XL-200 Operator Manual Version 1.2 - Draft PDF

Operator’s Manual
Clinical Chemistry Analyzer
Model:
XL-200 OM VER: 1.2 Last Updated: 14 t h January 2009

Table of Contents
Chapter 1 Warning Labels..................................................................................6
Chapter 2 Installation Conditions....................................................................12
Explaining Warnings.........................................................................................16
Chapter 3 Technical Specifications .................................................................17
3.1 General specifications......................................................................................... 18
3.2 Installation conditions......................................................................................... 20
3.3 Sampling unit ...................................................................................................... 21
3.4 Reagent unit ........................................................................................................ 22
3.5 Reaction unit ....................................................................................................... 24
3.6 Optical absorption measurement unit ................................................................. 26
3.7 Control unit ........................................................................................................ 27
3.8 Data processing................................................................................................... 28
3.9 Ion selective electrode (ISE) unit (optional)....................................................... 30
Chapter 4 Equipment List ................................................................................31
Chapter 5 Analyzer Overview...........................................................................36
5.1 Designation of each unit ...................................................................................... 37
5.2 Functionality of each unit .................................................................................... 39
5.2.1 Auto sampler unit (ASP) ............................................................................................... 39
5.2.2 Sample Barcode reader .......................................................................................... 41
5.2.3 Sample Pipette Unit /Reagent Pipette Unit................................................................... 42
5.2.4 Reaction Tray (RCT) ..................................................................................................... 44
5.2.5 Reagent Tray (RGT)...................................................................................................... 45
5.2.6 Reagent Barcode Reader ............................................................................................. 47
5.2.7 RGT Cooling Unit .......................................................................................................... 48
5.2.8 Photometer Unit ............................................................................................................ 48
5.2.9 Mixing stirrer unit (STIRRER) ....................................................................................... 49
5.2.10 Cuvette Rinsing Unit (CRU) ........................................................................................ 50
5.2.11 Pipetting Pump assembly............................................................................................ 51
5.2.12 Liquid Level Sensing for Cans .................................................................................... 52
5.2.13 Ion Selective Electrode Unit (ISE) 4-Channel............................................................. 53
5.3 Measurement flow .................................................................................................. 55
5.3.1 Normal measurement flow ............................................................................................ 55
5.3.2 Sequence of Operation ................................................................................................. 56
5.4 Basic operational information ............................................................................. 57
5.4.1 Procedure to Install the Analyzer .................................................................................. 57
5.4.2 Procedure to Install software for Analyzer .................................................................... 63
Chapter 6 Procedure of routine check ..........................................................102
6.1 Checks prior to work and power-on .................................................................. 103
6.1.1 Checks prior to work ................................................................................................... 103
6.1.2 Preparation of external can solutions ......................................................................... 104
6.1.3 Power-on..................................................................................................................... 106
6.2 Preparation and placement of reagent ............................................................... 109
6.2.1 Consumable defination for reagents...................................................................... 109
6.2.2 Placement and registration of reagents .......................................................................114

6.2.3 Reagent Level Scan...............................................................................................119
6.3 Preparation and Placement of Blank / Standard / Calibrator / Control ............. 122
6.3.1 Preparation of Blank, Standard, Calibrator and Control ....................................... 122
6.3.2 Placement of Blank, Standard and Calibrator....................................................... 134
6.3.3 Placement of Control ............................................................................................. 139
6.4 Preparation and placement of sample................................................................ 142
6.4.1 Sample barcode scan (Offline) ................................................................................... 142
6.4.2 Specifications of Barcode label.............................................................................. 143
6.4.3 Patient Entry ............................................................................................................... 144
(i) Mask Tests ....................................................................................................................... 150
(ii) Copy Tests ...................................................................................................................... 151
(iii) Clear Schedule............................................................................................................... 152
(iii) Worklist........................................................................................................................... 154
6.5 Initiation of measurement and monitoring............................................................ 156
6.5.1 Initiation of measurement ...................................................................................... 156
6.5.2 Monitoring of measurement ................................................................................... 156
6.5.3 Interruption and resumption of measurement........................................................ 164
6.6 Addition of sample and reagent during run .......................................................... 165
6.6.1 Addition of Barcoded sample during run................................................................ 165
6.6.2 Addition of Barcoded reagent during run ............................................................... 166
6.7 Reproduction of Results........................................................................................ 167
6.7.1 Calibration specific results ..................................................................................... 167
6.7.2 Control specific results........................................................................................... 181
6.7.3 Patient specific results ........................................................................................... 189
6.7.4 All results................................................................................................................ 196
6.8 Shut Down Options............................................................................................... 204
Chapter 7 Alterations of Operational Conditions .........................................206
7.1 Functional items ................................................................................................ 207
7.2 Test Parameters..................................................................................................... 209
7.2.1 Test Details.................................................................................................................. 209
7.2.2 Test Volumes Screen .................................................................................................. 228
7.2.3 Reference Ranges Screen.......................................................................................... 234
7.2.4 Test Sequence Screen................................................................................................ 239
7.3 Calculation Item ................................................................................................ 241
7.4 Profile Entry ...................................................................................................... 245
7.4.1 Procedure to Create a Profile ..................................................................................... 247
7.5 System Parameter Settings ................................................................................ 248
7.6 Backup ............................................................................................................... 255
7.7 Carry Over Pairs ................................................................................................... 257
7.8 Rerun Flags ........................................................................................................... 260
7.9 User Rights............................................................................................................ 260
7.10 Result Recalculation ........................................................................................... 263
7.11 Search.......................................................................................................... 266
7.11.1 Search – Patient and Samples.................................................................................. 266
7.11.2 Patient Results Search.............................................................................................. 268
7.11.3 Calib / Control Results Search .................................................................................. 270
7.11.4 Consumables Search................................................................................................ 272
7.11.5 Test Search ............................................................................................................... 274
7.12 Offline Results ............................................................................................ 276
Chapter 8 Maintenance...................................................................................279

8.1 Maintenance Program ........................................................................ 280
8.1.1 Maintenance Intervals................................................................................................. 280
8.1.2 Consumables-Diluents & Wash Solutions .................................................................. 286
8.2 Actions to be taken in the event of trouble........................................................ 287
8.2.1 Information requested by our customer service department ................................. 287
8.3 Malfunction at the time of power-on................................................................. 288
8.4 Anomalous measurement results ....................................................................... 289
8.4.1 Check for preparation of reagent, calibrator or QC sample.................................. 289
8.4.2 High resultant values from a specific method for all samples................................ 290
8.4.3 Low resultant values from a specific method for all samples ................................ 290
8.4.4 Randomly derived erroneous measurement results.............................................. 291
8.4.5 Anomalous resultant values from all methods for a sample .................................. 291
8.5 Equipment malfunction ..................................................................................... 292
8.5.1 Detection of mechanical problem ......................................................................... 292
8.5.2 Error messages for each unit................................................................................. 293
8.5.3 Error Log ................................................................................................................ 326
8.5.4 Measurement result error flags............................................................................. 326
8.6 Maintenance Menu ............................................................................................ 329
8.6.1 Span............................................................................................................................ 330
8.6.2 Wash ........................................................................................................................... 332
8.6.3 Dead Volume Calibration ............................................................................................ 337
8.6.4 ISE Unit ....................................................................................................................... 339
8.7 Service Check Screen ........................................................................................ 340
Appendix-A Introduction to ISE Module ...........................................................1
1 Introduction to the ISE Module .......................................................................2
1-1 Parts Location ........................................................................................................... 3
1-2 ISE Technical Specifications.................................................................................... 4
1-3 ISE Measurement Theory......................................................................................... 6
1-4 Electrodes and Reagents used................................................................................... 8
1-5 Storage and Usage of the Reagents .......................................................................... 9
1-6 When turning off the power...................................................................................... 9
1-7 Shutdown Procedure: Preparing the ISE module for storage ................................... 9
1-8 Procedure for Installation and Removal of ISE Electrodes.................................... 10
2. ISE Calibration and Sample Processing ..................................................... 11
2-1 Procedure for ISE calibration ................................................................................. 12
2-2 Operating Cycles in ISE Module............................................................................ 15
3. ISE Maintenance Schedule ..........................................................................16
4. Error Codes ...................................................................................................17
5. Trouble shooting...........................................................................................20

Foreword
Foreword
This manual is organized in a progressive sequence for easy study and reference. It is an
instructional aid to provide a reference for easy operation and general maintenance of this
analyzer. The manual contains detailed description of the analyzer features and
specifications. It consists of the main analyzer including software, and software on the
operational PC. The analyzer is used with operational PC and printer, and can interact with
the host computer. All the samples and reagents for measurements including samples
obtained from patients are controlled by bar codes enabling the analyzer to perform the
entire process of the analysis automatically. Use of the analyzer with proper knowledge will
ensure quality test results and trouble free analyzer operation and performance.
Assumptions are made that before making an attempt to operate the analyzer, the
operator is familiar with the operation of analyzer and has:
1. Read the Operator’s Manual.
2. Been trained by authorized personnel.
3. Personalized the analyzer, checked and/or modified methods, parameters,
profiles, serum control values etc.
Manufacturer
of the Analyzer
Registered Office:
TRANSASIA BIO-MEDICALS LTD.
Transasia House, 8, Chandivali Studio Rd.
Mumbai-400 072, India.
Production Facility:
TRANSASIA BIO-MEDICALS LTD.
SDF-VI, Unit No. 162, Phase I,
SEEPZ, Andheri (East),
Mumbai-400 096, India.
XL-200 OM VER: 1.2 5

Chapter 1 – Warning Labels
Chapter 1 Warning Labels
This chapter provides the user with necessary information on the warning labels. The user is
requested to read before installation of the analyzer.
XL-200 OM VER: 1.2 6

Meanings of warning symbols
WARNING ABOUT:
Biohazard
Electric shock
High temperature
Injury
Action to be taken as
directed by the
“OPERATOR’S
MANUAL”
XL-200 OM VER: 1.2 7

The following warning labels are affixed on the places that are the potentially hazardous.
WARNING ABOUT: PLACES:

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

CAUTION On the 4-piece Top Cover Panel
DO NOT OPERATE MACHINE WITH
COVER OPEN
DO NOT TOUCH MOVING PARTS WHEN
IN OPERATION-PERSONNEL INJURY MAY
RESULT DUE TO PROBE ARM
MOVEMENT
TO REDUCE DAMAGE TO THE
INSTRUMENT, DO NOT SPILL SAMPLE OR
REAGENT ON THE MACHINE

WARNING On the Biohazard waste can (10 Lt.)
THE TANK CONTAINS HAZARDOUS On the Waste Can (20 Lt)
MATERIAL
XL-200 OM VER: 1.2 8


WASTE On Waste Can (20 Lt)

CLEANING SOLUTION On Cleaning Solution Can (10 Lt)

DI WATER On DI water Can (20 Lt.)
XL-200 OM VER: 1.2 9

WARNING FOR SAFE USE
During operation, do not touch auto sampler unit, reagent container unit, 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, RPT nozzle, reaction cells, wash nozzles, waste
nozzles and MIX paddle in the same way.
Wear medical rubber gloves to keep skin from direct contact with patients'
samples.
Give special consideration to keep skin and mucous membrane from contact with
reagents to prevent operator from possible infection.
Wear medical rubber gloves, goggles, etc. to keep skin and mucous membrane
from contact with reagents.
Read the statements of virtues that came with reagents prior to their use.
The contact with the wastes such as used reaction cells 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. high- and low-concentrated wastes.
The access to the conductive parts within the analyzer may cause serious electric
shock.
When removing parts, make sure to shut off the power supply.
Leave any maintenance and repair of electrical parts inside the equipment to a
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.
XL-200 OM VER: 1.2 10

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.
XL-200 OM VER: 1.2 11

Chapter 2 – Installation 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.
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, air containing salt or sulfur,
etc.
c) Pay attention to inclination, vibration, shock (including shock during

transportation), etc.
d) Once the analyzer is positioned at customer end then adjust the leveling bolts
such that the castor wheels are just lifted above the ground level. Use level
indicator for ensuring the machine is leveled properly.
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) Pay attention to frequency, voltage and permissible current (or power

consumption).
g) Make sure that the analyzer is correctly and well grounded.
h) Connect the analyzer to the operational PC using accompanying LAN cable.

When the other cable is used, this may cause the analyzer to suffer from
disturbing noise, exert an adverse effect on its surroundings or get incorrect
measurement results.
3. The following cautions should be exercised before the analyzer is operated:

a) Check the power supply frequency, voltage and current capacity (power
consumption).
b) Ensure that the analyzer is correctly and well grounded.
c) Ensure that all the necessary electrical cables are correctly connected.
d) Check that the contact conditions of switches and indicators are appropriate
and that the analyzer is ready to be activated correctly. 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 equipment.
e) Wipe the nozzle tips of SPT and RPT several times with cloth or alike with
rubbing alcohol before the analyzer is used. At this time, do not forget to put
medical rubber gloves or alike on. Pay attention to prevent bare skins of hands
or arms from being touched by or pricked with the nozzle tip.
4. The following cautions should be exercised during operation:

a) Pay attention not to exceed time and volume necessary for diagnosis and
treatment.
b) Keep monitoring the behavior of whole system in order to detect any
malfunction.
c) Take immediate corrective measures including shutdown of operation when
any malfunction is detected in the analyzer.
d) Avoid possibilities of any direct access by patients.
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
XL-200 OM VER: 1.2 13

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 tip of Probe several times with cloth or alikeness impregnated
with alcohol after the analyzer was used. At this time, do not forget to put
medical rubber gloves or alikeness on. Pay also attention to prevent bare
skins of hands or arms from being touched by or pricked with the nozzle tip.
d) Pay attentions to the storage area.
e) Keep the analyzer out of the rain and any other water splash.
f) Avoid areas that are adversely affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust and air containing salt, sulfur,
etc.
g) Pay attention to inclination, vibration, shock (including shock during
transportation), etc.
h) Avoid areas adjacent to the storage room of chemicals or areas that are likely
to generate gases.
i) Organize and store parts and cords associated with the analyzer after they
have been cleaned.
j) Keep the analyzer clean not to cause any inconvenience to the next use.
6. In the event of trouble, call authorized service engineer for any repair. When
the safety mechanism is damaged, make contact to authorized service
engineer after pulling out the power cable from the main source outlet.
7. Maintenance and checks:

a. It is important for the analyzer and its associated parts to be periodically
checked.
b. Ensure that the analyzer operates normally and correctly, when it is reused
after being kept unused for some time.
8. The following cautions should be taken when using and handling the
reagents:
a) After unpacking the reagents, be sure not to allow dust, dirt or bacteria to come
in touch with the reagent.
b) Do not use reagents that are out of expiration date.
c) Handle a reagent gently to avoid formation of bubbles.
d) Take care not to spill the reagent. If it spills, wipe it off immediately using a wet
cloth.
e) Follow other instructions described in the package insert on each reagent.
f) Some reagents used with the system are strong acids or alkalis. To protect
yourself from injury, observe the following precautions.
WARNING
Some reagents are strong acids or alkalis. Exercise great care so that your
hands and clothing do not come into contact with reagents. If your hands or
clothing come into contact with either reagents, immediately wash them off
with soap and water. If a reagent comes into contact with your eye(s),
immediately rinse with water for at least 15 minutes.
9. Prohibit any alteration and/or modification to the analyzer without permission

by manufacturer.
10. The following precautions should be taken for preventing infection due to
sample handling:
XL-200 OM VER: 1.2 14

CAUTION
Do not touch the samples, mixtures & waste liquids with bare hands. Be
sure to wear gloves to protect yourself from infection. In case any samples
come in contact with your skin, thoroughly rinse the area that came in
contact with the sample & consult a physician. Immediately wipe off any
contaminants from the system.
11. The following precautions should be taken for disposing the bio-hazardous
waste:
CAUTION
Treat the drain water as infectious waste. Collect the drain water in reserve
can & allow it to be disposed of by expert distributors.
12. The follow ing cautions should be exercised w hen replacing the
halogen lamp.
a) Replace the halogen lamp by a new one after a lapse of 30 minutes

after 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.
13. Space Requirements:

Analyzer dimensions: 810mm (W) * 800mm (D) * 600mm (H)
XL-200 OM VER: 1.2 15

SAFETY SUMMARY
The RESPONS920 is designed to operate safely. When you operate the system in a
safe environment, in accordance with the guidelines and procedures stipulated in this
manual, and there are no known operating hazards.
When a special condition exists you will see a WARNING, BIO HAZARDOUS,
CAUTION or NOTE symbol in this service manual. The following information
explains these symbols.
Explaining Warnings
WARNING Indicates a hazardous condition that is associated with using the

analyzer
BIO HAZARD Indicates a condition involving infectious biological agents
CAUTION Indicates an action or condition that can lead to equipment damage or

loss of data
Indicates an important general rule that is associated with operating

NOTE
the analyzer an action or condition that can lead to equipment
damage or loss of data
XL-200 OM VER: 1.2 16

Chapter 3 – Technical Specifications
Chapter 3 Technical Specifications
XL-200 OM VER: 1.2 17

3.1 General specifications

Item Description
• 200 tests/hour (400 tests/hour with ISE) for a cycle time of 18

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

System type
reagent system
• Serum
• Urine
• CSF
Sample
• Plasma
• Whole Blood
• Others
• Turbidimetric Immunoassay
Measurement
• Colorimetry (Rate/End Point)
principle
• Ion Selective Electrodes (optional)
• Photometric assays
• Enzyme, lipid, protein, sugar, nitrides, inorganic substances,
complements and others
Applicable analytes
• Turbidimetric assays
• IgG, IgA, IgM, C3, C4, RF, CRP, ASO, Transferrin and others
• ISE Potentiometric Assays (Na, K, Cl, Li)
• Absolute measurement
Test method • Relative measurement
• ISE (optional)
• 50 items max (4 positions can be used for diluents and wash);
On board tests
54 test items with ISE
Programmable • No Limit for Programmed Tests or Calculation Items
parameters
• 1-Point
• 2-Point
Assay modes • Rate-A
• Rate-B
• ISE (optional)
Sample volume • 2-70 µl (adjustable in 0.2 µl step)
Reaction volume • 180µl – 550µl
Reaction • 37 °C
temperature • Temperature stability: ± 0.2 °C
• Depends on the designated cycle time and number of reagents
used
• For 1 step assay (using R1)
o 648 seconds (10 minutes 48 seconds) for a cycle time
Reaction time of 18 seconds
• For 2 step assay (using R1 and R2)
o 1st reaction 306 seconds (5 minutes 6 seconds) + 2nd
reaction 324 seconds (5 minutes 24 seconds) for a
cycle time of 18 seconds
XL-200 OM VER: 1.2 18

• 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
• Maintenance actions: Cuvette Rinse, Water Save, Auto Wash,
Maintenance
Probe Wash, Prime Wash, ISE maintenance and Calibration
• Sample tube barcode ID (NW7, code 39, code 128, 2 of 5

interleaved, 2 of 5 standard, ISBT-code 128 – 3 to 18 digits)
Barcode • Reagent barcode ID (8/14/18 digit)
identification • Sample Loading during Run
• Automatic Reagent Barcode Scan and Reagent Loading during
Run
• Water consumption: Less than or equal to 6 liters/hour

Water supply unit • Manufactures and supplies: Type 2 quality (by NCCLS
standards) ion exchange water
System Warm-up
• 5 minute system warm-up time
Time
• Vertical obstruction detection
Safety mechanism
• Capacitance based liquid level sensing
Noise level • Less than 65 dB
Auxiliary storage
• CD – ROM Drive
medium
• Analyzer – PC: USB bi-directional;

System interface • USB connectivity through USB
• Touch screen monitor

• Electrolyte measurement unit (for Na, K, Cl, Li)
• A4 size DeskJet color printer
Optional
• PC-Host Computer: USB
• Automatic Water Supply from an outside DI water unit
• Multimedia Speakers
XL-200 OM VER: 1.2 19

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: 600 VA (excluding PC/Printer/Monitor)
Fuses • 5A for 220V and 10A for 110V input supplies
• Used sample (concentrated waste solution) and washed sample
Drainage
(diluted waste) are to be drained separately
Ambient • 15 – 30°C
temperature • Variation during operation: less than ± 2 °C per hour
Relative humidity • 40 – 80% free from water dew formation
Dimensions • 810mm (W) * 800mm (D) * 600mm (H)
Weight • Approx. 120kg
Operating
• 85kPa – 110kPa
pressure
XL-200 OM VER: 1.2 20

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 • Adaptors will be provided for 5 and 7 ml tubes
container • Standard Hitachi cup 2 ml, Micro-cup (0.5ml), Micro Cup can be placed
on 10 ml tubes (Cup on Tube)
• Sample tray
• Outer Most Track: 15 routine samples with/without barcode, STAT
samples, blanks, calibrators, controls
Sample
• Middle Track: 15 routine samples with/without barcode, STAT samples,
placement
blanks, calibrators, controls
• Innermost Track: 9 positions for Blanks, Calibrators, Controls, ISE
Solutions, Samples without barcode, STAT samples
• Can be placed anywhere on the Sample 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
Sampling • Outside: Preheated de-ionized water
probe • Inside: Preheated de-ionized water
• Equipped with vertical obstruction detection facility to prevent probe
crash
• Dilution ratio: 2 to 150 times

• A cuvette is used as dilution vessel
• Set amount of diluent is dispensed into a cuvette by probe and set
Sample dilution
amount of sample is dispensed into it by probe
• Dilution possible for repeat run
• Direct reduced/increased volume runs are also possible
• Execution by repeat run list or auto execution
Repeat run • Auto execution according to abnormal marking and/or range over
• Reduced/increased volume repeat run also possible
• Sample bar-code ID (barcode reader provided as standard) readable
Sample
from 3-18 digits
identification
• Position ID for STAT samples
• ≤ 350μl for 5ml /7ml Sample Tubes
• ≤ 125μl for 2ml Sample Cup
Dead Volume
• ≤ 75μl for Micro cup
• ≤ 600μl for 10ml Sample Tubes
XL-200 OM VER: 1.2 21

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 ERBA Bottles
Reagent cooling
• 8-12°C cooled with refrigeration unit
temperature
• 50ml for Reagent 1 bottles and 20ml for Reagent 2 bottles

Reagent bottles • 5ml Tube Adapters can be placed on 20ml bottles
• Pipetting system with plunger, driven by stepping motor

Reagent dispensing • R1 dispensing in the 1st cycle
• R2 dispensing in the 17th cycle
Reagent steps • 1 step or 2 step
• Reagent 1: 50 – 300 µl (adjustable in 1 µl step)

Reagent volume
• Reagent 2: 0, or 10 – 300 µl (adjustable in 1 µl step)
• <2ml for 50ml Reagent Bottles

Dead volume • <1.5ml for 20ml Reagent Bottles
• <0.3ml for 5ml Tube Adapters
Reagent • Position ID
identification • Reagent bar-code ID (18 digit barcode readability)
Residual volume • Calculated by count down system as well as measured by

information capacitance type level sensor and displayed on screen
XL-200 OM VER: 1.2 22

Reagent positions • Total 50 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/Cuvette Skipping

Carry over actions
given for Carry-Over Pairs
XL-200 OM VER: 1.2 23

3.5 Reaction unit

Item Description
Type • Turn table
• Rotating tray
Reaction tray • Number of reaction cuvettes: 45
• Temperature control: Turn table direct heating by foil heater
Reaction
• 37 ± 0.2 °C
temperature
• Reusable
• Number of reaction cuvettes: 45
• 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: 550 µl maximum, 180 µl minimum
• Type: Immersion mixing by rotating mixer

• Single mixers (3 variable mixing speeds)
Reaction
• Mixing positions
liquid mixing
o The 1st position: 1st reagent + Sample
o The 2nd position: 1st reagent + Sample + R2
XL-200 OM VER: 1.2 24

• 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: 7 steps

o Reaction waste removal: 1 step
o Washing: 5 steps
o Residual liquid removal: 2 steps
Cuvette
• Number of washing solution application
washing
o Detergent solution: 1
o Ion exchange water: 5
• Washing solution container

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

and diluted waste) by pumps
• In built Cuvette overflow protection
XL-200 OM VER: 1.2 25

3.6 Optical absorption measurement unit

Item Description
Type • Multiple wavelength, static filter
Photometric • Multi-wavelength direct measurement of light after penetration into
system reaction cuvette (transmitted light)
Wavelength • 8 Wavelengths: 340, 405, 450, 505, 546, 570, 630, 660 nm
Wavelength per
• One or two wavelengths
Chemistry
Measurement • Total 36 points

interval • Every 18 seconds for 18 second cycle time
• OD 0 – 2.5
OD range
• Light path calculated as 10 mm
Resolution • 0.001 OD
• Pre-aligned Halogen lamp (12V/20W)
Light source
Detector • Silicon photo-diodes
Cell blank
• Corrected by water blank measured after cuvette washing
correction
Minimum reaction
• 180 µl
Liquid volume
XL-200 OM VER: 1.2 26

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 or above
User interface
• Hard disk: 80 GB / 40 GB
hardware
• Console: 15 inch color monitor
• External drives: CD-ROM drive
• Printer: DeskJet, Laser
• Multimedia Speakers
• Analyzer – PC: USB bi-directional

System interface • USB connectivity through USB
XL-200 OM VER: 1.2 27

3.8 Data processing

Item Description
• K-Factor, Linear (one point, two point and multipoint), Logit-log,
Spline, Exponential, Polynomial
Calibration
• Multipoint curves for up to 10 points
curve
• One point correction to multi-point calibration line is provided
• Automatic Dilution Line Created
• Within day as well as day-to-day X-Mean and X-Range control
Quality 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 o No Limit for Programming Calculation Items
between 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,
Report/list
Abnormal result wise, Doctor name wise
format
• Lists: Abnormal values list, Re-calculated results list, Repeat run list
• Selective Backup of following data is possible: Consumables, Patient,
Patient with Results, Test Parameters, Calibration, Error Log, System
Backup
parameters
• Full Backup
Special • Reagent blank correction
treatment • Sample Blank Correction
• Reference range check by age, gender, 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, erroneous test results
Alarms and
• Alarm level: Notice, temporary halt of analysis, suspension of
notices
analysis, system stop
• Prompts on display alarms
XL-200 OM VER: 1.2 28

Diagnostic • Mechanical movements and functional performance can be checked

checks through diagnostic menu
• Password provided to reject an access to selected menus
Password
• Access rights for multiple users
XL-200 OM VER: 1.2 29

3.9 Ion selective electrode (ISE) unit

(optional)
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)
Test items • Na, K, Cl, Li
Measurement • Serum: 40 seconds/sample

cycle • Urine: 90 seconds/sample
XL-200 OM VER: 1.2 30

Chapter 4 – Equipment List
Chapter 4 Equipment List
XL-200 OM VER: 1.2 31

The main unit and accessories are packed in separate cartons. Authorized representative is
responsible for unpacking, installing and initial setting up of the analyzer.
SR.
DESCRIPTION QTY.
NO
1. 20 LTR CAN ASSY FOR DI WATER 1 No.
a CAN ASSY FOR DI WATER 1 No.
CAP FOR 20 LTR DI WATER CAN 1 No.
20 LTRS CAN 1 No.
PHILLIPS CROSS RECESSED FLAT HEAD TAPPING SCREWS ST2.9
2 Nos.
X13L
SPIGOT FOR 20 LTR WATER CAN 1 No.
SS TUBE FOR WATER FILTER 1 No.
SOCKET SET SCREWS WITH FLAT POINT BN 617 M3 x 6 1 No.
25 MICRON FILTER 1 No.
`DI WATER' STICKER FOR 20L CAN 2 Nos.
ADAPTOR FOR LEVEL SENSOR 1 No.
GASKET FOR CAN ADAPTOR 1 No.
b. FLOAT SENSOR ASSY FOR 20 LIT DI WATER CAN 1 No.
CIRCLIP FOR SHAFT "A" TYPE BN 682 FOR SHAFT DIA 16 1 No.
FLOAT SENSOR MTG CAP 1 No.
FLOAT BASED LEVEL SENSOR (RSF56Y100RB) 1 No.
DI WATER CAN FLOAT SENSOR TUBE 1 No.
2. 20 LTR CAN ASSY FOR WASTE 1 No.

a. CAN ASSY FOR WASTE 1 No.
2 Nos.
X13L
20 LTRS CAN 1 No.
WASTE STICKER FOR 20L CAN 2 Nos.
CAP FOR 20 LTR WASTE CAN 1 No.
WASTE PVC PIPE 1 No.
ELBOW FOR WASTE 1 No.
NOZZLE FOR ELBOW 1 No.
b. FLOAT SENSOR ASSY FOR 20 LIT WASTE CAN 1 No.
BIO-HAZARD CAN FLOAT SENSOR TUBE 1 No.
3. 10 LTR CAN ASSY FOR BIO-HAZARDOUS WASTE 1 No.

a. 10 LTR. CAN ASSY. FOR BIO-HAZARD WASTE 1 No.
2 Nos.
X13L
STICKER FOR BIO-HAZARD WASTE CAN 2 Nos.
XL-200 OM VER: 1.2 32


CAP FOR 10 LTR. BIO-HAZARDOUS CAN 1 No.
10 LTRS CAN 1 No.
b. LEVEL SENSOR ASSY FOR 10 LIT BIO-HAZARDOUS SOLN CAN 1 No.
BIO-HAZARD CAN FLOAT SENSOR TUBE 1 No.
4. 10 LTR CAN ASSY FOR CLEANING SOLUTION 1 No.

a. 10 LTR. CAN ASSY. FOR CLEANING SOLN. 1 No.
10 LTR CAN 1 No.
10 LTR CAN DELRIN CAP 1 No.
2 Nos.
X13L
SILICON TUBE DIA. 2 X DIA. 4 X 280 LONG 1 No.
COUNTER WEIGHT FOR DETERGENT 1 No.
CLEANING SOLN STICKER FOR 10L CAN 2 Nos.
b. FLOAT SENSOR ASSY FOR 10 LIT CLEANING SOLN. CAN 1 No.
CLEANING SOLN FLOAT SENSOR TUBE 1 No.
5. REAGENT TRAY ASSEMBLY 1 No.

RGT TRAY-RESPONS 920 1 No.
6. REAGENT TRAY COVER ASSY. 1 No.

REAGENT COVER INSULATION 1 No.
SLOTTED FLAT HEAD MACHINE SCREW BN 1066 M3 X 12 1 No.
SLOTTED FLAT HEAD MACHINE SCREW BN 1066 M3 X 8 7 Nos.

REAGENT COVER LOCATING PLATE 1 No.
RGT COVER 1 No.
SENSOR RING 1 No.
PLASTIC SPACER 7 Nos.
7. STANDARD SAMPLE TRAY (1-30) ASSY. 1 No.
a. SAMPLE HOLDING TOP PLATE 1 No.
b. SAMPLE HOLDING BOTTOM PLATE 1 No.
XL-200 OM VER: 1.2 33

c. SAMPLE CUP RESTING PLATE 1 No.

d. SAMPLE TRAY KNOB 1 Nos.
e. SPACER FOR SAMPLE TUBE 3 Nos.
f. SPACER FOR SAMPLE CUP 3 Nos.
g. RUBBER CUP FOR SAMPLE TRAY 30 Nos.
h. TEST TUBE ADAPTER FOR MOULDED SAMPLE HOLDING PLATE 30 Nos.
PHILLIPS CROSS RECESSED FLAT HEAD MACHINE SCREWS BN 661
i. 15 Nos.
M3 X 8
8. SHIPPER BOX
a. REAR PANEL TO COMPUTER CABLE ASSY. 1 No.
b. POWER CORD 2 PIN 1 No.
c. SAMPLE TUBE WITH BAR CODE LEBELS 10 nos.
300
d. Sample Cups (2 ml HITACHI Cups)
Nos.
e. Calibration Plate 1 No.
TUBING-I FOR WASTE CAN
f. 1 No.
1/2" X 11/16"
TUBING-II FOR WASTE CAN
g. 1 No
1/8" x 1/4"
TUBING FOR BIO-HAZARD CAN
h. 2 Nos.
1/8" x 1/4"
TUBING FOR DI WATER
i. 1 No.
1/8" x 1/4"
TUBING FOR CLEANING SOLUTION CAN
J. 1 No.
1/8" x 1/4"
9. P. M. Kit --- Containing:

a. CUVETTE DRIER 2 Nos.
b. LAUNDRY ASPIRATION TUBING SET----containing: 2 Sets
TYGON LABORATORY TUBING FORMULATION R-3603 1/16" x 3/16" 1 Nos.
TYGON LABORATORY TUBING FORMULATION R-3603 1/16" x 3/16" 5 Nos.
c. LAUNDRY DISPENSING TUBING SET----containing: 1 Set
Silicon Tubing 1 x 3 mm 6 Nos.

Silicon Tubing 1 x 3 mm 2 Nos.
d. PHOTOMETER LAMP ASSY (GILWAY) 1 Nos.
LAMP GUIDE INSERT 1 No.

LAMP 12V/20W-WITH GOLD PLATING 1 No.
WIRE PVC23/36 GREEN 200 mm
RING TERMINALINSULATED M6 2 Nos.
LAMP HOLDER 1 No.
e. SET OF FUSES FOR RESPONS-920----containing: 1 Set
FUSE SB 500 mA/250VAC (5 X 20)MM 6 Nos.
XL-200 OM VER: 1.2 34

FUSE SB 1A/250VAC (5X20)MM 3 Nos.

FUSE SB 2A/250V (5 x 20)MM 1 No.
FUSESB 2.5A/250VAC (5X20)MM 1 No.
FUSE SB 3.15A/250VAC (5X20)MM 1 No.
FUSESB 5A/250VAC (5X20)MM 2 Nos.
f. TEFLON TIP FOR SYRINGE 500 μL (UHMWPE) 1 Nos.
g. 25 MICRON FILTER 2 Nos
h. PROBE CLEANER 1 No.
10. CD’s & Other Items

a. Operational Manual (No.-1) 1 No.
b. Application Software (No.-2) 1 No.
c. Unit Installation Instruction Sheet 1 No.
d. Hydraulic diagram sheet 1 No.
11 Accessories for ISE Unit

a. Reference Electrode for ISE 1 No.
b. Na Electrode for ISE 1 No.
c. K Electrode for ISE 1 No.
d. Cl Electrode for ISE 1 No.
e. CAL A bottle assembly 1 No.
f. ERBA Cleaning Solution 1 No.
g. ERBA Calibrant B 1 No.
h. ERBA Calibrant A 1 No.
XL-200 Analyzer Wooden Box : 1160mm X 1163mm X 1000mm : Wt: 170 Kg Approx.
XL-200 OM VER: 1.2 35

Chapter 5 – Analyzer Overview
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.
XL-200 OM VER: 1.2 36

5.1 Designation of each unit
Figure 5.1 – 1 Front View of the Analyzer
Figure 5.1 - 2 Side View of the Analyzer
XL-200 OM VER: 1.2 37

Figure 5.1 - 3 Front View of the Analyzer with Various Assemblies
XL-200 OM VER: 1.2 38

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 adaptor and
rotating mechanism with a bar code reader for identifying samples.
The ASP accommodates 30 sample tubes. Each sample is aspirated by the sample & reagent
pipette unit (SRPT) and dispensed into cuvettes of the Reaction Tray Unit (RCT).
Figure 5.2.1 - 1 ASP Tray
XL-200 OM VER: 1.2 39

The ASP Tray of the analyzer consists of 2 sections:
The outer section and middle section has 15 positions each for the patient samples, blanks,
calibrators or controls. STAT/EMERGENCY samples can be placed on any one of the
positions. Adapters are available for loading the primary tubes of different sizes. Primary
tubes as well as 2ml cups could be placed in the outer section.
The inner section consists of 9 positions for placing blank, control, stat/emergency samples,
standards/calibrators, non- barcoded patient samples and ISE solutions. On this tray, 2ml
Sample cups and 500µl Micro Cups can be placed in the positions as marked on the disk.
The types of usable sample tubes are shown below:
For 10ml/12ml tubes:
Diameter: 15 mm
Length: 101 mm
Extent of label fitting: Refer to below drawing.
Upto 42mm
20mm
For 5 or 7 ml tubes:
Diameter: 12 mm
Length: 75 mm
Extent of label fitting: Refer to below drawing.
Upto 42mm
20mm
XL-200 OM VER: 1.2 40

5.2.2 Sample Barcode reader
The barcode reader reads barcode of the label affixed on the outer surface of the sample
tube.
The barcode reader used is laser type bar code 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

Set A, Set characters (uppercase/lowercase), symbols, control
B, Set C characters]
XL-200 OM VER: 1.2 41

5.2.3 Sample Pipette Unit /Reagent Pipette Unit
LLS PCB
Figure 5.2.3 - 1 Sample and Reagent pipetting (Arm) Unit
The sample & reagent pipette unit (SRPT) consists of an probe (nozzle), up-and-down
movement mechanism, rotating mechanism, liquid level sensor and nozzle down limit
sensor. The sample & reagent pipette is connected to the syringe pump for sample
aspiration via PTFE tube. The sample or reagent on the ASP unit or RGT tray is aspirated
by the pipette and then dispensed into the cuvettes (reaction cells) in the RCT unit. Probe
has smooth finish surface from outside is passivated & polished from inside to minimize
any sample carry over.
When an optional ISE unit is fitted and the ISE measurement is performed, the SRPT
aspirates sample for ISE measurement and dispenses it into the sample port of the ISE
unit.
A) 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.
B) Nozzle down limit sensor
When the tip of nozzle hits the bottom during any of the downwards movement due to the
obstruction, the lower limit sensor detects that the tip of nozzle hits the bottom and stops
its downward movement (Vertical obstruction detection or VOD).
C) SRPT Washing Station
The wash station for the sample & reagent probe consists of a two position used as Drain
Position” (for internal cleaning of the probe) and as “Trough Position” (for external
XL-200 OM VER: 1.2 42

cleaning of the probe). After the sample & reagent probe has dispensed sample & reagent
1 or reagent 2 into the cuvette, the arm moves to the drain station where the chase volume
is dispensed & then moves to trough position where it is cleaned internally as well as
externally using a jet of DI Water at approx 40º C & 0.8 -1.2 bar pressure.
XL-200 OM VER: 1.2 43

5.2.4 Reaction Tray (RCT)
Cuvette
Figure 5.2.4 - 1 RCT Unit
The reaction tray (RCT) consists of the cuvette ring set and rotating mechanism. RCT is
provided with 45 hard glass cuvettes (5mm * 5mm) on its outer circumference and the
temperature inside is kept at 37ºC (+/- 0.2ºC) constantly. The cuvettes are moved at 18-second
step and a series of process including dispensing, stirring, photometric measurement and
washing is being performed.
XL-200 OM VER: 1.2 44

5.2.5 Reagent Tray (RGT)

The Reagent tray (RGT) consists of ERBA reagent tray (reagent bottle tray), barcode reader,
cooler, sensor and rotating mechanism.
The reagent tray of the RGT accommodates at maximum 30 Reagent bottles with mono & twin
type of containers.
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 Sample & reagent pipetting
unit and then dispensed into cuvettes in the RCT unit.
Figure 5.2.5 - 1 Reagent Tray
ERBA type Reagent Tray is used for accommodating Reagent bottles.

The reagent tray on the RGT accommodates at maximum 50 reagent bottles.
The type of usable reagent bottles are shown below:
1. 50ml bottles for R1 or R2

2. 20ml bottles for R1 or R2
3. 5ml Tube Adapters that can be placed on 50ml / 20ml bottles
Reagent Bottles
The reagent bottles are available in two design:
Large bottle of 50ml
Small bottle of 20 ml.
A picture of the Reagent bottles provided with the Analyzer is shown below:
:
XL-200 OM VER: 1.2 45

Figure 5.2.5 – 2 ERBA Reagent Bottles
All bottles are screw capped to prevent evaporation of reagents while not in use. Total 30 bottles
can be placed. Bar-code reader affixes bar coded labels on the reagent containers for
identification.
XL-200 OM VER: 1.2 46

5.2.6 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 readable bar codes are as follows:
Symbol Valid character and symbol
NW-7 Numerals (0 – 9), symbols (-, $, /, ., +)
Numerals (0 – 9), alphabetical characters, symbols (-, space,

Code39
$, /, +, %)
ITF Numerals only (0 – 9)
UPC Numerals only (0 – 9)
Code128:
All ASCII code characters [numerals (0 – 9), alphabetical
Set A, Set B,
characters (uppercase/lowercase), symbols, control characters]
Set C
XL-200 OM VER: 1.2 47

5.2.7 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 RGT Temperature Controller.
5.2.8 Photometer Unit
Photometer Unit
Figure 5.2.8 Photometer Unit
The Photometer Unit consists of the optical measurement system having narrow bandwidth,
wavelength specific filters with light source.
The absorbance inside the cuvette is measured by using a photometer. Measurement is performed
with any combinations of 2 wavelengths selected among the following 8 wavelengths:
340 nm, 405 nm, 450nm, 505 nm, 546nm, 570 nm, 630 nm, 660 nm.
The photometer consists of an illuminant (halogen lamp), lenses, optical filter and photoreceptor
(photodiode). The light passed thru cuvette (reaction mixture) is split by beam splitter which in turn
passes through wavelength specific filter on to diode. This eliminates several optical interferences
and greatly improves the efficiency of the photometer.
The current generated by each element of the detector array is converted to voltage and amplified
by high gain operational amplifiers. The amplified voltage processed in built Data Acquisition
System & processed data are send to CPU through serial communication.
XL-200 OM VER: 1.2 48

5.2.9 Mixing stirrer unit (STIRRER)

The mixing stirrer unit (STIRRER) consists of the up-and-down mechanism and the paddle
rotating mechanism.
Paddle
Figure 5.2.9 - 1 Stirrer
The sample and the primary reagent dispensed into cuvettes are stirred by rotating the paddle at
requested speed of high, low or medium. The paddle is washed in the STIRRER trough with
system water at 370 C – 41 º C(for primary & secondary reagent) and pressure of 0.8-1.2 bar.
The secondary reagent dispensed into the cuvettes is stirred by rotating the paddle at requested
speed of high, low or medium. The paddle is again washed in the STIRRER trough with system
water 40º C and pressure of 0.8-1.2 bar.
XL-200 OM VER: 1.2 49

5.2.10 Cuvette Rinsing Unit (CRU)
Aspiration Probe Drier
Figure 5.2.10 - 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
(probes 1 to 6 consist of 2 hollow nozzles, one for dispensing and the other one for aspirating) their
operation is described below:
Probe 1 – Aspirates the bio hazardous waste and dispenses cleaning solution.
Probe 2 to 6 - Aspirates the cuvette contents, and dispenses de-ionised water
Probe 7 - Aspirates the cuvette contents.
Probe 8 - Dries the reaction cuvette
XL-200 OM VER: 1.2 50

5.2.11 Pipetting Pump assembly
Sample & Reagent

Syringe
Assembly
Figure 5.2.11 - 1 Pipetting Pump Assembly
There is one syringe pump of 500 µl capacity for both reagents as well as sample.
The syringe pump of the analyzer is modular type by which aspirates & dispenses volumes
between 2 µl to 300 µl. Sample volumes can be increased in steps of 0.2 µl.
The syringe is located behind the front plate of the analyzer and connected to the probe using
appropriate tubing.
XL-200 OM VER: 1.2 51

5.2.12 Liquid Level Sensing for Cans
Float Sensor for Bio-hazard

and Diluted Waste Cans
Float Sensor for DI Water

and Detergent Cans
Figure 5.2.12 - 1 Liquid level Sensing for Cans
The Liquid Level Sensor are placed inside respective Cans are placed in to DI water, Cleaning
solution, Bio-hazardous waste & normal waste Can. Accordingly, for DI water & cleaning solution,
the float based level sensors will sense the low level of DI water or cleaning solution & respective
LED will lit on the instrument with the beep sound. Similarly, full levels are detected for both the
waste can & respective LED’s are lit accordingly with beep sound. All the LEDS are placed just
near to the tube connection for the same cans.
XL-200 OM VER: 1.2 52

5.2.13 Ion Selective Electrode Unit (ISE) 4-Channel
Waste pump
ISE
Cal B Pump Electrodes
Cal A Pump
Figure 5.2.13 - 1 ISE Unit
The concentration of electrolyte (sodium: Na, potassium: K, chloride: Cl, lithium: Li) contained
in serum, plasma or (sodium: Na, potassium: K, chloride: Cl) urine is measured by the ion
electrode of the ISE unit that is placed on the left-hand side of the analyzer. This unit is
optionally supplied.
The ISE unit consists of ISE module, ion electrode, supply and drain pump.
This module unit is fitted with electrodes (Na, K, Cl, Li & Reference) and
controls pumps, measurement of concentration by electrodes and rinsing
(1) ISE module
movement. Communication to the analyzer is carried out through
RS232C.
This unit consists of Na, K, Cl, Reference and Li electrodes.
The Reagent pack for Calibrant-A & Calibrant-B is placed on the top
(2) Ion electrode
cover. Dedicated wash solution are placed in the ASP unit and wash
solution is supplied by the SRPT in the same way as for the sample.
These pumps are performs the infusing of Calibrant-A and Calibrant-B
(3) Supply pump
into ISE module.
(4) Drain pump This pump performs the transferring of liquid in ISE module.
The following solutions are requested for the ISE unit:
1. Calibrant-A
Calibrant-A is used at the time of one-point calibration.
XL-200 OM VER: 1.2 53

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. 100µl
of Calibrant-A is automatically dispensed into the ISE unit every 30 minutes to prevent
the electrode from drying during standby cycle.
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.
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 position of the ASP tray.
This function should be carried out twice a day, once 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 placed in a reagent
bottle that is placed in the RGT unit at the user defined position. The necessary volume
for diluting one sample is 200µl. The dilution is carried out using a cuvette in the RCT
unit and therefore one cycle of chemistry analysis is allocated to this processing.
5. Sampling volume at each measurement
Measurement Volume
In the case of analytic Serum Sample: 70 µl
measurement Urine Sample: 140 µl
Calibrant-A: 180µl, Calibrant-B:
In the case of full calibration
180µl
Calibrant-A: 180µl, Calibrant-B:
180µl
In the case of 1-point calibration
Calibrant-A: 180µl
(Serum cycle)
In the case of 1-point calibration Calibrant-B: 230µl
(Urine cycle) Calibrant-A: 100µl
XL-200 OM VER: 1.2 54

5.3 Measurement flow
5.3.1 Normal measurement flow

Time
Cycle Number Analyzer action
(Minute)
0:00 0/45 Dry the cuvette
0:18 1 Add Reagent 1 + Sample
0:36 2 Stir 1 + Measure reaction mixture absorbance
0:54 3 Measure reaction absorbance
5:06 17 Add Reagent 2
5:24 18 Stir 2 + Measure reaction absorbance
10:48 36 Absorbance Measurement ends
11:06 37 Empty cuvette contents + Add detergent
11:24 38 Empty cuvette contents + Add DI Water
XL-200 OM VER: 1.2 55

Time
Cycle Number Analyzer action
(Minute)
12:36 42 Measure cuvette blank absorbance
12:54 43 Empty Cuvette contents
13:12 44 Drying the cuvette
13:30 45 Start next measurement
5.3.2 Sequence of Operation

The instrument works on the principle of light photometry and a combination of
robotics and hydraulics that are computer controlled to obtain a high degree of
precision and accuracy.
The sample under test is pipetted into the cuvette along with the reagent; this
reaction is then read at defined time interval of 18 seconds to obtain their optical
densities.
The entire operation can be divided into the following sequence.
b. Getting ready for Sampling
c. Cuvette rinsing (cleaning)
d. Reagent 1 + Sample Addition
e. Stirrer Mixing for R1 + Sample Mixture
f. Reading
g. Reagent 2 Addition (optional)
h. Stirrer Mixing after R2 addition (optional)
i. Reading (optional)
j. Reporting
k. Removal/empting of old biohazard reaction waste from the cuvette.
XL-200 OM VER: 1.2 56

5.4 Basic operational information
5.4.1 Procedure to Install the 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
period as agreed by ERBA. This warranty does not cover any defect, malfunction
or damage due to:
1. Accident, neglect or willful mistreatment of the product
2. Failure to use, operate, service, or maintain the product in accordance with the
applicable Operator’s Manual and Service Manual
3. Use of reagents or chemicals of corrosive nature
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.
XL-200 OM VER: 1.2 57

2. Remove the top and side panels of the wooden box as a whole
section by loosening the bolts from the back panel side.
3. Remove the four “Z” brackets, which are holding the analyzer on the
pallet.
4. Move the leveling bolt upwards so that the unit rests on the castor
wheels.
5. Gently lift the analyzer from the pallet to the floor.
6. Gently slide the Probe upwards, making sure you do not damage the
probe, once you have reached the top most position, rotate it and
position it over the trough.
7. Gently slide the Stirrer arm upwards, making sure you do not
damage the paddles, once you have reached the top most position,
rotate it and position it over the trough. Remove the protective
material.
8. Gently slide the CRU arm upwards to the top most position, making
sure you do not damage the probes, and remove the protective
material and clean debris.
9. Remove the buffers that are present in the RGT & ASP areas, as well
around the CRU & Stirrer.
d) Electrical Requirements
A proper grounding is highly essential for safety and proper functioning of the
analyzer.
VOLTAGE AND GROUND REQUIREMENTS
¾ Voltage & frequency: Single-phase continuous stabilized AC 220 volts ±
10%, 50/60Hz or AC 110 volts ± 10%, 50/60Hz supply. The analyzer comes
equipped with a three-pin power cord. The type of cord and plug depends on
the source voltage for the system.
¾ Grounding: It is absolutely necessary that a perfect earthing must be
provided at the power source with all applicable local requirement (Only a
certified grounded, 3 pin power plug should be used.)
¾ Plug points: Four 5Amp sockets must be available near the analyzer (Four
sockets are required, one each for the analyzer, computer, monitor and printer.
It is recommended that two extra sockets be provided near the analyzer, for
use by a measuring equipment or engineering tool if required while servicing
(Example Oscilloscope, Soldering iron etc.). Heavy-duty electrical devices
like Air conditioners, refrigerator's, ovens etc. should not be operated on the
same electrical lines as the Analyzer.
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Note:
Failure to properly ground the analyzer bypasses important safety features and
may result in an electrical hazard.
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e) Floor Requirements
All Dimensions on
mm
Figure 5.4.1 - 1 Floor Requirements for Analyzer
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f) Installing the Sample Tray and the Reagent Tray
Unpack the Sample tray from the accessories box Hold the sample tray with your
right hand
Gently place the sample tray into the Sample tray container, make sure that the
index pin on the Sample Transport, slides into the index hole provided on the
sample tray.
Unpack the Reagent tray from the accessories box. Hold the Reagent tray with
your right hand. Gently place the Reagent tray into the reagent tray well. Make
sure that the index pin on the Reagent transport slides into the index hole provided
on the Reagent tray. Place the Reagent tray lid over the Reagent Tray. Make sure
that the index pin on the Reagent transport slides into the index hole provided on
the Reagent tray.
g) Installing DI Water, Cleaning, Bio-hazardous and

Waste Cans
Unpack the Float Sensors for the 4 Cans and place them on one side.
From the accessory box remove the 20 liters De-ionized water can, 20 liters
Waste can, 10 liters Bio hazardous waste can and the10 liters Cleaning solution
can, and put them on floor. Place the Float Sensors (Longer Float Sensors with
blue & green sleeves for DI Water and Cleaning Solution Cans respectively &
Smaller Float Sensors with red & yellow sleeves for Bio-hazardous and Waste
Cans respectively).In the small outlet provided on the opposite side of the canister
where tubing for the cans need to be placed.
Fill the De-ionized Water can with 20 liters of fresh de-ionized water. Remove the
tubing’s from the accessory box. Connect one end of the 2 meter. (1/8” x 3/16”
size) Tygon tube to the analyzer outlet marked DI WATER, and connects the
other end into the DI Water can nozzle placed on steel tube. Take another tube of
same size & connect the one end of it to the analyzer outlet marked DI WATER –
LAMP. Connect another end of the tube on canister of DI water can connector
marked as DI WATER LAMP.
Connect the large diameter Tygon tube (3/8” x ½”) to the analyzer outlet marked
WASTE, and connect the other end of the tubing into the 20-litre Waste can
nozzle. Take another tube of size 1/8” x 3/16”. Connect one end of this tube to the
other yellow color connector on analyzer with the other end on connector
provided on waste can.
Connect the (1/8” x 3/16” size) 2 meter length, Tygon tube to the analyzer outlet
with red ring marked BIO HAZARDOUS WASTE, and connect the other end to
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the 10 liter Bio hazardous waste can nozzle. Connect the same size tube to the
connector with red ring having marked as ISE. (In case, ISE is not their on
board, this tube can still be kept connected preferably.)
Connect the (2 x 4mm) 2 meter length, silicone tube to the analyzer outlet with
GREEN ring marked DETERGENT, and connect the other end to the 10 liter
Cleaning solution can (make sure that the White Teflon weight provided at the
end of the tube, touches the bottom of the Detergent can)
Fill 10 liters of working cleaning solution into the Cleaning solution Can, (to
prepare Working Cleaning solution: Add 1 bottle of WASH KIT to 10 liters of
De-ionized water.
Note:
Take care that all the above-mentioned tubes reach their respective containers without
any sharp bends or obstructions.
Note:
The waste consist of a natural drain, it is very important that the large
Tygon waste tube from the rear of the analyzer to the Waste can, be
slanting downwards, there should not be any bends, and should slant in
the downwards direction (If not, then this could cause a back flow of
waste solution, out of the manifold air release tube on waste manifold. Or
could result in noisy operation, big gargling sounds being created by the
waste lines.
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5.4.2 Procedure to Install software for Analyzer

a) Introduction
This section will guide you through the Installation and the Un-installation process of
MultiXL Software. Please read this document before installing the software.
Overview
MultiXL Package is implemented by Transasia Bio-Medicals Ltd., Mumbai, India.

MultiXL software is application software for the analyzer. This package is multilingual and
also supports Asian languages like Chinese, Japanese, Thai etc.
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
Note:
All memory resident software including anti-virus software should be removed from
memory and screen-savers should be disabled before starting the Application Software.
Ensure that a default printer is added into the computer system.
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. MultiXL 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 dexktop
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.
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Figure 5.4.2 - 13 MultiXL setup process
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Step 4: Click on “Next” button and the following screen would appear.
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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
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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
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.
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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.
Step 5: Click on “CHECK DATABASE” to ensure proper creation of the database.

Following screen would appear
Step 6: 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
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Step 7: Click on “DELETE DATABASE” to delete the existing database. After deletion
following screen would be displayed.
Step 8: Warning message would be displayed to ensure deletion. Click on “Yes” to

continue deletion.
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Step 9: 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:
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Step 3: Click on “CHECK DATABASE” to check whether database is present. Following

screen would appear
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Step 4: Click on “DELETE DATABASE” to delete the existing database. After deletion,
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.
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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:
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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
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Step 4: Upgrade process would start and on completion of the upgrade process,
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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_Setup 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
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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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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
LOGIN screen is displayed. Enter Login ID and Password as Guest
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97
Step 2: Enter the Login ID and Password. Click on “OK”. Following is the main screen
appearing after the splash screen.
Main Menu Software Layout
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98
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 LJ Chart or Twin Plot. It is
also used for viewing the calibration curve for a particular test
e) Consumables – This screen is used for definition of Reagents, Standards, Blanks,
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99
Controls, Diluents and Wash Solution

f) Status Monitor – This screen is used for performing calibration/patient run, viewing
Reagent Level of different Tests and performing Sample & Reagent Barcode scans.
g) Search – This screen is used for searching Patient Results, Patients, Consumables
or Test Details
h) Reports – This screen is used for viewing Patient Reports or calculating Statistical
data using Test Statistics 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, Scheduling
QC/Calibration, Backup or Restore Data and viewing Reaction Curve for different
tests.
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 and forbidden pairs.
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 color.
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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100
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.
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101
Chapter 6 – Procedure of routine check
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 solution can

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

The external cans of the system DI water, detergent, bio-hazardous waste and diluted
waste are to be placed near the right-hand side of the analyzer and to be connected to
the analyzer with the corresponding tubes which includes float sensors.
Just before measurement, the external cans of the system DI water and detergent
solution are filled with the corresponded liquids, and the cans of the bio-hazardous waste
and diluted waste have to be empty.
Waste Bio-Hazardous Detergent DI Water

Waste
Figure 6.1.2 - 1 Picture of all 4 Cans
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Digital
Pressure
Indicator
Figure 6.1.2 - 2 Tube Connections on the Side Panel (Left to Right)
1. De-ionized Water ---- 20 liters (NCCLS Type II or better)

2. Detergent solution ----- 10 liters
3. Biohazard (Concentrated) Waste ---- 10 liters
4. Diluted Waste ----- 20 liters
The de-ionized water should have a resistivity of more than 1 Mega Ohm-cm (or
conductivity less than 1µS/cm). Also the pH of the DI Water should be maintained
between 5.0 - 7.0.
Preparation of detergent solution: Fill the detergent solution can (given with the
Accessories List) with 10 liter of DI water. Pour the concentrated detergent solution
(such as Erba XL Wash) into the can to prepare a 1% detergent solution). Mix well
before use.
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6.1.3 Power-on
A) Power-on of main unit
If the main unit is attached the ISE unit, all electrodes and Calibrant-A solution
should be fitted to the ISE unit in advance with the power switch is turned on.
The power switch is located on the side panel of the main unit.
Unpack the USB interface cable from the accessories box, and
connect the USB connector to the serial port 1 of the computer.
Connect the other end to the USB connector, located on LH side
panel of the instrument, as shown in below figure.
TO PC USB PORT TO MAINS SUPPLY
Figure 6.1.3 - 1 Power-on switch
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B) Power-on of personal computer (PC)

1. Power on the PC that is connected to the main unit.
2. Normally, the software for the main unit starts up automatically when the PC is
powered on. Make sure that the resolution of the monitor is set at 1024*768
pixels.
3. After installation of the analyzer, when the PC is powered on, the analyzer should
undergo prime operation for 4 - 5 minutes.
C) Deskjet / Laser Printer Installation

1. Check for following points before using Application Software to generate
printouts:
2. Check that printer driver is installed
3. Check that the cable between printer and the analyzer PC is connected properly
4. There should be no paper jam or any other obstruction in the printer
5. Feed the paper to the printer and switch it ‘ON’
6. Print a test page to confirm correct printing
D) Spool 32 Error
1. After getting a Spool32 error during run, do not opt to close the application. Let
the run be completed. After the run is over, close the application software and
restart the computer. Start the application software. The report of run results can
be seen in {Reports: Result Reprint} screen
2. Follow the troubleshooting procedure mentioned below (Close all the applications
including analyzer application before starting the following process).
3. Delete the existing printer driver.
4. Start the Windows Explorer. Click on the View menu and then select "Folder
options". On the "Folder options" window, click on the View tab. On this tab,
under the Advance settings window look for the selection for Hidden files and set
the selection to "Show all files" or ‘Do not show hidden files”. Click on <OK> and
close the Windows Explorer. This setting is necessary to view the system files.
5. Insert the CD Rom having Application Software in the CD drive.
6. Click on <Start> on the window desktop Task bar and then click <Run>
7. Type "sfc" and press <OK>. A window for "System File Checker" will open.
8. Select the option "Extract one file from installation disk" on the “System File
Checker” window.
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9. Click on <Browse> and select the file c:\windows\system\spool32.exe and then

click on <Open>.
10. Press <Start> on the “System File Checker” window.
11. Another window titled "Extract File" will open. Click <Browse> button next to the
"Restore From" field on this window.
12. Another window titled "Browse for folder" will open. Select CD drive, select the
folder named “Spool”, and press <OK> on this window.
13. Press <OK> on the "Extract File" window.
14. A window titled "Backup file" opens, press <OK> on this window. (If the wizard
asks permission to create a new folder press <Yes>). You will get a confirmation
"File has been successfully extracted" and you will be asked whether to restart
the computer. Select <NO>.
15. Repeat the steps from step 5 to 11 but this time in the step 6 select the file
c:\windows\system\spoolss.dll.
16. Close the "System File Checker" wizard by clicking on <Close>.
17. Restart the computer.
18. Search for *.tmp files from C:\Windows folder and delete them. There would be
some *.tmp files which will not be deleted.
19. Reinstall the printer driver.
20. Please check the cable connection from the PC to the printer. Check that there is
no paper jam or any other obstruction to the printer. Check the printer by printing
some other document. If it is working properly then start the application.
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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
¾ Click on {Consumables} button on the Main menu.
¾ The following screen is displayed:
Figure 6.2.1 - 1 Consumables - Reagents Screen
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¾ 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.
b) To ADD a new reagent,

¾ Click on the “…” button against Consumable
¾ Upon clicking the dotted button, the following screen opens up:
Figure 6.2.1 - 2 Reagent Addition Screen
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¾ 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.
¾ Following are the description of the buttons on the screen:
{ADD}: This button is used to Add a new Reagent.
{PRINT}: This button is used to print the list of reagents.
{SAVE}: This button is used to save the details.
{EDIT}: This button is used to edit the details.
{CANCEL}: This button is used to cancel add / edit mode.
{DELETE}: This button is ised to delete the reagent (till used either in batch run or
Test Parameters).
c) To ADD Lot details for a reagent
¾ Double click on the Reagent Name.
¾ 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 - 1) .
e) In both the above cases (c and d), the following screen opens up:
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Figure 6.2.1 - 3 Reagent Lot Addition
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¾ This screen is used for adding the Manufacturer and Lot Details for the
Reagent.
¾ Following Table gives a brief explanation on the different fields in the grid:
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
This field is used for entering the On-board shelf life of the reagent
Stability
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.
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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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¾ 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.
¾ 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.
¾ 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.
¾ If the checksum digit does not match the checksum of the bar-code digits,
“Checksum Mismatch” is displayed instead of the bar-code number.
¾ “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”).
¾ Meaning of “-“ in Barcode column – manual definition of Reagent
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b) For Non-Barcoded Reagent bottles (Manual assigning reagent

positions)
¾ Click on the { Utility: Reagent Positions} button on the Main menu
¾ The following screen is displayed:
Figure 6.2.2 - 2 Reagent Positions Screen
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¾ 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.
¾ 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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¾ The user can then select the position wherein he desires to keep the bottle.
¾ The reagent name can be selected from the Reagent field.
¾ Bottle type needs to be selected from the list.
¾ Lot No for the Reagent can be selected from the list of Active lots.
¾ After the above steps are completed, click on the Save Position Detail
button.
¾ 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.
This field displays the Barcode information obtained after
Barcode
scanning
This field displays the onboard stability period as defined in
Stability
Consumables.
This field displays unit of the stability period in terms of
Unit
hours/days as defined in Consumables.
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6.2.3 Reagent Level Scan
a) All Scan:
¾ This option is used for scanning the Reagent Level at position(s) where
reagent is defined in the {Utility: Reagent Position}.
¾ 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 >.
¾ 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:
¾ 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.
¾ 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:
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Figure 6.2.3 - 1 Reagent Details Screen
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¾ To view this screen click on {Status Monitor: Reagent Tray} screen.
¾ If the user right clicks on the bottle, it displays the consumable name, Reagent
Name, Reagent Type and the available volume in mL.
¾ 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 COLOR.
LOW: If the level in the reagent bottle is below 20% of the bottle capacity, then it
is indicated with YELLOW COLOR.
EMPTY: If the reagent bottle is empty, then it is indicated with WHITE COLOR.
VACANT: If the reagent position is free (reagent not defined), then it is indicated
with GRAY COLOR.
¾ Following legends are used in Bottle Cap to depict the bottles:
REAGENT DEFINATION: If reagent is assigned at a position on the reagent tray,
then it is indicated with BROWN COLOR.
DILUENT DEFINATION: If diluent is assigned at a position on the reagent tray,
then it is indicated with GREEN COLOR.
WASH SOLUTION DEFINATION: If wash solution is assigned at a position on
the reagent tray, then it is indicated with BLUE COLOR.
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 5ml/7ml/10ml Sample
tubes or 2ml Sample cups or Pediatric cups(500µl) on 10ml Sample tubes or 2ml Sample
cups on 10ml Sample tubes and on the innermost ring in 2ml 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 10ml tubes on the sample tray. If 2ml
sample cups are used, they should be kept on 10ml 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
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c) Steps in Defining a Blank:

¾ From Consumables screen, select Consumable type as Blank from drop down list.
¾ Click on the dotted button next to Consumable name.
¾ Enter new Blank name and select the tests associated with the Blank
¾ Click on Save.
¾ Once saved, the user can double click on the blank to enter the Manufacturer Name
and the Lot No
¾ Upon clicking ADD from the main screen, the display changes to second screenshot
as shown in figure 6.3.1 - 3
¾ The user can select the Manufacturer Name, enter the Lot No and enter the
concentration for the tests(optional).
¾ Manufacturer can be added from {Masters: Manufacturer} screen.
¾ After entering the details, the user can click on SAVE button.
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Figure 6.3.1 - 2 Consumables – Blank
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Figure 6.3.1 - 3 Consumables – Blank ADD
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d) Steps in Defining a Standard:

¾ From Consumables screen, select Consumable type as Standard from drop down list.
¾ Enter new Standard name and select a test associated with that Standard. Only one
Test can be selected for a Standard. Click on Save.
¾ Once saved, the user can double click on the standard to enter the Manufacturer
Name, Lot No and Concentration for that Standard.
¾ The user can select the Manufacturer, enter the Lot Number for the Standard, Expiry
Date and concentration for the Standard.
¾ Manufacturer can be added from {Masters: Manufacturer} screen
¾ After entering the details, the user can click on the Save button.
¾ For a test having multiple standards, every standard needs to be defined individually
using above steps
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Figure 6.3.1 - 4 Consumables – Standard
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Figure 6.3.1 - 5 Consumables – Standard ADD
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e) Steps in Defining a Calibrator:

¾ From Consumables screen, select Consumable type as Calibrator from drop down
list.
¾ Enter new Calibrator name and select the tests associated with that Calibrator.
¾ Click on Save.
¾ Once saved, the user can double click on the calibrator to enter the Manufacturer
Name, Lot No and Concentrations for that Calibrator.
¾ The user can select the Manufacturer; enter the Lot Number for the Calibrator &
Expiry Date for the Calibrator.
¾ Further, Concentrations for individual tests can be entered.
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Figure 6.3.1 - 6 Consumables – Calibrators
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Figure 6.3.1 - 7 Consumables – Calibrators
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f) Steps in Defining a Control:

¾ From Consumables screen, select Consumable type as Controls from drop
down list.
¾ 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.
¾ Click on Save.
¾ Once saved, the user can double click on the control to enter the
Manufacturer Name, Lot No and Mean & SD for tests selected for that
Control.
¾ Upon clicking ADD from the main screen, the display changes to second
screenshot as shown in figure 6.3.1 - 8
¾ The user can select the Manufacturer; enter the Lot Number for the
Control & Expiry Date for the Control.
¾ Further, Mean, SD can be selected for individual tests.
¾ 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.
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Figure 6.3.1 - 8 Consumables – Controls
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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.

¾ Select the Group No on which the calibration and QC run needs to be
preformed.
¾ 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.
¾ Select the Container Type.
¾ Select the Consumable Type.
¾ Select the name under Consumable Type.
¾ Select the Lot No of the Consumable Name.
¾ 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
Dilratio (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 color where
Auto-dilution not possible is for the curve types k-factor and Linear.
¾ 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.
¾ Similarly, select another position and assign another consumable along
with the tests associated with it and then Click on OK button.
¾ Once blanks, standards, calibrators and controls are defined, click on
Schedule button placed below the right hand grid.
¾ Upon clicking the Schedule button, the blanks, standards, calibrators and
controls get scheduled.
XL-200 OM VER: 1.2 134

¾ 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 Clear Positions Screen
Please note: If a blank / standard / calibrator from the scheduled test is

cleared, if the set doesn’t form a complete set (complete set includes
blank, standard and calibrator for a test), the entire remaining calibration
schedule for that test will also be removed.
¾ Place the calibrators (including blanks) and controls at the desired
positions on the sample tray.
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Figure 6.3.2 - 2 Scheduling – Blank
Figure 6.3.2 - 3 Scheduling – Standards
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Figure 6.3.2 - 4 Scheduling – Calibrators
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Figure 6.3.2 - 5 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
XL-200 OM VER: 1.2 139

d) Following procedure is used for scheduling the controls.

¾ Select the Group No on which the QC run needs to be preformed.
¾ 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.
¾ Select the Container Type
¾ Select the Consumable Type as Controls.
¾ Select the name under Consumable Type.
¾ Select the Lot No of the Consumable Name.
¾ Once above Steps are completed, and then the grid on the right side of the
section displays the available tests for running QC.
¾ Select the tests that are required whose QC needs to be performed. Click
on the OK button placed at the bottom of the grid.
¾ 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.
¾ Once controls are defined, click on Schedule button placed below the
right hand grid.
¾ Upon clicking the Schedule button, the controls get scheduled.
¾ 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.
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Figure 6.3.3 - 2 Clear Positions Screen
XL-200 OM VER: 1.2 141

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
XL-200 OM VER: 1.2 142

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 : 3 to 18 digits
Maximum Number Code39 : 3 to 18 digits
of Digits ITF : 3 to 18 digits
UPC : 3 to 18 digits
Code128（SetA）: 3 to 18 digits
Code128（SetB）: 3 to 18 digits
Code128（SetC）: 3 to 18 digits
Bar module · Fine bar: 0.25 to 1.0 mm
· Bar length ≥ 15 mm
Barcode printing · Bar code printing area ≤ 46 mm
Range
· Black on white background (B633)
· Numeric coding information is printed beside bar code.
Printing
· Printing on thermal paper is not allowed in order to prevent bar code from
time varying degradation.
Positioning of · The position is such that there is no obstacle between the barcode
barcode label printing area and the bar code reader.
· Angle alignment deviation: within ±1º
R920 OM VER: 1.7 143

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
R920 OM VER: 1.7 144

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.
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.
XL-200 OM VER: 1.2 145

{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}: The location names can be selected or added using the dotted button
adjacent to the Area field. Area name can be added from {Master: Area}
{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.
XL-200 OM VER: 1.2 146

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.
Figure 6.4.3 - 3 Analyst Screen
XL-200 OM VER: 1.2 147

{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 and hence the flags H / L will not be
applied. After the run is performed patient category can be updated and on re-
calculation 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.
{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:
BMI = (Weight)/(Height)2
{Urine Volume}: Use this field to define the volume of urine collected from a
patient in 24-hour duration. This is an optional parameter and is used in the
calculation item of Creatinine Clearance. This field can be ignored if user does
not want to use Creatinine Clearance calculation item.
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,
XL-200 OM VER: 1.2 148

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 on <Clear> or else if option of Clear on
Save is selected in system parameter screen then it presents 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.
The other buttons available on the ‘Patient Entry Screen’ are:

Mask Tests
Copy Tests
Clear schedule
Worklist
The functions of these buttons are described below.
XL-200 OM VER: 1.2 149

(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
XL-200 OM VER: 1.2 150

(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
XL-200 OM VER: 1.2 151

(iii) Clear Schedule

Clicking on the <Clear Schedule> button on the {Patient Entry} screen presents
the following sub-screen:
Figure 6.4.3 - 6 Clear Schedule
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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.
XL-200 OM VER: 1.2 153

(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
Description
Name
XL-200 OM VER: 1.2 154

Group This field shows the Group number that has been
No. selected
This field shows the Sample position assigned. For
Sample
bar-coded samples, the position is assigned after the
Position
sample barcode scan
Sample This field shows the Sample Id assigned to the
ID patient.
Sample This field indicates whether the Sample type is
Type Serum/ Urine/ CSF/ Whole Blood/ Other type.
Sample This field indicates whether the sample volume is
Vol Type Normal/ Increase/ Decrease
Test This field displays the test name
This field shows the number of repetitions that a test
Replicates
will undergo during run
Sample This field indicates the Sample volume programmed
Volume in test parameters for that particular test.
R1 This field indicates the R1 volume programmed in
Volume test parameters for that particular test.
R2 This field indicates the R2 volume programmed in
Volume test parameters for that particular test.
R1 This field shows the position of R1 for that particular
Position test as defined in Utility- Rgt. Position.
R2 This field shows the position of R2 for that particular
Position test as 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 5
minutes after switched on, hence the user needs to wait for 5min 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.
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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 COLOR.
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 COLOR.
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
COLOR. 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
COLOR.
d) Following are the RUN Option available on screen for selection:

¾ Calibration
¾ Controls
¾ Photometric
¾ 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.
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e) Following are the PRE-RUN Option available on screen for selection:
¾ 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.
¾ 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.
¾ Barcode Scan – Reagent

This option is used to perform reagent barcode scan before starting the run. On
selecting this option, All Reagent Level Scan option is automatically selected.
After the barcode 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. And also All reagent level scan is performed and
the volume details are updated.
¾ 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.
¾ 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
¾ 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
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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.
Figure 6.5.2 - 2 Status Monitor – Sample Tray – Test Schedule
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¾ The worklist screen is displayed after all the pre-run options are performed
¾ The worklist screen displays the schedule for the group selected.
¾ Required test details such as Reagent Position, Sample Volume, Reagent
Volume defined; when missing / incomplete are highlighted with red background.
¾ The reagent position for which reagent volume is 0 ml is highlighted with yellow
background.
¾ 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
¾ 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
¾ 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.
Figure 6.5.2 - 3 Status Monitor – Sample Tray – Test Schedule
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¾ In the above screen, if reagent volume is defined for various sample types, then
possible tests are displayed individually for each sample type defined from the
available reagent volume. For example in the above screenshot for the test ALB, R1
is defined at position 18, depending on the reagent volume available possible tests is
calculated as Reagent volume divided by the volume define in tests parameter.
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 Green color. When the temperature rises / falls
out of the range, then it is displayed in Red color.
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.
Figure 6.5.2 - 4 Result and Error Message Grid

Displays Error Message during
Run. Displays the Test Result
along with the Flag
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o) During run, schedule will be sent as follows:
¾ Blank, Standard, Calibrator, Control – Test-wise, according to test process

sequence defined in {Settings – Test Sequence} option.
¾ Patient Samples – Sample position no wise.
¾ Emergency patient samples will be performed at highest priority.
¾ If control interval is defined, control schedules will be sent between patient
samples according to the control interval defined in Test Parameters screen.
¾ 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
indicate the measurement points used for calculating the result.
Figure 6.5.2 - 5 Online Reaction Curve
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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.
¾ Emergency STOP
If the User clicks on the Stop button, then the run stops immediately and the
assemblies initialize.
¾ 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.
d) In case of a mixed run of calibration and patients together, if the calibration fails due to
sample / reagent absent then the patients followed will have the Calc* flag attached to the
result. This flag will be attached to the next batch patient results also if fresh calibration is
not done or previous successful calibration is not selected.
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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:
¾ 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.
¾ Click on the Add Sample Button.
¾ Message is displayed “Please Wait Sampling Is Being Paused”. Since
Sampling is paused after completing the current test in process.
¾ 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.
¾ 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.
¾ Sampling resumes after updating.
¾ The user can see the scanned data by clicking Barcode Scan button on the
same screen.
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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:
¾ The user clicks on the Add Reagent button.
¾ 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.
¾ 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.
¾ 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.
¾ 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”.
¾ After the completion of Reagent barcode scan, the Reagent positions along
with the barcode details of the new test are updated.
¾ The user can view the scanned reagent barcode data by clicking on the
Barcode Scan button.
¾ 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
¾ One can enter the calibration table by clicking on {QC/Calibrations:
Calibration} button:
Figure 6.7.1 - 1 Calibration Table Screen
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¾ 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.
¾ 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.
¾ 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.
¾ In order to view the calibration details for a test, the user needs to select the test from
the grid.
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
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¾ 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.
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{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 single
standard for calibration. It is applicable for all curves except K-factor.
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
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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)
K-Factor (Use of K-Factor for Enzymes)
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:
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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:
Cstd ( Asample − ABlank)

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

Csample = { }+ CBlank
Astd − ABlank
where CBlank = Concentration of the Blank
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 performed. Joining the 2nd
standard absorbance to 1st standard absorbance by a straight line creates the calibration
curve.
The concentration of the sample is calculated by using the following formula:
Cstd ( Asample − Astd1 )

Csample = { 2 } + Cstd1
Astd2 − Astd1
Where, Csample = Concentration of the sample,

Cstd2 = Concentration of the 2nd standard,
Cstd1 = Concentration of 1st standard,
Astd2 = Absorbance of the 2nd standard,
Astd1 = Absorbance of the 1st standard,
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and Asample = Absorbance of the sample
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 (ΔAbs/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 10 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
Where, Csample = Concentration of the sample, 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, 2 to 10 calibrators can be used (excluding
blank). The linear calibration curve is obtained by fitting a straight line to the available
standard concentrations and 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
Where, the intercept a and slope b are obtained by least square linear regression method and
are given by:
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a = Y − bX
⎡1 n ⎤
⎢ n ∑ ( X i Yi )⎥ − X .Y
b = ⎣ i =1n ⎦
⎡1 ⎤
( )
⎢n ∑ X i ⎥ − X
2 2
⎣ i −1 ⎦
The slope b is nothing but factor for a linear calibration curve type and therefore the
concentration of the sample is calculated as follows
Csample = (Asample - Ablank) * b
Where, Csample = concentration of the sample,
Asample = Absorbance of the sample,
Ablank = Absorbance of the blank, and
b = Factor = measured slope of the concentration vs. absorbance curve (or measured factor)
by least square linear regression method.
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:
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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,
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 available (excluding blank) for this
calibration curve type.
The equation of a straight line passing through two points (x1, y1) and (x2, y2) is
( x − x1 ) ( x2 − x1 )
=
( y − y1 ) ( y 2 − y1 )
If the absorbance of the sample Asample lies between the absorbance of two
standards Am and An, such that Am > Asample > An, the following equation is used
to calculate the concentration of the sample
A − An
C sample = m x( Asample − Am ) + C m
Cm − Cn
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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 − y j ⎞
x = ∑ xi∏ ⎜ ⎟
⎜
j≠i ⎝ y − y ⎟
i =1 i j ⎠
In a similar fashion, Lagrange’s polynomial is fitted to the standard absorbance

and concentrations available and the following equation is used to calculate the
sample concentration:
n ⎛ A sample − A j ⎞
C sample = ∑ C i ∏ ⎜ ⎟
⎜
j≠i ⎝ Ai − A j ⎟
i=1 ⎠
Where Csample = Concentration of the sample,

Asample = Absorbance of the sample,
Ai = Absorbance of the ith standards,
And Ci = Concentration of the ith 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.
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b) Calibration Trace
¾ 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
¾ 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.
{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.
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{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.
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c) Calibration Monitor
¾ 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
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¾ A description of different fields available on {Reports: Calibration

Monitor} is given in the table below.
Field Name Description

Sr. No. Serial Number
Tests Test name
Curve Type Type of Curve assigned for that chemistry
Type Either Blank or Standard S1,S2…etc
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
¾ The user can export the Calibration data to desired location using the ‘Export’
option.
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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) Levy Jennings Chart

¾ The Levy-Jennings Chart is useful for viewing the QC Results in Graphical
format. Multi Rule implementation has been on QC Results on the LJ Chart
and are marked with a symbol to indicate that which rule has been violated for
that test.
¾ The user should either rerun the controls again or recalibrate the test and run
the controls.
¾ If a user wants to view screen, then the user can click on {QC/Calibration:
Levy Jennings Chart} screen. The following screen is displayed as shown
below:
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Figure 6.7.2 - 1 LJ Chart Screen
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Figure 6.7.2 - 2 LJ Chart Screen
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¾ Following are the steps to view the results and chart:
(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, Levy Jennings and WestGard. If Levy Jennings option is selected
then all the results will be plotted on the graph lot-wise and if WestGard option is selected
then multi-rules are applied and 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 MultiRules are as follows:
A run is rejected when a single control measurement

1 13S
exceeds +3SD or –3SD limit.
When a single control measurement exceeds +2SD or –

2 12S
2SD limit a warning message should be generated
A run is rejected when 2 consecutive control

3 22S
measurements exceed the same +2SD or –2SD limit.
A run is rejected when 1 control measurement in a group

4 R4S
exceeds the mean +2SD and other exceeds –2SD limit.

5 41S
measurements exceed the same +1SD or –1SD limit.

6 10X
measurement fall on one side of the mean
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b) Twin Plot
¾ 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.
¾ 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 6.7.1 - 3 Twin Plot Screen
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Figure 6.7.1 - 4 Twin Plot Screen
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¾ Following are the steps to view the results and chart:
(i) 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.
(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 for X and also for Y and then click on Show Lot.
(iv) Select Lot no for that Control X and also for Y from the list displayed.
(v) 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.
(vi) Once the above selection is done, click on DATA button to view the results for
both the controls selected.
(vii) 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).
(viii) User can click on EXPORT button to export the data to an excel sheet.
(ix) User can click on PRINT button to print the data
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6.7.3 Patient specific results

a) Patient Report
¾ The Patient Reports screen is used for viewing and printing Patient
Reports.
¾ 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
¾ 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.
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¾ 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.
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.
¾ 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.
¾ 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
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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 2.23 shows the Graphical type of
Patient Report.
Show Location: This type of format is used when the user wants to print the
Reports without printing the Location
Show Analyst: This type of format is used when the user wants to print the
Reports without printing Analyst
Show Sample Remarks: This type of format is used when the user wants to print
the Reports without printing the Sample Remarks
Show Patient Remarks: This type of format is used when the user wants to print
the Reports without printing the Patient Remarks
Preview: This option is used to confirm the selected results before printing.
Following is the window displayed.
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
¾ One can enter this screen by clicking on {Reports: Result Reprint} button in
Main menu
Figure 6.7.4. - 1 Result Reprint Screen
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¾ This menu enables the user to retrieve and print the results batch wise or
date wise.
¾ There are multiple options at the top of the screen:
Latest Batch: Selecting this radio button 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
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.
¾ The columns displayed in the gird are explained below:

Field
Description
Name
Sample
This field shows the Sample ID of the patient
ID
Patient
This field displays the Patient Name
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
This field displays the date on which the test was performed
Date
Curve
This field displays the Reaction Curve Number
No
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b) Test Statistics
¾ One can enter this screen by clicking on {Reports: Test Statistics} button in
Main menu.
Figure 6.7.4 - 2 Test Statistics Screen
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¾ 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 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.
{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 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.
¾ 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 available.
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{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 Screen
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¾ This screen can be used to view the reaction course (absorbance vs. cycle
number) for any reaction. The reaction curve can be viewed Sample ID
wise and Test wise for Patient Results OR Sample ID wise and
Consumables wise for Blank, Standard and Control Results. This can be
achieved by double clicking on Sample ID field or Test field in the
appropriate field. The user can also select the reaction curve no. The user
has to click on ‘View’ to view the reaction curve as per selection.
¾ Reaction Curve number is a number assigned by the program during
analysis. The reaction curve number can be obtained from the real-time
printout or from the [Reports: Result Reprint] screen. The absorbance
values for the selected time course are displayed in a tabular format as
well as graphically.
¾ M1S, M1E, M2S, M2E and Extended M2E and also Ap, As, Ap-As for a
particular chemistry are shown on the time course. These points can be
identified by legends placed below the time course.
¾ R2 Addition line is shown with the red arrow.
¾ The time course display also contains the following details regarding that
Reaction Curve:
Result: This field displays the result of the test selected.
Flag: This field displays the flag associated with the Result.
Primary Wavelength: This field displays the primary wavelength used
for measurement of that test.
Secondary Wavelength: This field displays the secondary wavelength
used for measurement of that test.
Assay Type: This field displays the Assay Type used for that test.
Average O.D./Delta Abs/min: This field displays the Average O.D. or
Delta Abs/min value calculated within the specified time intervals for that
test. Average O.D. is displayed for End Point Assays and Delta Abs/min is
displayed for Rate Assays.
Format: This field allows selecting either to display only Ap or only As
or both Ap and As or Ap-As or All.
¾ An explanation of various columns shown in the table is given below:
Column
Description
Name
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Cycle Absorbance cycle number are displayed in this column.

Absorbance of the reaction mixture at primary wavelength after
Ap
subtraction of cuvette blank absorbance at primary wavelength.
Absorbance of the reaction mixture at secondary wavelength
As after subtraction of cuvette blank absorbance at secondary
wavelength
The difference in absorbance at primary and secondary
Ap-As wavelength after subtraction of cuvette blank absorbance (that
is, it is the difference of Ap and As).
The following figure shows the Zoomed Reaction Curve. The user can double
click on the Reaction Curve graph to obtain a zoomed view.
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Figure 6.7.4 - 4 Zoomed Reaction Curve
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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.

¾ Shut Down
(i) If this button is clicked then MultiXL software shuts down.
¾ Water Save and Shut Down
(i) If this button is clicked then MultiXL software is minimized and water save
operation is performed.
(ii) Once water save operation is completed, multixl software can be closed
using shut down option.
(iii) 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.
205
Chapter 7 - Alterations of Operational 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.
XL-200 OM VER: 1.2 206

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

7.2 Test Parameters
of 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
Specification of host communication, Temperature
7.5 Parameters
range and specifications of barcodes are specified.
Settings
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

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

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

7.9 User Rights
users.
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Result Re-
7.10 This is used to re-calculate the results.
Calculation
This is used to search patients / samples, patient

7.11 Search results, calibration / control results, consumables and
test.
This is used to program offline results for existing or

7.12 Offline Results
new 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
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b) Following is the explanation of each field:
(1) Test Name

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).
(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.
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(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. This field is visible
only if Host connection is enabled from system parameter screen.
(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
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 recorded
between M2Start and M2End points are taken and this is used for
the calculation of the sample results.
ABS
Rgt2
ABS2=Final abs
Rgt1
Time
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Figure 7.2.1 – 2 1 – Point Graph
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 recorded between M1Start and M1End and this
absorbance is subtracted from the final absorbance, which is the
mean of the absorbance 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
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
recorded between M2Start and M2End using the least square linear
regression method as per the following formula:
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⎡1 n ⎤
⎢ n ∑ (Ti Ai )⎥ − T A
ΔA / ΔT = ⎣ ⎦
i =1
⎡1 n 2 ⎤
( )
⎢ n ∑ Ti ⎥ − T
2
⎣ i −1 ⎦
Where, Ti is the time in minute and Ai is the absorbance, n is the number
of points.
ABS ABS
ABS
ABS/MIN
TIME
Figure 7.2.1 – 4 Rate – A Graph
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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ABS1/min
ABS2/min
Figure 7.2.1 – 5 Rate – B Graph
(7) Assay Points

The analyzer records absorbance for a cuvette every 18 seconds over a
span of 10 minutes 48 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 36 (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
(In seconds) seconds)
0 0 0 min 00 sec
1 (R1 + Sample
18 0 min 18 sec
Dispense)
2 36 0 min 36 sec
3 54 0 min 54 sec
4 72 1 min 12 sec
5 90 1 min 30 sec
6 108 1 min 48 sec
7 126 2 min 06 sec
8 144 2 min 24 sec
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Time of Time of measurement

Assay Point measurement (In minutes and
(In seconds) seconds)
9 162 2 min 42 sec
10 180 3 min 00 sec
11 198 3 min 18 sec
12 216 3 min 36 sec
13 234 3 min 54 sec
14 252 4 min 12 sec
15 270 4 min 40 sec
16 288 4 min 58 sec
17(R2 Dispense) 306 5 min 06 sec
18 324 5 min 24 sec
19 342 5 min 42 sec
20 360 6 min 00 sec
21 378 6 min 18 sec
22 396 6 min 36 sec
23 414 6 min 54 sec
24 432 7 min 12 sec
25 450 7 min 30 sec
26 468 7 min 48 sec
27 486 8 min 06 sec
28 504 8 min 24 sec
29 522 8 min 42 sec
30 540 9 min 00 sec
31 558 9 min 18 sec
32 576 9 min 36 sec
33 594 9 min 54 sec
34 612 10 min 12 sec
35 630 10 min 30 sec
36 648 10 min 48 sec
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 36 for 2POINT and RATE-B assays.
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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".
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 36. M2Start specifies the incubation time point. Similarly, M2End is the
time until when the absorbance is recorded for the purpose of
concentration calculation.
In case of 1POINT and 2POINT chemistries, the mean of the

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 8 fixed values provided. In case of bi-
XL-200 OM VER: 1.2 216

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.
Primary wavelength: The analyzer offers a choice of 8 wavelengths with

a narrow bandwidth (<8 nm) for programming the wavelength. The
choices are 340nm, 405nm, 450nm, 505nm, 546nm, 570nm, 630nm and
660nm.
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: 340nm, 405nm, 450nm, 505nm, 546nm,
570nm, 630nm and 660nm.
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.
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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'.
(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
updating 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.
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(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 preprogrammed units:

1. SEC
2. mg/dl
3. U/l
4. mEq/l
5. g/l
6. g/dl
7. %
8. mU/l
9. mU/ml
10. ng/ml
11. abs
12. µg/dl
13. ng/dl
14. mg/L
15. µg/L
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
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25. pmol/L
26. mIU/L
27. µkat/l
28. (User-defined)
(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(%).
{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
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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.
{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.
{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.
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Note:
If the Reaction Absorbance Limit field is not zero for RATE ASSAYS, then the Technical
Limit fields will be masked & vice-versa.
(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
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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.
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(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
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)
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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
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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.
For example, when the standard is prediluted but sample requires to be diluted 10 times,
the standard volume entries might be like {15, 0} and the normal sample volume entries
will be like {20, 2x}.
{Standard Volume: Sample}: This is the volume of the standard to be aspirated from
the standard container. When the standard is undiluted, the aspirated standard from the
standard container is directly deposited in the reaction cuvette (containing Reagent 1).
When the standard has to be prediluted, the standard from standard container is
deposited in the reaction cuvette (containing diluent).
Enter a value between 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
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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.
{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).
Enter a value between 2 to 70 µl using the numeric keyboard. In case of sample

without predilution, the total volume of sample and reagents should be more than
{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 100x 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.
(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.
{Decrease: Sample}: This is the volume of the sample to be aspirated from the sample

{Decrease: 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 100x in steps of 1x.
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(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.
{Increase: Sample}: This is the volume of the sample to be aspirated from the sample

{Increase: 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 100x in steps of 1x.
(5) RGT1/RGT2 Volume: Assign volume of reagent (in mL) 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.
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(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
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Figure 7.2.2 – 2 View Sample Volumes
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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
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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.
c) The user can define a Reference Range for a test by going to

{Master: Reference Ranges} screen. The following figure shows the
Reference Range Details:
Figure 7.2.3 – 2 Master-Reference Ranges Definition
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d) From the above screen, the user can define the Min and Maximum
Range (in Months, Years or Days) and the Range Title. Depending the
Range Title selected the Normal Ranges for Male, Female, Child or Other
would be used accordingly to generate the H and L flags.
e) 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
236
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
f) Following is the description of the buttons available on the right side

of the screen:
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.
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
237
Figure 7.2.3 – 3 View Reference Ranges
238
7.2.4 Test Sequence Screen

a) One can enter this screen by clicking on {Settings: Test
Sequence} button on the Main screen and then selecting Test Sequence
tab.
Figure 7.2.4 – 1 Test Sequence Screen
239
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. The following screenshot shows a new
Calculation Formula definition
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Figure 7.3 – 2 Calculation Formula Definition
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c) The user can enter a new formula from the above screen using the
numeric display grid. Once saved, the Calculation formula is displayed in
the Calculation Item screen.
d) If these calculation items are selected in the [Patient Entry] screen,

they are printed along with the result printout.
e) 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.
{Calculation Item: Decimal Places}: Enter the number of decimal places

for the calculation item.
f) Once, the formula is selected, the user can select the tests
associated with the calculation item. Additionally, the user can also use
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another calculation item (nested calculation items) for defining a new

calculation item.
g) 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.
XL-200 OM VER: 1.2 244

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
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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.
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7.4.1 Procedure to Create a Profile

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

¾ Click on Clear button to enter a new profile. Enter the Profile
Name and the Profile Report Name in the respective fields.
¾ Add the Tests by clicking on the Test Name from the Tests
Grid.
¾ Click on <Save> to Save the Profile.
¾ 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
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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
behavior 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.
Item Description
This field is used for displaying the Name of the Laboratory which
Laboratory Name
will appear as Header in Patient Report
This field is used for selecting the default language of the software.
Default Language Available options are English, German and Chinese. Default is
English
Clear Screen upon This field is used for selecting the clearing of screen upon Save
Save operation. Available Options are Yes and No
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 batch
Patient Report is completed (real time). Default is checked. If the user needs to
print the report offline, he/she can uncheck this option
This option allows the user to print the negative results during run. If
Print Negative
the user does not wish to print negative results on screen, then
Result
he/she may uncheck this option
This field is used to select the availability of Confirmation Message.
Confirmation
Default is checked. If checked, on performing any operation there
Message
will be a confirmation message displayed to confirm the action.
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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 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
RCT Temperature
Temperature. Default value is 0.2 °C. User can enter the range
Range
between 0 and 0.5.
RGT Temperature This field displays the RGT Temperature in °C. This value is 8 °C.
This field is used to set the allowable fluctuation in RGT
RGT Temperature
Temperature. Default value is 4°C. User can enter the range
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
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This field is used to enter the Minimum Cell Blank Absorbance. If the
absorbance of the cell blank falls below this limit, then the color of
Minimum Cell Blank the cuvette Absorbance value in the Cell Blank screen will change to
Blue. Default value is 0.03. Value between 0.1 to 0.2 can be
entered.
This field is used to enter the Maximum Cell Blank Absorbance. If
the absorbance of the cell blank falls above this limit, then the color
Maximum Cell Blank of the cuvette Absorbance value in the Cell Blank screen will change
to Red. Default value is 0.1. Value between 0.1 to 0.2 can be
entered.
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d) Laboratory Name by default is TRANSASIA BIO-MEDICALS LTD*,

e) To change laboratory name click on {Master: Laboratory} from the
main menu. Following screen is displayed.
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f) Select the default Laboratory name and click on EDIT button, as

shown below.
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g) Change the Laboratory name or the other laboratory details and

click on SAVE button. The updated Laboratory name will be hence
displayed as header in patient reports.
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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.
¾ XML: This mode of backup stores the Backup

Parameters in XML format.
¾ Text: This mode of backup stores the Backup
Parameters in Text format.
¾ XLS: This mode of backup stores the Backup
Parameters in Excel format.
¾ 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
b) On this screen, the user can define the Forbidden pair for a
particular chemistry. 5 options are available:
Item Description
Contaminant
The user can enter the Contaminant Chemistry
Test
Contaminated The user can enter the chemistry that could get
Test contaminated
XL-200 OM VER: 1.2 257

This option is used to skip the cuvette along with

the probe wash. Whenever a contaminated test
Skip Cuvette comes under a 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.
Wash For the Detergent Wash, the Arm will 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
Wash Cycles depending on the type of wash selected. The cycle
number varies from 1 to 4. Default is 1.
If Reagent Wash is selected, then the user can
R1/R2 Volume define the R1 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
System Wash internal DI water after picking up contaminant test
reagent and before picking contaminated test
reagent
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Note:
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.
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
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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
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
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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.
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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.
XL-200 OM VER: 1.2 265

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
XL-200 OM VER: 1.2 266

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:
¾ Search by entering the Patient Name
¾ Search by selecting a Doctor
¾ Search by selecting a Sample Type
¾ Search by entering the Sample ID
¾ 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)
¾ Search by Registration Date
first icon 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)
¾ 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.
XL-200 OM VER: 1.2 267

7.11.2 Patient Results Search
Figure 7.11.2 - 1 Patient Results Search Form
XL-200 OM VER: 1.2 268

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:
¾ Search by entering the Patient Name
¾ Search by selecting a Doctor
¾ Search by selecting a Test
¾ Search by entering the Flag associated with the test
¾ Search by Sample Type
¾ Search by entering Sample ID
¾ Search by selecting the Result Date
first icon near the Result Date text box to view and select a
second icon near the Result Date text box)
d) The above selection can be cleared using RESET button.
e) The results are displayed in the Grid.
XL-200 OM VER: 1.2 269

7.11.3 Calib / Control Results Search
Figure 7.11.3 - 1 Calib / Control Results Search Form
XL-200 OM VER: 1.2 270

a) Search for Calib / Control Results can be made using the above
form.
c) This search includes following:
¾ Blank
¾ Standards
¾ Calibrators
¾ Controls
¾ Following Filters are used for the search:
¾ Search by entering the Test Name
¾ Search by selecting Flags
¾ Search by selecting the Result Date
¾ Search by Lot No
d) The above selection can be cleared using RESET button.
e) The results are displayed in the Grid.
XL-200 OM VER: 1.2 271

7.11.4 Consumables Search
Figure 7.11.4 - 1 Consumables Search Form
XL-200 OM VER: 1.2 272

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.
¾ Search by entering Manufacturer Name
¾ Search by selecting the Expiry Date
This is not applicable to Blanks, Diluent or Wash Solution
¾ Search by Lot No.
¾ Search by Consumable Type
XL-200 OM VER: 1.2 273

7.11.5 Test Search
Figure 7.11.5 - 1 Test Details Search Form
XL-200 OM VER: 1.2 274

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.
¾ Search by selecting Primary Wavelength
¾ Search by selecting Secondary Wavelength
¾ Search by selecting Assay Type
¾ Search by selecting Calibration Type
¾ Search by Reaction Direction
XL-200 OM VER: 1.2 275

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
XL-200 OM VER: 1.2 276

b) A description of the fields available on this screen is given in the

following table:
Field
Description
Name
This field is used to select the Date of the Result.
Date
Default Date is Present Date
By clicking on the dotted button, the user can select
Laboratory
the name of the Laboratory from the available list
the name of the Instrument on which the test was
Instrument
conducted (from the available list) or Add a new
Instrument Name from {Master: Instrument}
Sample ID
the Sample ID
Sample The user can select the Sample Type from drop down
Type list
This field is for display purpose only and will display
Patient
the name of the Patient once the Sample ID is
Name
selected.
This field is for display purpose only and displays the
Age
patient’s age
Category This field displays the Gender of the patient
The user can select the Test Name from drop down
Test list or a new test name can be added upto 5
characters
Report The user can enter the Report Name of the selected
Name test
Unit The user can enter the Unit for the test
Normal
The user can enter the Lower Limit for the Test
Lower
XL-200 OM VER: 1.2 277

Limit
Normal
Upper The user can enter the Upper Limit for the Test
Limit
Result The user can enter the result for the Test
The user can enter the Flag associated with the
Flag
Result
XL-200 OM VER: 1.2 278

Chapter 8 - Maintenance
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.
XL-200 OM VER: 1.2 279

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.
XL-200 OM VER: 1.2 280

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. Replenish Or Replace Reagents If Necessary.
End of the day
1. Carry out Probe Wash
2. Carry out Acid and Alkali Wash (Auto Wash) if Latex based chemistries
are used during the day
3. Carry out Water Save operation
4. Empty the ASP Tray and clean the Reagent Table
5. Empty Concentrated and Diluted Waste Can
6. Wipe instrument panel
7. Clean working area/table
XL-200 OM VER: 1.2 281

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.
5. Clean the Analyzer External Surface.
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. Perform Precision Check And Note Down The %CV For an End Point and
Kinetic Test.
XL-200 OM VER: 1.2 282

c) Quarterly Maintenance
Surface.
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. 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. Make A Detailed Entry In The Error Log Book, Of The Maintenance
Carried Out And And Site Verifications.
XL-200 OM VER: 1.2 283

d) Annual Maintenance
5. Replace External Tubings to The Waste, Bio Hazardous Waste, Cleaning
Solution And Deionised Water Cans.
Surface.
Maintain Proper Room Cleanliness)
9. Check And Replace If Necessary The Probe.
10. Check And Replace If Necessary The Stirrer Paddle.
11. Replace The Laundry Probes.
12. Replace The Laundry Tubings.
13. Clean The ASP Tray
14. Clean The Reagent Tray.
15. Check And Replace if necessary the Syringe (Dilutor Assembly)
16. Clean the Analyzer Fans.
17. Clean the Sample and Reagent Bar Code Readers
18. Replace the Lamp.
19. Perform Prime, Cuvette Rinse & Probe Wash operations. Check Cell
Blanks
20. Perform A Precision Check And Note Down The %Cv For An End Point
And Kinetic Test.
XL-200 OM VER: 1.2 284

21. Carry Out A Site Verification For Temperature, Line Voltage, Electrical
Ground, Ventilation, External Interferences, Room Lighting, And
Laboratory Cleanliness Practice, As Described In Chapter “16.1
Servicing A Customer Site”.
22. Make A Detailed Entry In The Error Log Book, Of The Maintenance
Carried Out And Site Verifications.
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 9
2. STIRRER PADDLE 9 9
3. CUVETTE DRYER CHIP
9 9
(TEFLON)
4. LAUNDRY DISPENSE
9 9
TUBINGS
5. LAUNDRY ASPIRATION
9 9
TUBINGS
6. LAUNDRY PROBE ASSY 9
7. PHOTOMETER LAMP
9 9 9 9
ASSY
XL-200 OM VER: 1.2 285

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 / Wash solutions can be placed on any position of the Reagent Tray.
XL-200 OM VER: 1.2 286

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;
XL-200 OM VER: 1.2 287

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.
3. 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.
4. Check that the circuit breaker of the power supply system to which the
analyzer is connected is not cut off.
Fuse cover
Figure 8.3 - 1 Fuse Diagram
288
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 deionized
water or appropriate diluent?
B) Preparation of QC sample
1. Was the volume used for preparation correct?
2. Does the sample have been preserved as recommended?
3. Is the term of validity of the sample still valid?
4. Was the sample prepared using a pipette calibrated in terms of volume?
5. Is the term of validity of the sample lot still valid?
6. Was the sample prepared using appropriate diluent?
C) Preparation of calibrator
1. Was there any change of the lot number?
2. Was the calibrator prepared using volume correctly?
3. Does the calibrator have been preserved as recommended?
4. Is the term of validity of the calibrator still valid?
289
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.
8.4.2 High resultant values from a specific method for all samples
Cause Action
Check the preparation of the calibrator.
1. Incorrect calibration Check that the calibration settings are correct.
results The calibration is performed again if necessary.
Check the temperature shown in the [Service
Check: Temperature] picture. Call for service at
2. Too high inside our customer service department when the
temperature of RCT unit indicated 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
validity of reagent with the reagent kit for its stability.
Check the preparation of the reagent.
reagent
See the statement of virtues that comes together
3. Improper preservation of
with the reagent kit for its proper preservation
reagent
method.
Check the temperature shown in the [Service

Check: Temperature] picture. Call for service at
4. Too low inside
our customer service department when the
temperature of RCT unit
indicated temperature deviates from the specified
value of 37 ± 0.2ºC.
calibrator
6. Excessive volume of Check if there is any leakage or drip at junction
reagent dispensed of reagent sampling system.
290
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
positioned below the water or solution level.
solution supply from
Call for service at our customer service
respective external tank
department in case of trouble.
Check if the stirrer rotates in the center of

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

statement of virtues that comes together with
reagent
the reagent kit.
2. Expiration of term of Prepare newly the reagent referring to the

validity, contamination statement of virtues that comes together with
or paleness of reagent the reagent kit.
291
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.
XL-200 OM VER: 1.2 292

8.5.2 Error messages for each unit
Error Error Corrective Action to

Assembly Flags Possible Failures
code Description be Taken
1. Switch OFF the
analyzer; Rotate arm
1. Sample position by hand and make
Opto signal sure that nothing is
obstructing Arm
rotation
2. Then switch ON
the instrument; Go to
Arm Rotational [Service Check: Arm]
error - Trough to menu; Give
Arm 11 @R1 2. Interface board and
Reagent 1 <Initialize> and <Arm
position its connectors
Up> Execute <Arm
trough to reagent
inner> Execute
commands
3. Up/Down and 3. If the initialization

rotation stepper motor or rotation fails, call
and its connection Service Engineer
1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
error - Reagent menu; Give
Arm 12 @R1 2. Interface board and <Initialize> and <Arm
1 position to
Trough its connectors Up> Execute <Arm
trough to reagent
inner> <Reagent
outer/inner to trough>
Execute commands

1. Check the arm

alignment in [Service
Check]. If it is hitting
Arm 13 Arm VOD error 1. VOD Opto Sensor
at the edge , then
align the probe using
the calibrate facility.
XL-200 OM VER: 1.2 293

2. Remove the cover

(During service
2. The connectors of the arm and check
check)
and clean VOD opto
3. Go to Service
Check: Arm Menu.
Click on <Initialize>
3. Sample arm position button. Push the
in Trough during probe gently to cut
Reagent 1 operation the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization
or VOD generation
fails, call the Service
Engineer
1. Switch OFF the
analyzer; Move SPT
1. Arm VOD opto, arm
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
[Service Check: Arm]
Arm Up error - menu; Give
Trough during 2. Probe assembly
Arm 14 @R1 <Initialize> and <Arm
reagent 1 Up> Execute <Arm
operation Down in Trough>
Execute commands
3. Interface card and or up/down
its connector movement fails, call
Service Engineer
4. Up/down and
rotation stepper motor
and its connections
1. Switch OFF and

Arm Down error then switch ON the
1. Arm VOD opto &
Arm 15 @R1 - Reagent 1 instrument. Check if
arm optos
position the error comes
again
2. Remove the cover
2. Interface card and of the sample arm
its connector and check and clean
obstacle opto
3. Probe goes down

but doesn’t find LLS
3. Check the Arm
signal due to problem
assembly
in LLS card or its
connector
XL-200 OM VER: 1.2 294

4. Probe assembly 4. If still it is giving

error, call Service
Engineer
1. Switch OFF the

analyzer; Move SPT
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
menu; Give
<Initialize> and <Arm
Arm Up error - 2. Probe assembly Up> Execute <Arm
Arm 16 @R1 Reagent 1 trough to Reagent
position outer> Execute <Arm
Down> Execute
<Arm Up> Execute
commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF the

Arm rotation 1. Arm position Opto by hand and make
Arm 17
error signal sure that nothing is
obstructing Arm
rotation
2. Then switch ON
menu; Give
Up> Execute <Arm
(During service 2. Interface board and
trough to sample
check) its connectors
outer> Execute
<Sample Outer to R1
Cuvette> Execute
<R1 Cuvette to
Trough> Execute
commands
XL-200 OM VER: 1.2 295


1. Switch OFF the

1. Arm VOD opto, arm analyzer; Move arm
Arm up/down position optos, up and down by hand
error up/down optos and and make sure that
rotation optos nothing is obstructing
Arm movement
2. Then switch ON
menu; Give
(During service
2. Probe assembly <Initialize> and <Arm
check)
Arm 18 Up> Execute <Arm
Down in Trough>
Execute <Arm Up>
Execute commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF and

then switch ON the
1. Arm VOD opto &
instrument. Check if
arm optos
the error comes
again
2. Remove the cover
obstacle opto
Arm Down error 3. Probe goes down
- Trough during but doesn’t find LLS
Arm 19 @R1
3. Check the Arm
reagent 1 signal due to problem
operation assembly
in LLS card or its
connector

error, call Service
Engineer
Arm VOD error -

Arm 1A !R1
Reagent 1 Pos. 1. VOD Opto Sensor 1. Check the arm
at the edge , then
XL-200 OM VER: 1.2 296

2. Remove the cover

and clean VOD opto
3. Go to Service
Check: Arm Menu.
in Reagent tray at R1 probe gently to cut
position the VOD opto so that
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
1. VOD Opto Sensor
at the edge , then
2. Remove the cover
and clean VOD opto
Arm VOD error - 3. Go to Service
Trough during Check: Arm Menu.
Arm 1C !R1
Reagent 1 Click on <Initialize>
operation 3. Sample arm position button. Push the
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
Arm VOD error -
Arm 1C !D Trough during 1. VOD Opto Sensor
at the edge, then
Dilution
XL-200 OM VER: 1.2 297

2. Remove the cover

and clean VOD opto
3. Go to Service
Check: Arm Menu.
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Reagent is not kept

1. Place the reagent
in the reagent bottle or
at the required
reagent bottle not kept
reagent position
at the defined position
Reagent 1 2. Check the level of

Arm 1D R1* absent - Pos. 2. Reagent is below Reagent and ensure
XX the Dead volume that it is above the
Dead volume
3. Arm position in 3. Call Service
reagent tray Engineer
4. LLS circuit and its

connector problem

Diluent absent - in the reagent bottle or
Arm 1D D* at the required
Pos. XX reagent bottle not kept
reagent position
2. Check the level of
2. Reagent is below Reagent and ensure
the Dead volume that it is above the
Dead volume

XL-200 OM VER: 1.2 298


connector problem
1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
Arm Initialize the instrument; Go to
Arm 1E @R1 2. Interface board and
Rotational error [Service Check: Arm]
its connectors
menu; Give
<Initialize> command

rotation stepper motor fails, call Service
and its connection Engineer
1. Switch OFF the

analyzer; Move SPT
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
menu; Give
Arm Initialize 2. Probe assembly
Arm 1F @R1 <Initialize> and <Arm
Up/Down error Up> Execute <Arm
Down in Trough>
Execute commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF the

Arm Rotational analyzer; Rotate arm
error - Trough to 1. Sample position by hand and make
Arm 21 @R2
Reagent 2 Opto signal sure that nothing is
position obstructing Arm
rotation
XL-200 OM VER: 1.2 299

2. Then switch ON
menu; Give
2. Interface board and
its connectors
Up> Execute <Arm
trough to reagent
outer> Execute
commands

1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
Arm Rotational menu; Give
error - Reagent <Initialize> and <Arm
Arm 22 @R2 2. Interface board and
2 position to R2 Up> Execute <Arm
Cuvette its connectors
trough to reagent
outer> Execute
<Reagent outer/inner
to R2 cuvette>
Execute commands

1. Switch OFF the

Arm Rotational analyzer; Rotate arm
error - R2 1. Sample position by hand and make
Arm 23 @R2
Cuvette to Opto signal sure that nothing is
Trough obstructing Arm
rotation
2. Then switch ON
menu; Give
Up> Execute <Arm
its connectors
trough to reagent
outer> Execute
<Reagent outer/inner
to R2 cuvette>
Execute commands
XL-200 OM VER: 1.2 300


1. Switch OFF the

analyzer; Move SPT
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
Arm Up error - menu; Give
Trough during 2. Probe assembly
Arm 24 @R2 <Initialize> and <Arm
Reagent 2 Up> Execute <Arm
operation Down in Trough>
Execute commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF and

then switch ON the
1. Arm VOD opto &
arm optos
the error comes
again
2. Remove the cover
obstacle opto
Arm Down error
3. Probe goes down
Arm 25 @R2 - Reagent 2
position 3. Check the Arm
assembly
in LLS card or its
connector

error, call Service
Engineer
Arm Up error -
Arm 26 @R2 Reagent 2
1. Arm VOD opto, arm 1. Switch OFF the
position
position optos, analyzer; Move SPT
up/down optos and arm up and down by
rotation optos hand and make sure
XL-200 OM VER: 1.2 that
301nothing is
obstructing SPT
movement
2. Then switch ON
menu; Give
2. Probe assembly Up> Execute <Arm
trough to Reagent
outer> Execute <Arm
Down> Execute
<Arm Up> Execute
commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF and

then switch ON the
1. Arm VOD opto &
arm optos
the error comes
again
2. Remove the cover
obstacle opto
Arm Down error
- Cuvette during 3. Probe goes down
Arm 27 @R2
Reagent 2 but doesn’t find LLS
3. Check the Arm
operation signal due to problem
assembly
in LLS card or its
connector

error, call Service
Engineer
1. Switch OFF the

analyzer; Move SPT
arm up and down by
Arm Up error - position optos,
Arm 28 @R2 hand and make sure
R2 Cuvette up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
XL-200 OM VER: 1.2 302

2. Then switch ON
menu; Give
2. Probe assembly Up> Execute
<Trough to R2
cuvette> Execute
<Arm Down>
Execute <Arm Up>
Execute commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF and

then switch ON the
1. Arm VOD opto &
arm optos
the error comes
again
2. Remove the cover
obstacle opto
Arm Down error
- Trough during 3. Probe goes down
Arm 29 @R2
Reagent 2 but doesn’t find LLS
3. Check the Arm
operation signal due to problem
assembly
in LLS card or its
connector

error, call Service
Engineer
1. Check the arm

Arm VOD error - Check]. If it is hitting
Arm 2A !R2 1. VOD Opto Sensor
Reagent 2 Pos. at the edge, then
2. Remove the cover
and clean VOD opto
XL-200 OM VER: 1.2 303

3. Go to Service
Check: Arm Menu.
in Reagent tray at R2 probe gently to cut
position the VOD opto so that
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
1. VOD Opto Sensor
at the edge , then
2. Remove the cover
and clean VOD opto
Cuvette during Check: Arm Menu.
Arm 2B R2!
Reagent 2 Click on <Initialize>
operation 3. Sample arm position button. Push the
in Cuvette during probe gently to cut
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
Arm VOD error - alignment in [Service
Trough during Check]. If it is hitting
Arm 2C !R2 1. VOD Opto Sensor
Reagent 2 at the edge , then
operation align the probe using
2. Remove the cover
and clean VOD opto
3. Go to Service
Check: Arm Menu.
VOD Error will be
generated and Arm
initializes.
XL-200 OM VER: 1.2 304

or VOD generation
Engineer

in the reagent bottle or
at the required
reagent bottle not kept
reagent position

Reagent 2
Arm 2D R2* 2. Reagent is below Reagent and ensure
absent - Pos.XX
the Dead volume that it is above the
Dead volume

connector problem
1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
Arm 2E @R2 2. Interface board and
its connectors
menu; Give

1. Switch OFF the

analyzer; Move SPT
arm up and down by
1F/2F/ Arm Initialize position optos,
Arm @R2 hand and make sure
3F Up/Down error up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
menu; Give
2. Probe assembly
Up> Execute <Arm
Down in Trough>
Execute commands
Service Engineer
XL-200 OM VER: 1.2 305

4. Up/down and
and its connections
1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
Arm 31 @S error - Trough to menu; Give
Sample <Initialize> and <Arm
its connectors
Up> Execute <Arm
trough to sample
outer> Execute
commands

1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
Arm Rotational menu; Give
Arm 32 @S error - Sample <Initialize> and <Arm
to Cuvette Up> Execute <Arm
its connectors
trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute
commands

1. Switch OFF the

Arm Rotational
Arm 33 @S error - Cuvette
to Trough
obstructing Arm
rotation
XL-200 OM VER: 1.2 306

2. Then switch ON
menu; Give
Up> Execute <Arm
trough to sample
its connectors
outer> Execute
<Sample Outer to R1
Cuvette> Execute
<R1 Cuvette to
Trough> Execute
commands

1. Switch OFF the

1. Arm VOD opto, arm analyzer; Move arm
position optos, up and down by hand
up/down optos and and make sure that
rotation optos nothing is obstructing
Arm movement
2. Then switch ON
menu; Give
Arm Up error - 2. Probe assembly <Initialize> and <Arm
Trough during Up> Execute <Arm
Arm 34 @S
sample Down in Trough>
operation Execute <Arm Up>
Execute commands
Service Engineer
4. Up/down and
and its connections
Arm Down error 1. Arm VOD opto & 1. Switch OFF and
Arm 35 @S
- Sample arm optos then switch ON
position the instrument.
2. Interface card and
Check if the error
its connector
comes again
3. Probe goes down

2. Remove the cover
of the sample arm
and check and clean
in LLS card or its
obstacle opto
connector
4. Probe assembly 3. Check the Arm

assembly
XL-200 OM VER: 1.2 307

4. Go to [Service
Check: Arm] menu;
Give <Initialize> and
<Arm Up> Execute
<Arm trough to
Sample outer>
Execute <Arm
Down> Execute
commands
5. If still it is giving
error, call Service
Engineer
1. Switch OFF the
analyzer; Move SPT
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
menu; Give
Arm Up error - 2. Probe assembly Up> Execute <Arm
Arm 36 @S trough to Sample
Sample position
outer> Execute <Arm
Down> Execute
<Arm Up> Execute
commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF and

Arm Down error then switch ON the
1. Arm VOD opto &
Arm 37 @S - Sample instrument. Check if
arm optos
Cuvette the error comes
again
2. Remove the cover
obstacle opto
3. Probe goes down

3. Check the Arm
assembly
in LLS card or its
connector
XL-200 OM VER: 1.2 308


error, call Service
Engineer
1. Switch OFF the

analyzer; Move SPT
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
menu; Give
Up> Execute <Arm
trough to Sample
Arm Up error - 2. Probe assembly
Arm 38 @S outer> Execute
Sample Cuvette <Sample outer to R1
cuvette> Execute
<Arm Down in R1
cuvette> Execute
<Arm Up> Execute
commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF and

Arm Down error
then switch ON the
- Trough during 1. Arm VOD opto &
Arm 39 @S instrument. Check if
sample arm optos
the error comes
operation
again
2. Remove the cover
obstacle opto
3. Probe goes down

3. Check the Arm
assembly
in LLS card or its
connector
XL-200 OM VER: 1.2 309


error, call Service
Engineer
1. Check whether the

selected option is
1. VOD Opto Sensor
tube and instead of
tube a cup is placed
2. Check the Arm
2. The connectors
at the edge, then
3. Remove the cover
3. Sample arm position of the sample arm
in Sample tray and check and clean
Arm VOD error -
Arm 3A !S VOD opto
Sample Pos. XX
4. Go to Service
Check: Arm Menu.
button. Push the
Probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the Arm
1. VOD Opto Sensor
at the edge , then
2. Remove the cover
and clean VOD opto
3. Go to Service
Arm VOD error - Check: Arm Menu.
Arm 3A !DILN
Dilution Cuvette. Click on <Initialize>
button. Push the
3. Sample arm position
probe gently to cut
in Dilution cuvette
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
XL-200 OM VER: 1.2 310

1. Check the arm

1. VOD Opto Sensor
at the edge , then
2. Remove the cover
and clean VOD opto
Arm 3B S! During Sample Check: Arm Menu.
dispense Click on <Initialize>
button. Push the
3. Sample arm position
probe gently to cut
in Dispense cuvette
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
1. VOD Opto Sensor
at the edge , then
2. Remove the cover
and clean VOD opto
During Diluted Check: Arm Menu.
Arm 3B DILN!
Sample Click on <Initialize>
dispense 3. Sample arm position button. Push the
in Dispense cuvette probe gently to cut
during dilution the VOD opto so that
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
Arm VOD error - alignment in [Service
Trough during Check]. If it is hitting
Arm 3C !S! 1. VOD Opto Sensor
Sample at the edge , then
operation align the probe using
2. Remove the cover
and clean VOD opto
XL-200 OM VER: 1.2 311

3. Go to Service
Check: Arm Menu.
sample operation the VOD opto so that
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Check the arm
1. VOD Opto Sensor
at the edge , then
2. Remove the cover
and clean VOD opto
Arm VOD error -
3. Go to Service
Trough during
Arm 3C !DILN! Check: Arm Menu.
Dilution
operation
sample operation the VOD opto so that
VOD Error will be
generated and Arm
initializes.
or VOD generation
Engineer
1. Sample is not kept in
1. Place the sample
the sample tube / cup
at the required
at that particular
sample position
position
2. Sample tube / cup
Sample and ensure
absent at that
that it is above the
particular position
Sample absent - Dead volume
Arm 3D S*
Pos. XX
3. LLS circuit and its 3. Call Service
connector problem Engineer
4. Sample is below the

Dead volume
5. Arm position in
sample tray
XL-200 OM VER: 1.2 312

1. Switch OFF the

obstructing Arm
rotation
2. Then switch ON
Arm 3E @S 2. Interface board and
its connectors
menu; Give

1. Switch OFF the

analyzer; Move SPT
arm up and down by
position optos,
hand and make sure
up/down optos and
that nothing is
rotation optos
obstructing SPT
movement
2. Then switch ON
menu; Give
Arm Initialize 2. Probe assembly
Arm 3F @S <Initialize> and <Arm
Up/Down error Up> Execute <Arm
Down in Trough>
Execute commands
Service Engineer
4. Up/down and
and its connections
1. Switch OFF the

analyzer; Move the
Syringe up and down
R1 Syringe 1. Syringe position
Syringe 41 @R1 by hand and make
Initialize error opto
sure that nothing is
obstructing the
movement
2. Then switch ON
[Service Check:
Syringe]; Give
its connector
<Initialize> and
<Aspirate/Dispense>
commands
XL-200 OM VER: 1.2 313

3. Syringe up/down
or aspirate/dispense
motor
movement fails, call
Service Engineer
1. Switch OFF the

analyzer; Move the
Syringe up and down
1. Syringe position
by hand and make
opto
obstructing the
movement
2. Then switch ON
[Service Check:
Syringe]; Give
its connector
R1 Syringe <Initialize> and
Syringe 42 @R1
Up/Down error <Aspirate/Dispense>
commands
3. Syringe up/down or aspirate/dispense
motor movement fails, call
Service Engineer
1. Switch OFF the

analyzer; Move the
Syringe up and down
R2 Syringe 1. Syringe position
Syringe 52 @R1 by hand and make
Up/Down error opto
obstructing the
movement
2. Then switch ON
[Service Check:
Syringe]; Give
its connector
<Initialize> and
<Aspirate/Dispense>
commands
XL-200 OM VER: 1.2 314

3. Syringe up/down
motor
Service Engineer
1. Switch OFF the

analyzer; Move the
Syringe up and down
1. Syringe position
by hand and make
opto
obstructing the
movement
2. Then switch ON
[Service Check:
Syringe]; Give
its connector
Sample Syringe <Initialize> and
Syringe 61 @S
Initialize error <Aspirate/Dispense>
commands
3. Syringe up/down
motor
Service Engineer
1. Switch OFF the

analyzer; Move the
Syringe up and down
Sample Syringe 1. Syringe position
Syringe 62 @S by hand and make
Up/Down error opto
obstructing the
movement
2. Then switch ON
[Service Check:
Syringe]; Give
its connector
<Initialize> and
<Aspirate/Dispense>
commands
XL-200 OM VER: 1.2 315

3. Syringe up/down
motor
Service Engineer
1. Switch OFF the

analyzer; Rotate RGT
1. Position opto by hand and make
assembly of RGT tray sure that nothing is
obstructing the
rotation
Reagent tray 2. Then, switch ON
Reagent
71 RGT1 Initialize the instrument; Go to
Tray
Rotational error 2. Stepper motor and [Service Check:
its connections Reagent Tray]; Give
<Initialize>
command.
3. Interface card and 3. If initialization fails,
its connector call Service Engineer
1. Switch OFF the
analyzer; Rotate RGT
assembly of RGT tray sure that nothing is
obstructing the
rotation
Reagent tray 2. Then, switch ON
Reagent
72 RGT1 Rotational error the instrument; Go to
Tray
during run 2. Stepper motor and [Service Check:
its connections Reagent Tray]; Give
<Initialize>
command.
RGT Interlock ARM assembly UP

Reagent
7F RGT2 error during opto & Direction
Tray 1. Make sure that
service check opto.
arm assembly is
not down in RGT
tray during service
check for reagent
i.e service
command
1) RGT initialize
2) RGT tray rotate
XL-200 OM VER: 1.2 to316
“X” position. If
arm assembly is
not down then
check up opto &
2. Check opto
connectors are
connected properly
or not.
1. Switch OFF the
analyzer; Rotate ASP
assembly of ASP sure that nothing is
obstructing the
rotation
Sample tray 2. Then, switch ON
Sample
81 ASP1 Initialize the instrument; Go to
Tray
Rotational error 2. Stepper motor and [Service Check:
its connections Sample Tray]; Give
<Initialize>
command.
1. Switch OFF the
analyzer; Rotate ASP
assembly of ASP sure that nothing is
obstructing the
rotation
Sample tray 2. Then, switch ON
Sample
82 ASP2 Rotational error the instrument; Go to
Tray
during run 2. Stepper motor and [Service Check:
its connections Sample Tray]; Give
<Initialize>
command.
1. Make sure that
arm assembly is not
down in ASP tray
during service
check for ASP tray
ARM assembly UP i.e service
ASP Interlock
Sample opto & Direction command 1) ASP
8F ASP3 Error during
Tray opto & ARM home initialize 2) ASP
service check
opto tray rotate to “X”
position 2.
Check opto
connectors are
connected properly
or not.
XL-200 OM VER: 1.2 317

1. Switch OFF the

analyzer; Rotate RCT
assembly of RCT tray sure that nothing is
obstructing the
rotation
2. Then switch ON
RCT tray the instrument; Go to
RCT Tray 91 RCT1 Initialize 2. Stepper motor and
[Service Check: RCT
Rotational error its connections
Tray]; Give
3. If initialization fails,
otherwise call Service
its connector
Engineer
4. Arms are down in
RCT
1. Switch OFF the
analyzer; Rotate RCT
assembly of RCT tray sure that nothing is
obstructing the
rotation
2. Then switch ON
RCT tray the instrument; Go to
RCT Tray 92 RCT2 Rotational error 2. Stepper motor and
[Service Check: RCT
during run its connections
Tray]; Give
3. If initialization fails,
its connector
Engineer
4. Arms are down in
RCT
1. Make sure that
arm assembly is
not down in RCT
tray during
service check for
RCT tray i.e
ARM assembly UP service command
RCT Interlock opto & Direction 1) RCT initialize
RCT Tray 9F RCT3
error opto & ARM home 2) RCT tray
opto rotate to “X”
position
2. Check opto
connectors are
connected
properly or not.
XL-200 OM VER: 1.2 318

1. Switch OFF the

analyzer; Move CRU
1. CRU Position opto up and down by hand
signal and make sure that
nothing is obstructing
the CRU movement
2. Then switch ON
[Service Check: CRU
2. RCT Position opto
Unit]; Give
CRU signals
<Initialize> and
CRU A1 @CRU Initialization <Up/down>
error commands
or up/down
movement fails,
its connector
Engineer
4. Stepper motor and

its connections
5. RCT alignment
1. Switch OFF the
analyzer; Move CRU
1. CRU Position opto up and down by hand
signal and make sure that
the CRU movement
2. Then switch ON
[Service Check: CRU
2. RCT Position opto
Unit]; Give
signals
CRU Up/Down <Initialize> and
CRU A2 @CRU <Up/down>
error
commands
or up/down
movement fails,
its connector
Engineer
4. Stepper motor and

its connections
5. RCT alignment
CRU Down
CRU A3 @CRU CRU down opto
Opto Fail 1. Make sure the
down opto is
working i.e CRU
down opto LED is
ON when when
OPTO is open and
XL-200 OM VER: 1.2 319
CRU down opto
LED is OFF when
CRU opto is cut by

interrupter. Also
ensure that the
logic low signal is
reaching to CPU
board when opto is
open i.e LED is
ON & logic
high(3.3v) signal
reaches the CPU
board when opto is
cut i.e LED is
OFF.
2. Check opto
connectors are
connected properly
or not.
Make sure the up
opto is working i.e
CRU up opto led
is ON when when
OPTO is open and
CRU up opto led
is OFF when CRU
opto is cut by
interrupter. Also
ensure that the
logic low signal is
reaching to CPU
CRU Up Opto
CRU A4 @CRU CRU up opto board when opto is
Fail
open i.e LED is
ON & logic
high(3.3v) signal
reaches the CPU
board when opto is
cut i.e LED is
OFF.
2. Check opto
connectors are
connected properly
or not.
RCT_POSITION_O
CRU AF @CRU CRU Interlock
PTO and
1. Make sure
Error CRU_UP_OPTO and
1) RCT_position
opto is ON and
XL-200 OM VER: 1.2 320
CRU_UP_OPTO
is OFF and
CRU_DOWN_OP
TO is ON before
CRU goes down
in RCT when
down command is
executed during
service check.
CRU_DOWN_OPT
2) Ensure RCT
O
position opto is
ON when cru goes
down in RCT
during run.
2. Check opto
connectors are
connected properly
or not.
1. Switch OFF the
analyzer; Rotate
1. Position opto stirrer by hand and
assembly of stirrer make sure that
the rotation
2. Then switch ON
[Service Check:
Stirrer]; Give
Stirrer Up/Down
<Initialize> and
Stirrer B1 @STR1 error for
<Stirrer Up> Execute
Reagent 1 2. Interface card and
<Stirrer Arm Trough
its connector
to R1 Cuvette>
Execute <Down in
Cuvette> Execute
<R1 Cuvette to
Trough> commands
3. Stepper motor or rotation fails, call
Service Engineer
1. Switch OFF the
analyzer; Rotate
Stirrer
Stirrer B2 @STR1 Rotational error
for Reagent 1
the rotation
XL-200 OM VER: 1.2 321

2. Then switch ON
[Service Check:
Stirrer]; Give
<Initialize> and
its connector
<Stirrer Arm Trough
to R1 Cuvette>
Execute <R1 Cuvette
to Trough>
commands
Service Engineer
Make sure
RCT_POSITION_
OPTO is ON when
RCT_POSITION_O
stirrer down in
PTO and
cuvette command
Stirrer Interlock STR_HOME_OPTO
Stirrer BF @STR3 is executed during
Error and
service check
STR_DIRECTION_
2. Check opto
OPTO'
connectors are
connected properly
or not.
1. Switch OFF the
analyzer; Rotate
the rotation
2. Then switch ON
[Service Check:
Stirrer]; Give
Stirrer Up/Down
<Initialize> and
Stirrer C1 @STR2 error for
Reagent 2 2. Interface card and
<Stirrer Arm Trough
its connector
to R2 Cuvette>
Execute <Down in
Cuvette> Execute
<R2 Cuvette to
Trough> commands
Service Engineer
1. Switch OFF the
analyzer; Rotate
Stirrer
Stirrer C2 @STR2 Rotational error
for Reagent 2
the rotation
XL-200 OM VER: 1.2 322

2. Then switch ON
[Service Check:
Stirrer]; Give
<Initialize> and
its connector
<Stirrer Arm Trough
to R2 Cuvette>
Execute <R2 Cuvette
to Trough>
commands
Service Engineer
1. Switch OFF the
SRAM Memory 1. Interface Board Analyzer and Switch
Controller D1
Error (CPU). it on after few
minutes.
1. Malfunctioning of Check the pressure
pressure unit unit for
Low Pressure
Pressure G1 2. Leakage/Blockage in any leakage or
Level
pressure tubing blockage in
the tubing
High Pressure
Pressure G2 2. Leakage/Blockage in any leakage or
Level
the tubing
1. Check the
1. Reagent tray cover
placement of
placement
Reagent Cover
2. Check the logic
levels at the
Reagent RGT Cover 2. The logic levels at baseboard
H1 RGT!
the baseboard connectors/connector
Tray Open
connectors connections and
verify for proper
functionality.
3. Connector
connections
1. Check the
1. Cleaning solution
Cleaning solution
Level
Cleaning Low Cleaning Level
I1
Can Solution Level 2. Check the Sensor
2. Sensor output of
Output of Level
Level Sensors
Sensor
1. Check the Waste
Empty Waste 1. Waste Level
Level
Reservoir/Waste
Waste Can J1 2. Check the Sensor
Tank full to 2. Sensor output of
Capacity Output of Level
Level Sensors
Sensor
XL-200 OM VER: 1.2 323

1. Check the Bio-

1. Bio-Waste Level
Waste Level
Bio-Waste Bio-Waste Tank
K1 2. Check the Sensor
Can Full to Capacity 2. Sensor output of
Output of Level
Level Sensors
Sensor
Low DI Water
Pressure L1 2. Leakage/Blockage in any leakage or
Level
the tubing
1. Check the DI
1. DI Water Level
DI Water Tank Water Level
DI Water
M1 Level less than 2. Check the Sensor
Can 2. Sensor output of
or equal to 50% Output of Level
Level Sensors
Sensor
1. Goto Service
Check and give
1. PDC Card.
Emergency Stop
PDC
Command.
Photometer N1 Operational
ERROR 2. Switch OFF the
2. Interface Board and Analyzer and Switch
its connector. it on after few
minutes.
1. Goto Service
Check and give
1. PDC Card.
Emergency Stop
PDC
Command.
Photometer N2 Communication
ERROR 2. Switch OFF the
2. Interface Board and Analyzer and Switch
its connector. it on after few
minutes.
1. Reagent Barcode 1. Check the Reagent
Scanner barcode scanner
2. Check the Reagent
Reagent 2. Reagent barcode
Barcode barcode scanner
P1 Barcode scanner connections
Scanner connections
Scanner Status
its connections
1. Sample Barcode 1. Check the Sample

Scanner barcode scanner
2. Check the Sample
2. Sample barcode
Barcode Sample Barcode barcode scanner
Q1 scanner connections
Scanner Scanner Status connections

its connections
RGT Cover 1. Check the

Reagent 1. Reagent tray cover
R1 RGT!! open for 5 placement of
Tray placement
minutes under Reagent Cover
XL-200 OM VER: 1.2 324

standby 2. Check the logic

levels at the
2. The logic levels at baseboard
the baseboard connectors/connector
connectors connections and
verify for proper
functionality.
3. Connector
connections
1. Go to [Service
Check: RCT & RGT
Temp]; Give <Read>
1. RCT heater and its command. RCT &
connections RGT temperature
should be displayed
along with the RCT
sensor status
RCT/RGT 3. If the temperature
Reaction
T9 @TMP Temperature out 2. Interface board and is not coming within
Tray
of range its connections range, call Service
Engineer
3. RCT sensors and its

connections
4. RGT sensor and its

connections
XL-200 OM VER: 1.2 325

8.5.3 Error Log

a) This sub menu displays the list of errors occurred in m/c. 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) All the critical errors due to which run stopped will be displayed with
background color as red and font color as white and showed on the screen.
e) All the errors due to which sampling was paused will be displayed with
background color as green and font color as red and showed on the screen.
f) To print the details on the error, user can click on PRINT button.
g) Error description is displayed along with the date and time and also batch
no if applicable.
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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.
Flags Cause
No.
1 # This flag is issued to indicate that the result obtained is from a rerun. This flag is issued for all rerun results
When Linearity Extension Logic method is used to reduce the measurement range to match absorbance
2 ~
range setting, this flag should be given
This flag is used to indicate that correlation correction has been used to calculate the final result. That is,
3 F
this flag is issued if in the equation Y = aX + b, a is not equal to 1 or b is not equal to zero.
4 -1SD This flag is issued with control results to indicate that the result is below 1SD limit
5 +1SD This flag is issued with control results to indicate that the result is above 1SD limit
This flag is issued with patient or control result and indicates that something is wrong with the calibration
10 NOCAL table. The calibration table 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
This flag is issued with control result and indicates that the target Mean and SD values have not been
12 ?SD defined in Quality Control screen for the control. Therefore, flags such as “±1SD”, “±2SD”, “±3SD” cannot
be given
13 D This flag is issued with patient results and indicates a Decreased volume run
14 I This flag is issued with patient results and indicates a Increased volume run
This flag is issued with patient and control results when, for the concerned test, the absorbance of the
15 MONO
calibrators are not changing monotonically with the concentration of the calibrators in the calibration table.
This flag is issued with blank, patient, calibrator and control results to indicate that the sample was
16 PD
prediluted
This flag is issued with patient and control serum results to indicate that prozone (antigen excess) has
17 P*
occurred.
Lower technical limit violated. Measured value or absorbance slope is lower than the set minimum
18 TEC-L
technical limit.
Upper technical limit violated. Measured value or absorbance slope is higher than the set maximum
19 TEC-H
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 calibration curve.
2) This flag is also issued if the absorbance of the sample is higher than the absorbance of the blank (or
lowest concentration calibrator) in the calibration table for decreasing direction calibration curve.
1) This flag is issued with patient and control serum results to indicate that the absorbance of the sample
RANGL is lower than the absorbance of the blank (or lowest concentration calibrator) in the calibration table for
21 increasing direction calibration curve.
2) This flag is also issued if the absorbance of the sample is lower than the absorbance of highest
concentration calibrator for a decreasing direction calibration curve.
Measured value is larger than upper limit set for normal value range for the corresponding age, sex and
22 H
gender.
Measured value is smaller than lower limit set for normal value range for the corresponding age, sex and
23 L
gender.
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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 indicate that the patient result is lower
26 PANL
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 indicate that the patient result is higher
27 PANH
than the programmed Panic Limit Max. ISE tests too will be sent for a rerun
Linearity abnormal (checked only for Rate A and Rate B assays). When the reaction during measurement
28 LINxx points M2S and M2E is non-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 logic and when Reaction
29 Lim0
Absorbance Limit is present. If there are no points available for calculation, then this flag is issued
30 Lim1
Absorbance Limit is present. If there is only one point available for calculation, then this flag is issued
31 Lim2
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 calculation or an overflow error occurs in
32 ???
logarithmic or exponential calculation
33 @TMP This flag is issued when the RCT temperature was out of range while the measurement was in process.
34 TO This flag indicates Time Out while receiving result from the machine.
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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.
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8.6.1 Span
1. Manual Span
This screen is useful to view the filter absorbance and voltages at different
wavelengths. It is also used to view the photometer stability at different
wavelengths.
Figure 8.6.1 - 1 Manual Span
2. Auto Span
This option is useful to check gain of the photometer for all wavelengths.
The gain should be in range 50 – 900. If the gain obtained for any wavelength is
not within the range, it is highlighted with red background else if within range
then with green background.
Figure 8.6.1 - 2 Auto Span
XL-200 OM VER: 1.2 330

Note:
If the absorbance of the DI Water placed in front of the cuvette is not between
0.05-0.065 Abs, then corrective measures should be taken.
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8.6.2 Wash
The following screenshot shows the Wash Screen:
Figure 8.6.2 - 1 Wash Screen
1. 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 (depending on the time
set by the user: Max time is 5 minutes) to remove the air trapped inside the
tubings. Also, the valves of the CRU tubings are kept open to remove the air
trapped in them. The following operation occurs after the button is clicked:
1) Machine Initializes
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.
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
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to fill all the 45 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 45 cuvettes with the
detergent in the detergent can. Then using the Probe, the analyzer fills water
in all the 45 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. Cuvette Rinse:
On selecting <Cuvette Rinse> option, the user can perform a Cuvette
Wash of all 45 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 8.6.2 - 2 Cell Blank Screen
XL-200 OM VER: 1.2 333

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.
XL-200 OM VER: 1.2 334

Figure 8.6.2 – 3 Cell Blank Graph
abs}: It is the absorbance of the cuvettes with de-ionized

{Cell Blank: Present
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 {Maintenance: 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 Orange
background.
XL-200 OM VER: 1.2 335

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.
4. Auto Wash:
Auto Wash option can be used instead of the Cuvette Rinse option,
when operator wants to use external detergents/solutions to clean the
cuvettes, 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. Please 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. Small window will be displayed, user has
to click on OK to continue and Cancel to cancel the operation 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.
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.
XL-200 OM VER: 1.2 336

5. Probe Wash
This option enables the operator to wash the 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. First select

the desired number of cycles from 01 – 09. Clicking on
<Start> button prompts the user to enter the position for
Cleaning Solution (either 1% Extran or 0.05% Hypochlorous
Acid) on the Reagent Tray.
b. Once the user enters the cleaning solution position, clicks on
<OK>, the Probe picks up about 300 µl of cleaning solution
and dispenses it in the drain with internal and external
cleaning.
c. The Probe wash action is repeated based on the number of
cycles selected.
d. After the action is completed the analyzer gets initialized.
8.6.3 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 only once. The procedure to carry out the
Dead Volume
Calibration is given below:
i. For Reagent 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.
XL-200 OM VER: 1.2 337

ii) Enter 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) If the reagent volume present in the specified reagent bottle is beyond 1.5 of
the value entered, then message “Calibrated Value Out of Range of Specified
Value” is displayed.
vii) If the calibration is within range then it is automatically stored in the
Software.
ii. 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 type from the Dead Volume
Calibration list.
ii) Place the Container according to the container type on the position specified in
the list.
iii) Pipette the exact amount of volume in the Sample container as per the Dead
Volume required.
iv) Click on the Calibrate button.
v) Once the calibration process is completed then it is automatically stored in the
Software.
XL-200 OM VER: 1.2 338

iii. For Default Calibration:
The following steps should be done to reset the Dead Volume Calibration to
Default:
i. User should click on DEFAULT button.
ii. Select the Container Types from the list for which the Dead volume
calibration needs to be reset.
iii. User can click on OK to reset the selected containers.
Note
If the Application Software is changed, then the Dead Volume Calibration settings is
updated automatically and it can also be updated from the instrument from Service
Check>Read Current command. If any hardware program is changed, then the Dead
Volume Calibration should be repeated again.
8.6.4 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.
XL-200 OM VER: 1.2 339

8.7 Service Check Screen
Figure 8.7 Service Check screen
The Service Check screen can be used only by a Service Personnel. Only
specific users can be given access rights after permission from the Service
Personnel.
XL-200 OM VER: 1.2 340

The Service Check screen consist of following options:
• ARM/STIRRER: This option is used for checking the alignment of the ARM
Probe or Stirrer Assembly. Upon selecting the Arm or Stirrer Option, the
service personnel can check the alignment of the respective assembly in
trough, in sample tray (outer, middle and inner positions), in reagent tray
(outer positions and inner positions), in cuvette & in dilution cuvette. The
operator can check stirrer motor rotation speed at three different options as
shown in picture below:
• SAMPLE TRAY:
Initialize: This option is used to initialize the Sample Tray. (Position # 1)
Pulse: A PULSE button is also given for moving the sample tray step by
step (one pulse gives micro-step change between 2 positions)
Rotate to Position: This option is used for rotating the sample tray to “X”
position depending on the position selected by the service personnel. To
move to next position Sample Tray needs to be initialized.
Barcode Scan: This option is used to perform Sample Barcode Scan. All
the Barcode(s) Read are displayed on the screen (No cross check or
verification of Duplication done). Display remains until user performs
some other operation. To view the same Barcode(s) again user has to click
on the button with Barcode label (This option is available

until user remains on the Service Check Screen).
XL-200 OM VER: 1.2 341

ASP Barcode Scanner Beam ON/OFF: This option is used to Turn ON

or OFF the ASP Barcode Scanner Beam. On reading the Barcode the
Beam turns OFF automatically.
c) REAGENT TRAY:
Initialize: This option is used to initialize the Reagent Tray. (Position # 1)
Pulse: A PULSE button is given for moving the reagent tray step by step
(between 2 positions).
Rotate to Position: This option is used for used for rotating the reagent
tray to “X” position depending on the position selected by the service
personnel. (Positions are labeled as “01-I”, “01-O” represents position
One-Inner, One-Outer respectively).
Barcode Scan: This option is used to perform Reagent Barcode Scan. All
the Barcode(s) Read are displayed on the screen (No cross check or
verification of Duplication / Checksum / Number of Digits / Invalid
Reagent Code / Invalid Bottle Type are done). Display remains until user
performs some other operation. To view the same Barcode(s) again user
has to click on the button with Barcode label (This option

is available until user remains on the Service Check Screen).
RGT Barcode Scanner Beam ON/OFF: This option is used to Turn ON
or OFF the RGT Barcode Scanner Beam. On reading the Barcode the
Beam turns OFF automatically.
d) RCT TRAY:
Initialize: This option is used to initialize RCT Tray to initial position.
(Cuvette Number 39 in path of Light Beam).
Pulse: This option is given for moving the reaction tray in micro steps
(between 2 cuvettes) to check for the opto-coupler alignment.
Rotate To: This option is used for rotating the reaction tray to “X”
position.
e) CRU UNIT: This function allows the service personnel to check the CRU
Functionality. A CRU RUN CHECK button.
XL-200 OM VER: 1.2 342

Initialize: This option initializes the CRU Assembly to home position

(UP).
Run Check: This option is given to check the functionality of the
aspiration and suction probes of the CRU in this mode
DOWN: This option brings CRU Down in Cuvette
o NOTE: Make sure the RCT Cuvettes are aligned before executing this
command.
o Following options are available after CRU is Down in Cuvette.
CRU BIOHAZARD SUCTION PUMP ON / OFF: This option Turns
the Bio-Hazard Suction Pump ON or OFF.
CRU WATER DISPENSE ON / OFF: This option Turns the Water
Dispense Valve ON / OFF.
o NOTE: To try this option first bring CRU Down in Cuvette and keep Bio-
Hazard Suction Pumps ON to avoid any overflow and keep Overflow
Suction Valve OFF.
CRU DETERGENT DISPENSE PUMP ON / OFF: This option is used
to Turn ON / OFF the Detergent Dispense Pump ON or OFF.
o NOTE: To try this option first bring CRU Down in Cuvette and keep Bio-
Hazard Suction Pumps ON to avoid any overflow and keep Overflow
Suction Valve OFF.
CRU OVERFLOW SUCTION VALVE: This option Turns Overflow
Suction Valve ON or OFF.
o NOTE: To try this option CRU Water Dispense and Detergent Dispense
should be OFF.
f) SYRINGE:
Initialize: This option initializes the SYRINGE Assembly to home
position.
XL-200 OM VER: 1.2 343

Aspirate: The service personnel can check the ASPIRATE steps by

entering the desired volume in the field provided. The maximum volume
that can be entered for ASPIRATION movement is 375ul.
Dispense: The service personnel can check the DISPENSE steps by
entering the desired volume in the field provided. The maximum volume
that can be entered for DISPENSE movement is 375ul.
g) VALVE and PUMP: This option is used for checking the Valve
operations for ARM Trough, ARM PROBE and Stirrer Trough.
ARM Trough Valve: Turns ON or OFF the ARM Trough Valve.
ARM Probe Clean Valve: Turns ON or OFF the ARM Probe Clean
Valve.
STIRRER Trough Valve: Turns ON or OFF the Trough Valve of Stirrer.
h) RCT/RGT TEMP: This option is used for displaying the RCT & RGT
Temperature. The RCT Temperature should be within 37 +/-0.2 degrees &
the RGT Temperature within 8-12 degrees.
READ: This button starts reading operation and given Temperature

Display till Stopped.
STOP: STOP button should be clicked before moving out of next screen.
Sensor Status: Status of all three temperature sensors are indicated as
follows:
o P - Present and within limits (36.8 ~ 37.2 °C)
o O – Out of Range (Less than 36.8°C or Greater than 37.2°C)
o A - Absent (Error Condition)
o L – Lose (Error Condition)
XL-200 OM VER: 1.2 344

i) TEST COMMUNICATION: This option is used for checking the

communication between PC and the analyzer. The service personnel
selects the COM port and then clicks on the TEST COMMUNICATION
button.
j) CALIBRATION: This section of Service Check Form is used to

Calibrate ARM centering at various applicable positions. Pre-requisites for
this operation is to bring the ARM or STIRRER to required position using
the ARM/STIRRER Move options.
Clock Wise: Set direction of rotation for ARM / STIRRER as Clockwise.
Anti Clock Wise: Set direction of rotation for ARM / STIRRER as
Anticlockwise.
+++ : This button allows Course step movement of ARM / STIRRER.
+ : This button allows FINE step movement of ARM / STIRRER.
Accept: Saves the Course / FINE adjusted value of ARM / STIRRER in
to local memory. Values are not saved in Analyzer until “Save Calib.”
Button is clicked.
Cancel: Cancels the locally Accepted Value(s) of Course / FINE
adjustment(s) of ARM / STIRRER.
Default: Cancels and reloads the default position of ARM / STIRRER at
respective position of calibration.
Save Calib.: This option is mandatory after calibrating the ARM .
STIRRER. The locally Accepted values are Saved in the Analyzer Non-
volatile memory and are used by Analyzer henceforth.
Calibration Menu:
o Read Default Calibration: Reads the Default steps of ARM / STIRRER
at various positions.
o Read Current Calibration: Reads latest calibrated values from Analyzer
Non-volatile memory.
o Load Default Calibration: Loads Analyzer’s current calibration values to
Factory set values.
XL-200 OM VER: 1.2 345

o Show Current Calibration: Displays Analyzer’s current calibration

values
NOTE: Before doing calibration Read Default and Current Calibration
Values, as these values are required to check limits of calibration steps at
respective position of ARM / STIRRER.
k) Misc Commands: This option helps to view Version Numbers for

MultiXL Software and Embedded Software Versions (Analyzer, Micro
Blaze, FPGA, PDC and RCT Heater). Right Click on this button and then
click on “Software Version”.
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“Page Left Blank Intentionally”
XL-200 OM VER: 1.2 347

Appendix-A - Introduction to ISE Module
Appendix-A
Introduction to ISE Module
A-1
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.
A-2
1-1 Parts Location
ISE Electrodes
Waste Pump Cal B Pump Cal A Pump
Reagent Pack
A-3
1-2 ISE Technical Specifications
Sample type Serum, Plasma or Urine (Urine requires dilution)

Sample size 75 µl serum
160 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)
A-4
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 (SMPS, four channel ISE)
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
A-5
1-3 ISE Measurement Theory

The electrolyte measurement system measures Sodium, Potassium and Chloride ions in biological
fluids using ion selective electrode technology. A diagram of the electrode measurement system is
shown in Figure A.1.
Sample Port
Figure A1: Schematic diagram of the electrolyte measurement system
The flow-through electrodes use selective membrane tubing, specially formulated to be

sensitive to the respective ions. The potential of each electrode is measured relative to a fixed,
stable voltage established by the double junction Silver/Silver-chloride reference electrode.
An ion-selective electrode develops a voltage that varies with the concentration of the ion to
which it responds. The relationship between the voltage developed and the concentration of
the sensed ion is logarithmic, as expressed by the Nernst equation:
RT log(αC )
E = Eo +
nf
Where:
E = the potential of the electrode in sample solution
A-6
Eo = the potential developed under standard conditions
RT/nF = A temperature dependent “constant”, termed the slope
log = Base ten logarithm function
α = Activity coefficient of the measured ion in the solution
C = Concentration of the measured ion in the solution
A-7
1-4 Electrodes and Reagents used
Electrodes used in the ISE module

The electrodes are maintenance-free and are warranted on a prorated basis for up to 10,000
samples or 6 months, whichever occurs first Cleaning Solution, aspirated from an operator
designated sample cup, is used at least once a day at the end of the day in order to minimize
protein buildup in the fluid lines. A two-point calibration of the ISE module is also done at
least once a day at the beginning of the first sample run. If the user is running more than 50
samples a day, cleaning and calibration must be performed after completion of 50 samples.
The entire double-junction reference electrode is disposable. The reference electrode is filled
with sufficient KCl so that no filling solution must be added during the lifetime of the
electrode. The lifetime of the reference electrode is 6 months or 10,000 samples. No addition
of internal filling solution is required for this electrode.
Electrodes require Calibrant A sampling at 30-minute intervals for reliable operation, but this
is completely controlled by the electrolyte measurement system without any need for operator
intervention.
The electrodes require a 10 times sample dilution for measurement of urine so user has to
keep 10 times diluted (urine sample to urine diluent ratio 1:9) urine sample for the analysis of
electrolytes in urine samples.
It is not necessary to regulate the electrode housing temperature if its environmental

temperature does not exceed 32 °C.
Reagents used in the ISE Module:

The sample is aspirated from a sample cup and dispensed into the sample port at the top of the
ISE module by the sample probe. The sample is then positioned in front of the sensors using
the double detector and the waste pump.
Four reagents are needed to operate the ISE module:
1. Calibrant A: Used as wash solution and single-point calibrator. Calibrant A is pumped

into the sample port by the Calibrant A pump and then positioned in front of the sensors. A
volume of 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 buildup or at 8 hour
intervals if the ISE module performs more than 50 samples per day. Cleaning Solution may
be aspirated from a sample cup. 500 µl is sufficient for one day's requirements.
4. Urine Diluent: This is required for urine samples. Urine samples must be diluted by a
factor of 10 (urine sample to urine diluent ratio of 1:9) to perform urine measurement. The
operator must keep the urine diluent on the Reagent Tray.
A-8
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.
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.
1-7 Shutdown Procedure: Preparing the ISE module for storage
Preparing the ISE module for storage

If the laboratory plans to store the ISE module for a period greater than one week, during
which the analyzer will not be connected to power, the following steps should be
performed:
Before removing the electrodes, they should be cleaned using the cleaning solution and
then running 3 <Purge 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
A-9
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
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.
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 colored 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 colored
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 colored 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.
A-10
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 Troubleshooting
Guide for assistance.
Electrode
Electrode Handle
Compression plate
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).
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:
A-11
Important:
(1) The power switch of analyzer is turned off.

(2) Eight hours have passed since the last ISE calibration.
(3) Environmental temperature has changed more than 4 degrees C since the last ISE
calibration.
(4) More than 50 samples are processed after ISE Calibration in the morning
2-1 Procedure for ISE calibration

Before starting analysis of sample for electrolytes, user should first clean and calibrate the ISE
module. The following sequence should be used for ISE unit calibration:
1. 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:
Figure A-2 ISE Unit Screen
A-12
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 &
tubings. 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
color is displayed. . If slopes are out of range then a box with green color is 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 colored box else it is displayed NOK with red colored box.
14. To perform Bubble Calibration, select the option BUBBLE CALIBRATION and click
A-13
on START button. Bubble calibration allows the module to reestablish 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 colored box else it is displayed NOK with red colored box.
A-14
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-liters of the cleaning solution from sample
port to the ion selective electrodes, dwells until cleaning is completed, pumps Calibrant A to
wash the ion selective electrodes and then acquires single port calibration reading.
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.
A-15
3. ISE Maintenance Schedule

The electrolyte measurement system has been designed to require very little operator
maintenance.
Recommended maintenance/replacement schedule
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
Monthly Maintenance
1. Clean Electrode tip

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

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

2. Change tubing
A-16
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>
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.
A-17
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 Clibration 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.
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
A-18
ISE Error Messages

Digit 1 Digit 2 Digit 3 Digit 4 Digit 5 Digit 6 Digit 7
Error Air / mV Out MV Out mV Noise mV Noise Cal A Out of
Hardware Cal B/ Cal A in Cal B / Cal A in Drift in Slope /
Sample Calib / Sample Calib / Sample, Machine
Sample Sample Slope Ranges
mode, Cal mode, Cal Drift in
B in B in Calib
Urine Urine
Mode mode
Air in Sample S 0 0 0 0 0 0
/ Urine
Air in A 0 0 0 0 0 0
Calibrant A
Air in B 0 0 0 0 0 0
Calibrant B
Air in Cleaner C 0 0 0 0 0 0
Air in M 0 0 0 0 0 0
Segment
Pump Cal P 0 0 0 0 0 0
No Flow F 0 0 0 0 0 0
Bubble D 0 0 0 0 0 0
Detector
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
A-19
Troubleshooting
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 or
Reconnect or replace cable.
damaged
4. ISE Module connector has been
Replace board.
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
Replace Cal B first and retest. If still low
Cl < 40 2. Calibrator solutions
replace Cal A and retest
mV/decade
3. Electrode (low slope) Replace electrodes.
Or
High Slope 4. Air bubble on reference electrode Remove electrode, tap to dislodge
Na or K > 64 membrane bubble, replace, and recalibrate
mV/decade 5. Reference electrode Replace reference electrode and retest
Cl > 55
mV/decade 6. ISE Module or Fluid temperatures Change ISE Module location if ambient
exceed 320 C (high slope) temperature is too great.
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 Module
Replace Board.
board
Noise Error Flag Replace reference electrode and
1. Reference Electrode
Multiple recalibrate
electrodes
a) Check for electrical noise coincident
2. Electrical noise spike from
with activation.
environmental source
b) Check grounding of ISE Module
Replace board.
board.
Drift Error Flag Purge the Cal A and recalibrate the
Single Electrode 1. May occur when new electrode or module. If the electrode is new it may
new Calibrant A is installed initially drift as it rehydrates over the
course of 15 minutes
Appendix B
Troubleshooting
B-20
Troubleshooting
2. Electrode Replace the electrode and recalibrate.
Drift Error Flag 1. May occur when new electrode or
Purge Calibrant A and recalibrate
Multiple new Calibrant A is installed
Electrode
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
board
Air in Sample 1. Insufficient sample pipetted into Host instrument must deliver 70µl.
ISE Module sample entry port. Increase dispensed sample volume.
2. Fluid leaks Determine source of leak and resolve
a) Electrode not seated properly. Remove
3. Sample not positioned properly electrode. Inspect o-rings and reassemble
b) Replace pump tubing
4. Pump tubing obstructed Replace pump tubing
Air in Sample a) Electrodes are not properly seated or
1. Cal B and Cal A are segmented
and Cal A compressed. Check compression plate,
with air
spring and seal. Remove and reassemble
electrodes
a) Use Cleaning procedure <CLEN> for
module
2. Fibrin or salt is plugging the
b) Remove electrode and clean or replace
electrode flow path.
electrode with plugged flow path.
Reinstall electrodes and recalibrate.
3. Bubble detector is malfunctioning Replace bubble detector.
4. Waste pump is malfunctioning Replace Waste Pump
Air in Cal B and a) Electrodes are properly seated. Check

Air in Cal A compression plate, spring and seal.
b) Ensure that all electrodes and o-rings are
properly installed
1. Cal B and Cal A are segmented c) Ensure tubing between reagent module
with air and sample entry port is connected
properly.
d) Replace tubing between reagent
module and sample entry port.
Appendix B
Troubleshooting
B-21
Troubleshooting
a) Use Cleaning procedure <CLEN> for
module
2. Fibrin or salt is plugging the b) Remove electrodes and clean or
electrode flow path. replace electrode with plugged flow path.
Reinstall electrodes and recalibrate.
3. Bubble detector is malfunctioning Replace bubble detector.
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 working b) Replace pump tubing
properly c) Replace motor
d) Replace pump.
Appendix B
Troubleshooting
B-22
Troubleshooting
Appendix B
Troubleshooting
B-23

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Operator’s Manual

Clinical Chemistry Analyzer

XL-200 OM VER: 1.2 Last Updated: 14 t h January 2009

XL-200 OM VER: 1.2 Last Updated: 14 t h January 2009

XL-200 OM VER: 1.2 Last Updated: 14 t h January 2009

XL-200 OM VER: 1.2 Last Updated: 14 t h January 2009

XL-200 OM VER: 1.2 5

Chapter 1 Warning Labels

XL-200 OM VER: 1.2 6

Meanings of warning symbols

XL-200 OM VER: 1.2 7

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

XL-200 OM VER: 1.2 8

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

WARNING ABOUT: PLACES:

XL-200 OM VER: 1.2 9

WARNING FOR SAFE USE

Do not make a modification to the analyzer.

XL-200 OM VER: 1.2 10

XL-200 OM VER: 1.2 11

Chapter 2 Installation Conditions

1 Only qualified personnel should use the analyzer.

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

b) Avoid areas that are adversely affected by atmospheric pressure,

c) Pay attention to inclination, vibration, shock (including shock during

f) Pay attention to frequency, voltage and permissible current (or power

g) Make sure that the analyzer is correctly and well grounded.

h) Connect the analyzer to the operational PC using accompanying LAN cable.

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

b) Ensure that the analyzer is correctly and well grounded.

4. The following cautions should be exercised during operation:

XL-200 OM VER: 1.2 13

pre-use state as directed.

7. Maintenance and checks:

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

XL-200 OM VER: 1.2 14

a) Replace the halogen lamp by a new one after a lapse of 30 minutes

13. Space Requirements:

XL-200 OM VER: 1.2 15

WARNING Indicates a hazardous condition that is associated with using the

BIO HAZARD Indicates a condition involving infectious biological agents

CAUTION Indicates an action or condition that can lead to equipment damage or

Indicates an important general rule that is associated with operating

XL-200 OM VER: 1.2 16

Chapter 3 Technical Specifications

XL-200 OM VER: 1.2 17

3.1 General specifications

• 200 tests/hour (400 tests/hour with ISE) for a cycle time of 18

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

XL-200 OM VER: 1.2 18

• Setting of tests one by one or with profile key for each

• Sample tube barcode ID (NW7, code 39, code 128, 2 of 5

• Water consumption: Less than or equal to 6 liters/hour

• Analyzer – PC: USB bi-directional;

• Touch screen monitor

XL-200 OM VER: 1.2 19

3.2 Installation conditions

XL-200 OM VER: 1.2 20

3.3 Sampling unit

• Can be placed anywhere on the Sample Tray