Operator's Manual: Fully Automated Clinical Chemistry Analyzer

Operator’s Manual
Fully Automated Clinical

Chemistry Analyzer
th
X L- 640 O M VER: 2009.0 2 Releas ed on 12 Octo ber 2009
Table of Contents
Chapter 1 Warning Labels ............................................................................. 6
Chapter 2 Installation Conditions ............................................................... 10
Chapter 3 Technical Specifications ............................................................ 14

3.1 General specifications ................................................................................................... 15
3.2 Installation conditions .................................................................................................... 18
3.3 Sampling unit................................................................................................................. 19
3.4 Reagent unit .................................................................................................................. 20
3.5 Reaction unit ................................................................................................................. 21
3.6 Optical absorption measurement unit ........................................................................... 22
3.7 Control unit .................................................................................................................... 23
3.8 Data processing ............................................................................................................ 24
3.9 Ion selective electrode (ISE) unit .................................................................................. 26
Chapter 4 Equipment List ........................................................................... 27
Chapter 5 Analyzer Overview ...................................................................... 31

5.1 Designation of each unit ................................................................................................ 31
5.2 Functionality of each unit .............................................................................................. 34
5.2.1 Auto sampler unit (ASP).......................................................................................... 34
5.2.2 Sample Barcode reader .......................................................................................... 35
5.2.3 Sample Pipette Unit ................................................................................................ 36
5.2.4 Reagent 1 / 2 Pipette Unit (R1PT/R2PT) ................................................................ 37
5.2.5 Reaction Tray (RCT) ............................................................................................... 38
5.2.6 Reagent Tray (RGT) ............................................................................................... 39
5.2.9 Photometer Unit ...................................................................................................... 41
5.2.10 Mixing stirrer unit ................................................................................................... 41
5.2.11 Cuvette Rinsing Unit (CRU) .................................................................................. 42
5.2.12 Pipetting Pump assembly (SPP, R1PP and R2PP Syringes) ............................... 43
5.2.13 Ion selective electrode unit (ISE) .......................................................................... 44
5.2.14 Liquid Level Sensing Platform for external tank ................................................... 46
5.3 Measurement flow ......................................................................................................... 47
5.3.1 Normal measurement flow ...................................................................................... 47
5.4 Basic operational information ........................................................................................ 49
5.4.1 Procedure to Install the XL-640 Analyzer ............................................................... 49
5.4.2 Procedure to Install software for Analyzer .............................................................. 50
Chapter 6 Procedure of routine check ....................................................... 81

6.1 Checks prior to work and power-on .............................................................................. 82
6.1.1 Checks prior to work ............................................................................................... 82
6.1.2 Preparation of external tank solutions..................................................................... 83
6.1.3 Power-on ................................................................................................................. 85
6.2 Preparation and placement of reagent .......................................................................... 87
6.2.1 Consumable definition for reagents ........................................................................ 87
6.2.2 Placement and registration of reagents .................................................................. 90
6.2.3 Reagent Level Scan ................................................................................................ 94
6.3 Preparation and Placement of Blank / Standard / Calibrator / Control ...................... 96
6.3.1 Preparation of Blank, Standard, Calibrator and Control.......................................... 96
6.3.2 Placement of Blank, Standard and Calibrator ....................................................... 103
6.3.3 Placement of Control ............................................................................................ 107
6.4 Preparation and placement of sample ........................................................................ 108
6.4.1 Sample barcode scan (Offline) ............................................................................. 108
6.4.2 Specifications of Barcode label ............................................................................. 108
X L- 640 O M VER: 2009.0 2 2

6.4.3 Patient Entry .......................................................................................................... 110
6.5 Initiation of measurement and monitoring ................................................................... 124
6.5.1 Initiation of measurement...................................................................................... 124
6.5.2 Monitoring of measurement .................................................................................. 124
6.5.3 Interruption and resumption of measurement ....................................................... 131
6.6 Addition of sample and reagent during run ................................................................. 132
6.6.1 Addition of Barcoded sample during run ............................................................... 132
6.6.2 Addition of Barcoded reagent during run .............................................................. 132
6.7 Reproduction of Results .............................................................................................. 133
6.7.1 Calibration specific results .................................................................................... 133
6.7.2 Control specific results .......................................................................................... 142
6.7.3 Patient specific results .......................................................................................... 148
6.7.4 All results ............................................................................................................... 155
6.8 Shut Down Options ..................................................................................................... 159
Chapter 7 Alterations of Operational Conditions .................................... 162

7.1 Functional items .......................................................................................................... 162
7.2 Test Parameters .......................................................................................................... 163
7.2.1 Test Details ............................................................................................................ 163
7.2.2 Test Volumes Screen ............................................................................................ 163
7.2.3 Reference Ranges Screen.................................................................................... 181
7.3 Calculation Item........................................................................................................... 186
7.4 Profile Entry ................................................................................................................. 188
7.4.1 Procedure to Create a Profile ............................................................................... 188
7.5 System Parameter Settings ........................................................................................ 189
7.6 Backup ........................................................................................................................ 192
7.7 Carry Over Pairs.......................................................................................................... 194
7.8 Rerun Flags ................................................................................................................. 196
7.9 User Rights.................................................................................................................. 196
7.10 Result Recalculation ................................................................................................. 198
7.11 Search ....................................................................................................................... 200
7.11.1 Search – Patient and Samples............................................................................ 200
7.11.2 Patient Results Search ........................................................................................ 202
7.11.3 Calib / Control Results Search ............................................................................ 203
7.11.4 Consumables Search .......................................................................................... 204
7.11.5 Test Search ......................................................................................................... 205
7.12 Offline Results ........................................................................................................... 206
7.13 Other ......................................................................................................................... 208
7.14 Master ....................................................................................................................... 209
7.15 Serum Indices ........................................................................................................... 220
Chapter 8 Maintenance .............................................................................. 222

8.1 Maintenance Program ................................................................................................. 223
8.1.1 Maintenance Intervals ........................................................................................... 223
8.1.2 Consumables-Diluents & Wash Solutions ............................................................ 228
8.2 Actions to be taken in the event of trouble .................................................................. 229
8.2.1 Information requested by our customer service department ................................ 229
8.3 Malfunction at the time of power-on ............................................................................ 230
8.4 Anomalous measurement results ................................................................................ 230
8.4.1 Check for preparation of reagent, calibrator or QC sample .................................. 231
8.4.2 High resultant values from a specific method for all samples ............................... 232
8.4.3 Low resultant values from a specific method for all samples ............................... 232
8.4.4 Randomly derived erroneous measurement results ............................................. 233
8.4.5 Anomalous resultant values from all methods for a sample ................................. 233
8.5 Equipment malfunction ................................................................................................ 234
8.5.1 Detection of mechanical problem ......................................................................... 234
8.5.2 Error messages for each unit ................................................................................ 235
8.5.3 Error Log ............................................................................................................... 235
8.5.4 Measurement result error flags ............................................................................. 252
X L- 640 O M VER: 2009.0 2 3

8.6 Maintenance Menu ...................................................................................................... 256
8.6.1 Auto Span .............................................................................................................. 256
8.6.2 Manual Span ......................................................................................................... 257
8.6.3 Wash ..................................................................................................................... 257
8.6.4 Dead Volume Calibration ...................................................................................... 262
8.6.5 ISE Unit ................................................................................................................. 265
8.6.6 Auto - StartUp ........................................................................................................ 265
Chapter 9 Appendix-A Introduction to ISE Module ................................. 267

9.1 Introduction to the ISE Module .................................................................................... 268
9.1.1 Parts Location ....................................................................................................... 269
9.1.2 ISE Technical Specifications ................................................................................. 267
9.1.3 ISE Measurement Theory ..................................................................................... 272
9.1.4 Electrodes and Reagents used ............................................................................. 273
9.1.5 Storage and Usage of the Reagents ..................................................................... 274
9.1.6 When turning off the power ................................................................................... 275
9.1.7 Shutdown Procedure: ........................................................................................... 275
9.1.8 Procedure for Installation and Removal of ISE Electrodes ................................... 276
9.2 ISE Calibration and Sample Processing ..................................................................... 278
9.2.1 Procedure for ISE calibration ................................................................................ 278
9.2.2 Operating Cycles in ISE Module ........................................................................... 281
9.3 ISE Maintenance Schedule ......................................................................................... 282
9.4 Error Codes ................................................................................................................. 283
9.5 Trouble shooting.......................................................................................................... 287
X L- 640 O M VER: 2009.0 2 4

Chapter 1 – W arning Labels
Foreword
The XL-640 Analyzer is a fully automated, discrete, random access, Computerized Clinical
Chemistry Analyzer. It is intended in Vitro diagnosis of wide range of Analytes in various body
fluids. This Operator‟s manual is an instructional aid to perform various operations and
general maintenance of the analyzer. It contains detailed description of the XL-640 analyzer
features and specifications. The analyzer is used with operational PC and Printer, and can
interact with the host computer. The operational PC consists of the application software for
the user to operate the analyzer. All the samples and reagents for measurements including
samples obtained from patients are controlled by barcodes 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 has made that before attempting to operate the analyzer, the operator is
familiar with the operation of analyzer and has:
1. Read the Operator’s Manual.
2. Has been trained by authorized person.
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.
X L- 640 O M VER: 2009.0 2 5

Chapter 1 Warning Labels

This chapter provides the user with necessary information on the warning labels. The user is
requested to read the Operator Manual before installing the Analyzer.
X L- 640 O M VER: 2009.0 2 6

Chapter 1 – 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
XL-640 OM VER: 2009.02 7

Chapter 1 – Warning Labels

WARNING On the Biohazardous waste can (10 Lt.)
THE TANK CONTAINS HAZARDOUS On the Waste Can (20 Lt) Biohazardous
MATERIAL
WARNING ABOUT PLACES

WARNING On the 5-piece Top Cover
POTENTIAL HAND EXPOSURE TO DOME.
KEEP HANDS AWAY.
XL-640 OM VER: 2009.02 8

During operation, do not touch samples, reagents, nozzles and any other
moving mechanical parts in the analyzer. During operation, shut cover all
the time.
Never touch patients' samples with bare hands to prevent operator from
possible infection. Handle SPT nozzle, R1PT nozzle, R2PT nozzle, CRU
cuvette, CRU nozzles, Stirrer 1 and Stirrer 2 paddles in the same way.
Give special consideration to keep skin and mucous membrane from

contact with reagents to prevent operator from possible infection.
By virtue of design feature for continuous loading the machine dome can
be opened without use of tool as a result moving parts becomes
accessible. The user is advised to keep hands away from moving part
and should take other necessary precaution to avoid hazard and in case
of any injury immediately switch off switch provided on the front panel.
The contact with the wastes such as used cuvettes and solutions may
cause infection. Handle them with gloved hands without exception. Follow
the national or local laws and rules when they are thrown out. There are
two kinds of liquid wastes drained from this analyzer, i.e. diluted and bio-
hazardous wastes.
The access to the conductive parts within the analyzer may cause serious
electric shock. Leave any maintenance and repair of electrical parts inside
the equipment to qualified service personnel.
Never leave reagent bottles on the working table (upper surface inside the
analyzer). Careless handling of reagent bottles may cause tumble and
leak.
Do not make a modification to the analyzer.
The device is intended to be used by a trained personnel in controlled

environment and under continuously monitored operation
X L- 640 O M VER: 2009.0 2 9

Chapter 2 – Ins tallation Conditions
Chapter 2 Installation Conditions
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.
X L- 640 O M VER: 2009.0 2 10

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,
sulphur, 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).
3 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.
X L- 640 O M VER: 2009.0 2 11

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 behaviour 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.
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,
sulphur, 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.
X L- 640 O M VER: 2009.0 2 12

a. 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.
b. 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.
c. 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.
d. Prohibit any alteration and/or modification to the analyzer without permission by

manufacturer.
e. Space Requirements:
 Analyzer dimensions: 897(L) * 655(B) * 1170(H) mm
X L- 640 O M VER: 2009.0 2 13

Chapter 3 – Tec hnic al Spec if ic ations
Chapter 3 Technical Specifications

This chapter provides the user with necessary information on the technical specifications of
the instrument.
X L- 640 O M VER: 2009.0 2 14

3.1 General specifications

Item Description
390-400 tests/hour (640 tests/hour with ISE) for a cycle time

Throughput
of 9 seconds
Discrete, automated, random access, patient prioritized, 1/2
System type
reagent system
Serum
Urine
CSF
Sample
Plasma
Whole Blood
Others
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 complements and others
Analytes Turbidimetric assays
IgG, IgA, IgM, C3, C4, RF, CRP, ASO, Transferring and
others
Absolute measurement
Test method Relative measurement
ISE (optional)
On board tests 56 test items maximum; 60 test items with ISE
Any number of photometric tests
Programmable Any number of calculation items
parameters Serum indices
(Optional) 4 ISE tests (Na, K, Cl and Li)
1-Point
2-Point
Assay modes
Rate-A
Rate-B
Sample volume 2-70 µl (adjustable in 0.2 µl step)
Reaction volume 180µl – 660µl
Reaction 37 °C
temperature Temperature stability: ± 0.2 °C
Serum Degree of Lipemia, Icterus and Hemolysis can be measured
information and displayed
X L- 640 O M VER: 2009.0 2 15

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
Any number of calibrators can be used
Calibration Any number of calibrators maximum per test
Selective calibration possible
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
Maintenance actions: Cuvette Rinse, Water Save, Auto
Wash, Sample Probe Wash, R1/R2 Probe Wash, Prime
Maintenance
Wash, ISE maintenance and Calibration, Dead Volume
Calibration, Auto-span and manual span.
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 litres/hour
Water supply unit Manufactures and supplies: Type 2 quality (by NCCLS
standards) ion exchange water
Quality control Any number of control parameters
System Warm-up
30 minute system warm-up time
Time
Vertical obstruction detection
Safety
Clot Detection
mechanism
Capacitance based liquid level sensing
Noise level Less than 65 dB
Display 15 inch colour display
X L- 640 O M VER: 2009.0 2 16

Keyboard Standard keyboard

Printer External: A4 size DeskJet colour printer (optional)
Auxiliary storage
CD ROM
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 and Li)
Optional A4 size colour DeskJet / Laser printer
PC-Host Computer: TCP/IP bi-directional
Automatic Water Supply from an outside DI water unit
X L- 640 O M VER: 2009.0 2 17

3.2 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

Drainage
sample (diluted waste) are to be drained separately
Ambient 15 – 30°C
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
X L- 640 O M VER: 2009.0 2 18

3.3 Sampling unit

Item Description
Blood collection tube 10 ml (16 x 100 mm), 7 ml (14.5 x 84 mm),
5 ml (13 x 75 mm)
Sample container
Adaptors will be provided for 5 and 7 ml tubes
Standard cup 2 ml
Sample tray
Inner rim: 25 routine patient samples with/without barcode,
blanks, standards, calibrators and controls
Outer rim: 25 routine patient samples with/without barcode
(optional positions for STAT), blanks, standards, calibrators
and controls
Sample placement
Standard tray
Inner rim: 2 blanks, 8 controls & 2 ISE solutions and patient
sample without barcode
Outer rim: 20 positions each on Disc1 and Disc 2 separately for
standards/STAT/blanks/calibrators/control/patient sample
without barcode
Can be placed anywhere on the Sample Tray / Standard Tray

STAT samples STAT samples are measured preferentially
Interrupt permitted even during analysis
Pipetting system with plunger, driven by stepper motor

Sampling
Sample volume: 2-70 µl (adjustable in 0.2 µl step)
Discharges set volume of sample into Cuvette or the ISE module
Pipetting mode
(optional)
Micro-pipette with level sensor
Washing solution
Outside: Preheated de-ionized water
Sampling probe
Inside: Preheated de-ionized water
Equipped with vertical obstruction detection facility to prevent
probe crash and clot detection facility
Dilution ratio: 2 to 150 times
A Cuvette is used as dilution vessel
Set amount of diluent is dispensed into a Cuvette by reagent
Sample dilution 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
Execution by repeat run list or auto execution
Auto execution according to abnormal marking and/or range
Repeat run
over
Reduced/increased volume repeat run also possible
Sample Sample bar-code ID (barcode reader provided as standard)

identification Position ID for STAT samples
X L- 640 O M VER: 2009.0 2 19

3.4 Reagent unit

Item Description
Type Turn table type reagent tray
Common reagent tray for reagent 1/2
Reagent tray
Reagent Tray suitable for TBM bottles
Reagent cooling
4 to 12°C cooled with refrigeration unit
temperature
Reagent bottles 28 positions for 20 ml and 28 positions for 50 ml
Pipetting system with plunger, driven by stepping motor
Reagent dispensing R1 dispensing in the 0.5th cycle
R2 dispensing in the 25th cycle
Micro-pipette with level sensor
Outside washing solution: Preheated de-ionized water
Reagent probe 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 1: 60 – 300 µl (adjustable in 1 µl step)
Reagent volume
Reagent 2: 0, or 10 – 300 µl (adjustable in 1 µl step)
User programmable dead volumes for reagents, samples and
Dead volume
standards
Mixing positions
Mixing
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
Extra Reagent/Detergent Wash/System Wash given for Carry-

Carry over actions
Over Pairs
X L- 640 O M VER: 2009.0 2 20

3.5 Reaction unit

Item Description
Type Turn table
Rotating tray
Reaction tray Number of reaction cuvettes: 72
Temperature control: Turn table direct heating by foil heater
Reaction
37 ± 0.2 °C
temperature
Reusable
Number of reaction cuvettes: 72
Dimensions: 5 x 5 mm
Cuvettes Optical path length: 5 mm (factor to be fed for 10 mm)
Material: Hard glass
Volume: 700 µl
Reaction liquid volume: 660 µl maximum, 180 µl minimum
Reaction liquid Mixing positions
mixing o The 1st position: Right after sample dispense into the first
reagent
o The 2nd position: 1st reagent + sample + R2
Type: By the automatic washing system
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
Cuvette washing Number of washing solution application

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

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

waste and diluted waste) by pumps
In built Cuvette overflow protection
X L- 640 O M VER: 2009.0 2 21

3.6 Optical absorption measurement unit

Item Description
Type Multiple wavelength, diffraction spectrophotometer
Multi-wavelength direct measurement of light after penetration
Photometric system
into reaction Cuvette (transmitted light)
12 Wavelengths: 340, 376, 415, 450, 480, 505, 546, 570, 600,
Wavelength
660, 700 & 750 nm
Wavelength per
One or two wavelengths
chemistry
Total 63 points
Measurement interval
Every 9 seconds for 9 second cycle time
OD 0 – 2.5
OD range
Light path calculated as 10 mm
Resolution 0.0001 OD
Pre-aligned Halogen lamp (12V/20W)
Light source
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
X L- 640 O M VER: 2009.0 2 22

3.7 Control unit

Item Description
PC: Windows machine, IBM compatible
OS: Windows XP Service Pack 2
CPU: Pentium IV or above
RAM: 1 GB
User interface
Hard disk: 80 GB / 40 GB
hardware
Console: 15 inch colour monitor
External drives: CD-ROM drive
Printer: DeskJet, Laser printer.
Multimedia Speakers
System interface Analyzer – PC: RS-232C bi-directional
X L- 640 O M VER: 2009.0 2 23

3.8 Data processing

Item Description
K-Factor, Linear (one point, two point and multipoint), Logit-
log, Spline, Exponential, Polynomial
Calibration curve Multipoint curves for up to 10 points
One point correction to multi-point calibration line is provided
Auto-dilution for non linear curves
Within day as well as day-to-day X-Mean and X-Range
Quality control control diagram
Mean, SD, %CV, R are calculated for each chemistry
Execution by repeat run list or auto execution
Repeat run Auto execution according to abnormal marking or range over
Reduced/increased volume repeat run also possible
Reaction curve graphical display
Calibration curve graphical display
Monitor function
Operation status watching by run monitor
Cell blank graphical display
Correlation correction factor (Y = aX + b)
Calculation by the formula defined by user
Calculation between o Any number of calculated items can be programmed
items o Each calculation item can include up to 5 chemistries
Recalculation of results possible after modification in
Calibration Parameters or Test Parameters
Report generation: Patient wise, Test wise, Date wise,
Location wise, Abnormal result wise, Doctor name wise
Report/list format
Lists: Abnormal values list, Recalculated result list, Repeat
run list
Selective Backup of following data is possible:
Consumables, Patient, Patient with Results, Test
Backup Parameters, Calibration, Error Log, System parameters
Full Backup
Special treatment Reagent blank correction
Reference range check by age, sex, sample type
Panic limit check
Reaction linearity check
Data check
Reaction mixture absorbance checks
Antigen excess/prozone check (by reaction time course
analysis method)
Types of alarms: Erroneous operation, mechanical
malfunction of analyzer, data processor hardware error,
Alarms and erroneous test results
notices Alarm level: Notice, temporary halt of analysis, suspension
of analysis, system stop
Prompts on display alarms
X L- 640 O M VER: 2009.0 2 24

Mechanical movements and functional performance can be

Diagnostic checks
checked through diagnostic menu
Password provided to reject an access to selected menus
Password
Access rights for multiple users
X L- 640 O M VER: 2009.0 2 25

3.9 Ion selective electrode (ISE) unit

Item Description
Ion selective electrode
Type of Direct measurement for Serum samples
measurement 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, Li
Serum: 30 seconds/sample
Measurement cycle
Urine: 40 seconds/sample
X L- 640 O M VER: 2009.0 2 26

Chapter 4 – Equipm ent List
Chapter 4 Equipment List

This chapter provides the user with necessary information on the list of equipments.
X L- 640 O M VER: 2009.0 2 27

Chapter 4 – 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:
SR. NO. ITEM NO. DESCRIPTION QUANTITY

1. 105309 ASSEMBLY TRANSDUCER UNIT 1 No.
ASSEMBLY 20 LTR CAN ASSEMBLY FOR DI
2. 105396 1 No.
WATER
3. 105393 ASSEMBLY CAN 20 LTR FOR WASTE 1 No.
ASSEMBLY 10 LTR CAN FOR BIO-
4. 105397 1 No.
HAZARDOUS WASTE
ASSEMBLY 10 LTR CAN FOR CLEANING
5. 105390 1 No.
SOLUTION
6. 100263 CUVETTE (4C:0609) 5 Nos.
MOULDED REAGENT TRAY (WITH
7. 100616 1 No.
PARTITIONS)
ASSEMBLY OF REAGENT COVER FOR XL-
8. 105444 1 No.
640
9. 105450 ASSEMBLY TRAY STANDARD SAMPLE 1-50 1 No.
ASSEMBLY TRAY EMERGENCY SAMPLE 51-
10. 105451 1 No.
100
TOOL KIT – CONTAINING

11. 101494 PLASTIC TOOL BOX 1 No.
12. 101688 SCREW DRIVER X100L CR-V CARBON TIP (1 No) 1 No.
13. 101687 SCREW DRIVER X100L CR-V CARBON TIP (2 No) 1 No.
14. 101689 SCREW DRIVER IMPORTED ( - ) NO.3 1 No.
15. 101675 NUT DRIVER 5.5 MM FOR M3 1 No.
16. 101676 NUT DRIVER 7.0 MM FOR M4 1 No.
17. 101495 BOX SPANNER (10 -11MM) 1 No.
18. 101692 ALLEN DRIVER (M3) 2.5 MM T TYPE-9" LONG 1 No.
21. 101508 ALLEN KEY WHITE BIT HEX BALL SIZE: 1.5 MM 1 No.
27. 101514 NOSE PLIER 1 No.
28. 101515 FLAT SPANNER 10 / 11 1 No.
29. 101524 FLAT SPANNER 14-15 MM 1 No.
XL-640 OM VER: 2009.02 28

30. 100323 METALLIC FORCEP 2A-SA (NOSE WITH RADIUS) 1 No.

31. 100295 TRIMMER 933 NO 1 No.
32. 101516 SPANNER SET SIZE: 1 TO 8 NOS 1 No.
33. 101678 6" ADJUSTABLE SPANNER 1 No.
34. 100294 TUBE CUTTER --( LEGRIS-MAKE) 1 No.
35. 100679 CALIBRATION PLATE FOR XL - 600 1 No.
SHIPPER BOX
CABLE ASSEMBLY REAR PANEL TO COMPUTER
36. 101447 1 No.
SPCW316
INDIAN PLUG - IS16A3-V1625BA IS 3 X 1.5 SQ.MM
37. 100309 1 No.
2 MTR.LENGTH.
38. 101730 CUP 3 ML VOLEX FOR SAMPLE 450 Nos.
TUBE ADAPTER TEST TUBE FOR MOULDED
39. 100634 100 Nos.
SAMPLE HOLDING PLATE
ASSEMBLY TUBE FOR WASTE CAN WITH
40. 105381 1 Set
COUPLING BODY
ASSEMBLY CAN OF BIO-HAZARD TUBE WITH
41. 105467 1 No.
COUPLING BODY
REAGENT BOTTLE (20 ML ) ASSY. WITH LIGHT
42. 182581 28 Nos.
BROWN COLOR
REAGENT BOTTLE (50ML) ASSY. WITH DARK
43. 182584 28 Nos.
BROWN COLOR
REAGENT BOTTLES (20 ML) WITH CAPS
44. - 2 Nos.
AND BARCODE LABELS
REAGENT BOTTLES (50 ML) WITH CAPS
45. - 2 Nos.
AND BARCODE LABELS
46. 100631 REAGENT BOTTLE POSITIONING RING 1 Nos.
47. - TEST TUBES (5 ML) WITH BARCODE LABELS 25 Nos.
ASSEMBLY TUBE WITH COUPLING BODY FOR
48. 105469 1 No.
CLEANING SOLUTION
P.M. Kit ----- Containing

49. 102851 CUVETTE DRIER (4.4 SQ.) (REV 1) 2 Nos.
ASSEMBLY LAUNDRY ASPIRATION TUBING SET -
50. 105470 2 Set
TWO PROBE CONSTRUCTION
ASSEMBLY LAUNDRY DISPENSING TUBING SET -
51. 105471 1 Set
TWO PROBE CONSTRUCTION
ASSEMBLY LAMP PHOTOMETER WITH BASE
52. 105299 2 Nos.
(GILWAY) FOR XL
53. 102143 FILTER 25 MICRON 4 Nos.
54. 101843 STICKER SCREW COVER TRAYS OF LLS 8 Nos.
55. 105368 FUSES SET FOR CHEMIX-800 / XL-640 2 Set
XL-640 OM VER: 2009.02 29

56. 101677 CLEANER FOR PROBE 1 No.

57. 101773 BUFFER PM KIT FOR XL-300 & XL-600 1 No.
BOX XL PM KIT (SIZE: INSIDE DIMN. 9.5" X 7.5" X 5"
HT ; 5 PLY TOP 140 GSM WHITE DUPLEX BACK
58. 101820 1 No.
100 GSM KRAFT; WITH BLUE COLOUR PRINTING "
P. M. KIT " ON TWO OPP. SIDES)
59. 101774 BUFFER LAMP ASSEMBLY FOR XL-300 & XL-600 2 Nos.
60. 101804 BOX FOR PHOTOMETER LAMP ASSY. 2 Nos.
ACCESSORIES FOR ISE UNIT

61* 200004 ELECTRODE REFERENCE FOR ISE CAT # 5204 1 No.
62* 200001 ELECTRODE NA FOR ISE CAT # 5201 1 No.
63* 200002 ELECTRODE K FOR ISE CAT # 5202 1 No.
64* 200003 ELECTRODE CL FOR ISE CAT # 5203 1 No.
65* 100316 LI_ ELECTRODE - REF 5205 1 No.
66* 103444 ASSEMBLY OF XL-600 ISE BOTTLE WITH TUBE 1 No.
4 CHANNEL ISE MODULE CLEANING SOLUTION KIT
67* 105542 1 No.
CAT. NO. 5421
MISCELLANEOUS
68. - UNIT INSTALLATION INSTRUCTION SHEET 1 No.
69. - HYDRAULIC DIAGRAM SHEET FOR XL-640 1 No.
70. - CAN CONNECTION DIAGRAM 1 No.
71. - FQC REPORT 1 No.
72. 120273 ERBA (XL) WASH KIT 1 No.
73. - MULTIXL APPLICATION SOFTWARE 1 No.
74. 101248 OPERATOR MANUAL VERSION 1.2 FOR XL-640 1 No.
75. 182462 BARCODE ALIGNMENT KIT 1 No.
DI WATER PLANT ELGA MAKE (SR. NO.
76* - 1 Set
OS15D227619BP)
77* - PRE FILTER ASSEMBLY FOR D.I. WATER PLANT 1 Set
NOTE:
“Accessories Box B”: 42” (1070) * 27” (685) * 17” (435); Weight: 30 kg.
* : OPTIONAL (AS PER THE CUSTOMER REQUIREMENT).
XL-640 OM VER: 2009.02 30

Chapter 5 – Anal yzer O ver view
Chapter 5 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.
X L- 640 O M VER: 2009.0 2 31

5.1 Designation of each unit
Figure 5.1 - 1 Front View of the Analyzer
X L- 640 O M VER: 2009.0 2 32

Figure 5.1 – 2 Side View of the Analyzer
Figure 5.1 - 3 Front View of the Analyzer

With Various Assemblies
X L- 640 O M VER: 2009.0 2 33

5.2 Functionality of each unit
This section contains the description of each unit constituting the system.
5.2.1 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).
Standard Disk
Sample Disk
Figure 5.2.1 - 1 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, any position can
used as Emergency Positions. Adapters are available for loading the primary tubes of
different sizes. Primary tubes as well as 2 ml cups could be placed in the outer section.
Blank, control, stat/emergency samples and standards/calibrators can be placed at any

positions except ISE1 & ISE2. It is a detachable tray mounted on top of the routine tube
tray. 2 Standard Disks are available. On this tray, only 2 ml 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 B1 and
B2 for Disk 1 or B3 and B4 for Disk 2 respectively).
X L- 640 O M VER: 2009.0 2 34

The types of usable sample tubes are shown below:
For 10 ml tubes:
Diameter : 15 mm
Length : 101 mm
Extent of label fitting: Refer to below drawing.
For 5 or 7 ml tubes:
Diameter: 12 mm
Length: 75 mm
Extent of label fitting: Refer to below drawing.
5.2.2 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 (-, $, /, ., +)
Numerals (0 - 9), alphabetical characters, symbols (-,
Code39
space, $, /, +, %)
ITF Numerals only (0 - 9)
UPC Numerals only (0 - 9)
Code128: All ASCII code characters [numerals (0 - 9), alphabetical

characters (uppercase/lowercase), symbols, control
Set A, Set B, Set C characters]
X L- 640 O M VER: 2009.0 2 35

5.2.3 Sample Pipette Unit
Liquid Level Sensor

Board for SPT Arm
Figure 5.2.3 - 1 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.
1. Liquid level sensor (LLS)
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.
2. 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.
3. 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. Further action whether to permanently pause
sampling or continue with the next sample is done according to the setting in the
System Parameter screen.
X L- 640 O M VER: 2009.0 2 36

Cause Action
1. Fibrin clots formed on specific Clean the SPT nozzle.
sample tube or sample cup
4. 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.
5.2.4 Reagent 1 / 2 Pipette Unit (R1PT/R2PT)
Liquid Level Sensing Board for

R1PT Arm
Figure 5.2.4 - 1 R1PT Unit
Liquid Level Sensing Board for

R2PT Arm
Figure 5.2.4 - 2 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)
X L- 640 O M VER: 2009.0 2 37

contained in the reagent tray (RGT) and dispenses it into cuvettes (reaction cells) in the RCT
unit.
5. 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.
6. 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.
7. 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 Reagent 1/Reagent 2 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.
5.2.5 Reaction Tray (RCT)
Cuvettes
Figure 5.2.5 - 1 RCT Unit

The reaction tray (RCT) consists of the Cuvette ring set and rotating mechanism. RCT
is provided with 72 hard glass cuvettes (5 mm * 5 mm) on its outer circumference and
the temperature inside is kept at 37ºC (+/- 0.2ºC) constantly. The cuvettes are moved at
9-second step and a series of process including dispensation, stirring, photometric
measurement and washing be performed.
X L- 640 O M VER: 2009.0 2 38

5.2.6 Reagent Tray (RGT)

The Reagent tray 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.
Figure 5.2.6 - 1 Reagent Tray
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
X L- 640 O M VER: 2009.0 2 39

5.2.7 Reagent Bottles

The reagent bottles are available in two capacities: 20 ml 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:
A picture showing the Reagent bottles provided with the Analyzer is shown below:
50 ml Bottle
20 ml Bottle
Figure 5.2.7 – 1 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. The barcode
reader reads barcode of the label affixed on the outer surface of the reagent bottle.
5.2.8 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:
Symbol Valid character and symbol

NW-7 Numerals (0 – 9), symbols (-, $, /, ., +)
Numerals (0 – 9), alphabetical characters,
Code39
symbols (-, space, $, /, +, %)
ITF Numerals only (0 – 9)
UPC Numerals only (0 – 9)
Code128: All ASCII code characters [numerals (0 – 9), alphabetical
Set A, Set B, Set C characters (uppercase/lowercase), symbols, control characters]
X L- 640 O M VER: 2009.0 2 40

5.2.9 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.
5.2.10 Photometer Unit

The Photometer Unit consists of the optical measurement system and light source.
The absorbance inside the Cuvette of the RCT 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, 415 nm, 450 nm, 480 nm, 505 nm, 546 nm, 570 nm, 600 nm,
660 nm, 700 nm, 750 nm.
The photometer consists of an illuminate (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 pre-aligned twelve
elements 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.
5.2.11 Mixing stirrer unit

1. (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 5.2.11 - 1 Stirrer 1 and Stirrer 2
X L- 640 O M VER: 2009.0 2 41

8. 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.
9. 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.
5.2.12 Cuvette Rinsing Unit (CRU)
Figure 5.2.12 - 1 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.
X L- 640 O M VER: 2009.0 2 42

ASPIRATION PROBE
DRIER
Figure 5.2.12 - 2 Cuvette Rinsing Unit
5.2.13 Pipetting Pump assembly (SPP, R1PP and R2PP

Syringes)
Sample (SPP) Reagent 1 Reagent 2

Syringe (R1PP) Syringe (R2PP) Syringe
Figure 5.2.13 - 1 Pipetting Pump Assembly
X L- 640 O M VER: 2009.0 2 43

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 70 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.
5.2.14 Ion selective electrode unit (ISE)
Waste Pump
Cal A Pump
ISE Electrodes
Cal B Pump
Figure 5.2.14 - 1 ISE Unit

The concentration of electrolyte (sodium: Na, potassium: K, chloride: Cl and lithium: Li)
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.
X L- 640 O M VER: 2009.0 2 44

This module unit is fitted electrodes (Na, K, Cl, Li and Reference) and
controls pumps, measurement of concentration by electrodes and
(1) ISE module
rinsing movement. Communication to the analyzer is carried out through
RS232C.
This unit consists of Na, K, Cl, Li and Reference electrodes.
The Reagent pack for Calibrant-A & Calibrant-B is placed on the top
(2) Ion electrode
panel. Dedicated wash solution are placed in the ASP unit and wash
solution is supplied by the SPT in the same way as for the sample.
These pumps performs the infusing of Calibrant-A and Calibrant-B into
(3) Supply pump
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.

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. 130µl of Calibrant-A is automatically
dispensed into the ISE unit every 30 minutes to prevent the electrode
from drying during standby cycle.
Reagent pack containing Cal A solution is placed on the front panel
of the Analyzer
(2) Calibrant-B Calibrant-B is used at the time of two-point calibration.

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. Reagent pack containing Cal B solution is placed on the
front panel of the Analyzer
(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
user define 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) ISE Diluent: The dilution is carried out using two dilution cuvette in the CRU unit
and there for two cycles of chemistry analysis is allocated.
(6) Sampling volume at each measurement
X L- 640 O M VER: 2009.0 2 45

Measurement Volume
Sample for serum : 70 µl
In the case of analytic measurement
Sample for urine : 140 µl
Calibrant-A: 180µl, Calibrant-B:
180µl
In the case of full calibration
Calibrant-A: 180µl, Calibrant-B:
180µl
In the case of 1-point calibration Calibrant-A: 180µl
5.2.15 Liquid Level Sensing Platform for external tank
Tray for DI Tray for Bio-Hazardous

Water Can Tray for Cleaning Waste Can Tray for Diluted
Solution Can Waste Can
Figure 5.2.15 – 1 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.
X L- 640 O M VER: 2009.0 2 46

5.3 Measurement flow
5.3.1 Normal measurement flow

Time Cycle Analyzer action Time Cycle Anal yzer ac tion
(Minute) Number (minutes) number
0:00 0/72 Dry the Cuvette + Add 5:33 37 Meas ure reaction
Reagent 1 abs orbanc e
0:09 1.5 Measure reagent 5:42 38 Meas ure reaction
absorbance abs orbanc e
0:18 2 Add sample + Stir 1 + 5:51 39 Meas ure reaction
Measure reaction mixture abs orbanc e
absorbance
0:27 3 Measure reaction 6:00 40 Meas ure reaction
X L- 640 O M VER: 2009.0 2 47


3:45 25 Add Reagent 2 + Stir 2 + 9:18 62 Meas ure reaction
Measure reaction mixture abs orbanc e
absorbance
3:54 26 Measure reaction 9:27 63 Abs orbanc e
absorbance m eas urem ent ends
4:03 27 Measure reaction 9:36 64 Em pty Cuvette
absorbance c ontents + Add
deter gent
absorbance c ontents + Add DI
W ater
W ater
W ater
W ater
W ater
4:57 33 Measure reaction 10:30 70 Meas ure Cuvette
absorbance blank abs orbanc e
absorbance c ontents
5:15 35 Measure reaction 10:48 72 Drying the Cuvette
absorbance
5:24 36 Measure reaction
absorbance
X L- 640 O M VER: 2009.0 2 48

5.4 Basic operational information
5.4.1 Procedure to Install the XL-640 Analyzer
a) 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.
b) 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 wilful 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
c) 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.
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3. Remove the four “Z” brackets, which are holding the analyzer on the
pallet.
4. Move the levelling bolt upwards so that the unit rests on the castor
wheels.
5. Gently lift the analyzer from the pallet to the floor.
5.4.2 Procedure to Install software for Analyzer
a) Prerequisites
System Configuration should be as follows:
PC Pentium IV or Above
OS Microsoft Windows XP service pack 2.
HDD 40 GB or above
RAM 1 GB or above
PROCESSOR 1.7 GHZ or above
RESOLUTION OF 1024 X 768

MONITOR
Note:
1. All memory resident software including anti-virus software should be removed
from memory and screen-savers should be disabled before starting the
Application Software.
2. Ensure that printer drivers are installed and a default printer is added into the
computer system.
3. Delete Microsoft Office Doc Image Writer from the system. The user needs to
go to Start > Settings > Printers and Faxes > Select the MS Office Image
Writer and delete it.
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Regional and Language Options should be as follows:

To ensure the regional and language settings, go to Settings > Control Panel >
Regional and Language Options.
Following should be the settings for Regional Options:
Figure 5.4.2 - 1 Regional Options Settings
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Following should be the settings for Language tab:
Figure 5.4.2 - 2 Language Settings
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Following should be the settings for Advanced:
Figure 5.4.2 - 3 Advanced Settings
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b) Software Installation Procedure

This section would guide you through Installation process.
Software installation CD would consist of the following folders:

1. MSDE
2. Setup
3. Database Utility
Figure 5.4.2 - 4 Software installation CD folders
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 Installation of MSDE - Microsoft SQL Server Desktop

Engine
The folder to be referred is MSDE, which consists setup for MSDE. Before installing it please
check if MSDE is installed on the PC.
For installing MSDE, following are the instructions:
Step 1: Click on the folder named “MSDE”. A screen as shown below would appear.
Figure 5.4.2 - 5 MSDE folder contents
Step 2: Run “setup.exe” from the folder. Following screens would appear in a sequence.
Figure 5.4.2 - 6 MSDE setup process
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Please wait till the installation is completed. Hence, this completes the installation of
MSDE on the PC.
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 Restart PC
After installation of MSDE, please RESTART the PC.
After the PC restarts, please check for the icon on the taskbar. This icon ensures
proper installation of the MSDE software.
Figure 5.4.2 - 10 SQL icon on desktop
Note:
Do not proceed with the MultiXL setup until this icon is present on the taskbar.
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 Installation of MultiXL Setup

The folder to be referred is “MultiXL Setup”, which consists setup for MultiXL
software.
For installing MultiXL setup, following are the instructions:
Step 1: Click on the folder named “MultiXL” from the software installation CD. A
screen as shown below would appear.
Figure 5.4.2 - 11 MultiXL setup folder contents
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Step 2: Click on “setup.exe” to start the installation process. Following screen would be
displayed.
Figure 5.4.2 – 12 MultiXL setup process
Step 3: Click on “Accept” to continue with the installation. On Accept, following screens would
appear in a sequence.
Figure 5.4.2 - 13 MultiXL setup process
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Step 4: Click on “Next” button and the following screen would appear.
Step 5: Default installation folder is C:\Program Files\MultiXL\ where operating

system windows XP are installed on C Drive. User can change this default folder by
clicking Browse button. After selecting the folder, click on Next to continue with the
installation.
Following would be the next screen displayed to confirm installation.
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Step 6: The above screen is for confirmation of the installation. Click on “Next>” to
continue. Following would be the further screens appearing.
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Step 7: The above screen indicates your MultiXL software installation is completed
successfully. Click on “Close” button on the screen.
MultiXL software installed successfully.
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 Installation of Database
The folder to be referred is “Database Utility”, which consists exe for installing or
restoring the Database. Installation of New Database
For installing New Database, following are the instructions:
Step 1: Click on the folder named “Database Utility” from the software installation CD.
A screen as shown below would appear.
Figure 5.4.2 - 20 Database utility folder contents
Step 2: Click on “MultiXLDB.exe” to start the installation process. On clicking,

following screen would be displayed..
Figure 5.4.2 - 21 Database utility screen
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Step 3: Default Database folder would be from where the MultiXLDB.exe is running.
Database folder refers to the Database, which is to be used for performing the
various operations.
Step 4: Click on “CHECK DATABASE” to check whether the database is present. For
the First time installation of the software, database won‟t be present and the following
screen would appear.
Step 5: Click on “CREATE DATABASE”. It would create the database from the
database path specified on the screen. (Example: In the above screen path is
F:\Database Utility\MultiXL.BKP. After creating successfully following screen would
be displayed.
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Step 6: Click on “CHECK DATABASE” to ensure proper creation of the database.

Following screen would appear
Step 7: The above screen indicates your database installation is completed

successfully. Click on “X” button on the screen to exit the utility screen.
Else if the user wants to delete the already installed database and restore another,
following instructions can be followed
Step 8: Click on “DELETE DATABASE” to delete the existing database. After deletion
following screen would be displayed.
Step 9: Warning message would be displayed to ensure deletion. Click on “Yes” to

continue deletion.
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Step 10: On clicking “Yes”, another warning message would be displayed to ensure
once again the deletion of the database. Following screen would be displayed after
successful deletion of the database
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 Restore Old Database

For restoring Old Database, following are the instructions:
Step 1: Click on the folder named “Database Utility” from the software installation CD.
A screen as shown below would appear.
Step 2: Click on “MultiXLDB.exe” to start the installation process. On clicking,

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Step 3: Click on “CHECK DATABASE” to check whether database is present.

Following screen would appear
Step 4: Click on “DELETE DATABASE” to delete the existing database. After

deletion, following screen would be displayed.
Step 5: Warning message would be displayed to ensure deletion. Click on “Yes” to

continue deletion.
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Step 6: On clicking “Yes”, another warning message would be displayed to ensure

once again the deletion of the database. Following screen would be displayed after
successful deletion of the database.
Step 7: Click on “BROWSE FILE…” to select the path where the old database is
present. Following screen would appear.
Figure 5.4.2 - 34 Browse File
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Step 8: Click on “Open” to select the file. Following screen would appear indicating
the new path selected.
Step 9: Click on “CREATE DATABASE” to create the database from the new path.
After creating the database successfully, following screen would be displayed.
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Step 10: Click on “CHECK DATABASE” to ensure proper creation of the database.
Note:
User can use the option to take the Backup of the existing database by clicking F12.
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 Upgrade Database
For upgrading the Database, following are the instructions:
Step 1: Click on the folder named “Database Utility” from the software installation CD. A
screen as shown below would appear.
Step 2: Click on “MultiXLDB.exe” to start the installation process. On clicking, following

screen would be displayed.
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Step 3: Click on UPGRADE DATABASE to start the upgrade process. On clicking, path
for SQL script would be asked for as shown in the following screen. Select the script file
with extension as .SQL
Step 4: Upgrade process would start and on completion of the upgrade process,

Step 5: Once the upgrade process is done, click on “X” to close the utility.
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c) Software Un-Installation Procedure
This section would guide you through Un-installation process.

Following are the instructions to be followed for un-installing the MultiXL software.
Step 1: Click on Start - Control Panel – Add or Remove Programs. Select MultiXL from the
list of programs to uninstall & click on Remove button. A screen as shown below would
appear.
Figure 5.4.2 - 42 Control panel
Step 2: After clicking “Remove” following confirmation message would appear. Click on “Yes”
to continue with the un-installation.
Figure 5.4.2 - 43 Warning for removal of multixl software
MultiXL software would be hence un-installed successfully. Click on “X” button to exit
from Add or Remove Programs.
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Chapter 5 – Analyzer Overview
d) Access to MultiXL software for the Analyzer
To Access the software two shortcuts will be created, one on the Desktop and the other
Start/Programs menu with the Globe Icon.
Step 1: Click on any one of the shortcuts provided. After clicking on the icon, following
PRODUCT LOGIN screen is displayed. This screen is displayed only after the first
installation. Enter Product Login and Password as provided. Click on OK button.
Figure 5.4.3 – Product Login screen
Step 2: If the Product Login and Password are entered correctly then the following User Login
screen is displayed. This screen is displayed every time the software is started. Enter the
Login ID and Password provided and hence click on OK.
Figure 5.4.4 – Login ID screen
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Step 3: If the Login ID and Password are correctly entered then following is the main
screen appearing after the splash screen.
Figure 5.4.5 – Main Menu Software Layout
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Main Menu Software Layout
The Main Menu consists of following screens:

a) Patient Entry – This screen is used for defining patient demographics and scheduling
tests/calculation items or profiles.
b) Test Parameters – This screen is used for defining Test Details, Test Volumes &
Reference Ranges
c) Profiles/Calc – This screen is used for defining new Profiles or Calculation Items
d) QC/Calibrations – This screen is used for viewing the QC Data or Twin Plot. It is also
used for viewing the calibration curve for a particular test and for scheduling Blanks /
standards / calibrators / controls.
e) Consumables – This screen is used for definition of Reagents, Standards, Blanks,
Controls, Diluents and Wash Solution
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f) Status Monitor – This screen is used for performing calibration/patient run, viewing
Reagent Level of different Tests, and performing Sample & Reagent Barcode scans. It is also
used to view online reaction curve.
g) Search – This screen is used for searching Patient Results, Calibration / Control Results,
Patients, Consumables or Test Details.
h) Reports – This screen is used for viewing Patient Reports, calculating Statistical data
using Test Statistics screen, View the results on Result Reprint screen, View the calibration of
a test over a period of time on Calibration Trace, View the current calibration on Calibration
Monitor, Log of all the errors on Error Log screen, reaction curve of the results obtained on
Reaction Curve screen and Reagent consumption on Other screen.
i) Master – This screen is used for defining miscellaneous parameters like Area, Laboratory,
Doctor‟s Details, Analyst Details etc.
j) Utility – This screen is used for defining Reagent Positions, Backup Data, to view Offline
Results and recalculate the results obtained.
k) Service Check – This screen is used only by Service Personnel.
l) Maintenance – This screen is used for performing Maintenance operations at the start and
end of the day.
m) Settings – This screen is used for defining system parameters, carryover pairs, test
sequence, rerun flags and to assign user rights.
n) Shut Down – This screen is used to turn off the application software. The menus can be
accessed using the shortcut keys shown in brackets. The currently selected option is
highlighted with Yellow colour.
Following screenshot shows list of Common buttons used:
A – Moves to First Record

B – Moves to Previous Record
C – Moves to Next Record
D – Moves to Last Record
E – Prints the Screen Details in Report Format
F – Saves a new Entry or Modified Entry
G – Clears the data on the current screen
H – Edits/Modifies the data on the current screen
I – Deletes a Record
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Following is a three dotted button available on most of the screens. This button is to be
clicked either to select / enter data for that field.
For example: In the screenshot below, button is placed near a box with caption „Test‟. If this
button is clicked, small window opens up for selecting a particular test.
Following is a indication bar available on most of the screens. This provides help / warning
messages to the user.
Note:
Sign * near any of the fields on the software screens indicate that the field is mandatory.
Sign ** near any of the column in the master option indicate that row is a default row and
can‟t be deleted by the user.
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Chapter 6 – Pr oc edur e of r outine c heck
Chapter 6
Procedure of routine check
This chapter provides the operational procedures for routine check.
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6.1 Checks prior to work and power-on
6.1.1 Checks prior to work

A) System water can and waste can
Confirm that:
1. The system water can is filled with pure DI water and the pH of the water is
maintained at 7.0;
2. Each waste can is emptied.
B) Cleaning Can
Confirm that:
1. The cleaning solution tank is filled with sufficient wash solution.
C) ISE unit
1. Before performing measurement with the ISE unit, confirm that Electrode unit
(Na, K, Cl, Li and Reference electrodes) whose term of validity is not expired
is installed
2. The Reagent Pack 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 Reagent Pack is flowing from the side of sample port by executing of ISE
purge, In the following cases, ISE purge, i.e. PUGA and PUGB should be
carried out 5 times or more. First measurement of ISE at the time of
exchanging of the Reagent Pack. At the time of being pulled up the tube from
the Reagent Pack.
Note:
As much as possible, the analyzer should be kept on, because 130 µL 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.
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6.1.2 Preparation of external tank solutions

The external tanks of the system DI water, detergent, bio-hazardous waste and
diluted waste are to be placed near the right-hand side or rear side of the analyzer
and to be connected to the analyzer with the corresponding tubes which includes float
sensors.
Just before measurement, the external tanks of the system DI water and detergent
solution are filled with the corresponding liquid, and the tanks of the bio-hazardous
waste and diluted waste have to be empty.
DI Water
Bio-hazardous Waste
Can
Can
Cleaning Solution Diluted Waste
Can Can
Figure 6.1.2 - 1 Picture of all 4 Cans
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Tubing for DI Tubings for Diluted

Water Can Tubings for Waste Can
Tubing for Concentrated
Cleaning Waste Can
Solution Can
Figure 6.1.2 - 2 Tube Connections on the

Rear Panel (Left to Right)
1. De-ionized Water ---- 20 litres (NCCLS Type II or better)

2. Detergent solution ----- 10 litres
3. Biohazard (Concentrated) Waste ---- 10 litres
4. Diluted Waste ----- 20 litres
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 detergent solution:

Fill the detergent solution can (given with the Accessories List) with 10 litre of DI
water. Pour the 100 ul concentrated solution into the can to prepare a 1% detergent
solution. Mix well before use.
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6.1.3 Power-on
A) Primary 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.
Located at the rear side of the machine, this is the main switch of the analyzer
& supplies power to the Analyzer switch as well as the Reagent cooling system
& the ISE unit , if installed (ensure that the electrodes are fitted, the ISE
reagent pack is connected & the ISE power connector is connected)
220V ac Power
Supply, 5A Fuse or RS232 Cable
110V ac, 10A Fuse Cable for to Analyzer
LLS Platform
Figure 6.1.3 - 1 Power-on switch
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B) Secondary Power-on of main unit

This is the secondary switch, which supplies power to the rest of the analyzer
& is located at the front right side of the analyzer.
C) 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
1024*768 pixels.
3. If the analyzer is switched ON, the routine start up / maintenance procedure
are to be performed, using the 'Maintenance' program of the XL-640
application software.
D) Deskjet / Laser Printer Installation

Check for following points before using Application Software to generate
printouts:
1. Check that printer driver is installed
2. Check that the cable between printer and the analyzer PC is connected
properly
3. There should be no paper jam or any other obstruction in the printer
4. Feed the paper to the printer and switch it „ON‟
5. Print a test page to confirm correct printing.
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6.2 Preparation and placement of reagent

Necessary reagents, diluents and wash solutions for analysis are placed on the
reagent tray.
6.2.1 Consumable definition for reagents

a) To enter this screen
 Click on {Consumables} button on the Main menu.
 The following screen is displayed:
Figure 6.2.1 - 1 Consumables - Reagents Screen
 Following are the description of the buttons on the screen:
{Add}: This button is used to Add a lot.

{Save}: This button is used to Save a lot.
{Edit}: This button is used to Edit a lot.
{Clear}: This button is used to Clear selection.
{Print}: This button is used to Print the details present on the screen.
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b) To ADD a new reagent,

 Click on the “…” button against Consumable
 Upon clicking the dotted button, the following screen opens up:
Figure 6.2.1 - 2 Reagent Addition Screen

 Following are the description of the fields on the screen:
{Reagent}: This field is used for entering the name of the Reagent.
{Reagent Code}: This field is used for entering the 3-digit test code, which
would be used for updating the reagent position after reagent barcode scan.
This 3-digit test code is available on the Reagent Bottle barcode label.
{Reagent Type}: This field allows the user to select whether the reagent is
single reagent or dual reagent.
 Following are the description of the buttons on the screen:
{PRINT}: This button is used to print the list of reagents.

{SAVE}: This button is used to save the new reagent.
{EDIT}: This button is used to edit the details of the selected reagent.
{CLEAR}: This button is used to cancel add / edit mode.
{DELETE}: This button is used to delete the reagent (till not used either in
batch run or Test Parameters).
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c) To ADD Lot details for a reagent

 Double click on the Reagent Name.
 Click on the ADD button
d) To EDIT the lot details for a reagent

Double click on the Lot no in the grid (Refer Fig 6.2.1 - 3) .
e) In both the above cases (c and d), the following screen opens up:
Figure 6.2.1 - 3 Reagent Lot Addition

 This screen is used for adding the Manufacturer and Lot Details for the Reagent.
 Following Table gives a brief explanation on the different fields in the grid:
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Field Description
This field is used for selecting the Reagent Manufacturer. The user
Manufacturer
can select the Manufacturer by clicking on the dotted button
Lot No This field is used for entering the lot number of the reagent
This is a display field and shows the Lot Status (Active or Inactive).
Lot Status This field depends on the Expiry Date selected by the user. Expired
Reagents are displayed as Inactive.
Expiry Date The user can select the expiry date of the Reagent
On-board Stability This field is used for entering the On-board shelf life of the reagent
This field is used for selecting the On-board Stability unit. Options
Unit
available are Hours and Days
This field is used for selecting whether the Lot No selected is

Reagent Type common for R1 and R2. If R2 is having a different lot number, then
the user should save the details for R1 and add new details for R2.
6.2.2 Placement and registration of reagents

a) For Barcoded Reagent bottles
Click on the {Status Monitor – Barcode Scan} button on the Main menu,
The following screen is displayed:
Figure 6.2.2 - 1 Status Monitor Barcode Screen
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 If reagent barcode is checked in the {System Parameter settings} 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 {Utility-
Reagent Positions screen} accordingly to the Reagent code mentioned in the
barcode pattern with the Reagent code mentioned in Consumable screen for
that particular reagent.
 Default options before the run starts are given on the top right hand corner in
Status Monitor - Sample Tray screen under Pre-Run options. If the user has
checked the Reagent Barcode option, then prior to run, a Barcode scan of
the Reagent Bottles will be done and the positions along with bottle size will
be updated automatically in the {Utility – Reagent Positions} screen.
 After Reagent Barcode scan, the run will start only if the reagent positions are
available / known for all the scheduled tests in the selected group.
 If the checksum digit does not match the checksum of the bar-code digits,
“Checksum Mismatch” is displayed instead of the bar-code number.
 “BAD-BARCODE” is displayed if the digits read are not as per required
format or digits are less. (Acceptable Reagent Barcode label format is “2 of 5
Interleaved”).
 Meaning of “-“ in Barcode column – manual definition of Reagent
b) For Non-Barcoded Reagent bottles (Manual assigning reagent positions)

 Click on the { Utility: Reagent Positions} button on the Main menu
 The following screen is displayed:
Figure 6.2.2 - 2 Reagent Positions Screen
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 Following are the description of the fields on the screen:
{Clear Positions - All}: This option is used to clear all the position on the
reagent tray.
{Clear Positions - Selective}: This option is used to clear selective positions
on the reagent tray.
{Edit Position}: This option is used to enter new or edit existing positions
{Refresh Positions}: This option is used to refresh all/selective positions on
the reagent tray for which Empty Bottle (No volume) was detected during run.
After replacing the filled Reagent Bottle, use this option to notify the
availability of reagent in the bottle.
{Empty Bottle}: This indication is used to show at which reagent positions
the volume has become zero during run.
{Expired Lot}: This indication is used to show at which reagent positions the
reagent lot has expired. The expired reagent is not aspirated during run.
However, volume scan will scan the position.
 Procedure to Enter a Position Manually:
(i) Click on the Edit Position checkbox.

(ii) The following screen appears
Figure 6.2.2 - 3 Reagent Positions-Edit Mode
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 The user can then select the position wherein he desires to keep the bottle.
 The reagent name can be selected from the Reagent field.
 Bottle type needs to be selected from the list.
 Lot No for the Reagent can be selected from the list of Active lots.
 After the above steps are completed, click on the Save Position Detail button.
 The other fields in the grid are shown below:
Field Description
Position This field displays the reagent position
Reagent This field displays the Reagent Name
Bottle Type This field displays the bottle type of the Reagent name
Rgt Vol (ml) This field displays the Reagent Volume (ml)
Lot No This field displays the Lot Number for the selected Reagent
This field displays the expiry period of the Reagent as defined in

Expiry date
consumables.
Barcode This field displays the Barcode information obtained after scanning
This field displays the onboard stability period as defined in

Stability
Consumables.
This field displays unit of the stability period in terms of hours/days
Unit
as defined in Consumables.
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6.2.3 Reagent Level Scan

a) All Scan:
 This option is used for scanning the Reagent Level at position(s) where
reagent is defined in the {Utility: Reagent Position}.
 Rgt. All scan in stand still condition: On clicking the {Status Monitor: Reagent
tray:: Volume scan}, the probe moves to the bottles for scanning the Rgt.
volume and the same is memorized and displayed in < Reagent tray >.
 Rgt. All scan before run: On clicking the {Status Monitor: Sample tray: Pre-
Run Opt: RGT Level Scan: All: Click on Start Button}, the probe moves to the
bottles for scanning the Rgt. volume and the same is memorized and
displayed in < Reagent tray > and the run can be started.
b) Selective Scan:
 This option is used for scanning the Reagent Level for the tests programmed
in current group. Diluent & wash solution positions are also scanned, when
defined.
 Rgt. Selective scan before run: On clicking the {Status Monitor: Sample tray:
Pre-Run Opt: RGT Level Scan. Selective: Click on Start Button}, the probe
moves to the bottles, for which the tests have been programmed, for
scanning the Rgt. volume and the same is memorized and displayed in <
Reagent tray > and the run can be started.
c) REAGENT TRAY screen is displayed as follows:
Figure 6.2.3 - 1 Reagent Details Screen
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 The above screen is the Graphical view of the Reagent Volumes

 To view this screen click on {Status Monitor: Reagent Tray} screen.
 If the user right clicks on the bottle, it displays the consumable name,
Reagent Name, Reagent Type and the available volume in mL.
 Following legends are used to depict the Reagent bottle conditions:
NORMAL: If the level in the reagent bottle is normal, then it is indicated with
BLUE COLOUR.
LOW: If the level in the reagent bottle is below 20% of the bottle capacity,
then it is indicated with YELLOW COLOUR.
EMPTY: If the reagent bottle is empty, then it is indicated with WHITE
COLOUR.
VACANT: If the reagent position is free (reagent not defined), then it is
indicated with GRAY COLOUR.
 Following legends are used in Bottle Cap to depict the bottles:
REAGENT DEFINITION: If reagent is assigned at a position on the reagent
tray, then it is indicated with BROWN COLOUR.
DILUENT DEFINITION: If diluent is assigned at a position on the reagent
tray, then it is indicated with GREEN COLOUR.
WASH SOLUTION DEFINITION: If wash solution is assigned at a position on
the reagent tray, then it is indicated with BLUE COLOUR.
Refresh Positions button is enabled if there are any reagent positions which are to be
refreshed since an empty bottle was found at that reagent position. Click on the
button, a screen with the reagent positions to be refreshed will be displayed, select
the reagent positions and click on OK.
Note:
Reagent name can be assigned to a test from Test Parameters screen. (Refer
section 7.2.1)
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6.3 Preparation and Placement of Blank / Standard /

Calibrator / Control
The analyzer accommodates sample positions for routine samples, STAT Samples,
Blanks, Standards, Calibrators & Controls, on the outer and middle ring in 5 ml/7
ml/10 ml Sample tubes or 2 ml Sample cups or Pediatric cups(500µl) on 10 ml
Sample tubes or 2 ml Sample cups on 10 ml Sample tubes and on the innermost ring
in 2 ml Sample cups or Pediatric cups(500µl). 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 tray. If 500µl stat cups have to be used, they need to be
placed on 10 ml tubes on the sample tray. If 2 ml sample cups are used, they should
be kept on 10 ml tubes bearing the bar code labels and then placed on the sample
rack either in outer or middle ring. In either case, bar code labels must be affixed on
tubes to identify patient and sample.
6.3.1 Preparation of Blank, Standard, Calibrator and Control

a) Preparation of Blank/Standard/Calibrator/Control includes defining their name
along with their respective lot numbers, reconstituted dates, concentration
and on-board Stability of the Test are also defined in the same screen.
b) To define the consumable, click on {Consumables} button on the Main

Menu Screen
c) Steps in Defining a Blank:

 From Consumables screen, select Consumable type as Blank from drop
down list. Click on the dotted button next to Consumable name. This will
open a new window "Consumable".
 Enter new Blank name and select the tests associated with the Blank
Click on Save.
 Once saved, the user can double click on the Blank name for which he
wants to add Lot Details. This will close the window "Consumable" and
take him back to "Consumable" main screen. One can also leave the
screen by clicking on "X" when one do not want to add Lot and go back
to "Consumable" main screen.
 Upon clicking ADD from the main screen, the display changes to second
screenshot as shown in figure 6.3.1 – 3
 The user can select the Manufacturer Name, enter the Lot No and enter
the concentration for the tests (optional).
 Manufacturer can be added from {Masters: Manufacturer} screen.
 After entering the details, the user can click on SAVE button.
 Click on "Clear" button to go back to "Consumable" main screen.
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Figure 6.3.1 - 2 Consumables – Blank
Figure 6.3.1 - 3 Consumables – Blank ADD
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Chapter 6 – Pr oc edur e of routine c heck
c) Steps in Defining a Standard:
 From Consumables screen, select Consumable type as Standard

from drop down list.
 Click on the dotted button next to Consumable name. This will open a
new window "Consumable".
 Enter new Standard name and select a test associated with that
Standard. Only one Test can be selected for a Standard.
 Click on Save.
 Once saved, the user can double click on the standard name for
which he wants to add Lot Details. This will close the window
"Consumable" and take him back to "Consumable" main screen. One
can also leave the screen by clicking on "X"
 When one do not want to add Lot and go back to "Consumable" main
screen.
 Upon clicking ADD from the main screen, the display changes to
second screenshot as shown in figure 6.3.1 - 5
 The user can select the Manufacturer; enter the Lot Number for the
Standard, Expiry Date and concentration for the Standard.
 Manufacturer can be added from {Masters: Manufacturer} screen
 After entering the details, the user can click on the Save button.
 For a test having multiple standards, every standard needs to be
defined individually using above steps
 Click on “Print” to print the consumable details displayed on screen.
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Figure 6.3.1 - 4 Consumables – Standard
Figure 6.3.1 - 5 Consumables – Standard ADD
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e) Steps in Defining a Calibrator:

 From Consumables screen, select Consumable type as Calibrator from
drop down list.
 Click on the dotted button next to Consumable name.
 Enter new Calibrator name and select the tests associated with that
Calibrator.
 Click on Save.
 Once saved, the user can double click on the Calibrator name for which
he wants to add Lot Details. This will close the window "Consumable" and
take him back to "Consumable" main screen. One can also leave the
screen by clicking on "X"
 When one do not want to add Lot and go back to "Consumable" main
screen.
screenshot as shown in figure 6.3.1 - 7
 The user can select the Manufacturer; enter the Lot Number for the
Calibrator & Expiry Date for the Calibrator.
 Further, Concentrations for individual tests can be entered.
 Manufacturer can be added from {Masters: Manufacturer} screen
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Figure 6.3.1 - 6 Consumables – Calibrators
Figure 6.3.1 - 7 Consumables – Calibrators
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f) Steps in Defining a Control:
 From Consumables screen, select Consumable type as Controls from drop

down list.
 Click on the dotted button next to Consumable name. This will open a new
window "Consumable".
 Enter new Control name, the level for the Controls (available options are
Low, Normal, High, Very High) and select the tests associated with that
Control.
 Click on Save.
 Once saved, the user can double click on the Control name for which he
wants to add Lot Details. This will close the window "Consumable" and take
him back to "Consumable" main screen. One can also leave the screen by
clicking on "X"
 When one do not want to add Lot and go back to "Consumable" main screen.
screenshot as shown in figure 6.3.1 - 8
 The user can select the Manufacturer; enter the Lot Number for the Control &
Expiry Date for the Control.
 Further, Mean, SD can be selected for individual tests.
 Alternatively, if the user desires to enter the %CV for that test instead of SD,
then a radio button is available above the grid to make the selection. This
option is useful if the user needs to define his own %CV for that test. Once
entered, the user can select the SD radio button and new SD depending on
the %CV entered will be calculated.
 Manufacturer can be added from {Masters: Manufacturer} screen.
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Figure 6.3.1 - 8 Consumables – Controls
6.3.2 Placement of Blank, Standard and Calibrator

a) Placement of Blank / Standard / Calibrator includes scheduling positions for
them.
b) To view the scheduling screen, click on {QC/Calibrations –Schedule
QC/Calibration} button on the Main Menu Screen.
c) Following procedure is used for scheduling.
 Select the Group No on which the calibration and QC run needs to be
preformed.
 Select a desired position. If the position is occupied, then the user can view it
in the grid placed on the bottom side of the screen.
 Select the Container Type.
 Select the Consumable Type. Select the name under Consumable Type.
 Select the Lot No of the Consumable Name.
 Once consumable name is selected, grid is displayed on right side of the
screen where in option of Auto-Dilution can be selected and hence the Dil
ratio (Dilution Ratio) between 2X to 150X. Depending on the concentration
and the dilution ratio, the no of dilutions possible will be displayed in another
grid at the bottom from which further dilution numbers can be selected (As
shown in Figure 6.3.2 - 2).
 Auto-dilution is possible for specific curve. Indication of Rows with grey colour
where Auto-dilution not possible is for the curve types k-factor and Linear.
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 Select the tests that are required to undergo standardization or whose QC

needs to be performed. Click on the OK button placed at the bottom of the
grid.
 Similarly, select another position and assign another consumable along with
the tests associated with it and then Click on OK button.
 Once blanks, standards, calibrators and controls are defined, click on
Schedule button placed below the right hand grid.
 Upon clicking the Schedule button, the blanks, standards, calibrators and
controls get scheduled.
 To clear the schedule CLEAR POSITIONS button can be clicked. On clicking,
following screen is displayed to either clear selected positions or all the
positions.
 Hence either a particular position is selected or CLEAR ALL option is
checked.
Figure 6.3.2 - 1 Scheduling – Blank
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Figure 6.3.2 - 2 Scheduling – Standards
Figure 6.3.2 - 3 Scheduling – Calibrators
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Figure 6.3.2 - 4 Scheduling – Auto-Dilution

for Calibrators / Standards
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6.3.3 Placement of Control

a) Placement of Control includes scheduling positions for them.
b) To view the scheduling screen, click on {QC/Calibrations -Schedule
QC/Calibration} button on the Main Menu Screen
c) The display changes to the following screen:
Figure 6.3.3 - 1 Control Scheduling Screen

d) Following procedure is used for scheduling the controls.
 Select the Group No on which the QC run needs to be preformed.
 Select a desired position If the position is occupied, then the user can view it
in the grid placed on the bottom side of the screen.
 Select the Container Type
 Select the Consumable Type as Controls.
 Select the name under Consumable Type.
 Select the Lot No of the Consumable Name.
 Once above Steps are completed, then the grid on the right side of the
section displays the available tests for running QC.
 Select the tests that are required whose QC needs to be performed. Click on
the OK button placed at the bottom of the grid.
 Similarly, select another position and assign another control with a different
lot number or different name along with the tests associated with it and then
Click on OK button.
 Once controls are defined, click on Schedule button placed below the right
hand grid.
 Upon clicking the Schedule button, the controls get scheduled.
 To clear the schedule CLEAR POSITIONS button can be clicked.
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6.4 Preparation and placement of sample
6.4.1 Sample barcode scan (Offline)

If sample bar code is set ON in the {System Parameters} screen, this portion can be used to
scan the bar-code information on the sample tubes. Barcode scan of Samples is done prior
to Start of Run if the Sample Barcode Scan is enabled on the Status Monitor screen or on
Barcode Scan screen in Status Monitor menu. After the Sample Barcode scan is completed,
the position and the sample id are updated automatically in the Patient Entry screen.
Figure 6.4.1 - 1 Sample Barcode Scan
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6.4.2 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 Code39 : 6 to 18 digits
of 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
· Fine bar: 0.25 to 1.0 mm
Bar module
· 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.
· The position is such that there is no obstacle between the barcode
Positioning of printing area and the bar code reader.
barcode label
· Angle alignment deviation: within ±1º
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6.4.3 Patient Entry

a) Clicking on the {Patient Entry} button on the Main Menu Screen presents
the following screen on display:
Figure 6.4.3 - 1 Patient Entry Screen
b) This is the screen where patient demographics can be entered and

tests/calculation items/profiles to be performed on the patient sample can be
requested. Details of patient name, address, doctor referring patient, analyst,
age, sex etc. are all entered in this screen. The patient demographics are
used to generate the patient report after analysis of the sample.
c) The screen is divided into 2 sections:
First section is used for defining the Sample ID and other information related
to Sample definition. Second section is used for Patient Demographics entry.
One Patient can have more than one Sample ID.
d) The details of the different fields are given below:
{Sample ID}: This field is used for assigning an alphanumeric identification
number of up to 18 characters to each patient. Entry in this field is
compulsory and cannot be skipped. If the Sample ID is already entered, then
the user can view the Sample ID by clicking on the dotted button placed next
to the Sample ID field.
{Position}: 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. Any sample Positions on the sample tray can be entered
in this field. If there are more than maximum no of Sample Positions, then a
Different Group No. needs to be selected.
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For bar-coded samples the sample position is automatically assigned as per

the group number selected after the sample bar-code scan.
For emergency samples, any position that is vacant can be used for any
group during Patient Run.
{Group No}: This field is used to assign group numbers for various samples
processed during the day. If there are more than maximum sample positions,
then the user needs to select Group No 2 and so on. The user can assign the
Group Numbers from 1 to 99.
{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 assign one of the free positions for the sample.
Emergency samples are given priority over routine samples in a run.
{Barcoded}: The user can select whether to use sample bar-code facility or
not. If the bar-code option is set to ON in the {Utility: System Parameters}
screen, then the sample position fed by the user is ignored. The user has to
select/deselect the checkbox for whether the sample for the particular patient
is bar-coded or not. Barcoded option can be selected to only the outer two
rings of sample positions.
{Sample Type}: Select the sample type from the drop down list. The default
options available are: Serum, Urine, CSF, Plasma, Whole Blood and Other.
{Sample Volume Type}: Select the sample volume type using the drop
down list. The available options are Normal, Increase and Decrease. If the
sample has low concentration, then the user can select an increase volume.
If the sample is high concentration sample, then the user can select
Decrease volume.
{Container Type}: Select the sample container type from the pull down
option. There are various options available and one can select the Container
Type by selecting the drop down list.
{Registration Date}: This field is used to enter the date at which the patient
was registered in the hospital.
{Collection Date}: This field is used to enter the date at which the sample
was drawn.
{Sample Remarks}: Remarks about sample can be fed here using up to 50
alphanumeric characters. Previously fed remarks can be selected by pull-
down options. The remarks is printed in the patient report.
{Area}: This is used to select the area from where the sample is collected.
Alternatively, if the admin needs to enter the area details, then he/she can
enter from master screen. One can select the area list by clicking on the
dotted button. On clicking the dotted button, area help screen is displayed.
From the list displayed on screen, user can select the area by double clicking
on the particular name for the respective patient.
{Ref Doctor}: This is used to select the name of the referral doctor.
Alternatively, if the admin needs to enter the doctors‟ details, then he/she can
enter from master screen. One can select the doctor‟s list by clicking on the
dotted button. On clicking the dotted button, following screen is displayed.
From the list displayed on screen, user can select the doctor‟s name by
double clicking on the particular name for the respective patient.
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Figure 6.4.3 - 2 Doctor’s Details Screen
{Analyst}: This is used to enter the name of the analyst. Alternatively, if the admin
needs to enter the analysts‟ details, then he/she can enter from master screen. One
can select the analyst‟s list by clicking on the dotted button. On clicking the dotted
button, following screen is displayed. From the list displayed on screen, user can
select the analyst‟s name by double clicking on the particular name for the respective
patient.
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Figure 6.4.3 - 3 Analyst Screen
{Patient Name}: Enter patient name in the field using the keyboard. A maximum of
30 characters can be fed in this field. Alternatively, patient can be selected using the
dotted button placed next to the Patient Name. Also, if the user desires to use the
same patient with different sample ID, then he/she can double click on the dotted
button and select the patient name for a different Sample ID. Hence one Patient can
have multiple Sample IDs.
{Category}: This field is used to identify the sex of the patient. Select as either Male /
Female / Child / Other.
Note:
For a patient selecting the category is optional. But if the category is not selected then
reference ranges will not be applied. Hence the flags H / L and Panic Limit is not
applied. After the run is performed patient category can be updated and on
recalculation of the results, reference ranges will be applied and hence the H / L flags
will be attached.
{Age}: Enter the numerical age of the patient (in three digits maximum). Choose age
in Days/Months/Years using the pull down option. The patient age is used to issue H
and L flag for the corresponding age range as mentioned in the Test Parameters
(Chapter 7 Section 7.2 Alterations of operational conditions). If age of a patient is not
fed, default normal values are used to issue H and L flags.
{Patient Address}: 50 alphanumeric characters are allowed in this field where one
can enter the address of the patient.
{Patient Tel No:}: This field is used to enter the contact number of the patient.
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{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.
{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:
2
BMI = (Weight)/(Height)
{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.
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.
To add a new patient: Enter new sample ID, Sample Position (if non-barcoded) and
Group Number. It is essential to enter a Sample 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 scanning the sample bar codes. Select the Tests
and/or Calculation Items for scheduling from the bottom grid. Alternatively, one can
select the Profiles by clicking on the Profile Name. The Profile Grid & Calculation Item
grids are separated from the Tests Grid. Detailed Information on the Profiles can be
found in Chapter 7 Alteration of Operational Conditions. 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 sample 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). Alternatively, the user can click on the dotted button along
side sample ID to lookup for Sample IDs.
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f) To Schedule / Clear Schedule / Edit CEC for a patient, Click on CEC present in
the calculation item list. Following is the screen displayed.
Figure 6.4.4 - 4 CEC screen
a) Select the Patient Name. If the patient name is selected then sample Id‟s will be
displayed in the list for that patient only and if the patient name is not selected
then the entire list of sample Id‟s will be displayed in the list irrespective of the
patient name. (Patient Name selection is optional).
b) Patient ID is automatically displayed on selecting the patient name.
c) Following are the different options available for the user.
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I. Schedule CEC
Figure 6.4.5 - 5 Schedule CEC screen

To schedule CEC following is the procedure:
Step 1: Click on Show Sample ID button to view and select the sample id from the list.
Step 2: Select the Sample ID – Serum / Plasma from the list of sample id with sample
type as serum / plasma for the patient selected or all sample id‟s.
Step 3: Select the Sample ID – Urine from the list of sample id with sample type as
urine for the patient selected or all sample id‟s..
Step 4: Enter the Height in meters
Step 5: Enter the Weight in kg
Step 6: Enter the Urine Volume (ml/24 hrs)
Step 7: Click on SAVE button
Message will be displayed indicating that CEC is schedule successfully.
Figure 6.4.6 - 6 Schedule CEC screen
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Hence, CEC test along with Creatine test will be scheduled for both the Sample Ids.
Also the height, weight and urine volume will be displayed for both the Sample Ids.
Hence on starting the run Creatine result will be displayed for both the Sample Ids
and CEC result will be displayed once Creatine results for both the Sample Ids are
declared.
II. Clear CEC Schedule
Figure 6.4.3 - 7 Clear CEC Schedule screen

To clear CEC schedule following is the procedure:
Step 1: Click on Show Sample ID button to view and select the sample id from the
list.
Step 2: Select the Sample ID – Serum / Plasma from the list of sample id with sample
type as serum / plasma for the patient selected or all sample id‟s.
Step 3: Sample ID – Urine will automatically be displayed according to the Serum /
Plasma Sample Id selection.
Step 4: Height will be displayed according to the Patient Name / Sample Id selection.
Step 5: Weight will be displayed according to the Patient Name / Sample Id selection.
Step 6: Urine Volume (ml/24 hrs) will be displayed according to the Patient Name /
Sample Id selection.
Step 7: Click on DELETE button
Message will be displayed indicating that CEC schedule is cleared
successfully.
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Figure 6.4.3 - 8 Clear CEC Schedule Message
III. EDIT CEC Schedule
Figure 6.4.3 - 9 Edit CEC Schedule Message

To edit CEC schedule following is the procedure:
Step 1: Click on Show Sample ID button to view and select the sample id from the list.
Step 2: Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id‟s.
Step 3: Sample ID – Urine will automatically be displayed according to the Serum / Plasma
Sample Id selection.
Step 4: Height will be displayed according to the Patient Name / Sample Id selection. The
height displayed can be changed.
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Step 5: Weight will be displayed according to the Patient Name / Sample Id selection. The
weight displayed can be changed.
Step 6: .Urine Volume (ml/24 hrs) will be displayed according to the Patient Name / Sample Id
selection. The Urine Volume displayed can be changed.
Step 7: Click on DELETE button
Message will be displayed indicating that CEC schedule is cleared successfully.
The other buttons available on the „Patient Entry Screen‟ are:
Mask Tests
Copy Tests
Clear schedule
Work list
The functions of these buttons are described below.
(i) Mask Tests

Upon scheduling the tests, the user can click on the Mask Tests button to mask the
tests temporarily which should not be run immediately but can be run in the middle of
the run. This feature is useful if the reagent for the tests are not available but would
be made available during the middle of the run. In these cases, the use can mask the
tests and keep them on hold. Once the reagents are available, then the user can
unmask the tests by clicking on the same.
Figure 6.4.3 - 4 Mask Tests
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(ii) Copy Tests

If the user wishes to copy the same tests and calculation items across patients, then
the user can use this option. Once the patient and sample details are entered and the
tests/calculation items are scheduled, the user can click on the Copy Tests button.
Upon clicking this button, the user can copy the desired From and To Sample
Positions. The entire range of sample positions would be assigned the same tests
and calculation items. Also, the Sample ID with this feature would be incremented
with the positions if the “Generate Sample ID” option is checked.
Figure 6.4.3 - 5 Copy Tests
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(iii) Clear Schedule

Clicking on the <Clr Schedule> button on the {Patient Entry} screen presents the
following sub-screen:
Figure 6.4.3 - 6 Clear Schedule
This screen can be used to remove test requests from the WorkList. There are two
options to achieve this, Clear Schedule and Positions or Delete Sample. Using these
options, the user can either clear the entire patient schedule programmed along with
the positions or delete the patients using the „From Position‟ and „To Position‟ option.
{ Clear Schedule: Clear Schedules and Positions } The program deletes the test
requests scheduled for analysis and the positions for the selected positions on
clicking OK button. The samples and patients are not deleted.
{ Clear Schedule: Delete Sample } The program deletes the samples for the
selected positions along with demographics and the tests requests scheduled.
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(iii) Worklist
Click the <WorkList> icon on the screen of „Patient Entry‟. The display changes to
the following screen:
Figure 6.4.3 - 7 WorkList
On this screen, a list of tests requested for a particular sample is shown. The
WorkList for any group can be viewed by selecting either „All‟, „Patients‟,
„Calibrations‟ or „Controls‟ option. On selecting „Patients‟ option, only patient samples
are displayed in the work list. On selecting „Calibration‟, work list will display Blank,
Standards and Calibrators programmed. On selecting „Control‟, work list will display
controls programmed in the respective group.
The Work List includes the following details:
Field Name Description

Group No. This field shows the Group number that has been selected
This field shows the Sample position assigned. For bar-coded
Sample
samples, the position is assigned after the sample barcode
Position
scan
Sample ID This field shows the Sample Id assigned to the patient.
This field indicates whether the Sample type is Serum/ Urine/
Sample Type
CSF/ Whole Blood/ Other type.
Sample Vol This field indicates whether the sample volume is Normal/
Type Increase/ Decrease
Test This field displays the test name
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This field shows the number of repetitions that a test will

Replicates
undergo during run
Sample This field indicates the Sample volume programmed in test
Volume parameters for that particular test.
This field indicates the R1 volume programmed in test
R1 Volume
parameters for that particular test.
This field indicates the R2 volume programmed in test
R2 Volume
parameters for that particular test.
This field shows the position of R1 for that particular test as
R1 Position
defined in Utility- Rgt. Position.
This field shows the position of R2 for that particular test as
R2 Position
defined in Utility- Rgt. Position.
The WorkList includes the details of bar-coded samples too even though their
positions may not be known.
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6.5 Initiation of measurement and monitoring
6.5.1 Initiation of measurement

a) The analyzer performs automatically sample measurement, computation and
printout of measurement results and transfer of the measurement results to
the host computer
b) The lamp and the temperature in the analyzer are stabilized at least 30
minutes after switched ON, hence the user needs to wait for 30 minutes after
switching on the instrument. For the same there is a warm-up bar on the
Status Monitor.
6.5.2 Monitoring of measurement

a) This section explains the procedure to start calibration process, measuring of
control and patient sample concentration
b) Click on Status Monitor – Sample Tray screen. Following screen is displayed.
Figure 6.5.2 - 1 Status Monitor – Sample Tray
c) The legends shown near the Sample Tray are as follows:

Scheduled: If a sample position is having tests that are scheduled (prior to run), then
the circle is indicated with TURQUOISE COLOUR.
In Process: If a sample position is having tests whose sampling has been completed
but results are yet to be reported, then the circle is indicated with YELLOW
COLOUR.
Pending: If a sample position is having tests where Sample/Reagent/Diluent is
absent or some VOD error has taken place, then the circle is indicated with ROSE
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COLOUR. In such cases, these sample positions can be re-scheduled either during
run or at the start of the run
Completed: If a sample position is having tests whose results have been reported
and no test results are pending, then the circle is indicated with GREEN COLOUR.
d) Following are the RUN Option available on screen for selection:

 Calibration
 Controls
 Photometric
 ISE Patient
All of the above option can be selected using Select All button and de-selected
using De-Select All button. Depending on the selection, schedules will be
performed during run.
e) Following are the PRE-RUN Option available on screen for selection:

 Auto Rerun
This option is used for automatic re-sending of patient samples on flags.
For a particular test of a patient to be sent for rerun, following are the steps to be
followed:
(i) Auto Rerun option for that test should be selected in Test Parameters
screen
(ii) Prozone Limits, Technical Limits, Panic Limits and Reaction
Absorbance Limit should be checked in Test Parameters screen for
the respective test
(iii) Flags can be selected from Setting – Rerun Flags for which rerun
schedule has to be sent.
When Auto-Rerun option is selected, Disk change option will not be available.
 Disk Change
To enable the option to change the Sample disk during run, this option is
used.
When this option is selected, Auto Rerun option will not be available.
 Barcode Scan – Reagent

This option is used to perform reagent barcode scan before starting the run.
After the scan is over, reagent barcode details will get updated in Status
Monitor – Barcode Scan screen, Status Monitor – Reagent Tray screen and
also in Utility – Reagent Positions screen.
 Barcode Scan – Sample

This option is used to perform sample barcode scan before starting the run.
After the scan is over, sample barcode details will get updated in Status
Monitor – Barcode Scan screen and Patient Entry screen.
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 RGT Level Scan – Selective

This option is used for scanning the Reagent Level for the tests programmed
in current group before starting the run. Diluent & Wash Positions are also
scanned when programmed.
After the scan is over, reagent volume details will get memorized and
displayed in < Reagent tray > screen
 RGT Level Scan – All

This option is used for scanning the Reagent Level for all the positions
programmed before starting the run.
After the scan is over, reagent volume details will get memorized and
displayed in < Reagent tray > screen
All of the above option can be selected using Select All button and de-
selected using De-Select All button.
f) To start the run (measurement), select the group no and click on Start arrow
button.
g) On start of the run, firstly RCT temperature is checked. If the temperature is

not within the range then run doesn‟t proceed. Second Auto span is
performed. If auto span operation fails, again run is stopped. Also if there are
any errors occurred on initialization of the instrument then the run is halted.
h) On start of the run, WorkList will be displayed as shown below.
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 The WorkList screen is displayed after all the pre-run options are performed This
screen can also be viewed during run by clicking on the WORKLIST button
present on the Status Monitor screen.
 The WorkList screen displays the schedule for the group selected.
 Required test details such as Reagent Position, Sample Volume, Reagent
Volume defined; when missing / incomplete are highlighted with red background.
 The reagent position for which reagent volume is 0 ml is highlighted with yellow
background.
 Pending tests and masked tests are displayed in the grid at left bottom of the
screen named as „Pending and Masked Schedules‟. To reschedule the pending
tests, the corresponding tests should be selected and clicked on RE-SCHEDULE
button. Alternatively, the tests can be selected from the Test list, select Pending
option and click on RE-SCHEDULE button
 To reschedule the masked tests, the corresponding tests should be selected and
clicked on RE-SCHEDULE button. Alternatively, the tests can be selected from
the Test list, select Mask option and click on RE-SCHEDULE button
 To view the volume details for checking no of tests possible with the available
reagent volume, Volume Details option should be selected. Following screen is
displayed on selecting the Volume Details option.
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i) Click on OK button to start the run. Or else click on CANCEL to abort the run.
j) If the tests details for all the tests are complete i.e. without any tests having
background as red, when OK button is clicked run will be started else run will
not start.
k) Indication of RCT & RGT Temperature.
Once the run starts RCT & RGT temperature are displayed. If the RCT / RGT
temperature is within range specified in Settings – System Parameters
option, the temperature is displayed in Black colour. When the temperature
rises / falls out of the range, then it is displayed in Red colour.
l) Start time of the Run is displayed at top left corner of the screen.
m) During run, Progress of the measurement is displayed at the right hand side
of the screen
n) Results are displayed in the Result grid and errors if any are displayed in
Error grid at the bottom of the screen.
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Displays Error Message Displays the Test Result

during Run. along with the Flag
Figure 6.5.2 - 4 Result and Error Message Grid
o) During run, schedule will be sent as follows:
 Blank, Standard, Calibrator, Control – Test-wise, according to test

process sequence defined in {Settings – Test Sequence} option.
 Patient Samples – Sample position no wise.
 Emergency patient samples will be performed at highest priority.
 If control interval is defined, control schedules will be sent between
patient samples according to the control interval defined in Test
Parameters screen.
 After the run, for a test if control interval is defined, control schedule for
that test will not be cleared off.
p) During run, the user can monitor the online reaction curve for a test. In order
to view the reaction curve for a test, the user needs to double click on the test
name in the grid in the right-most corner of the screen. Upon double clicking
the test name, the Reaction Curve (till “x” cycles) will be displayed. The pink
arrows indicates the measurement points used for calculating the result.
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Figure 6.5.2 - 5 Online Reaction Curve
q) During run, pending tests / mask tests can be re-schedule by clicking on the
free space near the sample positions. On click, WorkList is screen is again
displayed, using which the tests can be selected and then RE-SCHEDULE
button can be clicked. (Pending / Mask tests can be scheduled only if the
reagent and test details are available).
r) During run, emergency patients can be added from Patient Entry screen by
selecting the option of „Emergency‟ for that particular patient, entering the
sample details and patient details.
s) During run, normal patients can be added from Patient Entry screen, entering
the sample details and patient details.
t) Reagent Multiple position
If there are multiple reagent positions defined for a reagent, during run
reagent will be picked from the position whose expiry is nearest, then position
number wise.
u) Addition of Non-barcoded Reagents during run
During run, non-barcode reagents can be added from Utility – Reagent
Position screen on empty Reagent positions.
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6.5.3 Interruption and resumption of measurement
a) The analyzer comes to rest when all the results are out.
b) During run, due to occurrence of some critical errors the run can be stopped in
between or paused temporarily / permanently.
c) During run, it can be interrupted and resumed manually also.
 Emergency STOP
If the User clicks on the Stop button, then the run stops immediately and the
assemblies initialize.
 Pause / Resume Sampling

If the user clicks on the Pause Sampling button, then the sampling is paused but
the results of the processed samples are given out.
User can click on resume to continue the sampling.
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6.6 Addition of sample and reagent during run
6.6.1 Addition of Barcoded sample during run

a) If the user wants to add a new barcoded sample (Continuous Sample
Loading), the following procedure should be used:
 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 Group
number as selected in the Run Monitor screen.
 Click on the Add Sample Button.
 Message is displayed “Please Wait Sampling Is Being Paused”. Since
Sampling is paused after completing the current test in process.
 Message is displayed “Please Add Samples Now” indicating that
sampling is paused, place the sample tubes in the sample tray, the user
should click on Sample Added.
 Once the user clicks on Sample Added, Sample Barcode scan starts
with message displayed as “Please Wait Sample Barcode Scan In
Process” and on completion of the scan, positions of new samples get
updated in the Patient Entry screen.
 Sampling resumes after updation.
 The user can see the scanned data by clicking Barcode Scan button on
the same screen.
6.6.2 Addition of Barcoded reagent during run

a) If the user wants to add a new barcoded reagent (Continuous Reagent
Loading), the following procedure should be used:
 The user clicks on the Add Reagent button.
 After the button is clicked, the message “Please Wait R1 Dispense Is In
Process”. Sampling will pause after the completion of Reagent 1
dispensing of the current test in process.
 After the button is clicked, the message “Please Wait R2 Dispense Is In
Process”. Sampling will pause after the completion of Reagent 2
dispensing. If no R2 is available, then this message is not displayed.
 Once the message disappears, a message prompt appears “Please Add
Reagent Now”. The user can then safely open the lid and place new
reagent bottles.
 Once the user is done with adding reagent, he can click on Reagent
Added. Reagent barcode scan will starts with message displayed as
“Please Wait Reagent Barcode Scan In Process”.
 After the completion of Reagent barcode scan, the Reagent positions
along with the barcode details of the new test are updated.
 The user can view the scanned reagent barcode data by clicking on the
Barcode Scan button.
 The user can view the scanned reagent barcode data in Utility –
Reagent Positions screen.
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6.7 Reproduction of Results
6.7.1 Calibration specific results

a) Calibration Table
 One can enter the calibration table by clicking on {QC/Calibrations:
Calibration} button:
Figure 6.7.1 - 1 Calibration Table Screen
 This screen enables the user to view a calibration curve and perform curve
related operations. Lot Number and Concentration for that test are defined in
the [Consumables] screen. Detailed explanation is given in section 6.3.1
Consumables - Calibrators and Standards.
 After the Calibration Run is completed, absorbance values obtained by the
analyzer are updated in the [Calibration] screen along with the K-Factor. The
date and time of calibration is also updated.
 One of the last five calibration curves can also be selected for use in result
calculations. Previous Calibration can be viewed using “Prev” and “Next”
Buttons. For using the calibration on the screen, click on “Set Latest
Calibration” button.
 In order to view the calibration details for a test, the user needs to select the
test from the grid.
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 To print the calibration table along with the calibration graph, click on PRINT
button.
Note:
If there has been some error during calibration (like reagent absent or calibrator
absent), the calibration data for which reagent, blank and calibrator was present
is updated however Unsuccessful Calibration message will be displayed
Following is the detailed explanation of the fields on the screen:

{Calib Table: Test }: This field is for display and shows the test name.
{Calib Table: Last Calibration Date}: This field is for display and shows when the
last Calibration was done for that test.
{Calib Table: Curve Type}: This field is for display purpose only and shows the
curve type selected for that test. The Curve Types for a test are defined in {Test
Parameters} screen. Detailed explanation of the various curve types is given below.
{Calib Table: Pos}: This field is used to display the Calibrator, Standard or Blank
position.
{Calib Table: Consumable}: This field is used to display the consumable name
(Blank or Standard or Calibrator) used for calibrating that test.
{Calib Table: Concentration}: This field is for display purpose and displays the
concentration of the blank or the calibrator used.
{Calib Table: Absorbance}: This column indicates the absorbance values that are
automatically obtained by the analyzer after the calibration is carried out.
{Calib Table: Lot No.}: This field is for display purpose only and shows the Lot
Number of the consumable used for Calibration of that test.
{Calib Table: Factor}: This field is for display purpose only and shows the
Calibration Factor obtained for that test.
{Calib Table: Calibration Date}: This field is used to display when the calibration for
that test was done. The display changes if previous calibration curves have been
selected.
{Calib Table: Calib Expiry Limit}: This field allows the user to enter the Calibration
Expiry Limit for that test in Days. This limit is a decremented counter that commences
after calibration for that test is done. The Test, for which the calibration is expired, is
highlighted with Green Background in Patient Entry screen.
{Calib Table: R1/R2 Lot No}: This field is used to display Reagent Lot Number used
for calibrating that test. If the test has only one reagent, then only R1 Lot No will be
displayed.
{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 updated with message Factor out of Range. This field is applicable only for
Linear curve types.
{Calib Table: Set Latest Calibration}: Use PREV / NEXT buttons on the screen to
view the calibration and select any one calibration which should be used for patient
result calculation. Click on this button to set the selected calibration.
{Calib Table: Selective Calibration}: Selective Calibration also known as One point
to Multipoint Calibration is used when a user wants to use only a reagent blank or a
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single standard for calibration. It is applicable for all curves except Kfactor. The user
can define this type of calibration for individual chemistries. It consists of following
fields:
Calibration Type: Two options are available in this field. Full and Selective. Full is
the default selection which schedules the entire calibration set again. Selective is
used to select either a blank or a calibrator or standard concentrations from multiple
standards & blanks available and then it uses the Slope method to correct the other
Factors.
Consumable List: This list box consists of Blanks and Standards Concentrations.
The user can select the Blank / Standard 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.
Schedule: Following is the process to schedule selective calibration Select the
available position from the list box. By default it will display the position at which it
was calibrated if that position is free. Select the Lot no of the consumable.
Concentration can be kept same or modified as per the requirement.
Same selective calibration can be selected for other tests by just selecting those tests
in the grid
Click on SCHEDULE
Figure 6.7.1 - 2 Selective Calibration
Note:
Selective Calibration is available for all Calibration Curves except K-factor only after
calibration has been performed at least once.
{Calib Table: Curve Type}: One of the following twelve methods can be selected
from Test Parameters – Test Details screen for calculation of the measurement
results.
Linear (For one standard or two standards)
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K-Factor (Use of K-Factor for Enzymes or substrates)

Linear (MultiPoint) (Multi Standard)
5P Calibration Logit-Log (Multi Standard)
Exponential (Multi Standard)
Point to Point
Polynomial (Multi Standard)
Cubic Spline (Multi Standard)
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. Additionally,
The concentration of the sample is calculated by using the following formula:
C std ( Asample ABlank )

C sample
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:
(C std ) ( Asample ABlank )

C sample { } CBlank
Astd ABlank
where CBlank = Concentration of the Blank
Additionally, when a linear response (between absorbance and concentration) is

expected but the 2 Standards are necessary for Calibration, then the same curve type
can be used. In this method a two-point calibration involving 2 Standards is
nd st
performed. Joining the 2 standard absorbance to 1 standard absorbance by a
straight line creates the calibration curve.
The concentration of the sample is calculated by using the following formula:
C std 2 ( Asample Astd 1 )

C sample { } C std 1
Astd 2 Astd 1
nd
Cstd2 = Concentration of the 2 standard,
st
Cstd1 = Concentration of 1 standard,
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nd
Astd2 = Absorbance of the 2 standard,
st
Astd1 = Absorbance of the 1 standard,
and Asample = Absorbance of the sample
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 change in absorbance per
minute during the linear phase of the reaction ( Abs/min
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.
Note:
The factor should be calculated for 5 mm path length and should be entered in the
box near label K - Factor below the graph.
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
Asample = Absorbance for sample,
Ablank = Absorbance for blank and
Factor = Theoretical factor
3. Linear (Multipoint): 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, 3 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
absorbance‟s 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
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Where, the intercept a and slope b are obtained by least square linear regression
method and are given by:
a Y bX
1 n
X i Yi X .Y
ni1
b
1 n
X i2 X2
ni1
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.
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
(excluding 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.
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
(excluding 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,
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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.
6. Point to Point: 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 three calibrator concentrations and absorbance‟s available
(excluding blank) for this calibration curve type.
The equation of a straight line passing through two points (x 1, y1) and (x2, y2) is
( x x1 ) ( x2 x1 )
( y y1 ) ( y2 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

Cm and Cn are the concentrations of the standards corresponding to the
absorbance‟s Am and An respectively.
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 (excluding 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 yj
x xi
i 1 j i yi yj
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 Asample Aj
C sample Ci
i 1 j i Ai Aj
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Where Csample = Concentration of the sample,

Asample = Absorbance of the sample,
th
Ai = Absorbance of the i standards,
th
And Ci = Concentration of the i standards
8. Cubic Spline: This calibration curve can be used for multipoint non-linear
curve types. It is necessary to use at least three calibrators (excluding 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.
b) Calibration Trace
 This screen is used for displaying the Calibration History for a test along with
the graphical representation of calibration data over 30 days at a time.
Figure 6.7.1 - 2 Calibration Trace

 Following is the detailed explanation of the fields present on the screen:
{Calibration Trace – Test Name}: This field is used for selecting the desired test
whose calibration history needs to be viewed.
{Calibration Trace – Month and Year}: This field is used for selecting the month
and the year for the test whose calibration history needs to be viewed. Once the test
and the month selection are done, the grid displays the different calibration dates and
time along with the absorbance‟s for blanks and standards. Also, a graphical
representation of the Blanks and Standards can be viewed.]
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{Calibration Trace – Blank Abs Scale}: This field is used to change the range of
blank absorbance.
{Calibration Trace – Standard/Calibrator Abs Scale}: This field is used to change
the range of Standard / Calibrator absorbance.
{Calibration Trace – Reset}: This field is used to reset the range for blank, standard
and calibrator absorbance to range according to the minimum and maximum
absorbance of the blanks, standards and calibrators.
{Calibration Trace – Export}: This field is used to export the data and graph
displayed on screen to an excel sheet.
{Calibration Trace – Print}: This field is used to print the data and graph displayed
on screen.
c) 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 {Reports : Calibration Monitor} screen. The following
screen is displayed as shown below:
Figure 6.7.1 - 3 Calibration Monitor Screen
 A description of different fields available on {Reports: Calibration Monitor} is given in

the table below.

Sr. No. Serial Number
Tests Test name
Curve Type Type of Curve assigned for that chemistry
Type Either Blank or Standard S1,S2…etc
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Consumable Name of the consumable

Lot# Lot no. of consumable used
Conc. Concentration of the consumable
Abs. Absorbance of the Blank/Standard
Factor Factor value of the standards
Calib. Exp Calibration Expiry Limit (in Days)
Acceptable Acceptable Limit for New Factor
 The user can export the Calibration data to desired location using the „Export‟ option.
 The user can print the Calibration data using the „Print‟ option.
6.7.2 Control specific results

“Quality Control” is used for day-to-day monitoring of the performance of the analyzer.
It 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)
a) QC Data
 The QC Data is useful for viewing the QC Results in Graphical format.
QC Rules implementation has been on QC Results on the QC Data and
are marked with a symbol to indicate that which rule has been violated
for that test.
 The user should either rerun the controls again or recalibrate the test
and run the controls.
 If a user wants to view screen, then the user can click on
{QC/Calibration: QC Data} screen. The following screen is displayed as
shown below:
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Chapter 6 – Procedure of routine check
Figure 6.7.2 - 1 QC Data Screen
Figure 6.7.2 - 2 QC Data Screen
¾ Following are the steps to view the results and chart:
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(i) Select From Date and To Date. The user can select the same date for viewing
the daily QC or select a range for viewing the Monthly QC.
(ii) To select Test, click on dotted button near the Test box, a small window will
open up through which test can be selected.
(iii) Select Control Level and hence control name for which results and graph
should be displayed. If user had selected From Date and To Date same, all
the control results can be seen. But if the user has selected From Date and To
Date different, then only one control results can be seen at a time.
(iv) Batch no can be selected if the From date and To date are same.
(v) Lot no for a control can be selected from the list.
(vi) Once the above selection is done, click on DATA button to view the results
for the selection in the result grids.
(vi) If a single date is selected, then the X-bar Calculation grid signifies the
following:
N: Number of replicates the control is run during that day.
Mean: Average of the replicates for that test on that day.
SD: Standard Deviation for that day
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum result (if replicates are done)
(vii) If the date range selected is from “x” period to “y” period, then the X-bar
Calculation grid signifies the following:
N: Number of days.
Mean: Average of the day‟s average done over the period specified.
SD: Standard Deviation for specified period.
R: Difference between maximum and minimum day‟s average (over specified
period)
(viii) If the date range selected is from “x” period to “y” period, then the R -
Calculation grid signifies the following:
N: Number of days.
Mean: Average of the day‟s range done over the period specified.
SD: Standard Deviation of range for specified period.
R: Difference between maximum and minimum day‟s range (over specified
period)
(ix) Click on GRAPH to view the graph for the selection. For display of graph, 2
options are available, QC Data and QC Rules. If QC Data option is selected
then all the results will be plotted on the graph lot-wise and if QC Rules
option is selected then the results plotted are highlighted if any of the rules is
violated.
(x) User can click on EXPORT button to export the data to an excel sheet.
(xi) User can click on PRINT button to print the data
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(xii) The different kinds of QC Rules indicated are as follows:
1 13S A single control measurement exceeds +3SD or –3SD limit.
2 12S A single control measurement exceeds +2SD or –2SD limit .
2 consecutive control measurements exceed the same

3 22S
+2SD or –2SD limit.
1 control measurement in a group exceeds the mean +2SD

4 R4S
and other exceeds –2SD limit.
4 consecutive control measurements exceed the same
5 41S
+1SD or –1SD limit.
10 consecutive control measurement fall on one side of the

6 10X
mean.
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b) Twin Plot
 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 different lot numbers are required. Period
and Test Name needs to be selected before viewing the Twin Plot.
 If a user wants to view screen, then the user can click on {QC/Calibration:
Twin Plot} screen. The following screen is displayed as shown below:
Figure 6.7.2 - 3 Twin Plot Screen
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Figure 6.7.2 - 4 Twin Plot Screen
 Following are the steps to view the results and chart:

a) Select From Date and To Date. The user can select the same date for
viewing the daily graph or select a range for viewing the Monthly graph.
b) To select Test, click on dotted button near the Test box, a small window will
open up through which test can be selected.
c) Select Control for X and also for Y and then click on Show Lot.
d) Select Lot no for that Control X and also for Y from the list displayed.
e) On selecting Lot no, following data will be displayed:
 Level – Level of the control selected.
 Target Mean – Target Mean of the selected lot.
 Target SD – Target SD of the selected lot.
 N – No of Days is date range is selected or no of replicates if single date
is selected.
 Mean – Mean of Daily averages if date range is selected Or Mean of all
the replicates for the single date selected.
 SD – Standard Deviation of Daily averages if date range is selected Or
Standard
 Deviation of all the replicates for the single date selected.
 CV - Coefficient of Variation calculated from Mean and SD.
 Range - Range of Daily averages if date range is selected Or Range of
all the replicates for the single date selected.
f) Once the above selection is done, click on DATA button to view the results
for both the controls selected.
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g) Click on GRAPH to view the graph for both the controls selected.. The daily
averages for Control Y are plotted (on the Y-axis) against the daily averages
for Control X (on the X-axis).
h) User can click on EXPORT button to export the data to an excel sheet.
i) User can click on PRINT button to print the data or graph
6.7.3 Patient specific results
a) Patient Report
 The Patient Reports screen is used for viewing and printing Patient Reports.
 One can enter this screen by clicking on {Reports: Patient Reports} button.
The following screen is displayed:
Figure 6.7.3 - 1 Patient Reports Screen
 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 generate the Report:
Doctor Name: If the user selects Doctor Name, then reports related to that Doctor
along with Patients associated with the doctor can be viewed depending on the From
and To Date selected. The user has to click on „Show‟ to display the selected reports.
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Test: If the user selects Test, then Patient reports related to that Test can be viewed
depending on the From and To Date selected. The user has to click on „Show‟ to
display the selected reports.
Location: If the user selects Location, then Patient Reports related to that Location
can be viewed depending on the From and To Date selected.
Patient Name: If the user selects Patient Name, then the Patient Reports related to
Patient Names can be viewed depending on the From and To Date selected. The
user has to click on „Show‟ to display the selected reports.
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
depending on the From and To Date selected.
 Following patient results can be viewed and printed depending on the
selection of radio button:
Photometric Tests: If the user selects this radio button, then only photometric test
results are displayed.
Calculation Items: If the user selects this radio button, then only calculation item
results are displayed.
Offline Results: If the user selects this radio button, then only Offline Entry results
are displayed.
ISE Results: If the user selects this radio button, then only ISE Results are
displayed.
Rerun Results :If the user selects this radio button , then only Rerun results are
displayed.
Recalculated Results: If the user selects this radio button, then only Recalculated
Results are displayed.
All: If the user selects this option, then all results are displayed.
Abnormal Results: If the user selects this option, then Results with flag are
displayed.
 Four types of Report Formats are available. If the user has clicked on the
Print Lab Details checkbox, then the Laboratory details are also printed. A
screenshot for one of the reports is shown below:
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Figure 6.7.3 - 2 Normal Patient Reports Screen
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Figure 6.7.3. - 5 Graphical Patient Report
Print Lab Details: This type of format is used when the user needs to print the Lab details.
Refer Section 7.5 System Parameters section for entering the Lab details.
Hide flags : This type of format is used when the user wants to print the Reports without
printing the associated flags.
Normal: This is a basic type of format available. If all the results are selected, then the
photometric results are displayed in one table, followed by calculation item, ISE and Offline
Results.
Multi Column: This type of format is used when the user needs to print the results column
wise. The results are displayed in a newspaper column format.
Profile: If the user has selected profiles for scheduling tests from Patient Entry screen, then
the user can print Patient Reports as per the various Profiles selected.
Graphical: If the user wishes to view and print the patient results in Graphical format, then
this option can be selected. Figure 6.7.3.-5 shows the Graphical type of Patient Report.
Show Location: This type of format is used when the user wants to print the Reports with or
without printing the Location
Show Analyst: This type of format is used when the user wants to print the Reports with of
without printing Analyst.
Show Sample Remarks: This type of format is used when the user wants to print the
Reports with or without printing the Sample Remarks.
Show Patient Remarks: This type of format is used when the user wants to print the Reports
with or without printing the Patient Remarks.
Preview: This option is used to confirm the selected results before printing. Following is the
window displayed.
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Figure 6.7.3. - 3 Graphical Patient Report

Print: This option is used to print the results
Undo Selection: This option is used to clear the previous selection
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6.7.4 All results

a) Result Reprint
 One can enter this screen by clicking on {Reports: Result Reprint} button in
Main menu
Figure 6.7.4. - 1 Result Reprint Screen

This menu enables the user to retrieve and print the results batch wise or date wise.
There are multiple options at the top of the screen:
Latest Batch: Press Show button after selecting radio button which will display the
results of the latest batch.
Date wise: Selecting this radio button will display results depending on the From and
To dates selected from the calendar drop down box.
Print Lab Details: If the user needs to print the Lab Details, then he/she can click on
the checkbox provided for printing out the Lab Details.
Total Tests: This field is only for display and shows the total number of tests
performed in a batch or between “x” days.
Send to Host: This button is visible only if the Host Connection in system parameter
is available. This button is used for sending the results to the LIS (if they were not
transmitted during run).
Print: This button is used for printing the Results on printer or PDF writer.
Export: This button is used for export the Results on an excel sheet.
Report Type: Any of the three options can be selected – Patients, Controls,
Standards. Depending on the option selected, the results will be displayed on the
result grid.
Test: All or any one of the tests can be selected from the list
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Sample ID: All or any one of the sample id can be selected from the list
Inv. Selection: Use this button to invert the selection that is made. Clicking on this
button will select the unselected items and vice versa.
Select All: Use this button to select all the results displayed on screen.
Show: Press show button after selecting Radio button which will display the result of
the latest batch.
 The columns displayed in the gird are explained below:

Sample ID This field shows the Sample ID of the patient
Patient Name This field displays the Patient Name

Test This field displays the Test Name
Result This field displays the Test Result
Unit This field displays the Test Unit
Flag This field displays the Flag associated with the Test Result
Result Date This field displays the date on which the test was performed
Curve No This field displays the Reaction Curve Number
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b) Test Statistics
 One can enter this screen by clicking on {Reports: Test Statistics} button in Main
menu.
Figure 6.7.4 - 2 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/controls that have been run on the analyzer for that chemistry.
{Report Type}: Using this radio button, select Patient to obtain the details of patient
results for the selected test or select Standard to obtain standard absorbance‟s for
any chemistry or select Controls to obtain results of controls for the selected test.
Within the specified Date Range.
{Date From}: Enter the beginning date for the results to be analyzed.
{Date To}: Enter the ending date for the results to be analyzed.
{Batches}: It is possible to search the results batch wise. Records are displayed
depending on the batch number selected from the drop down box depending on the
From and To Date selected.
{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.
{Invert Selection}: Use this button to invert the selection that is made. Clicking on
this button will select the unselected items and vice versa.
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{Select All}: Use this button to select all the results displayed on screen.
{Print}: This button is used for printing the Test Statistics for the selected Test in
Report format. If the user requires the Laboratory Details to appear as Header on the
Test Statistics report, then he/she can use the Print Lab Details checkbox.
{Export}: This button is used for export the Results on an excel sheet.
{Sr. No. Wise}: Use this button to define a range of results/absorbance‟s for which
you want to obtain the statistics. This range is of serial numbers given to the results.
{Patient Name Wise}: Use this button to specify patient name for which you want to
obtain the statistics. This range is of serial numbers given to the results.
 The other grid shows the following details:
{Reference Range}: This field displays the total number of results that were within
the normal range defined in the {Test Parameters: Reference Ranges} screen.
{Above normal range}: This field displays the total number of results that were
above the normal range defined in the {Test Parameters: Reference Ranges} screen.
{Below normal range}: This field displays the total number of results that were
below the normal range defined in the {Test Parameters: Reference Ranges} screen.
{Not Defined}: This field displays the total number of results whose reference ranges
were not defined in the Test Parameters screen.
{Total Tests}: This field displays total number of results/absorbance‟s available.
{N}: This field displays the total number of tests used for calculating the Mean, SD
and %CV for a test.
{Mean}: 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
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c) Reaction Curve
One can enter this screen by clicking on {Reports: Reaction Curve} button:
Figure 6.7.4 - 3 Reaction Curve
Following are the other buttons present on screen:
Move First / Move Previous / Move Next / Move Last: These buttons can be used
to view the previous or next reaction curve number details.
Print: Click on PRINT button to print the reaction curve details along with the graph.
Export: Click on EXPORT button to export the selected reaction curve details along
with the graph to the specified location.
Clear: Click on CLEAR button to remove the details of the selected reaction curve
number.
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6.8 Shut Down Options
a) Click on Shut Down from the main menu, the following screen is displayed.
Figure 6.8 - 1 Shut Down MultiXL

b) Following are the two options available on click of Shut Down.
1. Shut Down
If this button is clicked then MultiXL software shuts down.
2. Water Save and Shut Down

If this button is clicked then MultiXL software is minimized and water save
operation is performed.
Once water save operation is completed, MultiXL software will automatically
shutdown.
During water save operation, if application software is closed, warning
message is displayed for confirmation to stop water save operation and shut
down the software.
3. Sleep
Analyzer is switched off and MultiXL remains in sleep mode.
MultiXL icon is displayed as shown below in sleep mode. If auto-startup tasks
are scheduled for the particular day then automatically all the scheduled
tasks are performed on the scheduled time of the day.
MultiXL Icon
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If the user right clicks on the MultiXL icon, following options are displayed as
shown below:
MultiXL with Sleep Mode – If this option is selected then MultiXL software
screen is maximized and offline operations can be performed in the software.
Cancel Sleep Mode – If this option is selected then Analyzer and MultiXL
software comes out of the Sleep mode.
Exit Sleep and MultiXL - If this option is selected then sleep mode is
cancelled and MultiXL is shut down.
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Chapter 7 - Alter ations of O per ational Conditions
Chapter 7
Alterations of Operational Conditions
This chapter provides the procedures of settings and their alterations of operational conditions
including test parameters, result re-calculation, profile entry, system settings, backup and
Carryover pairs.
7.1 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

7.2 Test Parameters
them can be altered as necessary.
The equation is defined to derive the computed result

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

7.4 Profile Entry
multiple methods to be selected at a time.
System Parameters Specification of host communication, Temperature range

7.5
Settings and specifications of barcodes are specified.
This is the function to save the analyzer-specific

7.6 Backup operation parameters and user parameters to the appropriate
location.
This is used to program the Carry over pair to eliminate

7.7 Carryover Pairs
the Reagent probe carry over.
This is used to select Flags for which rerun schedule is to

7.8 Rerun Flags
be sent during run.
This is used to program the User Rights for different

7.9 User Rights
users.
Result Re-
7.10 This is used to re-calculate the results.
Calculation
This is used to search patients / samples, patient results,
7.11 Search
calibration / control results, consumables and test.
This is used to program offline results for existing or new

7.12 Offline Results
samples
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7.2 Test Parameters
7.2.1 Test Details

a) This is the first sub-menu available on “Main Menu” screen of the software and can
be viewed by clicking on the {Test Parameters: Test Details} button on the Main
Menu screen. This is to define the various parameters including measurement
conditions, test code, calibration curve type, time intervals, etc. The following
conditions need to be defined for all methods registered in the analyzer.
Figure 7.2.1 – 1 Test Details Screen
b) Following is the explanation of each field:

1) Test
This field is used to enter 5 characters Test Code that would be used for
scheduling patients or other details. Once the name is assigned, it will appear
at the bottom grid of the tests
2) Report Name
This field is used to store the full name (25 characters maximum) of the test
that will appear in the patient report. Enter the full name for the assay. For
example, one can feed Aspartate Transaminase in this field (while AST will
be entered in {Test} field).
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3) Total Reagents
This field is used for selecting the total number of reagents for that test. A
drop down list box having a selection of 1 or 2 Reagents is given.
4) Reagent Name R1/R2

Upon selecting the Total number of Reagents, the Reagent Name needs to
be selected. This is different from Test Name and the Reagent Name is
defined in {Consumables: Reagents} screen. The user can select the
Reagent Name for that test. This name will be used to define the Reagent
Position in {Utility: Reagent Position} screen if manual procedure is used
for assigning the Reagent Positions.
Note:
a. More than one test can share the same Reagent Name.
b. One test can have any number of multiple positions for R1 and R2
respectively.
5) Host Name
This field is used to define a 5 character Name assigned in the LIS. This
name could be same or different to the Test Name.
6) 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
a. 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
absorbance‟s recorded between M2Start and M2End points are taken and
this is used for the calculation of the sample results.
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ABS
Rgt2
ABS2=Final abs
Rgt1
Time
Figure 7.2.1 – 2 1 – Point Graph
b. 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 absorbance‟s recorded between
M1Start and M1End and this absorbance is subtracted from the final
absorbance, which is the mean of the absorbance‟s 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
Figure 7.2.1 – 3 2 – Point Graph
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c. 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 absorbance‟s recorded between M2Start and
M2End using the least square linear regression method as per the following
formula:
n
1
Ti Ai T A
n i 1
A/ T n
1
Ti 2 T2
n i 1
Where, Ti is the time in minute and Ai is the absorbance, n is the number of points.
ABS ABS
ABS
ABS/MIN
TIME
Figure 7.2.1 – 4 Rate – A Graph
d. 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.
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A A
A B B
B S S
S ABS1/min
ABS2/min
T
Figure 7.2.1 – 5 Rate – B Graph I
M
7) Assay Points
The analyzer records absorbance for a cuvette every 9 seconds over a span
of 9 minutes 27 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 (SELECT means “no entry”). The absorbance readings can be
obtained from the {Utility: Reaction Curve} 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
09 0 min 09 sec
(R1 Dispense)
2
18 0 min 18 sec
(Sample Dispense)
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
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
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Time of
Time of measurement
(In seconds)
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
225 3 min 45 sec
(R2 Dispense)
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
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Time of
Time of measurement
(In seconds)
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
a. 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 absorbance‟s 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".
b. 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.
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In case of 1POINT and 2POINT chemistries, the mean of the absorbance‟s

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.
8) 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, use “Select” for secondary
wavelength.
a. 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.
b. 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: 340, 376, 415,
450, 480, 505, 546, 570, 600, 660, 700 and 750 nm.
If bi-chromatic measurement is not desired, keep the choice as SELECT for
the value of the secondary wavelength.
9) 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. For example: Control Interval = 30 means that
control serum will be run after every 30th sample analyzed for that chemistry.
10) Sample Replicates

In this parameter, select the number of repeated sample measurements to be
performed for any chemistry by entering a value between 1 to 30. Repeated
sample measurements are usually used to check repeatability. All samples
programmed for this chemistry will be repeated for the programmed number
of times. For routine operation, this parameter is programmed as '1'.
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11) Standard Replicates

In this parameter, select the number of repeated blank and standard
measurements to be performed for any chemistry by entering a value
between 1 to 3. Average of the closest replicates would be taken during
updation of Blank and Standard field in the Calibration screen.
12) Control Replicates

In this parameter, select the number of repeated control measurements to be
performed for any chemistry by entering a value between 1 to 30. Repeated
control measurements are usually used to check repeatability.
13) Delta 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 less than the set limit,
then Linearity Check will not be performed.
14) Linearity Limit %:

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%-
30%. If the %Linearity exceeds the specified value in the Maximum Reaction
Linearity, then a LINXX 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.
15) Unit
Use this option to select unit of measurement for the analyte from a drop
down box. If user does not find the desired unit in the already provided
options, he/she can enter a new unit by going to {Master: Units} screen.
Below is a list of pre-programmed 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
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10. ng/ml
11. abs
12. µg/dl
13. ng/dl
14. mg/L
15. µg/L
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)
Note:
User can define or can create any number of units in Master.
16) Decimal Places

In this field, the user can enter the number of digits to be displayed after the
decimal point in the display and printout of test results. The user can enter
the number of digits after decimal place by entering 0, 1, 2, 3, 4 or 5 in the
textbox.
17) 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 Auto Rerun 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(%).
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a. {Prozone Limit: Upper/Lower}:

This field is to display whether the entered value is an upper limit or lower
limit. For increasing direction chemistries, it is displayed as “Lower” and for
decreasing direction chemistries, it is displayed as “Upper”.
18) Technical Limits

These fields are used to define the Linearity Limit of the reagents. For the
1POINT, 2POINT, Rate-A and Rate-B chemistries, feed the minimum and
maximum concentrations in the Minimum and Maximum Technical Limit
fields respectively.
If Tech Limit Min is violated, a flag “TEC-L” is issued with the result. If Auto
Rerun is set to YES, the sample is automatically sent for an Increased
volume rerun. Similarly, if Tech Limit Max is violated, a flag “TEC-H” is
issued with the result. If Auto Rerun is set to YES, the sample is
automatically sent for a Decreased volume rerun.
a. {Tech. Serum Limit: Min}:

Define a value ranging from -9999.99 to 9999.99 indicative of the minimum
technical limit or the linearity limit of the reagent. For end-point chemistries
and rate chemistries, feed the minimum concentration. The concentration
entered for Rate Chemistry will automatically be converted into rate after
calibration of that test. This value will be used for comparing with the slope
obtained during patient run. 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.
b. {Tech. Serum Limit: Max}:

Define a value ranging from -9999.99 to 9999.99 indicative of the maximum
technical limit or linearity limit of the reagent. For end-point chemistries and
rate chemistries, feed the maximum concentration. The concentration
entered for Rate Chemistry will automatically be converted into rate after
calibration of that test. This value will be used for comparing with the slope
obtained during patient run. 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.
Note:
If the Reaction Absorbance Limit field is not zero for RATE ASSAYS, then the
Technical Limit fields will be masked & vice-versa.
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19) Calibration Curve

This pull down list is used for defining the Calibration Curve Type for that test.
Available Curve Types are:
a. Linear
b. K-Factor
c. Linear (Multipoint)
d. Cubic Spline
e. 5P Calibration Logit-Log
f. Point To Point
g. Exponential
h. Polynomial
20) 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.
21) 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 Technical Limits are not entered and 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 Reaction Curve
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.
b. If only one point is available for slope calculation, then Lim1 flag is issued
along with the result.
c. If only 2 points are available for slope calculation, then Lim2 flag is issued
along with the result.
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Maximum permissible entry is 2.5. 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.
For rate chemistries, if Technical Limits are entered and if any point between
M2S and M2E exceeds the Reaction Absorbance, AbsLim Flag is attached along
with the result. If Auto Rerun is enabled, the test is sent for a decreased rerun.
For end point chemistries, if final O.D calculated exceeds the Reaction
Absorbance, AbsLim Flag is attached along with the result. If Auto Rerun is
enabled, the test is sent for a decreased rerun.
22) 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.
23) Initialize Tests

This option is used to initialize the test parameters from existing ones to
default settings. The tests with similar Test names are replaced from default
ones & the newly added tests are retained as it is. To initialize test
parameters, simply click on <INITIALIZE TEST(S)> button and confirm by
clicking on „Yes‟.
24) SET AUTO RERUN: This option is used to set the auto-rerun for multiple
tests – „Selective Tests‟ or All Tests - at once. Click on “SET AUTO RERUN”.
Following screen will appear:
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Figure 7.2.1 – 6 Set Auto Rerun Screen
Click on the desired option to choose Selective test auto rerun or All test(s) auto
rerun. If “Selective” is selected then user can select test(s) from the list below for
setting auto-rerun by clicking on the boxes in the front of tests. Then click on OK
button. If “All test(s)” is selected then automatically all the tests in the list below will be
selected for auto rerun. Click on OK button to save and apply settings. Click on
CLEAR button will close the window without saving changes.
25) 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
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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)
Figure 7.2.1 – 7 Instrument factor
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.
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7.2.2 Test Volumes Screen

a) This screen displays the Sample and Reagent Volumes for a test along with the
Sample Type. It also includes an option of copying the sample volumes if the CSF,
PLASMA or WHOLE BLOOD sample types share the same volumes as Serum
sample type. Click on {Test Parameters: Test Volume} to view the following screen.
Figure 7.2.2 – 1 Test Volume
b) The user needs to select a Sample Type prior to defining the Sample, Standard and
Reagent Volume for a test. Sample, Standard and Reagent Volumes are different for
different Sample Types.
c) Following is the description of the fields:

1) Standard Volume
This field enables the user to specify the standard/calibrator volumes to be
used for calibration.
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 requires dilution. This happens usually for esoteric assays for
which the standards available are prediluted and do not require dilution, but
the samples need to be diluted.
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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}.
a. {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 2 to 70 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.
If the standard needs to be diluted, then Auto Dilution procedure should be
adopted. The Auto Dilution procedure is available in the Schedule
QC/Calibration screen under Utility menu. The software prepares the
dilutions automatically from the base concentration using the Geometric
series.
2) Sample Volume Normal

These fields enable the user to specify normal (or default) sample volumes
depending on the selection of sample type. Different Sample Types can
share the same Sample Volumes.
a. {Normal: 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 (with Reagent 1). When
the sample needs to be prediluted, the sample from sample container is
deposited in the reaction cuvette (with diluent).
sample without predilution, the total volume of sample and reagents
b. {Normal: Dilution Ratio}:

This enables the user to define a dilution ratio if predilution of the
sample/urine is required. The available range is from 2x to 150x in steps of
1x. 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.
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3) 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.
a. {Decrease: Sample}:
b. {Decrease: Dilution Ratio}:

4) 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.
a. {Increase: Sample}:
b. {Increase: Dilution Ratio}:

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5) RGT1/RGT2 Volume:
Assign volume of reagent (in µL) to be aspirated for Reagent 1 and/or
Reagent 2. Volume for Reagent 1 is set between 60 and 300 µl and for
Reagent 2 between 10 and 300 µl. If a single reagent test is used, then RGT
2 Volume field is not shown on the screen.
6) {R1/R2 Reagent Mix Speed}:

There are 3 options available to set the Mixer speed for R1 and R2 in order to
mix the reagent and the sample. They are Low, Medium and High.
7) COPY VOLUMES:
This button is used for copying the volumes from current sample type to other
sample types. Multiple sample type selection for copying volumes is
available.
8) VIEW VOLUMES:
This button is used to view the volumes programmed as per the different
sample types. The following screenshot gives the serum volume details.
Figure 7.2.2 – 2 View Sample Volumes
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Chapter 7 - Alter ations of O per ational Cond itions
7.2.3 Reference Ranges Screen

a) Clicking on {Test Parameters: Reference Ranges} from the main menu and the display to the
following:
Figure 7.2.3 – 1 Reference Ranges
b) This field is used to define the Normal Ranges for Male/Female/Other/Child type of patients as
well as defining the Panic Limit values for the same as per the Sample Type. This screen is
also used to copy the Reference Ranges of one sample type to different sample types.
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c) Following is the description of the fields:
1) Normal Lower Limit and Normal Upper Limit

These fields are used to define the expected values or normal range for serum/urine/other
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, Female, Child and
Other 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 different sample types for different
assays.
Note:
For correct H and L flags, the patient‟s Reference Title and Gender should be set before the
patient‟s sample is analyzed.
2) Panic Limits (Lower and Upper Limits)

This field is used to define the minimum and maximum concentration limits beyond which
the serum or urine sample or other 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, Auto Rerun needs to be set
to YES. When the sample result violates the Panic Limit Minimum or Maximum, a flag
“PanL” or “PanH” is issued respectively. The rerun result is flagged “#” to indicate a rerun
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d) Following is the description of the buttons available on the right side of the screen:
1) COPY REFERENCE RANGE:

This button is used for copying the reference ranges from current sample type to other sample
types. Multiple sample type selection for copying volumes is available.
2) VIEW REFERENCE RANGE:
This button is used to view the reference ranges programmed as per the different sample types.
The following screenshot gives the reference range details
Figure 7.2.3 – 2 View Reference Ranges
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7.2.4 Test Sequence Screen

a) One can enter this screen by clicking on Settings button on the Main screen and then selecting
Test Sequence button.
Figure 7.2.4 – 1 Test Sequence Screen
b) This screen is used to define the sequence of a test during run or on the test grid. This
function is useful in avoiding forbidden pairs that may come together during the run. This
function will work only for same patients. In order to avoid the carry over between patients,
then use Forbidden Pairs program. There are 2 options available. One is used only for
displaying the sequence and the other for Processing during run.
2 different modes are available to define the sequence:

(i) Sort Ascending/Sort Descending: These buttons are used to sort the Tests in Ascending
or Descending order. Tests will be run in either ascending order of sequence or descending
order of sequence.
(ii) Move Up/Move Down: The user can manually assign the sequence by moving the desired
test up or down. The user needs to select the test and then click on the Move up or Move
down depending on how the order for display or processing should be done.
Note:
Define Test Process Sequence to reduce / eliminate the carryover effect. For each sample, the
tests will be performed in the order of processing sequence during run.
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7.3 Calculation Item

a) One can enter this screen by clicking on {Profiles/Calc Items: Calculated Items}
button on the Main screen and then selecting Calculation Item tab.
Figure 7.3 – 1 Calculation Item Screen
b) This menu enables the user to define a calculation item involving one or more
chemistries (up to 5 chemistries). It is also possible for the user to define the formula
as per his/her desire using the {Master: Calculation Formula} screen.
c) If these calculation items are selected in the [Patient Entry] screen, they are
printed along with the result printout.
d) A description of various fields available on the screen is given below.
{Calculation Items: Calculation Item}: In this field, the name of the calculation item
can be defined. This name will be shown in a separate Grid.
{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}: The user can select the desired formula from the drop
down list. If a new formula is required, then the user can use the “dotted button” to
add a new Calculation formula.
{Calculation Item: Unit}: Select the unit to be printed along with the Calculation
Item.
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{Calculation Item: Decimal Places}: Enter the number of decimal places for the
calculation item.
e) Once, the formula is selected, the user can select the tests associated with the
calculation item. Additionally, the user can also use another calculation item (nested
calculation items) for defining a new calculation item.
f) The user can select the normal ranges or panic limits (if desired) for the calculation
item depending on the sample type selected. Normal Range options are available for
Male, Female, Child or Other types.
g) CEC Calculation item is present by default. For this calculation item only the Report
Name, Unit, Decimal Places and Normal Ranges can be modified. Test A can also be
selected and Test B will be displayed same as Test A.
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7.4 Profile Entry

a) One can enter the Profile by clicking on the {Profiles/Calc Items: Profiles}
screen on the Main Menu. The display changes to the following screen:
Figure 7.4 – 1 Profile Entry Screen
b) This screen can be used during patient entry to request all the tests in a
profile by simply clicking at the profile button on the Profile Grid. 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 profiles using Prev /
Next arrow buttons.
7.4.1 Procedure to Create a Profile

a) The profile can be created from the {Profiles} screen.
b) The procedure is given below:

 Click on Clear button to enter a new profile. Enter the Profile Name
and the Profile Report Name in the respective fields.
 Add the Tests by clicking on the Test Name from the Tests Grid.
 Click on <Save> to Save the Profile.
 Once the Profile is saved, the name appears in the Profiles Grid.
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7.5 System Parameter Settings

a) One can enter this screen by clicking on the {Settings: System Parameters}
button. The display changes to the following screen:
Figure 7.5 – 1 System Parameter Settings Screen

b) This is one of the most important and useful sub-menu available on the
{Settings} screen. This sub-menu allows the user to configure behaviour of
the analyzer hardware and application software.
c) A description of the options available to the user is given in the table below.
These settings can be modified after clicking on the <EDIT> button at the
bottom of the screen.
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Item Description
This field is used for displaying the Name of the Laboratory which will
Laboratory Name
appear as Header in Patient Report.
This field is used for selecting the default language of the software.
Default Language List of available languages is displayed. User can choose the
language of his choice from this list.
This field is used for selecting the clearing of screen upon Save
Clear Screen upon Save
operation. Available Options are Yes and No.
This option is used if the user wants to print the results during Run. To
Online Report
enable this option click on the check box.
This option is used if the user wants to print the results during Run.
Printing Mode
Available options are Results printing, Patient Report printing and OFF
This option allows the user to print the patient report once the sample
is completed (real time). Default is Off. If the user wants to print the
Patient Report report online, he/she can select the patient report format from the list.
If the user wants to print the report offline, he/she can uncheck this
option.
This option allows the user to print the negative results during run. If
the user does not wish to print negative results on screen, then he/she
may uncheck this option.
Print Negative Result
In such case, the negative result will be printed as 0 (zero) in reports.
However, the negative results will be displayed on screen and also
printed in Online Results Report.
This field is used to select the availability of Confirmation Message.

Confirmation Message Default is checked. If checked, on performing any operation there will
be a confirmation message displayed to confirm the action.
This field is used to select the COM Port of the PC that is used for
Analyzer Port
communicating with the Analyzer. Default port is COM 1.
This option is used for determining whether the user wants the
Host Connection
transmission of results to LIS. Default is checked.
This field is used to select setting fro test parameters. Three options
are available Open, Semi-Closed and Closed. If Open option is
selected, all the fields on the test parameters can be edited and also
Open Channel Test new tests can be added. If Semi-Closed option is selected, some of
the fields on the test parameters can be edited and also new tests can
be added. If Closed option is selected, none of the fields on the test
parameters can be edited and also new tests can‟t be added.
RCT Temperature This field displays the RCT Temperature in C. This value is 37 C.
This field is used to set the allowable fluctuation in RCT Temperature.

RCT Temperature Range
Default value is 0.2 C. User can enter the range between 0 and 0.5.
RGT Temperature This field displays the RGT Temperature in C. This value is 8 C.
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RGT Temperature This field is used to set the allowable fluctuation in RGT Temperature.
Range Default value is 4 C. User can enter the range between 0 and 4.
This option is used to select the availability of Sample Barcode.
Sample Barcode
Default is checked
This option is used to select the availability of Reagent Barcode.

Reagent Barcode
Default is checked
This option is used to select the availability of ISE. Default is

ISE Module
unchecked
This field is used to enter the Minimum Cell Blank Absorbance. If the
absorbance of the cell blank falls below this limit, then the colour of the
Minimum Cell Blank
cuvette Absorbance value in the Cell Blank screen will change to Blue.
Default value is 0.03. User can enter the value from 0.01 to 0.05.
This field is used to enter the Maximum Cell Blank Absorbance. If the
absorbance of the cell blank falls above this limit, then the colour of the
Maximum Cell Blank
cuvette Absorbance value in the Cell Blank screen will change to Red.
Default value is 0.1. User can enter the value from 0.10 to 0.20.
This option is used to extrapolate the calibration graph to a particular

Extrapolation percentage. Value between 0 to 20% can be entered. If the value is 0,
the graph is not extrapolated.
Using this option default container type can be selected from the list.
Container Type Depending on the settings here, in Patient entry screen the default
container type would be selected.
Using this option Lithium (Li) test can be disabled or enabled. If this
Li in ISE option is ticked then Lithium is activated.
Using this option feature of Clot Detection can be disabled or enabled.

Clot Detection
If this option is ticked then Clot Detection feature is activated.
If Clot Detection feature is enabled then action on clot has to be set.
One of the two options Pause / Continue can be selected. On selection
Pause, during run if there occurs any clot then probe is washed and
further sampling will be paused permanently. On selection Continue,
Action On Clot
during run if there occurs any clot then probe is washed and sampling
will continue from next sample position. If three consecutive clots are
detected in total then sampling is paused permanently in that particular
run.
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7.6 Backup
a) One can enter this screen by clicking on {Utility: Backup} button. This
screen can be used to take backup of the information fed in the software.
b) Backup Mode:
The display changes according to the selection and provides necessary
guidance to perform the operation.
Figure 7.6 – 1 Backup Screen
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c) Method to Backup Data:
(i) {Backup Mode}: 2 options are available. Full and Selective.
(ii) {Format}: This drop down list is used to select the Mode of Backup.
Available options are XML, Text and Database.
 XML: This mode of backup stores the Backup Parameters in
XML format.
 Text: This mode of backup stores the Backup Parameters in
Text format.
 XLS: This mode of backup stores the Backup Parameters in
Excel format.
 Database: This mode of backup copies the entire database
and stores it on the hard disk at the path selected by user
using Browse button.
(iii) {Backup Path}: Click on the Browse button to select the path or
directory where the Parameters will be backed up. Backup can also
be taken on a removable USB disk.
(iv) {Backup Option}: A List of Parameters is available for Backup if the

user selects the Selective Backup Mode. The user can either check
all the parameters using Backup Option/All checkbox or make a
selection individually using the checkbox placed against each
parameter.
(v) After the following operations have been done, click on Backup
Button to take a backup of selected parameters.
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7.7 Carry Over Pairs

a) One can enter this menu by clicking on {Settings: Carry Over Pairs}
screen. The following screen is displayed:
Figure 7.7 – 1 Carry Over Pairs screen
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b) On this screen, the user can define the Forbidden pair for a particular
chemistry. 6 options are available:
Item Description
Contaminant Test The user can enter the Contaminant Chemistry
Contaminated Test The user can enter the chemistry that could get contaminated
This option is used to skip the cuvette along with the probe
wash. Whenever a contaminated test comes under a cuvette
Skip Cuvette
where the contaminant test has been run, the cuvette will be
skipped automatically
The user can select whether for that pair, a Reagent 1 or

Reagent 2 or a Detergent Wash or both Reagent 1 & Reagent
2 Washes are required. For the Detergent Wash, the Arm will
Wash
go to Wash Solution position defined by the user. For Reagent
Wash, the Arm shall go to the reagent position of the
Contaminated Test.
The user can define the number of cycles depending on the

Wash Cycles type of wash selected. The cycle number varies from 1 to 4.
Default is 1.
If Reagent Wash is selected, then the user can define the R1
R1/R2 Volume and R2 volume to be aspirated from the Contaminated test for
cleaning the Probe.
The user can select this option for a pair. During System Wash,
the Arm will be washed with internal DI water after picking up
System Wash
contaminant test reagent and before picking contaminated test
reagent.
Note:
a. Use “Test Sequence” option to define Test Processing Sequence. This sequence
will be followed during run while performing the tests of each Sample. This will
reduce the carryover effect.
b. For Detergent Wash, prepare Wash Solution (preferably phosphate-free neutral
1%Extran or 0.025% Hypochlorous Acid). Also, the same pair cannot be
programmed for 2 different type of wash.
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7.8 Rerun Flags
a) This field allows the user to select that flags that would appear for that test
should go for a Rerun.
b) If the user deselects a particular flag, then Rerun will not take place even if
the flag is issued along with the result for that test.
c) Click on {Setting: Rerun Flags}, the following screen appears as follows:
Figure 7.8 – 1 Rerun Flags Screen
d) Following are the explanation of the buttons on the screen:

PRINT: This button to be clicked to print the details whether a particular flag
is set for rerun
SAVE: This button to be clicked to save the details
CLEAR: This button to be clicked to undo the changes done
EDIT: This button to be clicked to change the setting for the flags
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7.9 User Rights
a) This screen allows the administrator to select User and define or redefine
their Rights.
b) Following screen is displayed on clicking {Setting: User Rights}
Figure 7.9 - 1 User Rights – User Name List Screen
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c) The selected User Rights can then be edited using the EDIT button. The
screen on next page gives the options available for the user.
Figure 7.9 - 2 User Rights – User Edit options Screen
d) To change the password, click on EDIT, enter the old password, new
password and also the confirm password.
e) If the user has forgotten the password, click on EDIT, select the option of
FORGOT PASSWORD and then enter the New Password and Confirm
Password.
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7.10 Result Recalculation

a) On clicking the {Utility: Recalculate}, the following screen is displayed:
Figure 7.10 – 1 Recalculate screen
b) This screen 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.
c) To obtain recalculated result, select result date or batch number or test or

sample id. Either of the 3 options Patients / Calibration / Controls can be
selected.
d) Once the above selection is done, click on <SHOW> button to view all the
results. Select the result for which re calculation needs to be done. Click
on the <Recalculate> button. The recalculated result and flag are
displayed along with the original result and flag.
e) Recalculated tests can be sent to Host by selecting the results and clicking
on the Send To Host button.
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7.11 Search
a) One can click on the Search button in the main menu to Search for
Consumables, Test Parameters, Patient Information, Sample Information and
Results.
7.11.1 Search – Patient and Samples
Figure 7.11.1 - 1 Patient Search Form
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b) Search for Patients and Sample details can be made using the above form.
c) Various filters can be applied during Search.
d) The following fields are available:
 Search by entering the Patient Name
 Search by selecting a Doctor
 Search by selecting a Sample Type
 Search by entering the Sample ID
 Search by Collection Date
(To select the From and To Date, click on the Calendar icon i.e. first icon
near the Collection Date text box to view and select a particular date. To
remove the date selection, click on „X‟ i.e. the second icon near the
Collection Date text box)
 Search by Registration Date
near the Registration Date text box to view and select a particular date.
To remove the date selection, click on „X‟ i.e. the second icon near the
Registration Date text box)
 Advanced Search using 2 or more combinations from above.
e) The above selection can be cleared using RESET button.
f) The results are displayed in the Grid.
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7.11.2 Patient Results Search
Figure 7.11.2 - 1 Patient Results Search Form

a) Search for Patient Results can be made using the above form.
b) Various filters can be applied during Search.
c) The following fields are available:
 Search by entering the Patient Name
 Search by selecting a Doctor
 Search by selecting a Test
 Search by entering the Flag associated with the test
 Search by Sample Type
 Search by entering Sample ID
 Search by selecting the Result Date
near the Result Date text box to view and select a particular date. To
Result Date text box)
d) The above selection can be cleared using RESET button.
e) The results are displayed in the Grid.
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7.11.3 Calib / Control Results Search
Figure 7.11.3 - 1 Calib / Control Results Search Form

a) Search for Calib / Control Results can be made using the above form.
c) This search includes following:
 Blank
 Standards
 Calibrators
 Controls
 Following Filters are used for the search:
 Search by entering the Test Name
 Search by selecting Flags
 Search by selecting the Result Date
 Search by Lot No
d) The above selection can be cleared using RESET button.
e) The results are displayed in the Grid.
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7.11.4 Consumables Search
Figure 7.11.4 - 1 Consumables Search Form

a) Search for Consumables can be made using the above form.
c) The user has a choice of searching the entire consumables or selecting one
consumable at a time.
 Search by entering Manufacturer Name
 Search by selecting the Expiry Date
This is not applicable to Blanks, Diluent or Wash Solution
 Search by Lot No.
 Search by Consumable Type
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7.11.5 Test Search
Figure 7.11.5 - 1 Test Details Search Form

a) Search for Test Details can be made using the above form.
c) The user has a choice of searching the entire consumables or selecting one
consumable at a time.
 Search by selecting Primary Wavelength
 Search by selecting Secondary Wavelength
 Search by selecting Assay Type
 Search by selecting Calibration Type
 Search by Reaction Direction
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7.12 Offline Results

a) One can enter this screen by clicking on {Utility: Offline Results} button.
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 Results> tab is clicked on the {Utility} menu:
Figure 7.12 – 1 Offline Results Screen
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b) A description of the fields available on this screen is given in the following

table:
This field is used to select the Date of the Result. Default Date is
Date
Present Date
By clicking on the dotted button, the user can select the name of the
Laboratory
Laboratory from the available list
By clicking on the dotted button, the user can select the name of the
Instrument Instrument on which the test was conducted (from the available list) or
Add a new Instrument Name from {Master: Instrument}
Sample ID By clicking on the dotted button, the user can select the Sample ID
Sample Type The user can select the Sample Type from drop down list
This field is for display purpose only and will display the name of the
Patient Name
Patient once the Sample ID is selected.
Age This field is for display purpose only and displays the patient‟s age
Category This field displays the Gender of the patient

The user can select the Test Name from drop down list or a new test
Test
name can be added upto 5 characters
Report Name The user can enter the Report Name of the selected test
Unit The user can enter the Unit for the test
Normal Lower Limit The user can enter the Lower Limit for the Test
Normal Upper Limit The user can enter the Upper Limit for the Test
Result The user can enter the result for the Test
Flag The user can enter the Flag associated with the Result
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7.13 Other
One can enter this screen by clicking on {Reports: Other} button.
a) This menu enables the user to view the number of patient, calibrators
(including blanks and standards) and controls run on the machine for each
test. This screen is useful to view the approximate reagent consumption. The
following screen is displayed when <Other> tab is clicked on the {Reports}
menu:
Figure 7.13.1 – 1 Reagent Consumption

a. The date range can be selected using From Date and To Date options.
b. Data button needs to be clicked to view the data over the selected date range.
c. Print button can be clicked to print the details displayed on screen.
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7.14 Master
This screen can be selected from the main menu to enter the master details for Area,
Doctor, Analyst, Laboratory, Manufacturer, Reference Range, Unit, Calculation Formula
and Instrument.
7.14.1 Master –Area
This tab can be used to enter the Area from which the samples are collected. This list of
area is available in Patient Entry screen and hence for each patient a particular area
can be selected Click on {Master: Area} to view this screen as shown below:
Figure 7.14.1 – 1 Area Master

 To Edit a row:
Select the Area from the grid
Click on EDIT button
Change the Area name
Click on SAVE button.
The updated Area will be hence displayed in the grid.
 To Add a row:
Click on CLEAR button
Enter the Area name
Click on SAVE button
The updated Area will be hence displayed in the grid.
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 To Delete a row:
Select the Area from the grid
Click on DELETE button
 The deleted Area will not be displayed in the grid.
 To Print the list of Area, click on PRINT button.
7.14.2 Master –Doctor

This tab can be used to enter the name and demographics of referring Doctor. This
list of doctor is available in Patient Entry screen and hence for each patient a
particular doctor can be selected. Click on {Master: Doctor} to view this screen as
shown below:
Figure 7.14.2 – 1 Doctor Master

 To Edit a row:
Select the Doctor from the grid
Change the Doctor‟s name and its demographics
The updated Doctor will be hence displayed in the grid.
 To Add a row:
Enter the Doctor‟s name and its demographics
The updated Doctor will be hence displayed in the grid.
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Select the Doctor from the grid
 The deleted Doctor will not be displayed in the grid.
 To Print the list of Doctor, click on PRINT button.
7.14.3 Master –Analyst

This tab can be used to enter the name and demographics of Analyst. This list of
analyst is available in Patient Entry screen and hence for each patient a particular
analyst can be selected. Click on {Master: Analyst} to view this screen as shown
below:
Figure 7.14.3 – 1 Analyst Master

 To Edit a row:
Select the Analyst from the grid
Change the Analyst‟s name and its demographics
The updated Analyst will be hence displayed in the grid.
 To Add a row:
Enter the Analyst‟s name and its demographics
The updated Analyst will be hence displayed in the grid.
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Select the Analyst from the grid
 The deleted Analyst will not be displayed in the grid.
 To Print the list of Analyst, click on PRINT button.
7.14.4 Master –Laboratory

This tab can be used to enter the name and details of Laboratory. This list of
laboratory is available in Settings>Offline Results screen and hence for each patient
a particular laboratory can be selected. Click on {Master: Laboratory} to view this
screen as shown below:
Figure 7.14.4 – 1 Laboratory Masters

There is always a default row with laboratory name as My Laboratory marked with **
sign. This row can‟t be deleted but it can be edited. The name and address of this row
is printed as header in the patient reports.
 To Edit a row:
Select the Laboratory name from the grid
Change the Laboratory name or the other laboratory details
The updated Laboratory name will be hence displayed in the grid.
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 To Add a row:
Enter the laboratory name and other laboratory details
The updated Laboratory name will be hence displayed in the grid.
Select the Laboratory name from the grid
 The deleted Laboratory name will not be displayed in the grid.
 To Print the list of laboratory, click on PRINT button.
7.14.5 Master –Manufacturer

This tab can be used to enter the name of Manufacturer. This list of manufacturer is
available in Consumables screen and hence for each consumable a particular
manufacturer can be selected. Click on {Master: Manufacturer} to view this screen as
shown below:
Figure 7.14.5 – 1 Manufacturer Master

There is always a default manufacturer present marked with ** sign. This row can‟t be
deleted but it can be edited i.e. the name can be changed.
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 To Edit a row:
Select the Manufacturer from the grid
Change the Manufacturer
The updated Manufacturer will be hence displayed in the grid.
 To Add a row:
Enter the Manufacturer
The updated Manufacturer will be hence displayed in the grid.
Select the Manufacturer from the grid
 The deleted Manufacturer will not be displayed in the grid.
 To Print the list of Manufacturer, click on PRINT button.
7.14.6 Master –Reference Range

This tab can be used to enter the min and max years/months/days for a reference range.
This list of reference range is available in Test reference ranges screen and hence for
each test a particular reference range can be selected and the min / max values can be
entered. Click on {Master: Reference range} to view this screen as shown below:
Figure 7.14.6 – 1 Reference Ranges Master
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There is always a default row present marked with ** sign. This row can‟t be deleted, it
can only be selected.
 To Edit a row:
Select the reference range from the grid
Change the reference range
The updated reference range will be hence displayed in the grid.
 To Add a row:
Enter the min and max reference range
The updated reference range will be hence displayed in the grid.
Select the reference range from the grid
 The deleted reference range will not be displayed in the grid.
 To Print the list of reference range, click on PRINT button.

7.14.7 Master –Unit
This tab can be used to enter the Unit. This list of units is available in Test
Parameters screen and hence for each test a particular unit can be selected. Click on
{Master: Unit} to view this screen as shown below:
Figure 7.14.7 – 1 Unit Master
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 To Edit a row:
Select the Unit from the grid
Change the Unit
The updated Unit will be hence displayed in the grid.
 To Add a row:
Enter the Unit
The updated Unit will be hence displayed in the grid.
Select the Unit from the grid
 The deleted Unit will not be displayed in the grid.
 To Print the list of Unit, click on PRINT button.
7.14.8 Master –Calculation Formula

This tab can be used to enter calculation formula. This list of calculation formula is
available in Calculation Item screen and hence for each calculation item a particular
calculation formula can be selected. Click on {Master: Calculation formula } to view this
screen as shown below:
Figure 7.14.8 –1 Calculation Formula Definition
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There are ten default calculation formulas. These formulas can be used or can also be
deleted if not required.
 To Edit a row:
Select the calculation formula from the grid
Change the calculation formula
A, B, C, D, E : Used for test names
a, b, c, d, e : Used for Coefficients
0 to 9: Used in formula for calculation
Various arithmetic operators are available to be used in the formula
Backspace – Used to clear one previous character
Clear Formula – Used to remove the complete formula
The updated calculation formula will be hence displayed in the grid.
 To Add a row:
Enter the calculation formula
The updated calculation formula will be hence displayed in the grid.
Select the calculation formula from the grid
 The deleted calculation formula will not be displayed in the grid.
 To Print the list of calculation formula, click on PRINT button.
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7.14.9 Master –Instrument

This tab can be used to enter instrument. This list of instrument is available in offline
results screen and hence for each offline result a particular instrument can be selected.
Click on {Master: Instrument} to view this screen as shown below:
Figure 7.14.9 – 1 Instrument Master

 To Edit a row:
Select the Instrument from the grid
Change the Instrument
The updated Instrument will be hence displayed in the grid.
 To Add a row:
Enter the Instrument
The updated Instrument will be hence displayed in the grid.
Select the Instrument from the grid
The deleted Instrument will not be displayed in the grid.
To Print the list of Instrument, click on PRINT button.
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The Range for the different indices can be modified as per the user
requirements by clicking on EDIT, change the field on the screen and click on SAVE.
Reagent Volume and Sample volume used for this test is displayed on
screen. Click on EDIT to change the volume and after changing click on SAVE.
Reagent for SI can be selected either SI Reagent or Diluent.
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7.15 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
where A, B, C, D, E and F are constants and client entry items.

α= 600, β= 700, γ= 570, δ= 450, ε= 510
xxx represents the absorbance values of each wavelength rxxx that are
obtained from measurements of sample and phosphoric acid buffer and
corrected by water blank wxxx. For example, in the case of wavelength of
600 nm,
600 = r600 - w600.
On clicking the {Settings: Serum Indices}, the following screen is displayed:
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Figure 7.13 - 1 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 Lipemia, 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 by
clicking on EDIT, change the field on the screen and click on SAVE.
Reagent Volume and Sample volume used for this test is displayed on screen. Click
on EDIT to change the volume and after changing click on SAVE.
Reagent for SI can be selected either SI Reagent or DIluent.
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Chapter 8 - Maintenanc e
Chapter 8
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.
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8.1 Maintenance Program
8.1.1 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:
Change the reagent bottles from time to time before adding the fresh reagent.
It is recommended to check and maintain a stock of spares and consumables.
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Table 1: Maintenance Schedule for Operator

a) Daily Maintenance
Start of the day
1. Empty Waste Can.
2. Empty Bio Hazardous Waste Can.
3. Fill Deionised Water Can.
4. Fill Cleaning Solution Can.
5. Clean The Analyzer External Surface.
6. Replace Printer Paper If Necessary.
7. Clean The Computer, Trolley, Monitor, Keyboard And Printer External Surface.
8. Perform Prime, Cuvette Wash and Probe Wash operations & Check Cell Blanks
9. Verify Reaction Tray & Reagent Tray Temperatures
10. Remove the Reagent Tray and clean the water condensed on the tray
11. Check the Lamp Gain at 340 nm using Auto Span (if required)
12. Clean Sample, Reagent1 and Reagent 2 probes from outside using Alcohol
13. Perform ISE Purge Cal A, Purge Cal B and Calibration
14. Replenish Or Replace Reagents If Necessary.
End of the day
1. Carry out Sample Probe Wash
2. Carry out Reagent1 / Reagent2 Probe Wash
3. Carry out Acid and Alkali Wash (Auto Wash) if Latex based chemistries are used
during the day
4. Carry out Cuvette Rinsing
5. Carry out Water Save operation
6. Empty the ASP Tray and clean the Reagent Table
7. Empty Concentrated and Diluted Waste Tank
8. Wipe instrument panel
9. ISE Cleaning using ISE Cleaning solution
10. Clean working area/table
11. Clean the Analyzer External Surface.
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b) Weekly Maintenance
1. Clean the Waste Can.
2. Clean the Bio Hazardous Waste Can.
3. Clean and Fill The Deionised Water Can.
4. Clean the Cleaning Solution Can.
6. Clean the Computer, Trolley, Monitor, Keyboard And Printer External Surface.
7. Clean the Area Around The Analyzer, Discard Any Unwanted Item.( Maintain Proper
Room Cleanliness.
8. Clean the Probe.
9. Clean the Stirrer Paddle.
10. Clean the Laundry Probes.
11. Clean the ASP Tray
12. Clean the Reagent Tray.
13. Clean the Syringe.
14. Perform Prime, Cuvette Rinse & Probe Wash Operations. Check for Cell Blanks
15. Clean Sample Barcode Reader
16. Clean Reagent Barcode Reader
17. Auto Wash
18. Perform Precision Check And Note Down The %CV For an End Point and Kinetic
Test.
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c) Quarterly Maintenance
Room Cleanliness.
8. Clean the Probe.
9. Clean the Stirrer Paddle.
10. Clean the Laundry Probes.
11. Clean the ASP Tray
12. Clean the Reagent Tray
13. Clean the Syringe.
14. Clean the Analyzer Fans
15. Clean the Sample and Reagent Bar Code Readers
16. Replace the Lamp
17. Clean the Analyzer Internal Surface Free Of Dust
18. Perform Prime, Cuvette Rinse & Probe Wash Operations. Check for Cell Blanks
19. Perform A Precision Check And Note Down The %Cv For An End Point And Kinetic
Test.
20. Clean CRU nozzles and drier chip externally
21. Clean ISE Electrode Tip
22. Check the alignment of electrodes and bubble detector
23. Wash the troughs with 1% NaOCl (5ml) for all arms and stirrers
24. Make A Detailed Entry In The Error Log Book, Of The Maintenance Carried Out And
Site Verifications.
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d) Annual Maintenance
5. Replace External Tubing‟s to The Waste, Bio Hazardous Waste, Cleaning Solution
and Deionised Water Cans.
Room Cleanliness)
9. Clean The ASP Tray
10. Clean The Reagent Tray.
11. Clean the Analyzer Fans.
12. Clean the Sample and Reagent Bar Code Readers
13. Perform Prime, Cuvette Rinse & Probe Wash operations. Check Cell Blanks
Table 1 Showing the Daily, Weekly Quarterly and Annual schedule for the
operator
Note:
Average life of the Lamp is 1000 hours. Replacement of Lamp depends on its usage
and ON Time.
Average use life of water filter is 3 months. Replacement of water filter depends on
quality of DI water used.
Table 2: Replacement schedule for consumables and spares

Sr. No. Spares/Consumables 3 6 9 12
Months Months Months Months
1 PROBE ASSY 
2 STIRRER PADDLE 
CUVETTE DRYER CHIP
3 
(TEFLON)
4 LAUNDRY DISPENSE TUBING‟S 
LAUNDRY ASPIRATION
5
TUBING‟S

6 LAUNDRY PROBE ASSY 

7 PHOTOMETER LAMP ASSY 
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8.1.2 Consumables-Diluents & Wash Solutions
Figure 8.1 – 1 Consumables – Diluents & Wash Solutions
a) The user can program various diluents for Serum or Urine from {Consumables – Diluents}
screen. The user can add a new diluent name by clicking on the dotted button alongside
Consumable name.
b) Once the diluent is added, the user can click on the new button to add the Manufacturer
name of the diluent. Lot No. is not mandatory.
c) Similar option is given for adding the Wash solution, which is used when forbidden pairs
are programmed.
Note:
Diluents can be placed on any position of the Reagent Tray.
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8.2 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.
8.2.1 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;
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8.3 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 rear 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 8.3 - 1 Fuse Diagram
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Chapter 8 – Maintenanc e
8.4 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
8.4.1 Check for 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 deionised 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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8.4.2 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 RCT unit
temperature deviates from the specified value of 37
± 0.2ºC.
3. Improper preparation of
Check the preparation of the reagent.
reagent
calibrator
8.4.3 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 with
validity of reagent the reagent kit for its stability.
Check the preparation of the reagent.
reagent
3. Improper preservation of See the statement of virtues that comes together with
reagent the reagent kit for its proper preservation method.
Check the temperature shown in the [Service Check:

4. Too low inside temperature Temperature] picture. Call for service at our customer
of RCT unit service department when the indicated temperature
deviates from the specified value of 37 ± 0.2ºC.
calibrator
6. Excessive volume of reagent Check if there is any leakage or drip at junction of

dispensed reagent sampling system.
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8.4.4 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 solution
positioned below the water or solution level. Call for
supply from respective
service at our customer service department in case
external tank
of trouble.
Check if the stirrer rotates in the centre of cuvette

3. Insufficient stirring
and at the correct speed.
8.4.5 Anomalous resultant values from all methods for a sample
Cause Action
1. Improper preparation of Prepare newly the reagent referring to the statement

reagent of virtues that comes together with the reagent kit.
2. Expiration of term of
Prepare newly the reagent referring to the statement
validity, contamination or
of virtues that comes together with the reagent kit.
paleness of reagent
X L- 640 O M VER: 2009.0 2 233

8.5 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.
8.5.1 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.
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 period of Error List can be selected using From and To Date Calendar.
Remedial actions for all error conditions are given below in section 8.5.2 Error Messages for each
unit.
Note:
When user clicks on Start Run button on Status Monitor, if any error is detected during initialization of
the instrument then the error message will be displayed in the error grid on the Screen. In such case,
the instrument will hault. The user has to take the corrective action.
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 occurs, 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.
X L- 640 O M VER: 2009.0 2 234

8.5.2 Error messages for each unit
Error Error
Assembly Possible Failures Action to be Taken
Code Message
Stirrer 1 A1 Stirrer1 Up/Down Opto/ Home  Switch OFF the analyzer.
up/down Opto/ Direction Opto Move the stirrer 1 up and
error during  Motor driver card down manually and make sure
init and its connector that nothing is 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/ Direction Opto  Switch OFF the analyzer.
rotation error  Motor driver card Move the stirrer 1 in rotational
during init and its connector path manually and make sure
that nothing is obstructing the
 Stepper Motor
movement
(rotational)
Stirrer 1<rotation> commands.
 If the rotation movement fails,
call the Service Engineer
A3 Stirrer1 Up/Down Opto  Switch OFF the analyzer.
up/down  Motor driver card Move the stirrer 1 up and
error and its connector down manually and make sure
 Stepper Motor
movement
Service Engineer
A4 Stirrer1 Home Opto/ Direction Opto  Switch OFF the analyzer.
rotation error  Motor driver card Move the stirrer 1 in rotation
and its connector path manually and make sure
 Stepper Motor
movement
(rotational)
X L- 640 O M VER: 2009.0 2 235

Error Error
Code Message
Stirrer 1 rotation commands.
AF Stirrer 1 Stop Opto/ Base Opto  Switch OFF the analyzer.
Interlocked  Motor driver card rotate RCT manually and
and its connector make sure that nothing is
obstructing the movement
 Stepper Motor
 RCT Alignment
 Interlock effect due Check:RCT and CRU Menu.
to malfunctioning of Click on RCT button and then
other related on <Initialize> button and
assemblies check the sequence for RCT
<Rotate> commands.
Stirrer 2 B1 Stirrer 2 Up/Down Opto/ Home  Switch OFF the analyzer.
up/down Opto/ Direction Opto Move the stirrer 2 up and
init and its connector that nothing is obstructing the
movement
 Stepper Motor
 RCT Alignment
Service Engineer
B2 Stirrer 2 Home Opto/ Direction Opto  Switch OFF the analyzer.
rotation error  Motor driver card Move the stirrer 2 in rotational
during init and its connector path manually and make sure
 Stepper Motor
movement
(rotational)
Stirrer 2 <rotation>
commands.
B3 Stirrer 2 Up/Down O pto  Switch OFF the analyzer.
up/down  Motor driver card Move the stirrer 2 up and
error and its connector down manually and make sure
 Stepper Motor
movement
X L- 640 O M VER: 2009.0 2 236

Error Error
Code Message
Service Engineer
B4 Stirrer 2 Hom e O pto/ Direc tion  Switch OFF the analyzer.
rotation error O pto Move the stirrer 2 in rotation
 Motor driver card path manually and make sure
and its connector that nothing is obstructing the
movement
 Stepper Motor
(rotational)  Then switch ON the
Stirrer 2 rotation commands.
BF Stirrer 2 Stop O pto/ Bas e O pto  Switch OFF the analyzer.
 Stepper Motor
 RCT Alignment
<Rotate> commands.
CRU C1 CRU Up/Down O pto  Switch OFF the analyzer.
up/down  Motor driver card Move the CRU up and down
error during and its connector manually and make sure that
init nothing is obstructing the
 Stepper Motor
movement
 CRU Alignment
Check:RCT and CRU Menu.
Click on CRU button and then
on <Initialize> button and
execute the CRU Up/Down
commands.
Service Engineer
C2 CRU Up/Down O pto  Switch OFF the analyzer.
up/down  Motor driver card Move the CRU up and down
error and its connector manually and make sure that
nothing is obstructing the
 Stepper Motor
movement
 CRU Alignment
X L- 640 O M VER: 2009.0 2 237

Error Error
Code Message
commands.
Service Engineer
C5 CRU Up/Down O pto  Switch OFF the analyzer.
Initialize  Motor driver card Move the CRU up and down
Error and its connector manually and make sure that
nothing is obstructing the
 Stepper Motor
movement
 CRU Alignment
commands.
Service Engineer
CF CRU Stop O pto/ Bas e O pto  Switch OFF the analyzer.
 Stepper Motor
 RCT Alignment
<Rotate> commands.
RCT E1 RCT Stop O pto/ Bas e O pto  Switch OFF the analyzer.
rotational  Motor driver card Rotate RCT manually and
error and its connector make sure that nothing is
 Stepper Motor
 RCT Alignment
<Rotate> commands.
E2 RCT Stop O pto/ Bas e O pto  Switch OFF the analyzer.
rotational  Motor driver card rotate RCT manually and
X L- 640 O M VER: 2009.0 2 238

Error Error
Code Message
 Stepper Motor obstructing the movement
 RCT Alignment  Then switch ON the
 Interlock effect due instrument; go to Service
to malfunctioning of Check:RCT and CRU Menu.
other related Click on RCT button and then
assemblies on <Initialize> button and
check the sequence for RCT
<Rotate> commands.
Rotation  Motor driver card rotate RCT manually and
Interlocked and its connector make sure that nothing is
due to R2 obstructing the movement
 Stepper Motor
Arm  Then switch ON the
 RCT Alignment
<Rotate> commands.
due to CRU obstructing the movement
 Stepper Motor
 RCT Alignment
<Rotate> commands.
due to obstructing the movement
 Stepper Motor
Sample Arm  Then switch ON the
 RCT Alignment
<Rotate> commands.
due to R1 obstructing the movement
X L- 640 O M VER: 2009.0 2 239

Error Error
Code Message
Arm  Stepper Motor  Then switch ON the
 RCT Alignment instrument; go to Service
 Interlock effect due
Click on RCT button and then
to malfunctioning of
other related
check the sequence for RCT
assemblies
<Rotate> commands.
due to Stirrer obstructing the movement
 Stepper Motor
1  Then switch ON the
 RCT Alignment
<Rotate> commands.
due to Stirrer obstructing the movement
 Stepper Motor
2  Then switch ON the
 RCT Alignment
<Rotate> commands.
Miscellaneou F1 Check Fluid DI W ater Level  Check the DI Water Level,
s Levels  Sensor output of Cleaning Solution Level,
Load Level Waste Level and Bio-Hazard
Sensing Platform Waste Level in the respective
cans.
 Check the Sensor Output of
Load Level Sensing Platform
H1 Check water Malf unc tioning of  Check the pressure unit for
pressure press ure unit any leakage or blockage in the
 Leakage/Blockage tubing
in pressure tubing  Low DI water supply - Check
25 micron filter or water level
in DI Water Can
X L- 640 O M VER: 2009.0 2 240

Error Error
Code Message
K1 RGT cover Reagent Cover  Check the placement of
switch closed Plac em ent Reagent Cover
/open  The logic levels at  Check the logic levels at the
the baseboard baseboard
connectors connectors/connector
 Connector connections and verify for
connections proper functionality.
R1 Arm 11 R1 arm Up/Down O pto/ Hom e  Switch OFF the analyzer.

up/down O pto/ Direc tion O pto Move the R1 Arm up and
initialization. and its connector that nothing is obstructing the
movement
 Stepper Motor
(Up/Down)  Then switch ON the
Check:R1 Arm Menu. Click on
<Initialize> button and execute
the R1 Up/Down commands.
Service Engineer
12 R1 arm Up/Down opto/Hom e  Switch OFF the analyzer.
rotational O pto/Direc tion Op to Move the R1 Arm in rotation
error during  Motor driver card path manually and make sure
movement
 Stepper Motor
(Rotational)  Then switch ON the
the R1 rotation commands.
13 R1 arm Up/Down O pto/ Hom e  Switch OFF the analyzer.
error  Motor driver card down manually and make sure
movement
 Stepper Motor
Service Engineer
rotational O pto/ Direc tion O pto Move the R1 Arm in rotation
error  Motor driver card path manually and make sure
movement
 Stepper Motor
X L- 640 O M VER: 2009.0 2 241

Error Error
Code Message
16 Reagent 1 No reagent 1 bottle is  Switch OFF the analyzer.
absent at plac ed in reagent tray Check the Reagent 1 Level
Pos.  Empty reagent 1 and ensure that it is above the
bottle set Dead Volume.
 Reagent 1 Level is
below the set Dead
Volume
 LLS Board
placement of
reagent bottles
 Reagent 1 Arm
Position in Reagent
Tray
18 R1 Arm VOD The c onnec tors  Switch OFF the analyzer.
Error at  VOD Opto Sensor Move the R1 Arm up and
Trough down manually and make sure
 Placement of
Reagent Bottles
movement
 Reagent 1 Arm
Position in Cuvette
 Reagent 1 Arm Check:R1 Arm Menu. Click on
Position in Trough <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
Error at RGT  VOD Opto Sensor Move the R1 Arm up and
Tray Pos. down manually and make sure
 Placement of
Reagent Bottles
movement
 Reagent 1 Arm
Position in Cuvette
initializes.
Service Engineer
1A R1 Arm VOD The c onnec tors  Switch OFF the analyzer.
Error at RCT  VOD Opto Sensor Move the R1 Arm up and
down manually and make sure
X L- 640 O M VER: 2009.0 2 242

Error Error
Code Message
Tray  Placement of that nothing is obstructing the
Reagent Bottles movement
 Reagent 1 Arm  Then switch ON the
Position in Cuvette instrument; go to Service
initializes.
Service Engineer
1F R1 Arm Stop O pto/ Bas e O pto  Switch OFF the analyzer.
 Stepper Motor
 RCT Alignment
<Rotate> commands.
RGT 21 RGT Stop O pto/Base O pto  Switch OFF the analyzer.
rotational  Motor driver card Rotate RGT manually and
error during and its connector make sure that nothing is
initialization obstructing the movement
 Stepper Motor
 RGT Alignment
 Interlock effect due Check: Reagent Tray Menu.
to malfunctioning of Click on <Initialize> button
other related and check the sequence for
assemblies Reagent Tray <Rotate>
commands.
 If the initialization or rotation
Service Engineer
22 RGT Stop opto/Bas e O pto  Switch OFF the analyzer.
rotational  Motor driver card Rotate RGT manually and
 Stepper Motor
 RGT Alignment
 Interlock effect due Check: Reagent Tray Menu.
assemblies Reagent Tray <Rotate>
commands.
X L- 640 O M VER: 2009.0 2 243

Error Error
Code Message
Service Engineer
R1 Syringe 31 R1 syringe R1 Syringe Connec tors  Switch OFF the analyzer.
up/down  Motor driver card Move the R1 Syringe up and
error and its connector down manually and ensure
 Stepper Motor
movement.
 R1 Syringe Opto
Check: Syringes Menu. Click
on R1 Syringe and then
<Initialize> button and check
the sequence.
Service Engineer
32 R1 syringe R1 Syringe Connec tors  Switch OFF the analyzer.
error and its connector down manually and ensure
 Stepper Motor
movement.
 R1 Syringe Opto
the sequence.
Service Engineer
R2 Arm 41 R2 arm Up/Down O pto/ Hom e  Switch OFF the analyzer.
movement
 Stepper Motor
Service Engineer
42 R2 arm Up/Down opto/Hom e  Switch OFF the analyzer.
rotational O pto/Direc tion Opto Move the R2 Arm in rotation
error during  Motor driver card path manually and make sure
movement
 Stepper Motor
X L- 640 O M VER: 2009.0 2 244

Error Error
Code Message
movement
 Stepper Motor
Service Engineer
44 Reagent 2 Up/Down opto/Hom e  Switch OFF the analyzer.
absent at O pto/Direc tion Opto Move the R2 Arm in rotation
Pos.  Motor driver card path manually and make sure
movement
 Stepper Motor
46 Reagent 2 No reagent 2 bottle is  Switch OFF the analyzer.
absent at plac ed in reagent tray Check the Reagent 2 Level
Pos.  Empty reagent 2 and ensure that it is above the
bottle set Dead Volume.
 Reagent 2 Level is
below the set Dead
Volume
 LLS Board
placement of
reagent bottles
 Reagent 2 Arm
Position in Reagent
Tray
Error at  VOD Opto Sensor Move the R2 Arm up and
 Placement of
Reagent 2 Bottles
movement
 Reagent 2 Arm
Position in Cuvette
initializes.
X L- 640 O M VER: 2009.0 2 245

Error Error
Code Message
Service Engineer
Error at RGT  VOD Opto Sensor Move the R2 Arm up and
Pos. down manually and make sure
 Placement of
Reagent 2 Bottles
movement
 Reagent 2 Arm
Position in Cuvette
initializes.
Service Engineer
4A R2 Arm VOD The c onnec tors  Switch OFF the analyzer.
Error at RCT  VOD Opto Sensor Move the R2 Arm up and
down manually and make sure
 Placement of
Reagent 2 Bottles
movement
 Reagent 2 Arm
Position in Cuvette
initializes.
Service Engineer
4F R2 Arm Stop O pto/ Bas e O pto  Switch OFF the analyzer.
 Stepper Motor
 RCT Alignment
<Rotate> commands.
R2 Syringe 61 R2 syringe R2 Syringe Connec tors  Switch OFF the analyzer.
error during and its connector down manually and ensure
initialization- that nothing is obstructing the
 Stepper Motor
Discard movement.
X L- 640 O M VER: 2009.0 2 246

Error Error
Code Message
previous two  R2 Syringe Opto  Then switch ON the
results in instrument; go to Service
Run Check: Syringes Menu. Click
the sequence.
Service Engineer
62 R2 syringe S yringe Connec tors  Switch OFF the analyzer.
error-Discard and its connector down manually and ensure
previous two that nothing is obstructing the
 Stepper Motor
results in movement.
Run  R2 Syringe Opto
the sequence.
Service Engineer
Sample Arm 71 sample arm Up/Down opto/Hom e  Switch OFF the analyzer.
up/down O pto/Direc tion Opto Move the Sample Arm up and
movement
 Stepper Motor
Check: Sample Arm Menu.
Click on <Initialize> button
and execute the Sample
Up/Down commands.
Service Engineer
72 sample arm Up/Down opto/Hom e  Switch OFF the analyzer.
rotational O pto/Direc tion Opto Move the Sample Arm in
error during  Motor driver card rotation path manually and
initialization. and its connector make sure that nothing is
 Stepper Motor
rotation commands.
73 Sample arm Up/Down opto/Hom e  Switch OFF the analyzer.
up/down O pto/Direc tion Opto Move the Sample Arm up and
X L- 640 O M VER: 2009.0 2 247

Error Error
Code Message
 Stepper Motor movement
Up/Down commands.
Service Engineer
74 Sample arm Up/Down opto/Hom e  Switch OFF the analyzer.
rotational O pto/Direc tion Opto Move the Sample Arm in
error  Motor driver card rotation path manually and
 Stepper Motor
rotation commands.
75 Sample arm The c onnec tors  Switch OFF the analyzer.
VOD error at  VOD Opto Sensor Move the Sample Arm up and
Pos. down manually and make sure
 Placement of
Sample on
movement
Sample/Standard
Tray  Then switch ON the
 Sample Arm
Position in Cuvette
Click on <Initialize> button.
 Sample Arm Push the Sample probe gently
Position in Trough to cut the VOD opto so that
VOD Error will be generated
and Sample Arm initializes.
Service Engineer
76 sample No s am ple is plac ed in  Switch OFF the analyzer.
absent at s am ple/s tandard tray Check the Level of Sample
Pos.  Empty sample tube and ensure that it is above the
set Dead Volume.
 Sample is below
the set Dead
Volume
 LLS Board
placement of
Sample Tubes
 Sample Arm
Position in
Sample/Standard
Tray
X L- 640 O M VER: 2009.0 2 248

Error Error
Code Message
77 Clot  Sample Probe  Clean the Sample Probe
Detected at  If clot continues, change
Pos. sample probe.
78 Sample Arm The c onnec tors  Switch OFF the analyzer.

VOD Error at  VOD Opto Sensor Move the Sample Arm up and
 Placement of
Sample on
movement
Sample/Standard
 Sample Arm
Position in Cuvette
Service Engineer
79 Sample Arm The c onnec tors  Switch OFF the analyzer.
ASP Pos. down manually and make sure
 Placement of
Sample on
movement
Sample/Standard
 Sample Arm
Position in Cuvette
Service Engineer
7A Sample Arm The c onnec tors  Switch OFF the analyzer.
RCT down manually and make sure
 Placement of
Sample on
movement
Sample/Standard
 Sample Arm
Position in Cuvette
Service Engineer
7B SPT Arm The c onnec tors  Switch OFF the analyzer.
X L- 640 O M VER: 2009.0 2 249

Error Error
Code Message
ISE  Placement of down manually and make sure
Sample on that nothing is obstructing the
Sample/Standard movement
 Sample Arm instrument; go to Service
Position in Cuvette Check: Sample Arm Menu.
 Sample Arm
Push the Sample probe gently
Position in Trough
to cut the VOD opto so that
Service Engineer
7F Sample Arm Stop O pto/ Bas e O pto  Switch OFF the analyzer.
 Stepper Motor
 RCT Alignment
<Rotate> commands.
ASP 81 ASP Stop opto/Bas e O pto  Switch OFF the analyzer.
rotational Rotate ASP manually and
 Motor driver card
error during make sure that nothing is
and its connector
initialization obstructing the movement
 Stepper Motor
 ASP Alignment instrument; go to Service
 Interlock effect due Check: Sample Tray Menu.
assemblies Sample Tray <Rotate>
commands.
Service Engineer
82 ASP Stop opto/Bas e O pto  Switch OFF the analyzer.
rotational  Motor driver card Rotate ASP manually and
 Stepper Motor
 ASP Alignment
 Interlock effect due Check: Sample Tray Menu.
assemblies Sample Tray <Rotate>
commands.
X L- 640 O M VER: 2009.0 2 250

Error Error
Code Message
Service Engineer
Sample 91 Sample Sam ple Syringe  Switch OFF the analyzer.
Syringe syringe Connec tors Move the Sample Syringe up
up/down  Motor driver card and down manually and
error during and its connector ensure that nothing is
initialization- obstructing the movement.
 Stepper Motor
Discard  Then switch ON the
previous two  Syringe Opto
results and Check:Syringes Menu. Click
onwards in on Sample Syringe and then
run <Initialize> button and check
the sequence.
Service Engineer
92 Sample Sam ple Syringe  Switch OFF the analyzer.
syringe Connec tors Move the Sample Syringe up
up/down  Motor driver card and down manually and
error-Discard and its connector ensure that nothing is
previous two obstructing the movement.
 Stepper Motor
results and  Then switch ON the
onwards in  Syringe Opto
run Check: Syringes Menu. Click
on Sample Syringe and then
the sequence.
Service Engineer
Instrument - Analyzer is  Wrong PC COM  Make sure that a correct port
either OFF port selection for has been selected in [Service
OR analyzer. Check: PC Communication]
Instrument  Problem in screen
not Communication  Make sure the continuity of
responding cable the RS 232 communication
 RS 232 isolator cable between Analyzer and
board PC
 Problem in RCT  Change RS 232 isolator PCB.
rotation
X L- 640 O M VER: 2009.0 2 251

8.5.3 Error Log

a) This sub menu displays the list of errors occurred in machine. This data is
generally useful for servicing/diagnostic purposes. One can enter this screen
by clicking on {Reports: Error Log} button. The following screen is displayed:
Figure 8.5.3 - 1 Error Log Screen
b) The user can select the date range by changing the From and To Date.
c) The user can select operation (Service, Maintenance, Run or All operations)
during which the errors occurred.
d) Once the above selection is done, user needs to click on SHOW button to
view all the errors.
e) In the grid following are the different fields present:
 Date - Date and Time of the occurrence of the error
 Batch No - During run, if there was any error then in which batch it
occurred
 Description - Description of the error occurred
 Action - Action taken on the error occurrence is displayed in this column
f) To print the details the error log, user can click on PRINT button
X L- 640 O M VER: 2009.0 2 252

8.5.4 Measurement result error flags

The measurement result flags printed out together with the measurement result
are shown in the following list.
Sr. No. Flags Cause

This flag is issued to indicate that the result obtained is from a rerun.
1 #
This flag is issued for all rerun results
When Linearity Extension Logic method is used to reduce the
2 ~ measurement range to match absorbance range setting, this flag
should be given
This flag is used to indicate that correlation correction has been used
3 F to calculate the final result. That is, this flag is issued if in the
equation Y = aX + b, a is not equal to 1 or b is not equal to zero.
This flag is issued with control results to indicate that the result is
4 -1SD
below 1SD limit
5 +1SD
above 1SD limit
6 -2SD
below 2SD limit
7 +2SD
above 2SD limit
8 -3SD
below 3SD limit
9 +3SD
above 3SD limit
This flag is issued with patient or control result and indicates that
something is wrong with the calibration table. The calibration table
10 NOCAL needs to be checked and corrected to calculate a result (e.g., no
calibration is present or number of standards provided for multipoint
calibration is less than required.
This flag is issued with control result and indicates that the target
Mean and SD values have not been defined in Quality Control
12 ?SD
screen for the control. Therefore, flags such as “±1SD”, “±2SD”,
“±3SD” cannot be given
This flag is issued with patient results and indicates a Decreased
13 V-D
volume run
This flag is issued with patient results and indicates a Increased

14 V-I
volume run
This flag is issued with patient and control results when, for the
concerned test, the absorbance‟s of the calibrators are not changing
15 MONO
monotonically with the concentration of the calibrators in the
calibration table.
This flag is issued with blank, patient, calibrator and control results to
16 PD
indicate that the sample was prediluted
This flag is issued with patient and control serum results to indicate
17 P*
that prozone (antigen excess) has occurred.
X L- 640 O M VER: 2009.0 2 253

Lower technical limit violated. Measured value or absorbance slope

18 TEC-L
is lower than the set minimum technical limit.
Upper technical limit violated. Measured value or absorbance slope
19 TEC-H
is higher than the set maximum technical limit.
1) This flag is issued with patient and control serum results to
indicate that the absorbance of the sample is higher than the
absorbance of the
highest concentration calibrator in the calibration table for increasing
20 RANGH direction test.
2) This flag is also issued with patient and control serum results if the
absorbance of the sample is lower than the absorbance of the
highest concentration calibrator in the calibration table for decreasing
direction test.
1) This flag is issued with patient and control serum results to
indicate that the absorbance of the sample is lower than the
absorbance of the blank (or lowest concentration calibrator) in the
RANGL calibration table for increasing direction test.
21
2) This flag is also issued with patient and control serum results if the
absorbance of the sample is higher than the absorbance of blank (or
lowest concentration calibrator) for a decreasing direction test.
Measured value is larger than upper limit set for normal value range
22 H
for the corresponding age, sample type and category.
Measured value is smaller than lower limit set for normal value range
23 L
for the corresponding age, sample type and category.
Calculation Item calculation does not take place for any of the
following reasons
1) Denominator is 0 (zero) in the process of calculation for
compensation.
24 CALC! 2) The test to be used for Calculation Item has not been measured
yet.
3) Any test to be used for Calculation Item has data/calibration
alarms (such as Chk Calib)
4) Any test to be used for Calculation Item errors (S*, R1* etc)
1) The absorbance value between M2S and M2E exceeded the

Reaction Absorbance limit.
25 ABSLIM 2) This flag should be issued only for End-Point Chemistries (For
Rate-Chemistries, this flag will not be issued due to extension logic
program)
Low Panic value error. This flag is issued with a sample result to
26 PANL indicate that the patient result is lower than the programmed Panic
Limit Min. ISE tests too will be sent for a rerun
High Panic value error. This flag is issued with a sample result to
27 PANH indicate that the patient result is higher than the programmed Panic
Limit Max. ISE tests too will be sent for a rerun
X L- 640 O M VER: 2009.0 2 254

Linearity abnormal (checked only for Rate A and Rate B assays).

When the reaction during measurement points M2S and M2E is non-
28 LINxx linear beyond the set limit for linearity of reaction this flag is given
and the percent linearity of reaction is indicated by a two digit
number xx after “LIN”.
This flag is applicable for Rate Chemistries, only during the extension
29 Lim0 logic and when Reaction Absorbance Limit is present. If there are no
points available for calculation, then this flag is issued
30 Lim1 logic and when Reaction Absorbance Limit is present. If there is only
one point available for calculation, then this flag is issued
32 Lim2 logic and when Reaction Absorbance Limit is present. If there are 2
points available for calculation, then this flag is issued
This flag is issued when the denominator becomes zero during
34 ??? calculation or an overflow error occurs in logarithmic or exponential
calculation
Rgt Abs This flag indicates that the reagent 1 absorbance is lower than the
35
Min programmed Reagent Absorbance Min
Rgt Abs This flag indicates that the reagent 1 absorbance is greater than the
36
Max programmed Reagent Absorbance Min
This flag indicates that a clot has been detected during sampling for
37 CD
that test. The result “NA” is associated with the flag.`
@TM This flag is issued when the RCT temperature was out of range
38 while the measurement was in process.
P
39 TO This flag indicates Time Out while receiving result from the
machine.
This flag is issued with the patient and control results to indicate
40 Cal*
that the results are being calibrated with previous calibration data.
X L- 640 O M VER: 2009.0 2 255

8.6 Maintenance Menu

The user can enter the Maintenance screen by clicking on the {Maintenance}:
Figure 8.6 – 1 Maintenance Menu

These functions should be used for routine maintenance of the analyzer.
8.6.1 Auto Span
Figure 8.6.1 - 1 Auto Span

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} bullet and clicks on <Start> button. Whether the
gain is within the factory set limits or not is indicated by a green or red
background. If the gain at any wavelength is not within the factory set limits,
the background is filled with red colour.
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The photometer gains can also be adjusted manually, however it is not

recommended.
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.
8.6.2 Manual Span

This screen can be used to view the photometer stability. It displays the
Voltage and Absorbance at different wavelengths.
Figure 8.6.2 - 1 Manual Span
Following is the procedure:

a) Select a wavelength using which the absorbance and voltage needs to be
checked.
b) Click on START button. Continuous online update of voltage and
absorbance takes place and is displayed on the screen.
c) Click on STOP once the check is performed.
d) User can select another wavelength to check the voltage and the
absorbance at the other wavelength. Again user needs to click on START to
start the reading and STOP to stop the reading.
8.6.3 Wash
The following screenshot shows the Wash Screen:
Figure 8.6.3 - 1 Wash Screen
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1. Cuvette Rinse:
On selecting <Cuvette Rinse> option, the user can perform a Cuvette Wash of
all 72 cuvettes by clicking on the Start button. This wash is done using DI Water.
At the end of Cuvette Rinse, the cell blanks are updated automatically and can
be seen by clicking on the <Cell Blank> tab under Maintenance menu:
Figure 8.6.3 - 2 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. There is
also a Graph option available for display. The cuvette blank table consists
of three sections.
X L- 640 O M VER: 2009.02 258

Figure 8.6.3 - 3 Cell Blank Graph

{Cell Blank: Present abs}: It is the absorbance of the cuvettes with de-
ionized water measured after the last run or Cuvette Rinse.
{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: 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.
The maximum and minimum acceptable value of the cuvette blank

absorbance can be set in the {Settings: System Parameter} 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 Blue
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.
Note:
If the cuvette blank for some cuvettes are less than 0.03, 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 starting the batch.
X L- 640 O M VER: 2009.02 259

2. Water Save:
One can perform this action by selecting <Water Save> option in Maintenance
screen & clicking on START button. This option can be used to fill all the 72
cuvettes with DI water. Overnight filling of the cuvettes with DI water is helpful in
loosening the dirt on the cuvette walls. On clicking this button, the analyzer first
washes all the 72 cuvettes with the detergent in the detergent can and DI water
in the SI water can. Then using the 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.
Note:
Poor quality DI water should not be used for Water Save, as bacteria growth can
take place inside the cuvettes.
3. 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, probe,
and stirrer. Usually 0.1 N HCl and 0.1 N 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.
a. Place 5.2 ml each of Cleaning A and Cleaning B solutions at sample

positions 1 and 3.
b. Place about 24 ml of Cleaning A and Cleaning B solutions (in Large
bottles) on reagent positions 1 & 3 respectively.
c. Click on <Start> button to start the washing procedure to perform the
acid and alkali wash. At the end of the procedure, the user can check
the Updated Cuvette Blanks by going to the {Maintenance: Cell Blank}
screen. If the user wants to stop the operation, he/she can click on the
Stop button that is active after the Start button is clicked.
Note:
Cleaning A Solution:- HCl (Acidic)
Cleaning B Solution:- NaOH (Basic)
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 0.1 N HCl and 0.1 N NaOH solutions.
X L- 640 O M VER: 2009.02 260

3. 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 or at beginning of the day.
a. Click on the {Maintenance: Probe Wash} menu. Keep 500µl wash
solution on ISE2 position. Clicking on <Start> button.
b. Warning message is displayed to keep wash solution at ISE2 position.
Once the user clicks on <OK>, the Probe picks up about 60 µl of
cleaning solution and dispenses it in the drain with internal and external
cleaning.
c. The Probe wash action is repeated 5 times.
d. After the action is completed the analyzer gets initialized.
4. Reagent 1/2 Probe Wash

This option enables the operator to wash the Reagent 1 / 2 Probe with
some cleaning solution at the end of a day‟s work or at beginning of the
day.
a. Click on the {Maintenance: Probe Wash} menu. Clicking on <Start>
button. (Keep either 1% Extra or 0.05% Hypochlorous Acid on the
Reagent Tray).
th
b. Warning message is displayed to keep wash solution at 59 position.
Once the user clicks on <OK>
c. The Probe wash action is repeated 5 times.
d. After the action is completed the analyzer gets initialized.
5. Prime Wash:
This option is used at the beginning of the day before the Cuvette Rinse
operation. The CKD valve of the Probe is kept ON (time is 5 minutes) to
remove the air trapped inside the tubing‟s. Also, the valves of the CRU
tubing‟s are kept open to remove the air trapped in them. The following
operation occurs after the button is clicked:
1) Machine Initializes
2) CRU goes in DOWN position in the RCT.
3) The CKD Valves for CRU and Probe open sequentially.
4) The priming continues for “x” minutes.
5) After the priming operation is completed, the CRU initializes to home
position.
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8.6.4 Dead Volume Calibration

This screen enables the user to calibrate the Dead Volume for Sample
Containers and Reagent Bottles.
This procedure should be carried out at time of software installation (application
or analyzer embedded).
The procedure to carry out the Dead Volume Calibration is given below:
i. For Reagent 1 Bottle Calibration:
The following steps should be done to carry out the Reagent Bottle calibration:
i) User should select the Reagent bottle type from the Dead Volume Calibration
list.
ii) Select the desired dead volume within the range displayed.
iii) Pipette the exact amount specified for the Dead Volume in the Reagent
Bottle.
iv) Place the Reagent bottle according to the bottle type on the position specified
in the list.
v) Click on the calibrate button.
vi) Once the calibration process is completed, .message is displayed whether
successful or failed.
vii) If the calibration is successful then the values are automatically stored in the
Software.
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ii. For Reagent 2 Bottle Calibration:
The following steps should be done to carry out the Reagent Bottle calibration:
i) User should select the Reagent bottle type from the Dead Volume Calibration
list.
iii) Pipette the exact amount specified for the Dead Volume in the Reagent
Bottle.
iv) Place the Reagent bottle according to the bottle type on the position specified
in the list.
Software.
X L- 640 O M VER: 2009.02 263

iii. For Sample Cup/Standard Cup Calibration:
The following steps should be done to carry out the Sample container
calibration:
i) User should select the Sample container from the Dead Volume Calibration
list.
iii) Pipette the exact amount specified for the Dead Volume in the Sample
container.
iv) Place the Sample container according to the Sample container type on the
position specified in the list.
Software.
iv. For Default Calibration:

User should click on RESET CALIBRATION button.
Note:
If the Application Software or any hardware program is changed, then the
Dead Volume Calibration should be repeated again.
X L- 640 O M VER: 2009.02 264

8.6.5 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.
8.6.6 Auto - StartUp

This screen is used to set the weekly auto-startup schedule. On the schedule
time and scheduled day of the week, the machine will switch on automatically
and perform all the tasks scheduled for the day.
Click on {Maintenance: Auto-StartUp} to view the following screen.
Figure 8.6.6 - 1 Auto-StartUp screen
The above screen shows the list of Activities that can be scheduled for the seven days of
a week.
Following are the different fields present on the screen:
1. Activate:
This option is to be ticked for the days for which the autostartup feature is
required to be executed. Once this option is ticked, further activities can be
selected and scheduled for the day.
2. Set Time:
This option is used to set the auto-startup time for the day. On the set time, the
machine will switch on automatically and perform the tasks.
3. Warmup Time:
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This option is used to set the Warmup time required between the switching on of
the machine and start performing scheduled tasks. Tick the option to enable the
feature and enter the time in minutes in the box near.
4. Prime:
Tick this option to enable Prime operation for the selected day. Time in minutes
can also be entered in the box.
5. Auto Span:
Tick this option to enable Auto Span operation for the selected day.
6. Cuvette Rinse:
Tick this option to enable Cuvette Rinse operation for the selected day.
7. Sample Probe Wash:

Tick this option to enable Sample Probe Wash operation for the selected day.
8. ISE Purge A:
Tick this option to enable ISE Purge A operation for the selected day. Number of
times this operation is to be performed can be entered in the box.
9. ISE Purge B:
Tick this option to enable ISE Purge B operation for the selected day. Number of
times this operation is to be performed can be entered in the box.
10. ISE Clean:

Tick this option to enable ISE Clean operation for the selected day.
11. ISE Calibration:

Tick this option to enable ISE Calibration operation for the selected day.
12. ISE Purge A:

Tick this option to enable ISE Purge A operation again after the ISE Clean and
Calibration operation are done for the selected day. Number of times this
operation is to be performed can be entered in the box.
Following are the buttons available on the screen:

1. SAVE - Click on this button to save the changes
2. CLEAR – Click on this button to clear the changes made before click on save
button
3. EDIT – Click on this button to edit / schedule the weekly auto startup
functionality
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Chapter 9 – Appendx-A
Chapter 9
Appendix-A
Introduction to ISE Module
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9.1 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, Cl and Li of serum,
plasma or diluted urine with the ion electrodes.
The ISE unit consists of ISE module, ion electrode and three pumps, two for supply
and other for waste.
ISE module This module consists of electrodes (Na, K, Cl, Li 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, Li and Reference electrodes.
Cal A pump This pump supplies Calibrant-A into ISE module.
Cal B pump This pump supplies Calibrant-B into ISE module.
Waste pump This pump drains liquid from 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.
X L- 640 O M VER: 2009.0 2 268

9.1.1 Parts Location
Reagent
ISE
Electrodes
Waste Pump Cal A Pump
Cal B Pump
Figure 9.1.1 – ISE Part Location
XL-640 OM VER: 2009.02 269

9.1.2 ISE Technical Specifications
Sample type Serum, Plasma or Urine (Urine requires dilution)
Sample size 70 µl serum

140 µl diluted urine
Reproducibility Maximum imprecision (within run) Serum

Na SD < 1.6 (100-136 mmol/L)
CV < 1% (136 – 146 mmol/L)
CV < 1.5% (146 – 160 mmol/L)
K SD < 0.05 (2-3.5 mmol/L)

CV < 1.5% (3.5 – 5.1 mmol/L)
CV < 2% (5.1 – 6 mmol/L)
Cl SD < 2 (80-98 mmol/L)

CV < 1.5% (98 – 106 mmol/L)
CV < 1.7% (106 – 120 mmol/L)
Li SD < 0.03 (0.2-0.6 mmol/L)

CV < 3% (0.6 – 1.6 mmol/L)
CV < 2% (1.6 – 3.5 mmol/L)
Reproducibility Maximum imprecision (between-day) Serum

Na SD < 3.2 (100-136 mmol/L)
CV < 2% (136 – 146 mmol/L)
CV < 3% (146 – 160 mmol/L)
K SD < 0.06 (2-3.5 mmol/L)

CV < 2% (3.5 – 5.1 mmol/L)
CV < 2.5% (5.1 – 6 mmol/L)
Cl SD < 2.5 (80-98 mmol/L)

CV < 1.8% (98 – 106 mmol/L)
CV < 2% (106 – 120 mmol/L)
Li SD < 0.05 (0.2-0.6 mmol/L)

CV < 5% (0.6 – 1.6 mmol/L)
CV < 3% (1.6 – 3.5 mmol/L)
Reproducibility Maximum imprecision ((within run) Urine

Na CV < 3.5% (10 – 500 mmol/L)
K CV < 3.5% (5 – 200 mmol/L)
Cl CV < 3.5% (15 – 400 mmol/L)
Reproducibility Maximum imprecision (between-day) Urine

Na CV < 5.0% (10 – 500 mmol/L)
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K CV < 5.0% (5 – 200 mmol/L)

Cl CV < 5.0% (15 – 400 mmol/L)
Typical Carry-over
Na < 0.5 %
K < 1.5 %
Cl < 1.0 %
Analysis time Serum – 35 seconds, including one point calibration

Urine – 40 seconds, including one point calibration
Throughput Serum – 100 samples per hour

Urine – 90 samples per hour
Power 24V DC, 1.0A
Module Size 161 mm high x 65.5 mm wide x 98.6 mm deep
Reagents Manufacturer Recommended use of Calibrant A, Calibrant B,

Cleaning Solution, Urine Diluent
Operating ambient 15°C - 32°C

Temperature
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9.1.3 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.
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:
X L- 640 O M VER: 2009.02 272

RT log( C )
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
9.1.4 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 build-up 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 32 C.
a) 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.
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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 180 µl is sufficient for each serum sample run and 100 µl
is sufficient for each urine sample run.
2. Calibrant B:
Used as the second point in two-point calibration. Calibrant B is pumped into
the sample port by the Calibrant B pump and then positioned in front of the
sensors. A volume of 180 µl is sufficient for each urine sample run.
3. Cleaning Solution:
Should be run once a day to prevent protein build-up 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 Reagent Tray.
9.1.5 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 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) Reagent Pack has one month of on board stability.
X L- 640 O M VER: 2009.02 274

9.1.6 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-A 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.
9.1.7 Shutdown Procedure:
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 A> 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
 Reinsert the reference electrode flow path line with yellow flag, if available, and
then put into individual sealed bags.
+ +
K and Li 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 and Li electrode until fluid
fills the lumen
+ +
 Cover both ends of the lumen (both sides of K and Li electrode) with
cellophane tape to hold the Calibrant A in place
+ +
 Insert the K and Li electrode into a sealed bag
Reagent Pack
 Remove the Reagent pack from the analyzer and discard it
Analyzer Tubing
 Remove all the fluidic tubing and thoroughly rinse with DI water.
Analyzer re-activation
X L- 640 O M VER: 2009.02 275

 Remove all electrodes from sealed bags

 Remove cellophane tape from K+ and Li+ 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 reagent pack on analyzer
 Use Purge cycle to prime the calibrants
 Calibrate the analyzer.
9.1.8 Procedure for Installation and Removal of ISE

Electrodes
Installation of ISE Electrodes:
1. Install the NA, K, Cl, Li 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, Calibrant B 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 and connect
the power input connector to the ISE module.
5. Install the Reagent Pack.
6. Rehydrate the electrodes by requesting multiple <PURGE A> cycles
from the [Maintenance: ISE Unit] screen. When the ISE Module
transmits a <ISE!> back to the analyzer (highlighted as Green colour
box), Calibrant A has filled all tubing and sensors. Request 3 Additional
<PURGE A> cycles after tubing is primed and allow the electrodes to be
exposed to fluid for 20 minutes before calibrating.
7. Request multiple <PURGE B> cycles from the [Maintenance: ISE Unit]
screen. When the ISE Module transmits a <ISE!> back to the analyzer
(highlighted as Green colour box), Calibrant B has filled all tubing and
sensors. Request 3 Additional <PURGE B> cycles after tubing is primed
and allow the electrodes to be exposed to fluid for 20 minutes before
calibrating.
8. Rehydrate the electrodes with Calibrant A by requesting multiple
<PURGE A> cycles from the [Maintenance: ISE Unit] screen. When the
ISE Module transmits a <ISE!> back to the analyzer (highlighted as
Green colour box), Calibrant A has filled all tubing and sensors. Request
3 Additional <PURGE A> cycles after tubing is primed and allow the
electrodes to be exposed to fluid for 20 minutes before calibrating.
Request a <Calibration> from the [Maintenance: ISE Unit] screen.
9. 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.
10. If the results from the module are unacceptable, refer to the section
X L- 640 O M VER: 2009.02 276

Troubleshooting Guide for assistance.
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).
X L- 640 O M VER: 2009.02 277

9.2 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:
a. The power switch of analyzer is turned off.

b. Eight hours have passed since the last ISE calibration.
c. Environmental temperature has changed more than 4 degrees C since the last
ISE calibration.
d. More than 50 samples are processed after ISE Calibration in the morning
9.2.1 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. Install the Reagent Pack and connect it to the ISE module. If the Reagent Pack
is already in place, shake it gently.
2. Dispense the Cleaning solution into the sample cup and place on the ISE2
position of the sample tray.
3. Go to the [Maintenance] screen by clicking on the <Maintenance> button on the
Main Menu Screen. The display changes to the following screen:
X L- 640 O M VER: 2009.02 278

Figure A-2 ISE Unit Screen
4. Click on <ISE ON> to switch On the ISE unit.

5. Select <Purge A> and click on <START> to remove air from the liquid
column. Repeat the procedure if required. Each Purge cycle takes
about 30 seconds using 100 µl of Calibrant A for each Purge cycle and
130 µl of Calibrant A solution is used for each sip.
6. Select <Purge B> and click on <START> to remove air from the liquid
column & tubing‟s. Repeat the procedure if required. Each Purge cycle
takes about 30 seconds using 100 µl of Calibrant B for each Purge
cycle
7. After completion of Purge cycle select <Clean> and click on <START>
button. 100 µl of Cleaning solution and 180 µl of Cal A is used during
the cleaning process. It requires 130 seconds to complete the cleaning
of the electrodes.
8. After cleaning cycle is over, perform 6 to 8 Purge A cycles. Now the
system is ready for calibration.
9. Select <Calibrate> and click on <START> button to start the ISE
Calibration. 360 µl of Calibrant B Solution & 360 µl of Calibrant A
Solution is used during two-point calibration. It takes about 75 seconds
to complete the Calibration process.
10. After Calibration is completed, electrode calibration slopes are
displayed on the screen at the side. If any error occurs during the
calibration process, the error code is also displayed in the error
message grid and if slopes are within range then a box with red colour
is displayed. . If slopes are out of range then a box with green colour is
X L- 640 O M VER: 2009.02 279

displayed. Calibration date and time along with the slope values are
updated. To view them select Calibration, click on SHOW REPORT.
11. If the electrode calibration slopes are in the acceptable range, the
electrolyte measurement system is ready for the sample analysis.
12. For Serum samples 70 µl and for Urine 140 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:
Li+ 47-64 mV/dec

Na+ 52-64 mV/dec
K+ 52-64 mV/dec
Cl- 40-55 mV/dec
13. To perform Pump Calibration, select the option PUMP CALIBRATION

and click on START button. 100µl of Cal A solution is dispensed in the
sample port. Once the process is completed successfully, values for all
the 3 pumps Cal A, Cal B and Waste are displayed. If the values are
between 1500 and 3000, calibration is displayed OK with green colour
box else it is displayed NOK with red colour box.
14. To perform Bubble Calibration, select the option BUBBLE

CALIBRATION and click on START button. Bubble calibration allows
the module to re-establish a baseline for detecting air-liquid interface. It
can be used as a diagnostic tool to see if the bubble detector is
functioning properly. If the process is successful without any error it s
displayed OK with green colour box else it is displayed NOK with red
colour box.
X L- 640 O M VER: 2009.02 280

9.2.2 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, module is rinsed

with Calibrant B and then diluted sample is pumped from sample port to ion
selective electrodes. Module acquires sample reading, pumps Calibrant B to
wash the ion selective electrodes and then acquires calibrant reading and
passes back the true patient results which reflects the 10 times dilution and then
finally pumps Calibrant A to wash the ion selective electrodes.
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 is pumped into ion selective electrodes, acquires Calibrant B
reading, pumps Calibrant A to wash the ion selective electrodes and then
acquires Calibrant A reading.
Purge A Cycle: Purges air from Calibrant A fluid lines by pumping Calibrant A
from the reagent pack until Calibrant A fills the lumens of all electrodes. Several
cycles may be required to fully purge air from fluid lines.
Purge B Cycle: Purges air from Calibrant B fluid lines by pumping Calibrant B
from the reagent pack until Calibrant B 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 100 micro-litres 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.
Show Last Slope Calculated: Causes the ISE Module to send the last stored
calibration results.
Standby Cycle: Pumps 130 µl of Calibrant A in front of ISE electrodes every 30

minutes to keep electrodes moist. The ISE module automatically initiates this
cycle.
X L- 640 O M VER: 2009.02 281

9.3 ISE Maintenance Schedule

The electrolyte measurement system has been designed to require very little
operator maintenance.
Recommended maintenance/replacement schedule
1) Daily Maintenance
1. Purge Cal A 4-5 times
2. Purge Cal B 4-5 times
3. Clean cycle at the beginning
4. Purge cycles 5 times after cleaning ISE
5. Two point calibration before beginning the first sample
6. Clean cycle at the end of the day
7. For more than 50 samples per day clean and calibrate the ISE
module
2) Monthly Maintenance
1. Clean Electrode tip
2. Check alignment of electrodes and bubble detector
3) 6 Monthly Maintenance
1. Change electrodes after 10,000 samples or 6 months
2. Check arm positioning and calibrate if necessary
4) 9 Monthly Maintenance
1. Change tubing
X L- 640 O M VER: 2009.02 282

9.4 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.
Error codes transmitted are only relevant to the cycle which generated the error.
Subsequent cycles will not be affected by previous error codes, and the ISE module
will always report results.
Error codes are transmitted as a consequence of two separate events. In the first
instance, an error code appears embedded in the result string of every calibration
and sample analysis. The errors (or lack of errors) identified by this error code are
related to measurement limits exceeded in the just completed cycle. In the second
instance, an error code is transmitted independent of a result string and relates
directly to a failure to complete an assigned task. The errors identified by this error
code are related to fluid positioning and device operation. The two error types are
mutually exclusive within a cycle. Receiving an independent error code precludes
receiving a result string. Receiving a result string means no device errors occurred
within the cycle.
Independent error codes have the following format:

-Calibration <ERC CAL x000000>
-Serum Sample <ERC SER x000000>
-Urine Sample <ERC URN x000000>
-Clean <ERC CLE x000000>
-Pump Calibration <ERC PMC x000000>
-Bubble Calibration <ERC BBC x000000>
-Sipping Cycle <ERC SIP x000000>
-Purge/Position Calibrant A <ERC PGA x000000>
-Purge/Position Calibrant B <ERC PGB x000000>
-Read/Write Dallas <ERC DAL x000000>
-Maintenance <ERC MAT x000000>
-Communication <ERC COM x000000>
X L- 640 O M VER: 2009.02 283

The 7 digit error codes are interpreted as follows and displayed in the
corresponding cycle.
Digit 1: Air/Hardware
All the Air related errors and hardware errors are represented by this byte.
“S” represents Air in Sample/Urine
“A” represents Air in Calibrant A
“B” represents air in Calibrant B
“C” represents air in Cleaner
“M” represents air in Segment
“P” represents Problem in Pump Cal
“F” represents No Flow
“D” represents Bubble Detector
“R” represents Dallas Read
“W” represents Dallas Write
“T” represents Invalid command
Digit 2: mV Out Cal B / Sample

mV Out for Calibrant B or Sample are represented numbers 1….9 and alphabets
A….F.
Digit 3: mV Out for Cal A in Calibration / Sample Mode or mV Out for Cal B in
Urine Mode
mV Out for Calibrant A in Calibration cycle / Sample Or for Calibrant B in Urine cycle
are represented numbers 1….9 and alphabets A….F.
Digit 4: mV Noise for Cal B / Sample
mV Noise for Calibrant B or Sample are represented numbers 1….9 and alphabets
A….F.
Digit 5: mV Noise for Cal A in Calibration / Sample Mode or for Cal B in Urine
Mode
mV Noise for Calibrant A in Calibration cycle / Sample cycle or for Calibrant B in
Urine cycle are represented numbers 1….9 and alphabets A….F.
Digit 6: Cal A Drift in Sample or Slope Drift in Calibration
Calibrant A Drift in Sample cycle or Slope Drift in Calibration cycle are represented
numbers 1….9 and alphabets A….F.
Digit 7: Out of Slope / Machine Ranges
Out of Slope or Machine ranges are represented numbers 1….9 and alphabets
A….F.
X L- 640 O M VER: 2009.02 284

Notice that “0” in any byte location means No Error and above numbers 1 to 7 and
A…F corresponds to:
1. Li
2. Na
3. Na, Li
4. K
5. K, Li
6. K, Na
7. K, Na, Li
8. Cl
9. Cl, Li
A. Cl, Na
B. Cl, Na, Li
C. Cl, K
D. Cl, K , Li
E. Cl, K, Na
F. Cl, K, Na, Li
X L- 640 O M VER: 2009.02 285

ISE Error Messages

Digit 1 Digit 2 Digit 3 Digit 4 Digit 5 Digit 6 Digit 7
MV Out mV Noise
Cal A
Cal A in Cal A in
Drift in Out of
Air / mV Out Calib / mV Noise Calib /
Sample, Slope /
Error Hardwa Cal B/ Sample Cal B / Sample
Slope Machine
re Sample mode, Cal Sample mode, Cal
Drift in Ranges
B in Urine B in Urine
Calib
Mode mode
Air in Sample /
S 0 0 0 0 0 0
Urine
Air in Calibrant A A 0 0 0 0 0 0
Air in Calibrant B B 0 0 0 0 0 0
Air in Cleaner C 0 0 0 0 0 0
Air in Segment M 0 0 0 0 0 0
Pump Cal P 0 0 0 0 0 0
No Flow F 0 0 0 0 0 0
Bubble Detector D 0 0 0 0 0 0
Dallas Read R 0 0 0 0 0 0
Dallas Write W 0 0 0 0 0 0
Invalid
T 0 0 0 0 0 0
Command
No Error 0 0 0 0 0 0 0
Li 0 1 1 1 1 1 1
Na 0 2 2 2 2 2 2
Na, Li 0 3 3 3 3 3 3
K 0 4 4 4 4 4 4
K, Li 0 5 5 5 5 5 5
K, Na 0 6 6 6 6 6 6
K, Na, Li 0 7 7 7 7 7 7
Cl 0 8 8 8 8 8 8
Cl, Li 0 9 9 9 9 9 9
Cl, Na 0 A A A A A A
Cl, Na, Li 0 B B B B B B
Cl, K 0 C C C C C C
Cl, K, Li 0 D D D D D D
Cl, K, Na 0 E E E E E E
Cl, K, Na, Li 0 F F F F F F
X L- 640 O M VER: 2009.02 286

9.5 Trouble shooting

Symptom Problem Correction
System does not 1. No power

respond
2. Communication failure Turn off power, reapply power.
3. RS232 cable is disconnected

Reconnect or replace cable.
or damaged
4. ISE Module connector has

Replace board.
been damaged
5. Component failure on board Replace board
Low Slope Remove electrodes. Inspect o-rings.

1. Misalignment of electrodes
Na or K < 52 Reassemble properly.
mV/decade
Cl < 40 Replace Cal B first and retest. If still low
2. Calibrator solutions
mV/decade replace Cal A and retest
3. Electrode (low slope) Replace electrodes.

Or
High Slope 4. Air bubble on reference Remove electrode, tap to dislodge
Na or K > 64 electrode membrane bubble, replace, and recalibrate
mV/decade
Cl > 55 5. Reference electrode Replace reference electrode and retest
mV/decade
6. ISE Module or Fluid
0 Change ISE Module location if ambient
temperatures exceed 32 C (high
temperature is too great.
slope)
Noise Error Flag Replace problem electrode and

1. Electrode.
Single electrode recalibrate
2. Electrical noise spike from a) Find source of spike and eliminate.

environmental source b) Check grounding of ISE module.
3. Component failure on ISE

Replace Board.
Module board
Noise Error Flag Replace reference electrode and

1. Reference Electrode
Multiple electrodes recalibrate
a) Check for electrical noise coincident

2. Electrical noise spike from with activation.
environmental source
b) Check grounding of ISE Module

Replace board.
Module board.
X L- 640 O M VER: 2009.0 2 287

Drift Error Flag Purge the Cal A and recalibrate the

Single Electrode 1. May occur when new electrode module. If the electrode is new it may
or new Calibrant A is installed initially drift as it rehydrates over the
course of 15 minutes
2. Electrode Replace the electrode and recalibrate.
Drift Error Flag 1. May occur when new electrode

Purge Calibrant A and recalibrate
Multiple Electrode or new Calibrant A is installed
Replace reference electrode and

2. Reference electrode
recalibrate
3. Electrical spikes from a) Find source of spike and eliminate

environmental source b) Check the grounding of ISE Module.

Replace the board
Module board
Air in Sample 1. Insufficient sample pipetted

Host instrument must deliver 70µl.
into ISE Module sample entry
Increase dispensed sample volume.
port.
2. Fluid leaks Determine source of leak and resolve
a) Electrode not seated properly.

Remove electrode. Inspect o-rings and
3. Sample not positioned properly reassemble
b) Replace pump tubing
4. Pump tubing obstructed Replace pump tubing
Air in Sample and 1. Cal B and Cal A are a) Electrodes are not properly seated or
Cal A segmented with air compressed. Check compression plate,
spring and seal. Remove and
reassemble electrodes
a) Use Cleaning procedure <CLEN> for

module
2. Fibrin or salt is plugging the
electrode flow path. b) Remove electrode and clean or
replace electrode with plugged flow path.
Reinstall electrodes and recalibrate.
3. Bubble detector is
Replace bubble detector.
malfunctioning
4. Waste pump is malfunctioning Replace Waste Pump
X L- 640 O M VER: 2009.0 2 288

Air in Cal B and Air a) Electrodes are properly seated.

in Cal A Check compression plate, spring and
seal.
b) Ensure that all electrodes and o-rings
1. Cal B and Cal A are are properly installed
segmented with air c) Ensure tubing between reagent
module and sample entry port is
connected properly.
d) Replace tubing between reagent
module and sample entry port.
a) Use Cleaning procedure <CLEN> for

module
2. Fibrin or salt is plugging the
electrode flow path. b) Remove electrodes and clean or
replace electrode with plugged flow path.
Reinstall electrodes and recalibrate.
3. Bubble detector is
Replace bubble detector.
malfunctioning
4. Waste pump is malfunctioning Replace Waste Pump
Air in Cal A Replace reagent module with new one,

1. Calibrant A
purge and recalibrate
2. Tubing from reagent module is

Reconnect or replace tubing.
disconnected, plugged or crimped
a) Check electrical connections.

3. Calibrant A pump is not b) Replace pump tubing
working properly c) Replace motor
d) Replace pump.
X L- 640 O M VER: 2009.0 2 289

Operator's Manual: Fully Automated Clinical Chemistry Analyzer

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Operator's Manual: Fully Automated Clinical Chemistry Analyzer

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Operator’s Manual

Fully Automated Clinical

Chapter 2 Installation Conditions ............................................................... 10

Chapter 3 Technical Specifications ............................................................ 14

Chapter 4 Equipment List ........................................................................... 27

Chapter 5 Analyzer Overview ...................................................................... 31

Chapter 6 Procedure of routine check ....................................................... 81

X L- 640 O M VER: 2009.0 2 2

Chapter 7 Alterations of Operational Conditions .................................... 162

Chapter 8 Maintenance .............................................................................. 222

X L- 640 O M VER: 2009.0 2 3

Chapter 9 Appendix-A Introduction to ISE Module ................................. 267

X L- 640 O M VER: 2009.0 2 4

X L- 640 O M VER: 2009.0 2 5

Chapter 1 Warning Labels

X L- 640 O M VER: 2009.0 2 6

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

XL-640 OM VER: 2009.02 7

WARNING ABOUT: PLACES:

WARNING ABOUT PLACES

XL-640 OM VER: 2009.02 8

Give special consideration to keep skin and mucous membrane from

Do not make a modification to the analyzer.

The device is intended to be used by a trained personnel in controlled

X L- 640 O M VER: 2009.0 2 9

Chapter 2 Installation Conditions

X L- 640 O M VER: 2009.0 2 10

1 Only qualified personnel should use the analyzer.

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

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

a) Check that the contact conditions of switches and indicators are

X L- 640 O M VER: 2009.0 2 11

4 The following cautions should be exercised during operation:

X L- 640 O M VER: 2009.0 2 12

b. Maintenance and checks:

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

X L- 640 O M VER: 2009.0 2 13

Chapter 3 Technical Specifications

X L- 640 O M VER: 2009.0 2 14

3.1 General specifications

390-400 tests/hour (640 tests/hour with ISE) for a cycle time

X L- 640 O M VER: 2009.0 2 15

Depends on the designated cycle time and number of

X L- 640 O M VER: 2009.0 2 16

Keyboard Standard keyboard

X L- 640 O M VER: 2009.0 2 17

3.2 Installation conditions

Used sample (concentrated waste solution) and washed

X L- 640 O M VER: 2009.0 2 18

3.3 Sampling unit

Can be placed anywhere on the Sample Tray / Standard Tray

Pipetting system with plunger, driven by stepper motor

Sample Sample bar-code ID (barcode reader provided as standard)

X L- 640 O M VER: 2009.0 2 19

3.4 Reagent unit

Residual volume Calculated by count down system as well as measured by

Extra Reagent/Detergent Wash/System Wash given for Carry-

X L- 640 O M VER: 2009.0 2 20

3.5 Reaction unit

Cuvette washing Number of washing solution application

Washing solution container

Reaction waste is collected into two waste cans (concentrated