field to indicate the batch of the Reagent 1 and Reagent 2.
User can enter an alphanumeric code of up to 10 characters in this field.
{Effective Days}: In this field, define the number of days for which a fresh
reagent is effective/stable on-board. This field is user specified and can take any
value between 1 and 99. The (remaining) number of days for which the reagent
will be stable on board, is calculated as:
Remaining Days = Number of days passed since Renew Date – Effective Days
The remaining number of days for reagent stability is shown on the [Reagents] as
well as [Run Test] screens.
{Renew Date}: This field is to set the date on which the Reagent 1 or Reagent 2
bottles are replaced/refilled with fresh reagents. The user can renew the reagent
refill/change date by clicking on <Renew R1> or <Renew R2> buttons. The
remaining number of days, for which a reagent will be stable on board, is
calculated as mentioned above and is shown on the [Reagents] as well as [Run
Test] screens.
Operation 17
4.4.16 {React. Abs This parameter defines the absorbance limit of reaction mixture for Serum/Urine
Limit} samples. Enter an absorbance limit for Serum and Urine depending on the
reaction direction (increasing or decreasing). For rate chemistries, the absorbance
limit is that absorbance at which the substrate depletion is detected. For
increasing direction chemistries, enter the maximum allowed final absorbance
before substrate depletion takes place. For decreasing direction chemistries, enter
the minimum allowed final absorbance before substrate depletion takes place. If
the absorbance for a reaction mixture crosses the React Abs Limit at the M2E
measurement point, a flag “AbsLim” is issued with the result. If AutoRerun is set
to YES, the sample will automatically be sent for a Decreased volume run.
Maximum permissible entry is 3.5. In case the reaction absorbance check is not
desired, put “0” in the React Abs Limit entry.
4.4.17 {Reaction Dir.} This parameter defines the direction of the absorbance change with time for the
reaction mixture. Specify whether the absorbance of the reaction mixture increases
or decreases with time. Select one of two options by clicking the mouse over the
bulleted choices. The selected choice is highlighted in Turquoise color.
Operation
4.4.18 {Reagent ABS} Use these fields to define the minimum and maximum allowed absorbance of the
reagent before it degrades. This parameter is used to check the stability of the
reagent.
{Reagent ABS: Max.}: Specify the maximum permissible initial absorbance of the
reagent. Enter a value ranging between 0 and 2.5. It is a value defining the
deterioration limit of the reagent and helps to check the quality of the reagent.
During test performance, if the reagent absorbance is higher than the programmed
maximum value, a flag 'RgtAbsMax' is printed along with the test result.
4.4.19 {Tech. Serum These fields are used to define the Linearity Limit of the reagents. For the
/Urine Limits} 1POINT and 2POINT chemistries, feed the minimum and maximum
concentrations in the Minimum and Maximum Technical Limit fields respectively.
For RATE-A and RATE-B chemistries, feed minimum and maximum absorbance
change per minute in the Minimum and Maximum Technical Limit fields
respectively.
If Tech Limit Min is violated, a flag “Lin.L” is issued with the result. If
AutoRerun is set to YES, the sample is automatically sent for an Increased
volume rerun. Similarly, if Tech Limit Max is violated, a flag “Lin.H” is issued
with the result. If AutoRerun is set to YES, the sample is automatically sent for a
Decreased volume rerun.
18 Operation
{Tech. Serum/Urine Limit: Min}: Define a value ranging from 0 to 99999 indicative
of the minimum technical limit or the linearity limit of the reagent. For end-point
chemistries, feed the minimum concentration whereas for rate/kinetic chemistries
feed the minimum absorbance change per minute (between 0 and 2.5). Samples
that violate this limit are sent for Increased volume rerun. If you do not wish to
use technical limit minimum, feed a zero value.
{Tech. Serum/Urine Limit: Max}: Define a value ranging from 0 to 99999 indicative
of the maximum technical limit or linearity limit of the reagent. For end-point
chemistries, feed the maximum concentration whereas for rate/kinetic chemistries
feed the maximum absorbance change per minute (between 0 and 2.5). Samples
that violate the programmed technical limit maximum are sent for Decreased
volume rerun. If you do not wish to use technical limit maximum, feed a zero
value.
4.4.20 {Serum Panic This field is used to define the minimum and maximum concentration limits
Limit} beyond which the serum sample will go for a “same” rerun. A same rerun means
that if the sample was programmed for a normal volume run, the rerun too will be
performed using a normal sample volume. Similarly, if the sample was
Operation
programmed for Decreased or Increased volume run, the rerun will be performed
using a Decreased or Increased volumes respectively.
For an automatic rerun to take place due to Panic Limit violation, AutoRerun
needs to be set to YES. When the sample result violates the Panic Limit Minimum
or Maximum, a flag “Panic.L” or “Panic.H” is issued respectively. The rerun
result is flagged “#” to indicate a rerun. If you do not want to use the Panic limit
minimum and maximum, feed a zero value.
The Panic Limits are defined for Serum samples only and not for Urine or Other
samples.
4.4.21 {Prozone This field is used to specify the minimum limit for the absorbance at the end of an
Limit} immunoturbidimetric reaction as a percentage of the maximum absorbance
observed during the course of a reaction. Prozone limit should be between 0 to
100%. If the percent ratio of the final absorbance (at M2E) with the maximum
absorbance in the time course (up to the point M2E) violated the prozone limit, a
flag P* is issued with the result. If AutoRerun is set to YES, the sample is
automatically sent for a Decreased volume rerun. If you want to make sure that
the absorbance is increasing monotonically in the time course, feed a value of
100(%).
{Prozone Limit: Upper/Lower}: Use this field to specify whether the entered value
is an upper limit or lower limit. For increasing direction chemistries, you can
select only “Lower” and for decreasing direction chemistries, you can select only
“Upper”. The selected choice is highlighted in Turquoise.
Operation 19
4.4.22 {Unit} Use this pull-down option to select unit of measurement for the analyte. If user
does not find the desired unit in the already provided pull-down options, user can
enter additional unit as desired. Below is a list of preprogrammed units:
1. IU/L
2. IU/ml
3. U
4. U/L
5. %
6. g/dl
7. mg/dl
8. µg/dl
9. mEq/ml
10. ng/ml
11. mmol/l
12. µmol/l
13. µg/ml
14. KUN-C
15. MAC-U
16. D-PH
17. (User-defined)
Operation
4.4.23 {Decimal In this field, the user can select the number of digits to be displayed after the
Point} decimal point in the display and printout of test results. The user can select the
number of digits after decimal place by selecting 0, 1 or 2 from the pull-down
option.
4.4.24 {Normal value These fields are used to define the expected values or normal range for serum
serum} samples being assayed. These limits are used to issue H or L flag, which indicate a
higher concentration than normal or lower concentration than normal respectively.
Normal range values for both Male and Female subjects can be specified for two
different age groups. Additionally, default normal range values can also be
defined for Male and Female subjects. The default normal range is used if the age
of the patient is not known.
Use these fields to enter the expected values range for serum samples for different
assays.
For correct H and L flags, the patient’s age and sex should
be set before the patient’s sample is analyzed.
20 Operation
{Normal value serum: Age}: Use this field to enter the numerical age for this range
of reference values. Enter the appropriate number between 0 and 100. The serum
results are compared with normal serum range of the corresponding age group
(that is, the reference range corresponding to the age higher than the patient age).
Range values fed in front of Default are used when the age of the patient is not
available.
{Normal value serum: Male}: Use this field to enter the lower limit and upper limit
of the reference value for serum samples for males.
{Normal value serum: Female}: Use this field to enter the lower limit and upper
limit of the reference value for serum samples for females.
4.4.25 {Urine Values} Similar to the {Normal Values Serum} fields, these fields are used to enter the
lower limit and upper limit of the normal value for urine samples.
4.4.26 {AutoRerun} This option enables the user to select whether the analyzer should carry out an
automatic rerun or not for samples that violate the Technical Limits, React Abs
Operation
Limit, Prozone Limit or Panic Limit. The user can select either YES or No.
4.4.27 {Y = aX + b} These fields can be used to perform correlation correction so that the results
obtained on this analyzer can be matched with those obtained on some other
analyzer. For some assays, the analyzer might give results that are consistently
higher or lower than expected or obtained on another analyzer. To match the
results with the expected results or the results obtained on another analyzer, a
correlation correction can be incorporated in the result calculations. The equation
used for correlation correction is:
Y=aX+b
When the results obtained on this analyzer are as expected feed a = 1 and b = 0.
Operation 21
The following plot shows the relation of results obtained on any two compatible
analyzers: (Here b = 0 and a = 1)
40
+B
AX
Y=
30
20
10
10 20 30 40 50
Results on this analyzer
Operation
obtained by two different analyzers
Correction factor a should have values between 0.0001 and 9999.9 while
correction factor b should have values between -99999.99 and 99999.99.
4.4.28 Test The three other buttons on the [Test Parameter] screen are:
Parameters sub- 1. <TESTS>
menus 2. <Calib Table>
3. <Copy>
4.4.29 [Test Parameters: Clicking on <Tests> changes the display to the following:
TESTS]
Operation
The software displays 99 test icons in three pages. The test icons are arranged as
defined by the user in {Previous Data: System Switch: Test Sequence} or in the order in
which they were added. Use <page up >and < page down > to scroll current page
to previous and next page. The use of this screen is to enable user to select a test
name by clicking on icons instead of using the pull-down option on the [Test
Parameters] screen.
4.4.30 [Test Parameters: Clicking on <Calib Table> button on the [Test Parameters] screen presents the
Calib Table] following screen:
The following sequence should be used for calibration (more details given in
section on [Standardisation] screen):
a. Define the calibrator names at desired positions in the [Standardisation:
Positions] screen and select desired tests for the calibrator. The
designated calibrator positions are automatically updated in [Calib
Table] of the corresponding tests.
b. In the [Calib Table] screen, define the calibrator concentrations for
different tests and select Calibration Curve Type.
c. In the [Standardisation] screen, click on different positions on the
Standards Wheel and select the tests for which calibration needs to be
performed.
d. Start the Standardisation run in [Run Test: Run Status: Run Monitor]
screen by clicking on the <Start Std Run>.
e. Absorbance values obtained by the analyzer after the standardisation
run are updated in the [Calib Table] screen. The date and time of
calibration is also updated.
Operation
Up to three previous calibration curves/values can also be viewed or selected for
use in result calculations. The paragraphs below describe various fields and
options available on the [Test Parameters: Calib Table] screen.
{Calib Table: Last calibration date}: This field displays the date and time when
the last calibration was carried out. This date and time is automatically updated
by the software after a successful calibration run and cannot be changed by the
operator. If no calibration has been performed for a test, this field remains empty
(for example, for all newly added tests).
{Calib Table: Calibration Expiry Limit}: Use this field to define the number of
days after which the calibration expires after a calibration. User can enter a value
up to 999 days in this field. If calibration for a test has expired, the application
software gives a warning about it at the time of test selection and saving a patient
entry. A calibration expired warning is also issued in the [Run Test: Run Status]
screen.
{Calib Table: Calibrator Name}: This button can be used to view the calibrator
names which have been defined in the [Standardisation: Positions] screen. Clicking
on <Calibrator Name> button changes the right side of the screen as shown in the
following figure:
Operation
This screen helps the user in selecting an appropriate calibrator position in the
calibration table and placing a correct calibrator on the Standard tray on the
analyzer.
{Calib Table: Test}: Use this pull-down option to select a particular test item (for
display of calibration table). The calibration table for the selected test is shown
immediately.
{Calib Table: Pos}: The pull-down options below this field are used to select blank
and standard positions as described below.
{Calib Table: Blank}: Use this pull-down option to select one of the two positions
where blank can be programmed namely, B1 and B2. It is possible to leave the
position empty, when the user wants to manually feed the blank absorbance. If the
user selects a blank position in [Calib Table] for a test for which blank has not
been selected in the [Standardisation: Positions] screen, a warning is given and the
position cannot be saved until modification is made in the [Standardisation: Positions]
screen.
Operation 25
{Calib Table: STD1/STD2/STD3/STD4/STD5}: Use the pull-down options to
select the standard positions S1 to S20 for STD1 to STD5 as desired. It is possible
to leave the position empty, when the user wants to manually feed the standard
absorbance and do not want to run a calibrator. If the user selects a standard
position for a test in [Calib Table] that has not been set for the test in the
[Standardisation: Positions] screen, a warning is given and the position cannot be
saved until modification is made in the [Standardisation: Positions] screen.
{Calib Table: Absorbance}: This column indicates the absorbance values that are
automatically obtained by the analyzer after the calibration is carried out.
However, if the calibration data are wrong or need to be fed manually, the user can
set absorbance values after clicking on <Modify> button at the bottom. The
absorbance values can be fed between –3.5 and +3.5 in the steps of 0.0001.
{Calib Table: Exp Abs}: The fields in this column can be used to set the expected
absorbance for the corresponding standard and blank. The values of the expected
absorbance (along with ±Abs Limit) are used to monitor whether absorbances
Operation
obtained during calibration are within acceptable limits or not. If the blank or
standard absorbance is not within the corresponding Exp Abs ± Abs Limit range, a
warning “Calibration of … is out of Abs Limit range” is displayed on the lower
portion of the [Calib Table] screen. Additionally, a “Calibration Expired” warning
is issued at the time of test selection in [Patient Entry: Tests] screen if a standard
absorbance is not within the corresponding Exp Abs ± Abs Limit.
{Calib Table: ± Abs Limit}: Use this field to enter the maximum allowed
difference in the absorbance of the standards and blanks from their expected
absorbance as fed in the corresponding field under the “Exp Abs” column. If the
difference between absorbance of a standard/blank and its expected absorbance is
more than the ±Abs Limit, a warning message “Calibration of … is out of Abs
Limit range” is displayed on the lower portion of the [Calib Table] screen.
Additionally, a “Calibration Expired” warning is issued at the time of test
selection in [Patient Entry: Tests] screen if a standard absorbance is not within the
corresponding Exp Abs ± Abs Limit.
{Calib Table: Calibration}: One of the following twelve methods can be selected
for calculation of the measurement results.
1. Straight: Use this method when a linear response (between absorbance and
concentration) is expected but a calibration is necessary. In this method a two-
point calibration involving a blank and a standard is performed. Joining the
sample absorbance to blank absorbance by a straight line creates the calibration
curve. A Straight type calibration curve is shown below:
Operation
Operation
Figure 4.14: Absolute calibration curve
TV x 1000
Factor =
SV x Mol. Extn. Coeff x P
The factor can also be fed for End-point test where Standards are not available.
It is possible to use a reagent blank for Absolute curve type. That is, a blank
calibration can be performed for Absolute curve type. The sample concentration is
calculated as follows:
3. Linear (Multipt): Use this calibration curve type when linear response
between absorbance and concentration is expected and you want to use multiple
standards to generate the linear curve. For this method, 2 to 6 calibrators can be
used (including blank). The linear calibration curve is obtained by fitting a straight
line to the available standard concentrations and absorbances using the least
square linear regression method. If a set of points (x1, y1), (x2, y2), (x3, y3) …….
(xn, yn) is available, the equation of a best-fit line fitted is given by
Y=a+bX
Where, the intercept a and slope b are obtained by least square linear regression
method and are given by:
a = Y − bX
⎡1 n ⎤
⎢ n ∑ ( X iYi )⎥ − X Y
b = ⎣ i =1n ⎦
⎡1 2 ⎤
( )
⎢n ∑ Xi ⎥ − X
2
⎣ i −1 ⎦
Operation
The slope b is nothing but factor for a linear calibration curve type and therefore
the concentration of the sample is calculated as follows
K
A= B+
1 + exp(− a − b log C − c log C )
Once the constants a, b, and K are known, the concentration of the sample is
obtained by feeding known absorbance in the above equation and finding the root
by Newton-Raphson method.
Operation
Figure 4.16: Logit-log calibration curve
The logit-log curve fit may not be good if fewer than four
standards are used for calibration and/or blank has not
been calibrated
30 Operation
5. Exponential: This is one of the most frequently used calibration curve type for
multipoint calibration. It is necessary to have at least three calibrators (including
blank) to use this calibration curve type. The model for non-linear exponential
calibration curve approximation is given by the following equation:
The above equation is fitted to the absorbance and concentration of calibrators and
blanks and the constants K, a, b, and c are obtained using matrix solving methods.
Once the constants are known, the concentration of the sample is obtained by
feeding the sample absorbance in the above equation and finding the root by
Newton-Raphson method.
The equation of a straight line passing through two points (x1, y1) and (x2, y2) is
( x − x1 ) ( x2 − x1 )
=
( y − y1 ) ( y 2 − y1 )
If the absorbance of the sample Asample lies between the absorbance of two
standards Am and An, such that Am > Asample > An, the following equation is used to
calculate the concentration of the sample
Am − An
C sample = x( Asample − Am ) + C m
Cm − Cn
Operation
Cm and Cn are the concentrations of the standards corresponding to the
absorbances Am and An respectively.
A calibration curve created by using Line Segment principle is shown in the figure
below:
If there are n points (x1, y1), (x2, y2), ……(xn, yn), then there is only one unique
equation to define the curve that passes through all the n points. This is known as
Lagrange’s polynomial and is given by:
n ⎛ y − y j ⎞
x = ∑ xi∏ ⎜
⎜
j≠i ⎝ y i − y j
⎟
⎟
i =1 ⎠
n ⎛ A sample − A ⎞
= ∑ ∏ ⎜ ⎟
Operation
j
C C
sample i ⎜ Ai − A j ⎟
i =1 j≠i ⎝ ⎠
A calibration curve obtained using natural cubic Spline is shown in the figure
below:
Operation
Figure 4.20 Cubic Spline calibration curve
9. Poly1, Poly2, Poly3, and Poly4: These different order polynomials can be
fitted to the calibration concentration and absorbances. These polynomial curves
can be used for multipoint curve types. Poly1 can be used for multipoint linear
curve whereas Poly2, Poly3, and Poly4 can be used for multipoint non-linear
curves. It is necessary to use at two calibrators (including blank) for Poly1
whereas it is necessary to use at least three calibrators (including blank) for Poly2,
Poly3 and Poly4 calibration curves.
The following equations are fitted to the calibrator concentrations and absorbances
using least square linear regression method.
Once the coefficients a, b, c, d, and e are known, the sample absorbance is fed in
the equation and sample concentration is directly calculated.
34 Operation
4.4.31 [Test Parameters: This option is used to copy the test parameters from one test to another. To copy
Copy] test parameters from one test to another, simply click on <Copy> button and feed
a new test name to which you want to copy the test parameters. Finish by clicking
on <OK> button.
4.5 [Patient Entry] Clicking on the <Patient Entry> button on the Main Menu Screen presents the
following screen on display:
This is the screen where patient demographics can be entered and tests to be
performed on the patient sample can be requested. Details of patient name,
address, doctor referring patient, blood drawn by, age, sex etc are all entered in
this screen. The patient demographics are used to generate the patient report after
analysis of the sample.
To add a new patient: Click on the <Add> button on the screen and enter new
sample number, patient ID. It is essential to enter a patient ID. A position will
Operation
also be required if the sample container is not bar-coded. If bar code (optional) is
activated, the sample position is updated by the analyzer after scanning the sample
bar codes. After making necessary entries click <Save>. Clicking on <Save>
saves the programmed patient details and present a fresh screen for programming
the next patient where the patient ID and sample positions are automatically
incremented.
To browse through patient records and locate a patient: One can browse
through all the patient data by using the <Previous> or <Next> buttons. During
this browsing, entries are shown only for those patients that have been added or
modified today. To view the patient entries that were made earlier, the user can
select the date (below the Sample Pos field). One can also search for a particular
patient by the patient ID.
Operation 35
To search a patient by the patient ID, do the following:
To modify the patient data: Locate the patient record you want to modify. Then
click the <Modify> button and modify patient demographics or any other data for
the patient data being displayed. It is suggested that the patient demographics,
especially the age and sex of the patient be entered before the sample run. If the
age and sex of the patient are modified after the sample run, they will not reflect in
the Patient Report. Additionally, the modifications made in patient demographics
will reflect in the Patient Report only if the modifications have been made on the
same day as that of the sample run.
Operation
To delete the patient data: There are several ways to delete patient data.
If you want to delete only one patient’s data, first locate the patient data and then
click on the <Delete> button at the bottom of the screen. A query “Do you wish to
delete this patient?” is posed. One can choose to continue or abort the delete
operation.
If you want to delete all patients’ data, simply click on <Delete All> button at the
bottom. The software prompts the user to confirm before deleting all patient data.
If you want to delete patient data of one disk at a time, click on <Del Disk> button
on the lower right edge of the screen. Select the appropriate disk number which
you want to delete and click on <OK>.
The details of the different fields on the [Patient Entry] screen are given in the
following subsections.
4.5.1 {Sample No.} It is the sequence number generated automatically by the program (i.e. no entry is
required by the operator). This can be used to track the number of patient entries
made in the day.
4.5.2 {Sample Pos} In case the sample is not bar-coded, the user should specify the sample position in
this field. An assigned sample position cannot be used for some other sample. For
disk number 1, a position between 1 and 50 cn be used for normal samples. For
disk number 2, a position between 51 and 100 can be used for normal samples.
For disk number 3, a position between 101 and 150 can be used for normal
samples, and so on up to position number 500 for disk number 10.
36 Operation
For bar-coded samples the sample position is automatically assigned as per the
disk number selected after the sample bar-code scan. If Query Mode is set to
“ON” in [Previous Data: System Switch], the sample’s details (including disk
number) are downloaded from the Host PC (even if the patient ID already exists in
[Patient Entry]) and the sample position is updated in the Patient Entry
corresponding to the disk number obtained from Host PC.
For emergency samples, positions E1- E20 can be used for any disk. Additionally,
last five positions on any disk can also be used for emergency samples (for
example, positions 46 to 50 on disk 1 can be used for emergency samples by
specifying these positions as E46 to E50). Emergency samples programmed
during run at E1 to E20 positions are run in the same batch.
4.5.3 {Patient ID} This field is used to assign an alphanumeric identification number of up to 10
characters to each patient. Entry in this field is compulsory and cannot be skipped.
4.5.4 {Patient Name} Enter patient name in the field using the key board. A maximum of 30 characters
can be fed in this field.
Operation
4.5.5 {Disk No.} Select disk nos. 1-10 from the pull down option. For disk number 1, a sample
position between 1 and 50 cn be used for normal samples. For disk number 2, a
position between 51 and 100 can be used for normal samples. For disk number 3,
a position between 101 and 150 can be used for normal samples, and so on up to
position number 500 for disk number 10.
4.5.6 {Date} This is the date of creation or last modification of a patient entry. By using
<Previous> and <Next> buttons at the bottom, one can scroll through the patient
IDs created/modified on a particular date.
4.5.7 {Date of Birth} Use this field to specify the Date of birth of the patient. Alternately pull-down the
date of birth optin and the software displays a calendar of dates where the user can
select appropriate date, month and year. When date of birth is entered, the patient
age is calculated automatically.
4.5.8 {Sample Cup} Select the sample container type from the pulldown option. The options available
are Cup and Tube. If sample bar-code is used (optional), the sample holder type
can be Tube only. The default sample container type can be set in [Previous Data:
System Switch] sceen in the {Container} field.
4.5.9 {Age} Enter the numerical age of the patient (in three digits maximum) and press
<Enter>. Choose age in Days/Months/Years using the pull down option. When
date of birth is entered, the patient age is calculated automatically. The patient age
is used to issue H and L flag for the corresponding age range as mentioned in the
sections 4.4.24 {Normal value serum}and 4.4.25 {Urine Values}. If age of a
patient is not fed, default normal values are used to issue H and L flags.
Operation 37
4.5.10 {Address} 50 alpha numeric characters are allowed in this field where one can enter the
address of the patient.
4.5.11 {Referred by} This is a pull-down option to select the doctor’s name who referred the patient.
The names previously listed in the doctor’s list in the [Previous Data: Doctor’s List]
screen are shown in this pull-down option. The doctors name can be quickly
selected by entering the first character of the name. The doctor’s name is printed
in the patient report.
4.5.12 {Drawn This is a pull-down option to select the Analyst’s name. The names previously
by/Analyst} listed in the Analyst list in the [Previous Data: Analyst/Location] screen are shown in
this pull-down option. The analyst name can be quickly selected by entering the
first character of the name. The analyst’s name is printed in the patient report.
4.5.13 {Sample Remarks about sample can be fed here using up to 50 alpha numeric characters.
Remarks} Previously fed remarks can be selected by pull-down options. These remarks are
printed in the patient report.
Operation
4.5.14 {Patient Remarks about patient can be fed here using up to 50 alpha numeric characters.
Remarks} Previously fed remarks can be selected by pull-down options. These remarks are
printed in the patient report.
4.5.15 {Location} This is a pull-down option to select the location of the patient. The location names
previously listed in the Location list in the [Previous Data: Analyst/Location] screen
are shown in this pull-down option. The location can be quickly selected by
entering the first character of the location.
4.5.16 {Draw date} Use this field to enter the date and time on which the sample was drawn.
4.5.17 {Body Mass Use this field to define the surface area of the patient in m2. This is an optional
Index} parameter and is used in the calculation item of Creatinine Clearance. This field
can be ignored if user does not want to use Creatinine Clearance calculation item.
If user wants to use Creatinine Clearance calculation item, charts are available in
standard text books which can be used to find the surface area of a patient of a
particular age and height. 1.73 m2 is the surface area of a normal individual and is
taken as default for all patients.
4.5.18 {Urine Use this field to define the volume of urine collected from a patient in 24 hour
Volume} duration. This is an optinal parameter and is used in the calculation item of
Creatinine Clearance. This field can be ignored if user does not want to use
Creatinine Clearance calculation item.
If user wants to use Creatinine Clearance calculation item, entry in this field is
necessary and the user should feed the urine volume (in ml) collected in 24 hours
in this field.
38 Operation
4.5.19 {Sample type} Select the sample type from the pull-down option. The options available are:
Serum, Urine and Other. Please note that for Other sample type, all the
parameters of Serum sample are used apart from the normal range. For Other
sample types, H and L flags are not generated.
4.5.20 {Emergency} Whether the given sample is an emergency sample or not is specified using this
tick option. To designate a sample as an emergency sample, tick in this field and
select one of the emergency position for the sample as suggested in the
section 4.5.2 {Sample Pos}. Emergency samples are given priority over routine
samples in a run. Emergency samples programmed during run at E1 to E20
positions are run in the same batch.
4.5.21 {Category} Use this field to identify the sex of the patient. Select as either Male or Female.
4.5.22 {Bar-code} The user can select whether to use sample bar-code facility or not. If the bar-code
option is set to ON in the [Previous Data: System Switch] screen, then the sample
position fed by the user is ignored. The user has to select Yes/No for whether the
Operation
4.5.23 {Calculated Use this section of the screen to select Calculation Items that need to be calculated
Item} from the test results. Up to ten Calculation Items can be selected. The Calculation
Items defined in [Previous Data: Calculation Item] screen are available for selection.
Select the calculated items by clicking in appropriate box. It is necessary to
request the Tests used in the calculation to calculate a Calculation Item.
4.5.24 {Selected Test} In this section of the screen, all requested tests for the patient are displayed. A
“9” mark to the left of the Test name indicates that the Test is pending for
analysis. Additional tests can be requested from the [Patient Entry: Tests] screen.
Operation
Figure 4.22: [Patient Entry: Tests] screen
This screen, instead of the [Patient Entry] screen, can be used to make a quick
entry of patient data. The following fields are available for entry on this screen:
• Patient ID
• Sample position
• Sample Volume type [Normal|Decrease|Increase]
• Emergency [YES|NO]
• Bar-code [YES|NO]
• Sample cup [Cup|Tube]
• Calculated Items
In addition to these fields, the software displays 99 tests stored in three pages. The
user needs to select the required Tests by clicking the mouse at the required test
name icon. The software highlights the selected test names for easy identification.
On completing the test selection and calculation item selection, the request can be
saved by clicking on <Save> button.
Previously saved patient tests and other details can be changed by clicking on the
<Modify> button at the bottom of the screen. You can also use the Copy function
to copy test items from one patient to another.
To copy tests from one patient to other, follow the steps mentioned below:
1. Locate the patient whose tests need to be copied to other patient
2. Click on <Modify> button at the bottom
3. Enter the position or position range of the samples in the From and To
fields and click on <Save> button at the bottom.
4. The selected tests for the current patient are copied to the samples of the
mentioned positions. If the positions do not exist, the application software
automatically creates the patient IDs and positions and then copies the
tests.
40 Operation
4.5.26 [Patient Entry: Click the [Profile] button on the ‘Patient Entry’ screen. The display changes to the
Profile] following screen:
Operation
This screen can be used during patient entry to request all the tests in a profile by
simply clicking at the profile button on this screen.
1.Click on <Create Profile> button. The display changes to the following screen.
The software is now programmed for required tests (profiles) for any particular
patient.
4.5.27 [Patient Entry: Click the <WorkList> icon on the screen of ‘Patient Entry’. The display changes
WorkList] to the following screen:
Operation
Figure 4.25: [Patient Entry: WorkList] screen
On this screen, a list of tests requested for a particular sample is shown. The
WorkList for any sample can be viewed by simply selecting an appropriate ID
from the pull-down option. The WorkList includes the following details in the
form of a chart: Disk No., Sample position, Test name, Replicates, Run type and
Sample volume type. The WorkList includes the details of bar-coded samples too
even though their positions may not be known.
On the right side of the WorkList screen, there are two buttons namely, <Backlog
Worklist/Entire Worklist> and <Selective Worklist>. <Backlog Worklist> can be
used to view the samples which are pending for processing. <Selective Worklist>
can be used to run only selective samples from the WorkList. To run only
selective samples, user has to fill the positions of the sample to be run in the {from}
and {to} fields and then click on the button <Selective Worklist>. To change the
choice to run the entire Worklist click on <Entire Worklist>. Please note
emergency positions cannot be entered in the {from} and {to} fields and already
programmed emergency samples will not run. Emergency samples added during
the run will be analyzed.
On the right side of the WorkList screen, the total number of tests requested is also
displayed.
42 Operation
4.5.28 [Patient Entry: Clicking on the <Clr Sched> button on the [Patient Entry] screen presents the
Clr Sched] following sub-screen on the [Patient Entry] screen:
Operation
This screen can be used to remove test requests from the WorkList. There are two
options to achieve this, Entire Schedule or Selected Schedule. Using these options,
the user can either clear the entire patient schedule programmed (i.e., clear all tests
selected for all patient samples) or clear the test requests for only selective
samples that are tick marked.
{Clr Sched: Entire Schedule} The program deletes the entire patient test requests
scheduled for analysis after the user confirms the intention.
4.5.29 [Patient Entry: This button is used to receive latest patient data from the host computer if the
Refresh] analyzer PC is connected to a host computer. To use this facility, it is necessary to
set the Host Selection ONLINE or OFF LINE in [Previous Data: System Switch]
screen.
Operation 43
4.5.30 [Patient Entry: This button can be used to delete patients’ entries or sample positions disk wise as
Del Disk] well as for selective sample positions. By clicking on <Del Disk> button, a sub-
screen as shown below appears on the [Patient Entry] screen:
Operation
Figure 4.27: [Patient Entry: Del Disk] screen
To delete all patients details on one particular disk: Select the disk number and
click on <OK> to delete all patient entries (including patient IDs) for the selected
disk.
4.6 [Reagents] This screen is useful for checking volumes of the reagent kept on the analyzer.
The reagent tray has 50 reagent positions. On clicking on the <Reagents> button
on the Main Menu Screen, the display changes to the following screen:
Operation
<Scan volume>: This button can be used to start scanning the reagent volume. If
the reagent bar-code is ON in the [Previous Data: System Switch] screen, first the
reagent bar-codes are scanned and then the reagent volumes are scanned by the
liquid level sensing mechanism of the analyzer. Click <Scan Volume> on the
screen. Upon command, the analyzer scans all the 50 reagent positions for reagent
volume and displays the following updated information:
{Position}: This row indicates the reagent bottle position. When reagent bar-code
option is ON, the analyzer scans all reagent position from 1 to 50 and correlates
each reagent bottle placed at a position with the concerned test name using the test
code as programmed in the [Test Parameters].
{Test}: This row shows the test name for which the reagent can be used. If the
reagent position has Reagent 2 for a chemistry, the test name is followed by “:2”.
For example, for the test CRE if the Reagent 2 is kept at position 23, at that
position the {Test} field will read “CRE:2”. If the reagent can be used for
multiple tests, only one test name is displayed in {Test} field. However, other test
names can be seen in the tool-tip by taking the mouse pointer over the current Test
name shown.
{#Test}: This row indicates the number of tests that can be carried out with the
available volume of the reagent (after subtracting the dead volume). This number
is calculated based on the reagent volume available in the bottle and the reagent
volume to be used per test as defined in [Test Parameters]. The reagent volume
used for #Test calculation is after subtracting the dead volume. The dead volume
for 50 ml bottle is 2.0 ml and for 20 ml bottle it is 1.5 ml. The dead volume could
be up to 3 times of these when multiple reagent positions are used for the same
reagent.
Operation 45
{#Days}: This row indicates the number of days the reagent is stable on-board.
These numbers are shown at the lower part of the bottle shape. If the reagent has
expired, the number of days will be shown as a negative number in red color.
The reagent bottle shapes are shown in different colors and a legend is shown at
the right bottom of the [Reagents] screen. The legend is explained below.
Normal: A Turquoise color is used to indicate that the volume of the reagent
in the bottle is enough to carry at least 10 tests. The height of the Turquoise
column in the bottle shape gives an indication of the level up to which the
reagent bottle is filled.
Free position: The complete bottle shape is marked in white to indicate that
the reagent position is not being used by any test and therefore that reagent
position is free for assignment.
Empty: The complete bottle shape is marked in red to indicate that the
reagent bottle is empty although a test has been defined for the reagent
position.
Operation
Low: The bottle level is shown in yellow to indicate that reagent bottle is
nearly empty. Yellow bar is used to indicate either that the reagent volume is
less than 5% of the bottle capacity or that fewer than 10 tests can be
performed with the available volume of the reagent.
4.7 [Standardisation] Click on <Standardisation> button on the Main Menu Screen and the display
changes to the following screen:
This menu is used to designate calibrator positions and calibrator names and to
request tests for calibration. The circular ring on the left side of the screen will be
referred to as Standards Wheel in the text. The controls to be run as part of
standardisation run or for real time quality control during patient run are also
requested in this screen.
46 Operation
The following fields are shown in different columns in the table shown on the
screen:
These positions can be used for any disk number. The Standards Wheel aids the
operator to select the calibrator/control positions and request related tests for them.
The blank, calibrator and control to be run can be chosen by clicking on the
desired blank, calibrator and control positions and selecting appropriate tests from
the sub-screen which pops-up. The pop-up is shown below:
Figure 4.30: The pop-up screen prompting the user to select tests to be run
for a particular calibrator/blank position
If any test for a position is requested, the tests are automatically put on the
Worklist. The position numbers as well as the test names are marked in green
color as shown in the figure above to indicate that these have been selected. User
can define various blanks and standards at the desired positions on the standard
tray as described in the next section.
Operation 47
4.7.1 [Standardisation: Click on the <Positions> button on the [Standardisation] screen and the screen
Positions] changes to the following display:
Operation
Figure 4.31: [Standardisation: Positions] screen
<Page Up> and <Page Down> are to scroll through the chemistry names.
in [Calib Table] of the selected tests. The only calibrator position, to which the test
has been designated, can be selected for concentration entry in the [Calib Table]
screen. During run, it is not possible to modify tests for a calibrator which is
being processed.
To request tests to a particular control position: First select the desired position
from the pull-down option {Position}. (For controls, the test designated in the
[Quality Control: Control Data] are shown at the positions which are designated in
the [Standardisation: Controls] screen). Click on the <Modify> button and select any
of the tests by clicking on the test name icons. The test names can also be selected
from the [Standardisation: Positions: Profile] screen. The selected test names are
highlighted in blue text whereas the unselected test names are shown in black text.
Finally, click on the <Save> button to save the test requests.
These selected controls are marked in green color in the [Standardisation] screen.
Observe the color change (from pink to green) on the [Standardisation] screen on
the standardisation wheel after designating a test to a control position.
The tests for a control can also be performed at the [Standardisation] screen by
clicking on the control positions on the Standards Wheel.
Operation 49
4.7.2 [Standardisation: Calibration table usage and procedure has already been explained in the
Calib Table] section 4.4.30 [Test Parameters: Calib Table].
4.7.3 [Standardisation: Click on the <Controls> button on the [Standardisation] screen and the display
Controls] changes to the following screen:
Operation
Figure 4.32: [Standardisation: Control] screen
This screen is used to assign controls (which are earlier defined in the [Quality
Control:Control Data] screen) to control positions C1 to C8.
To assign a control to a position, simply drag the name of the control from the 30
options available and place it on any one of the desired positions C1 to C8. A 31st
icon is left blank and can be dragged over any control position to overwrite it.
These instructions are also given on the screen.
Once the controls have been assigned to the positions, they become available for
selection in the [Standardisation: Positions] screen. The final test requests for
controls can be made in the [Standardisation: Positions] screen or in the
[Standardisation] screen. The controls also become available for real time QC
during patient run and the controls will run at the predefined interval as defined in
the {Test Parameters: Control Interval} field.
For example, if the user wants to select Erba Path to be run at control position
number C2, then drag the displayed item Erba Path icon from its position (among
the 30 items displayed) with the mouse and drop over the position C2. The
instrument is now set to run Erba Path at position C2.
During run, it is possible to add new controls but it is not possible to modify or
delete tests for a control which is scheduled to run.
4.7.4 [Standardisation: A description of WorkList has already been given in the section 4.5.27 [Patient Entry:
WorkList] WorkList].
50 Operation
4.7.5 [Standardisation: Clicking on the <Clr Sched> button on the [Standardisation] screen presents the
Clr Sched] following sub-screen on the [Standardisation] screen:
Operation
This screen can be used to remove blank/standard/control test requests from the
WorkList. There are two options to achieve this, {Entire Schedule} or {Selected
Schedule}. Using these options, the user can either clear the entire schedule i.e.,
clear all tests selected for all the calibrators and controls or remove test requests
for selective calibrators/controls.
{Clr Sched: Entire Schedule} The program deletes the entire standardisation and
quality control schedule for the analysis after the user confirms the intention.
{Clr Sched: Selected Schedule} The program displays a list of calibrator and
control positions pending for analysis. Tick the appropriate boxes to select the
calibrators and controls to be eliminated from the run. The program requests a
confirmation before removing the calibrators and controls from the WorkList.
4.7.6 Steps for 1. Go to [Calib Table] screen and select the appropriate calibration curve
standardisation type which you want to use.
2. Designate calibrators at desired positions in the [Standardisation: Positions
screen as mentioned in the section 4.7.1 [Standardisation: Positions]. If
Controls are to be run as part of standardisation, define the Controls in the
[Quality Control: Control Data] screen.
3. Designate calibrator concentrations in the [Calib Table] screen as
mentioned in the section 4.4.30 [Test Parameters: Calib Table]. Define the
target and SD values for controls in the [Quality Control] screen.
4. Designate the controls at desired positions (C1 to C8) in the [Standardisation:
Controls] screen following the procedure described in the section 4.7.1
[Standardisation: Positions]. Request tests for calibration and QC in the
[Standardisation] screen by clicking on the desired positions in the
Standards Wheel and selecting the relevant tests as mentioned in the
section 4.7.1 [Standardisation: Positions].
5. View the selected tests in the [Worklist] screen. If necessary, make
modifications in the test requests by following the aforementioned steps.
Operation 51
6. Place the calibrators (including blanks) and controls at the desired
positions on the standard tray.
7. Go to [Run Test: Run Status: Run Monitor] screen and click on <Start STD
run> button to start the run. (To start standardisation run followed by a
patient run, click on <Start Mixed Run> on the [Run Test: Run Status: Run
Monitor] screen).
8. If Printer is set to ON in the [Previous Data: System Switch], the calibration
table details will be printed immediately after the standardisation run.
(These details are not printed during a Mixed Run).
9. After the run, the absorbance values for calibrators are updated in the
[Calib Table] screen and the control values obtained are updated in the
[Quality Control: Daily QC] screen.
4.8 [Run Test] Click the <Run Test> button menu on the Main Menu Screen and the display
changes to the following screen:
Operation
Figure 4.34: [Run Test] screen
Information related to sample & reagent bar codes (optional) and reagent volume
& stability is displayed on this screen. The details about the options available on
this screen are explained in the sub-sections below.
4.8.1 {Run Test: If reagent barcode (optional) is set to ON in the [Previous Data: System Switch]
Reagent Bar-code screen, this portion can be used to scan the bar-code information on the reagent
Scan} bottles and update the reagent positions for the corresponding tests in [Test
Parameters] accordingly to the test code mentioned in the barcode pattern. To start
the bar-code scan, click on the <Start> button next to {Reagent Bar-code Scan}.
18-digit barcodes of reagent bottles are read and the reagent position is
automatically associated to the corresponding test using the Test Code. After the
reagent barcode scan, a query is posed to the operator to confirm whether the
operator would like to set non bar-coded reagent positions (for other tests) to zero
where a bar-coded reagent bottle has been found. If the operator answers “No”, the
bar-coded reagent positions are updated in [Test Parameters] but the common
positions for other tests are not set to zero. If the operator answers “Yes”, the
positions where bar-coded reagent bottles have been found are set to zero for other
tests.
52 Operation
If the checksum digit does not match the checksum of the 18 bar-code digits,
“Checksum Mismatch” is displayed instead of the bar-code number.
To clear the reagent bar-code information displayed, click on the <Clear> button
displayed next to Reagent Bar-code Scan.
4.8.2 {Run Test: This portion can be used to scan the volume of the reagents. To start the reagent
Reagent Level Scan} volume scan, click on the <Start> button next to Reagent Level Scan. The
program updates the volume of the reagents of the scheduled tests and displays it
on the screen.
4.8.3 {Run Test: If sample bar code (optional) is set to ON in the [Previous Data: System Switch]
Sample Bar-code screen, this portion can be used to scan the bar-code information on the sample
Scan} tubes. To start the bar-code scan, click on the <Start> button next to Sample Bar-
code. 10-character bar code from sample tube is obtained and the position is
assigned. If the position, where a bar-coded sample has been found, is used by any
other sample, it is set to zero in [Patient Entry].
To clear the sample bar-code information displayed, click on the <Clear> button
displayed next to Sample Bar-code.
Operation 53
4.8.4 [Run Test: Run The following screen is displayed when the user clicks on the <Run Status> button
status] on the [Run Test] screen.
Operation
Figure 4.35: [Run Test: Run Status] screen
This screen enables the user to view the status of the reagents on-board before
starting a run and the status of a run (the number of tests which are scheduled, in
process, completed, and pending) during and before a run. The details shown in
various columns on this screen are described below:
If the total number of tests scheduled is more than the Possible Tests, a warning is
issued to the user to add more reagent. If the Reagent 1/Reagent 2 volume and
position information is not available for any test, the corresponding row is marked
in red color. These tests cannot be performed and will be omitted from the run
unless both the volume and position are assigned. For mono-reagent chemistries,
Reagent 2 position as well as volume could be zero.
54 Operation
4.8.5 [Run Test: Run On clicking on the <Run Monitor> button on the [Run Test: Run Status] screen, the
Status: Run Monitor] following screen is displayed:
Operation
No.: (1-51) It is the cycle number, which a reaction cuvette for a particular test
is undergoing at that instant. The detailed description is given in
section 錯誤! 找不到參照來源。. The test name is updated every
10 seconds
S Indicates the sample dispensing cycle
R1 Indicates the Reagent 1 dispensing cycle
R2 Indicates the Reagent 2 dispensing cycle
Sample Pos Shows the sample position from which sample is being processed
Test Shows the test name which is being performed in the cuvette
Time Shows the time after which the test result will be available
52-60 It is the cycle number during which the cuvette undergoes washing
RCT Displays the reaction tray temperature in °C
Temperature
RGT temp Displays the reagent tray temperature in °C
Sample Pos. It shows the sample position from which sample is being aspirated
at that instant
Total Tests It shows the total number of tests for the current sample
No pending After a run is over, a green circle indicates that no tests are pending
tests/Pending tests (due to sample or reagent absent errors) and a red circle indicates
that some tests are pending and the user can request rerun of these
tests from the [Previous Data: Pending List] screen.
{Current Disk This pull-down option can be used to select the disk number (1 to
No.} 10) for which the user wants to start the analysis. Click on
<Modify> to modify the disk number.
Patients with no Here the number of patient samples which do not have positions
sample position assigned is displayed. This number includes the bar-coded sample
entries sent from Host PC.
At the end of analysis, the software displays the results on the upper right side of
the [Run Monitor] screen and prints it on the external printer (if online printing is
set to ON in [Previous Data: System Switch] screen).
Operation 55
A description of other buttons available on [Run Monitor] screen is given below.
<Reagent Status>: This button can be used to check the reagent status during the
run. A detailed description of this screen is given in section 4.6 [Reagents].
<Start Pat Run>: This button can be used to start a run where only patient
samples are analyzed. After making necessary entries for patient samples and
reagents, the user can start the run by clicking at the <Start Pat Run> button. A
query is posed to the operator about whether he/she intends to perform a reagent
level scan as shown in the figure below:
Operation
Figure 4.37: Reagent level scan query on the [Run Test: Run Status: Run
Monitor] screen
Click on <Scan> to scan the reagent volumes for only the tests that have been
requested in the present run. Click on <All Scan> to scan volume of all 50
reagents. Click on <NO> to skip the reagent volume scan.
The availability of the patient schedule in the program and diluent in the reagent
tray is checked. In addition, if the cuvette blank absorbances of more than 10
cuvettes are higher than 0.2, a message asking the operator to clean the cuvettes is
given and run is aborted. Otherwise, analyzer performs AutoSpan and proceeds
with the analysis.
<Start Std Run>: This button can be used to start a run where only calibrators
(and/or controls) are analyzed. A query about reagent level scan is posed. The
availability of the standard/control schedule in the program and diluent in the
reagent tray is checked. After that analyzer performs AutoSpan and proceeds with
the analysis.
56 Operation
<Start Mixed Run>: This facility can be used if user wants to perform the
calibration followed by a patient run in the same batch. User can start a mixed run
by clicking on the <Start Mixed Run> button. A query about reagent level scan is
posed. The availability of the standard/patient schedule in the program and diluent
in the reagent tray is checked. After that analyzer performs AutoSpan and
proceeds with the analysis. In this case, at first the calibration is performed first
and is followed by patient run.
During a mixed run, the program cannot execute chemistries that require
PreDilution of standard. Therefore, during a mixed run it is not possible
to request such chemistries.
<Pause Sampling>: It is possible to add samples on the sample tray during a run.
Operation
However, it is advised that sample probe be paused before placing samples in the
sample tray to avoid any possible injury by the sample probe. To pause the
sample probe during a run, the user can click on the <Pause Sampling> button.
The analyzer pauses after about 1 minute and a message is displayed on the screen
to indicate that the sampling probe has paused. It is then safe to load more
samples on the sample tray. After placing the sample on the sample tray, click on
<Resume Sampling> button to resume the sampling and analysis of the pending
samples.
The sampling also pauses during some error conditions such as low water level in
DI water can, low detergent level in Detergent can, low water pressure etc.
4.8.6 Emergency Emergency stop can be performed during run by clicking on the <Stop> button.
Stop during run Upon clicking on <Stop>, a query is posed to the operator to confirm whether the
operator is sure about stopping the run. If the operator answers “Yes”, the sample
analysis process is aborted immediately and the analyzer starts removing the
reaction mixtures from the cuvettes. This action takes about 5 minutes. The
analyzer and application software should be restarted after or during the cuvette
rinse for proper functioning of the analyzer and application software. Please note
that the cuvette blanks are not updated after an emergency stop.
4.9 Procedure for The results obtained can be printed as patient reports or otherwise. The details are
obtaining result mentioned in the sections 錯誤! 找不到參照來源。 and 錯誤! 找不到參照來
printout 源。.
Operation 57
4.10 [Exit] Clicking on the <Exit> button on the Main Menu screen of the application
software, presents following screen with a query “Do you want to start water
save?”
Analyzer
Operation
Figure 4.38: The Exit screen
Click on <Yes> to start water save. Click on <No> to skip water save and
continue with the exiting process. Click on <Cancel> to cancel the exiting process.
If the user clicks on <Yes>, a confirmation is required from the user whether
he/she intends to exit and user can choose Yes/No.
Chapter 5
5. Quality Control ................................................................................................................................................ 3
5.1 [Quality Control] ..................................................................................................................................... 3
5.2 [Quality Control: TESTS]............................................................................................................................ 5
5.3 [Quality Control: Daily QC] ........................................................................................................................ 5
5.4 [Quality Control: Monthly QC]..................................................................................................................... 6
5.5 [Quality Control: Twin Plot] ....................................................................................................................... 7
5.6 [Quality Control: Control Data] .................................................................................................................. 8
5.7 [Quality Control: Reports] .......................................................................................................................... 9
5.7.1 [Indv Mon] ......................................................................................................................................... 9
5.7.2 [Indv List]......................................................................................................................................... 10
5.7.3 [Cuml Mon] ...................................................................................................................................... 11
5.7.4 [Data Reprint]................................................................................................................................... 11
5.8 Procedure to run a Control................................................................................................................... 12
2 Quality Control
Quality Control 3
5. Quality Control
5.1 [Quality Control] “Quality Control” is the next option on the Main Menu Screen and is used for day-
to-day monitoring of the performance of the analyzer. [Quality Control] menu
allows one to monitor the following:
a) Accuracy of the analysis (i.e. whether the values obtained are correct)
b) Precision (i.e. the reproducibility – whether the same values are obtained
when the sample is analyzed repeatedly)
The user can reach the [Quality Control] screen after clicking on the <Quality
Control> button on the 'Main Menu' Screen. The Display changes to the following
screen:
Quality Control
Figure 5.1: [Quality Control] screen
This screen aids the operator in selecting the test and for that test set the target (or
mean) and SD values for each of the defined Controls. The field {Test Name} is a
pull-down option to select the test. Enter the target (or mean) and SD data
corresponding to the Controls for the selected test. To define a new Control,
follow the procedure mentioned in the section Control Data. (In that section, the
user can assign a level and an easily identifiable name to the Controls. Three
choices namely, A, B, and C are available for level selection).
To change/define target values (i.e. Mean and SD) for the Controls (defined in the
[Quality Control: Control Data] screen) on the [Quality Control] screen, the
following procedure should be followed:
After Quality Control sera are run, the program calculates some parameters which
are displayed under the headings of X-Calculation, X-bar-Calculation and R-
Calculation. These parameters are presented in three rows corresponding to the
Controls of levels A, B, and C respectively. Five parameters namely N, Mean,
SD, %CV and R are presented in five columns. The calculations for these
parameters have been explained below.
X-Calculation - These parameters are obtained from the Control results of the day
for all the three different level of Controls (A, B, and C). The test selection can be
done from the pull-down option {Test Name}. A brief description of the
parameters shown under this heading is given below:
1) N: The total number of runs in the day for the Control for the selected test
2) Mean: Average of the Control results in the day for the selected test
3) SD: Standard Deviation of the Control results in the day for the selected
test
4) %CV: Percent coefficient of variation of the Control results in the day for
the selected test
5) R: Range, that is, the difference between the maximum and minimum
values obtained for that Control during the day for the selected test
X-Bar Calculation - These parameters are obtained from the daily averages of
Control results for the selected test. For the calculation of these parameters, only
last one month’s Control results are considered. The test selection can be done
from the pull-down option {Test Name}. A brief description of the parameters
shown under this heading is given below:
1) N: The total number of days on which Control results of the
Quality Control
corresponding level Control for the selected test were available in the last
one month
2) Mean: Average of daily averages of the results of the corresponding
Control obtained in last one month for the selected test
3) SD: Standard Deviation of the daily averages of the results of the
corresponding Control obtained in last one month for the selected test
4) %CV: Percent coefficient of variation of the daily averages of the results
of the corresponding Control obtained in last one month for the selected
test
5) R: Range, that is, the difference between the maximum and minimum
average values obtained for the corresponding Control during last one
month for the selected test
Range Calculation - These range values are obtained from the daily ranges of
Control results for the selected test. For the calculation of these parameters, only
last one month’s Control results are considered. The test selection can be done
from the pull-down option {Test Name}. A brief description of the parameters
shown under this heading is given below:
1) N: The total number of days on which Control results of the corresponding
level Control for the selected test were available in the last one month
2) Mean: Average of daily ranges of the results of corresponding Control
obtained in last one month for the selected test
3) SD: Standard Deviation of daily ranges of the results of the corresponding
Control obtained in last one month for the selected test
4) %CV: Percent coefficient of variation of the daily ranges of the results of
the corresponding Control obtained in last one month for the selected test
5) R: Range, that is, the difference between the maximum and minimum
range values obtained for the corresponding Control during last one month
for the selected test
Quality Control 5
The other six buttons available on the [Quality Control] screen are:
1. <TESTS>
2. <Daily QC>
3. <Monthly QC>
4. <Twin Plot>
5 <Control Data>
6. <Reports>
5.2 [Quality Control: This screen is used to select an appropriate tests for which the user wants to set or
TESTS] view Control parameters. Forty test names are displayed at a time. Use <Page Up>
and <Page Down> buttons to scroll through the test names. Clicking at any desired
chemistry name will take the user to the [Quality Control] data entry screen for the
corresponding test.
5.3 [Quality Control: The following screen appears if you click on the <Daily QC> button on the
Daily QC] [Quality Control] screen.
Quality Control
Figure 5.2: [Quality Control: Daily QC] screen
This screen gives a graphical presentation of the Control results of the day for the
selected test and Control level. The variation in the results with each run (within
±3 SD) can be monitored on this screen. Last ten results of the day of any Control
serum are displayed. On the Y-axis of the graphical display, the values
corresponding to mean – 3SD, mean – 2SD, mean – 1SD, mean, mean + 1SD,
mean + 2SD and mean + 3SD are shown. The mean and SD are as entered by the
user on the [Quality Control] screen for that particular test and Control level.
To view the Daily QC of any particular chemistry, click on <TESTS> and select
any chemistry from the available choices on the screen by clicking on the test
name. Clicking on the test name will bring you back to [Quality Control: Daily QC]
screen.
6 Quality Control
The pull down option {Control level} allows the user to select Daily QC chart of
A, B or C level Control of the selected test. The Daily QC data can be viewed only
on the day the Control sera are run.
The [Quality Control: Daily QC] screen also shows calculated Mean, calculated SD
(Standard Deviation), calculated %CV (percent Coefficient of variation),
calculated R (the range, which is the difference between the maximum and
minimum test results obtained for the corresponding Control level during the day),
N (number of Control results available which are used for calculation of Mean,
SD, %CV, and R).
5.4 [Quality Control: The following screen appears if you click on the <Monthly QC> button on the
Monthly QC] [Quality Control] screen.
Quality Control
This screen is a graphical representation of the daily means and daily ranges of
Control results. The variations in daily means and daily ranges for any Control
within past 31 days are displayed with dates on which they were run. The upper
plot can be used to monitor the variation in the daily average values of the Control
for the past 31 days. On the y-axis of the upper plot, the mean and SD values are
as entered by the user on the [Quality Control] screen for that particular test and
Control level. The lower plot can be used to view the daily range values of the
Controls. In this plot, the variation in the daily range values (the difference
between the maximum and minimum Control results obtained for the Control on a
day) can be monitored for the Control for past 31 days.
To view the Monthly QC of any chemistry, click on <TESTS> button and select
any chemistry from the available choices on the screen by clicking on the test
name. Clicking on the test name will bring you back to [Quality Control: Monthly
QC] screen. The pull down option {Control level} allows the user to select the QC
chart for A, B or C level Control for the selected test. Range data for a maximum
of 31 days can be stored and displayed for that particular test Item (for the Control
level A, B, or C).
Quality Control 7
The [Quality Control: Monthly QC] screen also shows calculated Mean (Average
of daily averages for the selected level Control over a period of one month), SD
(Standard Deviation of daily averages for the selected level Control over a period
of one month), %CV (percent Coefficient of Variation obtained from the daily
averages of the selected level Control over a period of one month), R (Range of
daily averages, that is, the difference between the maximum and minimum
average values obtained for the selected level Control during last one month), and
N (The total number of days on which the selected Control was run).
5.5 [Quality Control: This screen can be accessed by clicking on <Twin Plot> button on the [Quality
Twin Plot] Control] screen. The display changes to the following screen.
Quality Control
Figure 5.4: [Quality Control: Twin Plot] screen
This feature of Quality Control helps the user to compare the trend in the values of
the different level Controls for any chemistry. It provides a running check on the
linearity of instruments and integrity of calibration. For Twin Plot, two levels of
Control samples with known concentrations are required. The daily averages for
Control level 2 are plotted (on the Y-axis) against the daily averages for Control
level 1 (on the X-axis). The green, red, and black squares on the Twin Plot define
the limits for ±1SD, ±2SD and ±3SD respectively for the two Controls. The daily
averages obtained for one month are shown graphically on the Twin Plot where
each marker depicts the value of the daily mean for level 1 and level 2.
The screen also includes the following details: Period during which the results
were obtained, Name of the Controls, Levels of the Controls (A or B or C), Mean,
and SD as set by the operator, and the calculated Mean (average of daily means)
and calculated SD (standard deviation of daily means) which are calculated by the
software.
To view Twin Plot for any test, use the pull-down option {Test} on the screen to
select the appropriate test. Then, select the Control material name with the pull
down option against {Name} below X-Control and the Y-Control. This allows the
user to view the Twin Plot chart of corresponding Control levels.
8 Quality Control
5.6 [Quality Control: On clicking the <Control Data> button on the [Quality Control] screen, the display
Control Data] changes to the following screen:
This screen is used to add/modify Control Sera names, their levels, and the tests
for which the Controls are meant to run. User can assign an easily identifiable
Quality Control
name to the Controls and its level. Three choices namely, A, B, and C are
available for level selection.
1. Click on the <Add> button on the [Quality Control: Control Data] screen.
2. Enter a Control name.
3. Select the level of this Control A, B or C using the pull-down option.
4. Select the tests either individually by clicking on the test name icons or by
using the <Profile> button to define the tests for which the Control will be
run.
5. Click on the <Save> button.
6. Click on the <Go Back> button. You will reach the [Quality Control]
screen. Update the expected values for the particular test expected for the
Control as described in section 5.1 [Quality Control].
Quality Control 9
5.7 [Quality Control: You can reach this screen by clicking on <Reports> button on [Quality Control]
Reports] screen. There are four options available on this screen.
5.7.1 [Indv Mon] Clicking on <Indv Mon> button on [Quality Control: Reports] screen changes the
display to the following screen:
Quality Control
Figure 5.6: [Quality Control: Reports: Indv Mon] screen
This screen provides a listing of the results for last one month for the selected
Control and selected test. The Control name can be selected in the pull-down
option of {Control} field and the test can be selected in the pull-down option of
{Test} The Control level, mean and SD as fed by the user on [Quality Control]
screen are also displayed.
The QC results are contained in six columns. The values shown in {Sr. No.},
{Date} and {Time} columns are self-explanatory. The other three columns are
explained below:
• Result: This column displays the measured Control value.
• Deviation: This column displays the deviation of the measured
Control result from the mean value fed in the [Quality Control] screen.
• %Error: This column displays the percent error in the measured
result with respect to the preset mean value in the [Quality Control]
screen.
10 Quality Control
5.7.2 [Indv List] Clicking on <Indv List> on the [Quality Control: Reports] screen changes the display
to the following screen:
This screen lists all the results for a particular Control. Use {Control} field to
select the Control for which data are to be displayed. The results of all tests for
Quality Control
that Control level selected are displayed. The QC data are displayed in ten
columns with the information listed below. None of these columns permits
operator entry.
Previously used Controls: This is used for showing the Quality Control
parameters of previously used Control, which have been replaced by a new
Control. To make the view different from the view of present Controls, the
previously used Controls are shown with a “Turquoise” background.
Quality Control 11
5.7.3 [Cuml Mon] Clicking on <Cuml Mon> changes the screen to the following display:
This screen displays the cumulative data of measured Control values for each test.
The Control name can be selected in the pull-down option of {Control} field and
the test can be selected in the pull-down option of {Test}. The Control level, mean
Quality Control
and SD as fed by the user on [Quality Control] screen are displayed.
The QC data are contained in eight columns. The values shown in {Sr. No.},
{Date} and {Time} columns are self-explanatory. The other five columns are
explained below:
• Result: This column displays the measured average value on the day
• N: This column displays the number of runs in the day
• Range: This column displays the difference between the maximum and
the minimum result of the day
• Deviation: This column displays the deviation of the measured mean
shown in {Result} column from the mean value fed in [Quality Control]
screen
• %Error: This column displays the percent error in the measured mean
shown in the {Result} column with respect to the preset mean value in the
[Quality Control] screen.
5.7.4 [Data Reprint] Clicking on <Data Reprint> shows the archive of all the data available for the
Quality Control for the entire month (i.e. the data for individual QC list, Individual
QC Monitor, Cumulative QC Monitor are available together).
12 Quality Control
5.8 Procedure to run 1. Click <Control Data> on the [Quality Control] screen.
a Control
2. Select the Control name with the help of the pull-down option, for which
tests need to be selected. Steps for modifying, adding, and deleting QC
Sera are given below:
3. Click <Go Back> to return to the [Quality Control] Control screen. Click
on <Modify> and then set target Mean and SD values for and click
<Save> to save the data. Do this for each test.
4. Return to the Main Menu screen by clicking <Go Back>. Click on the
[Standardisation] button on the Main Menu screen. Click on <Controls>
Quality Control
button on this screen. Wait for the screen to display the list of available
Controls. Then drag and drop the required Controls on position C1 to C8.
6. Click on <Modify> button and select the tests for analysis by clicking on
the test names. The color of the selected tests change to pink indicating
that they have been selected for analysis.
9. Click on <Go Back> once again, to return to the 'Main Menu Screen'.
Click on the <Run Test> button. On this screen click on <Run Status>
button. On this screen click on <Run Monitor> button. Now click on
<Start Std Run> to start the QC sera analysis (and calibration) on the
analyzer.
10. After the analysis is over, view the updated QC data on the [Quality
Control] screen by clicking on <Quality Control> button on the “Main
Menu Screen”.
Chapter 6
6. Previous Data .................................................................................................................................................. 3
6.1 [Previous Data] ........................................................................................................................................ 3
6.2 [Previous Data: Analyst/Location] ............................................................................................................. 3
6.3 [Previous Data: Backup] .............................................................................................................................. 4
6.3.1 {Previous Data: Backup: Test Parameters} .............................................................................................. 5
6.3.2 {Previous Data: Backup: Patients} ........................................................................................................... 5
6.3.3 {Previous Data: Backup: Standardisation} ............................................................................................... 5
6.3.4 {Previous Data: Backup: Control}............................................................................................................ 5
6.3.5 {Previous Data: Backup: System Switch} ................................................................................................ 5
6.4 [Previous Data: Calculation Item] .............................................................................................................. 6
6.5 Procedure to Enter a Calculation Item .................................................................................................. 8
6.6 [Previous Data: Calibration Monitor]........................................................................................................ 8
6.7 Procedure for modifying the calibration data....................................................................................... 9
6.8 [Previous Data: Calibration Trace] .......................................................................................................... 10
6.9 [Previous Data: Cuvette Blank] ................................................................................................................ 11
6.10 [Previous Data: Database Status] ........................................................................................................... 12
6.11 [Previous Data: Delete Data] ................................................................................................................... 13
6.12 [Previous Data: Doctors List] .................................................................................................................. 14
6.13 [Previous Data: Error Record] ............................................................................................................... 15
6.14 [Previous Data: Offline Entry] ................................................................................................................ 16
6.15 [Previous Data: Patient Report] ............................................................................................................. 17
6.16 [Previous Data: Pending List] ................................................................................................................. 20
6.17 [Previous Data: Print Test Parameters] ................................................................................................. 20
6.18 [Previous Data: Reagent Status] ............................................................................................................. 21
6.19 [Previous Data: Recalculation] ............................................................................................................... 22
6.20 [Previous Data: Rerun List] .................................................................................................................... 23
6.21 [Previous Data: Result Backup].............................................................................................................. 24
6.22 [Previous Data: Result Reprint] ............................................................................................................. 25
6.23 [Previous Data: Serum Indices]............................................................................................................... 27
6.24 [Previous Data: System Switch] .............................................................................................................. 28
6.25 [Previous Data: Test Statistics] ............................................................................................................... 31
6.26 [Previous Data: Time Course] ................................................................................................................ 33
2 Previous Data
Previous Data
Previous Data 3
6. Previous Data
6.1 [Previous Data] When the user clicks on the <Previous Data> button on the Main Menu screen, the
display changes to the following screen:
6.2 [Previous Data: On clicking on the <Analyst/Location> button the following sub-screen is
Analyst/Location] displayed:
Previous Data
This screen can be used to enter Analyst and Location names that can be selected
later in [Patient Entry] screen by means of pull-down options.
4 Previous Data
To add Analyst/Location: Click on the <Add> button on the sub-screen and enter
the Analyst and/or Location and click on the <Save> button on the sub-screen.
6.3 [Previous Data: This screen can be used to take backup of the information fed in the software. The
Backup] backups that can be taken can be categorized as backup for test parameters,
patients’ details, standardisation details, control data and results and system switch.
The user can take backup of any of these as desired. The options available on the
screen are shown in the figure below and are explained in following sub-sections.
Previous Data
For restoring any backed up data, it is necessary that the date format
in System Switch of application software and Regional Settings of
Windows should be the same as were at the time of backup.
The display changes according to the selection and provides necessary guidance to
perform the operation.
Previous Data 5
6.3.1 {Previous Data: There are three options under {Previous Data: Backup: Test Parameters} namely,
Backup: Test Initialise, Backup and Restore. Use these options to initialize test parameters to
Parameters} default parameters and backup/restore test parameters.
{Test Parameters: Initialise}: Use this option to initialize Test Parameters to default
Test Parameters. The user can initialize all the default test parameters or a few
desired test parameters by ticking the desired test name(s).
{Test Parameters: Backup}: Use this option to take a backup of test parameters,
calibration table, and test performance sequence & test icon location order in a
text file. This selection can be further categorized as back up of 1) All tests and 2)
Selected tests only.
{Test Parameters: Restore}: Use this option to restore the test parameters or
calibration table or test performance sequence & test icon location order from a
previously stored backup file.
6.3.2 {Previous Data: This includes two options: Backup and Restore.
Backup: Patients}
{Patients: Backup}: Use this option to save the patients’ demographics in a text
file. The user can select all the Patients or a few patients individually.
{Patients: Restore}: Use this option to restore patient data from a previously stored
backup file.
6.3.3 {Previous Data: This includes two options: Backup and Restore.
Backup:
Standardisation} {Standardisation: Backup}: Use this option to save the details related to calibrator
and control positions in [Standardisation: Positions] screen. The user can select all
calibrator positions or select a few desired positions for backup.
Previous Data
6.3.4 {Previous Data: This includes two options: Backup and Restore.
Backup: Control}
{Control: Backup}: Use this option to save the details related to controls in
[Quality Control] and [Quality Control: Control Data] screens. The user can select
all the control names or select a few desired controls for backup.
{Control: Restore}: Use this option to restore control names and target and SD
values a previously stored backup file. Note that if controls with the same names
exist at the time of restoring old control data, the restored control data are updated
and appended to the existing control data.
6.3.5 {Previous Data: This includes two options: Backup and Restore.
Backup: System
Switch} {Standardisation: Backup}: Use this option to save the details related to [Previous
Data: System Switch] screen.
{Standardisation: Restore}: Use this option to restore System Switch data from a
previously stored backup file.
6 Previous Data
6.4 [Previous Data: This menu enables the user to define a calculation item involving one or more
Calculation Item] chemistries. At least twelve (fixed) calculation formulae are provided for the
calculation of certain supplementary items during the analysis. If these calculation
items are selected in the [Patient Entry] screen, they are printed along with the
result printout. The following screen appears when the user clicks on <Calculation
Item> button on the [Previous Data] screen.
{Calculation Item: Calculation Item Name}: In this field, the name of the
calculation item can be defined. Click on <Add> button to add any new
calculation item. The Calculation Item parameters can be modified and deleted
with the help of <Modify> and <Delete> buttons.
Previous Data
{Calculation Item: Formula}: Select one of the pre-defined formulae for calculation
of results from the pull-down option. The formulae available are:
• A/(B-A)
• A+B
• A-B
• A-B-C
• (A/B)*a + b
• (A-B)/A
• (aA + bB+ cC+ d)
• A/a
• (A/B)*100
• aA + bB+ c
• aA + b
• (A/B)*e*(f/1440)
Previous Data 7
In these formulae, A, B, and C are tests names and a, b, c, and d are user-defined
constants. e is the Body Mass Index of the patient and f is the Urine Volume
collected from the patient in 24 hour, as defined in the Patient Entry. e and f are
required for the calculation of Creatinine Clearance.
{Calculation Item: Test item A/B/C}: Select an appropriate chemistry for A, B, and
C to be used in the Calculation Item using the pull-down option.
{Calculation Item: Unit}: Select/feed the unit to be printed along with the
Calculation Item.
{Calculation Item: Sample}: Select the sample type for which the Calculation Item
will be used. Options available are Serum and Urine.
{Calculation Item: Normal values (Serum)}: Enter normal range for serum sample
(minimum and maximum) for male and female samples considering the age in
years, months and days. In case the age of the patient is not mentioned then the
program compares the patient values with the default values.
{Calculation Item: Urine Values}: Enter normal range for urine sample (i.e., min
and max) for male and female patients.
Previous Data
Procedure to calculate Creatinine Clearance: For Creatinine Clearance
calculation item, the sample type can be kept as Serum in [Previous Data:
Calculation Items] screen. However, the Creatinine Clearance calculation requires
that both serum and urine Creatinine results be available. Since the analyzer’s
application software accepts only one sample for one patient ID, follow the steps
mentioned below to calculate Creatinine Clearance using the formula
(A/B)*e*(f/1440) where e is the Body Mass Index of the patient and f is the Urine
Volume collected from the patient in 24 hour, as defined in the Patient Entry. A
and B are the Creatinine results in Urine and Serum samples respectively.
1. Program a serum sample for the patient and select Creatinine test (among
other tests). Run the serum sample.
2. Once the result for serum Creatinine is available, go to the Patient Entry
of the same patient and change the sample type to Urine. Select
Creatinine test (among other tests) for Urine sample. Additionally, select
the calculation item for Creatinine Clearance. Feed the Body Mass Index
and Urine Volume for the patient and save the Patient Entry.
3. Run the Urine sample with the above selections and entries. The
Creatinine Clearance result will be available during the Urine run.
8 Previous Data
6.5 Procedure to 1. On the [Previous Data: Calculation Item] screen, click on <Add> button.
Enter a Calculation 2. Enter an alphanumeric name in the {Calculation Item Name} field and
Item enter the report name in the adjoining {Report Name} field.
3. Select an appropriate formula from the pull down option {Formula}.
4. Select Test Items A/B/C and units with the help of the pull-down options.
5. Select sample type Serum/Urine by clicking at the bulleted choice.
6. Enter appropriate numeric values for a, b, c, and d. Urine Volume and
Body Mass Index need to be entered in Patient Entry for the particular
patient, if required.
7. Enter expected range of values for serum samples. Values for both male
and female can be specified in three different age groups.
8. Enter expected range of values for urine samples. Values for both male
and female can be specified.
9. Click on <Save> button to save the entered data.
6.6 [Previous Data: This sub-menu enables the user to view the latest calibration details of all tests at
Calibration Monitor] the same time. The following screen is displayed after the user clicks on the
<Calibration Monitor> button on the [Previous Data] Screen.
Previous Data
As the [Calib Table] provides details of only a single calibration (i.e. for a single
chemistry) on the screen, Calibration Monitor can be used to view calibration data
related to all chemistries at the same time. A description of different fields
available on [Previous Data: Calibration Monitor] is given in the table below.
Previous Data 9
6.7 Procedure for If the user intends to modify the calibration data for one or more chemistries like
modifying the concentration, position, absorbances etc. then following steps can be followed:
calibration data
1. Click on <Modify> button in [Previous Data: Calibration Monitor] screen.
2. Click on the desired absorbance or concentration cell in the table to
modify it.
3. Click on <Save> button to save the changes made. The changes made can
be seen in the [Calib Table] screen.
Previous Data
10 Previous Data
6.8 [Previous Data: This sub-menu displays the absorbance values obtained during previous
Calibration Trace] calibrations. The following screen is displayed after the user clicks on the
<Calibration Trace> button on the [Previous Data] Screen.
The pull-down option on the left side of the screen allows the user an option to
select the chemistry (for viewing its calibration Trace). Alternatively, the user can
scroll through various test calibrations by using <Previous> and <Next> buttons.
A description of the fields on the [Previous Data: Calibration Trace] screen is given
below.
{RESULT DATE}: This field displays the date and time of the calibration.
6.9 [Previous Data: This sub menu enables the user to view the cuvette blank absorbance values
Cuvette Blank] (obtained with DI water in the cuvette) at any particular wavelength. The
following screen is displayed after clicking on the <Cuvette blank> button on the
[Previous Data] screen.
The screen displays the cuvette blank for the requested wavelength. Wavelength
can be selected by the pull-down option provided on the left side of the screen.
The <Next> and <Previous> buttons can also be used to view the cuvette blanks
for the next and previous wavelength. The cuvette blank table consists of two
sections.
Previous Data
water measured after the last run or Cuvette Rinse.
{Cuvette Blank: Previous abs}: It is the absorbance of the cuvettes with de-
ionized water measured after the second last run or Cuvette Rinse.
The maximum and minimum acceptable value of the cuvette blank absorbance can
be set in the [Previous Data: System Switch] menu. If the absorbance of the cuvette
blank exceeds the set maximum blank absorbance, then that particular cuvette
absorbance is indicated by Red background. On the other hand, if the absorbance
of the cuvette blank is below the minimum acceptable absorbance, then it is
indicated by Orange background.
The values on the cuvette blank value table display should not exceed 0.1
normally. Cuvette Rinse and/or Cuvette Wash procedure from [Maintenance]
menu must be performed if the cuvette blanks are higher than the maximum limit.
If the cuvette blank for some cuvettes are less than 0.05, the cuvette with
the lowest blank absorbance should be placed at cuvette position 1 in
the reaction tray.
12 Previous Data
6.10 [Previous Data: The following screen is displayed, when the user clicks on <Database Status>
Database Status] button on the [Previous Data] screen.
The screen provides the user information about the used space in the database and
the remaining number of record positions in the database. The details include
information about tests, patients, profiles, controls, calculation items, and doctors
stored in the database.
Patients: Number of patient results stored in the memory of the system, the
availability of storing more records (out of 1000).
Previous Data
Profiles: The number of profiles stored in the system and the number of profiles
available, giving the total number of profiles programmable
Calculation Items: The total number of calculation items that can be programmed,
the number of positions available for programming and the number of calculation
items already programmed in the system
6.11 [Previous Data: This sub menu enables the user to delete redundant data from the database. The
Delete Data] program provides three options, based on the type of data:
a) QC data
b) Patient data
c) ISE (optional) data
The user can choose to delete either individual datum (date wise) or entire data
stored in the database. At the time of deletion, the data are erased from Result
Reprint, Patient Report (when applicable) as well as Quality Control (when
applicable). When the user clicks on the <Delete Data> button on the [Previous
Data] screen, the display changes to the following screen:
{QC Delete}: The QC Delete displays details of, Test name, result, result date and
Previous Data
provides the following options:
Delete Datewise: Deletes patient/ISE (optional) data for that date only.
Patient/ISE details are displayed in the grid.
6.12 [Previous Data: This menu can be used to maintain a list of doctors who refer patient samples to
Doctors List] the laboratory for testing. When the user clicks the <Doctors list> button icon on
the [Previous Data] screen, the following screen is displayed:
To add a doctor’s name in the list, click on the <Add> button. Then enter the
name of the doctor and click on <Save> button. The “Doctorwise Patients}
section can be used to display a list of patients for a particular doctor and result for
a particular patient. In this screen, a patient ID can also be searched. To obtain a
printout of patients referred by any particular doctor, please follow the procedure
as mentioned below:
1. Select doctor name with the help of the pull down option.
2. Select patient from the displayed list or search the patient ID. The
analyzer displays a list consisting of patient ID, investigation, patient’s
Previous Data
6.13 [Previous Data: The following screen appears when the user clicks on <Error Record> button on
Error Record] the [Previous Data] screen.
This screen can be used to view all the errors occurred on the analyzer during the
test run or service check. This data is generally useful for servicing/diagnostic
purposes. The errors can be saved in a text file using the <Save Errors> button.
Options available on this screen are:
1. Date wise
2. Latest Batch
3. Service Check Errors
{Date Wise}: The {Date Wise} report format has three fields that need to be
selected before display of data.
Previous Data
{Date Wise: Date}: The analyzer displays a calendar of the dates; the user
can select the date for which he/she wants to see the error record.
{Date Wise: Batches}: If multiple batches are run during the requested day,
then this pull-down option provides the user a choice to select an appropriate
batch.
{Date Wise: All data}: For any particular date, the analyzer displays all
errors.
{Latest Batch}: The Latest Batch report format projects all errors of the latest
batch run on the analyzer. It displays column wise details including Sr no.,
Mechanical error, Error time, Batch number and Error code.
{Service Check Errors}: Here the errors observed in Service Check menu are
listed.
Note that, separate batch are created for ISE module related errors. Remedial
actions for all error conditions are given in Troubleshooting section of the
Maintenance chapter.
16 Previous Data
6.14 [Previous Data: This menu enables the user to enter data for any patient without having to actually
Offline Entry] perform a test on analyzer. In this case, the application software is simply used to
print the patient report. The following screen is displayed when <Offline Entry>
button is clicked on the [Previous Data] menu.
Click on <Add/Modify > to enter/modify any offline data. The offline result
entries can be made only to the current samples by selecting their patient ID. It is
also possible to search for a particular patient ID. A description of the fields
available on this screen is given in the following table:
{Offline Complete Data}: The analyzer displays all offline entries here. Here,
the entries can also be deleted by selecting entries and clicking at the <Delete>
button.
Previous Data 17
6.15 [Previous Data: The user can obtain patient reports using this sub-menu. Click on <Patient
Patient Report] Report> button on the [Previous data] screen and the display changes to the
following screen:
The following tab options are available to the user on this screen
On each of this tabs, the program displays the following patient and result details:
{Result date}, {Patient ID}, {Patient Name}, {Test}, {Result}, {Unit}, {Flag},
{Normal Range}, {Age}, {Sex}, and {Referred by} details
Previous Data
The user can select the test results and preview the report before printing it. The
patient reports can be printed for one patient ID at a time or for all the patients for
a particular day. To view the patient results for a particular day, select the desired
date from the {Datewise} field. For this particular date, one can choose the
patients by IDs from the {Patient ID} field or can click on the radio button next to
“All data patient report for the day” to print all the patient reports for the day.
By default, all result data which are not “NA” are marked for printing. However,
the user can select the desired data by ticking the tick-button next to the result date.
Please note that although “NA” results are printed, the associated flags are not
printed in the Patient Report. The <Invert Selection> button, inverts the selection;
that is, clicking on this button will unselect all the selected data and select all the
unselected data.
18 Previous Data
{Patient Report: Headings}: Click on the <Headings> button on the [Previous Data:
Patient Report] screen and wait for it to change to the following display.
{Patient report: Print Selected Results} Click on <Selected Results> button. Wait
for the display to change to the following screen.
Previous Data
This screen lists the results that have been selected for printing. The user can edit
the patient result before printing the Patient Report (these changes are stored
permanently in the database; however, the actual results can be viewed in the
[Previous Data: Result Reprint] screen).
Previous Data 19
User can choose to print the report with or without flags. In addition, with the
Condense report format, more results are printed on the same pages and the
headings are repeated on each page of the patient report.
By default, only the result data which are not “NA” are marked for printing. Even
when “NA” results are ticked for printing by the user, the associated flags are not
printed in the Patient Report. Only the following result flags are printed in the
Patient Report: #, AbsLim, Lin.H, Lin.L, H, L, D, I, OutOfRange.L,
OutOfRange.H, Panic.L, Panic.H, P*, PD, RgtAbsMax, RgtAbsMin.
Feed the paper on the printer and click on the <Print> button at the bottom to start
printing of the patient report(s). If you want to have a preview of the results before
printing, click on the <Print Preview> radio button before and clicking on the
<Print> button. The program will display the preview of the patient report(s) as
shown in the figure below:
Previous Data
Figure 6.16: Preview of the Patient Report
Feed the paper on the printer and click on the printer icon to print the report. User
can cancel the printout of the patient report by closing this preview window.
20 Previous Data
6.16 [Previous Data: The following screen is displayed when the user clicks on the <Pending List>
Pending List] button on the [Previous Data] screen:
This screen provides the user a list of tests that are pending due to sample or
reagent absent errors. The user can select the tests that he/she wants to send to the
WorkList and send the selected tests to the WorkList by clicking on the <Rerun>
button.
6.17 [Previous Data: The following screen is displayed when the user clicks on <Print Test Parameters>
Print Test button on the [Previous Data] screen:
Parameters]
Previous Data
This screen can be used to print multiple test parameters at a time. The test
parameters to be printed can be selected by tick marks.
Previous Data 21
6.18 [Previous Data: On clicking on the <Reagent Status> button on the [Previous Data] screen, the
Reagent Status] following screen is displayed:
This sub-menu is useful in viewing the volume status of reagents for all the tests
along with their Batch number, position, and the bottle type (Large/Small/Tube)
Previous Data
Volume (ml): Volume of reagent (in ml)
Size: Bottle size: Large (50 ml) or Small (20 ml) or Tube (5 ml)
6.19 [Previous Data: On clicking the <Recalculation> button on the [Previous Data] screen, the
Recalculation] following screen is displayed:
This sub-menu is useful in recalculating results if any changes are made in the test
parameters or calibration data after analysis. This is particularly useful because
one does not have to rerun a sample if a mistake was made in Test Parameters or
the Calibration Table.
6.20 [Previous Data: Click on the <Rerun List> button on the [Previous Data] screen and the display
Rerun List] changes to the following screen:
This screen enables the user to view the details of tests for which a rerun was
performed. A description of the various columns shown on the screen is given in
the table below:
Previous Data
Reagent Position Position of the reagent for the corresponding test
Sample Replicates Number of sample replicates
Rerun The type of rerun performed (Normal, Decreased,
Increased)
24 Previous Data
6.21 [Previous Data: The following screen is displayed when the user clicks on <Result Backup>
Result Backup] button on the [Previous Data] screen:
This screen is useful to view the backed up patient results. The application
software automatically takes a backup of all the assay results immediately after the
result is available. These backed up results are indexed according to the assay
date. The software also provides the user the choice of viewing the backup data for
a particular Patient ID on a chosen date.
The program displays the following information listed in the table below:
6.22 [Previous Data: Click on the <Result Reprint> button on the [Previous Data] screen and the
Result Reprint] following screen is displayed:
This menu enables the user to retrieve and print the results batchwise or datewise.
For this, two options available on this screen: {Date wise} and {Latest batch}.
The date wise report formatting has three fields that need to be selected before the
results are displayed.
1. Date: User can select the date of choice. Alternately, the user can
enter the date manually using the keyboard.
2. Batches: If more than one batch was run on the selected date, the
pull-down option provides the batch number choices to the user.
Previous Data
Select any appropriate batch and the analyzer immediately displays
the result for the particular batch.
Even among the results displayed, the user has the chose of selecting the results
that he/she wants to print. This selection can be made by ticking the corresponding
patient IDs whose results one wants to print.
The results shown on screen are sorted by Patient ID and then by the time or result.
The results seen on the screen can be printed by clicking on the <Print> button at
the bottom of the screen.
26 Previous Data
The second option available on [Previous Data: Result Reprint] screen is {Latest
Batch}. Clicking on this tab changes the display to the following screen:
This screen displays the results obtained in the last batch (Latest Batch). There are
two options available on this sub-menu: {Sample Position} and {All Data}. Enter
the sample position from the pull-down option. The analyzer immediately displays
the results obtained for that sample position in the last batch. By selecting the All
Data bullet, all the data of the latest batch can be viewed. The data can be printed
by clicking on the <Print> button at the bottom of the screen.
The columns displayed on the {Datewise} and {Latest Batch} tabs are explained
below:
Host Status Indicates whether the result has been sent to Host PC or not.
a. “Sent to Host” indicates that the result was
sent to host successfully
b. “Not sent” indicates that the result has not
been sent to host but can be sent to host
manually
c. No status indicates that the result was
obtained with a flag so the result was not
sent to host. Results having flags D*, S*,
R1*, R2*, Chk Calib, MONO, Panic.H,
Panic.L, Lin.H, Lin.L, AbsLim, P*, SYS!
are not send to host.
Sa pos Sample Position
Test Test name
Result Result of analysis
Unit Unit specified for the chemistry
Result date Date and time of the analysis
Flag Error/Flag obtained with the result, if any
T course Time course number
Previous Data 27
<Send to Host>: This button can be used to send selected patient results to a Host
PC, if available. Select the desired data to be sent to host by ticking the desired
patient result(s).
For sending results to a Host PC using the <Send to Host> button, the
{Host Selection} in the [Previous Data: System Switch] screen should
be set to OFFLINE or ON LINE.
The button <Send to Host> will not be available during run if the
selection {Host Selection} is set to ON LINE.
6.23 [Previous Data: This sub-menu can be obtained by clicking on the <Serum Indices> button on the
Serum Indices] [Previous Data] screen. The screen changes to the following screen:
Previous Data
The screen shows 15 values, which are factory set for the degree of Ictericity,
Lipemia & Hemolysis. The constants set are:
1. SI Parameter TA
2. SI Parameter TB
3. SI Parameter TC
4. SI Parameter HA
5. SI Parameter HB
6. SI Parameter BA
7. SI Parameter L1
8. SI Parameter L2
9. SI Parameter L3
10. SI Parameter H1
11. SI Parameter H2
12. SI Parameter H3
13. SI Parameter I1
14. SI Parameter I2
15. SI Parameter I3
28 Previous Data
6.24 [Previous Data: Click on the <System Switch> button and the display changes to the following
System Switch] screen:
This is one of the most important and useful sub-menu available on the [Previous
Data] screen. This sub-menu allows the user to configure behavior of the analyzer
hardware and application software. Options for printer, bar-code (optional), ISE
(optional), diluent position, test order sequence and test icon placement order etc.
are available to the user.
A description of the options available to the user is given in the table below.
These settings can be modified after clicking on the <Modify> button at the
bottom of the screen.
Item Description
Previous Data
{Level Selection} Select number of levels for Control interval 1-(A), 2-(A,
B), 3-(A, B, C). This selection decides the control sera
that will run for real-time QC (during the patient run as
programmed in the {Test Parameters: Control Interval}
field).
{Host Selection} Set this option to OFF or OFF LINE or ON LINE to
enable or disable bi-directional communication with a
Host PC.
OFF means no connection is present to Host PC
OFF LINE selection will allow the user to send the
results from Analyzer PC to Host PC manually
from the [Previous Data: Result Reprint] screen
ON LINE selection automatically sends the results
from Analyzer PC to Host PC in real-time without
user intervention.
{Temperature This is a (multiplication) correction factor for the
Factor} temperature and corrects the displayed temperature due
to change in settings over time. The default value of this
factor is 1.
{Range ±} This is the maximum deviation allowed in the reaction
tray temperature from 37 0C. A warning is issued on the
[Run Test: Run Status: Run Monitor] screen if this limit is
violated.
{Date Format} Select date format (i.e. dd/mm/yyyy or yyyy/dd/mm or
mm/dd/yyyy. This selection changes the date format
across the database and format of the dates displayed on
various screens of the software.
{Unit ID} This is used as an analyzer ID and is printed at the
beginning of a run in the real-time result report printout.
{Diluent Position} In this field, the diluent position can be defined. This
diluent will be used for sample pre-dilution. If a bar-
coded diluent bottle is to be used, its position will be
updated if it uses the test code 96 of SI
Previous Data
{Diluent Batch} In this field, the batch number of the diluent being used
for dilution of samples can be fed.
{Min/Max Blank Minimum and maximum allowed absorbance of the
Absorbance} cuvette blank can be fed here for monitoring the
cleanliness of the cuvette. Depending on these settings,
the cuvette absorbances outside these absorbances are
marked in different color on the [Previous Data: Cuvette
Blank] screen.
{Std Replicate} This is the number of standard replicates to be used
during calibration. Set this number to 1, 2, or 3.
{Enable This option is to set up the passwords for different levels
password}(Level for the secured use of the analyzer and application
1/2/3/4) software.
Level 1 password is for application start up,
Level 2 is for System Switch,
Level 3 is for Service Check, and
Level 4 is for Test Parameters, Calibration, and QC.
<Change password> This button can be used to change the passwords for
different levels. This button is available only after
clicking on the <Modify> button at the bottom.
<Chemistry This button can be used for defining the sequence in
sequence> which the tests are performed and the position of test
name icons on different screens. A more detailed
description of use of this button is given in the
paragraphs below.
{Query Mode} Set this option to ON/OFF to enable online query from
the PC to LIMS (if any) after a sample with unknown
bar-code ID is found. Such a query is sent after
performing sample bar-code scan. It is necessary for the
Host to be Online for Query Mode to be set to ON.
{Result Send to This option can be set to Send All Results or Stop
Host} Flagged Results to send all results to host and to stop
flagged results from being sent to host respectively. If
you select Send All Results i) All results are send to
host, ii) If a sample goes for rerun, the first as well as the
second result are sent to host, and iii) The control and
standard results are also sent to host.
In this sub-screen, three columns appear namely, {Chemistry}, {Seq. No.} and
{Location}. A description of these is given below.
{Seq. No.}: This column can be used to program the sequence in which the user
wants to run the tests. If the user puts the same sequence number for two tests,
then a warning “Duplicate sequence no.” is issued and the user has to re-enter the
sequence number of the test. The tests are performed in the increasing order of the
sequence number given to the tests. After performing the tests which have a
sequence number assigned, the program performs the tests which do not have an
assigned sequence number (that is the tests for which the sequence number is zero).
The user has to press OK after all the changes are made and can save the changes
by clicking <Save> at the bottom of the screen.
{Location}: This column can be used to program the location order of the test
icons on different screens. The same order is used for all the Test Name pull-down
options too. The order of the test icons in the [Patient Entry: Tests], [Test Parameters:
Tests] and other such screens is set according to the location number assigned by
the user. If the user enters same location number for two tests, then a warning
message ”Duplicate Location no.” appears and the user has to re-enter the location
number of the test. The test icons are placed on screens in the increasing order of
the location number given to the tests. After placing the test icons that have a
location number assigned, the program places the test icons that do not have an
assigned location number (that is the tests for which the location number is zero).
The user has to press OK after all the changes are made and can save the changes
by clicking <Save> at the bottom of the screen.
6.25 [Previous Data: On clicking the <Test Statistics> button on the [Previous Data] screen, the display
Test Statistics] changes to the following screen:
Previous Data
{Test}: Select the test/chemistry name to view its statistics. The program displays
the patients/standards that have been run on the analyzer for that chemistry.
<Sort by Age>: Clicking on this button will display test statistics of patients
within the specified age range in the Min Age and Max Age fields.
{Min Age}: Feed the lower limit age for the age range, if test statistics for a
particular age group are required.
{Max Age}: Feed the upper limit age for the age range, if test statistics for a
particular age group are required.
{Age Unit}: Select the unit of the age fed in the Min Age and Max Age fields.
{Period}: Define the period by choosing “from” and “to” dates to view the results
for a desired duration.
{Patient/Standard}: Using this radio button, select Patient to obtain the details of
patient results or select Standard to obtain standard absorbances for any chemistry.
{Results}: This field is used to display the number of result/absorbance items that
have been selected (tick-marked)
{Average}: This field displays the average of the result/absorbance items that
have been selected (tick-marked)
{Std. Dev}: This field displays the Standard Deviation of the result/absorbance
Previous Data
<Range>: Use this button to define a range of results/absorbances for which you
want to obtain the statistics. This range is of serial numbers given to the results.
<Selective>: Use this button to obtain the statistics for the results/absorbances that
are selected (tick-marked) by the operator.
<Inv. Selection>: Use this button to invert the selection that is made. Clicking on
this button will select the unselected items and vice versa.
{No. of results in normal range}: This field displays the number of results that
were within the normal range defined in the [Test Parameters] screen. If the
normal ranges were not defined at the time of assay, those results are not counted.
Previous Data 33
{No. of results above normal range}: This field displays the number of results
that were above the normal range defined in the [Test Parameters] screen.
{No. of results below normal range}: This field displays the number of results
that were below the normal range defined in the [Test Parameters] screen.
The table on the [Previous Data: Test Statistics] menu displays a list consisting of Sr.
No., Patient ID, Result, Unit, Patient’s Age, Date, and Flag of analysis.
6.26 [Previous Data: Click on the <Time Course> button on the [Previous Data] screen, and the display
Time Course] changes to the following screen:
This screen can be used to view the absorbance course (absorbance vs. time curve)
Previous Data
for any reaction. This can be achieved by entering a time course number in the
{Time Course} field. Time Course number is a number assigned by the program
during analysis and the last 9999 time courses are kept in the database (after which
they are overwritten by the newer ones on a first-in-first-out basis). The time
course number can be obtained from the real-time printout or from the [Previous
Data: Result Reprint] screen. Enter a desired time course number in the field next
to {Time Course} and click on the <Show Timecourse> button to view the time
course of a reaction in any cuvette. The absorbance values for the selected time
course are displayed in a tabular format as well as graphically.
The time course display also contains the following details regarding that Time
Course: ID, Position, Test name, Result, unit, flag, cuvette blank value for both
primary wavelength and secondary wavelengths, and date and time of assay.
There is a table below these details and this table contains the absorbance data.
An explanation of various columns shown in the table is given below:
34 Previous Data
This screen enables the user to view the course of any reaction, as it is occurs in
the cuvette and identify abnormalities (if any). The x-axis contains cycle number
of the reaction and the y-axis contains the absorbance of the reaction mixture.
Previous Data 35
The following options are available to change the time course graphic display:
Span Select the span depending on the reaction. A choice of 0.01, 0.02,
0.05, 0.1, 0.2, 0.5, 1.0, 2.0, 5.0 is available on the screen. This
changes the focus of the reaction to the defined range, allowing a
better view of the reaction. All readings falling below or above
the range are omitted from the graph.
Magnify Click the cursor at the choice, which is indicated by a 'tick' in the
indicator box. Hit <Next> or <Previous> icons on the screen to
view the next or previous time course. Selecting this choice
maximizes the view span. Click at the indicator box once again
and the display changes back to the zoomed-in view of the
reaction.
Previous Data
Chapter 7
7. Maintenance .................................................................................................................................................... 3
7.1 Maintenance and Analyzer Care ............................................................................................................ 3
7.2 [Service Check] ........................................................................................................................................ 9
7.3 [Maintenance] .......................................................................................................................................... 9
7.3.1 {Reset} ............................................................................................................................................. 10
7.3.2 {Photometer}.................................................................................................................................... 10
7.3.3 {Cuvette Rinse} ............................................................................................................................... 10
7.3.4 {Auto Wash} .................................................................................................................................... 11
7.3.5 {Water Save} ................................................................................................................................... 11
7.3.6 {Sample Probe Wash} ...................................................................................................................... 12
7.3.7 {ISE unit} ......................................................................................................................................... 12
7.4 In case of long shutdown ....................................................................................................................... 12
7.5. Troubleshooting .................................................................................................................................... 13
2 Maintenance
Maintenance
Maintenance 3
7. Maintenance
7.1 Maintenance The Clinical Chemistry Analyzer has been designed to require very little user
and Analyzer maintenance compared to the others analyzers of the same class. Regular cleaning
Care and periodic maintenance as per the schedule keeps the analyzer in good working
condition without any trouble. For example, clean the cuvettes externally once every
few months as per the cleaning procedure.
Chart 1 is the maintenance log for operator. This chart should be used as a reference
for performing daily, weekly and monthly maintenance. After performing the
maintenance, it should be recorded in respective column of the Maintenance log.
Regular maintenance of the analyzer will ensure trouble free operation and consistent
quality test results throughout its working. Hence, the user should perform daily
cuvette rinsing.
Maintenance
Maintenance
Signature
Signature
Maintenance
End of the week 1st week 2nd week 3rd week 4th week 5th week
Maintenance
6 Maintenance
2 Stirrer 9 9
5 Halogen Lamp 9 9 9 9
6 25 µ Water filter 9 9 9 9
10 Fuses As needed
1. Maintenance
2.
3.
4.
8 Maintenance
7.2 [Service Check] Select [Service Check] on the main menu screen. The screen changes to the
following display:
Most of the functions are meant for service personnel and are not described here in
detail. Please see Service Manual of the analyzer for details.
7.3 [Maintenance] Select [Maintenance] on the main menu screen. The screen changes to the
following display:
Maintenance
7.3.1 {Reset} This button is used to initialize the analyzer units to their default positions. Click
on <Reset> button to initialize the reaction tray, sample tray, reagent tray, sample
probe, reagent1 probe, reagent2 probe, stirrers, and cuvette-rinsing units to their
“home” positions.
7.3.2 {Photometer} Clicking on <Photometer> button on the [Maintenance] screen brings you to the
following screen:
This screen is useful to view and adjust the photometer gains at different
wavelengths. The analyzer adjusts the photometer gains automatically if one
selects {Auto Span Set} bullet and clicks on <Start> button. Whether the gain is
within the factory set limits or not is indicated by a green or red circle below the
numbers 1 to 12. If the gain at any wavelength is not within the factory set limits,
the circle is filled with red.
7.3.3 {Cuvette Rinse} On clicking on <Cuvette Rinse> button on the [Maintenance] screen, the system
initializes and the cuvette-rinsing unit washes all 60 cuvettes. During cuvette rinse,
the detergent in the detergent can is used to clean the cuvette.
The procedure should be done daily before the starting the batch.
Maintenance 11
7.3.4 {Auto Wash} Auto Wash option can be used instead of the Cuvette Rinse option, when operator
wants to use external detergents/solutions to clean the cuvettes, sample and
reagent probes, and stirrers. Usually 1 M HCl and 1 M NaOH solutions can be
used for this procedure. However, any other detergent or cleaning solution in
appropriate concentration can be used. These detergents/solutions are not kept in
the detergent can but in reagent bottles on the reagent tray and in sample tubes on
the sample tray.
7.3.5 {Water Save} This option can be used to fill all the 60 cuvette with DI water. Overnight filling
Maintenance
of the cuvettes with DI water is helpful in loosening the dirt on the cuvette walls.
On clicking on <Water Save> button on the [Maintenance] screen, the analyzer
first washes all the 60 cuvettes with the detergent in the detergent can. Then using
the reagent1 probe, the analyzer fills water in all the 60 cuvettes. This water
remains in the cuvettes until the next run or cuvette wash/rinse.
7.3.6 {Sample Probe This option is to enable the operator to wash the sample probe with some cleaning
Wash} solution at the end of a day’s work. Clicking on this button prompts the user to put
500 µl of a cleaning solution at the ISE2 position in the Standard Tray. Once the
user clicks on <OK>, the sample probe picks up about 60 µl of cleaning solution
and dispenses it in the drain in micro jets. It performs this action 5 times. The ISE
cleaning solution itself is recommended for this cleaning but other cleaning
solutions such as 1% to 2% Sodium Hypochlorite can be used for this purpose.
After the sample probe wash with cleaning solution, the probe is washed internally
and externally with water to remove traces of cleaning solution.
7.3.7 {ISE unit} This option is available only when Ion Selective Electrode unit (optional) is
installed on the analyzer to perform routing maintenance, purging, cleaning and
calibration on the ISE unit.
7.4 In case of long If the analyzer is not likely to be used for more than two days, please follow the
shutdown following procedure before the long shutdown as well as after the first startup after
the long shutdown:
7.5. Troubleshooting
Error
Error Description Possible Failures Checks and Corrective Actions
Code
Instrument not • Wrong PC Com port 9 Make sure that a correct port has
responding selection for analyzer. been selected in [Service Check:
• Problem in PC Communication] screen
Communication cable 9 Make sure the continuity of the
• RS 232 isolator board RS 232 communication cable
• Problem in RCT rotation between Analyzer and PC
9 Change RS 232 isolator PCB.
9 Check whether RCT is rotating
during initialization or not
9 Contact Service Engineer
A00 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal R2PT arm by hand and make
Reagent Inner Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
A10 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal R2PT arm by hand and make
Reagent Outer R2PT • Steparm card and its sure that nothing is obstructing
Rotation connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
A20 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Reagent to signal R2PT arm by hand and make
Cuvette Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
A30 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Cuvette to Drain signal R2PT arm by hand and make
Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
A80 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Drain to Trough signal R2PT arm by hand and make
Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
A90 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Initialization signal R2PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
A92 R2PT Up/Down • R2PT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error during arm optos R2PT arm up and down by hand
Initialization • R2PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 2 Arm] menu; Give <Initialize>
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
A94 R2PT Rotational Error • R2PT obstacle opto 9 Check the Reagent 2 arm
during Initialization due • R2PT probe assembly alignment through [Service
to Obstacle in R2PT and its spring action Check]. If it is hitting at the
Path edge of the reagent bottle, then
align the probe using calibrate
facility
9 Remove the cover of the
Reagent 2 arm and check and
clean obstacle opto
9 Check Reagent 2 probe spring
and its total assembly
9 Call Service Engineer
C00 RGT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Initialization RGT tray RGT by hand and make sure
• Stepper motor and its that nothing is obstructing the
connections rotation
• Steptray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Reagent
• Sen3 PCB and its Tray] menu; Give <Initialize>
connector command.
9 If initialization fails, call Service
Engineer
C01 RGT Rotational Error • R1 or R2 arm is down in 9 Check whether R1 and R2 arms
during Initialization due RGT tray are down in RGT tray
to R1 or R2 Arm Down • R1 or R2 arm opto is 9 Switch OFF the instrument;
giving wrong signal Bring R1 and R2 arms to their
home positions and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
C20 RGT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Rotate_1 RGT tray RGT by hand and make sure
Command Execution • Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Reagent
• Tray] menu; Give <Initialize>
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
C30 RGT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Rotate_50 RGT tray RGT by hand and make sure
Command Execution • Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Reagent
• Sen3 PCB and its Tray] menu; Give <Initialize>
connector command.
9 If initialization fails, call Service
Engineer
C31 RGT Rotational Error • R1 or R2 arm is down in 9 Check whether R1 and R2 arms
due to R1 or R2 Arm RGT tray are down in RGT tray
Down during Rotate_50 • R1 or R2 arm opto is 9 Switch OFF the instrument;
Command Execution giving wrong signal Bring R1 and R2 arms to their
home positions and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
C40 RGT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Link Mode RGT RGT by hand and make sure
• Mechanical setting of that nothing is obstructing the
POS1 opto PCB rotation
• Stepper motor and its 9 Then, switch ON the instrument;
connections Go to [Service Check: Reagent
• Step-tray card and its Tray] menu; Give <Initialize>
connector command.
• Sen3 PCB and its 9 If initialization fails, call Service
connector Engineer
C41 RGT Rotational Error • R1 or R2 arm is down in 9 Check whether R1 and R2 arms
due to R1 or R2 Arm RGT tray are down in RGT tray
Down during Link • R1 or R2 arm opto is 9 Switch OFF the instrument;
Mode giving wrong signal Bring R1 and R2 arms to their
home positions and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
Maintenance
C50 RGT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Barcode Scan RGT RGT by hand and make sure
• Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Reagent
• Sen3 PCB and its Tray] menu; Give <Initialize>
connector command.
9 If initialization fails, call Service
Engineer
Maintenance 17
Error
Error Description Possible Failures Checks and Corrective Actions
Code
C51 RGT Rotational Error • R1 or R2 arm is down in 9 Check whether R1 and R2 arms
due to R1 or R2 Arm RGT tray are down in RGT tray
Down during Barcode • R1 or R2 arm opto is 9 Switch OFF the instrument;
Scan giving wrong signal Bring R1 and R2 arms to their
home positions and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
C80 RGT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
During Run RGT tray RGT by hand and make sure
• Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Reagent
• Sen3 PCB and its Tray] menu; Give <Initialize>
connector command.
9 If initialization fails, call Service
Engineer
D00 RCT Rotational Error • Three POS1 opto 9 Switch OFF the analyzer; Rotate
during Initialization assembly of RCT RCT by hand and make sure
• Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then switch ON the instrument;
connector Go to [Service Check: CRU &
• Sen3 PCB and its Reaction Tray] menu; Give
connector <Initialize> command
9 If initialization fails, otherwise
call Service Engineer
D01 RCT Rotational Error • Any arm is down in 9 Check whether any arm is down
due to Arm Down RCT tray in RCT
during Initialization • Arm optos are giving 9 Switch OFF the instrument;
wrong signal Bring sample, R1 and R2 arms
to their home positions and then
switch ON the instrument
9 If still it is giving error, call
Service Engineer
Maintenance
D30 RCT Rotational Error • Three POS1 opto 9 Switch OFF the analyzer; Rotate
During Rotate_50 assembly of RCT RCT by hand and make sure
Command Execution • Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then switch ON the instrument;
connector Go to [Service Check: CRU &
• Sen3 PCB and its Reaction Tray] menu; Give
connector <Initialize> command
9 If initialization fails, otherwise
call Service Engineer
18 Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
D31 RCT Rotational Error • Any arm is down in 9 Check whether any arm is down
due to Arm Down RCT tray in RCT
during Rotate_50 • Arm optos are giving 9 Switch OFF the instrument;
Command Execution wrong signal Bring sample, R1 and R2 arms
to their home positions and then
switch ON the instrument
9 If still it is giving error, call
Service Engineer
D40 RCT Rotational Error in • Three POS1 opto 9 Switch OFF the analyzer; Rotate
Link Mode assembly of RCT RCT by hand and make sure
• Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then switch ON the instrument;
connector Go to [Service Check: CRU &
• Sen3 PCB and its Reaction Tray] menu; Give
connector <Initialize> command
9 If initialization fails, otherwise
call Service Engineer
D41 RCT Rotational Error • Any arm is down in 9 Check whether any arm is down
due to Arm Down RCT tray in RCT
during Link Mode • Arm optos are giving 9 Switch OFF the instrument;
wrong signal Bring sample, R1 and R2 arms
to their home positions and then
switch ON the instrument
9 If still it is giving error, call
Service Engineer
D52 CRU Up/Down • CRU POS1 opto signal 9 Switch OFF the analyzer; Move
Movement Error during • RCT POS1 opto signals CRU up and down by hand and
Initialization • Step-tray card and its make sure that nothing is
connector obstructing the CRU movement
• Stepper motor and its 9 Then switch ON the instrument;
connections Go to [Service Check: CRU &
Reaction Tray] menu; Give
<Initialize> and <Up/down>
commands
9 If the initialization or up/down
movement fails, otherwise call
Maintenance
Service Engineer
D53 CRU–RCT Alignment • CRU POS1 opto signal 9 Check RCT and CRU alignment
Error during • RCT POS1 opto signals 9 Initialize CRU as well as RCT
Initialization • Step-tray card and its through [Service Check] menu
connector 9 Switch OFF the instrument and
• Stepper motor and its then switch ON the instrument
connections 9 If still it is giving error call
Service Engineer
Maintenance 19
Error
Error Description Possible Failures Checks and Corrective Actions
Code
D62 CRU Up Movement • CRU POS1 opto signal 9 Switch OFF the analyzer; Move
Error • Step-tray card and its CRU up and down by hand and
connector make sure that nothing is
• Stepper motor and its obstructing the CRU movement
connections 9 Then switch ON the instrument;
Go to [Service Check: CRU &
Reaction Tray] menu; Give
<Initialize> and <Up/down>
commands
9 If the initialization or up/down
movement fails, otherwise call
Service Engineer
D72 CRU Down Movement • CRU POS1 opto signal 9 Switch OFF the analyzer; Move
Error • RCT POS1 opto signals CRU up and down by hand and
• Step-tray card and its make sure that nothing is
connector obstructing the CRU movement
• Stepper motor and its 9 Then switch ON the instrument;
connections Go to [Service Check: CRU &
Reaction Tray] menu; Give
<Initialize> and <Up/down>
commands
9 If the initialization or up/down
movement fails, otherwise call
Service Engineer
D73 CRU Down Movement • RCT POS1 opto signals 9 Initialize RCT and check RCT
Error Due to RCT • Step-tray card and its and CRU alignment
misalignment connector 9 If still it is giving error, call
• Stepper motor and its Service Engineer
connections
D82 CRU Up/Down • CRU POS1 opto signal 9 Switch OFF the analyzer; Move
Movement Error in • RCT POS1 opto signals CRU up and down by hand and
Link Mode • Step-tray card and its make sure that nothing is
connector obstructing the CRU movement
• Stepper motor and its 9 Then switch ON the instrument;
connections Go to [Service Check: CRU &
Reaction Tray] menu; Give
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
E00 RCT Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Run RCT tray RCT by hand and make sure
• Stepper motor and its that nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then switch ON the instrument;
connector Go to [Service Check: CRU &
• Sen3 PCB and its Reaction Tray] menu; Give
connector <Initialize> command
• Arms are down in RCT 9 If initialization fails, otherwise
call Service Engineer
E02 CRU Up/Down Error • RCT alignment 9 Switch OFF the analyzer; Move
• Step-tray card and its CRU up and down by hand and
connector make sure that nothing is
• Sen3 PCB and its obstructing the CRU movement
connector 9 Then switch ON the instrument;
• Stepper motor and its Go to [Service Check: CRU &
connections Reaction Tray] menu; Give
<Initialize> and <Up/down>
commands
9 If the initialization or up/down
movement fails, otherwise call
Service Engineer
E03 CRU Down Movement • RCT alignment 9 Switch OFF the analyzer; Check
Error due to RCT • Step-tray card and its RCT and CRU alignment
Rotation connector 9 Switch ON the instrument;
• Sen3 PCB and its Initialize CRU as well as RCT
connector in [Service Check]
• Stepper motor and its 9 If still it is giving error, call
connections Service Engineer
3B0 Stirrer Rotational Error • POS1 opto PCB 9 Switch OFF the analyzer; Rotate
during Initialization • Step-tray card and its stirrers by hand and make sure
connector that nothing is obstructing the
• Stepper motor rotation
9 Then switch ON the instrument;
Go to [Service Check: Stirrers]
menu; Give <Initialize> and
<Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
Maintenance 21
Error
Error Description Possible Failures Checks and Corrective Actions
Code
3B2 Stirrer Up/Down • POS1 up opto PCB 9 Switch OFF the analyzer; Move
Movement Error during • Step-tray card and its stirrers up and down by hand
Initialization connector and make sure that nothing is
• Stepper motor obstructing the movement
• RCT alignment 9 Then switch ON the instrument;
Go to [Service Check: Stirrers]
menu; Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
302 Stirrer Up Movement • POS1 up opto PCB 9 Switch OFF the analyzer; Move
Error • Step-tray card and its stirrers up and down by hand
connector and make sure that nothing is
• Stepper motor obstructing the movement
• RCT alignment 9 Then switch ON the instrument;
Go to [Service Check: Stirrers]
menu; Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
313 Stirrer Down • RCT alignment 9 Give RCT offset command and
Movement Error • RCT is not at offset try the same action
condition or RCT 9 If still it is giving error, call
alignment is not proper Service Engineer
Error
Error Description Possible Failures Checks and Corrective Actions
Code
Error
Error Description Possible Failures Checks and Corrective Actions
Code
421 ASP Rotational Error • Sample arm is down at 9 Check whether sample arm is
due to Sample Arm ASP tray down in ASP tray
Down during Rotate_1 • SPT arm opto is giving 9 Switch OFF the instrument;
Command Execution wrong signal Bring the sample arm to its
home position and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
430 ASP Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Rotate_50 ASP stepper motor and ASP by hand and make sure that
Command Execution its connections nothing is obstructing the
• Step-tray card and its rotation
connector 9 Then, switch ON the instrument;
• Sen3 PCB and its Go to [Service Check: Sample
connector Tray] menu; Give <Initialize>
command.
9 If initialization fails, call Service
Engineer
431 ASP Rotational Error • Sample arm is down in 9 Check whether sample arm is
due to Sample Arm ASP tray down in ASP tray
Down during Rotate_50 • SPT arm opto is giving 9 Switch OFF the instrument;
Command Execution wrong signal Bring the sample arm to its
home position and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
440 ASP Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Link Mode ASP ASP by hand and make sure that
• Mechanical setting of nothing is obstructing the
POS1 opto PCB rotation
• Stepper motor and its 9 Then, switch ON the instrument;
connections Go to [Service Check: Sample
• Step-tray card and its Tray] menu; Give <Initialize>
connector command.
• Sen3 PCB and its 9 If initialization fails, call Service
connector Engineer
Maintenance
441 ASP Rotational Error • Sample arm is down in 9 Check whether sample arm is
due to Sample Arm ASP tray down in ASP tray
Down in Link Mode • SPT arm opto is giving 9 Switch OFF the instrument;
wrong signal Bring the sample arm to its
home position and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
24 Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
450 ASP Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Barcode Scan ASP ASP by hand and make sure that
• Stepper motor and its nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Sample
• Sen3 PCB and its Tray] menu; Give <Initialize>
connector command.
9 If initialization fails, call Service
Engineer
451 ASP Rotational Error • Sample arm is down in 9 Check whether sample arm is
due to Sample Arm ASP tray down in ASP tray
Down during Barcode • SPT arm opto is giving 9 Switch OFF the instrument;
Scan wrong signal Bring the sample arm to its
home position and then switch
ON the instrument.
9 If still it is giving error, call
Service Engineer
460 ASP Rotational Error • POS1 opto assembly of 9 Switch OFF the analyzer; Rotate
during Run ASP ASP by hand and make sure that
• Stepper motor and its nothing is obstructing the
connections rotation
• Step-tray card and its 9 Then, switch ON the instrument;
connector Go to [Service Check: Sample
• Sen3 PCB and its Tray] menu; Give <Initialize>
connector command.
• Sample arm is down in 9 If initialization fails, call Service
ASP tray Engineer
• SPT arm opto is giving
wrong signal
5A5 SPT Syringe Up/Down • POS1 opto card 9 Switch OFF the analyzer; Move
Movement Error • Step-tray card and its the Sample syringe up and down
connector by hand and make sure that
• Syringe up/down motor nothing is obstructing the
movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
5E2 SPT Up/Down • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos SPT arm up and down by hand
• SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
5F0 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during ISE Sample signal SPT arm by hand and make sure
Dispense • Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
5F2 SPT Up/Down • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos SPT arm up and down by hand
• SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
5F4 SPT VOD Error • SPT obstacle opto 9 Check whether the selected
• SPT probe assembly and option is tube and instead of
its spring action or tube a cup has been kept
because of any obstacle 9 Check the sample arm
alignment in [Service Check]. If
Maintenance
or misalignment
it is hitting at the edge of the
sample cup or tube, align the
probe using the calibrate facility
9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
9 Call Service Engineer
26 Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
SPT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
5F5 • Steparm card and its the Sample syringe up and down
connector by hand and make sure that
• Syringe motor nothing is obstructing the
movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu; Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
5F6 ISE Sample Absent • Sample is not kept or 9 Place the sample in the sample
sample tube or cup tray at the required position
misplaced 9 Call Service Engineer
• LLS circuit and its
connector problem
5F9 SPT Probe Shorted • The distance between 9 Clean the dual probe and dry it
dual sample probe is not
proper so it is holding
liquid
522 SPT Up/Down • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos SPT arm up and down by hand
• SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
523 SPT Down Movement • SPT POS1 up opto 9 Switch OFF and then switch ON
Error Due to RCT/ASP signals the instrument
Rotating • ASP/RCT tray are 9 If still it is giving error, call
rotating or their optos Service Engineer
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
524 SPT Down Error due to • SPT obstacle opto and 9 Check whether the selected
Obstacle in SPT Path arm optos sample container is tube and
• SPT probe assembly and instead of tube, a cup has been
its spring action or any kept
obstacle 9 Check the sample arm
alignment through [Service
Check] menu. If it is hitting at
the edge of the sample cup or
tube, then align the probe using
the probe calibration facility
9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
9 Call Service Engineer
526 SPT Down Error due to • Sample probe goes 9 Place the sample in the sample
Sample Absent down but doesn’t find tray at the required position
LLS signal due to 9 If still it is giving error, call
problem in LLS card or Service Engineer
its connector
• Sample absent
532 SPT Up/Down • SPT POS1 up opto 9 Switch OFF the analyzer; Move
Movement Error signals SPT arm up and down by hand
• Steparm card and its and make sure that nothing is
connector obstructing SPT movement
• Up/down stepper motor 9 Then switch ON the instrument;
and its connections Go to [Service Check: Sample
Arm] menu; Give <Initialize>
and <Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
545 SPT Syringe • Syringe opto signal 9 Switch OFF the analyzer; Move
Initialization Error. • Steparm card and its the Sample syringe up and down
connector by hand and make sure that
•
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
550 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Initialization signal SPT arm by hand and make sure
• Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
Stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
552 SPT Up/Down Error • SPT obstacle opto and 9 Switch OFF the analyzer; Move
during Initialization arm optos SPT arm up and down by hand
• SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
554 SPY Obstacle Error • SPT obstacle opto and 9 Check the sample arm
during Initialization arm optos alignment at trough position If it
• SPT probe assembly and is hitting at the edge of the
its spring action or any trough, then align the probe.
obstacle 9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
9 Call Service Engineer
555 SPT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
during Initialization • Steparm card and its the Sample syringe up and down
connector by hand and make sure that
• Syringe motor nothing is obstructing the
movement
9 Then switch ON the instrument;
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
560 SPT Link Halted due to • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
SPT Rotational Error signal SPT arm by hand and make sure
• Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
562 SPT Link Halted due to • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Up/Down Movement arm optos SPT arm up and down by hand
Error of SPT • SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
564 SPT Link Halted due to • SPT obstacle opto and 9 Check the sample arm
Obstacle in SPT Path arm optos alignment, through Service
• SPT probe assembly and Check. If it is hitting at the edge
its spring action of the sample cup or tube, then
align the probe using calibrate
facility
9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
9 Call Service Engineer
566 SPT Link Halted due to • Sample absent 9 Place the sample in the sample
Sample Absent • LLS connection tray at the required position
9 If still it is giving error, call
Service Engineer
Maintenance
570 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
signal SPT arm by hand and make sure
• Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
30 Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
572 SPT Up/Down • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos SPT arm up and down by hand
• SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
573 SPT Up/Down • ASP/RCT tray are 9 Switch OFF and then switch ON
Movement Error due to rotating or their optos the instrument
Sample/Reaction Tray are giving false signal 9 Initialize ASP/RCT as well as
Rotation • Steptray and Steparm Sample Arm again in [Service
card and its connector Check]
9 If still it is giving error, call
Service Engineer
574 SPT VOD Error • SPT obstacle opto 9 Check whether the selected
• SPT probe assembly and option is tube and instead of
its spring action or tube a cup has been kept
because of any obstacle 9 Check the sample arm
alignment in [Service Check]. If
it is hitting at the edge of the
sample cup or tube, then align
the probe using the calibrate
facility.
9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
9 Call Service Engineer
575 SPT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
• Steparm card and its the Sample syringe up and down
connector by hand and make sure that
• Syringe motor nothing is obstructing the
Maintenance
movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu; Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
Maintenance 31
Error
Error Description Possible Failures Checks and Corrective Actions
Code
576 Sample Absent • Sample is not kept or 9 Place the sample in the sample
sample tube or cup tray at the required position
misplaced 9 Call Service Engineer
• LLS circuit and its
connector problem
577 SPT syringe volume • Wrong volume entry 9 Make sure that the sample
error volume in Test Parameters of
the application software is
within range
579 SPT Probe Shorted • The distance between 9 Clean the dual probe and dry it
dual sample probe is not
proper so it is holding
liquid
580 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
signal SPT arm by hand and make sure
• Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
582 SPT Up/Down • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos SPT arm up and down by hand
• SPT probe assembly and and make sure that nothing is
its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Up/down and rotation Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
584 SPT VOD Error • SPT obstacle opto 9 Check the sample arm
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
585 SPT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
• Steparm card and its the Sample syringe up and down
connector by hand and make sure that
• Syringe motor nothing is obstructing the
movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu; Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
586 Sample Absent • Sample is not kept or 9 Place the sample in the sample
sample tube or cup tray at the required position
misplaced 9 Call Service Engineer
• LLS circuit and its
connector problem
587 SPT Syringe Volume • Wrong volume entry 9 Make sure that the sample
Error through text file volume in Test Parameters of
the application software is
within range
589 SPT Probe Shorted • The distance between 9 Clean the dual probe and dry it
dual sample probe is not
proper so it is holding
liquid
594 SPT VOD Error • SPT obstacle opto 9 Check the sample arm
• SPT probe assembly and alignment in dilution cuvette in
its spring action or [Service Check] menu. If it is
because of any obstacle hitting at the edge of the cuvette,
or misalignment align the probe using the
calibrate facility
9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
6A0 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Initialization signal SPT arm by hand and make sure
• Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
6A2 SPT Up/Down • SPT obstacle opto 9 Switch OFF the analyzer; Move
Movement Error during • SPT probe assembly and SPT arm up and down by hand
Initialization its spring action and make sure that nothing is
• Steparm card and its obstructing SPT movement
connector 9 Then switch ON the instrument;
• Up/down and rotation Go to [Service Check: Sample
stepper motor and its Arm] menu; Give <Initialize>
connections and <Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
6A4 Obstacle in SPT Path • SPT obstacle opto 9 Check the sample arm
during Initialization • SPT probe assembly and alignment in [Service Check]. If
its spring action it is hitting/stuck at the edge of
the trough, switch OFF the
analyzer and free the arm.
Then, switch ON the analyzer
9 Remove the cover of the sample
arm and check and clean
obstacle opto
9 Check SPT probe spring and its
total assembly
9 Call Service Engineer
6B0 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Dilution Cuvette signal SPT arm by hand and make sure
to Sample Cuvette • Steparm card and its that nothing is obstructing SPT
Rotation rotation
Maintenance
connector
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
34 Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
600 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal SPT arm by hand and make sure
Sample Outer Rotation • Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
610 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal SPT arm by hand and make sure
Sample Inner Rotation • Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
620 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal SPT arm by hand and make sure
Standard Outer • Steparm card and its that nothing is obstructing SPT
Rotation connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
630 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal SPT arm by hand and make sure
Standard Inner Rotation • Steparm card and its that nothing is obstructing SPT
Error connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
640 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Sample to signal SPT arm by hand and make sure
Cuvette Rotation • Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
650 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Sample to ISE signal SPT arm by hand and make sure
Sample Port Rotation • Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
660 SPT Rotational Error • SPT POS1 up opto 9 Switch OFF the analyzer; Rotate
during ISE to Drain signal SPT arm by hand and make sure
Rotation • Steparm card and its that nothing is obstructing SPT
connector rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Sample
connections Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
682 SPT up/Down • SPT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error during arm optos SPT arm up and down by hand
Cuvette to Drain • SPT probe assembly and and make sure that nothing is
Rotation. its spring action obstructing SPT movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Sample
• Arm] menu; Give <Initialize>
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
722 R1PT Down Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Move
signal R1PT arm up and down by hand
• Steparm card and its and make sure that nothing is
connector obstructing the movement
• Up/down Stepper motor 9 Then switch ON the instrument;
and its connections Go to [Service Check: Reagent
1 Arm] menu; Give <Initialize>
and <Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
723 R1PT Down Error due • R1PT POS1 up opto 9 Initialize RGT and give offset
to RGT/RCT Rotating signals RCT; Try the desired action
• RGT/RCT tray are 9 Switch OFF and switch ON the
rotating or their optos instrument
are giving false signal 9 If still it is giving error, call
• Steptray and Steparm Service Engineer
card and its connector
724 Obstacle in R1PT Path • R1PT obstacle opto and 9 Check the Reagent 1 arm
during Down arm optos alignment through [Service
Movement • R1PT probe assembly Check]. If it is hitting at the
and its spring action edge of the reagent bottle, then
• Steparm card and its align the probe using probe
connector calibration facility.
9 Remove the cover of the
Reagent 1 arm and check and
clean obstacle opto
9 Check Reagent 1 probe spring
and its total assembly
9 Call Service Engineer
726 R1PT Down Error due • R1 probe goes down but 9 Place Reagent in the reagent
to Reagent Absent doesn’t find LLS signal tray at the required position
due to problem in LLS 9 If still it is giving error, call
card or its connector Service Engineer
• Reagent absent
732 R1PT Up/Down Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Move
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
745 R1PT Syringe • POS1 opto card 9 Switch OFF the analyzer; Move
Up/Down Movement • Step-tray card and its Reagent 1 syringe up and down
Error connector by and make sure that nothing is
• Syringe up/down motor obstructing the movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu, Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
750 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Initialization signal R1PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
752 R1PT Up/Down Error • R1PT obstacle opto and 9 Switch OFF the analyzer; Move
during Initialization arm optos R1PT arm up and down by hand
• R1PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 1 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
754 R1PT Obstacle Error • R1PT obstacle opto and 9 Check the Reagent 1 arm
during Initialization arm optos alignment at trough position. If
• R1PT probe assembly it is hitting at the edge of the
and its spring action trough, then align the probe.
• 9 Remove the cover of the
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
755 R1PT Syringe Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Do
during Initialization signal up/down of R1PP syringe by
• Steparm card and its hand and make sure that nothing
connector is obstructing the up/down
• Up/down and rotation movement
stepper motor and its 9 Then switch ON the instrument;
connections Go to [Service Check: Reagent
1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
760 R1PT Link Halted due • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
to Rotational Error signal R1PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
Stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
762 R1PT Link Halted due • R1PT obstacle opto and 9 Switch OFF the analyzer; Move
to Up/Down Movement arm optos R1PT arm up and down by hand
Error • R1PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 1 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
764 R1PT Link Halted due • R1PT obstacle opto and 9 Check the Reagent 1 arm
to Obstacle in R1PT arm optos alignment through [Service
Path • SPT probe assembly and Check]. If it is hitting at the
its spring action edge of the reagent bottle, then
align the probe using probe
Maintenance
calibration facility.
9 Remove the cover of the
Reagent 1 arm and check and
clean obstacle opto
9 Check Reagent 1 probe spring
and its total assembly
9 Call Service Engineer
766 R1PT Link Halted due • Reagent absent 9 Place Reagent in the reagent
to Reagent Absent tray at the required position
9 If still it is giving error, call
Service Engineer
Maintenance 39
Error
Error Description Possible Failures Checks and Corrective Actions
Code
770 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Reagent Pickup signal R1PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
772 R1PT Up/Down • R1PT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos R1PT arm up and down by hand
• R1PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 1 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
774 R1PT VOD Error • R1PT obstacle opto 9 Check the Reagent 1 arm
during Reagent Pickup • R1PT probe assembly alignment, in [Service Check].
and its spring action If it is hitting at the edge of the
• Any other obstacle in the reagent bottle, align the probe
down path of the probe using the calibrate facility
9 Remove the cover of the
Reagent 1 arm and check and
clean obstacle opto
9 Check Reagent 1 probe spring
and its total assembly
9 Call Service Engineer
775 R1PT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
during Reagent Pickup • Steparm card and its Reagent 1 syringe up and down
connector by and make sure that nothing is
• Syringe motor obstructing the movement
9 Then switch ON the instrument;
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
777 R1PT Syringe Volume • Wrong volume entry 9 Make sure that the Reagent 1
Error volume in Test Parameters of
the application software is
within range
779 R1 Probe Shorted • The distance between 9 Clean the dual probe and dry it
during Reagent Pickup dual sample probe is not
proper so it is holding
liquid
780 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Reagent signal R1PT arm by hand and make
Dispense • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
782 R1PT Up/Down • R1PT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos R1PT arm up and down by hand
• R1PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 1 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
784 R1PT VOD Error • R1PT obstacle opto 9 Check the Reagent 1 arm
during Reagent • R1PT probe assembly alignment, in [Service Check].
Dispense and its spring action If it is hitting at the edge of the
• Any other obstacle in the reagent bottle, align the probe
down path of the probe using the calibrate facility
9 Remove the cover of the
Reagent 1 arm and check and
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
785 R1PT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
during Reagent • Steparm card and its Reagent 1 syringe up and down
Dispense connector by and make sure that nothing is
• Syringe motor obstructing the movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu, Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
787 R1PT Syringe Volume • Wrong volume entry 9 Make sure that the Reagent 1
Error volume in Test Parameters of
the application software is
within range
789 R1 Probe Shorted • The distance between 9 Clean the dual probe and dry it
during Reagent Pickup dual sample probe is not
proper so it is holding
liquid
800 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal R1PT arm by hand and make
Reagent Inner Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
810 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Trough to signal R1PT arm by hand and make
Reagent Outer Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
840 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Cuvette to Drain signal R1PT arm by hand and make
Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
850 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Drain to trough signal R1PT arm by hand and make
Rotation • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
860 R1PT Rotational Error • R1PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Initialization signal R1PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
Stepper motor and its Go to [Service Check: Reagent
connections 1 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
862 R1PT Up/Down • R1PT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error during arm optos R1PT arm up and down by hand
Initialization • R1PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 1 Arm] menu; Give <Initialize>
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
922 R2PT Down Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Move
signal R2PT arm up and down by hand
• Steparm card and its and make sure that nothing is
connector obstructing the movement
• Up/down Stepper motor 9 Then switch ON the instrument;
and its connections Go to [Service Check: Reagent
2 Arm] menu; Give <Initialize>
and <Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
923 R2PT Down Error due • R2PT POS1 opto signals 9 Initialize RGT and RCT and try
to RGT/RCT Rotating • RGT/RCT tray are the same action
rotating or their optos 9 Switch OFF and switch ON the
are giving false signal instrument
• Steptray and Steparm 9 If still it is giving error, call
card and its connector Service Engineer
924 Obstacle in R2PT Path • R2PT obstacle opto and 9 Check the Reagent 2 arm
during Down arm optos alignment through [Service
Movement • R2PT probe assembly Check]. If it is hitting at the
and its spring action or edge of the reagent bottle, then
any obstacle like bottle align the probe using calibrate
lid facility
9 Remove the cover of the
Reagent 2 arm and check and
clean obstacle opto
9 Check Reagent 2 probe spring
and its total assembly
9 Call Service Engineer
926 R2PT Down Error due • R2 probe goes down but 9 Place reagent in the reagent tray
to Reagent Absent doesn’t find LLS signal at the required position
due to problem in LLS 9 If still it is giving error, call
card or its connector Service Engineer
• Reagent absent
932 R2PT Up Movement • R2PT POS1 up opto 9 Switch OFF the analyzer; Move
Error R2PT arm up and down by hand
Maintenance
signals
• Steparm card and its and make sure that nothing is
connector obstructing the movement
• Up/down stepper motor 9 Then switch ON the instrument;
and its connections Go to [Service Check: Reagent
2 Arm] menu; Give <Initialize>
and <Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
44 Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
945 R2PT Syringe • POS1 opto card 9 Switch OFF the analyzer; Move
Up/Down Movement • Step-tray card and its Reagent 2 syringe up and down
Error connector by and make sure that nothing is
• Syringe up/down motor obstructing the movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu, Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
950 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Initialization signal R2PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
Stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
952 R2PT Up/Down Error • R2PT obstacle opto and 9 Switch OFF the analyzer; Move
during Initialization arm optos R2PT arm up and down by hand
• R2PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 2 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
954 R2PT Obstacle Error • R2PT obstacle opto and 9 Check the Reagent 2 arm
during Initialization arm optos alignment at trough position. If
• R2PT probe assembly it is hitting at the edge of the
and its spring action trough, then align the probe.
• Steparm card and its 9 Remove the cover of the
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
955 R2PT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
during Initialization. • Steparm card and its Reagent 2 syringe up and down
connector by and make sure that nothing is
• Syringe motor obstructing the movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu, Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
960 R2PT Link Halted due • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
to Rotational Error signal R2PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
962 R2PT Link Halted due • R2PT obstacle opto and 9 Switch OFF the analyzer; Move
to Up/Down Movement arm optos R2PT arm up and down by hand
Error • R2PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 2 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
964 R2PT Link Halted due • R2PT obstacle opto and 9 Remove the cover of the R2PT
to Obstacle in R2PT arm optos arm and check and clean
Path • R2PT probe assembly obstacle opto
and its spring action 9 Check R2PT probe spring and
its total assembly
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
970 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Reagent Pickup signal R2PT arm by hand and make
• Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
971 R2PT Up/ Down • R2PT obstacle opto and 9 Switch OFF the analyzer; Move
Movement Error arm optos R2PT arm up and down by hand
• R2PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 2 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
972 R2PT Down Movement • R2PT obstacle opto and 9 Switch OFF the analyzer; Move
Error arm optos R2PT arm up and down by hand
• R2PT probe assembly and make sure that nothing is
and its spring action obstructing the movement
• Steparm card and its 9 Then switch ON the instrument;
connector Go to [Service Check: Reagent
• Up/down and rotation 2 Arm] menu; Give <Initialize>
stepper motor and its and <Up/down> commands
connections 9 If the initialization or up/down
movement fails, call Service
Engineer
974 R2PT VOD Error • R2PT obstacle opto 9 Check the Reagent 2 arm
during Reagent Pickup • R2PT probe assembly alignment, in [Service Check].
and its spring action or If it is hitting at the edge of the
misalignment of arm reagent bottle, align the probe
using the calibrate facility
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
975 R2PT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
during Reagent Pickup • Steparm card and its Reagent 2 syringe up and down
connector by and make sure that nothing is
• Syringe motor obstructing the movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu, Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
976 Reagent Absent for R2 • Reagent is not kept or 9 Place reagent in the reagent tray
reagent bottle is at the required position
misplaced 9 Call Service Engineer
• LLS circuit and its
connector
977 R2PT Syringe Volume • Wrong volume entry 9 Make sure that the Reagent 2
Error volume in Test Parameters of
the application software is
within range
979 R2 Probe Shorted • The distance between 9 Clean the dual probe and dry it
during Reagent Pickup dual sample probe is not
proper so it is holding
liquid
980 R2PT Rotational Error • R2PT POS1 up opto 9 Switch OFF the analyzer; Rotate
during Reagent signal R2PT arm by hand and make
Dispense • Steparm card and its sure that nothing is obstructing
connector the rotation
• Up/down and rotation 9 Then switch ON the instrument;
stepper motor and its Go to [Service Check: Reagent
connections 2 Arm] menu; Give <Initialize>
and <Rotate> commands
9 If the initialization or rotation
fails, call Service Engineer
982 R2PT Down Movement • R2PT obstacle opto and 9 Switch OFF the analyzer; Move
Maintenance
Error
Error Description Possible Failures Checks and Corrective Actions
Code
984 R2PT VOD Error • R2PT obstacle opto 9 Check the Reagent 2 arm
during Reagent • R2PT probe assembly alignment, in [Service Check].
Dispense and its spring action or If it is hitting at the edge of the
misalignment of arm reagent bottle, align the probe
using the calibrate facility
9 Remove the cover of the
Reagent 2 arm and check and
clean obstacle opto
9 Check Reagent 2 probe spring
and its total assembly
9 Call Service Engineer
985 R2PT Syringe Error • Syringe opto signal 9 Switch OFF the analyzer; Move
during Reagent • Steparm card and its Reagent 2 syringe up and down
Dispense connector by and make sure that nothing is
• Syringe motor obstructing the movement
9 Then switch ON the instrument;
Go to [Service Check: Syringes]
menu, Give <Initialize> and
<Up/down> commands
9 If the initialization or up/down
movement fails, call Service
Engineer
987 R2PT Syringe Volume • Wrong volume entry 9 Make sure that the Reagent 2
Error volume in Test Parameters of
the application software is
within range
Maintenance
Appendix – A
A. Electrolyte Measurement by ISE ................................................................................................................... 3
A.1 Introduction to the ISE module ............................................................................................................. 3
A.2 Technical Specifications ......................................................................................................................... 3
A.3 ISE Measurement Theory .................................................................................................................. 196
A.4 Electrodes ............................................................................................................................................ 197
A.5 Reagents Used ..................................................................................................................................... 197
A.6 Installation ........................................................................................................................................... 198
A.7 Removal of Electrodes ........................................................................................................................ 198
A.8 Calibration and Sample Processing .................................................................................................. 198
A.9 ISE Test Scheduling ............................................................................................................................ 200
A.10 Operating Cycles ............................................................................................................................... 201
A.11 Maintenance Schedule ...................................................................................................................... 202
A.12 Shutdown Procedure ........................................................................................................................ 202
A.13 Error Codes ....................................................................................................................................... 203
A.14 Trouble-shooting Guide ................................................................................................................... 205
2 Electrolyte Measurement by ISE
Electrolyte Measurement by ISE 3
A.2 Technical
Specifications Sample Serum, Plasma or Urine (Urine requires dilution)
Sample size 70 µl, (3 channels) serum
160 µl diluted urine
Reproducibility Maximum imprecision (within run) Serum
Na CV < 1.5% (100 – 160 mmol/L)
K CV < 2.0% (3 – 6 mmol/L)
Cl CV < 2.0% (80 – 120 mmol/L)
Reproducibility Maximum imprecision (between day) Serum
Na CV < 2.0% (100 – 160 mmol/L)
K CV < 2.3% (3 – 6 mmol/L)
Cl CV < 2.3% (80 – 120 mmol/L)
Reproducibility Maximum imprecision (between day) Urine
Na CV < 2.0% (20 – 500 mmol/L)
K CV < 2.3% (1 – 500 mmol/L)
Cl CV < 2.3% (20 – 500 mmol/L)
Typical Carry-over
Na < 0.5 %
K < 1.5 %
Cl < 1.0 %
Analysis time Serum – 30 seconds, including one point calibration
Urine – 60 seconds, including one point calibration
Throughput Serum – 120 samples per hour
Urine – 60 samples per hour
Power 12V DC, 0.6A
Module Size 100 mm high x 102 mm wide x 91 mm deep
Reagents Calibrant A, Calibrant B, Cleaning Solution, Urine
Diluent
Maximum ambient 38 °C
Temperature
196 Electrolyte Measurement by ISE
A.3 ISE The electrolyte measurement system measures Sodium, Potassium and Chloride
Measurement ions in biological fluids using ion selective electrode technology. A diagram of the
Theory electrode measurement system is shown in Figure A.1.
Sample Port
RT log(αC )
E = Eo +
nf
A.4 Electrodes The electrodes are maintenance-free and are warranted on a prorated basis for up
to 10,000 samples or 6 months, whichever occurs first. Cleaning Solution,
aspirated from an operator designated sample cup, is used at least once a day at the
end of the day in order to minimize protein buildup in the fluid lines. A two-point
calibration of the ISE module is also done at least once a day at the beginning of
the first sample run. If the user is running more than 50 samples a day, cleaning
must be performed at 8 hours intervals.
A.5 Reagents Used The sample is aspirated from a sample cup and dispensed into the sample port at
the top of the ISE module by the sample probe. The sample is then positioned in
front of the sensors using the double detector and the waste pump.
4. Urine Diluent: This is required for urine samples. Urine samples must be
diluted by a factor of 10 (urine sample to urine diluent ratio of
1:9) to perform urine measurement. The operator must
thoroughly mix the diluent and sample before keeping the diluted
sample on the sample tray.
198 Electrolyte Measurement by ISE
A.6 Installation 1. Install the Na, K, Cl and Reference electrodes in position. Depressing the
compression plate will make insertion of last electrode easier.
2. Connect all the tubing following number codes on tubing.
3. Connect the Calibrant A and Waste motors to the ISE Module, according
to the labels on the ISE Module.
4. Connect the communications cable to the Analyzer I/O Port.
5. Install the Calibrant A and Wash bottles.
6. Rehydrate the electrodes by requesting multiple <PURGE> cycles from
the [Maintenance: ISE Unit] screen. When the ISE Module transmits a
<ISE!> back to the analyzer, Calibrant A has filled all tubing and sensors.
Request 3 Additional <PURGE> cycles after tubing is primed and allow
the electrodes to be exposed to fluid for 15 minutes before calibrating.
7. Fill a sample cup with Calibrant B and place it on ISE1 position of the
sample tray. Request a <Calibration> fro the [Maintenance: ISE Unit]
screen.
8. If the request of additional cycles confirms that the electrodes are
rehydrated (Slopes are within range and are reproducible), the system is
already to begin analyses.
9. If the results from the module are unacceptable, refer to the section
Troubleshooting Guide for assistance. Waiting for the <ISE!> signal will
assure that fluid is drained from the electrodes.
A.7 Removal of 1. To remove an electrode, you must first request a maintenance cycle by
Electrodes clicking <MAINTENANCE> on the [Maintenance: ISE Unit] screen and
wait for <ISE!>.
2. Next, depress the compression plate to release the compression on the
electrodes.
3. Then squeeze the electrode handle towards the right while pulling the
electrode out.
4. If you have forgotten to request <MAINTENANCE> before removing a
sensor, you must wipe the spilled fluid form the sensors and inside the
housing. Failure to do so may create a salt bridge and cause data errors
(Noise, Drift, Range).
A.8 Calibration and The sequence of use of Calibrant A and patient samples during processing is as
Sample Processing follows:
1. Sample is deposited into ISE module sample port by the analyzer
2. Sample is positioned in front of the electrodes by the waste pump
3. Sample equilibration and reading occurs during 7 second period
4. Calibrant A is pumped into the electrode module
5. Calibrant A equilibration and reading occurs during 7 second period
6. Results are reported
7. ISE module is ready for next cycle
EB − E A
Slope =
log (C B C A )
The module’s electronics processor checks these slopes and an error code will be
transmitted if they are outside the required range. Typical slopes are
approximately 55 mV/decade for Na, K, and 45 mV/decade for Cl.
Slope (mV/decade)
Na 50-63
K 50-63
Cl 40-59
Range (mmol/L)
Serum Urine
Na 20-200 20-1000
K 0.2-20.0 1-50
Cl 25-200 20-500
200 Electrolyte Measurement by ISE
A.9 ISE Test If ISE unit has been installed on the analyzer, the first three test parameters are for
Scheduling the Na, K and Cl tests. For these tests, one can modify only a few parameters. The
parameters that can be modified are:
1. Control Interval
2. Sample Replicates
3. Reference ranges for Male and Female for Serum as well as Urine
samples
4. Panic limits for Serum samples
Before starting analysis of sample for electrolytes, user should first clean and
calibrate the ISE module. The following sequence should be used for ISE unit
calibration:
1. Fill the Calibrant A solution in Calibrant A bottle and connect it to the ISE
module. If the Calibrant A bottle is already in place, shake the Calibrant A
bottle so that any water condensed on the bottle wall is included in the
calibrant A solution.
2. Dispense Calibrant B solution into the sample cup and place it on the
ISE1 position of the sample tray.
3. Dispense the Cleaning solution into the sample cup and place on the ISE2
position of the sample tray.
4. Go to the [Maintenance] screen by clicking on the <Maintenance> button
on the Main Menu Screen then click on the <ISE Unit> button. The
display changes to the following screen:
Urine Sample Cycle: Calibrant A is pumped from electrodes, and then diluted
sample is pumped from sample port to ion selective electrodes. Module acquires
sample reading, pumps Calibrant A to wash the ion selective electrodes and then
acquires calibrant reading and passes back the true patient results which reflects
the 10 times dilution.
Purge Cycle: Purges air from Calibrant A fluid lines by pumping Calibrant A
from the container until Calibrant A fills the lumens of all electrodes. Several
cycles may be required to fully purge air from fluid lines.
Maintenance Cycle: Purges all fluid from ISE module to allow removal of
electrodes without fluid spills. This cycle disables the automatic sipping (Standby
Cycle).
Cleaning Cycle: The module pumps the cleaning solution from sample port to the
ion selective electrodes, dwells until cleaning is completed, pumps Calibrant A to
wash the ion selective electrodes and then acquires single port calibration reading.
Last Data Transmission: Causes the ISE Module to respond with last stored
results.
A.11 Maintenance The electrolyte measurement system has been designed to require very little
Schedule operator maintenance. The only daily maintenance required is to perform a two
point calibration at the beginning of the day and to clean the electrodes using
Cleaning Solution at the end of the day. All other parts and expendables are
replacement items (see schedule below)
Before removing the electrodes, they should be cleaned using the cleaning
solution and then running 3 <Purge> cycles. Enter the Maintenance cycle of the
analyzer (by clicking on the <Maintenance> button in the [Maintenance: ISE] screen)
which purges all fluid from the analyzer fluid path.
K+ electrode
9 Aspirate a small volume of Calibrant A from the top port of the reagent
module into a syringe fitted with a blunt needle
9 Inject sufficient Calibrant A into the lumen of the K+ electrode until fluid
fills the lumen
9 Cover both ends of the lumen (both sides of K+ electrode) with cellophane
tape to hold the Calibrant A in place
9 Insert the K+ electrode into a sealed bag
Calibrant A
9 Remove the Calibrant A from the analyzer and discard it
Analyzer re-activation
9 Remove all electrodes from sealed bags
9 Remove cellophane tape from K+ electrode
9 If necessary, soak the reference electrode in warm water until the lumen of
the electrode has been cleared of salt build-up
9 Place electrodes into the sensor module
9 Place new calibrant on analyzer
9 Calibrate analyzer
A.13 Error Codes If the ISE module detects an error during any cycle, an error code will be shown
immediately after the result or slope string.
The error codes have a compact format of only 4 ASCII characters. The format of
the error code is: <1234>, where
Byte 4: Out of Range for Sample/Calibrant B and the special Na urine error.
Out of Range for either Sample or Calibrant B are represented by numbers 1 to 7.
These numbers also apply in the urine mode, but if there is only a special Na urine
error and no out of range error, the error code is “K”. If there are both out of range
and Na errors, the error code will be letters “L, M, N, O, P, Q, R” as shown in the
following table.
Notice that “0” in any byte location means No Error and above numbers 1 to 7
corresponds to:
1. Na
2. K
3. Na and K
4. Cl
5. Na and Cl
6. K and Cl
7. Na and K and Cl
204 Electrolyte Measurement by ISE
Decimal Point, 53 O
Del Disk, 77
Delete Data, 117 Offline Entry, 120
Diluent Batch, 133 Online Print Format, 132
Diluent Position, 133 OutOfRange.H, xiv
Disk No., 70 OutOfRange.L, xiv
Doctors List, 118
Draw date, 71
P
Drawn by, 71
P*, xiv
E Packing List, 13
Panic Limit, 52
Emergency, 72 Panic.H, xiv
Error Record, 119 Panic.L, xiv
Exit, 91 Password, 133
Patient Entry, 68
F Add a new patient, 68
Browse through patient records, 68
Formula. See Calculation Item Delete patient data, 69
Modify patient data, 69
H Refresh, 76
Patient ID, 70
Host Selection, 133 Patient Name, 70
Patient remarks, 71
I Patient Report, 90, 121
Headings, 122
Indv List, 101 Preview, 123
Indv Mon, 100 Pause Sampling, 90
ISE, 132 Pending List, 124
Photometer, 32, 148
Precautions, 37
L
Preventive maintenance log, 145
Level Selection, 133 Previous Data, 107
Lin.H, xiv Print Test Parameters, 124
Lin.L, xiv Printer, 132
List of flags, xiii Printer installation, 20
Location, 71, 107 Printout, 90
Location of Test Icons, 135 Profile, 74
Create, 74
Prozone Limit, 52
M