XL640 User Manual

Operator’s Manual
Clinical Chemistry Analyzer
XL 640 Version 1.3 Last Updated: 03rd March 2007

Table of Contents
Chapter 1 Analyzer Overview ...................................................................... 1
1.1 Designation of each unit ..........................................................................................2
1.2 Functionality of each unit .........................................................................................5
1.2.1 Auto sampler unit (ASP) ................................................................................................................... 5
1.2.2 Sample pipette unit (SPT)................................................................................................................. 7
1.2.3 Reagent 1/2 pipette unit (R1PT/R2PT)............................................................................................. 8
1.2.4 Reaction Tray (RCT)......................................................................................................................... 9
1.2.5 Reagent Tray (RGT) ......................................................................................................................... 9
1.2.6 Photometer Unit.............................................................................................................................. 11
1.2.7 Mixing stirrer unit (STIRRER-1/STIRRER-2).................................................................................. 12
1.2.8 Cuvette Rinsing Unit (CRU)............................................................................................................ 13
1.2.9 Pipetting Pump assemblies (SPP, R1PP and R2PP Syringes)................................................ 14
1.2.10 Ion selective electrode unit (ISE).................................................................................................. 15
1.2.11 Liquid Level Sensing Platform for external tank ........................................................................... 17
1.3 Measurement flow ....................................................................................................18
1.3.1 Normal measurement flow.............................................................................................................. 18
1.4 Basic operational information.................................................................................20
1.4.1 Procedure to Install the XL 640 Analyzer ....................................................................................... 20
1.4.2 Procedure to Install Application software for XL 640 Analyzer...................................................... 21
1.4.2 Layout of operational picture on the screen ................................................................................... 22
Chapter 2 Procedure of routine check ...................................................... 24
2.1 Checks prior to work and power-on .......................................................................25
2.1.1 Checks prior to work ....................................................................................................................... 25
2.1.2 Preparation of external tank solutions ...................................................................................... 26
2.1.3 Power-on.................................................................................................................................... 28
2.2 Preparation and placement of reagent...................................................................31
2.2.1 Reagents ........................................................................................................................................ 31
2.2.2 Placement and registration of reagents and diluents ..................................................................... 32
2.2.3 Reagent Level Scan ....................................................................................................................... 34
2.2.4 Previous Data: Reagent Status ...................................................................................................... 34
2.3 Preparation and placement of sample ...................................................................36
2.3.1 Sample barcode scan ..................................................................................................................... 36
2.3.2 Specifications of Barcode Label ..................................................................................................... 37
2.4 Calibration Measurement..........................................................................................38
2.4.1 Calibration Table............................................................................................................................. 38
2.4.2 Calibration Menu............................................................................................................................. 51
2.4.3 Calibration Monitor.......................................................................................................................... 56
2.4.4 Calibration Trace ............................................................................................................................ 57
2.5 Patient Entry .............................................................................................................59
2.5.1 Doctor’s List .................................................................................................................................... 61
2.5.2 Analyst/Location ............................................................................................................................. 62
2.5.3 Patient Entry: Tests ........................................................................................................................ 66
2.5.4 Patient Entry:Profile ........................................................................................................................ 67
2.5.5 Patient Entry:Worklist ..................................................................................................................... 67
2.5.6 Patient Entry: Clear Schedule ........................................................................................................ 68
2.5.7 Patient Entry: Refresh..................................................................................................................... 69
2.5.8 Patient Entry:Del Disk..................................................................................................................... 69
2.6 ASTM Host ............................................................................................................71
2.7 Initiation of measurement and monitoring.................................................................72
2.7.1 Initiation of measurement ............................................................................................................... 72
2.7.2 Measurement and monitoring of Sample during Standardisation ............................................... 72
2.7.3 Measurement and monitoring of Sample during Run..................................................................... 73
2.7.4 Detection of Clot during Run...................................................................................................... 74
2.7.5 Measurement and monitoring of Reagent during Patient Run/Mixed Run..................................... 76
2.8 Reproduction of Measurement Results..................................................................78

2.8.1 Result Backup................................................................................................................................. 78
2.8.2 Result Reprint ................................................................................................................................. 79
2.8.3 Test Statistics ................................................................................................................................. 81
2.8.4 Time Course ................................................................................................................................... 83
2.9 Patient Report........................................................................................................86
2.9.1 Offline Entry .................................................................................................................................... 89
2.10 Sample Rerun.........................................................................................................92
2.11 Pending List............................................................................................................93
2.12 Quality Control ...................................................................................................94
2.12.1 Tests ............................................................................................................................................. 96
2.12.2 Daily QC........................................................................................................................................ 96
2.12.3 Monthly QC................................................................................................................................... 97
2.12.4 Twin Plot ....................................................................................................................................... 98
2.12.5 Control Data.................................................................................................................................. 99
2.12.6 Reports ....................................................................................................................................... 100
2.12.7 Procedure to run a Control ......................................................................................................... 103
Chapter 3 Alterations of Operational Conditions................................... 105
3.1 Functional items...................................................................................................106
3.2 Test Parameters .....................................................................................................107
3.2.1 Method Conditions:....................................................................................................................... 107
3.2.2 Reagent Details Screen................................................................................................................ 114
3.2.3 Print Multiple Test Parameters ..................................................................................................... 119
3.3 SERUM INDICES ...................................................................................................120
3.4 Calculation Item ...................................................................................................122
3.4.1 Procedure to Add a Calculation Item............................................................................................ 123
3.4.2 Procedure to calculate Creatinine Clearance: .............................................................................. 124
3.5 Profile Entry .........................................................................................................125
3.5.1 Procedure to Create a Profile ....................................................................................................... 125
3.6 Result Re-calculation ...........................................................................................126
3.7 System Switch .....................................................................................................127
3.8 Backup/Restore ...................................................................................................131
3.8.1 Backup/Restore: Test Parameters ............................................................................................... 132
3.8.2 Backup/Restore: Patients ............................................................................................................. 132
3.8.3 Backup/Restore: Calibration ......................................................................................................... 132
3.8.4 Backup/Restore: Controls............................................................................................................. 132
3.8.5 Backup/Restore: System Switch .................................................................................................. 133
3.8.6 Backup/Restore: Time Course ..................................................................................................... 133
3.8.7 Backup/Restore: Calibration Trace............................................................................................... 133
3.8.8 Backup/Restore All ....................................................................................................................... 133
3.9 Delete Data.............................................................................................................134
3.10 Database Status ...................................................................................................135
3.11 Carry-Over Pairs ...............................................................................................136
Chapter 4 Maintenance............................................................................. 138
4.1 Maintenance Program..........................................................................................139
4.1.1 Maintenance Intervals................................................................................................................... 139
4.2 Actions to be taken in the event of trouble ...........................................................141
4.2.1 Information requested by our customer service department ................................................... 141
4.3 Malfunction at the time of power-on .....................................................................142
4.4 Anomalous measurement results ........................................................................143
4.4.1 Check of preparation of reagent, calibrator or QC sample ..................................................... 143
4.4.2 High resultant values from a specific method for all samples.................................................. 144
4.4.3 Low resultant values from a specific method for all samples ................................................. 144
4.4.4 Randomly derived erroneous measurement results................................................................ 144
4.4.5 Anomalous resultant values from all methods for a sample ................................................... 145
4.5 Equipment malfunction ........................................................................................146
4.5.1 Detection of mechanical problem ........................................................................................... 146
4.5.2 Error messages for each unit:.................................................................................................. 148

4.6 Error flags associated with measurement results ................................................160
4.6.1 Measurement result error flags............................................................................................... 160
4.7 Maintenance Menu ..............................................................................................162
4.7.1 Reset............................................................................................................................................. 162
4.7.2 Photometer ................................................................................................................................... 162
4.7.3 Cuvette Rinse ............................................................................................................................... 163
4.7.4 Water Save ................................................................................................................................... 164
4.7.5 Wash............................................................................................................................................. 165
4.7.6 Prime............................................................................................................................................. 166
4.7.7 Dead Volume Calibration......................................................................................................... 167
4.7.10 ISE Unit....................................................................................................................................... 168
Appendix-A Introduction to ISE Module ..................................................... 2
1 Introduction to the ISE Module ................................................................. 3
1-1 Parts Location ............................................................................................................4
1-2 ISE Technical Specifications ......................................................................................5
1-3 ISE Measurement Theory...........................................................................................6
1-4 Electrodes and Reagents used ..................................................................................7
1-5 Storage and Usage of the Reagents ..........................................................................8
1-6 When turning off the power ........................................................................................8
1-7 Shutdown Procedure: Preparing the ISE module for storage .....................................8
1-8 Procedure for Installation and Removal of ISE Electrodes .........................................9
2. ISE Calibration and Sample Processing ............................................... 11
2-1 Procedure for ISE calibration....................................................................................11
2-2 Operating Cycles in ISE Module...............................................................................13
3. ISE Maintenance Schedule .................................................................... 14
4. Error Codes ............................................................................................. 15
5. Trouble shooting..................................................................................... 17

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 XL 640 analyzer features and specifications. It consists of the main analyzer
including software, and software on the operational PC. The analyzer is used with operational PC and
printer, and can interact with the host computer. All the samples and reagents for measurements including
samples obtained from patients are controlled by bar codes enabling the analyzer to perform the entire
process of the analysis automatically. Use of the analyzer with proper knowledge will ensure quality test
results and trouble free analyzer operation and performance.
Assumptions are made that before making an attempt to operate the analyzer, the operator is
familiar with the operation of analyzer and has:
1. Read the Operator’s Manual.
2. Been trained by authorized personnel.
3. Personalized the analyzer, checked and/or modified methods, parameters, profiles, serum
control values etc.
Manufacturer
of the Analyzer
Registered Office:
TRANSASIA BIO-MEDICALS LTD.
Transasia House, 8, Chandivali Studio Rd.
Mumbai-400 072, India.
Production Facility:
TRANSASIA BIO-MEDICALS LTD.
SDF-VI, Unit No. 162, Phase I,
SEEPZ, Andheri (East),
Mumbai-400 096, India.
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WARNING LABELS
The following warning labels are affixed on the places that are the potentially hazardous.
WARNING ABOUT: PLACES:

WARNING On the 5-piece Top Cover
POTENTIAL HAND EXPOSURE TO
PROBE.
KEEP HANDS AWAY.

CAUTION On the 5-Piece Top Cover
DO NOT OPERATE MACHINE WITH
COVER OPEN
DO NOT TOUCH MOVING PARTS WHEN
IN OPERATION-PERSONNEL INJURY MAY
RESULT DUE TO PROBE ARM
MOVEMENT
TO REDUCE DAMAGE TO THE
INSTRUMENT, DO NOT SPILL SAMPLE OR
REAGENT ON THE MACHINE

WARNING On the Biohazardows waste can (10 Lt.)
THE TANK CONTAINS HAZARDOUS On the Waste Can (20 Lt)
MATERIAL
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WARNING On the 5-piece Top Cover
POTENTIAL HAND EXPOSURE TO DOME.
KEEP HANDS AWAY.

CAUTION On the 5-piece Top Cover
ENSURE FOLLOWING BEFORE ISE
OPERATION:
ALL ELECTRODES ARE IN PLACE
CAL-A BOTTLE CONNECTION OK
ISPS PCB CONNECTION OK
CAL-A SOLUTION IS WELL SHAKEN
“CLEAN” OPERATION IS PERFORMED
BEFORE START AND END OF DAY
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Installation Conditions (Safe use of Operation)
The user is requested to read this instruction before he/she uses the analyzer for the first time and
becomes acquainted with how to operate the analyzer.
1 Only qualified personnel should use the analyzer.
2 The following precautions should be taken when the analyzer is installed:

a) Keep the analyzer out of the rain and any other water splash.
b) Avoid areas that are adversely affected by atmospheric pressure, temperature,
humidity, ventilation, sunlight, dust and air containing salt, sulfur, etc.
c) Pay attention to inclination, vibration, shock (including shock during transportation),
etc.
d) When the analyzer is lifted, do it in a team of four or more. Lift carefully the
analyzer by grabbing grips embedded in four bottom corners of the analyzer by
one each hand and supporting the other places of the bottom by another each
hand.
e) Do not install the analyzer at the place adjacent to the storage room of chemicals or
the place where any gas is likely to be generated.
f) At the installation of analyzer, the space from wall to the back of analyzer needed is
100 mm more to ventilation.
g) Pay attention to frequency, voltage and permissible current (or power consumption).
h) The power cable of analyzer that is accompanied with the accessory package or
specified by the analyzer’s manufacture should be used for the analyzer main unit.
i) When the analyzer is used in the Member states of EC together with accessories
including PC, visual display and printer, use CE-marking or local regulatory
accessories.
j) Connect the analyzer to the operational PC using accompanying RS232C cable. When
the other cable is used, this may cause the analyzer to suffer from disturbing noise or
exert an adverse effect on its surroundings.
k) Room Temperature should be 15°C to 30 °C and the temperature fluctuation during
analysis should not be more than ±2 °C.
l) Maximum relative humidity is 80% (non-condensing).
2 The following cautions should be exercised before the analyzer is operated:

a) Check that the contact conditions of switches and indicators are appropriate and that
the analyzer is ready to be activated correctly.
b) Make sure that the analyzer is correctly and well grounded.
c) Make sure that all the necessary electrical cables are correctly connected.
d) Extreme care must be taken not to result in misdiagnosis or pose any danger to the
analyzer or human body when the analyzer in conjunction with other equipments.
e) Wipe the nozzle tips of SPT and RPT several times with cloth or alikeness
impregnated with rubbing alcohol before the analyzer is used. At this time, do not
forget to put medical rubber gloves or alikeness on. Pay also attention to prevent bare
skins of hands or arms from being touched by or pricked with the nozzle tip.
f) Exchange the halogen lamp for a new one after a lapse of 30 minutes since the power
switch of the analyzer is turned off to avoid danger of burns. Keep hands away from
glass part of new halogen lamp. Make sure that there is no crack or breakage in the
glass part. Make sure also that gas does not have been leaked.
4. The following cautions should be exercised during operation:

a) Pay attention not to exceed time and volume necessary for diagnosis and treatment.
b) Keep monitoring the behavior of whole system in order to detect any malfunction.
c) Take immediate corrective measures including shutdown of operation when any
malfunction is detected in the analyzer.
d) Avoid possibilities of any direct access by patients.
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5. The following cautions should be exercised after the use of the analyzer:
a) Turn off the power after every operational switch and control is restored to its pre-use state
as directed.
b) Do not remove the line cord plugs from receptacles by cords not to give undue stress to
cords.
c) Wipe the nozzle tips of SPT and RPT several times with cloth or alikeness impregnated
with alcohol after the analyzer was used. At this time, do not forget to put medical rubber
gloves or alikeness on. Pay also attention to prevent bare skins of hands or arms from being
touched by or pricked with the nozzle tip.
d) Pay attentions to the storage area.
e) Keep the analyzer out of the rain and any other water splash.
f) Avoid areas that are adversely affected by atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust and air containing salt, sulfur, etc.
g) Pay attention to inclination, vibration, shock (including shock during transportation), etc.
h) Avoid areas adjacent to the storage room of chemicals or areas that are likely to generate
gases.
i) Organize and store parts and cords associated with the analyzer after they have been
cleaned.
j) Keep the analyzer clean not to cause any inconvenience to the next use.
6. In the event of trouble, call authorized service engineer for any repair. When the safety
mechanism is damaged, make contact to authorized service engineer after pulling out the
power cable from the main source outlet.
7. Maintenance and checks:

a) It is importance for the analyzer and its associated parts to be periodically checked.
b) Make sure without fail that the analyzer operates normally and correctly, when it is reused
after being kept unused for some time.
c) Do not use any parts and materials for repairs or consumables without being specified by
the analyzer’s manufacturer.
8. The following cautions should be taken when using and handling the reagents
a) After unpacking the reagents, be sure not to allow dust, dirt or bacteria to come in touch with the
reagent.
b) Do not use reagents that are out of expiration date.
c) Handle a reagent gently to avoid formation of bubbles.
d) Take care not to spill the reagent. If it spills, wipe it off immediately using a wet cloth.
e) Follow other instructions described in the package insert on each reagent.
f) If a reagent happens to enter your eye, wash it off immediately using plenty of water, and take
medical treatment at once.
g) If you swallow it inadvertently, call for a doctor immediately and drink plenty of water.
9. Prohibit any alteration and/or modification to the analyzer without permission by

manufacturer.
Space Requirements:
Analyzer dimensions: 897(L) * 655(B) * 1170(H) mm
0-5
“Page Left Blank Intentionally”
0-6
Technical Specifications
1.General specifications
Item Description
• 390-400 tests/hour (640 tests/hour with ISE) for a cycle time of
Throughput
9 seconds
• Discrete, automated, random access, patient prioritized, 1/2

System type
reagent system
• Serum
Sample • Urine
• Others (CSF, Plasma, etc.)
• Latex Turbidimetric Immunoassay
Measurement • Turbidimetric Immunoassay
principle • Colorimetry (Rate/End Point)
• Ion Selective Electrodes (optional)
• Photometric assays
• Enzyme, lipid, protein, sugar, nitrides, inorganic substances,
Applicable analytes complements and others
• Turbidimetric assays
• IgG, IgA, IgM, C3, C4, RF, CRP, ASO, Transferrin and others
• Absolute measurement
Test method • Relative measurement
• ISE (optional)
On board tests • 56 test items maximum; 59 test items with ISE
• 96 photometric tests
Programmable • 40 calculation items
parameters • Serum indices
• (Optional) 3 ISE tests (Na, K, Cl)
• 1-Point
• 2-Point
Assay modes
• Rate-A
• Rate-B
Sample volume • 2-70 µl (adjustable in 0.2 µl step)
Reaction volume • 180µl – 550µl
Reaction • 37 °C
temperature • Temperature stability: ± 0.2 °C
• Degree of Lipemia, Icterus and Hemolysis can be measured
Serum information
and displayed
• Depends on the designated cycle time and number of reagents
used
• For 1 step assay (using R1)
• 567 seconds (9 minutes 27 seconds) for a cycle time of 9
Reaction time seconds
• For 2 step assay (using R1 and R2)
• 1st reaction 216 seconds (3 minutes 36 seconds) + 2nd
reaction 351 seconds (5 minutes 51 seconds) for a cycle time of
9 seconds
• Setting of tests one by one or with profile key for each
sample
Test selection • Group order entry is possible
• Setting from host computer via interface (optional)
• Setting according to bar-code data on sample container
• Maximum 40 calibrators can be used
Calibration • 10 calibrators maximum per test
• Selective calibration possible
0-7
• User programmable dead volumes for sample, standard and
Dead volumes
reagent positions
• Type: Immersion mixing by rotating mixers
• Two mixers (3 variable mixing speeds)
• Mixing positions
Mixers
• The 1st position: Right after sample dispense into the first
reagent
• The 2nd position: 1st reagent + sample + R2
• Programmable maintenance actions: Prime, Wash, ISE
Maintenance
maintenance
• Sample tube barcode ID (NW7, code 39, code 128, 2 of 5
interleaved, 2 of 5 standard, ISBT-code 128)
Barcode
• Reagent barcode ID
identification
• Automatic bar code scan performed whenever reagent tray lid is
removed and kept again
• Water consumption: Less than or equal to 13.5 liters/hour
Water supply unit • Manufactures and supplies: Type 2 quality (by NCCLS
standards) ion exchange water
Quality control • 60 types of control parameters maximum (4 types per test item)
System Warm-up
• 30 minute system warm-up time
Time
• Vertical obstruction detection
Safety mechanism • Clot Detection
• Capacitance based liquid level sensing
Noise level • Less than 65 dB
Display • 15 inch color display
Keyboard • Standard keyboard
Printer • External: A4 size DeskJet color printer (optional)
Auxiliary storage
• 3.5 inch floppy disk
medium
• Analyzer – PC: RS-232C bi-directional
System interface • PC – Host computer: TCP/IP bi-directional (optional)
• Remote diagnostics: Ethernet/modem (optional)
• Touch screen monitor
• Electrolyte measurement unit (for Na, K, Cl)
Optional • A4 size color printer
• PC-Host Computer: TCP/IP bi-directional
• Automatic Water Supply from an outside DI water unit
2. Installation conditions
Item Description
Power source/ • AC 220 V ± 10%, 50 ± 1 Hz or AC 110 V ± 10%, 60 ± 1 Hz
consumption • Power consumption: 800 VA
Fuses • 5A for 220V and 10A for 110V input supplies
• Used sample (concentrated waste solution) and washed sample
Drainage
(diluted waste) are to be drained separately
• 15 – 30°C
Ambient temperature
• Variation during operation: less than ± 2 °C per hour
Relative humidity • 40 – 80% free from water dew formation
Dimensions • 897 (L) x 655 (B) x 1170 (H) mm
Weight • Approximately 200 kg
0-8
3. Sampling unit
Item Description
Sample • Blood collection tube 10 ml (16 x 100 mm), 7 ml (14.5 x 84 mm), 5 ml
container (13 x 75 mm)
• Adaptors will be provided for 5 and 7 ml tubes
• Standard cup 2 ml
Sample • Sample tray

placement • Inner rim: 25 routine patient samples with/without barcode
• Outer rim: 25 routine patient samples with/without barcode (optional
5 positions for STAT)
• Standard tray
• Inner rim: 2 blanks, 8 controls & 2 ISE solutions
• Outer rim: 20 positions each on Disc1 and Disc 2 separately for
standards/STAT
STAT samples • Can be placed on the outer rim of Standard Tray or Sample Tray
• STAT samples are measured preferentially
• Interrupt permitted even during analysis
Sampling • Pipetting system with plunger, driven by stepper motor
• Sample volume: 2-70 µl (adjustable in 0.2 µl step)
Pipetting • Discharges set volume of sample into Cuvette or the ISE module
mode (optional)
Sampling • Micro-pipette with level sensor
probe • Washing solution
• Outside: Preheated de-ionized water
• Inside: Preheated de-ionized water
• Equipped with vertical obstruction detection facility to prevent probe
crash and clot detection facility
Sample • Dilution ratio: 5 to 150 times
dilution • A Cuvette is used as dilution vessel
• Set amount of diluent is dispensed into a Cuvette by reagent probe
and set amount of sample is dispensed into it by sample probe
• Dilution possible for repeat run
• Direct reduced/increased volume runs are also possible
Repeat run • Execution by repeat run list or auto execution
• Auto execution according to abnormal marking and/or range over
• Reduced/increased volume repeat run also possible
Sample • Sample bar-code ID (barcode reader provided as standard)
identification • Position ID for STAT samples
0-9
4. Reagent unit
Item Description
Type • Turn table type reagent tray
Reagent tray • Common reagent tray for reagent 1/2
• Reagent Tray suitable for TBM bottles
Reagent cooling • 8 to 12°C cooled with refrigeration unit
temperature
Reagent bottles • 28 positions for 20ml and 28 positions for 50ml
Reagent dispensing • Pipetting system with plunger, driven by stepping motor
• R1 dispensing in the 0.5th cycle
• R2 dispensing in the 25th cycle
Reagent probe • Micro-pipette with level sensor
• Outside washing solution: Preheated de-ionized water
• Inside washing solution: Preheated de-ionized water
• Equipped with vertical obstruction detection facility to prevent
probe crash
Reagent steps • 1 step or 2 step
Reagent volume • Reagent 1: 60 – 300 µl (adjustable in 1 µl step)
• Reagent 2: 0, or 10 – 300 µl (adjustable in 1 µl step)
Dead volume • User programmable dead volumes for reagents, samples and
standards
Mixing • Type: Immersion mixing by rotating mixers
• Two mixers (3 variable mixing speeds)
• The 1st position: Right after sample dispense into the first
reagent
• The 2nd position: 1st reagent + sample + R2
Reagent • Position ID
identification • Reagent bar-code ID
Residual volume • Calculated by count down system as well as measured by
information capacitance type level sensor and displayed on screen
Reagent positions • Total 56 positions which can be used for reagent 1/2
Reagent protection • Reagent cover protection from evaporation, dust, and direct light
Carry over actions • Extra Reagent/Detergent Wash given for Carry-Over Pairs
0-10
5. Reaction unit
Item Description
Type • Turn table
Reaction tray • Rotating tray
• Number of reaction cuvettes: 72
• Temperature control: Turn table direct heating by foil heater
Reaction • 37 ± 0.2 °C
temperature
Cuvettes • Reusable
• Number of reaction cuvettes: 72
• Dimensions: 5 x 5 mm
• Optical path length: 5 mm (factor to be fed for 10 mm)
• Material: Hard glass
• Volume: 700 µl
• Reaction liquid volume: 550 µl maximum, 180 µl minimum
Reaction • Type: Immersion mixing by rotating mixers
liquid mixing • Two mixers (3 variable mixing speeds)
o The 1st position: Right after sample dispense into the
first reagent
o The 2nd position: 1st reagent + sample + R2
Cuvette • Type: By the automatic washing system
washing
• The reaction waste is aspirated out, then Cuvette is washed by
washing solution and repeatedly by DI water, finally residual liquid is
removed
• Number of washing operation steps: 8 steps

o Reaction waste removal: 1 step
o Washing: 6 steps
o Residual liquid removal: 2 steps
• Number of washing solution application

o Detergent solution: 1
o Ion exchange water: 5
• Washing solution container

o Detergent: 10 liters
• Reaction waste is collected into two waste cans (concentrated waste

and diluted waste) by pumps
• In built Cuvette overflow protection
0-11
6. Optical absorption measurement unit
Item Description
Type • Multiple wavelength, diffraction spectrophotometer
Photometric • Multi-wavelength direct measurement of light after penetration into
system reaction Cuvette (transmitted light)
Wavelength • 12 Wavelengths: 340, 376, 415, 450, 480, 505, 546, 570, 600, 660,
700 & 750 nm
Wavelength per • One or two wavelengths
chemistry
Measurement • Total 63 points
interval • Every 9 seconds for 9 second cycle time
OD range • OD 0 – 2.5
• Light path calculated as 10 mm
Resolution • 0.0001 OD
Light source • Pre-aligned Halogen lamp (12V/20W)
• Life expectancy 600 hours
Grating • Concave grating
Detector • Silicon photo-diode array
Cell blank • Corrected by water blank measured after Cuvette washing
correction
Minimum reaction • 180 µl
liquid volume
7. Control unit
Item Description
User interface • PC: Windows machine, IBM compatible
hardware • OS: Windows XP
• CPU: Pentium IV or above
• RAM: 512 MB
• Hard disk: 40 GB
• Console: 15 inch color monitor
• External drives: CD-ROM drive, 3.5” floppy drive
• Printer: Dot Matrix, Epson LX-300+
• Multimedia Speakers
System interface • Analyzer – PC: RS-232C bi-directional
0-12
8. Data processing
Item Description
Calibration • K-Factor, Linear (one point, two point and multipoint), Logit-log,
curve Spline, Exponential, Polynomial (second, third, and fourth order)
• Multipoint curves for up to 10 points
• One point correction to multi-point calibration line is provided
Quality control • Within day as well as day-to-day X-Mean and X-Range control
diagram
• Mean, SD, %CV, R are calculated for each chemistry
Repeat run • Execution by repeat run list or auto execution
• Auto execution according to abnormal marking or range over
• Reduced/increased volume repeat run also possible
Monitor • Reaction curve graphical display
function • Calibration curve graphical display
• Operation status watching by run monitor
• Cuvette blank monitor
Calculation • Correlation correction factor (Y = aX + b)
between items • Calculation by the formula defined by user
o Up to 40 calculated items can be programmed
o Each calculation item can include up to 3 chemistries
• Recalculation of results possible after modification in Calibration
Parameters or Test Parameters
Data storage • Test results: 1,000,000
capacity • Reaction curve: 9999 tests
Report/list • Report generation: Patient wise, Test wise, Date wise, Location
format wise, Abnormal result wise, Doctor name wise
• Lists: Abnormal values list, Pending run list, Repeat run list
Backup • Backup of following data is possible: Assay parameters, Calibration
data, Results, QC data, System parameters, Mechanical data, Probe
Calibration and Dead Volume settings
Special • Reagent blank correction
treatment
Data check • Reference range check by age, sex, sample type
• Panic limit check
• Reaction linearity check
• Reaction mixture absorbance checks
• Antigen excess/prozone check (by reaction time course analysis
method)
Alarms and • Types of alarms: Erroneous operation, mechanical malfunction of
notices analyzer, data processor hardware error, erroneous test results
• Alarm level: Notice, temporary halt of analysis, suspension of
analysis, system stop
• Prompts on display alarms
Diagnostic • Mechanical movements and functional performance can be checked
checks through diagnostic menu
Password • Password provided to reject an access to selected menus
0-13
9. Ion selective electrode (ISE) unit
Item Description
Type of • Ion selective electrode
measurement • Direct measurement for Serum samples
• Urine sample to be diluted with urine diluent (on board, on Reagent
Tray)
Sample types • Serum and Urine (10 times diluted on board, on Reagent Tray)
Test items • Na, K, Cl
Measurement • Serum: 36 seconds/sample
cycle • Urine: 90 seconds/sample
0-14
EQUIPMENT LIST
The main unit and accessories are packed in separate cartons. Authorized representative is responsible for
unpacking, installing and initial setting up of the analyzer. Standard accessories are as follows:
Serial Number Description Quantity
1. Transducer Unit Assembly 1 No.

2. 20 litre can assembly for DI Water with Tubing 1 No.
3. 20 litre can assembly for Waste 1 No.
4. 10 litre can assembly for Bio-hazardous Waste 1 No.
5. 10 litre can assembly for Cleaning Solution 1 No.
6. Cuvette 4C:0609 5 Nos.
7. RGT TRAY 50+20ml; 56 BOTTLES (INJ) 1 No.
8. Reagent Tray Cover Assembly 1 No.
9. Moulded Sample Tray assembly with standard plate 1 No.
10. Moulded Sample Tray assembly with Emergency plate 1 No.
Tool kit – Containing 1 No.

11. Plastic Tool Box 1 No.
12. Screw Driver X100l, Cr-V Carbon Tip (1 No) 1 No.
13. Screw Driver X100l, Cr-V Carbon Tip (2 No) 1 No.
14. Screw Driver Imported (-) No. 3 1 No.
15. Nut Driver (For M3) – 5.5mm 1 No.
16. Nut Driver (For M4) – 7.0mm 1 No.
17. Box Spanner 10 – 11mm 1 No.
18. M3 Allen Driver 1 No.
21. Hex Ball Allen Key Size 1.27 mm 1 No.
22. Hex Ball Allen Key (Size 1.5 mm) 1 No.
28. Nose Plier 1 No.
29. Flat Spanner 10 / 11 1 No.
30. Flat Spanner 14 – 15 mm 1 No.
31. Forcep – 6” 1 No.
32. Trimmer 933 No 1 No.
33. Spanner Set (Size 1 to 8 nos.) 1 No.
34. 6” Adjustable Spanner 1 No.
35. Tube Cutter 1 No.
36. Calibration Plate 1 No.
Shipper Box
37. Rear Panel to Computer Cable Assembly 1 No.
38. Power Cord 1 No.
39. Sample Cups (Big) 500 Nos.
40. Test Tube Adapter for Moulded sample holding plate 100 Nos.
41. Assy. of waste can tube & Can cap 1 Set
42. Assy. of Bio-hazard Can tube & Can cap 1 No.
43. Reagent Bottles (20ml) with Caps 10 Nos.
44. Reagent Bottles (50ml) with Caps 10 Nos.
45. Reagent Bottles (20ml) with Caps and Barcode Labels 2 Nos.
0-15
Serial Number Description Quantity
46. Reagent Bottles (50ml) with Caps and Barcode Labels 2 Nos.
47. Test Tubes (5ml) with Barcode Labels 5 Nos.
48. Assy. of Cleaning solution can tube & Can cap 1 No.
P.M. Kit ----- Containing: 1 No.

49 Cuvette Drier 2 Nos.
50 Laundry Aspiration Tubing Set – Three Probe Laundry Connection 2 Set
51 Laundry Dispensing Tubing Set – Three probe construction 1 Set
52 Photometer Lamp Assembly 2 Nos.
53 Set of Fuses 1 Set
54 Screw Cover sticker trays of LLS 8 Nos.
55 Probe Cleaner 1 No.
56 25 micron filter 4 Nos
Accessories for ISE Unit 1 No.

57* Reference Electrode for ISE 1 No.
58* Na Electrode for ISE 1 No.
59* K Electrode for ISE 1 No.
60* Cl Electrode for ISE 1 No.
61* CAL A bottle assembly 1 No.
62 ERBA Cleaning Solution 1 No.
63 ERBA Calibrant B 1 No.
64 ERBA Calibrant A 1 No.
Miscellaneous
65 Unit Installation Instruction Sheet 1 No.
66 Hydraulic Diagram sheet for XL-640 1 No.
67 Can connection diagram 1 No.
68 FQC Report 1 No.
69 “ERBA XL wash” kit 1 No.
70 Application Software – (Version - ) 1 No.
71 Operator Manual XL 640 Version 1.3 1 No.
72 BARCODE Alignment Kit 1 No.
73 DI Water Plant ELGA Make (Sr. No. OS15D227619BP) 1 set
74 Pre filter Assembly for D.I. Water Plant 1 set
* - Optional (As per customer requirement)
Notes: “Accessories Box B”: 42” (1070) * 27” (685) * 17” (435); Weight: 30kg.
0-16
0-17
Chapter 1- Analyzer overview
Chapter 1
Analyzer Overview
This chapter provides the user with necessary background on the analyzer for its use. The user is
requested to read before starting operation.
Chapter 1 Analyzer overview

1
Chapter 1 - Analyzer Overview
1.1 Designation of each unit
ON/OFF Switch
Figure 1.1 Front View of the Analyzer
2
Chapter 1 – Analyzer Overview
Figure 1.2 Side View of the Analyzer
3
Figure 1.3 Front View of the Analyzer with Various Assemblies
4
1.2 Functionality of each unit

This section contains the description of each unit constituting the system.
1.2.1 Auto sampler unit (ASP)

The auto sampler unit (ASP) consists of a removable turntable with sample tube holder and rotating
mechanism and a bar code reader for identifying samples.
The ASP accommodates 50 sample tubes. Each sample is aspirated by the sample pipette unit
(SPT) and dispensed into cuvettes of the Reaction Tray Unit (RCT).
A) Turntable (ASP tray)
Standard Disk
Sample Disk
Figure 1.4 ASP Tray with Standard Disk
The ASP Tray of the analyzer consists of 2 sections:

The outer section has 50 positions for the patient samples. Position numbers 46E-50E are also
available for STAT/EMERGENCY samples. During Patient Run, Positions S1-S20 can also be
used as Emergency Positions. Adapters are available for loading the primary tubes of different
sizes. Primary tubes as well as 2ml cups could be placed in the outer section.
The inner section is for placing blank, control, stat/emergency samples and standards/calibrators. It
is a detachable tray mounted on top of the routine tube tray. 2 Standard Disks are available. On
this tray, only 2ml Sample cups can be placed in the positions as marked on the disk. The outer
ring of the standard tray contains 20 positions for Standards (marked S1-S20 or S21-S40 for Disk
2). The inner ring contains 8 positions for Controls (marked C1-C8 or C9 to C16 for Disk 2), 2
separate positions for optional ISE solution (marked ISE1 and ISE2) and 2 positions for blanks
(marked B1and B2 for Disk 1 or B3 and B4 for Disk 2 respectively).
The types of usable sample tubes are shown below:
5
For 10ml tubes:

Diameter: 15 mm
Length: 101 mm
Extent of label fitting: Refer to below drawing.
Upto 42mm
20mm
For 5 or 7 ml tubes:
Diameter: 12 mm
Length: 75 mm
Extent of label fitting: Refer to below drawing.
Upto 42mm
20mm
B) Sample Barcode reader

The barcode reader reads barcode of the label affixed on the outer surface of the sample
tube.
When the reader does not read the barcode even if the bar code label exists, the appropriate
error message is indicated. The barcode reader used is Leuze BCL 8 laser type reader.
The readable bar codes are as follows:
Symbol Valid character and symbol

NW-7 Numerals (0 – 9), symbols (-, $, /, ., +)
Code39 Numerals (0 – 9), alphabetical characters, symbols (-, space, $, /, +, %)
ITF Numerals only (0 – 9)
UPC Numerals only (0 – 9)
Code128: All ASCII code characters [numerals (0 – 9), alphabetical characters
Set A, Set B, Set C (uppercase/lowercase), symbols, control characters]
6
1.2.2 Sample pipette unit (SPT)
Liquid Level
Sensor Board
for SPT Arm
Figure 1.5 SPT Unit
The sample pipette unit (SPT) consists of an up-and-down movement mechanism, rotating
mechanism, clot detection sensor, liquid level sensor and nozzle down limit sensor. The sample
pipette is connected to the syringe for sample aspiration via PTFE tube. The sample on the ASP unit
is aspirated by the pipette and then dispensed into the cuvettes (reaction cells) in the RCT unit. The
sample probe is coated with Teflon from outside as well as inside to minimize any sample carry over.
When an optional ISE unit is fitted and the ISE measurement is performed, the SPT aspirates
sample for ISE measurement and dispenses it into the sample port of the ISE unit. The SPT arm is
equipped with Clot detection sensor to detect the presence of clot in the sample.
A) Liquid level sensor

When the tip of the nozzle reaches and touches the sample surface, the electrostatic capacitance
of the metallic nozzle varies. The variation of the capacitance is detected and consequently the
level of sample is detected.
B) Nozzle down limit sensor

When the tip of nozzle hits the bottom of sample tube (or sample cup) due to the insufficient
volume of sample in it, the lower limit sensor detects that the tip of nozzle hits the bottom and
stops its downward movement.
C) Clot Detection sensor

When the tip of the nozzle detects the clot in the sample tube/sample cup, the clot detection sensor
detects the clot and stops sampling of the current schedule and performs sample probe wash before
proceeding to the next sample.
D) SPT Washing Station

The wash station for the sample probe consists of a single arrangement. The same position is
used as Drain Position” (for internal cleaning of the probe) and also as “Trough 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 where it is throws away the excess sample into the
drain and is cleaned internally as well as externally using a jet of DI Water.
7
1.2.3 Reagent 1/2 pipette unit (R1PT/R2PT)
Liquid Level Sensing Liquid Level Sensing

Board for R1PT Arm Board for R2PT Arm
Figure 1.6 R1PT/R2PT Unit
The reagent pipette unit (R1PT and R2PT) consists of an up-and-down movement mechanism,
rotating mechanism, level sensor and lower limit sensor. The R1PT aspirates primary reagent
contained in the reagent tray (RGT) and dispenses it into cuvettes (reaction cells) in the RCT unit. The
R2PT aspirates the secondary reagent (during the 25th cycle) contained in the reagent tray (RGT) and
dispenses it into cuvettes (reaction cells) in the RCT unit.
A) Liquid level sensor

When the tip of the nozzle reaches and touches the reagent surface, the electrostatic capacitance
of the metallic nozzle varies. The variation of the capacitance is detected and consequently the
level of reagent is detected.
B) Nozzle down limit sensor

When the tip of nozzle hits the bottom of reagent bottle due to the insufficient volume of reagent in
it, the lower limit sensor detects that the tip of nozzle hits the bottom and stops its downward
movement.
C) R1PT/R2PT Washing Station

The wash station for the reagent probes (R1PT and R2PT) consists of a double arrangement. The
same position is used as Drain Position” (for internal cleaning of the probe) and also as “Trough
Position” (for external cleaning of the probe). After the Reagent1/Reagent2 probe has dispensed
the reagent into the Cuvette, the reagent arm moves to the wash station where it is throws away
the excess reagent into the drain and are cleaned internally as well as externally using a jet of DI
Water.
8
1.2.4 Reaction Tray (RCT)
Cuvettes
Figure 1.7 RCT Unit
The reaction tray (RCT) consists of the Cuvette ring set and rotating mechanism. RCT is provided with
72 hard glass cuvettes (5mm * 5mm) on its outer circumference and the temperature inside is kept
at 37ºC (+/- 0.2ºC) constantly. The cuvettes are moved at 10-second step and a series of process
including dispensation, stirring, photometric measurement and washing be performed.
1.2.5 Reagent Tray (RGT)

The Reagent tray (RGT) consists of TBM reagent tray (reagent bottle tray), barcode reader, cooler,
sensor and rotating mechanism.
The reagent tray of the RGT accommodates at maximum 56 Reagent bottles (28 on the inner side
and 28 on the outer side).
The reagent tray rotates and the required reagent bottle is moved to the position where the reagent is
aspirated. At this position, the reagent is aspirated by the R1PT/R2PT and then dispensed into
cuvettes in the RCT unit.
i. Reagent tray
Figure 1.8 Reagent Tray
9
1) TBM type Reagent Tray is used for accommodating Reagent bottles.
The reagent tray on the RGT accommodates at maximum 56 reagent bottles.
The type of usable reagent bottles are shown below:
For TBM type Reagent Tray:

(1) Inner circumference: 50 ml
(2) Outer circumference: 20 ml
B) Reagent Bottles
The reagent bottles are available in two capacities: 20ml and 50 ml (Reagent Bottles). Both the
bottles are graduated and the user can visualize the amount of reagent present in each bottle. A
picture showing the Reagent bottles provided with the Analyzer is shown below:
50 ml Bottle
20 ml Bottle
Figure 1.9 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 50 ml and 20 ml bottles. Bar-code reader affixes Barcoded
labels on the reagent containers for identification.
C) Reagent Barcode Reader

The barcode reader reads barcode of the label affixed on the outer surface of the reagent
bottle.
When the reader does not read the barcode even if the bar code label exists, the appropriate
error message is indicated. The barcode reader used is Leuze BCL 8 Laser type reader.
The readable bar codes are as follows:
10
Symbol Valid character and symbol

NW-7 Numerals (0 – 9), symbols (-, $, /, ., +)
Code39 Numerals (0 – 9), alphabetical characters, symbols (-, space, $, /, +, %)
ITF Numerals only (0 – 9)
UPC Numerals only (0 – 9)
Code128: All ASCII code characters [numerals (0 – 9), alphabetical characters
Set A, Set B, Set C (uppercase/lowercase), symbols, control characters]
D) RGT Cooling Unit

Even if the analyzer is switched OFF, the temperature inside the RGT unit is kept within the
specified limits by the Peltier element that is controlled by CPU.
1.2.6 Photometer Unit

The Photometer Unit consists of the optical measurement system and filter rotating mechanism.
The absorbance inside the Cuvette of the CRU unit is measured by using a photometer.
Measurement is performed with any combinations of 2 wavelengths selected among the following 12
wavelengths:
340 nm, 376 nm, 415nm, 450 nm, 480 nm, 505 nm, 570 nm, 600 nm, 660 nm, 700 nm,
750nm.
The photometer consists of an illuminant (halogen lamp), lenses, optical filter and photoreceptor
(photodiode). A flat field polychromator is used for measuring the optical densities of reaction
mixtures. This polychromator is constructed with a concave grating which is optimized for forming
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 gain operational amplifiers. The amplified
voltage signals are shielded and transmitted to a high precision Data Acquisition System.
11
1.2.7 Mixing stirrer unit (STIRRER-1/STIRRER-2)

The mixing stirrer unit (STIRRER) consists of the up-and-down mechanism and the paddle rotating
mechanism.
Stirrer 2 Stirrer 1
Figure 1.10 Stirrer 1 and Stirrer 2
A) STIRRER-1
The sample and the primary reagent dispensed into cuvettes are stirred by rotating the paddle. The
paddle is washed in the STIRRER-1 trough with system water at 38º C and pressure of 0.8-1.2 bar.
B) STIRRER-2
The secondary reagent dispensed into the cuvettes is stirred by rotating the paddle. The paddle is
washed in the STIRRER-2 trough with system water 38º C and pressure of 0.8-1.2 bar.
12
1.2.8 Cuvette Rinsing Unit (CRU)
Figure 1.11 Cuvette Rinsing Unit
The Cuvette Rinsing Unit (CRU) is to wash the insides of cuvettes in which the measurement of
specimen have been completed and allow them to be reused. The CRU consists of 8 stages of
drainage and 6 injection nozzles (one of them is for drainage only), one stage of residual wipe tip,
nozzle up-and-down mechanism and overflow sensor. An additional nozzle is provided along with the
drainage and injection nozzles for Cuvette overflow protection. The processed solution in the Cuvette
is drained at the end of the completion of measurement and then their insides are washed with system
water or wash solution.
The overflow sensor observes whether the liquid in the Cuvette is fully drained or not.
Drier
Aspiration Probe
13
1.2.9 Pipetting Pump assemblies (SPP, R1PP and R2PP

Syringes)
Sample (SPP)
Syringe
Reagent 2
Reagent 1 (R2PP) Syringe
(R1PP) Syringe
Figure 1.12 Pipetting Pump Assemblies
There are 3 different syringes each for the Sample, Reagent 1 and Reagent 2.
1. Sample Syringe: The sample syringe of the analyzer is positive displacement type and dispenses
volumes between 2 µl to 60 µl. Sample volumes can be increased in steps of 0.2 µl. The sample syringe
is located behind the front panel of the analyzer and connected to the sample arm/probe using
appropriate tubing.
2. Reagent 1/2 Syringes: The reagent syringes of analyzer are positive displacement type and are
located alongside the sample syringe. Both the syringes of Reagent 1 and Reagent 2 have a maximum
capacity of 500µl each. Reagents (R1 and R2) can be programmed in steps of 1 µl. R1 dispenses volume
from 60µl to a maximum of 300 µl. R2 dispenses volume from 10µl to maximum of 300µl. The reagent
syringes are connected to reagent arms by PTFE tubing.
14
1.2.10 Ion selective electrode unit (ISE)
Waste Pump
Cal A Pump ISE Electrodes
Tube from Cal A
Pump to Cal A
Bottle
Figure 1.13 ISE Unit
The concentration of electrolyte (sodium: Na, potassium: K, chloride: Cl) contained in serum, plasma
or urine is measured by the ion electrode of the ISE unit that is placed on the left-hand side of the
analyzer. This unit is optionally supplied.
The ISE unit consists of ISE module, ion electrode, supply and drain pump.
This module unit is fitted electrodes (Na, K, Cl and Reference) and
controls pumps, measurement of concentration by electrodes and rinsing
(1) ISE module
movement. Communication to the analyzer is carried out through
RS232C.
This unit consists of Na, K, Cl and Reference electrodes.
The bottles of Calibrant-B and dedicated wash solution are placed in the
(2) Ion electrode
ASP unit and both solutions are supplied by the SPT in the same way as
for the sample.
(3) Supply pump This pump performs the infusing of Calibrant-A into ISE module.
(4) Drain pump This pump performs the transferring of liquid in ISE module.
The following solutions are requested for the ISE unit:
(1) Calibrant-A Calibrant-A is used at the time of one-point calibration.
15
The one-point calibration is carried out at the same time when the
Calibrant-A is dispensed to wash electrodes every time the sample
measurement is performed. 120µl of Calibrant-A is automatically
dispensed into the ISE unit every 30 minutes to prevent the electrode
from drying during standby cycle.
This bottle is placed on the front panel of the Analyzer supported by a
mount.
(2) Calibrant-B Calibrant-B is used at the time of two-point calibration.

As necessary, 500µl of Calibrant-B is dispensed into a sample cup that
is placed on ISE1 position of the ASP tray. The two-point calibration
should be carried out at the beginning of the day and at least once
every 8 hours or after completion of 50 samples.
(3) Cleaning solution The Cleaning solution needs to be dispensed into the unit to avoid
deposition of protein on the electrodes.
As necessary, 500µl of the wash solution is dispensed into a sample

cup and it is placed on ISE2 position of the ASP tray.
This function should be carried out twice a day, one in the beginning of
the day before the Calibration and at the end of day. When more than
50 samples of measurement are carried out, washing must be carried
out.
(4) Diluent The diluent is used to dilute urine to one-tenth in concentration. It is

contained in a reagent bottle that is placed in the RGT unit on the 53rd
position. The necessary volume for diluting one sample is 200µl. The
dilution is carried out using a Cuvette in the CRU unit and therefore
one cycle of chemistry analysis is allocated to this processing.
(5) Sampling volume at each measurement
Measurement Volume
In the case of analytic measurement Sample: 100µl
Calibrant-A: 200µl, Calibrant-B: 75µl
In the case of full calibration
Calibrant-A: 120µl, Calibrant-B: 75µl
In the case of 1-point calibration Calibrant-A: 120µl
16
1.2.11 Liquid Level Sensing Platform for external tank
Pan for DI Pan for Bio-Hazardous

Water Can Pan for Cleaning Waste Can Pan for Diluted
Solution Can Waste Can
Figure 1.14 Liquid level Sensing Platform
The Liquid Level Sensing Platform Unit is located on the outside of the Main Analyzer, and connected to the Main
Analyzer with a D-shape connector. The unit has a Tank Rack for the DI Water Can, Cleaning Solution Can, Bio-
hazardous (Concentrated) Waste can and Diluted Waste can and also has an optical or float switch sensor for
liquid level sensing against each tank.
17
1.3 Measurement flow
1.3.1 Normal measurement flow

Time Cycle Time Cycle
Analyzer action Analyzer action
(Minute) Number (minutes) number
Measure reaction
0:00 0/72 Dry the Cuvette + Add Reagent1 5:33 37
absorbance
Measure reaction
0:09 1.5 Measure reagent absorbance 5:42 38
absorbance
Add sample + Stir 1 + Measure Measure reaction
0:18 2 5:51 39
reaction mixture absorbance absorbance
Measure reaction
0:27 3 Measure reaction absorbance 6:00 40
absorbance
Measure reaction Measure reaction
0:36 4 6:09 41
absorbance absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
Measure reaction
absorbance
3:27 23 Measure reaction absorbance 9:00 60 Measure reaction
18
Time Cycle Time Cycle
Analyzer action Analyzer action
(Minute) Number (minutes) number
absorbance
Measure reaction
absorbance
Add Reagent2 + Stir 2 + Measure Measure reaction
3:45 25 9:18 62
reaction mixture absorbance absorbance
Absorbance
measurement ends
Empty Cuvette
4:03 27 Measure reaction absorbance 9:36 64 contents + Add
detergent
Empty Cuvette
4:12 28 Measure reaction absorbance 9:45 65 contents + Add DI
Water
Empty Cuvette
Water
Empty Cuvette
Water
Empty Cuvette
Water
Empty Cuvette
Water
Measure
4:57 33 Measure reaction absorbance 10:30 70 Cuvette blank
absorbance
Empty Cuvette
contents
Drying the
Cuvette
5:24 36 Measure reaction absorbance
19
1.4 Basic operational information
1.4.1 Procedure to Install the XL 640 Analyzer

Receiving Instructions
The analyzer is thoroughly tested before shipment and is packed carefully to prevent
damage during shipping and handling. Please follow these guidelines on receipt of the
analyzer:
1. 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.
2. 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.
3. Notify your service representative that the analyzer system and its components have
arrived.
4. Wait for your local service representative to unpack the system and open the
packages.
5. Follow the unpacking and storage instructions provided on the outside of the
package. Special requirements such as refrigeration are clearly marked on the
outside of the cartons and will be included in the unpacking instructions and pack
inserts.
Warranty Information
All analyzers are warranted against defective materials or workmanship for a given period
warranty does not cover any defect, malfunction or damage due to:
1. Accident, neglect or willful mistreatment of the product

2. Failure to use, operate, service, or maintain the product in accordance with the
applicable Operator’s Manual and Service Manual
3. Use of reagents or chemicals of corrosive nature
Unpacking the Analyzer

The analyzer is packed carefully to prevent any shipping damage. Upon arrival, inspect the
packing according to the list and notify the carrier of any apparent damage. Follow the steps
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.
2. Remove the top and side panels of the wooden box as a whole section by loosening
the bolts from the 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. Gently lift the analyzer from the pallet to the floor.
20
1.4.2 Procedure to Install Application software for XL 640

Analyzer
Application Software Installation

The pre-requisites for installing the application software are:
1. Verify whether the application software is already installed on the analyzer PC.
2. If the analyzer PC already has a version of application software installed, un-install
the previous version of application software.
Un-installing the previous version of application software
1. Take a backup of the file C:\Program Files\XL 640\xl.mdb.

2. Click <Start> button on the task bar menu.
3. Select Settings-Control Panel option.
4. In the Control Panel window, double click on Add/Remove programs icon. It will
open Add/Remove Program properties window.
5. Select the installed version of the application software from the Install/Uninstall tab
and click on the <Add/Remove> button.
6. A message “Are you sure you want to remove XL640 “version number” and all its
components?” shall be displayed. Click <Yes> to proceed with the uninstallation
procedure.
7. Another message will appear asking you whether all shared components should be
removed. Click <Remove All> option. A confirmation message “You are about to remove
all shared files that are no longer in use” is displayed.
8. Complete the Uninstallation process.
Software installation process

1. Insert the application software CD in the CD drive of the analyzer PC.
2. The CD automatically starts the installation of the application software.
3. If the application software screen does not appear, click on the <Start> button on the
task bar and select Run option. Click on <Browse> and select setup.exe file from
CD drive and click on <Open>. Click <OK> to start the installation process.
4. Follow the instructions displayed on the screen.
5. If a version conflict message is displayed, click <No to All>.
6. After completion of installation process, shutdown and restart the computer.
NOTE: All memory resident software including anti-virus software should

be removed from memory and screen-savers should be disabled before
starting the Application Software
21
Running the application for the first time

1. Before starting the application software, make sure that the monitor display
resolution is 800*600. Also, make sure that in the Taskbar properties, Auto Hide
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 under the name of XL 640.
3. Enter the user name and password as shown below:
Username: xl640
Password: xl640itb (for Analyzer with ISE)
Password: xl640tb (for Analyzer without ISE)
4. Click on <OK> button to proceed.
5. Go to {Previous Data: Backup} screen.
6. Click on Initialize button to initialize the Test Parameters. Further details can be
found in section 3.8 Backup/Restore.
Switching ON the Analyzer

1. Start the application software; wait for 15 seconds, then switch ON the analyzer.
2. OR Switch ON the analyzer; wait for the assemblies to get initialized, then start the
application software.
3. Once the analyzer is powered on, a timer for 45 seconds comes up in the
application software. The time delay is used for the pressure tank of the analyzer to
attain the pressure of 1.0 bar.
1.4.2 Layout of operational picture on the screen

The layout of operational picture of this analyzer is displayed on the screen as shown below.
Figure 1.15 XL 640 Application Software Main Menu
22
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 (from Left to Right):
• Patient Entry
• Reagents
• Run Test
• Calibration
• Quality Control
• Previous Data
• Test Parameters
• Maintenance
• Service Check
• Exit
The common buttons of the application software are shown below. These buttons are available on all menus
of the screen except the Main Screen.
1. Stop: This button is used for Emergency Sampling Stop.

2. Previous: This button is used for moving to the Previous record.
3. Next: This button is used for moving to the Next Record.
4. Delete All: This button is used for deleting all the records in the database.
5. Delete: This button is used for deleting a single record in the database.
6. Add: This button is used for Adding a New Record.
7. Print: This button is used for printing the record to the available printer.
8. Cancel: This button is used to cancel Add/Modify operation.
9. Modify: This button is used to modify a particular record.
10. Save: This button is used for saving a record to the database.
11. Go Back: This button is used to scroll between the sub-menus or for going back to the previous
menu.
23
Chapter 2 - Procedure of routine check
Chapter 2
Procedure of routine check
This chapter provides the operational procedures for routine check.
24
2.1 Checks prior to work and power-on

2.1.1 Checks prior to work
A) System water tank and waste tank
Confirm that
1. The system water tank is filled with pure DI water and the pH of the water is maintained at 7.0;
2. Each waste tank is emptied.
B) Cleaning solution tank

Confirm that
1. Each cleaning solution tank is filled with sufficient wash solution.
C) ISE unit
Before performing measurement with the ISE unit, confirm that
1. Electrode unit (Na, K, Cl and Reference electrodes) whose term of validity is not expired is
installed
2. The Calibrant-A bottle beside the ISE unit is filled with sufficient liquid
3. Cleaning was carried out at the end of the last ISE measurement, and
4. The Calibrant-A is flowing from the side of sample port by executing of ISE purge.
In the following cases, ISE purge should be carried out 5 times or more:
5. First measurement of ISE.
6. At the time of exchanging of the Calibrant-A.
7. At the time of being pulled up the tube from the Calibrant-A.
Note: As much as possible, the analyzer should be kept on, because 120µL of Calibrant-A is
automatically dispensed into the ISE unit every 30 minutes to prevent the electrodes from
drying. Even under the sleep condition, this function is performed.
Just after turning on the analyzer, 3-4 times of ISE purge should be carried out. All electrodes should
be fitted to the ISE module, otherwise the liquid of Calibrant-A is flooded into the inside of analyzer. It
may cause serious problem.
25
2.1.2 Preparation of external tank solutions

The external tanks of the system DI water, cleaning solution, bio-hazardous waste and diluted waste
are to be placed near the right-hand side of the analyzer on the LLS platform, and to be connected
to the analyzer with the corresponding tubes.
At just before measurement, the external tanks of the system DI water and wash solution are filled
with the corresponded liquids, and the tanks of the bio-hazardous waste and diluted waste have to
be empty.
DI Water Can Cleaning Solution Can Bio-hazardous Waste Can Diluted Waste Can
Figure 2.1 Picture of all 4 Tanks
26
Tubing for
Cleaning
Solution Can Tubings for

Tubings for
Diluted Waste
Tubing for DI Concentrated
Can
Water Can Waste Can
Figure 2.2 Tube Connections on the Rear Panel (Left to Right)
1. De-ionized Water ---- 20 liters (NCCLS Type II or better)

2. Wash solution ----- 10 liters
3. Biohazard (Concentrated) Waste ---- 10 liters
4. Diluted Waste ----- 20 liters
The de-ionized water should have a resistivity of more than 1 Mega Ohm-cm (or conductivity
less than 1µS/cm). Also the pH of the DI Water should be maintained between 5.0 - 7.0.
Preparation of wash solution: Fill the cleaning solution can (given with the Accessories List) with
10 liter of DI water. Pour the concentrated cleaning solution (such as Extran XL Wash MA03
Phosphate free) into the can to prepare a 1% detergent solution). Mix well before use.
27
2.1.3 Power-on
A) Power-on of main unit

If the main unit is attached the ISE unit, all electrodes and Calibrant-A solution should be fitted to the
ISE unit in advance with the power switch is turned on.
The power switch is located on the rear panel of the main unit.
220V Power RS232 Cable

Cable for
Supply, 5A to Analyzer
LLS Platform
Fuse or
110V, 10A Fuse Figure 2.3 Power-on switch
B) Power-on of personal computer (PC)

1. Power on the PC that is connected to the main unit.
2. Normally, the software for the main unit starts up automatically when the PC is powered on.
Make sure that the resolution of the monitor is set at 800*600 pixels.
3. After installation of the analyzer, when the PC is powered on, the analyzer should undergo
prime operation for 4 minutes.
28
C) Epson LX-300+ Printer Installation

1. Check for following points before using Application Software to generate printouts:
2. Check that printer driver is installed
3. Check that the cable between printer and the analyzer PC is connected properly
4. There should be no paper jam or any other obstruction in the printer
5. Feed the paper to the printer and switch it ‘ON’
6. Print a test page to confirm correct printing
D) Setting correct font on Epson LX-300+ Printer

1. Follow the following steps to set the printer font to Draft Condensed on Epson LX-300+
printer. This font setting is necessary for correct formatting of online result printout in
Compact mode (which can be set in the {Previous Data: System Switch} screen in the
{Online Print Format} option).
2. Turn the printer ON.
3. 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.
4. 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.
5. 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.
6. Switch OFF the printer and after 5 seconds switch it ON. The Draft Condensed font settings
are saved.
E) Spool 32 Error
1. After getting a Spool32 error during run, do not opt to close the application. 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
2. Follow the troubleshooting procedure mentioned below (Close all the applications including
analyzer application before starting the following process).
3. Delete the existing printer driver.
4. Start the Windows Explorer. Click on the View menu and then select "Folder options". On
the "Folder options" window, click on the View tab. On this tab, under the Advance settings
29
window look for the selection for Hidden files and set the selection to "Show all files" or ‘Do
not show hidden files”. Click on <OK> and close the Windows Explorer. This setting is
necessary to view the system files.
5. Insert the CD Rom having Application Software in the CD drive.
6. Click on <Start> on the window desktop Task bar and then click <Run>
7. Type "sfc" and press <OK>. A window for "System File Checker" will open.
8. Select the option "Extract one file from installation disk" on the “System File Checker”
window.
9. Click on <Browse> and select the file c:\windows\system\spool32.exe and then click on
<Open>.
10. Press <Start> on the “System File Checker” window.
11. Another window titled "Extract File" will open. Click <Browse> button next to the "Restore
From" field on this window.
12. Another window titled "Browse for folder" will open. Select CD drive, select the folder named
“Spool”, and press <OK> on this window.
13. Press <OK> on the "Extract File" window.
14. 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>.
15. Repeat the steps from step 5 to 11 but this time in the step 6 select the file
c:\windows\system\spoolss.dll.
16. Close the "System File Checker" wizard by clicking on <Close>.
17. Restart the computer.
18. Search for *.tmp files from C:\Windows folder and delete them. There would be some *.tmp
files which will not be deleted.
19. Reinstall the printer driver.
20. 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.
30
2.2 Preparation and placement of reagent

Necessary reagents, diluents and wash solutions for analyses are placed in the reagent tray. The
Reagent tray accommodates 56 bottles of them in total.
2.2.1 Reagents
One can enter this screen by clicking on {Reagents} button on the Main menu. The following screen
is displayed:
Figure 2.4 Reagents Screen
This screen is useful for checking volumes of the reagent kept on the analyzer. The reagent tray has
56 reagent positions.
{Scan}: This button can be used to start scanning the reagent volume. If the reagent bar-code is
ON in the [System Switch section 3.7] 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 56 reagent positions for
reagent volume and displays the 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 56 and correlates each reagent bottle placed at a
position with the concerned test name using the test code as programmed in the [Test Parameters].
31
{Test}: This row shows the test name for which the reagent can be used. Reagent 1 position for the
chemistry is shown by the test name followed by “:1”. 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 1 is kept at
position 25 and Reagent 2 is kept at position 26, at that position the {Test} field will read “CRE:1” and
“CRE:2” respectively. 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 volumes for reagent type bottles are user programmable and the option is made available
in [Maintenance] screen.
{#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 Light Green 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 Light Green 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 Tan 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 Chilli Red to indicate that the reagent bottle is
empty although a test has been defined for the reagent position.
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.
2.2.2 Placement and registration of reagents and diluents

The Reagent bottles are loaded in the reagent tray and kept on-board. Serum Diluent position is
variable and can be kept on one of the inner Reagent Positions. ISE Urine Diluent Position is
variable and can be set by the user using the System Switch screen (if user enters i in the password
at startup). Wash Solution is to be kept at 55th position. This Solution is used during run for first
Cuvette wash and when a Carry-Over Pair (Detergent Wash) is programmed.
32
If the reagent bottles are non-barcoded, then the user can go to the {Test Parameters} screen and
modify the position manually.
If the reagent bottles are barcoded, then the following procedure is followed:
When the user clicks on the {Run Test} button on the Main menu, the following screen is displayed:
Figure 2.5 Run Test Screen
{Run Test: Reagent Barcode scan}: If reagent barcode (optional) is set to ON in the {System
Switch section 3.7} screen, this portion can be used to scan the bar-code information on the reagent
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}. 8-digit, 14-digit or 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.
If the checksum digit does not match the checksum of the 8/14/18 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.
33
2.2.3 Reagent Level Scan

This portion can be used to scan the volume of the reagents whose tests are scheduled in the
Patient Entry screen. To start the reagent 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.
The reagent level scan is performed only for the tests that are requested (and
are in the WorkList).
Position This column indicates the position of the reagent bottle in the reagent tray
Regent This column indicates the volume of the reagent present in the reagent bottle
Level (including the dead volume)
This column indicates the name of the Tests programmed for the particular
Tests
reagent position
This column indicates the number of days for which the reagent is stable on
Stability
board as calculated from the information provided in {Test Parameters:
Days
Reagent Stability} screen.
2.2.4 Previous Data: Reagent Status

After the reagent level scan is complete, the user can either go to the {Reagents} screen to check
the reagent volume or can go to {Previous Data: Reagent Status} screen. This screen is displayed
below:
Figure 2.6 Previous Data: Reagent Status Screen
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).
34
The following details are available on the display:
Field Name Description
Test Chemistry Name
Type Reagent 1/Reagent 2
Reagent Position Position on Reagent tray
Current Volume (ml) Volume of Reagent in ml
Bottle size
Size
50 ml and 20 ml for TBM type bottles
Lot No. Reagent Lot Number
35
2.3 Preparation and placement of sample

The analyzer accommodates 50 samples for Normal and Emergency samples in Sample tubes or 2
ml cups. When the ASP is with the bar code reader, the sample tubes with caps removed and bar
code labels attached can be placed directly in the sample rack. In either case, bar code labels must
be affixed on tubes to identify patient and sample.
2.3.1 Sample barcode scan

If sample bar code is set to ON in the {Previous Data: System Switch} screen, this portion
can be used to scan the bar-code information on the sample tubes. To start the bar-code
scan, click on the <Start> button next to Sample Bar-code on the Run Test screen. 6-13
character barcode from sample tube can be read and the position is assigned accordingly. 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} screen. During Patient Run, Standard Disk Positions S1-S20 could
be used to program Emergency/STAT samples.
To clear the sample bar-code information displayed, click on the <Clear> button displayed
next to Sample Bar-code. The following screen is displayed after sample barcode scan:
Figure 2.7 Run Test Screen for Barcode Scan
36
2.3.2 Specifications of Barcode Label
Item Description
Symbols NW-7、Code39、ITF、UPC、Code128 (Set A, B, C)
The bar codes must be in conformity with one of the following
bar modules and with bar code printing range.
The maximum allowable number of digits varies depending on symbols.
NW-7 : 6 to 18 digits
Maximum Number of Code39 : 6 to 18 digits
Digits ITF : 6 to 18 digits
UPC : 6 to 18 digits
Code128（SetA）: 6 to 18 digits
Code128（SetB）: 6 to 18 digits
Code128（SetC）: 6 to 18 digits
Bar module · Fine bar: 0.25 to 1.0 mm
· Bar length ≥ 15 mm
Barcode printing · Bar code printing area ≤ 46 mm
range
· Black on white background (B633)
· Numeric coding information is printed beside bar code.
Printing
· Printing on thermal paper is not allowed in order to prevent bar code from time
varying degradation.
Positioning of · The position is such that there is no obstacle between the barcode printing area
barcode label and the bar code reader.
· Angle alignment deviation: within ±1º
37
2.4 Calibration Measurement

2.4.1 Calibration Table
One can enter the calibration table by clicking on {Calib Table} button in the Test Parameters
screen as shown below:
Figure 2.8 Calibration Table Screen

This screen enables the user to view a calibration curve, designate calibrator concentration, define
calibration curve types, and change calibrator positions after defining them in the [Calibration:
Positions] screen.
The following sequence should be used for calibration (more details given on [Calibration] screen):
1 Select the disk number on which the calibration needs to be performed.
2 Define the calibrator and blank names at desired positions in the {Calibration: Positions}
screen and select desired tests for the calibrator. The designated calibrator positions
are automatically updated in {Calib Table} of the corresponding tests.
3 In the [Calib Table] screen, define the calibrator concentrations and blank
concentrations for different tests and select Calibration Curve Type.
4 In the [Calibration] screen, click on different positions on the Standards Wheel and
select the tests for which blank and calibration needs to be performed.
5 Put the Blank on the scheduled position and the calibrator/standard on the scheduled
calibrator position.
6 Start the Standardization run in {Run Test: Run Status: Run Monitor} screen by clicking on
the <Start Std Run>.
7 Absorbance values obtained by the analyzer after the standardization run are updated
in the [Calib Table] screen. The date and time of calibration is also updated.
38
Up to three previous calibration curves/values can also be viewed or selected for use in result
calculations. It is also possible to calibrate the ISE from this 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).
If there has been some error during calibration (like reagent absent or calibrator
absent), the calibration date is updated however no absorbance values are put in
the {Calib Table}
{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: R1 Lot Number}: This field displays the lot number of Reagent 1 bottle after the
Reagent Barcode Scan. This is similar to the one used in {Test Parameters: Reagent Details}
screen.
{Calib Table: R2 Lot Number}: This field displays the lot number of Reagent 2 bottle after Reagent
Barcode Scan. This is similar to the one used in {Test Parameters: Reagent Details} screen.
Calibration Expired warning is not issued if
a) Calibration Curve Type is K-Factor, or
b) Calibration Date is available and the Calibration Expiry Limit is set as zero.
{Calib Table: Previous/Next Calibration}: Up to three previous calibration curves/values can be

viewed/obtained. One can view the previous calibration values by first clicking on <Modify> and
then on <Previous> button (below the calibration table and not the button at the bottom of the
screen). One can browse through the present calibration values and previous two calibration values
using this. The present/last calibration values are shown as the first earlier calibration to enable the
operator to view the actual calibration values in case the operator has modified the
absorbance/concentration values manually.
39
{Calib Table: Calibrator Name}: This button can be used to view the calibrator names which have
been defined in the {Calibration: Positions} screen.
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. If 2nd disk is being used for
calibration, then the user can click on the “Disk 2” button to display the positions of the calibrators on
the 2nd disk.
{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 (or B3 and B4 for disk 2). 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 {Calibration: Positions} screen, a
warning is given and the position cannot be saved until modification is made in the {Calibration:
Positions} screen.
{Calib Table: STD1/STD2/STD3/STD4/STD5/STD6/STD7/STD8/STD9/STD10}: Use the pull-down
options to select the standard positions S1 to S20 (or S21 to S40 for disk 2) for STD1 to STD10 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 {Calibration: Positions} screen, a warning
is given and the position cannot be saved until modification is made in the {Calibration: Positions}
screen.
{Calib Table: Concentration}: Use these fields to define concentrations of the standards STD1 to
STD10. The concentration values can be between 0.01 and 999999. The concentration of a blank
cannot be defined as it is considered as zero.
{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: % Acceptable Limit}: Use this field to enter the acceptable limit allowable between 2
calibrations. The user can feed any value between 1% to 10% and is expressed in terms of
percentage. The comparison is made on basis of the factor obtained. The new factor obtained is
compared with the old one and based on the acceptance limit entered, the new calibration details
are updated. If the value falls outside the acceptable limits, then the old calibration details are kept
and the new details are not updated.
Please note that the above field is applicable only for Straight and 2-
Point Mode of operation.
40
{Calib Table: Selective Calibration}: The Selective Calibration also known as One-point to
Multipoint Calibration is used when a user wants to use only a reagent blank or a single standard for
calibration. The user can define this type of calibration for individual chemistries. Default is Full. It
consists of 2 fields:
a) Type of Calibration: Three options are available in this field. Full, Blank and
Standard. Full is the default field. Blank is used if Reagent Blank correction needs to
be done. Standard Type of Calibration uses one of the concentrations from multiple
standards available and then uses the Slope method to correct the other Factors.
b) Type of Standard: This list box consists of Standard Concentrations from STD1 to
STD10. The user can select the Concentration number for which the calibration needs
to be done. Accordingly, after the calibration, all the factors for other concentrations
are updated using Slope Correction (Factor) method.
Selective Calibration would be made available to the user only

after Full Calibration of that test is performed.
{Calib Table: Calibration}: One of the following twelve methods can be selected for calculation of
the measurement results.
1. Linear (For one standard)
2. K-Factor (Use of K-Factor for Enzymes)
3. Linear (multipt) (Multi Standard)
4. 5P Logit-log (Multi Standard)
5. Exponential (Multi Standard)
6. Line segment (Multi Standard)
7. Polynomial (Multi Standard)
8. Cubic Spline (Multi Standard)
9. Poly 1 (Multi Standard)
13. 2-Point (Use of 2 Standards without Blank)
The calibration curve types are described in detail below:

1. Linear: 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 Linear type calibration curve is shown below:
41
Figure 2.9 Linear Curve
The concentration of the sample is calculated by using the following formula:
Cstd ( Asample − ABlank)

Csample =
Astd − ABlank
Where, Csample = Concentration of the sample,

Cstd = Concentration of the standard,
Astd = Absorbance of the standard,
ABlank = Absorbance of the blank,
and Asample = Absorbance of the sample
If the Blank concentration is entered, then the following formula will be used in the calculation of
Concentration of unknown sample:
(Cstd ) ( Asample − ABlank)

Csample = { }+ CBlank
Astd − ABlank
where CBlank = Concentration of the Blank
2. K-Factor: Use this method when a linear response between absorbance and concentration
is expected and you do not want to perform a calibration. The result can be obtained by
feeding a theoretical factor. For example rate assays are monitored by measuring the rate of
42
change in absorbance per minute during the linear phase of the reaction (∆Abs/min). The
K-Factor curve type is shown in the figure below:
Figure 2.10 K-Factor Curve

The results of enzyme determinations are obtained by multiplying the change in absorbance with a
factor. The factor for kinetic assay is calculated by the following formula:
TV x 1000
Factor =
SV x Mol. Extn. Coeff x P
Where, TV = Total Volume in ml,

SV = Sample Volume in ml, and
P = Optical path length in cm.
The factor should be calculated for 10 mm path length and should be entered in
the Conc column in front of the STD1 field.
The sign of the entered factor is ignored. The sign of the factor is assumed
negative and positive for decreasing and increasing direction chemistries
respectively.
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:
Csample = (Asample - Ablank) * Factor
43
Where, Csample = Concentration of the sample, Asample = Absorbance for sample,

Ablank = Absorbance for blank, and Factor = Theoretical factor
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 10 calibrators can be used (excluding 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 i Yi )⎥ − X .Y
b = ⎣ i =1n ⎦
⎡1 ⎤
( )
⎢n ∑ X i ⎥ − X
2 2
⎣ i −1 ⎦
The slope b is nothing but factor for a linear calibration curve type and therefore the concentration of
the sample is calculated as follows
Csample = (Asample - Ablank) * b
Where, Csample = concentration of the sample,
Asample = Absorbance of the sample,
Ablank = Absorbance of the blank, and
b = Factor = measured slope of the concentration vs. absorbance curve (or measured factor) by
least square linear regression method.
A screen containing Linear calibration curve is shown below:
Figure 2.11 Linear(Multipoint) Curve
44
4. 5P Calibration Logit-log: This calibration curve can be used for multipoint non-linear curve
types. It is necessary to use at least three calibrators (including blank) for this calibration curve
type. For this calibration curve type, the following equation is fitted using least square linear
regression:
K
A= B+
1 + exp(− a − b log C − c log C )
Where, A = Absorbance of the standards,
B = Absorbance of the blank,
C = Concentration of the standards
K, a, and b are constants and are evaluated using least square linear regression method.
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.
An example of Logit-log calibration curve is shown in the figure below:
Figure 2.12 Logit-Log Curve
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:
A = B + K exp {a (In C) + b (ln C)2 + c (ln C)3}

Where, A = absorbance of standards,
B = absorbance of blank,
45
C = concentration of the standards,

K, a, b, and c = calibration curve constants
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.
An example of exponential curve fitting is given in figure below:
Figure 2.13 Exponential Curve
6. Line Segment: This calibration curve type can be used when one wants to approximate different
segments of concentration vs. absorbance curve by a linear model. Therefore, this calibration curve
is obtained by linear approximation of different standard concentration segments. It is necessary to
have at least two calibrator concentrations and absorbances available (including blank) for this
calibration curve type.
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
Where, Csample = Concentration of the sample
46
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:
Figure 2.14 Line Segment Curve
7. Polynomial: This calibration curve is useful for multipoint calibration when one wants the
estimation error to be zero at the concentrations where standards are defined. Therefore, the
polynomial calibration curve obtained in this method passes through the available concentration-
absorbance points precisely. It is necessary to have at least three calibrators (including blank) to
use this calibration curve type.
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 ⎠
In a similar fashion, Lagrange’s polynomial is fitted to the standard absorbance and concentrations
available and the following equation is used to calculate the sample concentration:
n ⎛ A sample − A ⎞
= ∑ ∏ ⎜ ⎟
j
C C
sample i ⎜ Ai − A j ⎟
i=1 j≠i ⎝ ⎠
Asample = Absorbance of the sample,
Ai = Absorbance of the ith standards,
47
And Ci = Concentration of the ith standards

A calibration curve obtained using Lagrange’s polynomial is shown in the figure below:
Figure 2.15 Polynomial Curve
8. Cubic Spline: This calibration curve can be used for multipoint non-linear curve types. It is
necessary to use at least three calibrators (including blank) for this calibration curve. A mathematical
description of Cubic Spline is beyond the scope of this manual. Suitable Mathematics textbooks can
be referred to get more information on this type of curve fitting.
A calibration curve obtained using natural cubic Spline is shown in the figure below:
Figure 2.16 Cubic Spline Curve
48
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.
Calibration Equation fitted
Curve
Poly1 C=a+bA
Poly2 C = a + b A + c A2
Poly3 C = a + b A + c A2 + d A3
Poly4 C = a + b A + c A2 + d A3 + e A4
Where A = Absorbance of the standard,
C = Concentration of the standard,
a, b, c, d, and e are coefficients which are obtained by matrix solving 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.
10. 2-Point: Use this method when a linear response (between absorbance and concentration) is
expected but the 2 Standards are necessary for Calibration. In this method a two-point calibration
involving 2 Standards is performed. Joining the 2nd standard absorbance to 1st standard absorbance
by a straight line creates the calibration curve. A 2-Point type calibration curve is shown below:
Figure 2.17 2-Point Curve
49
The concentration of the sample is calculated by using the following formula:
Cstd ( Asample − Astd1 )

Csample = { 2 } + Cstd1
Astd2 − Astd1

Cstd2 = Concentration of the 2nd standard,
Cstd1 = Concentration of 1st standard,
Astd2 = Absorbance of the 2nd standard,
Astd1 = Absorbance of the 1st standard,
and Asample = Absorbance of the sample
Note: Zero Concentration cannot be entered for 2-Point

Calibration Curve Type
50
2.4.2 Calibration Menu

Click on {Calibration} button on the Main Menu Screen and the display changes to the following
screen:
Figure 2.18 Calibration 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. A drop-down box is used to select the Disk Number.
The following fields are shown in different columns in the table shown on the screen:
Field
Description
Name
Pos Indicates the position of the blank/standard/control
Indicates the tests designated for the blank/standard/control position in the
Tests
{Calibration: Positions} screen
Conc Indicates the concentration of the standard/control for that particular test
Indicates the name of the blank/standard/control, given in the [Calibration:
Name
Positions] or [Quality Control: Control Data] screens
The Standards Wheel displays various positions for standard/control/blank as they are on the
Standard tray. The positions available on the standards tray are:
a) 20 positions for standards, S1 to S20 (S21 to S40 on Disk 2)
b) 8 positions for controls, C1 to C8 (C9 to C16 on Disk 2)
c) 2 positions for blanks, B1 to B2 (B3 and B4 on Disk 2)
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
51
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.
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.
{Calibration: Positions}: Click on the <Positions> button on the {Calibration} screen and the
screen changes to the following display:
Figure 2.19 Calibration: Positions Screen
This screen is used to designate different calibrators at different positions and assign appropriate
tests that can be calibrated using the particular calibrator. A description of different fields/buttons
available on this screen is given below.
{Calibration: Positions: Position}: This Is a pull-down option to select the current blank, standard
or control position.
{Calibration: Positions: Profile}: During test designation to a position, user can also designate the
tests using the Profiles as earlier defined in the [Patient Entry: Profiles] screen. This function enables
the user to select a number of chemistries without having to click individual test icons.
{Calibration: Positions: Name}: This field is used to display the name of a calibrator if it has been
assigned. In the [Calibration: Positions] screen, names can be designated only to blanks and
standards. The names for controls are designated in the [Quality Control: Control Data] screen.
{Calibration: Positions: Disk No.}: This field is used to change the disk number.
<Page Up> and <Page Down> are to scroll through the chemistry names.
52
Different functions, which can be performed on the {Calibration: Positions} screen, are described in
the following paragraphs.
To browse/view tests selected for a particular blank/standard/control position: Use the pull-
down option {Position} to select the desired position. Alternatively, use <Previous> and <Next>
buttons at the bottom to browse through the test designations for different positions. The positions
are shown in this order: B1/B2, S1 to S20, C1 to C8. (B3/B4, S21 to S40, C9 to C16 for Disk 2)
To designate a name to a calibrator associated with a position: First select the desired position
from the pull-down option {Position}. Then, click on <Modify> button at the bottom and designate a
name as desired in the small pop-up window. The name designated will be shown in the
[Calibration] screen. The names will also be shown on the {Calib Table} screen after clicking on the
<Calibrator Name> buttons. In the [Calibration: Positions] screen, names can be designated only to
blanks and standards. The names for controls are designated in the [Quality Control: Control Data]
screen and the control position assignment is done in the [Calibration: Controls] screen.
To designate/modify tests to a particular calibrator position: First select the desired position
from the pull-down option {Position}. Then, click on the <Modify> button. Now, select the tests by
clicking on the test name icons. The selected test names are highlighted in blue text whereas the
unselected test names are kept in black color. Finally, click on the <Save> button to save the test
selection. The calibrator position for the designated tests is automatically stored 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 that is being processed. In the [Calibration: Positions] screen, for blanks and
standards all the test names are available for selection. However, for control positions, only the tests
selected in the [Quality Control: Control Data] screen are shown.
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 [Calibration: 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 {Calibration:Positions:Profile} screen. The selected test names are
highlighted in blue text whereas the unselected test names are shown in black text. Finally, one can
click on the <Save> button to save the test requests.
The tests that are selected for control positions are automatically included in the
WorkList.
53
These selected controls are marked in green color in the {Calibration} screen. Observe the color
change (from pink to green) on the {Calibration} screen on the standardisation wheel after
designating a test to a control position.
The tests for a control can also be performed at the {Calibration} screen by clicking on the control
positions on the Standards Wheel.
{Calibration:Calib Table}: Calibration table usage and procedure has been explained in section 2.4
Calibration Table.
{Calibration: Controls}: Click on the <Controls> button on the {Calibration} screen and the display
changes to the following screen:
Figure 2.20 Calibration: Controls Screen
To assign a control to a position, simply drag the name of the control from the 60 options available
and place it on any one of the desired positions C1 to C8 (or C9 to C16 if disk 2 is selected). A
61st 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
{Calibration: Positions} screen. The final test requests for controls can be made in the {Calibration:
Positions} screen or in the {Calibration} 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 60 items displayed) with the
mouse and drop over the position C2. The instrument is now set to run Erba Path at position C2.
54
During run, it is possible to add new controls but it is not possible to modify or delete tests for a
control that is scheduled to run.
{Calibration:Worklist}: A description of WorkList has already been given in the section {2.4.5
Patient Entry:Worklist}.
{Calibration:Clr Sched}: Clicking on the <Clr Sched> button on the [Calibration] screen presents
the following sub-screen on the [Calibration] screen:
Figure 2.21 Calibration: Clear Schedule Screen

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.
55
2.4.3 Calibration Monitor

If a user wants to view the latest calibration details of all the tests at the same time, then the user
can click on {Previous Data: Calibration Monitor} screen. The following screen is displayed as
shown below:
Figure 2.22 Previous Data: Calibration Monitor Screen

A description of different fields available on {Previous Data: Calibration Monitor} is given in the
table below.

Sr. No. Serial Number
Tests Test name
Rgt Pos. (R1, R2) Reagent position for R1 and R2
Calib Curve Type of Curve assigned for that chemistry
Blank pos Position of the blank (i.e. B1 / B2 / B3 / B4)
Std 1/2/3/4/5/6/7/8/9/10 pos Position of the Standard (i.e. S1-S20 or S21-S40)
Blank Abs Absorbance of blank
Abs 1/2/3/4/5/6/7/8/9/10 Absorbance of the standards 1/2/3/4/5/6/7/8/9/10
Conc 1/2/3/4/5/6/7/8/9/10 Concentration of the standards
1/2/3/4/5/6/7/8/9/10
Factor S1/S2/S3/S4/S5/S6/S7/S8/S9/S10 Factor value of the standards 1/2/3/4/5/6/7/8/9/10
Expected Blank Expected Blank absorbance

Expected S1/S2/S3/S4/S5/S6/S7/S8/S9/S10 Expected absorbance of the standards
1/2/3/4/5/6/7/8/9/10
56
Procedure to modify a Calibration Data:

If the user intends to modify the calibration data for one or more chemistries like concentration,
position, absorbances etc. then following steps can be followed:
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.
A warning “Concentration is not increasing monotonously” will be given if the

aborbance of the previous standard entered is lower than the next one.
2.4.4 Calibration Trace

This menu displays the absorbance values obtained during previous calibrations along with the
graph for Standard and Blank. The user can go to this screen by clicking on the {Previous Data:
Calibration Trace} button on the {Previous Data} screen. The display changes to the following
screen:
Figure 2.23 Previous Data: Calibration Trace 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). One can select the month and the year for displaying the Standard
and Blank data. Print Graph checkbox is enabled indicating that the graph will automatically get
printed along with the Standard and Blank data for that test. 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.
57
{RESULT DATE}: This field displays the date and time of the calibration.
{POS}: This field displays the position of the blank/standard.
{ABS}: This field displays the absorbance of the blank/standard.
{Restore Data}: This button shows the Standard and Blank data that have been restored after
installation of new software.
{Current Data}: This button shows the existing Standard and Blank data that have been executed
with the new application software.
58
2.5 Patient Entry

Clicking on the {Patient Entry} button on the Main Menu Screen presents the following screen on
display:
Figure 2.24 Patient Entry Screen

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.
The details of the different fields are given below:

{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.
{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 can 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.
For bar-coded samples the sample position is automatically assigned as per the disk number
selected after the sample bar-code scan.
For emergency samples, positions E1- E20 can be used for any disk during Patient Run.
Additionally, last five positions on any disk can also be used for emergency samples (for example,
59
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.
{Patient ID}: This field is used to assign an alphanumeric identification number of up to 20

characters to each patient. Entry in this field is compulsory and cannot be skipped.
{Patient Name}: Enter patient name in the field using the keyboard. A maximum of 30 characters
can be fed in this field.
{Disk No.}: Select disk nos. 1-10 from the pull down option. For disk number 1, a sample position
between 1 and 50 can 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.
{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.
{Date of Birth}: Use this field to specify the Date of birth of the patient. Alternately pull-down the
date of birth option 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.
{Sample Cup}: Select the sample container type from the pull down 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} screen in the
{Container} field.
{Sample Volume}: This field is masked and calculates the total sample volume that will be needed
for that sample. This volume is calculated on the number of tests selected and includes the dead
volume of the sample container (i.e. depending on the selection of cup or tube). For Sample Cup,
the dead volume is calculated from the Dead Volume Calibration done by the user for the 2ml Cup.
For 5ml, 7ml and 10ml tubes, the dead volume is calculated from the Dead Volume Calibration done
by the user for 5ml and 7ml tubes.
{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
60
range as mentioned in the Test Parameters (Chapter 3 Section 3.1 Alterations of operational
conditions). If age of a patient is not fed, default normal values are used to issue H and L flags.
{Address}: 50 alphanumeric characters are allowed in this field where one can enter the address of
the patient.
{Referred By}: This is a pull-down option to select the doctor’s name that had 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.
2.5.1 Doctor’s List

This menu can be used to maintain a list of doctors who refer patient samples to the laboratory for
testing. When the user clicks the <Doctors list> button icon on the [Previous Data] screen, the
following screen is displayed:
Figure 2.25 Previous Data: Doctor’s List Screen

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 {Doctor wise 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 value, unit, date, flag etc.
3. Click on the <Print> button on the screen.
61
The following screen displays the Doctor wise Patients:
Figure 2.26 Doctor Wise Patients Screen
{Drawn By/Analyst}: This is a pull-down option to select the Analyst’s name. The names previously
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.
2.5.2 Analyst/Location
On clicking on the <Analyst/Location> button in the {Previous Data} screen, the following sub-screen
is displayed:
Figure 2.27 Previous Data: Analyst/Location Screen
62
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. A radio button is provided to select whether Analyst or
Location should be added/modified.
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.
To modify Analyst/Location: Select the Analyst or Location which you want to modify. Click on
the <Modify> button on the sub-screen. Make the desired modifications and click on the <Save>
button on the sub-screen.
To delete Analyst/location: Select the Analyst or Location which you want to delete. Click on the
<Delete> button on the sub-screen.
{Sample Remarks}: Remarks about sample can be fed here using up to 50 alpha numeric
characters. Previously fed remarks can be selected by pull-down options. These remarks are printed in
the patient report.
{Patient Remarks}: Remarks about patient can be fed here using up to 50 alphanumeric characters.
Previously fed remarks can be selected by pull-down options. These remarks are printed in the patient
report.
{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 (as explained in
section 2.5.2 Analyst/Location) are shown in this pull-down option. The location can be quickly selected
by entering the first character of the location.
{Draw Date}: This field is used to enter the date and time at which the sample was drawn.
{Height}: This field is used to enter the height of the patient (in meters).
{Weight}: This field is used to enter the weight of the patient (in kilograms).
Body Mass Index (BMI) for the patient is calculated automatically that is used for Creatinine
Clearance calculation. BMI is calculated by the following formula:
BMI = (Weight)/(Height)2
{Urine Volume}: Use this field to define the volume of urine collected from a patient in 24-hour
duration. This is an optional 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.
63
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.
{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.
{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 positions for the sample. 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.
The last 5 positions can be used for Emergency during a patient run as well as
during a Mixed run. The positions S1 to S20 can be used only during a Patient run.
{Category}: This field is used to identify the sex of the patient. Select as either Male or Female.
{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 sample for the particular patient
is bar-coded or not.
{Calculation Item}: Use this section of the screen to select Calculation Items that need to be
calculated from the test results. Upto forty 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.
{Selected Test}: In this section of the screen, all requested tests for the patient are displayed. A
“ ” 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.
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 also be required if the sample container
is not bar-coded. If sample bar code is activated, the analyzer updates the sample position after
64
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.
To search a patient by the patient ID, do the following:

1. Click on the <Search ID> button (under the Patient ID field)
2. Feed the patient ID you want to search
3. Press <Enter>. If the patient ID exists, the patient’s record is presented immediately. Otherwise,
a message “Patient not available” is displayed.
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.
Patient ID cannot be modified
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 that you want to delete and click on <OK>.
The other buttons available on the ‘Patient Entry Screen’ are:

1. <TESTS>
2. <Profile>
3. <WorkList>
4. <Clr. Sched>
65
5. <Del Disk>
The functions of these buttons are described below.
2.5.3 Patient Entry: Tests

Upon clicking the <TESTS> button on the [Patient Entry] screen, the display changes to the
following screen:
Figure 2.28 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:
a. Patient ID
b. Sample position
c. Sample Volume type [Normal|Decrease|Increase]
d. Emergency [YES|NO]
e. Bar-code [YES|NO]
f. Sample cup [Cup|Tube]
g. Calculation Items
h. Profile Name selection
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.
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If the calibrations for the test have not been done or if the calibration of the tests have expired,
then a warning “Calibration for .. not done/expired” is issued on the screen. If the sample barcode
is set to “YES”, then the warning “Sample position will be ignored” is given and that test is run
only after a Sample barcode scan is done for that patient.
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.
2.5.4 Patient Entry:Profile

The detailed explanation can be found in section 3.4 of chapter 3 Alterations in operational
conditions.
2.5.5 Patient Entry:Worklist

Click the <WorkList> icon on the screen of ‘Patient Entry’. The display changes to the following
screen:
Figure 2.29 Patient Entry:Worklist Screen
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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:

Disk No. This field shows the disk number that has been selected
This field shows the Sample position assigned. For bar-coded
Sample Position
samples, the position is assigned after the sample barcode scan
Test Name This field displays the test name
This field shows the number of repetitions that a test will undergo
Replicates
during a run
Run Type This field indicates whether the run is Serum/Urine/Other type
This field indicates whether the sample volume is
Sample Volume
Normal/Increased/Decreased
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.
2.5.6 Patient Entry: Clear Schedule

Clicking on the <Clr Sched> button on the {Patient Entry} screen presents the following sub-screen:
Figure 2.30 Patient Entry: Clear Schedule Screen
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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.
{Clr. Sched: Selected Schedule} The program displays a list of sample positions pending for
analysis. Tick the appropriate boxes to select the samples to be eliminated from the run. The
program confirms the intention before removing the samples from the WorkList.
2.5.7 Patient Entry: Refresh

This button is used to receive latest patient data from the host computer if the analyzer PC is
connected to a host computer. To use this facility, it is necessary to set the Host Selection ON in
{Previous Data: System Switch} screen.
2.5.8 Patient Entry:Del Disk

This button can be used to delete patients’ entries or sample positions disk wise as well as for
selective sample positions. By clicking on <Del Disk> button, a sub-screen as shown below appears
on the [Patient Entry] screen:
Figure 2.31 Patient Entry: Delete Disk
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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.
To delete patients details on selective positions: Enter the sample positions in the “From Pos”
and “To Pos” fields. Click on <OK> button. (There is no need to select a disk number). The positions
could be overlapping from one disk to another.
Once the Patient IDs are deleted, they cannot be retrieved again
To delete samples positions and schedule on one particular disk without deleting patient
details: Select the disk number and tick the option “Delete Positions and Schedule only”. Click on
<OK> button.
To delete selective positions and schedule on selective positions without deleting patient
details: Enter sample positions in the “From Pos” and “To Pos” fields. Tick the option “Delete
Positions and Schedule only” and click on <OK> button. (There is no need to select a disk number).
The positions could be overlapping from one disk to another.
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2.6 ASTM Host

A built-in ASTM Host is available in the Application Software. Host Settings are provided in the
Previous Data:Host Settings screen. Following parameters are available in the Host Settings screen:
A) Through RS232C:
Sr. No Parameter Explanation

1 COM Port Select COM Port selection with LIS
2 Baud Rate Selection of Baud Rate. Default is 9600
3 Parity Selection of Parity Bits. Default : None
4 Data Length Selection of Data Length in Bits. Default : 8
5 Stop Bits Default: 1
B) Through TCP/IP:
Sr. No Parameter Explanation

1 IP Address Enter IP Address (LAN Address) of the computer system where LIS is installed
2 Port Select available port on computer system IP
The following screenshot shows the Host Settings in the Previous Data screen:
Figure 2.32 ASTM Host Settings
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2.7 Initiation of measurement and monitoring
2.7.1 Initiation of measurement

The analyzer performs automatically sample measurement, computation and printout of
measurement results and transfer of the measurement results to the host computer
The lamp and the temperature in the analyzer are stabilized at least 30 minutes after switched on.
2.7.2 Measurement and monitoring of Sample during

Standardisation
Steps required by a user to perform standardisation are given below:
1. Go to [Calib Table] screen and select the appropriate calibration curve type that you want to
use. Designate calibrators at desired positions in the {Calibration: Positions} screen as
mentioned in the section 2.4.2 Calibration Menu. If Controls are to be run as part of
standardisation, define the Controls in the {Quality Control: Control Data} screen.
2. Designate calibrator concentrations in the [Calib Table] screen as mentioned in the section
2.4 Calibration Table. Define the target and SD values for controls in the [Quality Control]
screen.
3. Designate the controls at desired positions (C1 to C8) or (C9 to C16 for Disk 2) in the
[Calibration: Controls] screen following the procedure described in the section 2.4.2
Calibration Menu. Request tests for calibration and QC in the [Calibration] screen by
clicking on the desired positions in the Standards Wheel and selecting the relevant tests.
4. View the selected tests in the [Worklist] screen. If necessary, make modifications in the test
requests by following the aforementioned steps.
5. Place the calibrators (including blanks) and controls at the desired positions on the standard
tray.
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. After the user has clicked on the “Start Run” button, 4 options
come up on the Run Monitor screen:
i. Scan: If the user clicks on this button, the Reagent 1 arm will scan the reagent
positions of the scheduled chemistries and then start the sampling.
ii. All Scan: If the user clicks on this button, the Reagent 1 arm will scan all 56 reagent
positions and then start the sampling.
iii. No Scan: If the user clicks on this button, sampling will start immediately without
performing any level scan.
iv. Cancel: If the user does not wish to start the run, then he/she can click on this button.
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Figure 2.33a Run Monitor Screen

If Printer is set to ON in the {Previous Data: System Switch}, the calibration table details will be
printed immediately after the Standardisation run for Detail mode Printer Selection. (These details
are not printed during a Mixed Run). The user can enter the Patient Entry screen by clicking on the
Patient Entry button placed next to Reagent Status button. The user can go to Patient report by
clicking on the Report button, the button is disabled at the start of run & gets enabled as the Test
results are displayed in the grid.
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.
2.7.3 Measurement and monitoring of Sample during Run

The user can monitor the Sample measurement on the Run Monitor screen shown above. If the
user wants to add a new sample (Continuous Sample Loading), the following procedure should be
used:
1. When the user wants to add new samples, Entries should be done in the Patient Entry
screen keeping Barcode “ON” and not assigning any sample Position to the Patient.
The user must use the same disk number as selected in the Run Monitor screen.
2. Add new samples in the Sample Tray.
3. Click on the Sample Added button (This button is located on below the <Start STD Run>
button.
4. Sampling is paused for 30 seconds. Sample Barcode scan starts and the positions of new
samples get registered in the Patient Entry screen.
5. Sampling resumes after 30 seconds.
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Two kinds of STOP are available to the user during the run. They are “Emergency Stop” and “Stop
Sampling”. The following screenshot shows the 2 different kinds of Stop during the run:
Figure 2.33b STOP Function
a. Emergency Stop: If the User selects the Emergency Stop button and clicks OK,
then the run stops immediately and the assemblies initialize.
b. Stop Sampling: If the user selects the Stop Sampling button and clicks OK, then
the sampling is stopped but the results of the processed chemistries are given out.
2.7.4 Detection of Clot during Run

If a clot is detected during the run, then the following message will appear on the screen and the sample
will go to ISE position for Sample Probe Wash (4 times):
Figure 2.33c Clot Detection function
Figure 2.33c Clot Detection function
If a clot is detected again for the same sample, then the sample will be skipped (depending on the number
of times clot detection in a sample is done in the System Switch) and the Sample Probe will go for a
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Wash. The following screenshot shows the message that appears when the Clot is detected continuously
in the same sample:
Figure 2.33c Clot Detection function for one sample
If a clot is detected for another sample, then the sampling is paused and the results for those tests in the
cuvette are printed out. The remainder patients along with the patient samples where clot is detected will
be placed in the Pending List. After the Run is complete, the Sample Probe automatically performs
Sample Probe Wash for further cleaning. The following figure shows Sampling paused after repeated clot
detection:
Figure 2.33d Clot Detection function for repeated samples
Note: If a clot is detected, then all the Dilution chemistries and ISE Urine
chemistries will not be executed. Also, the user needs to manually
remove the clot if it has not been cleaned by internal and external
washing
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2.7.5 Measurement and monitoring of Reagent during Patient

Run/Mixed Run
The user can monitor the Reagent Level graphically by clicking on the Reagent Status button. Also,
the User can go back to the Run Status screen to check the amount of Reagent Level left over for
individual chemistries.
The following screen is displayed on clicking the Run Status button:
Figure 2.34 Run Status Screen

This screen enables the user to view the status of the reagents on-board before the run and during
the run. The details of the various columns is shown below:
Tests In this column, short names of the scheduled chemistries are shown.
Scheduled In this column, total number of tests scheduled for the chemistries are shown.
In this column, number of tests completed is shown. Before starting a run, this number is
Completed
zero.
In this column, number of tests that are being performed on the analyzer is shown. Before
In Process
starting a run, this number is shown as zero.
In this column, the number of tests that are pending still are shown. Before starting the run,
this number is same as Scheduled. If a run completes without any error, this number will be
Pending
zero at the end of the run. Otherwise, this number will show the number of tests that have not
been performed due to sample/reagent absent errors.
Reagent
In this column, position of Reagent 1 and Reagent 2 (if any) for each test is shown.
Position
Reagent In this column, the size of the reagent bottle (Large or Small) is shown as defined in the Test
Bottle Size Parameters screen.
Reagent In this column, the volume of the reagent available for analysis is shown after subtracting the
Available dead volume.
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Possible In this column, the number of tests that are possible to be performed with the available
Tests reagent volume is shown.
If the user wants to add a new Reagent bottle, the user can click on the Add Reagent button in the
Run Monitor screen. This facility is known as Continuous Reagent Loading. Following is the
procedure for carrying out the Continuous Reagent Loading:
a. The user clicks on the Add Reagent button.

b. After the button is clicked, the message “Please do not open the lid” appears on
the screen. Sampling will pause after the completion of Reagent 2 dispensing.
c. Once the message disappears, the user can safely open the lid and place new
reagent bottles.
d. After the lid is closed, Reagent barcode scan starts after 30 seconds.
e. After the completion of Reagent barcode scan, the Reagent positions of the new
test are updated.
f. Sampling resumes after 40 seconds.
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2.8 Reproduction of Measurement Results

2.8.1 Result Backup
One can enter this screen by clicking on {Previous Data: Result Backup} button in the {Previous
Data} screen.
Figure 2.35 Previous Data: Result Backup 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. This information is also stored
in .txt format in C:/XLBackup.
The program displays the following information listed in the table below:
Sr. No. Serial number of the entry
Patient I.D. ID of the sample
Patient Name Name of the patient
Sample Position Sample position at the time of analysis
Test Test name
Result Result obtained
Unit Unit of the concentration
Flag Flag, if any has been generated
Time course Time course number
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2.8.2 Result Reprint

One can enter this screen by clicking on {Previous Data: Result Reprint} button in {Previous Data} screen.
Figure 2.36 Previous Data: Result Reprint Screen
This menu enables the user to retrieve and print the results batch wise or date wise. For this, two
options available on this screen: {Latest Batch} and {Date wise}.
The Date wise report formatting has three fields that need to be selected before the results are
displayed.
Date: User can select the date of choice. Alternately, the user can enter the date manually using the
keyboard.
Batches: If more than one batch was run on the selected date, the pull-down option provides the
batch number choices to the user. Select any appropriate batch and the analyzer immediately
displays the result for the particular batch.
All data: Instead of viewing results of a particular batch, all batch results of a particular date can be
viewed by selecting this bullet.
Normal/Multi-Column Format: This selection enables the user to select the mode of printing the
results. Multi-column format is used to print selects column-wise. This type of format can be used to
fit more results on the same page.
Total Records: This field shows the number of records that are run in a batch or over several
batches during the day.
Archived Data: This field shows the list of files that have been archived. Click on Archive data check
box and select the required file.
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.
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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.
The second option available on {Previous Data: Result Reprint} screen is {Latest Batch}.
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 {Date wise} and {Latest Batch} tabs are explained below:
Patient I.D. Patient ID
Indicates whether the result has been sent to Host PC or not.
“Sent to Host” indicates that the result was sent to host successfully. The font is
indicated in Green Color.
“Not sent” indicates that the result has not been sent to host but can be sent to
Host Status
host manually. The font for “Not Sent” is indicated in Red Color
No status indicates that the result was obtained with a flag so the result was not
sent to host. The flags required to be sent to host can be set in the system switch
screen.
Sa pos Sample Position
Test Test name
Result of analysis. If the patient result is high or low, then the text for entire data
Result
along with the sample position is indicated in Blue color
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
{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 OFF or ON LINE.
The button <Send to Host> will not be available during run if the selection {Host Selection}
is set to ON LINE.
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2.8.3 Test Statistics

One can enter this screen by clicking on {Previous Data: Test Statistics} button in {Previous Data} screen.
Figure 2.37 Previous Data: Test Statistics Screen
A description of various fields available on this screen is given below:

{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.
{All Results}: Checking this option displays all the results.
<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.
{From}: Enter the beginning date for the results to be analyzed.
{To}: Enter the ending date for the results to be analyzed.
{Patient/Standard/Controls}: Using this radio button, select Patient to obtain the details of patient
results or select Standard to obtain standard absorbances for any chemistry or select controls for
obtaining statistics on the different levels of controls run.
{Results}: This field is used to display the number of result/absorbance items that have been
selected (checked).
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{Average}: This field displays the average of the result/absorbance items that have been selected
(checked).
{Std. Dev}: This field displays the Standard Deviation of the result/absorbance items that have been
selected.
{%CV}: This field displays the %CV (coefficient of variation) of the result/absorbance items that have
been selected (tick-marked)
{Range}: This field shows the Range of the results that fall within the selected criteria. It shows the
difference between the minimum and maximum range for the same.
<Sr. No. Wise>: 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.
{Total Tests}: This field displays total number of results/absorbances available.
{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. This is applicable only for patient results.
{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. This is applicable only for patient results.
{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. This is applicable only for patient results.
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2.8.4 Time Course

One can enter this screen by clicking on {Previous Data: Time Course} button in {Previous Data}
screen.
Figure 2.38 Previous Data: Time Course Screen
This screen can be used to view the absorbance course (absorbance vs. time curve) 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 Time course> 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. M1S, M1E, M2S and M2E for a particular chemistry are shown on the time
course. These points can be identified by legends placed below the time course.
NOTE: If the Chemistry is deleted, then the Assay Points on the

Time Course will not be shown.
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
83
contains the absorbance data. An explanation of various columns shown in the table is given
below:
Column
Description
Name
Cuv. Pos. Cuvette position (1 to 63) in the absorbance cycle
Absorbance of the reaction mixture at primary wavelength after subtraction of
Ap
Cuvette blank absorbance at primary wavelength.
Absorbance of the reaction mixture at secondary wavelength after subtraction of
As
Cuvette blank absorbance at secondary wavelength
The difference in absorbance at primary and secondary wavelength after
Ap-As
subtraction of Cuvette blank absorbance (that is, it is the difference of Ap and As).
Current This shows the reaction curves of the tests that have been run with the installed
Data software
Restore This shows the backed up reaction curves from previous version or results
Data obtained from existing version and data being backed up on the hard disk
{Time Course: Graphic}: Graphical representation of the reaction is available on the right hand
side of the [Previous Data: Time Course] screen.
Double click on the graphic to enlarge the graphical presentation. (Double clicking on the enlarged
graphic will bring it back to normal size). An enlarged graphic of time course is shown below:
Figure 2.39 Time Course Graph Zoom

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.
The following options are available to change the time course graphic display:
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For graphical representation of the reaction, the options available are Ap, As, Ap – As,
Format
All
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
Magnify
choice maximizes the view span. Click the indicator box once again and display changes
back to the zoomed-in view of the reaction.
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2.9 Patient Report

One can enter this screen by clicking on {Previous Data: Patient Report} button in {Previous Data}
screen. The following screen is displayed:
Figure 2.40 Patient Report Screen

The following tab options are available to the user on this screen
1. Results (displays photometric test results)
2. Calc Item Results (displays Calculation Item results)
3. Offline Results (displays Offline Entry results)
4. ISE (optional) Results (displays ISE results)
On each of these tabs, the program displays the following patient and result details:
Field Description
{Result Date} This displays the date and time of the result
{Patient ID} This displays the Patient ID
{Patient Name} This displays the name of the patient if entered in the
Patient Entry screen)
{Test} This displays the value of the obtained result
{Result} This displays the value of the obtained result
{Unit} This displays the unit of that test
{Flag} This displays the assessment flag (if generated)
{Normal Range} This displays the Normal Range of the test as
specified in the Test Parameters screen
{Age} This displays the age of the person in Years, Months
or Days
{Sex} This displays the Sex of the person
{Referred By} This displays the Doctor’s Name
{Modified} This displays whether the result has been modified
{Last Modified} This displays the last date when the result had been
modified
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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.
Five different types of options are available to the user for viewing the patient data:
1 Date Wise Selection: To view the patient results for a particular day, select the desired
date from the {Date wise} 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.
2 Patient ID Selection: It is also possible to search for a particular patient’s records, by
searching the Patient ID. This facility enables a user to obtain a particular patient’s
results. Note that all the results (including the old results) of the patients are displayed
when the Patient ID is searched.
3 Patient Name: It is also possible to search the patient record by the individual’s name.
4 Location: It is possible to search for a patient’s record by location. This location is
similar to the one selected in <Previous Data: Analyst/Location> screen. This helps
the user to get all the patient records from a particular location.
5 Batch: It is possible to search the patient results batch wise. Patient Records are
displayed depending on the batch number selected from the drop down box.
Data Archive : Click on Archive data check box and select file and double click on the
archive file list box.
By default, all result data that 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. The <Refresh> botton
helps in displaying the new patient results during run.
{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.
Figure 2.41 Patient Report: Headings Screen
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Enter the address of the hospital/laboratory as Heading 1, 2, 3, 4, and 5 in the five lines provided.
These headings are stored in the memory of the program and are printed as the headings for the
patient report.
{Patient report: Print Selected Results}: Click on <Selected Results> button. Wait for the display
to change to the following screen.
Figure 2.42 Patient Report: Print Selected Results
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).
Two different types of Report Formats are available which are further divided into 4 different
formats.
b. Normal Reports
c. Graphical Reports
A) Normal Reports: 4 different types of formats are available in this category.

a) Normal All Flags: This type of Report will display all patient results.
b) Normal HL Flags: This type of Report is used for viewing patient results with H
and L flags only.
c) Multi All Flags: This type of report is used for viewing all patient results in
multiple column formats.
d) Multi HL Flags: This type of report is used for viewing only H and L patient
results in multiple column formats.
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b. Graphical Reports: 4 different types of formats are available in this category.

a) Normal All Flags: This type of Report will give a graphical display of all Patient
Results. A graphical representation of the Patient Result will be shown with
reference to the Normal Values fed in the Test Parameters screen. If the result
falls below the normal range, it would be shown in the “Yellow” region. If the
result falls within normal range, then it would be shown in the “Blue” region. If
the result falls above the normal range, then the results shall be shown in the
“Red” region.
b) Normal HL Flags: This type of Report is used for viewing patient results with H
and L flags in Graphical format.
c)Multi All Flags: This type of report is used for viewing all Patient results in multiple
column formats in graphical format.
d) Multi HL Flags: This type of report is used for viewing only H and L patient
results in multiple column formats in graphical format.
By default, only the result data that 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, Lim0, Lim1,
Lim2, LINXX.
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.
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.
2.9.1 Offline Entry

One can enter this screen by clicking on {Previous Data: Offline Entry} button in {Previous Data}
screen.
This menu enables the user to enter data for any patient without having to actually 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:
89
Figure 2.43 Previous Data: Offline Entry Screen
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:
Sequence No. This is a serial number generated by the software to aid the operator in keeping a
count of the number of offline entries made
Result date Select/enter an appropriate date for patient report
Patient ID Select Patient ID with the pull-down option provided.
It is also possible to search for a particular patient ID using the search option
provided.
Sample position Enter an appropriate sample position
Result Enter an appropriate numeric data

Normal min Enter an appropriate normal value minimum of the assay
Test Enter chemistry name
Unit Select an appropriate unit for assay
Flag Enter the flags to be printed with the result
Normal max Enter an appropriate normal value maximum of the assay
{Offline Entry: Complete Data}: The analyzer displays all offline entries here. Here, the entries can also
be deleted by selecting the desired results and clicking the <Delete> button at the bottom. The offline entry
result of that patient is displayed in the patient report where the user can print this result in a report format.
This screen is shown below:
90
Figure 2.44 Offline Entry: Offline Complete Data Screen
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2.10 Sample Rerun

If a user wants to view the details of the tests that have gone for a rerun, one can click on {Previous
Data:RerunList}. The following screen is displayed:
Figure 2.45 Previous Data: Rerun List

A description of the various columns on the screen is shown below:
Sr. No. Serial number of the entry
Patient I.D. ID of the sample which has gone for rerun
Sample Position Sample position at the time of analysis
Date Date and time when the test was performed
Batch No. Batch number during which sample was assayed
Run type Sample type (Serum/Urine/Other)
Test Test name
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)
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2.11 Pending List

One can enter this screen by clicking on {Previous Data: Pending List} button on {Previous Data}
screen.
Figure 2.46 Previous Data: Pending List

This screen provides the user a list of tests that are pending due to Sample, Reagent 1, Reagent 2
and Diluent 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. The following screen
shows the {Patient Entry} screen after the user has clicked on “Rerun” button in Pending List.
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2.12 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:
Accuracy of the analysis (i.e. whether the values obtained are correct)
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:
Figure 2.47 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 type and an easily identifiable name to the Controls. Four choices namely, A,
B, C and D are available for type 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:
1. Select a test name with the pull-down option
2. Click on the <Modify> button
3. Enter Mean and SD values and click on the <Save> button
After Quality Control sera are run, the program calculates some parameters that are displayed
under the headings of X-Calculation, X-bar-Calculation and R-Calculation. These parameters are
presented in four rows corresponding to the Controls of levels A, B, C and D respectively. Five
parameters namely N, Mean, SD, %CV and R are presented in five columns. The calculations for
these parameters have been explained below.
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a) X-Calculation - These parameters are obtained from the Control results of the day for all the four
different types of Controls (A, B, C and D). 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:
N: The total number of runs in the day for the Control for the selected test
Mean: Average of the Control results in the day for the selected test
SD: Standard Deviation of the Control results in the day for the selected test
%CV: Percent coefficient of variation of the Control results in the day for the selected test
R: Range, that is, the difference between the maximum and minimum values obtained for that
Control during the day for the selected test
b) 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:
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
Mean: Average of daily averages of the results of the corresponding Control obtained in last one
month for the selected test
SD: Standard Deviation of the daily averages of the results of the corresponding Control obtained in
last one month for the selected test
%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
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
c) 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:
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
Mean: Average of daily ranges of the results of corresponding Control obtained in last one month for
the selected test
SD: Standard Deviation of daily ranges of the results of the corresponding Control obtained in last
one month for the selected test
%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
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.
95
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>
A description of each of these sub-menus is given below:
2.12.1 Tests
This screen is used to select appropriate tests for which the user wants to set or 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.
2.12.2 Daily QC
The following screen appears if you click on the <Daily QC> button on the [Quality Control] screen:
Figure 2.48 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.
96
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.
The pull down option {Control level} allows the user to select Daily QC chart of A, B C or D type
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).
2.12.3 Monthly QC
The following screen appears if you click on the <Monthly QC> button on the [Quality Control]
screen.
Figure 2.49 Monthly QC Screen
This screen is a graphical representation of the daily means and daily ranges of Control results. “To”
Range is given for displaying the last 30 days QC results. This date range can be changed using the
Date Calendar provided. Once the date is selected, the From Date period display automatically
changes to 30 days prior to the “To” Date selected. 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 type. The lower plot can be used to view the daily range values of the
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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 type} 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 type A, B, C or D).
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 type Control during last one month), and N (The total number of
days on which the selected Control was run).
2.12.4 Twin Plot

This screen can be accessed by clicking on <Twin Plot> button on the [Quality Control] screen. The
display changes to the following screen.
Figure 2.50 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
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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, Types of the Controls (A or B C or D), 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.
2.12.5 Control Data

On clicking the <Control Data> button on the [Quality Control] screen, the display changes to the
following screen:
Figure 2.51 Control Data 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 name to the Controls and its level.
Four choices namely, A, B, C and D are available for type selection.
To add a Control, follow the procedure mentioned below:
1. Click on the <Add> button on the {Quality Control: Control Data} screen.
2. Enter a Control name.
3. Select the type of this Control A, B, C or D using the pull-down option.
99
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
Mean and SD values for the particular test as given in the Control Sheet.
7. He/She can modify the Control Name along with the tests using the Modify button.
8. If the user wishes to delete a control, he/she can use the delete button at the bottom menu.
2.12.6 Reports
You can reach this screen by clicking on <Reports> button on [Quality Control] screen. There are
four options available on this screen.
1. <Indv Mon>: Individual Monitor
2. <Indv List>: Individual List
3. <Cuml Mon>: Cumulative Monitor
4. <Data Reprint>: Data Reprint
These options have been described in the following sub-sections.
Individual Monitor
Clicking on <Indv Mon> button on [Quality Control: Reports] screen changes the display to the
following screen:
Figure 2.52 Individual Monitor 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:
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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.
Individual List
Clicking on <Indv List> on the [Quality Control: Reports] screen changes the display to the following
screen:
Figure 2.53 Individual List 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 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.
Sr. no. This column displays the sequence number

Rgt Pos This column displays the reagent position assigned to a specific
test
Test This column displays the short test name
N This column displays the number of Control runs for that test
Calc It is the calculated average of measurement result values for each
Mean test item
2SD This is the preset mean value +/- 2X the preset SD value set at
Limits [Quality Control] screen for that test
Calc SD This is the SD calculated from the N observations for each test
item
CV (%) The CV % is calculated from the mean and SD for each test item
Range The range is the maximum measured value minus the minimum
measured value for that Control for the corresponding test
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Mean This is the preset mean value set at [Quality Control] screen for
the corresponding test
SD This is the preset SD value set at [Quality Control] screen for the
corresponding test
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.
Cumulative Monitor
Clicking on <Cuml Mon> changes the screen to the following display:
Figure 2.54 Cumulative Monitor Screen

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 type, mean 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.
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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).
2.12.7 Procedure to run a Control

1. Click <Control Data> on the [Quality Control] screen.
2. Follow the procedure as given in Section 2.12.5 Control Data for addition of controls along
with the test associated with the control.
3. Return to the Main Menu screen by clicking <Go Back>. Click on the [Calibration] button on
the Main Menu screen. Click on <Controls> 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 (C9 to C16 if disk 2 is selected). Click <Go Back> to return to the [Calibration]
screen. Click on <Positions> and on the {Calibration: Positions} screen, select the desired
Control position (C1 to C8) for which tests need to be designated. If disk 2 is selected on the
Calibration screen or on Controls screen, then the control positions available will be
between C9 to C16. For detailed information please refer Section 2.4.2 Calibration Menu.
4. 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.
5. Click on <Save> to save the selections.
6. Click on <Go Back> to return to [Calibration] screen and notice that the colors of the Control
positions change to green on the Calibration wheel. This indicates that the analyzer will
perform analysis on that Control. If the user has selected the option of running Controls at
fixed intervals, the Controls at selected positions will run during the patient run. For detailed
information on programming the controls please refer Section 2.4.2 Calibration Menu.
7. 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.
8. After the analysis is over, view the updated QC data on the [Quality Control: Daily QC]
screen by clicking on <Quality Control> button on the “Main Menu Screen”.
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104
Chapter 3 - Alterations of Operational Conditions
Chapter 3
Alterations of Operational Conditions
This chapter provides the procedures of settings and their alterations of
operational conditions including test parameters, serum indices, result re-
calculation, profile entry, system switch, backup and restore, delete data, etc.
105
3.1 Functional items

This chapter addresses how to enter and change the operational conditions and parameters of
each functional item. Such functional items are shown below:
Section Functional item Description

Analytical conditions have been predefined but part of them can be
3.2 Test Parameters
altered as necessary.
Serum Indices Entry of various parameters for the measurements of turbidity (L),
3.3
hemolysis (H) and icterus (I) in the serum.
The equation is defined to derive the computed result using results

3.4 Calculation Items
obtained from multiple tests.
The profile (check in a set) is specified to enable the multiple

3.5 Profile Entry
methods to be selected at a time.
This is used for recalculating values for blanks, standards, controls

3.6 Result Recalculation
and results without running patient samples.
Specification of serial communication with the host computer, date,

3.7 System Switch
time and specifications of barcodes and ISE are specified.
Backup/Restore This is the function to save the analyzer-specific parameters and

3.8
operation user parameters to and load them from the appropriate location.
3.9 Delete Data This is used to delete the redundant data from database
This is used to display the present database status and the total
3.10 Database Status
number of records that can still be programmed.
This is used to program the Carry over pair to eliminate the

3.11 Carry Over Pairs
Reagent probe carry over.
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3.2 Test Parameters

3.2.1 Method Conditions:
This is the first sub-menu available on “Main Menu” screen of the software and can be viewed by
clicking on the <Test Parameters> button on the Main Menu screen. This is to define the various
parameters including measurement conditions, sampling volume, dilution conditions, type of
reagent, etc. The following conditions need to be defined for all methods registered in the
analyzer.
Figure 3.1 Test Parameters Screen
(1) Test Code

This field is used to give a unique number between 1 to 99 to different assays. This code is used as
a 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.
(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.
It is prohibited to give the name in duplicate, even if it is applied to different

method number.
(3) Test 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).
107
(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:
1POINT for end point chemistries
2POINT for end point chemistries using sample or reagent blank
RATE–A for kinetic/rate assay
RATE–B for kinetic/rate assay with differential slope
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
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.
ABS2
ABS1
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
∆A / ∆T = ⎣ ⎦
i =1
⎡1 n 2 ⎤
( )
⎢ n ∑ Ti ⎥ − T
2
⎣ i −1 ⎦
Where, Ti is the time in minute and Ai is the absorbance, n is the number of points.
108
ABS ABS
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.
ABS1/min
ABS2/min
(5) Assay Points

The analyzer records absorbance for a Cuvette every 10 seconds over a span of 10 minutes 30
seconds. Operator should select/fix Cuvette readings to be used for result calculation. These
measurement points are referred to as M1Start, M1End, M2Start and M2End and can be given a
value between 1 and 63 (zero means “no entry”). The absorbance readings can be obtained from the
[Previous Data: Time Course] screen. The table below shows the measurement times
corresponding to values of assay points chosen.
Time of
Time of measurement
Assay Point measurement
(In minutes and seconds)
(In seconds)
0 0 0 min 00 sec
1 (R1 Dispense) 09 0 min 09 sec
2 (Sample Dispense) 18 0 min 18 sec
3 27 0 min 27 sec
4 36 0 min 36 sec
5 45 0 min 45 sec
6 54 0 min 54 sec
7 63 1 min 03 sec
8 72 1 min 12 sec
9 81 1 min 21 sec
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Time of
Time of measurement
Assay Point measurement
(In minutes and seconds)
(In seconds)
10 90 1 min 30 sec
11 99 1 min 39 sec
12 108 1 min 48 sec
13 117 1 min 57 sec
14 126 2 min 06 sec
15 135 2 min 15 sec
16 144 2 min 24 sec
17 153 2 min 33 sec
18 162 2 min 42 sec
19 171 2 min 51 sec
20 180 3 min 00 sec
21 189 3 min 09 sec
22 198 3 min 18 sec
23 207 3 min 27 sec
24 216 3 min 36 sec
25(R2 Dispense) 225 3 min 45 sec
26 234 3 min 54 sec
27 243 4 min 03 sec
28 252 4 min 12 sec
29 261 4 min 21 sec
30 270 4 min 30 sec
31 279 4 min 39 sec
32 288 4 min 48 sec
33 297 4 min 57 sec
34 306 5 min 06 sec
35 315 5 min 15 sec
36 324 5 min 24 sec
37 333 5 min 33 sec
38 342 5 min 42 sec
39 351 5 min 51 sec
40 360 6 min 00 sec
41 369 6 min 09 sec
42 378 6 min 18 sec
43 387 6 min 27 sec
44 396 6 min 36 sec
45 405 6 min 45 sec
46 414 6 min 54 sec
47 423 7 min 03 sec
48 432 7 min 12 sec
49 441 7 min 21 sec
50 450 7 min 30 sec
51 459 7 min 39 sec
52 468 7 min 48 sec
53 477 7 min 57 sec
54 486 8 min 06 sec
55 495 8 min 15 sec
56 504 8 min 24 sec
57 513 8 min 33 sec
58 522 8 min 42 sec
59 531 8 min 51 sec
60 540 9 min 00 sec
61 549 9 min 09 sec
62 558 9 min 18 sec
63 567 9 min 27 sec
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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 63 for 2POINT and
RATE-B assays.
In case of 2POINT chemistries, the mean of the absorbances obtained between M1Start and M1End
is calculated. In case of RATE-B chemistries, the change in absorbance per minute is calculated
between M1Start and M1End points using least square linear regression method.
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".
M2Start and M2End: It is essential to program M2Start and M2End parameters for all the tests and
these parameters can have values from 1 to 63. M2Start specifies the incubation time point.
Similarly, M2End is the time until when the absorbance is recorded for the purpose of concentration
calculation.
In case of 1POINT and 2POINT chemistries, the mean of the absorbances obtained between
M2Start and M2End is calculated. In case of RATE-A and RATE-B chemistries, the change in
absorbance per minute is calculated between M2Start and M2End points using least square linear
regression method.
For 2POINT and RATE-B chemistries, M2Start has to be more than or equal to M1End.
(6) Wave Length

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.
Primary wavelength: The analyzer offers a choice of 12 wavelengths with a narrow bandwidth (<8
nm) for programming the wavelength. The choices are 340, 376, 415, 450, 480, 505, 546, 570, 600,
660, 700 and 750 nm.
Secondary wavelength: When the methodology specifies bi-chromatic measurement for an assay,
user can select a secondary wavelength at which the absorbance can has to be measured. The
selection is made with the pull-down option provided. The following secondary wavelengths are
available in the analyzer: 0, 340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700 and 750 nm.
If bi-chromatic measurement is not desired, enter zero for the value of the secondary wavelength.
(7) Control Interval

The Control Interval parameter enables the user to define number of samples after 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 under “Quality Control” chapter.
(8) Sample Replicates

In this parameter, select the number of repeated sample measurements to be 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
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number of times. A value from 1 to 20 can be selected in this parameter. For routine operation, this
parameter is programmed as '1'.
(9) ∆Abs/min
This field is used for cancellation of Reaction Linearity Check and is used for low linearity samples.
The user needs to enter the delta absorbance/min for that test where the Linearity Check should not
be performed. Once fed, if the delta absorbance/min of the reaction for that test is greater than the
set limit, then Linearity Check will not be performed.
(10) Maximum Reaction Linearity: This field is applicable only for Rate-A and Rate-B assay types
and monitors the linearity during the reaction. The user can feed any value between 1%-50%. If the
%Linearity exceeds the specified value in the Maximum Reaction Linearity, then a LIN flag is
displayed along with the specified value. For e.g. if the user specified a value of 5% in the Reaction
Linearity field and if the linearity percentage is exceeded, then flag LIN5 will be issued along with the
result.
(11) Standard Volume

These fields enable the user to specify the standard/calibrator volumes to be used for calibration.
The fields are divided into two columns: Sample and Dilution Ratio.
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} and the normal sample volume entries will be like {20,
2x}.
{Standard Volume: Sample}: This is the volume of the standard to be aspirated from the standard
container. When the standard is undiluted, the aspirated standard from the standard container is
directly deposited in the reaction Cuvette (containing Reagent 1). When the standard has to be
prediluted, the standard from standard container is deposited in the reaction Cuvette (containing
diluent).
Enter a value between 1 to 60 µl using the numeric keyboard. In case of standard without
predilution, the total volume of standard and reagents should be more than or equal to 180 µl.
{Standard Volume: Dilution Ratio}: This enables the user to define a dilution ratio if predilution of
the standard is required. Default will be 1x and this will mean that no predilution will be done. A
dilution ratio Nx means 1 part of standard and (N-1) part of diluent. The following predefined values
have been provided: (1x, 5x, 10x, 25x, 50x, 100x, 150x).
(12) Sample Volume Normal

These fields enable the user to specify normal (or default) sample volumes of serum or urine. The
fields are divided into three columns: Serum/Urine Sample and Serum/Urine Dilution Ratio.
{Normal: Serum/Urine Sample}: This is the volume of the sample to be aspirated from the sample
container. When the sample is undiluted, the aspirated sample from the sample container is directly
deposited in the reaction Cuvette (containing Reagent 1). When the sample has to be prediluted,
the sample from sample container is deposited in the reaction Cuvette (containing diluent).
Enter a value between 1 to 60 µl using the numeric keyboard. In case of sample without
predilution, the total volume of sample and reagents should be more than or equal to 180 µl.
{Normal: Serum/Urine Dilution Ratio}: This enables the user to define a dilution ratio if predilution
of the sample/urine is required. Default will be 1x and this will mean that no predilution will be done.
A dilution ratio Nx means 1 part of sample and (N-1) part of diluent. The following predefined values
have been provided: (1x, 5x, 10x, 25x, 50x, 100x, 150x).
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(13) Sample Volume Decrease

These fields are used to specify (lower than normal) sample volumes to carry out 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 two columns: Serum/Urine Sample, Serum/Urine
Dilution Ratio.
{Decrease: Serum/Urine Sample}: This is the volume of the sample to be aspirated from the
sample container. When the sample is undiluted, the aspirated sample from the sample container is
directly deposited in the reaction Cuvette (containing Reagent 1). When the sample has to be
prediluted, the sample from sample container is deposited in the reaction Cuvette (containing
diluent).
{Decrease: Serum/Urine Dilution Ratio}: This enables the user to define a dilution ratio if
predilution of the sample/urine is required. Default will be 1x and this will mean that no predilution will
be done. A dilution ratio Nx means 1 part of sample and (N-1) part of diluent. The following
predefined values have been provided: (1x, 5x, 10x, 25x, 50x, 100x, 150x).
(14) Sample Volume Increase

These fields are used to specify (higher than normal) sample volumes to carry out 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 two columns: Serum/Urine Sample and
Serum/Urine Dilution Ratio.
{Increase: Serum/Urine Sample} This is the volume of the sample to be aspirated from the sample
container. When the sample is undiluted, the aspirated sample from the sample container is directly
deposited in the reaction Cuvette (containing Reagent 1). When the sample has to be prediluted,
the sample from sample container is deposited in the reaction Cuvette (containing diluent).
{Increase: Serum/Urine Dilution Ratio}: This enables the user to define a dilution ratio if
predilution of the sample/urine is required. Default will be 1x and this will mean that no predilution will
be done. A dilution ratio Nx means 1 part of sample and (N-1) part of diluent. The following
predefined values have been provided: (1x, 5x, 10x, 25x, 50x, 100x, 150x).
(15) Reagent Details (R1/R2)

This parameter consists of the following fields:
{R1/R2 Volume}: Assign volume of reagent (in micro-liters) to be aspirated for Reagent 1 or
Reagent 2. Volume for Reagent 1 is set between 60 and 300 µl and for Reagent 2 between 10 and
300 µl. (Reagent 2 volume can also be set to zero if second reagent is not used).
{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 56 pre-defined positions for
reagent placement. In case if 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 and R2 reagents.
ISE Urine Diluent Position, Wash Position and Serum Diluent position can be
changed depending on the placement of barcoded bottle on the reagent tray.
{R1/R2 Size}: This parameter represents the size of the bottle. Two types of bottle sizes are
possible – Large (50 ml) and Small (20 ml). These bottles can be selected as the L or S 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.
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{R1/R2 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.
(16) {R1/R2 Reagent Mix Speed}: There are 3 options available to set the Mixer speed in order to
mix the reagent and the sample. They are Low, Medium and High.
(17) R1/R2 Reagent Multiple Positions and Reagent Stability

When the user clicks on the “Reagent Details” button, the following screen is displayed on the
screen:
3.2.2 Reagent Details Screen

This screen displays the multiple positions for Reagent 1 and Reagent 2 along with the different
Reagent Stability parameters. The following screen is shown on clicking the Reagent Details button:
Figure 3.2 Reagent Details Screen
Explanation for R1/R2 Position, Size, Reagent Code and Effective Days is similar as given in the
Reagent Details. The operator can assign upto 5 reagent positions for R1 and R2 respectively.
Make sure to do a reagent volume scan before starting a run with tests that use multiple
positions for Reagent 1 and Reagent 2.
Please note that same positions cannot be assigned for R1 and R2
{R1/R2 Expiry Year and Expiry Week}: This will contain year and the week number from the
reagent barcode about when the reagent will expire. This information will be updated when an 18-
digit barcoded bottle is used. This will be for display purpose only and cannot be entered by the user.
{R1/R2 Expiry Month and Expiry Year}: This field will give information on the expiry month and the
expiry year. This information will be updated when a 14-digit barcoded bottle is used. This field shall
be for display purpose only and cannot be entered by the user.
{R1/R2 Lot Number}: This will be the lot number of a reagent. Default value is zero. If barcoded
reagent bottles are used, then that number us specified on the reagent barcode bottle.
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{R1/R2 Bottle Number}: This will be the bottle number in a lot. Default could be zero.
The bottle number can change for each position. If barcoded reagent bottles are used, then that
number is specified on the reagent barcode bottle.
{R1/R2 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.
(18) Reaction Absorbance Limit

This parameter defines the absorbance limit of reaction mixture for Serum/Urine 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. The absorbance limit entered would be in direct absorbance and not in terms of delta
absorbance per minute. 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 Reaction Absorbance Limit is exceeded during the course of reaction, the last point of the
measurement interval (i.e. M2E) is automatically shifted to the point where this limit has been
exceeded to avoid rerun phenomenon. This new point is automatically used for calculation of sample
concentration. Also, in the Time Course Screen, the new point would be shown using a dotted line
indicating that the extension logic has been applied.
Note: a) If no points are available for slope calculation, then Lim0 flag is issued along
with the result and the result will be displayed as NA.
b) If only one point is available for slope calculation, then Lim1 flag is issued along
with the result and the result will be displayed as NA.
c) If only 2 points are available for slope calculation, then Lim2 flag is issued along
with the result.
Maximum permissible entry is 3.5. In case the reaction absorbance check is not desired, put “0” in
the React Abs Limit entry. Extension logic will not be applied if the Reaction Absorbance limit is set
to zero.
(19) Reaction Direction

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.
(20) 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. SEC
2. mg/dl
3. U/l
4. mEq/l
5. g/l
6. g/dl
7. %
8. mU/l
9. mU/ml
10. ng/ml
11. abs
12. µg/dl
13. ng/dl
14. mg/L
15. µg/L
115
16. ng/L
17. µmol/Ls
18. µmol/L
19. mmol/l
20. µg/ml
21. µIU/l
22. mmol/ml
23. µmol/ml
24. nmol/L
25. pmol/L
26. mIU/L
27. µkat/l
28. (User-defined)
(21) Decimal Point

In this field, the user can select the number of digits to be displayed after the 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, 2, 3 or 4 from the pull-down option.
(22) Prozone Limit

This field is used to specify the minimum limit for the absorbance at the end of an
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”.
(23) Instrument Factor (Correlation correction factor)

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
Where, Y is the corrected result

X is the actual result obtained on this analyzer
a is the multiplication correction factor
b is the offset correction factor
When the results obtained on this analyzer are as expected feed a = 1 and b = 0.
The following plot shows the relation of results obtained on any two compatible analyzers: (Here b =
0 and a = 1)
116
Results Obtained on any Analyser

50
40
+B
AX
Y=
30
20
10
10 20 30 40 50
Results on this analyzer
However, when there is a difference in the result between two machines, correlation correction
factors a and b can be calculated and fed to obtain consistent results on both the 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.
(24) Reagent Blank Absorbance Limit

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: Min.}: This parameter specifies the minimum permissible absorbance of the
reagent. Enter an appropriate value between 0 and 2.5. The analyzer measures the absorbance of
the reagent in the first cycle of measurement for that particular Cuvette and if this absorbance is
lower than the programmed minimum limit, the software prints a flag 'RgtAbsMin' along with the test
result. In this manner, it is possible to keep track of reagent stability.
For increasing direction reactions, usually this parameter is set as zero.
{Reagent ABS: Max.}: This parameters specifies 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.
For decreasing direction reactions, usually this parameter is set as zero.
(25) Technical Limits

These fields are used to define the Linearity Limit of the reagents. For the END POINT and RATE
Chemistires, feed the minimum and maximum concentrations in the Minimum and Maximum
Technical Limit fields respectively. This field is masked for Rate chemistries.
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.
{Tech. Serum Limit: Min}: Define a value ranging from -99999 to 99999 indicative of the minimum
technical limit or the linearity limit of the reagent. For end-point chemistries or rate chemistries, feed
the minimum concentration. 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 Limit: Max}: Define a value ranging from -99999 to 99999 indicative of the maximum
technical limit or linearity limit of the reagent. For end-point chemistries or rate chemistries, feed the
maximum
concentration. 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.
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(26) Panic Limits (Serum/Urine)

This field is used to define the minimum and maximum concentration limits beyond which the serum
or urine 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 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 and Urine samples and not for Other type samples.
(27) Normal Ranges

These fields are used to define the expected values or normal range for 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.
{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.
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 and Other Samples.
(28) Auto Rerun

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 Limit, Prozone Limit or Panic Limit. The
user can select either YES or No.
(29) Copy Function

This option is used to copy the test parameters from one test to another. To 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. Semi-close parameters cannot be
copied.
(30) Tests Function

Clicking on <Tests> changes the display to the following:
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Figure 3.3 Tests Screen
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.
3.2.3 Print Multiple Test Parameters

If a user needs to print multiple test parameters at the same time, one can click the Prt Multi
Param button in the Test Parameters screen and select the tests required to be printed.
Figure 3.4 Print Multiple Parameters
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3.3 SERUM INDICES

Depending on the assay method, chemical or its metabolite may affect the measurement results in the
case of high turbidity, hemolysis, bilirubin, etc. in the serum. Through the use of this phenomena, the
levels of turbidity (L), hemolysis (H) and icterus (I) are numerically expressed and can be determined
qualitatively.
<Method of measurement>
• Photometering points: 2 points measurement
here A, B, C, D, E and F are constants and client entry items.

α=λ600, β=λ700, γ=λ570, δ=λ450, ε=λ510
λxxx represents the absorbance values of each wavelength λrxxx that are obtained from
measurements of sample and phosphoric acid buffer and corrected by water blank λwxxx.
For example, in the case of wavelength of 600 nm,
λ600 = λ r600 - λ w600.
120
• Picture for entry of serum information
Figure 3.5 Serum Indices Screen
The coefficients A,B,C,D,E and F can be modified and the modified information shall be used to
calculate the Lipemic, Hemolytic or Icteric indices. Also, the Qualitative chart is shown that will be
displayed along with the Index on the printout. For e.g. if the Lipemic Index is 20, Hemolytic Index is
100 and Icteric Index is 10, then the following result is displayed on the printout:
Serum Indices L++ (20) H- (100) I+ (10)
The Range for the different indices can be modified as per the user requirements.
If the user wants to check the Serum Information for all patients, then he/she should go to the
{Previous Data: System Switch} and enable the checkbox near the Serum Indices label.
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3.4 Calculation Item

One can enter this screen by clicking on Previous Data button on the Main screen and then
clicking on the Calculation Item button as shown below:
Figure 3.6 Calculation Item Screen
This menu enables the user to define a calculation item involving one or more chemistries.
Twelve (fixed) calculation formulae are provided for the calculation of certain supplementary
items during the analysis. It is also possible for the user to define the formula as per his/her
desire. The user can add 40 different calculation items. If these calculation items are selected
in the [Patient Entry] screen, they are printed along with the result printout.
A description of various fields available on the screen is given below.
{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.
{Calculation Item: Report Name}: In this field, enter description/name of the calculation item
(i.e., A/G ratio). This name is printed on the patient report.
{Calculation Item: Formula}: Either select one of the pre-defined formulae for calculation of
results from the pull-down option or the user can define their own formulae. The pre-defined
formulae available are:
1. A/(B-A)
2. A+B
3. A-B
4. A-B-C
5. (A/B)*a + b
6. ((A-B)/A)*a
7. (aA + bB+ cC+ d)
8. A/a
9. (A/B)*100
10. aA + bB+ c
11. aA + b
12. (A/B)*e*(f/1440)
13. User definable formula
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Note: 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 (calculated automatically from the height and
weight defined in Patient Entry screen) 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. If the user wants to define their own formulae,
then they should use only A,B,C for defining the test names. Use of numeric values is
permitted.
{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.
For example,
Test Name A/G ratio
Formula A/B
Test A ALB
Test B GLU
Test C -
{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, Urine and Other.
{Calculation Item: Coefficient a/b/c/d/e/f}: These coefficients are used in different formulae to
calculate any Calculation Item. 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: 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.
{Calculation Item: Other Values}: Enter normal range for other sample (i.e., min and max) for
male and female patients.
3.4.1 Procedure to Add a Calculation Item

1. On the [Previous Data: Calculation Item] screen, click on <Add> button.
2. Enter an alphanumeric name in the {Calculation Item Name} field and 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/Other 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.
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3.4.2 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
(calculated automatically from the weight and height defined in the patient entry) 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 (along with 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 (along other tests) for
Urine sample. Additionally, select the calculation item for Creatinine Clearance. Feed the
Height, Weight 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.
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3.5 Profile Entry

One can enter the Profile by clicking on the {Patient Entry} screen on the Main Menu and then
clicking the {Profile} button. The display changes to the following screen:
Figure 3.7 Profile Entry Screen
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. 20 different Profiles can be created and 2 or more
profiles can be selected for a patient at the same time. If more than 10 Profiles are entered, the
user can browse to the next 10 profiles using Page Up and Page down buttons shown by Up
and Down arrows.
3.5.1 Procedure to Create a Profile

The profile can be created from the {Patient Entry} screen.
The procedure is given below:
1.Click on <Create Profile> button. The display changes to the following screen.
2. Click the <Add> / <Modify> icon.
3. Use the pull-down option to select either existing profile or overwrite for new profile name.
4. Select combination of tests for the new profile.
5. Click on the <Save> icon.
The software is now programmed for required tests (profiles) for any particular patient.
If R1/R2 position of that test is not defined, then the user will not be able to select
the test. Also, “Calibration not done” warning will be issued if the user has not
calibrated the test.
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3.6 Result Re-calculation

On clicking the {Previous Data: Recalculation} button on the [Previous Data] screen, the
following screen is displayed:
Figure 3.8 Recalculation Screen
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.
To obtain recalculated result, enter an appropriate Time Course number. Time Course number
is assigned by the software and the number can be obtained from the [Previous Data: Result
Reprint] screen. This number can also be checked from the real-time printout of assay data.
Only the last 9999 time courses are stored in the database.
After making the necessary modifications in the Test Parameters or Calibration Table, enter the
time course number in the {Enter Time Course} field on the {Previous Data: Recalculation}
screen and click on the <Recalculate> button. The recalculated result is displayed along with
the Sample Position, Patient ID, Test Name, Recalculated Result, Unit and Flag (for the
recalculated result).
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3.7 System Switch

One can enter this screen by clicking on the {Previous Data: System Switch} button. The
display changes to the following screen:
Figure 3.9 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), serum indices,
serum 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
Set this option to On/Off to enable/disable negative result. If this option
{Minus Data}
is set to Off, the negative results are displayed as zero.
Set this option to On/Off to enable/disable real-time printing (during
{Printer}
run). If this option is set to On, the results are printed in real-time.
{Container Set this option to Tube/Cup to set the default container type in Patient
Type} Entry. Default is Tube when Barcode is kept “ON”
{Online Print Set this option to Compact/Detail to select multiple or single result per
Format} line report formats for the online result printout respectively.
{Sample Set this option to On or Off to enable/disable bar-code option for
Barcode} samples respectively.
{Reagent Set this option to On or Off to enable/disable bar-code option for
Barcode} reagents respectively.
Set this option to On or Off to enable/disable ISE module (optional)
{ISE}
respectively.
Select number of levels for Control interval 1-(A), 2-(A, B), 3-(A, B, C
{Level
and 4-(A, B, C, D)). This selection decides the control sera that will run
Selection}
for real-time QC (during the patient run as programmed in the {Test
Parameters: Control Interval} field).
{Host Set this option to OFF or ONLINE to enable or disable bi-directional
Selection} communication with a Host PC.
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OFF means no connection is present to Host PC
ONLINE selection automatically sends the results from Analyzer PC to
Host PC in real-time without user intervention.
This is a (multiplication) correction factor for the temperature and
{Temperature corrects the displayed temperature due to change in settings over time.
Factor} The default value of this factor is 1. This feature is enabled when “t” is
used in the password during installation.
This is the maximum deviation allowed in the reaction tray temperature
{Range ±} from 370C. A warning is issued on the {Run Test: Run Status: Run
Monitor} screen if this limit is violated.
Select date format (i.e. dd/mm/yyyy or yyyy/dd/mm or mm/dd/yyyy}.
{Date Format} This selection changes the date format across the database and format
of the dates displayed on various screens of the software.
If the field is checked, then the Patient Report is printed automatically
{Online Patient after the patient run is completed. The user can select the format of the
Report} patient report (8 different types available) that he/she wants to print after
the run is completed.
This is used as an analyzer ID and is printed at the beginning of a run in
{Unit ID}
the real-time result report printout.
{Serum Diluent In this field, the serum diluent position can be defined. This diluent will
Position} be used for sample pre-dilution. Default position is 49.
{Urine Diluent In this field, the urine diluent for photometric chemistries can be defined.
Position} This diluent will be used for urine pre-dilution. Default position is 51.
In this field, the wash position for Carry Over Pairs and the first wash
{Wash}
cycle can be defined. Default position is 55.
{ISE Urine In this field, the Urine Diluent position for ISE can be defined. This
Diluent diluent will be used for ISE Urine pre-dilution (10 times). Default position
Position} is 53.
In this field, the batch number of the diluent being used for dilution of
{Diluent Batch}
samples can be fed.
Minimum and maximum allowed absorbance of the Cuvette blank can
{Min/Max Blank be fed here for monitoring the cleanliness of the Cuvette. Depending on
Absorbance} these settings, the Cuvette absorbances outside these absorbances are
marked in different color on the [Previous Data: Cuvette Blank] screen.
This is the number of standard replicates to be used during calibration.
{Std Replicate}
Set this number to 1, 2, or 3.
This option is to set up the passwords for different levels for the secured
use of the analyzer and application software.
{Enable
Level 1 password is for application start up,
password}(Lev
Level 2 is for System Switch,
el 1/2/3/4)
Level 3 is for Service Check, and
Level 4 is for Test Parameters, Calibration, and QC.
{Exclude
This field allows the user to select/deselect the flags that need to be
Result Display
sent to LIS via ASTM Host
Flags}
A list of available printers from the Control Panel: Printers are displayed.
Printer
The user can select the default printer for online and offline printing.
{Sample Clot
This field displays the number of times that Sample Probe will go for
Detection:No
Wash after clot is detected. Default fixed value is 4
of Wash}
{Sample Clot
This option is available to the user for selecting the abortion of sampling
Detection:Max
from a sample cup/tube and moving to the next sample. It allows the
Clot Detected
user to select when the sampling should be aborted when the sample
for indv.
probe detects the clot “x” times for that sample.
Samples}
{Sample Clot
Detection:Max This option is available to the user for aborting the sampling after “n”
Clot detected number of times a clot is detected in “x” consecutive samples. Default is
for cons. 2.
Samples}
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{Clot Detection
This option allows the user to select whether Clot detection feature
Option: Detect
should be enabled or disabled. Default is OFF.
Sample Clot}
{Clot Detection
Option: Pause This option allows the user to select whether the sampling should be
Sampling after paused after a Clot is detected.
Clot detected}
<Change This button can be used to change the passwords for different levels. This
password> button is available only after clicking on the <Modify> button at the bottom.
{Serum If the check box is ticked, then Serum Information for all patient samples will
Indices} be shown.
<Chemistry This button can be used for defining the sequence in which the tests are
sequence> 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.
<Chemistry Sequence>: This button is accessible only after clicking on the <Modify> button.
By clicking on the <Chemistry Sequence> button, the top portion of the {Previous Data:
System Switch} screen changes to the following screen as shown below. The user using the
Sequence Number/Location can set the sequence or the sequence can be done automatically
using Alphabetical mode.
Figure 3.10 Sequence Screen

In this sub-screen, three columns appear namely, {Chemistry}, {Seq. No.} and {Location}. A
description of these is given below:
{Chemistry}: This column displays the short name of the tests.
{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
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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.
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3.8 Backup/Restore
One can enter this screen by clicking on {Previous Data: Backup} button. This screen can be
used to take backup of the information fed in the software. The backups that can be taken can
be categorized as backup for test parameters, patients’ details, calibration details, control data
and results, probe calibration data 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:
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.
Figure 3.11 Backup Screen
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3.8.1 Backup/Restore: Test Parameters

There are three options under {Previous Data: Backup: Test Parameters} namely, Initialize,
Backup and Restore. Use these options to initialize test parameters to default parameters and
backup/restore test parameters.
{Test Parameters: Initialize}: 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.
3.8.2 Backup/Restore: 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.
{Patients: Archieve}: Use this option to save Patient report in separate database in case of
huge database.
3.8.3 Backup/Restore: Calibration

{Calibration: Backup}: Use this option to save the details related to calibrator and control
positions in [Calibration: Positions] screen. The user can select all calibrator positions or select
a few desired positions for backup.
{Calibration: Restore}: Use this option to restore calibration and control position data from a
previously stored backup file.
3.8.4 Backup/Restore: Controls

{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.
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3.8.5 Backup/Restore: System Switch

{System Switch: Backup}: Use this option to save the details related to [Previous Data:
System Switch] screen.
{System Switch: Restore}: Use this option to restore System Switch data from a previously
stored backup file.
3.8.6 Backup/Restore: Time Course

{Time Course: Backup}: Use this option to save the details related to [Previous Data: Time
Course] screen.
{Time Course: Restore}: Use this option to restore Time Course data from a previously stored
backup file.
3.8.7 Backup/Restore: Calibration Trace

{Calibration Trace: Backup}: Use this option to save the calibration trace details along
with the graph related to [Previous Data: Calibration Trace] screen.
{Calibration Trace: Restore}: Use this option to restore Calibration Trace data along
with the graph from a previously stored backup file.
3.8.8 Backup/Restore All

Here, all the above parameters are backed up in a directory. Similarly, if a user wants
to restore all the parameters, then one can click on “Restore All” button.
It is possible to Backup the Data on a 3¼” Floppy Disk.

However, the user should note that all the data backed up on
the Floppy Disk might not get restored
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3.9 Delete Data

One can enter this menu by clicking on {Previous Data: Delete Data} screen in {Previous
Data} menu.
This menu enables the user to delete redundant data from the database. The 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:
Figure 3.12 Delete Data Screen
{QC Delete}: The QC Delete displays details of, Test name, result, result date and provides the
following options:
Delete All: Deletes all QC data stored in the database.
Delete Date wise: Deletes QC data for that date only.
{Archive Delete / ISE Delete}:
Deletes all patient/ISE (optional) result data stored in the

Delete All: database
Deletes patient/ISE (optional) data for that date only.

Delete Date
Patient/ISE details are displayed in the grid.
wise:
Delete Deletes patient/ISE (optional) data for a particular patient

Patient:
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3.10 Database Status

One can enter this menu by clicking on {Previous Data: Database Status} screen in {Previous
Data} menu. The following screen is displayed:
Figure 3.13 Database Status 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.
Tests: Number of tests programmed in the system, the number of remaining positions available for
programming and the total of all programmable tests (99)
Patients: Number of patient results stored in the memory of the system, the availability of storing
more records (out of 1000).
Profiles: The number of profiles stored in the system and the number of profiles available, giving the
total number of profiles programmable. (out of 20)
Controls: The analyzer displays the number of Controls stored in the memory, the number of
positions available to be programmed and the total number of possible positions for Requested
parameters (out of 60)
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 (out of 40)
Doctors: Number of reference doctors stored in the analyzer, the number of possible entries for
further up gradation and the total number of such records possible on the system. (out of 250)
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3.11 Carry-Over Pairs

One can enter this menu by clicking on {Previous Data: Carryover Pairs} screen in {Previous
Data} menu. The following screen is displayed:
Figure 3.14 Carry-Over Pairs Screen
On this screen, the user can define the Carry-Over pair for a particular chemistry. 3 options are
available:
Item Description
This is the preceeding chemistry or the Contaminant. The user can enter the
Test1
Contaminant Chemistry
This is the following chemistry or the contaminated chemistry. The user can enter
Test2
the chemistry that could get contaminated
The user can select whether for that pair, a Detergent or a Reagent Wash is
required. For the Detergent Wash, the Reagent Arm will go to position 55 for R1
Action
and R2 respectively. For Reagent Wash, the R1PT/R2PT shall go to the reagent
position of the Following Chemistry.
Cycle The user can define the number of cycles depending on the type of wash selected.
No. The cycle number varies from 1 to 4. Default is 1.
For Detergent Wash, prepare Wash Solution (preferably phosphate-

free neutral 1%Extran). Also, the same pair cannot be programmed for
2 different type of wash.
136
137
Chapter 4 - Maintenance
Chapter 4
Maintenance
This chapter provides the procedures of the necessary and minimal amount of maintenance in order
to ensure that the analyzer operates correctly and provides the accurate measurement results.
138
4.1 Maintenance Program
4.1.1 Maintenance Intervals

The Clinical Chemistry Analyzer has been designed to require very little user maintenance compared
to the others analyzers of the same class. Regular cleaning 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.
For easy understanding, different tables are included in this chapter.
Table 1 is the maintenance schedule for operator. This table should be used as a reference for
performing daily, weekly and monthly maintenance.
Table 2 is the replacement schedule for different consumables.
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.
Note 1. Change the reagent bottles from time to time before adding the fresh
reagent.
Note 2. It is recommended to check and maintain a stock of spares and
consumables.
Table 1 showing the Daily, Weekly and Monthly schedule for the operator
Daily Maintenance
Start of the day
1. Fill the DI Water Can
2. Check/Fill the wash solution can
3. Remove the Reagent Tray and clean the water condensed on the tray
4. Check the Lamp Gain at 340nm using Auto Span (if required)
5. Carry out Priming for at least 2 minutes
6. Clean Sample, Reagent1 and Reagent 2 probes from outside using Alcohol
7. Carry out Cuvette rinsing
8. Shake Cal A bottle and Purge ISE 3-4 times.
9. Perform ISE Cleaning and Purge ISE 6-7 times.
10. Perform ISE Calibration
End of the day
1. Carry out Cuvette Rinsing
2. Carry out Water Save
3. Carry out Sample Probe Wash
4. Carry out Reagent1/Reagent2 Wash
5. ISE Cleaning using ISE Cleaning Solution
6. Clean Reagent Table
7. Empty Concentrated and Diluted Waste Tank
8. Wipe instrument panel
9. Clean working area/table
10. Carry out Acid and Alkali Wash (Auto Wash) if Latex based chemistries are used during the day
139
Weekly Maintenance
1. Clean Sample Bar-code Reader
2. Clean Reagent Bar-code Reader
3. Auto Wash
4. Clean Sample Tray
5. Clean DI Water Can
Monthly Maintenance
1. Clean CRU nozzles and drier chip externally
2. Clean ISE Electrode Tip.
3. Check the alignment of electrodes and bubble detector
4. Wash the troughs with 1% NaOCl (5ml) for all arms and stirrers
Table 2: Replacement schedule for consumables and spares

Sr. Spares/Consumables 3 6 9 12
No. Months Months Months Months
1. Drier chip of CRU
2. Stirrer
3. CRU Aspiration Tubing
4. CRU Dispense Tubing
5. Halogen Lamp
6. 25-micron Water Filter
7. Sample Syringe Plunger
Reagent 1 and Reagent 2
8.
Syringe Plunger
9. ISE Pump Cassette
ISE Cal A and Waste
10.
Tubing
11. ISE Electrodes
12. Fuses As required
Note 1. Average life of the Lamp is 600 hours. Replacement of Lamp depends on
its usage and ON Time.
Note 2. Average use life of water filter is 3 months. Replacement of water filter
depends on quality of DI water used.
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4.2 Actions to be taken in the event of trouble

When any abnormal conditions are found in the analyzer, the operator is requested to check the
following items:
1. Preparation and preservation methods of reagents;
2. Preparation and preservation methods of sample;
3. Operational procedures of the analyzer, and
4. Maintenance work.
When such an abnormal condition is considered to be caused by an electrical or mechanical
failure, do not try to carry out the inspection of the analyzer's innards by your own and call for
service at our customer service department.
In the event of a trouble, the corresponding alarm message is indicated. Deal with the trouble
referring to in section "List of alarm codes". It is presumed that the trouble will be solved and the
proper operation will be resumed in many cases.
4.2.1 Information requested by our customer service department

When any technical service will be called for at our customer service department, the following
information is requested to be prepared:
A) Trouble in assay
1. Serial number of analyzer in use;
2. Method code in question;
3. Explanation of encountered trouble;
4. Serial number and lot number of reagent, calibrator and QC sample in use;
5. A few calibration results that were carried out recently;
6. A few measurement results of QC sample that were carried out recently, and
measurement results.
B) Trouble in analyzer
1. Serial number of analyzer in use;
2. Software version numbers in use (PC, Mechanical and Sub-CPU);
3. Explanation of relevant alarm and problem, and any other information about the
analyzer in use and maintenance;
141
4.3 Malfunction at the time of power-on

If the analyzer cannot be activated, follow the procedures shown below:
1. Check that the main switch located on the left side panel of the analyzer is at "ON" position.
2. Check that the main fuses are not burnt.
When the main fuses are checked, turn the main switch off without fail and then pull out the
plug of power supply cable from its receptacle on the analyzer. Open up the fuse cover and
pull the fuses out.
3. Check that the circuit breaker of the power supply system to which the analyzer is connected
is not cut off.
Fuse cover
Fuse holder
Figure 4.1 Fuse Diagram
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4.4 Anomalous measurement results

There may be two cases that the analytical errors are noticed, i.e., by error flag or unexpected results.
In the following cases, troubleshooting is requested.
1. Error flag is set to the calibration results.
2. Error flag is set to the measurement results of QC sample or normal sample.
3. The measurement results of QC sample are out of range of judgment criteria.
Investigate which situation shown below is applicable to the error in the measurement results of
calibration, QC sample or normal sample. Based on the investigation, further check may be requested.
4. The resultant values obtained from measurements of a specific method are high for all
samples.
5. The resultant values obtained from measurements of a specific method are low for all
samples.
6. Erroneous results are randomly derived from measurement.
7. Two or more anomalous measurement results are observed:
– from all methods, or
– randomly
4.4.1 Check of preparation of reagent, calibrator or QC sample

Perform the following checks in order to track down the cause for high, low or random resultant
measurement results.
When a reagent, calibrator or QC sample is prepared, read the respective statement of virtues
carefully and follow its instruction.
A) Preparation of reagent
1. Was there any change of the reagent?
2. Is the term of validity of the prepared reagent still valid?
3. Was the reagent prepared according to the correct procedures?
4. Was the reagent prepared using fresh, non-bacteria contaminated and deionized water
or appropriate diluent?
B) Preparation of QC sample
1. Was the volume used for preparation correct?
2. Does the sample have been preserved as recommended?
3. Is the term of validity of the sample still valid?
4. Was the sample prepared using a pipette calibrated in terms of volume?
5. Is the term of validity of the sample lot still valid?
6. Was the sample prepared using appropriate diluent?
C) Preparation of calibrator
1. Was there any change of the lot number?
2. Was the calibrator prepared using volume correctly?
3. Does the calibrator have been preserved as recommended?
4. Is the term of validity of the calibrator still valid?
5. Was the calibrator prepared using a pipette calibrated in terms of volume?
6. Was the calibrator prepared using appropriate diluent?
The further checks are requested to track down the cause referring to the following lists after
the above checks have been completed.
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4.4.2 High resultant values from a specific method for all samples
Cause Action
Check the preparation of the calibrator.
1. Incorrect calibration results Check that the calibration settings are correct. The
calibration is performed again if necessary.
Check the temperature shown in the [Service
Check: Temperature] picture. Call for service at our
2. Too high inside temperature
customer service department when the indicated
of CRU unit
temperature deviates from the specified value of 37
± 0.2ºC.
3. Improper preparation of
Check the preparation of the reagent.
reagent
calibrator
4.4.3 Low resultant values from a specific method for all samples
Cause Action
1. Expiration of the term of See the statement of virtues that comes together
validity of reagent with the reagent kit for its stability.
Check the preparation of the reagent.
reagent
See the statement of virtues that comes together
3. Improper preservation of
with the reagent kit for its proper preservation
reagent
method.
Check the temperature shown in the [Service
Check: Temperature] picture. Call for service at our
4. Too low inside temperature
customer service department when the indicated
of CRU unit
temperature deviates from the specified value of 37
± 0.2ºC.
calibrator
6. Excessive volume of Check if there is any leakage or drip at junction of
reagent dispensed reagent sampling system.
4.4.4 Randomly derived erroneous measurement results

Cause Action
1. Fibrin clots formed on
specific sample tube or Clean the SPT nozzle.
sample cup
Check if the tip of water or solution tube is
2. Insufficient water or
positioned below the water or solution level. Call for
solution supply from
service at our customer service department in case
respective external tank
of trouble.
Check if the stirrer rotates in the center of Cuvette
3. Insufficient stirring
and at the correct speed.
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4.4.5 Anomalous resultant values from all methods for a sample

Cause Action
Prepare newly the reagent referring to the
statement of virtues that comes together with the
reagent
reagent kit.
2. Expiration of term of Prepare newly the reagent referring to the
validity, contamination or statement of virtues that comes together with the
paleness of reagent reagent kit.
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4.5 Equipment malfunction

It may be difficult for the user to deal with the problem, the troubleshooting of which is beyond this
limited extent. In such a case, call for service at our customer service department.
4.5.1 Detection of mechanical problem

All the mechanical movements are controlled and monitored by the computer. When a problem arises,
the computer becomes aware of it and generates the visual error message to call the operator's
attention.
In the event of the problem that may affect the performance of the analyzer, the sampling stop or
emergency stop will be executed. In the case of sampling stop mode, the analyzer carries on and
completes the processing of the sample that is not affected by the problem. In the case of problem
that may affect the entire measurements of sample, the emergency stop will be executed. All the
types equipment-related error messages can be seen by going in {Previous Data: Error Record}
screen as shown below:
Figure 4.2 Error Record 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
4. Read from File
{Date Wise}: The {Date Wise} report format has three fields that need to be selected before display of
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.
146
{Latest Batch}: The Latest Batch report format projects all errors of the latest batch run on the
analyzer. It displays column wise details including Serial number, Mechanical error, Error time, Batch
number and Error code.
{Service Check Errors}: Here the errors observed in Service Check menu are listed.
{Read from File}: This tab is used for restoring any mechanical errors that have been saved for
current or previous software.
Note that, separate batch are created for ISE module related errors. Remedial actions for all error
conditions are given below in section 4.5.2 Error Messages for each unit.
The analyzer generates two types of error messages, i.e., result-related flag as explained in section
4.6 and analyzer-related alarms as explained in section 4.5.2.
Note: Problem may arise, which is not monitored by the computer. Any alarm message
may not be indicated on the display for such a problem. Such a problem includes
abrasion of parts, leakage in the sampling system, etc. When this type of problem
occures, decide whether the processing of sample is carried on or the measurement is
terminated, considering that such problem may result in a damage to the analyzer or
erroneous outcome of measurements.
147
4.5.2 Error messages for each unit:
Assembly Error Error Possible Failures Action to be Taken

Code Message
Stirrer 1 A1 Stirrer1 Up/Down Opto/ Switch OFF the analyzer.
up/down error Home Opto/ Move the stirrer 1 up and
during Direction Opto down manually and make
initialization Motor driver card sure that nothing is
and its connector obstructing the movement
Stepper Motor Then switch ON the
RCT Alignment instrument; go to Service
Check: Stirrers Menu and
Click <Initialize> button for
Stirrer 1 and execute the
Stirrer 1 Up/Down
commands.
If the initialization or
up/down movement fails,
call the Service Engineer
A2 Stirrer1 Home Opto/ Switch OFF the analyzer.
rotational error Direction Opto Move the stirrer 1 in
during Motor driver card rotational path manually
initialization and its connector and make sure that nothing
Stepper Motor is obstructing the
(rotational) movement
Then switch ON the
instrument; go to Service
Stirrer 1<rotation>
commands.
If the rotation movement
fails, call the Service
Engineer
A3 Stirrer1 Up/Down Opto Switch OFF the analyzer.
up/down error Motor driver card Move the stirrer 1 up and
during run and its connector down manually and make
Stepper Motor sure that nothing is
obstructing the movement
Then switch ON the
Stirrer 1 Up/Down
commands.
A4 Stirrer1 Home Opto/ Switch OFF the analyzer.
during run Motor driver card rotation path manually and
and its connector make sure that nothing is
Stepper Motor obstructing the movement
(rotational) Then switch ON the
148

Code Message
Stirrer 1 rotation
commands.
Engineer
Stirrer 2 B1 Stirrer2 Up/Down Opto/ Switch OFF the analyzer.
up/down error Home Opto/ Move the stirrer 2 up and
Stirrer 2 Up/Down
commands.
B2 Stirrer2 Home Opto/ Switch OFF the analyzer.
during Motor driver card rotational path manually
initialization and its connector and make sure that nothing
Stepper Motor is obstructing the
(rotational) movement
Then switch ON the
Stirrer 2 <rotation>
commands.
Engineer
B3 Stirrer2 Up/Down Opto Switch OFF the analyzer.
up/down error Motor driver card Move the stirrer 2 up and
during and its connector down manually and make
initialization Stepper Motor sure that nothing is
obstructing the movement
Then switch ON the
Stirrer 2 Up/Down
commands.
B4 Stirrer2 Home Opto/ Switch OFF the analyzer.
Motor driver card rotation path manually and
and its connector make sure that nothing is
149

Code Message
Stepper Motor obstructing the movement
(rotational) Then switch ON the
Stirrer 2 rotation
commands.
Engineer
CRU C1 CRU Up/Down Up/Down Opto Switch OFF the analyzer.
Movement Motor driver card Move the CRU up and
Error during and its connector down manually and make
Initialization Stepper Motor sure that nothing is
CRU Alignment obstructing the movement
Then switch ON the
Check:RCT and CRU
Menu. Click on CRU button
and then on <Initialize>
button and execute the
CRU Up/Down commands.
C2 CRU up/down Up/Down Opto Switch OFF the analyzer.
error during Motor driver card Move the CRU up and
run and its connector down manually and make
Stepper Motor sure that nothing is
CRU Alignment obstructing the movement
Then switch ON the
Check:RCT and CRU
Menu. Click on CRU button
and then on <Initialize>
button and execute the
CRU Up/Down commands.
RCT E1 RCT rotational Stop Opto/ Base Switch OFF the analyzer.
error during Opto Rotate RCT manually and
initialization Motor driver card make sure that nothing is
Interlock effect Check:RCT and CRU
due to Menu. Click on RCT button
malfunctioning of and then on <Initialize>
other related button and check the
assemblies sequence for RCT
<Rotate> commands.
Engineer
E2 RCT Stop Opto/ Base Switch OFF the analyzer.
Rotational Opto rotate RCT manually and
150

Code Message
Error during Motor driver card make sure that nothing is
run (Time out and its connector obstructing the movement
Error) Stepper Motor Then switch ON the
Interlock effect Check:RCT and CRU
due to Menu. Click on RCT button
malfunctioning of and then on <Initialize>
other related button and check the
assemblies sequence for RCT
<Rotate> commands.
Engineer
Miscellaneous F1 Check Fluid DI Water Level Check the DI Water Level
Levels Sensor output of Check the Sensor Output
Load Level of Load Level Sensing
Sensing Platform Platform
H1 Check Malfunctioning of Check the pressure unit for

Pressure pressure unit any leakage or blockage in
Levels Leakage/Blockage the tubing
in pressure tubing
K1 RGT cover Reagent Cover Check the placement of

switch Placement Reagent Cover
closed/open The logic levels at Check the logic levels at
the baseboard the baseboard
connectors connectors/connector
Connector connections and verify for
connections proper functionality.
L1 Clot Detected Sample Clot Perform Sample Probe

detected in the Wash using Cleaning
sample cup/tube Solution on ISE2 Position
R1 Arm 11 R1PT Arm up Up/Down Opto/ Switch OFF the analyzer.
/down Error Home Opto/ Move the R1 Arm up and
(Up/Down) instrument; go to Service
Check:R1 Arm Menu. Click
on <Initialize> button and
and execute the R1
Up/Down commands.
12 R1PT Arm Up/Down Switch OFF the analyzer.
Rotational opto/Home Move the R1 Arm in
Error during Opto/Direction rotation path manually and
initialization Opto make sure that nothing is
Motor driver card obstructing the movement
and its connector Then switch ON the
Stepper Motor instrument; go to Service
(Rotational) Check:R1 Arm Menu. Click
and execute the R1 rotation
151

Code Message
commands.
Engineer
13 R1PT Arm Up/Down Opto/ Switch OFF the analyzer.
Up/Down Error Home Opto/ Move the R1 Arm up and
during run Direction Opto down manually and make
Motor driver card sure that nothing is
and execute the R1
Up/Down commands.
14 R1PT Arm Up/Down Opto/ Switch OFF the analyzer.
Rotational Home Opto/ Move the R1 Arm in
Error during Direction Opto rotation path manually and
run Motor driver card make sure that nothing is
(Rotational) instrument; go to Service
commands.
Engineer
15 R1PT Arm The connectors Switch OFF the analyzer.
VOD Error VOD Opto Sensor Move the R1 Arm up and
Placement of down manually and make
Reagent Bottles sure that nothing is
Reagent 1 Arm obstructing the movement
Position in Then switch ON the
Cuvette instrument; go to Service
Reagent 1 Arm Check:R1 Arm Menu. Click
Position in Trough on <Initialize> button. Push
the R1 probe gently to cut
the VOD opto so that VOD
Error will be generated and
R1 Arm initializes.
If the initialization or VOD
generation fails, call the
Service Engineer
16 Reagent No reagent 1 Switch OFF the analyzer.
Absent For R1 bottle is placed in Check the Reagent 1 Level
reagent tray and ensure that it is above
Empty reagent 1 the set Dead Volume.
bottle
Reagent 1 Level
is below the set
Dead Volume
LLS Board
placement of
152

Code Message
reagent bottles
Reagent 1 Arm
Position in
Reagent Tray
RGT 21 RGT Stop Opto/Base Switch OFF the analyzer.

Rotational Opto Rotate RGT manually and
Error During Motor driver card make sure that nothing is
Initialization and its connector obstructing the movement
RGT Alignment instrument; go to Service
Interlock effect Check: Reagent Tray
due to Menu. Click on <Initialize>
malfunctioning of button and check the
other related sequence for Reagent Tray
assemblies <Rotate> commands.
rotation movement fails,
22 RGT Stop opto/Base Switch OFF the analyzer.
Rotational Opto Rotate RGT manually and
run and its connector obstructing the movement
RGT Alignment instrument; go to Service
Interlock effect Check: Reagent Tray
due to Menu. Click on <Initialize>
malfunctioning of button and check the
other related sequence for Reagent Tray
assemblies <Rotate> commands.
R1 Syringe 31 R1 syringe R1 Syringe Switch OFF the analyzer.
up/down error Connectors Move the R1 Syringe up
during Motor driver card and down manually and
initialization and its connector ensure that nothing is
Stepper Motor obstructing the movement.
R1 Syringe Opto Then switch ON the
Check: Syringes Menu.
Click on R1 Syringe and
then <Initialize> button and
check the sequence.
32 R1 syringe R1 Syringe Switch OFF the analyzer.
during run Motor driver card and down manually and
and its connector ensure that nothing is
153

Code Message
check the sequence.
R2 Arm 41 R2PT up/down Up/Down Opto/ Switch OFF the analyzer.
error during Home Opto/ Move the R2 Arm up and
initialization Direction Opto down manually and make
and execute the R2
Up/Down commands.
42 R2PT Up/Down Switch OFF the analyzer.
initialization Opto make sure that nothing is
commands.
Engineer
43 R2PT Up/Down Opto/ Switch OFF the analyzer.
Up/Down Error Home Opto/ Move the R2 Arm up and
during run Direction Opto down manually and make
and execute the R2
Up/Down commands.
44 R2PT Up/Down Switch OFF the analyzer.
run Opto make sure that nothing is
commands.
154

Code Message
Engineer
45 R2PT Arm The connectors Switch OFF the analyzer.
VOD Error VOD Opto Sensor Move the R2 Arm up and
Placement of down manually and make
Reagent 2 Bottles sure that nothing is
Reagent 2 Arm obstructing the movement
Position in Then switch ON the
Cuvette instrument; go to Service
Reagent 2 Arm Check:R2 Arm Menu. Click
Position in Trough on <Initialize> button. Push
the R1 probe gently to cut
the VOD opto so that VOD
Error will be generated and
R2 Arm initializes.
Service Engineer
46 Reagent 2 No reagent 2 Switch OFF the analyzer.
Absent bottle is placed in Check the Reagent 2 Level
reagent tray and ensure that it is above
Empty reagent 2 the set Dead Volume.
bottle
Reagent 2 Level
is below the set
Dead Volume
LLS Board
placement of
reagent bottles
Reagent 2 Arm
Position in
Reagent Tray
R2 Syringe 61 R2 syringe R2 Syringe Switch OFF the analyzer.

during Motor driver card and down manually and
check the sequence.
62 R2 Syringe Syringe Switch OFF the analyzer.
Up/Down Error Connectors Move the R2 Syringe up
during run Motor driver card and down manually and
155

Code Message
check the sequence.
Sample Arm 71 SPT up/down Up/Down Switch OFF the analyzer.
error during opto/Home Move the Sample Arm up
initialization Opto/Direction and down manually and
Opto make sure that nothing is
(Up/Down) Check: Sample Arm Menu.
Click on <Initialize> button
and and execute the
Sample Up/Down
commands.
72 SPT rotational Up/Down Switch OFF the analyzer.
error during opto/Home Move the Sample Arm in
initialization Opto/Direction rotation path manually and
Opto make sure that nothing is
(Rotational) Check: Sample Arm Menu.
and and execute the
Sample rotation
commands.
Engineer
73 SPT Up/Down Up/Down Switch OFF the analyzer.
Movement opto/Home Move the Sample Arm up
Error during Opto/Direction and down manually and
(Up/Down) Check: Sample Arm Menu.
and and execute the
Sample Up/Down
commands.
74 SPT Up/Down Switch OFF the analyzer.
Rotational opto/Home Move the Sample Arm in
(Rotational) Check: Sample Arm Menu.
156

Code Message
and and execute the
Sample rotation
commands.
Engineer
75 SPT VOD The connectors Switch OFF the analyzer.
Error VOD Opto Sensor Move the Sample Arm up
Placement of and down manually and
Sample on make sure that nothing is
Sample/Standard obstructing the movement
Tray Then switch ON the
Sample Arm instrument; go to Service
Position in Check: Sample Arm Menu.
Cuvette Click on <Initialize> button.
Sample Arm Push the Sample probe
Position in Trough gently to cut the VOD opto
so that VOD Error will be
generated and Sample Arm
initializes.
Service Engineer
76 Sample No sample is Switch OFF the analyzer.
Absent placed in Check the Level of Sample
sample/standard and ensure that it is above
tray the set Dead Volume.
Empty sample
tube
Sample is below
the set Dead
Volume
LLS Board
placement of
Sample Tubes
Sample Arm
Position in
Sample/Standard
Tray
ASP 81 ASP Stop opto/Base Switch OFF the analyzer.

Rotational Opto Rotate ASP manually and
Initialization and its connector obstructing the movement
ASP Alignment instrument; go to Service
Interlock effect Check: Sample Tray Menu.
due to Click on <Initialize> button
malfunctioning of and check the sequence for
other related Sample Tray <Rotate>
assemblies commands.
82 ASP Stop opto/Base Switch OFF the analyzer.
Rotational Opto Rotate ASP manually and
157

Code Message
run and its connector obstructing the movement
ASP Alignment instrument; go to Service
Interlock effect Check: Sample Tray Menu.
due to Click on <Initialize> button
malfunctioning of and check the sequence for
other related Sample Tray <Rotate>
assemblies commands.
Sample 91 SPT syringe Sample Syringe Switch OFF the analyzer.
Syringe up/down error Connectors Move the Sample Syringe
during Motor driver card up and down manually and
Syringe Opto Then switch ON the
Check:Syringes Menu.
Click on Sample Syringe
and then <Initialize> button
and check the sequence.
92 SPT Syringe Sample Syringe Switch OFF the analyzer.
up/down Error Connectors Move the Sample Syringe
during run Motor driver card up and down manually and
Syringe Opto Then switch ON the
Click on Sample Syringe
and then <Initialize> button
and check the sequence.
Instrument - Analyzer is Wrong PC COM Make sure that a correct
either OFF OR port selection for port has been selected in
Instrument not analyzer. [Service Check: PC
responding Problem in Communication] screen
Communication Make sure the continuity of
cable the RS 232 communication
RS 232 isolator cable between Analyzer
board and PC
Problem in RCT Change RS 232 isolator
rotation PCB.
158
Alternatively, the error alarms along with the failures and necessary countermeasure are shown on the Run
Monitor screen in the Application Software. A screenshot showing the Error Message along with the
Troubleshooting function is shown below:
Error Alarm
Figure 4.3 Error Alarm on Run Monitor Screen
If the user wants to see the possible failures that could have resulted in this error message along with the
further action to be taken; he/she can double click on the Error Alarm. The following screen appears after
double clicking on the Error Alarm:
Error Alarm
Help Screen
Figure 4.4 Error Alarm with Help Message
The user can follow the help given on the screen. If he/she is unable to resolve the problem even after reading
the help function, the operator can contact the service engineer for further help.
159
4.6 Error flags associated with

measurement results
When the measurement result is higher or lower than the defined value, the appropriate error flag is
printed out together with the result.
4.6.1 Measurement result error flags

The measurement result flags printed out together with the measurement result are shown in the
following list.
Sr.
Flag Cause/Action
No.
This flag is issued with a patient result to indicate a same rerun that took place due to
1. #
violation of Serum/Urine Panic Limits
This flag is issued with a control serum result to indicate that the result is below or
2. +/- 1SD
above 1SD limit
3. +/- 2SD
above 2SD limit
4. +/- 3SD
above 3SD limit
This flag can be issued with a patient, calibrator and control result for End-Point
Assays.
1) For increasing direction chemistries, this flag indicates that the reaction
mixture absorbance is higher than the programmed Reaction Absorbance
5. AbsLim 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, then the patient sample is sent for a Decreased
volume run
This flag indicates that the Calibrant A for ISE Module is absent or air bubble is
6. Cal A*
present in Calibrant A
This flag is issued with a patient or control serum result and indicates that something
7. Chk Calib is wrong with the calibration and the calibration table needs to be checked and
corrected t calculate the result
Chk QC This flag is issued with a control serum result and indicates that the target Mean and
8.
Param SD values have not been defined in Quality Control screen for that control
9. D This flag is issued with patient results and indicates a Decreased Volume run
This flag is issued with patient, calibrator and control results and indicates diluent
10. D*
absent error
This flag is issued with a patient result to indicate that the result is higher than the
11. H
programmed maximum reference value
12. I This flag is issued with patient results and indicates a Increased Volume run
This flag is issued with a patient result to indicate that the result is lower than the
13. L
programmed minimum reference value
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 (∆Abs/min) is
more than the programmed concentration in Technical Limit Max
14. Lin.H
2) For Endpoint Chemistries, this flag indicates that the sample concentration is
higher than the concentration programmed in Technical Limit Max
If AutoRerun is se to YES, then the patient sample is sent for Decreased Volume
run
This flag is issued with patient, calibrator and control results to indicate that the lower
15. Lin. L
limit of linearity of the reagent has been violated
160
1. For Rate Chemistries, this flag indicates that the rate of reaction (∆Abs/min) is
less than the programmed concentration in Technical Limit Min
2. For Endpoint Chemistries, this flag indicates that the sample concentration is
lower than the concentration programmed in Technical Limit Min
If AutoRerun is se to YES, then the patient sample is sent for Increased Volume run
This flag is issued with patient result when, for concerned test, the absorbance’s of
16. MONO the calibrators are not changing monotonically with the concentration of calibrators in
the calibration table
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
OutofRange
17. table. If AutoRerun is set to YES, the patient sample is sent for Decreased Volume
H.
run for increasing direction chemistries and Increased Volume run for decreasing
direction chemistries
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
OutofRange
18. table. If AutoRerun is set to YES, the patient sample is sent for Increased Volume run
L.
for increasing direction chemistries and Decreased Volume run for decreasing
direction chemistries
This flag is issued with patient and control serum results to indicate the prozone
19. P* (antigen excess) has occurred. If AutoRerun is set to YES, the patient sample is sent
for a Decreased Volume run
This flag is issued with a serum sample result to indicate that the patient result is
20. Panic.H higher than the programmed Serum/Urine Panic Limit Max. If AutoRerun is set to
YES, the sample is sent for the same run
This flag is issued with a serum sample result to indicate that the patient result is
21. Panic.L lower than the programmed Serum/Urine Panic Limit Min. If AutoRerun is set to YES,
the sample is sent for the same run
22. PD This flag indicates that the sample was prediluted
This flag indicates that the volume of Reagent 1 is insufficient or Reagent 1 is not
23. R1*
present
This flag indicates that the volume of Reagent 2 is insufficient or Reagent 2 is not
24. R2*
present
This flag is issued when the value in the Maximum Reaction Linearity field is
25. LINXX
exceeded. This flag is issued only for Rate-A and Rate-B assays
This flag is issued when no points are available for calculation and all points within the
26. LIM0 specified time interval (M2S to M2E) have exceeded the reaction absorbance limit
specified in the Test Parameters field. Actual Result is displayed with the flag
This flag is issued when only one point (M2S) is available for calculation and all other
27. LIM1 points within the specified interval have exceeded the Reaction Absorbance Limit.
Actual Result is displayed with the flag
This flag is issued when only two points are available for calculation within the
28. LIM2
specified time interval. Actual Result is displayed with the flag
This flag indicates that the reagent absorbance is higher than the programmed
29. RgtAbsMax
Reagent Absorbance Max
This flag indicates that the reagent absorbance is lower than the programmed
30. RgtAbsMin
Reagent Absorbance Min
31. S* This flag indicates that the volume of Sample is insufficient or Sample is not present
This flag indicates that there was some problem with the transmission between the
32. SYS!
analyzer and PC which has affected the result
This flag indicates that a clot has been detected during sampling for that test. The
33. CD
result “NA” is associated with the flag.
161
4.7 Maintenance Menu

He/She can enter the Maintenance screen by clicking on the {Maintenance} button on the Main menu.
Figure 4.5 Maintenance Screen
These functions should be used for routine maintenance of the analyzer.
4.7.1 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, Reagent 1 probe,
Reagent 2 probe, Stirrer 1, Stirrer 2 and Cuvette Rinsing unit to their “home” positions.
4.7.2 Photometer
Clicking on <Photometer> button on the [Maintenance] screen brings you to the following
screen:
Figure 4.6 Photometer Screen
162
This screen is useful to view and adjust the photometer gains at different wavelengths. The
analyzer adjusts the photometer gains automatically if he/she 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.
The photometer gains can also be adjusted manually, however it is not recommended. Manual
Span Set can be used to view the photometer stability. It displays the Voltage and Absorbance at
different wavelengths.
Note: Before starting Manual Span Set, it is necessary to do one Auto Span
Set so that a cuvette filled with DI water stands between the lamp and the
photometer.
4.7.3 Cuvette Rinse

On clicking on <Cuvette Rinse> button, the system initializes and the Cuvette
Rinsing unit washes all 72 cuvettes. During Cuvette rinse, the detergent in the
detergent can is used to clean the Cuvette. After the Cuvette rinse is completed, the
Cuvette blanks are updated and the user can check the values by going to
{Maintenance: Cell Blank} screen. The explanation of the Cuvette blank screen is
given below:
Figure 4.7 Cell Blank Screen
This menu enables the user to view the Cuvette blank absorbance values (obtained with DI water in
the Cuvette) at any particular wavelength.
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 three sections.
{Cell Blank: Present abs}: It is the absorbance of the cuvettes with de-ionized water measured after
the last run or Cuvette Rinse.
163
{Cell Blank: Previous abs}: It is the absorbance of the cuvettes with de-ionized water measured after
the second last run or Cuvette Rinse.
{Cell Blank: Range}: This field shows the difference between the minimum and maximum absorbance
for that wavelength. The Range is given for Previous Absorbance as well as for Present Absorbance.
{Cell Blank: Show Graph}: On clicking this button, the user can view a graphical format of Present
Absorbance obtained at different wavelengths and also can view the graph for Previous absorbance.
A comparison of both graphs can be done using “ALL” option. A screenshot of the graph is shown
below:
Figure 4.8 Cell Blank Graph Screen
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 Auto Wash procedure from [Maintenance] menu must be performed if the Cuvette blanks are
higher than the maximum limit. If the Cuvette O.D.s exceed 0.2 Absorbance, the Cuvette should be
replaced with a new Cuvette or should be cleaned externally using fresh water.
If the cuvette blank for some cuvettes are less than 0.04, the cuvette with
the lowest blank absorbance should be placed at cuvette position 1 in the
reaction tray.
This procedure should be done daily before the starting the batch.
4.7.4 Water Save

This option can be used to fill all the 72 Cuvette with DI water. Overnight filling of the cuvettes with DI
water is helpful in loosening the dirt on the Cuvette walls. On clicking on <Water Save> button on the
164
[Maintenance] screen, the analyzer first washes all the 72 cuvettes with the detergent in the detergent
can. Then using the reagent1 probe, the analyzer fills water in all the 72 cuvettes. This water remains
in the cuvettes until the next run or Cuvette wash/rinse.
Perform water save daily, at the end of the day’s work.
Poor quality DI water should not be used for Water Save, as bacteria
growth can take place inside the cuvettes.
4.7.5 Wash
This screen consists of the following options:
Figure 4.9 Wash Screen
1. 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.
Clicking on <Auto Wash> button on the [Maintenance] screen presents the following screen:
165
Figure 4.10 Auto Wash Screen
Please place 7 ml each of Cleaning A and Cleaning B solutions at sample positions 1 and 3 and place
about 25 ml of Cleaning A and Cleaning B solutions at the corresponding reagent positions. Click on
<Start> button to start the washing procedure. At the end of the procedure, the user can check the
Updated Cuvette Blanks by going to the {Maintenance: Cell Blank} screen as explained in 4.7.3.
It is recommended to perform this procedure once a week or when needed. If one is using latex based
assays regularly, it is recommended to perform a Cuvette Wash daily with 1 M HCl and 1 M NaOH
solutions.
2. Sample Probe Wash

This option enables the operator to wash the sample probe with some cleaning 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 on 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.
3. R1PT/R2PT Wash
This option enables the operator to wash the Reagent 1 and Reagent 2 Probes with cleaning
solution at the end of day’s work. The user has to put the Cleaning Solution (same as Wash
Solution) on Reagent Position 55. When the button is clicked, the following operations occur:
1) Machine Initializes
2) R1 Probe aspirates the Wash Solution from 55th position.
3) R2 Probe aspirates the Wash Solution from 55th position.
4) The above action is performed 5 times.
4.7.6 Prime
This option is used at the beginning of the day before the Cuvette Rinse operation. The CKD valves of
Sample Probe, Reagent 1 Probe and Reagent Probe are kept ON for 4 minutes to remove the air
trapped inside the tubings. Also, the valves of the CRU tubings are kept open to remove the air
trapped in them. The following operation occurs after the button is clicked:
1) Machine Initializes
166
2) CRU goes in DOWN position in the RCT.
3) The CKD Valves for CRU, SPT, R1PT and R2PT open sequentially.
4) The priming continues for 4 minutes.
5) After the priming operation is completed, the CRU initializes to home position.
6) If the user desires to stop the priming, he/she can click on the STOP button located at the
bottom of the menu.
4.7.7 Dead Volume Calibration
Figure 4.11 Dead Volume Calibration Screen
This screen enables the user to calibrate the Dead Volume for Sample Cups and Reagent Bottles.
This procedure should be carried out only once. The procedure to carry out the Dead Volume
Calibration is given below:
a. For 2-Point Reagent Volume Calibration: The following steps should be done to
carry out the 2-Point Reagent Volume Calibration:
a. First Step of 2-Point Reagent Volume Calibration involves the Dead Volume Calibration of
50ml and 20ml bottles. The user has to select the bottle type and depending on the bottle
type, the Reagent Position on the which the bottle has to be kept for dead volume
calibration will be shown.
b. For 50ml bottle, pipette 2ml into the bottle and keep it on position 1. Click on Calibrate
button.
c. For 20ml bottle, pipette 1.5ml and keep it on position 56 and then click on Calibrate
button.
d. Once the Dead Volume Calibration is successful, then the user can select any position for
performing the reagent volume calibration.
e. For 50ml bottles, the user has to select which position the volume calibration needs to be
done and accordingly select the volume shown in the Reagent Volume list box. The same
principle applies for 20ml bottles.
b. For Sample Cup/Standard Cup Calibration: The following steps should be done to carry out the
Sample Cup Calibration:
a. User should select the position from the Dead Volume Calibration screen.
167
b. If Sample Cup is selected, then place the Cup on the 2nd position on Sample Tray. If Sample
Standard or 500µl Standard Cup is selected, then place the Cup on B1 position on Standard
Disk. If 5ml/7ml/10ml Tube is selected, then place the Cup on 1st position on Sample Tray.
c. Select the desired volume from the available volumes.
d. Pipette the exact amount specified for the Dead Volume in the Sample/Standard Cup.
e. Click on the Calibrate button.
Please note that if the Application Software or any hardware program is

changed, then the Dead Volume Calibration should be repeated again.
4.7.10 ISE Unit

This option is available only when Ion Selective Electrode unit is installed on the analyzer to perform
routing maintenance, purging, cleaning and calibration on the ISE unit. The details of this screen have
been explained in Appendix-A.
168
169
Appendix-A - Introduction to ISE Module
A-1
Appendix-A
Introduction to ISE Module
A-2
1 Introduction to the ISE Module

ISE (Electrolyte Measurement System) is placed on extreme left side of the chemistry analyzer, and it
measures the concentration of Na, K and Cl of serum, plasma or diluted urine with the ion electrodes.
The ISE unit consists of ISE module, ion electrode and two pumps, one for supply and other for waste.
ISE module This module consists of electrodes (Na, K, Cl and Reference) and
pumps. Measurement of concentration is done at electrodes and
rinses/calibrates after every measurement
Communication to the analyzer is carried out through RS232C.
Ion electrode This unit consists of Na, K, Cl and Reference electrodes.
Supply pump This pump supplies Calibrant-A into ISE module.
Waste pump This pump drains liquid in ISE module.
All waste liquid are discharged into the external tank for high concentration waste liquid.
The Module is completely self-contained. All sample and calibrant positioning within the module is
controlled by an integral microprocessor, which assures reliable electrode operation and maximum lifetime.
The electrolyte measurement system’s microprocessor applies proprietary mathematical algorithms to
electrode output voltages, converting them to clinical units of mmol/L.
A-3
1-1 Parts Location
Waste Pump
Cal A Pump ISE Electrodes

Tube from Cal A
Pump to Cal A
Bottle
A-4
1-2 ISE Technical Specifications

Sample type 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 < 5.0% (20 – 500 mmol/L)
K CV < 5.0% (1 – 500 mmol/L)
Cl CV < 5.0% (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 Manufacturer Recommended use of Calibrant A, Calibrant B, Cleaning
Solution, Urine Diluent
Operating ambient 25°C - 38°C
Temperature
A-5
1-3 ISE Measurement Theory

The electrolyte measurement system measures Sodium, Potassium and Chloride ions in biological fluids using
ion selective electrode technology. A diagram of the electrode measurement system is shown in Figure A.1.
Sample Port
Figure A1: Schematic diagram of the electrolyte measurement system
The flow-through electrodes use selective membrane tubing, specially formulated to be sensitive to the
respective ions. The potential of each electrode is measured relative to a fixed, stable voltage established by
the double junction Silver/Silver-chloride reference electrode. An ion-selective electrode develops a voltage that
varies with the concentration of the ion to which it responds. The relationship between the voltage developed
and the concentration of the sensed ion is logarithmic, as expressed by the Nernst equation:
RT log(αC )
E = Eo +
nf
Where: E = the potential of the electrode in sample solution

Eo = the potential developed under standard conditions
RT/nF = A temperature dependent “constant”, termed the slope
log = Base ten logarithm function
α = Activity coefficient of the measured ion in the solution
C = Concentration of the measured ion in the solution
A-6
1-4 Electrodes and Reagents used

Electrodes used in the ISE module
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 and calibration must be
performed after completion of 50 samples.
The entire double-junction reference electrode is disposable. The reference electrode is filled with
sufficient KCl so that no filling solution must be added during the lifetime of the electrode. The lifetime
of the reference electrode is 6 months or 10,000 samples. No addition of internal filling solution is
required for this electrode.
Electrodes require Calibrant A sampling at 30-minute intervals for reliable operation, but this is
completely controlled by the electrolyte measurement system without any need for operator
intervention.
The electrodes require a 10 times sample dilution for measurement of urine so user has to keep 10
times diluted (urine sample to urine diluent ratio 1:9) urine sample for the analysis of electrolytes in
urine samples.
It is not necessary to regulate the electrode housing temperature if its environmental temperature does
not exceed 38 °C.
Reagents used in the ISE Module:

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.
Four reagents are needed to operate the ISE module:
1. Calibrant A: Used as wash solution and single-point calibrator. Calibrant A is pumped into the
sample port by the Calibrant A pump and then positioned in front of the sensors. A volume of 200 µl is
sufficient for each sample run.
2. Calibrant B: Used as the second point in two-point calibration. Calibrant B is aspirated from a cup
on the analyzer at least once a day or every 8 hours depending upon the laboratory schedule. A
volume of 500 µl is sufficient for one day's requirements. This calibrant, however, should be placed on
the host analyzer just before use to prevent a change in values from evaporation.
3. Cleaning Solution: Should be run once a day to prevent protein buildup or at 8 hour intervals if the
ISE module performs more than 50 samples per day. Cleaning Solution may be aspirated from a
sample cup. 500 µl is sufficient for one day's requirements.
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 keep the
urine diluent on the 53rd position on the Reagent Tray.
A-7
1-5 Storage and Usage of the Reagents

(1) Store all solutions in a dark and cool place at room temperature.
Don't preserve the reagents such as Calibrant-B or cleaning solution once they are dispensed to
sample cup.
(2) Don't use the expired solution.
(3) When opening new bottle for a solution, don't mix remaining solution from the previous bottle.
(4) Calibrant-A has one month of on board stability.
Having the bottle more than one month requires swirling the bottle every day to assure homogeneity of
the solution.
(5) Dispense Calibrant-B into a sample cup just before ISE calibration to avoid evaporation.
1-6 When turning off the power

As Calibrant-A is automatically dispensed into ISE unit every 30 minutes to prevent electrodes from drying
out, it is not recommended to turn off the main power supply of the analyzer. Switch off only the analyzer at
the end of the day. This will keep the above function activated.
When Calibrant-A remains in fluid path for over two hours without flowing, the Na ion from reference
electrode can reach Na electrode and saturate the membrane resulting in effected Na measurement.
When the power to the analyzer needs to be turned off for a reason such as maintenance, follow the
procedure below to purge Calibrant solution in the path. Also refer to the procedure when turning off the
power for more than several hours, as it requires storage of the electrodes.
1-7 Shutdown Procedure: Preparing the ISE

module for storage
Preparing the ISE module for storage
If the laboratory plans to store the ISE module for a period greater than one week, during which the
analyzer will not be connected to power, the following steps should be performed:
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) that purges all fluid from the analyzer fluid path.
Reference, Na+ and Cl- electrodes

Depress the compression plate and remove all electrodes, including the reference electrode from the
sensor module
Place the Reference, Na+ and Cl- electrodes into individual sealed bags
K+ electrode
Aspirate a small volume of Calibrant A from the top port of the reagent module into a syringe fitted
with a blunt needle
Inject sufficient Calibrant A into the lumen of the K+ electrode until fluid fills the lumen
Cover both ends of the lumen (both sides of K+ electrode) with cellophane tape to hold the Calibrant
A in place
Insert the K+ electrode into a sealed bag
Calibrant A
Remove the Calibrant A from the analyzer and discard it
A-8
Analyzer re-activation
Remove all electrodes from sealed bags
Remove cellophane tape from K+ electrode
If necessary, soak the reference electrode in warm water until the lumen of the electrode has been
cleared of salt build-up
Place electrodes into the sensor module
Place new calibrant on analyzer and calibrate the analyzer.
1-8 Procedure for Installation and Removal of

ISE Electrodes
Installation of ISE Electrodes:
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 20 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.
Electrode
Electrode Handle
Compression plate
A-9
Note: Don’t mix Calibrant-A solution from old bottle with the new bottle.
After exchanging Calibrant-A, perform ISE priming more than 10 times.
If any water drop is found in the back of Calibrant-A bottle cap, wiped out with clean gauze.
Removal of ISE Electrodes:

1. To remove an electrode, you must first request a maintenance cycle by 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-10
2. ISE Calibration and Sample

Processing
It is mandatory to perform calibration (two points) before ISE measurement. It is recommended to
make it a routine operation to run calibration before running first sample of the day.
One point calibration is automatically performed at each sample processing by Calibrant-A and
Calibrant-B is used for two-point calibration.
The calibration is required at the following cases:
Important:
(1) The power switch of analyzer is turned off.
(2) Eight hours have passed since the last ISE calibration.
(3) Environmental temperature has changed more than 4 degrees C since
the last ISE calibration.
(4) More than 50 samples are processed after ISE Calibration in the
morning
2-1 Procedure for ISE calibration

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 300ul of 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:
Figure A-2 ISE Unit Screen
A-11
5. Click on <Purge> to remove air from the liquid column. Repeat the procedure if required. Each
Purge cycle takes about 30 seconds and 120 µl of Calibrant A solution is used for each sip.
6. After completion of Purge cycle click on <Clean> button.100 µl of Cleaning solution and 200 µl
of Cal A is used during the cleaning process. It requires 150 seconds to complete the cleaning
of the electrodes.
7. After cleaning cycle is over, perform 6 to 8 Purge cycles. Now the system is ready for
calibration.
8. Click on <Calibrate> button to start the ISE Calibration.140 µl of Calibrant B Solution is used
during two-point calibration. It takes about 60 seconds to complete the Calibration process. ISE
calibration can also be performed from the [Calib Table] screen of the Na, K, and Cl test
parameters.
9. After Calibration is completed, electrode calibration slopes are displayed on the screen below
the common keys. If any error occurs during the calibration process, the error code is also
displayed along with the slopes. Calibration date and time are updated in [Calib Table] and
“Fresh ISE Calibration suggested” warning disappears.
10. If the electrode calibration slopes are in the acceptable range, the electrolyte measurement
system is ready for the sample analysis.
11. For Serum samples 70 µl and for Urine 160 µl (10 times diluted with urine diluent) of sample is
required for the Electrolyte measurement.
The slope is defined as:

EB − E A
Slope =
log (C B C A )
Where CA = Calibrant A concentration in mmol/L

CB = Calibrant B concentration in mmol/L
EA = ISE Potential developed in Calibrant A solution in mV
EB = ISE Potential developed in Calibrant B solution in mV
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.
A-12
Acceptable Slope limits are:
Slope (mV/decade)
Na 50-63
K 50-63
Cl 40-59
2-2 Operating Cycles in ISE Module

The electrolyte measurement system performs 8 types of cycles:
Serum Sample Cycle: Calibrant A is pumped from electrodes and then sample is pumped from the
sample port to ion selective electrodes. Module acquires sample reading, pumps Calibrant A to wash
the ion selective electrodes and then acquires calibrant reading.
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.
Note: Electrolyte tests for Urine Samples and photometric tests, which
require sample predilution, should not be performed in the same run.
The analyzer could get stalled.
Calibration Cycle: Calibrant A is pumped from electrodes. Module pumps Calibrant B from sample
port to ion selective electrodes, acquires Calibrant B reading, pumps Calibrant A to wash the ion
selective electrodes and then acquires Calibrant A reading.
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 500 micro-liters of 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.
Standby Cycle: Pumps 120 µl of Calibrant A in front of ISE electrodes every 30 minutes to keep
electrodes moist. The ISE module automatically initiates this cycle.
A-13
3. ISE Maintenance Schedule

The electrolyte measurement system has been designed to require very little operator maintenance.
Recommended maintenance/replacement schedule
Daily Maintenance
1. Shake Cal A bottle

2. Clean cycle at the beginning
3. Purge cycles 5 times after cleaning ISE
4. Two point calibration before beginning the first sample.
5. Clean cycle at the end of the day
6. For more than 50 samples per day clean and calibrate the ISE module
Monthly Maintenance
1. Clean Electrode tip

2. Check alignment of electrodes and bubble detector
6 Monthly Maintenance
1. Change electrodes after 10,000 samples or 6 months

2. Check arm positioning and calibrate if necessary
9 Monthly Maintenance
1. Change pump cassette.

2. Change tubing
A-14
4. 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 1: Sample/Calibrant B noise or air.

Noise errors are represented by numbers 1 to 7. An air message is represented by “S” for air in sample
and “B” for air in Calibrant B. Notice that when there is air, the module does not read and does not send a
noise message.
Byte 2: Calibrant A noise or air

Noise errors, as above are represented by numbers 1 to 7. An air message is represented by “A” for air in
Calibrant A.
Byte 3: Calibrant A Drift

Drift errors are represented by numbers 1 to 7.
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
A-15
ISE Module Error Codes
Byte 1 Byte 2 Byte 3 Byte 4 Byte 4

Noise or Noise Out of Out of
Air for or Drift in Range for Range and/or
Sample/Cal Air for Cal A Sample/Cal B and Na Error for
B Cal A urine Urine only
Serum, Plasma, Urine
No
0 0 0 0
error
Na 1 1 1 1
K 2 2 2 2
Noise Na, K 3 3 3 3
Drift or Cl 4 4 4 4
Out Na,
Of 5 5 5 5
Cl
Range K, Cl 6 6 6 6
Na,
7 7 7 7
K, Cl
S A - -
Air
B - - -
Urine Only
Na urine Error
No
0 0 0 0 K only, no out of
Error
range error
Na 1 1 1 1 L
K 2 2 2 2 M
Na, K 3 3 3 3 N
Noise
Cl 4 4 4 4 O Na Urine
Drift or
Na, Error And
Out of 5 5 5 5 P
Cl Out of Range
Range
K, Cl 6 6 6 6 Q
Na,
7 7 7 7 R
K, Cl
A-16
5. Trouble shooting
Symptom Problem Correction
System does not 1. RS232 cable is disconnected or
Reconnect or replace cable.
respond damaged
2. Module connector has been damaged Replace board.
3. Component failure on board Replace board
Low Slope 1. Misalignment of sensors Remove and replace sensor to reseat.
Na or K < 45
mV/decade Replace Cal B first and retest. If still low
2. Deterioration of Calibrator solutions
Cl < 35 replace Cal A and retest
mV/decade 3. Deterioration of sensing electrode. Replace problem sensor and test.
Or 4. Air bubble on reference electrode Remove electrode, tap to dislodge bubble,
High Slope membrane replace, and recalibrate
Na or K > 63
mV/decade 5. Deterioration of reference electrode Replace reference electrode and retest
Cl > 60 6. Interaction between sensing electrodes Replace CL electrode only and retest.
mV/decade
7. Module or Fluid temperatures exceed Monitor temperature. Change instrument
370 C location if ambient is too great.
Noise Error Flag 1. Deterioration of sensing electrode Replace problem sensor and test.
Single electrode
a) Check for electrical noise coincident
2. Electrical noise spike from with activation.
environmental source b) Component failure on module board.
Replace board.
Noise Error Flag 1. Deterioration of reference electrode Replace reference electrode and retest.
Multiple electrodes
2. Electrical noise spike from with activation.
environmental source b) Component failure on module board.
Replace board.
Drift Error Flag 1. Deterioration of sensing electrode Replace problem sensor and test.
Single Electrode
Purge the Cal A and recalibrate the
2. May occur when new sensor or new module. If the sensor is new it may initially
bottle of Cal A is installed on system drift as it rehydrates over the course of 15
minutes
Drift Error Flag 1. Deterioration of reference electrode Replace reference electrode and retest.
Multiple Electrode
2. Electrical spikes from environmental with activation.
source b) Component failure on module board.
Replace board.
3. May occur when new sensor or new Purge the Cal A and recalibrate the
bottle of Cal A is installed on system module.
Air in Sample a) Host instrument must deliver 70 µl.
Increase dispense volume
1. Insufficient sample pipetted into
b) Operator must place sufficient sample
module sample port
in sample cup to account for all test
programmed
A-17
Symptom Problem Correction

a) Pump not connected properly.
2. Sample not positioned properly b) Pump tubing obstructed or tubing length
is excessive.
Air in Sample and a) Sensors are not properly compressed.
Cal A 1. Sample and Cal A are segmented with Check compression plate, spring and seal.
air. b) Ensure that all sensors and o-rings are
in place
a) Use Cleaning procedure <CLEN> for
2. Fibrin or salt is plugging the sensor module
flow path. b) Disassemble module and clean or
replace sensor with plugged flow path
3. Bubble detector is malfunctioning Replace bubble detector.
4. Waste pump is malfunctioning Replace Waste Pump
Air in Cal B and Air a) Sensors are not properly compressed.
1. Cal B and Cal A are segmented with
in Cal A Check compression plate, spring and seal.
air
b) Ensure that all sensors and o-ring are in
place.
a) Use Cleaning procedure <CLEN> for
2. Fibrin or salt is plugging the sensor module
flow path. b) Disassemble module and clean or
replace sensor with plugged flow path.
3. Bubble detector is malfunctioning Replace bubble detector.
4. Waste pump is malfunctioning Replace Waste Pump
Air in Cal B a) Host instrument must deliver 70 µl.
Increase dispense volume
1. Insufficient Cal B pipetted into module
b) Operator must place sufficient sample
sample port
in sample cup to account for all test
programmed
a) Pump not connected properly.
2. Sample not positioned properly b) Pump tubing obstructed or tubing length
is excessive.
Air in Cal A (no Replace Cal A Bottle with a new one,
1. Cal A bottle is empty.
“Air” errors purge and recalibrate.
reported for
Sample or Cal B) 2. Tubing is disconnected Reconnect or replace tubing.
a) Check electrical connections

3. Cal A pump is not working properly. b) Replace pump cassette.
c) Replace motor.
4. Tubing is plugged, split or crimped. Replace tubing.
A-18
Appendix-B
APPENDIX-B
REMOVAL OF WATER DROPLET
FROM PROBE TIP USING
DISCHARGING KIT
B-i
Appendix-B
Steps in Removal of Bubble from Reagent 1/ Reagent 2/ Sample Probe Tip:
Whenever water droplets sticking to the tip of any of the probes (Sample/ Reagent 1 / Reagent 2) are
observed , the following procedure to be adopted to minimize the sticking of droplets onto the tip of the
probes This should be done periodically in order to ensure that there is no bubble formation at the tip of the
probe.
1. Analyzer should be switched ON during the above operation. However, no sample processing
should be done while following this procedure.
2. Remove the discharging kit from the accessories box provided with the analyzer.
3. Ensure that one of the ends tinned ends of the discharging kit is made in contact with any one of the
screw heads on the Top Plate, nearest to the Probe under consideration. Keeping one tinned end of
the discharging kit in contact with the screw head, touch the surface of guide rod of the Arm /Probe
under consideration as shown in the figure below for 5 seconds:
Figure A: Discharging Cable from Chassis to Arm Shaft
4. Keeping one tinned end of the discharging kit in contact with the screw head, touch the surface of
metallic portion of the probe under consideration as shown in the figure below for 5 seconds:
B - ii
Appendix-B
Figure B: Discharging Cable from Chassis to Steel Probe
5. Repeat the above steps from 2 to 4 for all the Probes (Sample/Reagent 1/Reagent 2).
B - iii

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Operator’s Manual

Clinical Chemistry Analyzer

XL 640 Version 1.3 Last Updated: 03rd March 2007

XL 640 Version 1.3 Last Updated: 03rd March 2007

XL 640 Version 1.3 Last Updated: 03rd March 2007

XL 640 Version 1.3 Last Updated: 03rd March 2007

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

1 Only qualified personnel should use the analyzer.

2 The following precautions should be taken when the analyzer is installed:

2 The following cautions should be exercised before the analyzer is operated:

4. The following cautions should be exercised during operation:

7. Maintenance and checks:

9. Prohibit any alteration and/or modification to the analyzer without permission by

• Discrete, automated, random access, patient prioritized, 1/2

Sample • Sample tray

• Number of washing operation steps: 8 steps

• Number of washing solution application

• Washing solution container

• Reaction waste is collected into two waste cans (concentrated waste

• In built Cuvette overflow protection

Serial Number Description Quantity

1. Transducer Unit Assembly 1 No.

Tool kit – Containing 1 No.

P.M. Kit ----- Containing: 1 No.

Accessories for ISE Unit 1 No.

* - Optional (As per customer requirement)

Chapter 1 Analyzer overview

1.1 Designation of each unit

Figure 1.1 Front View of the Analyzer

Figure 1.2 Side View of the Analyzer

Figure 1.3 Front View of the Analyzer with Various Assemblies

1.2 Functionality of each unit

1.2.1 Auto sampler unit (ASP)

A) Turntable (ASP tray)

Figure 1.4 ASP Tray with Standard Disk

The ASP Tray of the analyzer consists of 2 sections:

The types of usable sample tubes are shown below:

For 10ml tubes:

B) Sample Barcode reader

The readable bar codes are as follows:

Symbol Valid character and symbol

1.2.2 Sample pipette unit (SPT)

A) Liquid level sensor

B) Nozzle down limit sensor

C) Clot Detection sensor

D) SPT Washing Station

1.2.3 Reagent 1/2 pipette unit (R1PT/R2PT)

Liquid Level Sensing Liquid Level Sensing

Figure 1.6 R1PT/R2PT Unit

A) Liquid level sensor

B) Nozzle down limit sensor

C) R1PT/R2PT Washing Station

1.2.4 Reaction Tray (RCT)

Figure 1.7 RCT Unit

1.2.5 Reagent Tray (RGT)

Figure 1.8 Reagent Tray

1) TBM type Reagent Tray is used for accommodating Reagent bottles.