Operator Manual For ELAN 30s - v2016.00.02

Operator Manual
For
Fully Automated ELISA Microwell Strip Batch

Analyzer
Document Version: 2016.00.02
Last Updated: January 19, 2017
Transasia Bio-medicals Limited, Transasia House, 8 Chandivali Studio Road, Andheri (East),
Mumbai-400072, India
Operator Manual ELAN 30s
Foreword
This manual is organized in a progressive sequence for easy study and reference. It is an
instructional aide to provide a reference for easy operation and general maintenance of
this analyzer. It contains detailed description of the analyzer features and specifications.
The analyzer is used with operational PC and Printer, and can interact with the host
computer. The operational PC consists of the application software for the user to operate
the analyzer.
All the samples and reagents for measurements including samples obtained from patients
are controlled by barcodes enabling the analyzer to perform the entire process of the
analysis automatically.
Use of the analyzer with proper knowledge will ensure quality test results and trouble free
analyzer operation and performance.
This operation manual is prepared based on the assumption that the user has knowledge
of immunology.
Before operating the analyzer, user should:
1. Read and understand this manual.
2. Be trained by authorized person.
3. Be familiar with the operation of the analyzer.
Keep this manual in an easily accessible place.
ii
Legal Information
All rights are reserved by manufacturer of this product.
Manufacturer is the copyright owner of this document.
The contents of this document are subject to change without prior notice and without legal
obligation.
This document and the information herein are provided for the sole use of the intended
recipient(s) and for information purposes only.
This document contains contents which are the confidential and proprietary information of
the manufacturer.
This document cannot be modified, reproduced, translated, or transmitted in any form or

by any means for any purpose, without prior written permission from the manufacturer.
No part of this document can be copied or reprinted, in whole or in part, without prior
written permission from the manufacturer.
iii
Contents
1. Safety Information......................................................................................................... 1-1
1.1. Safety Instructions ............................................................................................... 1-1
1.2. Warning Labels.................................................................................................... 1-2
Precautionary Warning .............................................................................................. 1-3
1.3............................................................................................................................... 1-3
2. Introduction to the Analyzer......................................................................................... 2-1
2.1. Introduction .......................................................................................................... 2-1
2.1.1. Operating Principle..................................................................................................... 2-2
2.1.2. Sequence of Operation .............................................................................................. 2-5
2.2. Analyzer Overview ............................................................................................... 2-6
2.2.1. Front View with Dome Closed .................................................................................... 2-6
2.2.2. Front View with Dome Open ...................................................................................... 2-6
2.2.3. Left Side View ............................................................................................................ 2-7
2.2.4. Right Side View .......................................................................................................... 2-7
2.3. Technical Specification ........................................................................................ 2-8
2.3.1. General Specifications ............................................................................................... 2-8
2.3.2. Reader Specification*................................................................................................. 2-8
2.3.3. Washer Specification.................................................................................................. 2-9
2.3.4. Incubator Specification ............................................................................................... 2-9
2.3.5. Product Specification.................................................................................................. 2-9
2.3.6. Sample Pipetting ........................................................................................................ 2-9
2.3.7. Reagent Pipetting..................................................................................................... 2-10
3. Pre-installation Requirements...................................................................................... 3-1
3.1. Installation Conditions.......................................................................................... 3-1
3.2. Site Requirements ............................................................................................... 3-4
3.2.1. Proper Room Temperature and Humidity .................................................................. 3-4
3.2.2. External Interferences ................................................................................................ 3-4
3.2.3. Proper Room Lighting ................................................................................................ 3-5
3.2.4. Proper Laboratory Cleanliness (Practice) .................................................................. 3-5
3.2.5. Electrical Requirements ............................................................................................. 3-5
3.3. Floor Requirements ............................................................................................. 3-6
4. Installation ..................................................................................................................... 4-1
4.1. Accessories Checklist .......................................................................................... 4-1
4.2. Basic Operational Information.............................................................................. 4-3
4.2.1. Receiving Instructions ................................................................................................ 4-3
4.2.2. Warranty Information.................................................................................................. 4-3
4.3. Unpacking the Analyzer ....................................................................................... 4-4
4.4. Installing the Components of the Analyzer......................................................... 4-13
4.4.1. Installing the Sample and Reagent Tray (SRGT)..................................................... 4-13
4.4.2. Installing Handheld Barcode Scanner ...................................................................... 4-15
4.4.3. Installing DI Water, Wash Buffer and Waste bottles ................................................ 4-15
4.5. Connecting the Analyzer with Computer............................................................ 4-18
4.6. Printer Installation .............................................................................................. 4-18
4.7. Turning on the System....................................................................................... 4-19
4.8. Software Installation Procedure ......................................................................... 4-20
4.8.1. Minimum System Configuration ............................................................................... 4-20
iv
4.8.2. Pre-requisite ............................................................................................................. 4-20

4.8.3. Installing ELAN 30s Software................................................................................... 4-29
4.8.4. Upgrading ELAN 30s Software ................................................................................ 4-36
4.8.5. Installing USB Drivers .............................................................................................. 4-38
4.8.6. Database Utility Options........................................................................................... 4-38
4.8.7. Accessing ELAN 30s Software................................................................................. 4-45
5. Functional Description ................................................................................................. 5-1
5.1. System Description .............................................................................................. 5-1
5.1.1. Sample and Reagent Tray (SRGT) ............................................................................ 5-1
5.1.2. Strip Tray.................................................................................................................... 5-4
5.1.3. Robotic Arm................................................................................................................ 5-5
5.1.4. Washer Assembly ...................................................................................................... 5-6
5.1.5. Photometer................................................................................................................. 5-7
5.1.6. Tip Dispense Box ....................................................................................................... 5-8
5.1.7. Trough Assembly ....................................................................................................... 5-8
5.1.8. Pipette Pump Assembly ............................................................................................. 5-9
5.2. User Interface .................................................................................................... 5-10
5.2.1. Tests......................................................................................................................... 5-11
5.2.2. Search ...................................................................................................................... 5-12
5.2.3. Quality Control.......................................................................................................... 5-12
5.2.4. Service ..................................................................................................................... 5-12
5.2.5. Patient ...................................................................................................................... 5-12
5.2.6. WorkBench............................................................................................................... 5-12
5.2.7. Results ..................................................................................................................... 5-12
5.2.8. Maintenance............................................................................................................. 5-12
5.2.9. Shutdown ................................................................................................................. 5-12
6. Routine Task.................................................................................................................. 6-1
6.1. Starting up and logging on to the System ............................................................ 6-1
6.1.1. Switching on the System ............................................................................................ 6-1
6.1.2. Logging onto the System............................................................................................ 6-1
6.2. Shutting down the Software ................................................................................. 6-2
6.3. Checks prior to Work ........................................................................................... 6-3
6.3.1. DI Water ..................................................................................................................... 6-3
6.3.2. Wash Buffer and Waste Bottle ................................................................................... 6-3
7. Patient ............................................................................................................................ 7-1
7.1. Scan Barcode ...................................................................................................... 7-2
7.1.1. Adding Samples with Handheld Barcode Scanner..................................................... 7-2
7.1.2. Adding Samples without Handheld Barcode Scanner................................................ 7-2
7.1.3. Download Sample Details from the Host PC.............................................................. 7-3
7.2. Manual ................................................................................................................. 7-3
7.2.1. Sample Positions for Reagents .................................................................................. 7-4
7.3. Edit ...................................................................................................................... 7-7
7.4. Delete Text .......................................................................................................... 7-7
7.5. Test Selection ...................................................................................................... 7-7
7.5.1. Assigning Test to the Samples................................................................................... 7-8
7.6. Patient Entry ...................................................................................................... 7-12
7.7. Worklist .............................................................................................................. 7-14
v
8. Test Programming......................................................................................................... 8-1

8.1. New Test.............................................................................................................. 8-1
8.1.1. Manual Entry .............................................................................................................. 8-1
8.2. Open .................................................................................................................... 8-2
8.2.1. Kit Details ................................................................................................................... 8-3
8.2.2. Test Parameters......................................................................................................... 8-5
8.2.3. Test Sequence ......................................................................................................... 8-10
8.2.4. Calculations.............................................................................................................. 8-13
8.2.5. Calibration ................................................................................................................ 8-17
8.2.6. Validation Criteria ..................................................................................................... 8-19
8.3. Initialize.............................................................................................................. 8-21
8.4. Print ................................................................................................................... 8-21
8.5. Delete ................................................................................................................ 8-21
8.6. Copy Test .......................................................................................................... 8-21
8.7. Download........................................................................................................... 8-21
8.8. Upload ............................................................................................................... 8-21
8.9. Exit..................................................................................................................... 8-22
9. WorkBench .................................................................................................................... 9-1
9.1. Available Test ...................................................................................................... 9-2
9.2. Selected Test....................................................................................................... 9-5
9.3. Batch ID ............................................................................................................... 9-7
9.4. Fluidic Check ....................................................................................................... 9-7
9.5. Reagent Layout ................................................................................................. 9-10
9.5.1. List of Tests .............................................................................................................. 9-11
9.5.2. Location of Strips...................................................................................................... 9-11
9.5.3. SRGT Tray Layout ................................................................................................... 9-11
9.5.4. Test Requirements Screen....................................................................................... 9-11
9.5.5. Procedure for Loading Sample, Reagents and Controls on SRGT Tray.................. 9-13
9.5.6. Placing Tips.............................................................................................................. 9-13
9.5.7. Placing Strips ........................................................................................................... 9-14
9.5.8. Starting the Run ....................................................................................................... 9-16
9.5.9. Calibration (for Quantitative tests)............................................................................ 9-20
9.6. Common Reagents............................................................................................ 9-33
9.7. Test Details........................................................................................................ 9-36
9.8. Details of the Qualitative Test ............................................................................ 9-37
10. Results ....................................................................................................................... 10-1
10.1. Test wise Results............................................................................................. 10-2
10.2. Batch wise Results .......................................................................................... 10-4
10.3. Sample wise Results ....................................................................................... 10-4
10.4. Batch wise Results with Date........................................................................... 10-6
11. Search ........................................................................................................................ 11-1
11.1. Patient / Sample .............................................................................................. 11-1
11.2. Test Details...................................................................................................... 11-3
11.3. Doctor .............................................................................................................. 11-4
11.4. TableWise Report ............................................................................................ 11-5
11.5. StripWise Report.............................................................................................. 11-9
vi
12. Quality Control .......................................................................................................... 12-1

13. Maintenance............................................................................................................... 13-1
13.1. Maintenance Intervals...................................................................................... 13-1
13.1.1. Daily Maintenance.................................................................................................. 13-2
13.1.2. Weekly Maintenance .............................................................................................. 13-2
13.1.3. Quarterly Maintenance ........................................................................................... 13-3
13.1.4. Annual Maintenance............................................................................................... 13-3
13.2. Preventative Maintenance ............................................................................... 13-4
13.2.1. Actions Taken in the Event of Trouble ................................................................... 13-4
13.2.2. Equipment Malfunction........................................................................................... 13-6
13.3. Maintenance Screen ........................................................................................ 13-6
13.3.1. Routine ................................................................................................................... 13-6
13.3.2. Records ................................................................................................................ 13-10
13.3.3. Backup ................................................................................................................. 13-11
13.3.4. User Authentication .............................................................................................. 13-13
13.3.5. Configuration ........................................................................................................ 13-15
13.3.6. Span ..................................................................................................................... 13-22
13.3.7. Error Display......................................................................................................... 13-23
13.3.8. Raw Data.............................................................................................................. 13-25
13.4. Washer Calibration ........................................................................................ 13-26
13.4.1. Volume Calibration ............................................................................................... 13-26
13.4.2. Strip Height Calibration ........................................................................................ 13-28
13.5. Decontamination Procedure .......................................................................... 13-29
13.5.1. Washer Decontamination ..................................................................................... 13-29
13.5.2. Probe Decontamination........................................................................................ 13-30
13.5.3. Waste Bottle Decontamination ............................................................................. 13-30
14. Error Codes................................................................................................................ 14-1
14.1. Interpretation of the Error Codes ..................................................................... 14-1
14.2. List of Error Codes ........................................................................................... 14-3
14.2.1. Probe and Robotic Arm .......................................................................................... 14-3
14.2.2. SRGT ..................................................................................................................... 14-9
14.2.3. Strip Tray.............................................................................................................. 14-10
14.2.4. Heater................................................................................................................... 14-11
14.2.5. Washer ................................................................................................................. 14-11
14.2.6. Photometer........................................................................................................... 14-12
14.2.7. Syringe ................................................................................................................. 14-12
14.2.8. Fluid Level Sensing .............................................................................................. 14-13
15. Measurement Error Flag List.................................................................................... 15-1
16. Appendix .................................................................................................................... 16-1
16.1. TBM Image Installation .................................................................................... 16-1
16.1.1. Scenario ................................................................................................................. 16-1
16.1.2. Installing TBM Image into Analyzer PC.................................................................. 16-1
16.1.3. Identifying Various Drives....................................................................................... 16-6
17. Revision History ........................................................................................................ 17-1
vii
Document Conventions
Before reading the manual, please get familiarized with the following icons used in this
manual.
Icons Warning About
Bio-hazard
Electric Shock
High Temperature
Injury
Warnings and Caution
Notes, Usage, Tips, and

Additional information
viii
1. Safety Information
Before operating the analyzer, please read the safety information given in the
manual
1.1. Safety Instructions

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 and analyzer components with

bare hands to prevent operator from possible infection. Handle
SPT nozzle, RPT nozzle, reaction cells, wash nozzles, waste
nozzles and Stirrer paddle in the same way. Always wear
medical rubber gloves to keep skin from direct contact with
patients' samples.
Give special consideration to prevent skin and mucous
membrane from contact with reagents to prevent operator from
possible infection and chemical injuries. Wear medical latex
gloves, goggles, etc. to prevent skin and mucous membrane
from contact with reagents.
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 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.
Read the statements of virtues that came with reagents prior to
their use.
Do not make a modification to the analyzer.
The old halogen lamp should be replaced with the new lamp
only after the analyzer has been kept off for 30 minutes, so as to
avoid danger of burns.
1-1
1.2. Warning Labels

The following warning labels are affixed on the analyzer on different places that
are the potentially hazardous.
LABELS PLACES
On the 5-piece Top Cover Plates
On the 5-piece Top Cover Plates
On top of the front side of SMPS.
On the top cover.
On top of the power entry module
1-2
On the Bio-hazardous waste can

(4 liter)
On DI Water Can (4 liter)
On wash buffer can (1 liter)
1.3. Precautionary Warning

Pipetting of patient samples direct with Probe, especially those samples having
very high concentrations, has a residual risk of contamination of further 1 or 2
samples. Hence results of such further samples following a very high sample are
recommended to be reexamined. However such risks and reexamination can be
eliminated by use of Tips for pipetting of samples. It is up to the Laboratory to
establish the limits for reexamination and to set it’s polices for use of Tips or Probe
directly.
Washing & reusing of the TIPs is not recommended.

TIPs are for single use & user should use new TIPs for every run.
1-3
This Page is Intentionally Left Blank
1-4
2. Introduction to the Analyzer

2.1. Introduction
This analyzer is designed with the needs of modern clinical laboratories in mind
and fits easily into any laboratory environment. The analyzer is a fully automated,
time optimized ELISA batch analyzer.
Once programmed, it is a true walk-away system. The analyzer features user-
friendly operation with minimum operator intervention. It is a highly sophisticated
system and therefore it is of utmost importance that the operator and service
personnel reads the instructions carefully and becomes familiar with the operation
theory.
The working unit consists of a state of the art photometer and sophisticated
robotics combined with an Operating Console and Data Processing Unit (DPU).
This unit is connected by an USB bi-directional interface to the Analyzer PC, the
work schedule is transferred from the Analyzer PC to the analyzer, and after
executing the schedule as per the programmed sequence, the photometric results
are then transferred back to the Analyzer PC where the results are processed,
stored, and then reported.
The robotics consists of Robotic Arm (RA), Sample & Reagent Tray (SRGT), Strip
Tray (ST), Washer, Photometer (PHM), Sample - Reagent Probe, and Sample -
Reagent Syringe Assembly.
The Sample and Reagent tray consists of 59 sample tube positions for loading
patient samples, 1 sample tube position for cleaning solution(60), 30 vial positions
for controls & calibrators and 24 positions for reagents (Reagents can also be
programmed to be placed at Sample position 41 to 58).
Routine samples can be loaded as primary tubes.
Samples have a Barcode identification system. Bar coded sample tubes provides
positive sample identification and minimizes risk of human errors.
Other technical features of the analyzer:
 Unique soft start and stop of all mechanical assemblies, ensures smooth
operation and adds reliability.
 Software routines provide the user with all functions to run the analyzer.
 The user-friendly software continuously provides help & assistance to the
operator.
 The Sample & reagent probe’s vertical obstruction detection (VOD) system,
detects obstructions, thereby protecting the probes from potential damage.
 Capacitive level sensing ensures accurate level detection.
2-1
Advantages of the ELAN 30S analyzer:

 The Analyzer Sample & Reagent tray ...flexibility and convenience
The routine circular tray has positions to accommodate up to 59 routine
samples and 30 positions for standards, controls and calibrators and 24
Reagents.
The sample tray can accommodates standard tube sizes of 12mm X
75mm (5ml) tubes.
The analyzer reagent tray offers a 20ml of reagent bottles.
The analyzer offers up to 24 reagent bottles for loading at beginning of
RUN. All reagents are to be stored in refrigerated environment as
recommended by the reagent manufacturer to ensure extended stability.
The analyzer economy ...quick returns without compromise.
 The analyzer barcode identification
The handheld barcode sample identification minimizes programming time.
Bar-coded sample tubes provide sample identification.
 The analyzer optical system ensures reliability of results
The analyzer uses narrow bandwidth wavelength specific filters to ensure
high degree of photometric accuracy. The user can select from 4 available
wavelengths, from 405 nm - 630 nm to cover the entire clinical immunology
application range. (In addition 3 optional wavelengths can be supplied)
The long life quartz halogen light source and the wavelength specific
photodiode complete the photometric system of the analyzer.
2.1.1. Operating Principle

2.1.1.1. Measurement and Photometry
The ELAN30s analyzer is a Fully Automated ELISA Microwell Strip batch analyzer
based on the principle of vertical photometry, which measures light transmittance at
various wavelengths.
White light is actually composed of seven colors. This becomes evident, when we
pass a beam of white light through a prism. If the light emerging from the prism on
the opposite side is allowed to fall on a screen, we would see a wide spectrum of
colors, beginning with red on the top and ending with violet at the bottom. The
colors visible in between are in the order of indigo, blue, green, yellow, and orange.
2-2
Incident or white light contains the entire spectrum, objects that appear colored,
absorb light at a particular wavelength, and reflect others, thus giving different
colors. That is color is a function of its wavelength.
Light having a wavelength of less than 400 nm is termed Ultraviolet, whereas light
having a wavelength greater than 800 nm is described as Infrared, both ultraviolet
and infrared lights are invisible to the human eyes. Light corresponding to
wavelengths between 400 nm and 800 nm is visible to the human eye and is
termed as visible light.
2.1.1.2. Principles of Absorption Photometry

Beer’s Law
If light is allowed to pass through a colored solution, the solution will absorb some
light while the rest of it will be transmitted. The amount of light absorbed is
proportional to the nature, concentration and color of the solution. (Light absorbed
Concentration of the solution).
Lambert’s Law
The light absorbed by the colored solution is directly proportional to the light path
of the color solution (diameter of the cuvette): that is if the cuvette diameter is
doubled, the light absorbed will be doubled.
2-3
Since the total incident light = light absorbed + light transmitted, it follows that:
Therefore as the absorbed light (Absorbance) increases, the transmitted light will
decrease
As we increase the concentration of the colored solution, the light absorbed
increases, and we find that the transmittance varies inversely and logarithmically
with concentration.
Using the above formula, for different percentage of transmittance we obtain the
following absorbance.
Percentage Transmittance Absorbance
100 0.000
50 0.301
25 0.602
12.5 0.903
2-4
The study of the correlation between the concentration of a colored liquid, the
intensity of its color and the amount of light absorbed by the colored solution is
termed as Colorimetry.
Useful Information:
Percent Absorbance Absolute Error Per Cent Relative Error
10 1.000
11 0.959 0.041 4.1
45 0.347
46 0.337 0.001 2.9
90 0.046
91 0.041 0.005 10.9
95 0.022
96 0.018 0.004 8.2
The relative error is minimal at an absorbance of 0.434 (36.8 %T). Consequently,
methods should be designed such that readings fall near the center of the scale,
preferably within an absorbance of approximately 0.1 and 0.7 (20 and 80%T).
2.1.2. 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 pipette into the well along with
the reagent; this reaction is then read at the end to obtain their optical densities.
The entire operation mainly consists of the following sequence. (This sequence
depends on the programming of parameter).
1. Sample Pipetting
2. Reagent Pipetting
3. Washing
4. Photometer Reading
2-5
2.2. Analyzer Overview

The images used in the manual are of indicative nature and may
not reflect the final component due to continuous development of
the product.
2.2.1. Front View with Dome Closed
2.2.2. Front View with Dome Open
2-6
2.2.3. Left Side View
2.2.4. Right Side View
2-7
2.3. Technical Specification

The specification details are subject to change without prior
notice.
2.3.1. General Specifications

Item Description
Sample Serum / Plasma.
Measurement Principle Colorimetry (End Point).
Applicable Analytes Photometric Assay.
Antibodies, Antigens, Hormones, Cancer markers and others
Biomarkers.
Test Method Absolute measurement.
On Board Tests Max of 6 different tests can be programmed On-board (considering
an average of 4 Reagents per test and average of 5
Standards/Controls per test)
Assay Modes End-Point Assay – Qualitative, Quantitative and Semi Quantitative.
Reaction Time Depends on the assay protocol of different tests.
Reaction Volume Maximum 200 µl.
Test Selection Programming of the Batch of test is done using Workbench module.
Group Test entry is possible using Profile Option. Workbench entry
from host computer via interface (User selectable)
Barcode Identification Sample tube barcode ID Using Handheld CCD Barcode. Allowed
barcode types - Code 39, UPC A, Code 128 (A, B, C), EAN8,
Interleaved 2 of 5, NW7.
Quality Control QC reports are generated using LJ Chart / CV Evolution / O.D
Evolution / Conc. Evolution and Multi Rules.
Calibration Curve Point-to-Point, Linear Regression, Polynomial Regression, Cubic
Spline, 4PL etc.
Maintenance Wash (Auto Wash, Probe Wash), Prime, Strip cleaning.
2.3.2. Reader Specification*

Item Description
Wavelengths 4 standard (405nm, 450nm, 492nm, 630nm) and 3 Optional

(550nm, 595nm, 690nm)
Photometric Range 0.000 to 3.000 OD (At 405nm & 450nm)
(Dynamic)
Precision At 405nm and 450nm :
< 5% CV at 0.1 to 0.5 OD
< 2% CV at 0.5 to 2.0 OD
< 3% CV at > 2.0 OD
Accuracy ± 3% OD at 0.25 OD to 2.5 OD
Read Time 20 seconds / Strip for single wavelength
2-8
Linearity At 405nm & 450nm:

0.1 to 3.0 OD with R² > 0.95
* Stated values are with color solution in uncoated strip.
2.3.3. Washer Specification

Item Description
Manifold Configuration 8-way wash head
Residual Volume < 8 µl
Waste Container 1 waste container of 4.0L, 1 DI container of 4.0L 2 Wash bottles 1.0L
and 1 Optional wash buffer bottle 1.0 L with Level Sensing (Using
Float Sensors)
2.3.4. Incubator Specification

Item Description
*
Temperature Range 37 °C or Ambient (Heater OFF)
Temperature Accuracy ± 2 °C
Warm-up Time 20 minutes
* It is assumed that the standard Lab temperature is maintained in the range of 25-28 °C
2.3.5. Product Specification

Item Description
No. of Strips 30
No. of Sample Tubes 59
No. of Reagents 24
No. of Standards/Controls 30
Total no. of Tips 204
2.3.6. Sample Pipetting

Item Description
Sample Tip Size 300µl
No. of Sample Tips 180
Sample Pipetting Volume 5 µl – 100 µl
Standards/Controls Tube 1ml
size
Sample Tube Dimensions 12mm X 75mm (5ml)
Dead Volume for Samples 240 µl
Tube
Dead Volume for 180 µl
Standards/ Controls
Dead Volume for 1.1 ml
Reagents
Sample Pipetting Time With Tips: 12 minutes (100 µl in 96 wells)
With Probe: 12 minutes (100 µl in 96 wells)
2-9
Sample Pipetting Precision With Probe:

(Probe) < 2% CV at 10 µl
< 1% CV at 100 µl
Sample Pipetting Accuracy +/- 5% of the Target Volume for 10 µl
(Probe) +/- 2 % of the target volume above 50 µl
Sample Pipetting Precision < 3.5% CV at 10ml
(Tip) < 2.0% CV at 100ml
Sample Pipetting Accuracy +/- 5% of the Target Volume for 10ml
(Tip) +/- 2 % of the target volume above 50ml
2.3.7. Reagent Pipetting

Item Description
Reagent Tip Size 300 µl
Number of Reagent tips 24
Reagent Pipetting Volume 10 µl – 200 µl
Dead Volume for 1200 µl
Reagents
Reagent Bottle sizes 8ml/12ml
Reagent Pipetting +/-2 % of the target volume above > 50 µl
Accuracy (Probe)
Reagent Pipetting < 1% CV at 100 µl
Precision (Probe)
Reagent Pipetting Time < 8 minutes. (100 µl in 96 wells)
Lab temperature is recommended to be in the range of 25-28°C.
2-10
3. Pre-installation Requirements
Before installing the analyzer, you must follow the pre-installation requirements to
ensure the accuracy and precision of the analyzer.
The proper location is an important consideration. Poor location can lead to
malfunction of the analyzer.
3.1. Installation Conditions

The user is requested to read this instruction before using the analyzer for the first
time and get acquainted with operation of the analyzer.
1. Only qualified personnel should use the analyzer.
2. When the analyzer is installed, the following precautions should be taken.
a. Keep the analyzer away from 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. Use level indicator for ensuring that 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. Connect the analyzer to the operational computer using accompanying
USB cable.
h. If any other cable is used, it may cause the analyzer to suffer from
disturbing noise, exert an adverse effect on its surroundings, or get
incorrect measurement results.
3. Before operating the analyzer, you must follow the necessary instructions.
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
3-1
danger to the analyzer or human body when the analyzer in conjunction

with other equipment.
4. The following cautions should be exercised during the operation of analyzer.
a. Pay attention not to exceed the time and volume necessary for
diagnosis.
b. Keep monitoring the behavior of the 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 the patients.
5. The following cautions should be exercised after the use of the analyzer.
a. Turn off the power after every operation/end of day, so that control is
restored to its previous state as directed.
b. Do not remove the line cord plugs from receptacles by pulling the cords
so that no undue stress is developed in the cords.
c. Pay attention to the storage area.
i) Keep the analyzer out of the rain and any other water splash.
ii) Avoid areas that are adversely affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust, and air containing salt,
sulfur, etc.
iii) Pay attention to inclination, vibration, shock (including shock during
transportation), etc.
iv) Avoid areas adjacent to the storage room of chemicals or areas that
are likely to generate gases. Avoid areas that are likely to be subject to
inclination, vibration, and shock.
d. Organize and store parts and cords associated with the analyzer after
they have been cleaned.
e. Keep the analyzer clean to avoid any inconvenience for the next use.
6. In the event of trouble, do not fiddle with the analyzer. You must contact the
authorized service personnel for troubleshooting.
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.
3-2
8. The following cautions should be taken when using and handling the
reagents:
a. After unpacking the reagents, be sure not to allow contamination of
reagents (e.g. dust, dirt etc.).
b. Do not use reagents that are expired.
c. Handle reagent gently to avoid formation of bubbles.
d. Take care not to spill the reagent. If it spills, wipe it off immediately using
a wet cloth.
e. Follow other instructions described in the package insert on each
reagent.
f. If a reagent happens to enter your eye, wash it off immediately using
plenty of water, and take medical treatment at once.
g. If you swallow it inadvertently, call for a doctor immediately and drink
plenty of water.
Some reagents are strong acids or alkalis. Exercise great h
care so that your hands and clothing do not come into
contact with reagents. If your hands or clothing come into
contact with either reagent, 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.
Prohibit any alteration and/or modification to the analyzer without
permission from the manufacturer.
9. The following precautions should be taken for preventing infection due to
sample handling:
Do not touch the samples, mixtures, & waste liquids with
bare hands. Be sure to wear gloves to protect you from
coming in contact with infectious sample. 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.
10. The following precautions should be taken for disposing the bio-hazardous
waste:
Treat the drain water as infectious waste. Collect the drain
water in reserve can & allow it to be disposed off by expert
distributors.
11. Space Requirements:
Analyzer dimensions:
3-3
Dome close
754mm ( L) x 532mm (B) x 535mm (H)
Dome Open
754mm ( L) x 532mm (B) x 888mm (H)
3.2. Site Requirements

Only a trained service representative should install the analyzer.
Contact your local service representative for the installation and
relocation of the instrument.
Problems resulting from the installation and relocation of the
analyzer by anyone other than an authorized service
representative will not be covered under warranty.
A proper installation location is very important for accurate functioning of the
analyzer. It is advised to make sure that the environmental and electrical conditions
are met as recommended below to ensure accuracy and precision of the analyzer,
as well as to maintain a high level of safety for the operator.
Please leave a minimum of 0.25 meter space on the left and right sides, the rear,
and top of the analyzer for easy operation as well as maintenance and service.
The pre-installation site requirements are given below in more details.
3.2.1. Proper Room Temperature and Humidity

 The recommended temperature of the laboratory should be between 25°C
to 28 °C.
 There should not be a variation of more than 2 °C in room temperature per
hour.
 The relative humidity should be in between 40% to 80% and should be non–
condensing.
3.2.2. External Interferences

 Heavy-duty electrical devices like air conditioners, refrigerators, ovens,
centrifuges etc. should not be operated on the same electrical lines or in the
close vicinity of the analyzer.
 The room should be free of vibrations from heavy duty devices like
centrifuges and compressors.
 The room should be free from strong magnetic fields caused by other
medical equipment, like CT Scans, MRI etc.
 In case of any other external interference, the instrument may get hanged or
stopped. In such condition, manual intervention is required to restart the
instrument.
3-4
3.2.3. Proper Room Lighting

 There should be sufficient room lighting to enable efficient operator use and
clear visible access to the internal components of the instrument during
servicing.
3.2.4. Proper Laboratory Cleanliness (Practice)

 The instrument and the surrounding area should be maintained clean and
regularly decontaminated to prevent contaminating yourself and others.
 There should be no spillage of Serum, Reagents, Waste, or de-ionized
water.
 Make sure that no Reagents or Samples are placed on top of the analyzer
or trolley as they could spill causing a permanent damage to the analyzer.
3.2.5. Electrical Requirements

A proper grounding is highly essential for safety and proper functioning of the
analyzer.
3.2.5.1. Voltage and 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.
3.2.5.2. 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).
3.2.5.3. Plug Points

Four sockets of 5 Amp capacities must be available near the analyzer (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, refrigerators, ovens etc. should
not be operated on the same electrical lines as the analyzer.
Improper grounding to the analyzer bypasses the important safety
features and may results in electric hazard.
3-5
The 3 pin power cord plugs shipped with the analyzer, computer,
printer and monitor may not be compatible with the local electrical
sockets of some countries. Procure it from the local market prior
to the installation.
3.3. Floor Requirements
3-6
4. Installation
4.1. Accessories Checklist
The manufacturer reserves right to change the accessories
supplied with ELAN 30s analyzer without notice.
The main unit and accessories are packed in separate cartons. Authorized
representative is responsible for unpacking, installing, and initial setting up of the
analyzer.
Serial Item
Description Quantity
Number Code
FLS BOTTLE BOX
FLS BOTTLE (4 LIT.) ASSEMBLY WITH LEVEL SENSOR 1 No.
1
108317 FOR DI WATER
2
106540 FOR WASTE
3
106532 FOR BUFFER - 1
FLS BOTTLE (1 LIT.) ASSY. WITH LEVEL SENSOR FOR 1 No.
4
108323 BUFFER - 2
FLS BOTTLE (1 LIT.) ASSY. WITH LEVEL SENSOR FOR 1 No.
*5
108326 BUFFER - 3
6 111787 TUBING SET FOR FLS BOTTLE ASSY 1 Set
7 108026 BOTTLE TRAY 1 No.
8 106490 ASSEMBLY FOR SRGT 1 No.
9 107878 SRGT COVER 1 No.
10 107877 STRIP TRAY COVER 1 No.
11 120958 ERBA Auto Wash (10x100ml) 1 No.
SHIPPER BOX
12 120161 PLASTIC TEST TUBES(12MM X 75MM) 60 Nos.
13 114452 TIP BIN CONTAINER FOR ELAN 30 Nos.
14 130053 VAILS CAP: 2ML 50 Nos.
15 111967 20ml WIDE MOUTH REAGENT BOTTLE 50 Nos.
SAMPLE TIPS - BLACK NIGHT , ARTICLE NO. 49000-
16 113591 192 Nos.
0000; 300ul, One pack/rack of 96 tips : RITTER MAKE
17 111784 WHITE COLOUR UNCOATED STRIP 1 No.
18 115177 TEST TUBE (12mm X 75mm LONG) BLACK 3 Nos.
114769 CABLE USB JUMPER USB2.0 28x1P+ 24x2C - USB A to 1 No.
19 B 2.0 version WITH FERRITE CORE (BOTH SIDE A,B )
1.8 meter
POWER CORD INDIAN PLUG ST 250VAC/6A - IA6A3 3 x 1 No.
20
106046 0.75 sq. mm 1.8 mtr. Length
4-1
Serial Item
Number Code
*21 109788 HAND HELD BARCODE SCANNER 1 No.
22 170016 UNCOATED STRIP PLATE 1 No.
ADAPTOR FOR MICROCENTRIFUGE TUBE 10 Nos.
#23
113651 (EPPENDROF)
TOOL KIT
24 101494 PLASTIC TOOL BOX 1 No.
25 101688 SCREW DRIVER X100L CR-V CARBON TIP (1 No) 1 No.
26 101687 SCREW DRIVER X100L CR-V CARBON TIP (2 No) 1 No.
27 101689 SCREW DRIVER IMPORTED ( - ) NO.3 1 No.
28 101675 NUT DRIVER 5.5 MM FOR M3 1 No.
29 101676 NUT DRIVER 7.0 MM FOR M4 1 No.
30 101495 BOX SPANNER (10 -11MM) 1 No.
31 101692 ALLEN DRIVER (M3) 2.5 MM T TYPE-9" LONG 1 No.
HEX BALL ALLEN KEY SET CONSISTING OF 1.5mm,
34 111604 2mm, 2.5mm,3mm,4mm ,5mm ,6mm ALLEN KEYS WITH 1 Set
PLASTIC HOLDER & BLISTER PACKING
35 101514 NOSE PLIER 1 No.
36 101515 FLAT SPANNER 10 / 11 1 No.
37 101524 FLAT SPANNER 14-15 MM 1 No.
38 100323 METALLIC FORCEP 2A-SA (NOSE WITH RADIUS) 1 No.
39 100295 TRIMMER 933 NO 1 No.
40 101516 SPANNER SET SIZE: 1 to 8 Nos. 1 No.
41 101678 6" ADJUSTABLE SPANNER 1 No.
42 100294 TUBE CUTTER --( LEGRIS-MAKE) 1 No.
43 109350 KNOB FOR STRIP TRAY 2 Nos.
PM KIT
44 101677 PROBE CLEANER 1 No.
45 111755 PHOTOMETER LAMP ASSEMBLY 2 Nos.
46 107815 SET OF FUESES 1 Set
47 107180 25micron FILTER FOR DI 4 Nos.
48 107179 25micron FILTER FOR BUFFER 10 Nos.
1/8-27 NPT Thread with 7/16" Hex to Classic Series Barb, 1 No.
49 107170
3/16" (4.75 mm) ID Tubing;. 1850-1
NUT PANEL MOUNT 1/4-28 UNF WITH 7/16" HEX
50 100884
PMSN-X0 5 Nos.
PANEL MOUNT CONNECTOR, 1/4-28 UNF TO 200
51 107881
SERIES BARBS, 1/8"(3MM) ID TUBING,; PMS230-1 5 Nos.
52 -- OPERATOR MANUAL FOR ELAN 30S 1 No.
4-2
Serial Item
Number Code
53 -- SOFTWARE CD 1 No.
54 109375 HYDRAULIC DIAGRAM (ELAN 30s) With BOM Rev.07 1 No.
55 -- FQC report 1 No.
* - Optional (As per the customer’s requirement)
# Recommended Micro centrifuge Tube of 2.0ml “Tarsons/Eppendorf” make to be used with the ADAPTOR
FOR MICROCENTRIFUGE TUBE (EPPENDROF)
4.2. Basic Operational Information

4.2.1. 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:
 Check to see that the arrows on the sides of the packages are pointing up.
If the arrows do not point up, make a remark about this on the invoice copy.
 Visually inspect the outside of the package for rips, dents, or possible
shipping damage. Document any sign of damage on the bill of landing,
regardless of how insignificant it may appear. This is to protect your
interests.
 Notify your service representative that the analyzer system and its
components have arrived. Wait for your local service representative to
unpack the system and open the packages.
 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.
4.2.2. Warranty Information

All analyzers are warranted against defective materials or workmanship for a
period as agreed by manufacturer.
This warranty does not cover any defect, malfunction or damage due to:
 Accident, neglect, or willful mistreatment of the product failure to use,
operate, service, or maintain the product in accordance with the applicable
Operator Manual and Service Manual.
 Use of reagents or chemicals of corrosive nature.
4-3
4.3. 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 unpack the analyzer:

1. Remove the wooden box panels by loosening the bolt of the pallet for all the
four sides.
4-4
2. Remove the corrugated sheets and corrugated box.
3. Cut all the packing tape and remove the top, side, and outer buffer from
covering the analyzer.
4-5
4. Unscrew the analyzer clamps simultaneously as it supported above the

wooden pallet
4-6
5. Remove the clean film and masking tape from the analyzer outer body
6. open the drawer and take out the lifting handle
7. Screw the lifting handle (4 Nos) in the thread provided on the both side of
the analyzer (to shift the analyzer in working place).
4-7
8. Open the rear panel (bearing the serial No. plate).
9. Remove the packaging buffer sheet placed below the pump mounting &
stickers from the rear panel & dome front side.
4-8
10. Open the dome for unpacking the Robotic ARM, Photometer and Washer
11. Unscrew (2 Nos pan head screw) strip tray-washer packing bracket bearing
caution sticker.
12. Remove the masking tape and front packing buffer of the washer by slightly
lifting washer in upward direction.
4-9
13. Remove washer needle packing cap from washer manifold by slightly lifting
the pull out the cap slowly so that needle should not get damage
14. Remove masking tape from photometer.
15. Remove masking tape from buffer1 & buffer2
16. To remove Buffer1 from robotic ARM rotate the clockwise direction inside
the ID of the container .Remove Buffer2 by pulling up side after removing
the Buffer 1.
4-10
17. Unmask the tape from robotic ARM to remove Probe packing cap from its
location
18. Remove the masking tape from right side panel to unfix drain collection tray
19. Remove nozzle plugs.
4-11
20. Connect the DI, Waste, Buffer bottles to the analyzer. Follow the color
coding for tube & connector placement
21. Connect the power supply & PC, Analyzer will initialize. The disposable tip
used for packing probe will be ejected at the tip ejected at the tip ejecting
location
22. Place the analyzer at the desired place keeping in view the floor
requirement given in section 3.3 Floor Requirements.
4-12
4.4. Installing the Components of the Analyzer

The installation of the analyzer’s components should be performed by
the authorized service engineer.
4.4.1. Installing the Sample and Reagent Tray (SRGT)

Use the following steps for installing the Sample and Reagent tray:
1. Unpack the Sample and Reagent tray from the accessories box.
2. Rotate the Robotic arm towards Strip Tray to facilitate the insertion of SRGT
tray into the container.
3. Ensure that the index pin on the shaft assembly slides into the index hole
provided at the bottom of sample and reagent tray.
Figure 4-1 SRGT container
Figure 4-2 Bottom view of SRGT tray
4-13
4. Gently place the sample and reagent tray into the container on the
aluminum shaft.
5. After placing the sample and reagent tray into the container, hold the nut on
SRGT tray and slowly rotate it in clockwise/anticlockwise direction. The
index pin will now slide into the index pin hole.
6. Tighten the nut on SRGT tray by rotating it clockwise. Note that the nut will
not get engaged in the shaft if the index pin has not slide properly into the
index pin hole.
7. Unpack the Sample and Reagent tray lid, and place it over the Sample and
Reagent Tray.
8. Make sure that the notch on the SRGT lid fits into the cut provided on the
container.
4-14
4.4.2. Installing Handheld Barcode Scanner

Use the following procedure for connecting the Handheld Barcode Scanner:
1. Unpack the handheld barcode scanner from the accessories box.
2. Connect handheld barcode scanner USB cable to USB Port of the
analyzer PC.
3. After connecting the handheld barcode scanner, it is ready to use.

The handheld barcode scanner/reader is a Plug and Play device.
You do not need to install any device driver software.
4.4.3. Installing DI Water, Wash Buffer and Waste bottles

1. Unpack the Float Sensors for the 4 bottle and place them on one side.
2. From the accessory box remove the 4 liters DI Water bottle, 4 liters Waste
bottle, 1 liters Wash Buffer 1 bottle, 1 liter Wash Buffer 2 bottle, Wash Buffer
3 bottle and put them on the floor.
4-15
3. Unpack Float Sensors cables and connect one end to switch provided on
the right side of the panel and connect other end to the respective
BOTTLES (float sensor with blue sleeves for DI WATER, yellow sleeves for
WASH BUFFER 1, green sleeves for WASH BUFFER 2, and black sleeves
for WASH BUFFER 3, red sleeves for WASTE).
4. Fill the DI Water can with 4 liters of fresh DI water and unpack the tubing
from the accessory box.
5. Take two separate tubes and connect one end of one tube to the blue
ringed outlet marked IN and connect one end of another tube to the white
ringed outlet marked OUT. Connect other ends to the 4 liter DI WATER
BOTTLE on the steel nozzle and blue ringed nozzle. (Tube coming from the
blue ringed outlet marked IN should be connected to steel nozzle and the
tube from the white ringed outlet marked OUT should be connected to blue
ringed nozzle on the BOTTLE).
It is must to have proper connection of DI Water tubing to
proper water flow in washer manifold & probe..
6. Now, fill 1 liters Bottles with the cleaning solution. (Prepared as directed in
KIT insert)
7. Take another separate tube and connect one end to the yellow ringed outlet
marked IN and other end to the 1 liter WASH BUFFER 1 BOTTLE on the
steel nozzle.
8. Now take a tube and connect one end to the green ringed outlet marked IN
and other end to the 1 liter WASH BUFFER 2 BOTTLE on the steel nozzle.
9. Similarly, use the same procedure to connect the WASH BUFFER 3
BOTTLE (optional) on the steel nozzle, if required.
10. Now connect the silicon tube to the analyzer outlet marked WASTE marked
OUT and connect the other end of the tubing into the nozzle of 4 liter Waste
bottle.
4-16
Take care that all the above-mentioned tubes reach their

respective containers without any sharp bends or obstructions.
The waste consist of a natural drain, it is very important that the
waste tube from the rear of the analyzer to the Waste bottle, 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).
4-17
4.5. Connecting the Analyzer with Computer

Follow these instruction to connect the analyzer from the computer:
1. Unpack the USB cable from the accessories box, and connect one end to
the appropriate USB port of the computer and other end to the USB
connector located on the right side of the instrument, as shown in figure
below.
2. Connect one end of the power cord to the analyzer’s power inlet and other
end to the main power supply as shown in figure above.
Make sure that the On/Off power button should be in OFF
condition before turning on the main power supply.
After connecting the power cord and USB cable with the analyzer, turn on the
main power switch, and then turn on the On/Off power button on the analyzer.
4.6. Printer Installation

Check for following points before using application software to generate printouts:
1. Check that the English printer driver is installed. Follow the selected printer
installation procedure.
2. Check that the cable between printer and the analyzer PC is connected
properly.
3. There should be no paper jam or any other obstruction in the printer.
4. Feed the paper to the printer and switch it ‘ON’.
5. Print a test page to confirm correct printing.
4-18
4.7. Turning on the System

Perform the following verification before starting the equipment:
1. Verify the connections to Waste bottle.
2. Verify connection to DI Water bottle.
3. Verify connection to Wash Buffer bottles.
4. Verify the placement of all covers on SRGT and Strip tray unit.
Once the verification is done, follow this procedure for starting the equipment:
1. Connect the necessary connections between computer and analyzer.
Before turning ON the instrument, ensure that there is no
interfering material/hardware or operator near the trays and
robotic probe arm assembly.
2. The analyzer's power switch is located on the side panel.
3. To turn on the instrument, press the ON/Off power switch.
On turning ON the instrument, all the assemblies will initialize to their home
positions. The entire process may take 2-3 minutes approximately.
4. Now, turn on the computer that is connected to the main unit.
5. Turn on the Printer and handheld barcode scanner (optional), as and when
required.
In case if analyzer is not connected to PC or not switched
ON, following error will occur:
6. Start the ELAN 30s software, if installed in the computer else install the
software. For communicating with the analyzer, you must install the
software. (Refer section 4.8 Software Installation Procedure for installation
procedure in more detail).
When the ELAN 30s software is started, the screen resolution will
automatically initialize to 1024*768 to give best operating experience.
Software makes this setting on start-up automatically. Only if
the PC driver is not supporting the change then the user will
have to do it manually.
4-19
4.8. Software Installation Procedure

This section guides you through the installation and un-installation procedure of
Elan30s application. You must read the instructions before installing the software.
4.8.1. Minimum System Configuration

Processor Intel Core 2 Duo processor
Operating System Microsoft Windows 7
Embedded
Hard Disk 80 GB or above
RAM 2 GB or above
Monitor 17 inch TFT color.
Supporting 1024 X 768
resolution
Printer Laser Jet / Desk Jet
4.8.2. Pre-requisite
4.8.2.1. PC Settings Required for Windows 7
PC Settings will be applied automatically while installing the
customized image of Windows 7 Embedded as Operating System.
* A customized image of Windows 7 Embedded is provided as
Operating System for Analyzer PC.
 Remove all memory resident software including anti-virus software from the
Analyzer PC if available. To do this use the following procedure:
Click Start button, and click Control Panel. Now, under the Category view,
go to Programs > Programs and Features. Select the desired anti-virus
software from the list, and click Uninstall.
 Remove firewall, automatic update, other security software and from the
Analyzer PC.
go to System and Security > Windows Firewall, and click on the link Turn
off Windows Firewall on or off. Now select the option Turn off Windows
Firewall (not recommended), and then click OK button.
To turn off automatic updates, under Control Panel, go to System and
Security > Windows Update, click on the link Change settings, and select
the Never check for updates (not recommended) from the drop down list,
and click OK.
 Do not run any other application on the Analyzer PC during batch run on
Analyzer PC.
4-20
 Ensure that a default printer (Laser Jet / DeskJet) is configured and

connected to Analyzer PC. Appropriate printer should be set as default
printer.
 Delete the “Microsoft Office Document Image Writer” from the system.
go to Hardware and Sound > Devices and Printers. Right click on the
Microsoft Office Document Image Writer, and choose Remove Device to
delete.
 Disable Screen-savers and Power Management from the analyzer PC
before starting the application software.
Use the following procedure for disabling the screen saver and power
management:
a. Open Screen Saver Settings by clicking the Start button, clicking
Control Panel, clicking Appearance and Personalization under
Category view, clicking Personalization, and then clicking Screen
Saver.
b. To turn off all screen savers, under Screen Saver, select (None) from
the drop-down list, and then click OK.
c. Now click on the link Change power settings (Applicable only if option
is available). The following screen will be displayed.
4-21
d. Click on Balanced Change plan settings.

 Set Turn off the display to Never
 Set Put the computer to sleep to Never
e. Click on Change advanced power settings.
Set Turn off hard disk after to Never
4-22
Similarly apply same settings to power saver option. Repeat the step c
to e.
 User account control settings
f. Open User Account Control Settings by clicking the Start button, and
then clicking Control Panel. Under Small or Large icons view, click on
User Accounts and then click Change User Account Control
settings.
4-23
The following screen will be displayed:
g. Move Pointer to Never Notify and click OK.

You must re-start the analyzer PC to turn on the User Account Control.
 Regional and Language Settings
Use the following procedure for setting the regional and language options:
Ensure that the following regional and language settings are appropriate.
Note that these are critical settings for the communication with the analyzer.
Go to Settings > Control Panel > Clock, Regional and Language
Options > Change the date, time and number format.
4-24
h. Following should be the settings for Formats tab:
i. To set Number and Currency Click on Additional settings
4-25
j. Following should be the Location tab:
4-26
k. The above screen should be the Language tab.
4-27
l. Click on Change Keyboards. The following screen will display:
m. Following should be the settings for Administrative tab:
4-28
4.8.3. Installing ELAN 30s Software

To install the Elan30s software you must be logged on as an
“Administrator”. The normal user does not have the rights to
change/install any software.
Follow the instructions in this section in case you are installing the software for the
first time on the computer i.e. there is no previous installation of the software on
the computer.
Refer to section 4.8.4 Upgrading ELAN 30s Software to upgrade ELAN 30s
software from existing version to the new version.
The software installation CD contains the following folders and files:
1. Elan30s Database Utility
2. Setup
3. USB Driver
4.8.3.1. Installing ELAN 30s

Follow these instruction for installing the application:
1. Open Setup folder from the software installation CD. The following window
will be displayed.
2. Double-click on the setup.exe. On clicking, the following screen may be

displayed.
4-29
The following screen will appear in case Crystal Reports for

.NET framework 2.0 is not already installed on your
computer.
3. Click Accept to continue.

On clicking, the following screens will be displayed in a sequence.
Wait until the progress bar is complete and the following screen appears on
the screen.
4-30
4. Click Next.
The following screen will be displayed. The installer will install the software
in the default location C:\Elan30s\. It is recommended to install the software
in the default location. To install to a different location enter the appropriate
location or click Browse.
The installation in a location, different from the default one is
not recommendable.
4-31
5. Ensure that “Everyone” is selected, and click Next.
6. On clicking, a window will be displayed to confirm the installation. Click

Next to proceed.
4-32
7. On clicking, the installation is started and the status will be displayed, as

shown below.
Once the installation completes, the software icon will be created on the
desktop and the following screen will be displayed.
4-33
8. Click on Close or (on the top-right corner of this screen) to close the
screen and restart the computer.
4.8.3.2. Installing Database

To install the Elan30s software database you must be logged
on as an “Administrator”. The normal user does not have the
rights to change/uninstall any software.
4.8.3.2.1. Installing New Blank Database

The database is used for performing various operations and storing the result data.
The Database Utility folder contains the execution file for installing and restoring
the database file Elan_30.bkp.
Follow these instructions for installing a new database:

1. Open the Database Utility folder from the software installation CD.
2. Double-click DatabaseUtility.exe.
3. Click on CHECK DATABASE.
This command will check for the existing database on your computer. If no
database is available, a message is displayed on the following screen.
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4. Click on CREATE DATABASE.

This will create the database from the location specified on the screen.
After some time, the database will be created successfully and the
following screen will be displayed.
5. Once the database is created, click CHECK DATABASE to ensure the

proper creation of the database. The following screen will be displayed.
6. The above screen indicates that the database is created successfully. Now
you can access the ELAN 30s application (Refer section 4.8.7 Accessing
ELAN 30s Software in more details).
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4.8.4. Upgrading ELAN 30s Software

If the software is already installed on your computer and if you receive a newer
version of software, then the following steps should be performed:
 Upgrade Software
 Upgrade Database
Take a database backup before proceeding with software
upgrade.
4.8.4.1. Upgrade Software

Uninstall the existing software version from your computer and install the newer
version from the application CD.
4.8.4.1.1. Un-installing Software
1. To un-install the software, go to Start > Control Panel.
2. In the Control Panel, under view Large Icons, double click on Programs
and Features.
3. Select the Elan30s software, and then click Uninstall.
On clicking, the software will be removed from the computer.
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To uninstall the Elan30s software you must be logged on as

an “Administrator”. The normal user does not have the
rights to change/uninstall any software.
4.8.4.1.2. Installing Software - New Version

Refer section 4.8.3 Installing ELAN 30s Software for more details.
4.8.4.2. Upgrade Database

Upgrade the database using the software CD of the newer version whenever you
install the new software version.
Database can be upgraded to match the newer software version without deleting
the database of the existing version.
Ensure to take Database backup before upgrading the
database.
4.8.4.2.1. Upgrading Database

Follow these instructions for upgrading the database:
2. Double-click on DatabaseUtility.exe.
3. Click UPGRADE DB.
On clicking, the system will ask for the upgrade script file, as shown in the
following screen.
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Select the required upgrade script file, and then click Open.
The database up-gradation process will be started and the following
message will displayed “All Corresponding Databases Upgraded
Successfully” after completion.
4. Click to close the database utility screen.

5. Now you can access the Elan30s software. (Refer section 4.8.7 Accessing
ELAN 30s Software for more details).
4.8.5. Installing USB Drivers

For installing the USB driver, open USB Driver folder from the application CD, and
run USB_DRIVERS.exe.
Refer CP210x driver installation manual.pdf for more details.
4.8.6. Database Utility Options

The database utility can be used to take the Database Backup or change the
Database.
4.8.6.1. Database Backup

Follow these instructions for taking the backup of database:
2. Double-click DatabaseUtility.exe.
3. Click on CHECK DATABASE.
The following screen will be displayed.
4. Press F12 key. The following screen will be displayed.
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5. Choose the path to store the backup, and then click Save.
On clicking, the following screen will be displayed to confirm the successful
completion of database backup.
4.8.6.2. Change Database

In case, if you wish to change the database, you must delete the existing database
and then restore the backup of another database using database utility.
It is recommended to change the database with proper
guidance of expert service engineer. Improper restoration
may result into loss of data and impact the calibration of the
analyzer.
Before deleting or changing the database, you should take the database backup.
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Database can be changed in two parts:

1. Delete (existing) Database.
2. Restore Backup of another Database.
4.8.6.2.1. Deleting existing database
Follow these instructions for deleting the database:
2. Double-click on DatabaseUtility.exe.
3. Click on CHECK DATABASE to check whether the database is present.
4. Click on DELETE DATABASE to delete the existing database. The

5. Click on Yes to continue with database deletion or click No to cancel.

On clicking Yes, the warning message will be displayed to re-confirm the
deletion.
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6. Click Yes to continue

On clicking, a message will be displayed to take the database backup
before deletion.
7. Click Yes to take the backup.

The following window will be displayed. Select the appropriate location for
saving the database backup files.
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On clicking No, the database will be deleted without saving

the database backup.
This may result into loss of data, in case you do not have
latest backup.
8. Click Save to save the database backup.
On clicking, a copy of database will be saved in the desired location.
IMPORTANT: Note the path at which you have saved the backup. It is
recommended to copy this Database backup file on other media such as
CD or DVD.
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9. The following screen will be displayed after successful deletion of the database.
This indicates that the existing database is deleted successfully.

4.8.6.2.2. Restoring backup of new database
10. In the DATABASE RESTORE UTILITY window, click on the BROWSE
FILE. The following screen will be displayed.
Browse for the file and select the location where the database backup file is
saved.
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11. Select the desired database backup file, and then click Open.
12. Click on CREATE DATABASE to create the database.

On clicking, the database will be created and the following screen would
be displayed.
13. Click on CHECK DATABASE to ensure proper creation of the database.

14. Click to close the database utility screen.
15. Now you can access the ELAN 30s application. (Refer section 4.8.7
Accessing ELAN 30s Software for more details)
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4.8.7. Accessing ELAN 30s Software

The application software, on start-up, will automatically change the
screen resolution to 1024*768. In case the resolution is anything
other than the specified, the settings will be restored to their
original on closing the application software.
To access the software use one of the following steps:

 Double click on the Elan30s icon from the desktop.
 Go to Start > All Programs > Elan30s.
The following user login screen will be displayed. This screen will be
displayed every time when you start the application software.
Enter the following details, and then click OK. You may use this Login
details for the first time and create the other Login IDs with appropriate
Access Rights.
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Login ID : Guest or guest.

Password : guest (case – sensitive)
The main screen will be displayed.
At every startup of software, after login the software checks the compatibility
between application and embedded software. In case of mismatch between the
two, following message is displayed:
After Initializing Batch Analyzer, Ensure to check the Probe

centering on all container type for SRGT, Strip Tray Position, and
Tip Ejector by the analyzer.
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5. Functional Description
5.1. System Description
The images used in the manual are of indicative nature and may
not reflect the final component due to continuous development of
the product.
The SRGT and STRIP units are always covered by the plastic tray.
5.1.1. Sample and Reagent Tray (SRGT)

The Sample and Reagent Tray is a circular tray for placing the primary Sample
tubes, tips, Control, Calibrators, and Reagents bottles. This tray is divided into
different circles for placing the Sample tubes and Reagent bottles. Customized
reagent bottles are available. They are:
 Inner Reagent Circle
 Inner Reagent Tip Circle
 Outer Reagent Circle
 Outer Reagent Tip Circle
 Calibrators/Controls
 Calibrators/Control & Sample Tip (3 Circles)
 Inner Sample Circle
 Outer Sample Circle
5-1
5.1.1.1. Sample Containers

Sample containers types are describers as follows;
 Sample tubes
The sample tubes are available in 12 x 75 mm capacity. A picture showing the
sample tube provided with the analyzer is shown below:
5-2
 Micro Centrifuge Tube 2ml
Volume available for this Miro Centrifuge Tube is 2ml capacity
 Control /Calibrator Vial 1.5ml
Volume available for vial is 1.5ml capacity
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5.1.2. Strip Tray

The Strip Tray is a circular tray for placing the strips consisting of 8 wells each.
There are total of 30 positions and only 29 can be used for placing the strips. The
other two positions are used for:
 Washing wash manifold and
 Photometer calibration.
The strip tray can be removed by the user for strip loading, cleaning, and changing
the photometer lamp.
5-4
5.1.3. Robotic Arm

The robotic arm assembly is one of the most important modules in the analyzer.
It carries out the following functions:
 Aspiration and dispensing of Diluents, Samples, Controls, and Reagents as
and when required.
 Fixing and dispensation of tips.
Robotic arm has two movements:
 Rotary and up/down movement.
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5.1.4. Washer Assembly

The washer assembly is used for strip washing. It is a separate wash station which
is present on the Strip Tray. Washer manifold has up/down movement. Washing is
achieved with the help of pumps.
It consists of Wash manifold (consisting of 16 capillaries in 8 pairs for aspirating
and dispensing)
The wash manifold does the function of dispensing and also aspirating the wash
solution.
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5.1.5. Photometer
This module is used for reading the optical density of the samples in the micro
wells of the Strips. The analyzer consists of the movable reader.
The photometer consists of seven filters (4 standard + 3 optional). The
measurement is performed with any combinations of 2 wavelengths selected
among the following 7 wavelengths:
405nm, 450nm, 492nm, 550nm, 595nm, 630nm, 690nm
5-7
5.1.6. Tip Dispense Box

Tip dispense box is located on the lower front side of the analyzer. It is used to
throw the used tip by the robotic arm.
5.1.7. Trough Assembly

After the sample probe has dispensed sample into the strip, the sample probe
moves to the trough where it is throws away the excess sample into the drain and
is cleaned internally as well as externally using a jet of DI Water.
5-8
5.1.8. Pipette 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 it aspirates and
dispenses volumes between 5 μl to 300 μl. Sample volumes can be increased in
steps of 1 μl.
The reagents volumes can be increased in 1µl step. The syringe is located behind
the front panel of the analyzer and connected to the probe using appropriate
tubing. The syringe unit is shown below.
5-9
5.2. User Interface

When you have logged on, the ELAN 30s software main screen will be displayed.
It consist of the following screens:

 Tests
 Quality Control
 Search
 Service
 Patient
 WorkBench
 Results
 Maintenance
 Shutdown
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5.2.1. Tests
It consist of three options:
 New: It consists of one option that is used for defining new tests
parameters. The options is:
 Manual Entry: This option can be used for manually entering the Test
Details from Kit Insert provided with the Kit.
 There are three tests available for selection;
Qualitative Test, Quantitative Test and Semi-Quantitative Test
 Open: This screen is used for editing Test Parameters, Test Sequence,
Calculation details, External Control Details and Deleting Tests.
 Profiles: This screen is used for defining the new test profiles.
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5.2.2. Search
This screen is used for searching the Patient Results.
5.2.3. Quality Control

This screen is used for day-to-day monitoring of the performance of the analyzer.
5.2.4. Service
This screen is used for performing the service action by the service engineers.
5.2.5. Patient
This screen is used for entering the patient related entries like Sample Ids,
Selecting Tests etc.
Scan Barcode: Used for entering Sample Ids either by scanning barcode on
sample test tubes or by auto increment.
Test Selection: For selecting Tests corresponding to each sample Id.
Work List: This button is used for viewing the list of Pending Tests.
Patient Entry: For entering Patient related information.
5.2.6. WorkBench
This screen is used for selecting the tests to be performed by analyzer in the
current batch.
5.2.7. Results
This screen is used for displaying the results of the current and previous batches.
5.2.8. Maintenance
This screen is used for performing Maintenance operations at the start and end of
the day.
5.2.9. Shutdown
This screen is used to turn off the application software.
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6. Routine Task
This chapter describes the routine tasks that you need to perform to keep your
instrument running.
6.1. Starting up and logging on to the System

Always switch on the system components in the following order:
1. Instrument
2. Computer
3. Handheld Barcode Scanner (optional)
4. Printer
6.1.1. Switching on the System

6.1.1.1. Switching on the Instrument
To turn on the instrument, press the main ON/OFF switch.
6.1.1.2. Switching on the Computer

Press the On/Off switch of the computer. After completing the startup procedures,
you can open ELAN 30s software. Startup may take a few minutes.
If you start the software without starting the instrument, the
software will hang and communication error will be displayed on
the main screen. In this case, you must start the instrument,
connect it through the Maintenance screen, and initialize.
6.1.1.3. Switching on the Printer

Standard printers go into Standby mode as soon as they are connected to the
mains power.
If there is an On/Off switch on your printer, switch on the printer and follow your
printer instructions.
6.1.2. Logging onto the System

To log on, you must use the password and user ID that were created for you by
your system administrator. The software uses the ID of the person who is logged
on to record their actions. Refer section 4.8.7 Accessing the ELAN 30s Software
for more detail.
Your user access level determines the system features that are available to you.
Contact your system administrator if you do not have the privileges you require.
6-1
6.2. Shutting down the Software

To shut down the system, use the following steps:
1. Click on the ShutDown from the main screen.
On clicking, a message box will be displayed.
2. Click on Yes.
On clicking, two options will be displayed.
3. Click on the ShutDown.

This will be shut down the ELAN 30s software.
If the option Maintenance With ShutDown is clicked, the software will first
perform the maintenance activities, and on completion shutdowns the
software. On clicking this button, the following window will be displayed.
Put the required amount of decontamination solution at sample position 60.

After the completion of maintenance activity, the application will be closed.
6-2
6.3. Checks prior to Work

6.3.1. DI Water
Make sure that the DI water parameters are in the following required ranges:
Parameter Required Range
Electrical Conductivity, Max. (μS/cm @ 25°C) 0.066 - 0.056
Electrical Resistivity, Min. (M-cm @ 25°C) 15.0 - 18.0
pH @ 25°C 6-8
TOC max. μg/l <100
Sodium max. μg/l <1
Silica max. μg/l <3
Chloride max. μg/l <1
Total Bacteria Count max. CFU/ml <50
Parameter Requirement
Range
6.3.2. Wash Buffer and Waste Bottle

Make sure that:
1. The WASTE bottle must be emptied.
2. The WASH BUFFER bottle should be filled with enough cleaning solution.
3. Disposable tip bin container should be emptied.
6-3
6-4
7. Patient
The Patient screen is used for entering the patient related details into the system.
It can be accessed through Patient screen present on the toolbar. The patient
screen will be displayed as shown in figure below:
The following are some of the important functions performed by this module.
 Managing patient specific data.
 Managing reference doctor data
 Linking patient data with medical requirement such as tests (scheduling)
etc.
 Keeping account of the tests to be performed and also the list of pending
tests.
The following sections explain the functioning of the buttons provided in the Patient
screen.
7-1
7.1. Scan Barcode

This option is used to initiate the Sample Barcode Scan. The barcode scan will be
done by using external handheld barcode scanner. This device reads the sample
barcode on the tube and the details (ID) are updated in the position number and
displayed in the Patient screen.
7.1.1. Adding Samples with Handheld Barcode Scanner

To add the samples, use the following steps:
1. Open Patient screen.
2. Click on Scan Barcode button.
On clicking, this will initialize the analyzer assemblies and the following
message will be highlighted “Scan the barcode and place the Sample” on
the screen.
3. Take a required barcoded sample tube and with the help of handheld barcode
scanner scan the sample tube. After scanning, the sample ID will be updated
and displayed in the position number 1 text box. Also, the first position on the
SRGT tray will rotate to the placement position.
4. Select your sample tube type from the drop-down list. See figure.
5. Now, place the scanned sample tube on position number 1 on the SRGT tray.
6. Similarly, for placing the remaining barcoded samples follow the same step
from 3 to 4.
7. Click on Save to save the IDs.
7.1.2. Adding Samples without Handheld Barcode Scanner

2. Click on Scan Barcode button.
On clicking, this will initialize the analyzer assemblies and the following
message will be highlighted “Scan the barcode and place the Sample” on
the screen.
3. Click on the required sample position and enter the appropriate sample ID and
tube type from the drop-down list.
4. After entering the detail, press Enter on the keyboard.
On clicking, this will rotate the SRGT tray to the required sample placement
position.
7-2
5. Place the sample tube on the position.

6. Similarly, for placing the remaining samples follow the same step from 3 to 5.
7.1.3. Download Sample Details from the Host PC

The non-barcoded sample details along with the test details can be downloaded
from the Host PC to the analyzer PC for processing using Download Data From
Host button that is available in the Patient screen.
7.2. Manual
This option is used to add the multiple samples manually by entering the starting
position number. The sample details are added in the incremental order. To do this
you have to enter the start position, sample ID, and the number of samples to be
added. To add the samples, use the following step:
2. Click on Manual button.
On clicking, the following screen will be displayed:
3. Now enter the appropriate position of the sample in the Start Pos. field, sample
ID in ID filed, and the number of sample to be placed in the No. of Samples
field.
4. Click on Ok.
On clicking, the sample ID will be displayed on the screen.
Now, enter the appropriate tube type for each sample positions.
7-3
5. Now, click on the appropriate sample position. This will rotate the SRGT tray to
the required sample position.
6. Place a required Sample tube on the sample position.
Before placing the sample, make sure that you are placing
the correct Sample tube having same ID number.
7. Repeat the same step from 5 to 6 for the remaining sample tube.
7.2.1. Sample Positions for Reagents

There is a provision to define reagents on sample position. This will be performed
through Manual button in Patient screen.
Below are the steps to use sample positions (41-58) for reagents.
1. Open the Patient screen.
2. Click on Manual; enter the fields Start Pos., ID, & No. of Samples.
If you want to use samples positions for placing reagents, then select the
following option.
7-4
When this option is selected, you are not allowed to define

sample positions more than 40. Remaining positions (41-58)
will be used for reagents.
3. Define the number of samples for positions 1-40 and for reagents use
sample positions 41-58. Click OK button.
4. Click Save, and go to Next.
Select the Available Test by clicking the check box provided against each
test. (Refer section 7.5.1 Assigning Test to the Samples for more details).
5. In Workbench menu, select the required tests, under selected tests ->> Bottle
type, Click the check box against the respective Sample tube for which the
reagents has to be defined in tube (i.e. available positions between 41-58).
System will not allow selecting sample tube for Diluents.
For example, position defined for reagents R2, R3 & R4 as sample tube as
shown in below screen:
6. Click OK to proceed. Below shown screen will be displayed.
7-5
7. User can not define the sample position more than 40, if option "Use sample
positions (41-58) for reagents" is selected. In case, if sample positions are
more than 40, then the following message will be displayed.
7-6
7.3. Edit
This option is used to edit the sample ID of a sample by specifying the position
number.
1. To edit, click on this button and enter the sample position number, then click
OK.
2. On clicking, the cursor will blink on the entered position number.

3. Edit the sample ID, and then click on Save.
7.4. Delete Text

The Delete Text button on the Patient screen is used to delete the sample ID of a
sample by specifying the position number. To delete, click on this button and enter
the sample position number, and then click OK.
7.5. Test Selection

This screen is used to assign the Tests that are to be performed for the samples,
placed on the SRGT Tray.
7-7
Once the sample IDs are defined and the sample tubes are placed on the tray, you
can assign the required number of tests to the samples by clicking on the list of
available tests. Also, you will be able to program the number of replicates for each
sample for a particular test by clicking scroll button of the mouse on the space
provided.
Here you will be able to select the tests very quickly for the scanned samples
which are entered in the Patient screen.
7.5.1. Assigning Test to the Samples

To assign the test, use the following procedure:
1. Place the sample on the SRGT tray using Scan Barcode or Manual button
using Patient screen. (Refer section 7.1 Barcode Scan for more details)
2. After placing the sample on the appropriate position, click on Save, and
then OK.
7-8
3. Now click on Next or Test Selection button. On clicking the following

screen will be displayed.
7-9
The screen is divided into two windows. On the left side, the available tests
are listed, and on the right side, sample details with their assigned position
are listed.
4. Select the required tests to be performed by clicking checkboxes provided
against each tests as shown below.
7-10
On selecting, those tests will be automatically added as columns on the

right side of the window.
5. Now select the required test by clicking on the cells against each sample ID.
The yellow color on clicking indicates that the test is assigned to that
particular sample ID.
6. You can select a test for multiple samples by clicking on the cells for a test
against any sample ID and then right click & drag the mouse down for the
required samples. For example, to perform LH EM test on sample IDs 1235,
1236, 1237 click on cell for LH EM against 1235 and then right click & drag the
mouse down up to sample ID 1237. The test LH EM will now be selected for
these sample IDs.
7. You can also define the required number replicates to each test, if required.
To do this, use the following procedure:
a. Place the cursor over any test (for example sampleID 1237 and test
HIV), and single click Scroll button of the mouse. This will show
Replicates option.
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b. Click on the option and enter the number of replicates to be defined, and
click Ok.
The number of replicates of a test for a particular Sample ID will be as

shown on the screen.
8. In case, if you can select the listed Test profiles (this will automatically select all
the tests listed in that particular Profile).
7.6. Patient Entry

The Patient Entry screen is used to enter the patient details. Details of patient like
name, address, doctor referring patient, analyst, age, sex etc can be entered using
this screen. These patient demographics are used to generate the patient report
after analysis of the sample.
To go to this screen, in the Patient screen, click on the Patient Entry. The
7-12
1. To enter the patient details, click on the New button. Enter the required details
about the patient and click on Save to save the details.
Patient ID will be generated automatically.
2. Fields shown in red color are mandatory fields, which should not be left blank.
3. To enter the details for a particular sample, use the following procedure:
a. In the Patient Entry screen, click on New.
b. Click on the Sample ID text box. On clicking, a list of sample ID will be
displayed with dates.
c. Click on the appropriate sample ID. This will add the sample ID
d. After this, enter the appropriate details, and click Save to save the
details.
4. To edit the details for a particular sample, use the following procedure:
a. In the Patient Entry screen, click on the Sample ID text box.
b. Select the sample ID to be edited by clicking over it.
c. Now the previously entered details for that particular sample ID are
displayed. Now you can add the new details and then click Save to save
the settings.
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5. You can browse through the records using the arrow keys provided as shown
below.
7.7. Worklist
Click on the Worklist button on the Patient screen. Once the Tests are
programmed in the Test Selection screen, the details of the completed tests and
pending tests will be enlisted.
The screen is divided into two windows.
 Patient Worklist
 Pending Worklist
In the Patient Worklist, you can view the status of the all the scheduled samples
with their sample ID and the test to be performed on those samples.
In pending Worklist, you can view the status of the samples after at least one
complete Run of a batch. Once a batch of Tests is Run, the samples, programmed
for the remaining tests (i.e. the tests which were not present in the Batch, whose
Run is completed or the pending tests) are listed with their samples I.D’s.
The samples whose tests were kept pending are displayed in Yellow color and the
samples whose tests are complete are displayed in Green color.
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8. Test Programming
This screen is used for programming or entering the test parameters for the tests
to be performed by the analyzer. This is performed through the Test menu
available on the main screen.
The test programming menus consist of the following sub menus:
 New Test
To create/program a new test into the system.
 Open
To view/edit the tests, those are already programmed into the system.
 Profile:
To view an already existing profile/create a new profile.
8.1. New Test

This option is used for programming a new test in the system. It can be accessed
through the option “New” from the “Tests” menu.
For programming a new test in the system, select Manual Entry.
8.1.1. Manual Entry

This option is used to select following test types.
 Qualitative Test
 Quantitative Test
 Semi-Quantitative Test
8-1
User can not modify the Test type in manual entry.
8.2. Open
On clicking this option from the Tests menu, the following screen will be displayed:
It consists of following parameters:

 Kit Details
 Test Parameters
 Test Sequence
 Calculations
 External Control
 Calibration
 Validation Criteria
8-2
8.2.1. Kit Details

This screen is allows you to enter or edit the Kit Details. This module will allow the
application software to keep track of the kit that is being processed in the analyzer.
To open this screen, use the following steps:
1. Click on the Kit Details, and then select the required test.
2. On clicking the test, the following screen will be displayed.
3. Click on Modify.
4. Enter the required details and click on Save to save the details.
8-3
The Test for which Kit Details are not saved will appear in
red color indicating Incomplete status. After saving Kit
Details, the color of test will change depending on type of
test i.e. Green for Qualitative, Blue for Quantitative and
Pink for Semi-Quantitative.
5. Following are the explanation of the fields.

Test Details Kit Details
Test Code This field is used to enter the Lot Number This field is used to enter
test code. For example T3, T4, the lot number of the kit
etc. currently used.
Test name This field is used to enter the Exp. Date This field is used to enter
complete name of the test. For the expiry date of the kit.
example Triiodothyronine for
T3.
Type This field is used to enter the Mfg. Date This field is used to enter
Type of Test to be the manufacturing date of
programmed in the system. the kit currently used.
They are:
 Qualitative
 Quantitative
 Semi-Quantitative
Unit This field is used to select the Mfg. By This field is used to enter
units in which the results the name of the
should be reported from the manufacturer currently
list. used.
Total Tests This field is used to enter
the total number of test.
The default kits available are:
 Fertility
 Thyroid
 Infectious
8-4
You can add the new tests in the kit through the Profiles screen
 It should be noted that the Mfg. Date should be less than Expiry
Date.
 If you select Test Type as Qualitative for Qualitative tests, the
units will be O.D. (by default).
8.2.2. Test Parameters

This module is used to enter the parameters specific details to the Test. You can
also modify and save the existing Test details already programmed in the system.
To do this, use the steps:
1. Click on the Test Parameter, and then select the required test.
8-5
On clicking, the test parameters will appear with all the parameter Blank or
Pre-Set.
2. Click on Modify.
8-6
3. After updating the details, click on Save to save the details.

 Test Details
 Test Code: Enter the Test code (i.e. abbreviation for the Test). For
example T3, T4, etc.
 Test Name: Enter the complete name of the test. For example
Triiodothyronine for T3.
 Test ID: Enter the appropriate test ID.
 Type: Enter the Type of Test to be programmed in the system. They are:
 Qualitative
 Quantitative
 Semi-Quantitative
 Unit: User can select the units in which the results should be reported,
from the dropdown list.
 SMP/CO: This option is available only for Qualitative Tests. User can
select this for calculating the test results by Sample/Cut Off method.
 Wavelength
 Primary and Reference: It is used to enter the Primary (compulsory) and
Reference wavelength (if required). The available wavelength are 405,
450, 492, 630 (Optional three wavelength are 550nm, 595nm, 690nm )
 ORR
 Normally, plates are read first with the primary filter, then with the
secondary filter, and afterwards, final readings are calculated subtracting
the reading obtained with the secondary filter from the reading obtained
with the primary filter. For few parameters the third filter is used: that
filter is referred as the ORR filter.
 First, the read operation is performed with primary filter. If available, the
dual (differential) wavelength measurement is performed with the
secondary (reference) filter. Now, suppose it is known to the
manufacturer of the kit that the readings of the particular standard is
excessively high, while reading with the primary filter and those
excessively high values must be rectified using ORR filter (If the reader
8-7
is not capable of reading these high ODs). Provided factor should be

applied after taking reading with ORR filter.
 To use ORR filter, select ORR option provided in test parameters screen
in test details as below
 Enter the OD>value expected at primary filter

 Select the ORR wavelength from drop list.
 Select the Conversion ORR OD from drop down list
 Click Save to save details
 Sample Details
 Volume (µl): It is used enter the sample volume. You must enter the C.V.
Max that is acceptable, if replicates are selected for the samples in this
particular Test in Fast Test Entry module/ in Patient Entry module.
 Sample Dilution: Checkbox available for dilution of the sample. Select as
appropriate.
 Reagent: This option will be available to select the name of the reagent,
indicative of its function in the Rgt. Name field (e.g. Sample Diluent, Assay
Reagent, Conjugate, Color Reagent, Substrate, Stop Solution etc.).
Please ensure that the reagent names are correctly selected as different
actions like probe conditioning (in case if the reagent is conjugate) / single
shot Dispensing with Tip (in case of sample diluents) will be done
automatically by the software depending upon the selection.
8-8
User then has to enter the volume of the reagent required per test in the
Vol. /Test (µl) field. Select the bottle type as required from the Bottle Type
field. User can also define reagent volume for a blank well by selecting
Disp. in Blank and for a control by selecting Disp.in Control. The reagent
volume to be dispensed has to be entered in Blank Disp. Vol. and must be
within the range 25 and 200µl.
Click ADD button to add a reagent.
 Washing: In this section, washing specification will be entered by the
operator.
You are also able to program the No. of Wash cycles (Maximum 8 cycles,
from 3 to 10), Strip Type, Wash Type, and Soak Time (in seconds).
By default, the soak time is set to 30 seconds
In case, the number of wash cycles given by default (which is 4 in our

case) is not sufficient (in existing parameters); you can add more Wash
specification by clicking the ADD button.
 Incubation: In this section, incubation details will be entered by the
operator. This includes the incubation period (in minutes), Shake time (in
seconds), and Incubation Temperature (in ºC). You can specify two
incubation temperatures: 37ºC or RT (Room Temperature).
In case, the number of Incubation types given by default (which is 4 in our
case) is insufficient, User can add more Incubation type by clicking the ADD
button.
 Blank Details: This section is an optional. You may choose to enter or not
to enter the Blank details depending on test requirements. You are required
to enter the number of replicates. Maximum 7 replicates can be selected.
Also blank subtraction from sample results needs to be selected if the KIT
inserts guides so.
 Standard Details: This section is an optional. You may choose to enter or
not to enter the Standard details depending on test requirements. Various
inputs like Volume and Replicates (this is common to all the Standards) will
be entered in this section. You should also enter the concentration of the
standards. Click ADD button to add a Standard.
 Internal /External Control Details: In this section, you can enter the
control details like the control volume, control name, and number of
replicates. In case, if the number of control types given by default (which is
4 in our case) is insufficient, User can add more control type by clicking the
ADD button. It is mandatory to enter the lot number of the control. Also
make a proper selection for mixing option of the control as per the
established criteria. When click the Mix Ctrl option in test details, in every
define run tip will mix the control volume of 500ul.
8-9
8.2.3. Test Sequence

Using this screen, you can program the complete test sequence as defined in the
test kit.
To program the test sequence, use the following steps:
1. Click on the Test Sequence, and then select the required test from the
available kit. For example TSH EM.
2. Click on Modify.
On clicking, the screen will be displayed as below.
8-10
3. The screen displays the test parameters details of the selected test with the
defined test sequence. Click Modify to modify the test sequence. To clear
the test sequence, click on Clear All.
On clicking, the defined test sequence will be erased.
8-11
4. Now, define the new test sequence as per your requirement.

5. Click on Save to save the sequence.
To define a sequence, use the following steps:
1. Select the required test sequence button.
2. Now click on the parameter against the selected test sequence. It can be
Sample or Reagent.
3. On clicking the required sequence will be added and displayed in the Test
Sequence section. See figure below.
8-12
4. Similarly, use the same steps to add other required sequence.
Total volume dispensed in the well should be less than 300 µl
During the execution of the test, this sequence is performed from top to bottom.
To delete a programmed process, right click on the required sequence, and select
Delete.
In case, if you want to replace or change a specific process, right click on the
required sequence and choose Clear.
Once a test parameter has been used it cannot be reused and is disabled
immediately after selection except Read, Washing, and Incubation.
8.2.4. Calculations
This module is used to interpret the results. To do this, use the following steps:
1. Click on the Calculations.
2. Click on the required test. If we select Quantitative test e.g. TSH EM.
8-13
3. Click on Modify. On clicking, the following screen will be displayed.
8-14
4. Define the Calibration Curve; enter the values and interpretation details as
per the instruction provided in kit literature.
5. Enter your remarks for the test, which will appear in the final report.
6. Click on Save.
7. Else, if you select Qualitative test e.g. HIV EM and click on Modify. The
8. Enter the Cut off Formula, Gray Zone % and Cut off Sides details.
9. Select required Interpretation and enter Remarks.
10. Click on Save button to save the details.
11. If you select the Semi-Quantitative test in test parameters then following
screen will be displayed;
8-15
12. Click Modify, select the Calibration Curve, enter the Index formula and
Values with their corresponding Interpretation and Remarks.
13. Click Save to save details.
14. If CUSTOM UNIT CONVERT option is selected then screen will displayed
as below;
8-16
15. Click Modify, select the Calibration Curve, enter the Index Formula,
Result and Values with their corresponding Interpretation and Remarks.
17. Alternatively on clicking Modify, if USING STD. CURVE option is selected
then the screen will be displayed as below;
18. Select the Calibration Curve, enter the Index Formula, Values with their
corresponding Interpretation and Remarks.
8.2.5. Calibration
This module is used to see the previous calibration data and curve details in offline
mode. To view this, use the following steps:
1. Click on Calibration button.
2. Click on the required test, e.g. TSH EM.
8-17
3. Click on Modify.
On clicking, the following screen will be displayed.
8-18
4. Select the respective calibration curve and click Save button. Following
message will be displayed. Click OK.
5. The selected calibration curve will be used for result calculation of patient
sample and controls.
8.2.6. Validation Criteria

This screen is used to enter or view the constraint for the control (control that are
run during the test) and validity of test.
use the following steps:
1. Click on Calibration button.
2. Click on the required test, e.g. TSH EM.
8-19
3. Click on Modify. On clicking, the following screen will be displayed.
8-20
4. Click Save to save the details.
8.3. Initialize
This button will save the default parameters. When the test parameters are edited
as per test requirement, you can use this button to save the default parameters.
8.4. Print
This button is used to print the required test parameter. To print, click on the Print
button, and then click on the required test name.
8.5. Delete
This button is used to delete the required test. To delete, click on the Delete
button, and then click on the test name to be deleted.
8.6. Copy Test

This button is used to create and copy the test’s parameter to new test. To do this,
click on the Copy Test button, and click on the required test name. On clicking, a
text box will be displayed.
Now enter the new test name, the test name should be strictly less than 10
characters and click OK. This will create a new test of same type with the copied
parameters and is displayed on the screen.
To create a new test of specific type (Quantitative, Qualitative,
Semi-Quantitative) copy/select a test of same type.
8.7. Download
This button will download and save the test parameters details into the xml file at
location C:\Elan30s\DOWNLOAD PARAMETERS. To do this, click on the
Download button, and then click on the required test.
8.8. Upload
This button will upload test by uploading test parameters details xml file. To do
this, click on the Upload button, and browse for the required xml file. To upload a
test, you need to first download a test by clicking Download button and then select
the required test. This will download test parameters details xml file at location
8-21
C:\Elan30s\DOWNLOAD PARAMETERS. Open the downloaded xml file in text

format using Notepad and search the name of TestCode in TestCode tag for
example, “<TestCode>name of TestCode</TestCode>”. Select Find and replace
all the instances of TestCode name with desired TestCode name and save the file
with .xml extension. Click the Upload button and browse for this modified xml file
to upload the test.
The newly uploaded TestCode will appear in red color indicating Incomplete
status. Click Kit Details and select newly uploaded test to Modify kit details (i.e.
Lot No, Exp. Date, Mfg. Date, Mfg. By, Total tests) and click Save. The uploaded
Test Code text will now appear in color other than red depending on test type.
Manufacturing Date should be less than today’s date and Expiry
date should be greater than or equal to today’s date in Kit Details.
8.9. Exit
This button is used to exit the Patient screen
8-22
9. WorkBench
Before the Start of the RUN user should make sure that the Waste
Can and Tip Bin are emptied. The waste should be disposed as per
the Local Regulatory rules for waste disposal. During RUN, if waste
gets filled up then the RUN will be terminated to prevent
overflowing of waste.
This screen is used to schedule the run. On clicking this screen, it will display the
entire test that is available in the Test > Open. The group of test that operator
plans to perform in the current batch will be selected from this screen.
The WorkBench section is consisting of following section:
 Available test
 Selected test
 Batch ID
See figure below.
9-1
9.1. Available Test

In this section, the tests that are already programmed in the Test > Open screen
will be displayed. You can select the test to be performed on a particular Batch
from this section. Once the test is selected it is highlighted with the Yellow color.
After selection, you can save the Batch by clicking the Save button available on
the workbench module and brings the control on the Reagent layout screen.
The Clear button option, allows you to clear all the selected tests in one step.
When the operator selects the tests from the available test section, a dialogue box
appears. This dialogue box displays the Standards and External controls already
programmed for the test in Test Programming module.
In this screen you have option for selecting Standards and External Controls, Tips
for probes, Wash Fluids for the test Run in the current Batch. By default all
standards are selected. You can choose the tip for the Sample probe by selecting
the Sample check box under Tips For Probe label. By default wash bottle B1
filled with Distilled water is selected for Probe wash during the Run. User can
select the Buffer Bottle (From B1 to B3) in which the required Buffer solution is
stored. If the bottle is already selected for another test, a message will be
displayed.
9-2
Click Yes if you want to use the same wash solution. Select No for using different
wash solution and place the bottle at remaining position. Then click OK button to
save the settings.
It also displays the number reagents for the selected test. By default, large bottles
are used to place the reagents on tray but if you want to keep particular reagent in
a sample tube, then select Sample Tube option.
If you select the Mix Ctrl in Internal & External control details in test parameter s
following message will be displayed for min control volume of 500ul
9-3
Bottle Type will be enabled only if option “Use sample position

(41-58) for reagents”. See section 7.2.1 for more details.
If you are using Sample Tube, then before starting the run, you
must calibrate the sample tube for dead volume.
9-4
If you want to run any Quantitative test for the first time, then it is
mandatory to run the standards. If this is not done i.e. Standards
check box is not ticked in WorkBench screen, then the message
“This test was not calibrated, Please select All Standards” will be
displayed and the run will not proceed.
9.2. Selected Test

This section displays the list of tests selected for the Batch. If you click on the
Save button without selecting any test, a warning message pops up and asked to
select the test for the Batch.
9-5
You can remove a selected test from the Selected Test section, by right clicking
and select Delete option. After the User selects delete option that test will be
removed.
9-6
In case, during the selection of tests in the WorkBench module, the number of
selected tests exceeds six, a message, indicating the same will pop up.
Once the required tests are selected and you click on Save button, a message
box will be displayed. Select Yes if you want to define common reagent for
different tests, else No, as appropriate.
See section 9.6 Common Reagent for more details.
9.3. Batch ID
In this section, the Batch ID for the WorkBench is displayed. The software
automatically generates the Batch ID for the saved Batch. This Batch ID is unique
for a Batch.
You can any time “Exit” the WorkBench module by clicking Exit button. The Exit
option brings back the User to the main menu.
Save option on the WorkBench brings the control on the Reagent layout screen.
9.4. Fluidic Check

Once you save the Batch in the WorkBench, Fluidic Check screen will be
displayed.
9-7
Click on Fluidic Check button to start the fluidic check. You will be prompted to
put the SRGT cover in position before placing reagent/sample/control in position.
After placing SRGT cover in position, click OK. Following message will be
displayed.
9-8
You need to place the special Fluidic Check test tube at Sample position 58, 1.5 ml
of Probe Clean solution at position 60.
At the beginning of every RUN user needs to dispose of the old solutions at
Position 60 and fill the test tube with fresh solution. In case if test tube is not
placed at Position 58 or it is not emptied, then an error message will be displayed
and will prompt the user to place an empty Special Fluidic Check test tube.
The user will be also prompted to check the aspiration and dispensing of Washer,
user need to check the level of the fluids in all wells. Volume should be same in all
wells at Washer Priming position.
Click Yes to proceed. Following message will be displayed.
Click Yes to proceed. Following message will be displayed.
9-9
After completion of Fluidic Check the user needs to remove the Special Fluidic
Check test tube and place the respective sample.
Click OK to display Reagent Layout screen.

When Washer is brought to its rotary home position and when Tip
Bin is placed in its position a confirmation beep (long beep) is
given. A warning beep will be given every 10 seconds to indicate
that washer is not in its rotary home position.
9.5. Reagent Layout

After successful Fluidic Check, a Reagent Layout screen is displayed. This screen
gives the details of the placement of various consumables on the SRGT tray along
with their required volume.
9-10
Click on Place ST Cover button to move the Robotic Arm towards SRGT tray to
place the Strip Tray cover. Similarly, click on Place SRGT Cover button to move
the Robotic Arm towards Strip Tray to place the SRGT cover.
This screen gives the description about the following:
9.5.1. List of Tests

This section displays the list of tests which will be scheduled in the current Batch
along with the Batch ID represented by different colors (color designated for each
test is unique).
9.5.2. Location of Strips

This section displays the Strip location for each test. The bunch of strips for a
particular test is represented by its unique color code (as mentioned in List of Test
section).
9.5.3. SRGT Tray Layout

In this section the layout of the SRGT tray is displayed, indicating the position of
the Sample tubes, Reagent bottles, Control & Standard tubes. It helps you in
indicating where to place them.
Following are the details that will be displayed when the User positions the cursor
on any of the location of the SRGT tray layout:
 If cursor is placed on Sample: It displays > Sample ID & Test selected.
 If cursor is placed on Standards: It displays > Test Code & Concentration.
 If cursor is placed on External Controls: It displays > Test Code, Test
name & CV max.
 If cursor is placed on Reagent: It displays > Test Code, Reagent Name,
Volume (ml), LotNo, Expiry Date.
 If cursor is placed on Internal Control: It displays > Control name & Control
type.
 Specially provided probe LLS test tube is placed at 58th position of Sample.
 Probe conditioning solution is placed at 59th position of Sample, indicated by
pale green color.
 Probe decontamination solution is placed at 60th position of Sample,
indicated by red color.
9.5.4. Test Requirements Screen

You can access this section by clicking on any of the Tests listed in the Reagent
Layout screen. Whenever you click a test, the Test Requirement Sheet is
displayed.
9-11
This sheet gives the details about the Reagents, Standards, and Controls used for
that test.
Reagent details are displayed in the following column:
 Position: Displays the reagent position number on tray.
 Reagent Name: Displays the selected reagent name for the test.
 Bottle Type: Displays the bottle type to be used for placing the
reagents.
 Reagent Volume: Displays the required reagent volume in ml including
dead volume.
 Use Sample Tube: Displays Yes or No, indicating the bottle type (Small
or Large) to be used for the reagents. It displays “Yes” if the option
Sample Tube option is selected for the particular reagent. See page 9-3
for details.
Reagents are depicted by following colors in Test Requirement Sheet and SRGT
tray layout as shown in above screen:
9-12
 Sample Diluent: White color

 Stop Solution: Yellow color
 Substrate: Violet color
 Conjugate: Pink color
Standard and Control details are displayed in the following column:
 Position
 Standard Name/Control Name
 Standard Volume/Control Volume
 Standard concentration/ Control Concentration
The sample on which the test is to be performed is highlighted in the SRGT tray
shown in the above figure.
Click the Close button to close the Requirement Sheet.
To make any changes in the selected tests, click the Back button and the control
goes to the Workbench menu.
9.5.5. Procedure for Loading Sample, Reagents and Controls

on SRGT Tray
Sample: In case if samples are not placed at the beginning that is during patient
entry then the sample can be placed using the Test Requirement screen. To do
this, click on the sample position at which the sample is to be loaded and SRGT
will automatically rotate to its loading position.
For example, if sample is to be placed at position 1, then click on the sample circle
as shown by the Red circle in the above figure.
Reagent: To place a reagent, click on the respective reagent position in the Test
Requirement screen and SRGT will automatically rotate to its loading position.
For example, if the reagent is to be loaded at Reagent Position 1, then click on the
Reagent circle as indicated by red circle in above figure.
Standard / Calibrators / Control: To place a Control; click on the respective
Control position in the Test Requirement Screen and SRGT will automatically
rotate to its loading position.
For example, if Control is to be placed at position 1 then click on the control circle
as shown by the red circle in the above figure.
9.5.6. Placing Tips

After clicking Run > Start, you will be prompted by a message box which will
indicate the number of Tips required for the entire Batch.
9-13
You need to place the Tips starting from the position close to the sample position
number 1 (this is indicated by a dark line) on SRGT tray near the tip starting
position. Number of Tips required are 10 more than the actual requirement of tips.
This is required to account for the Tips that are disposed off; in case of an error
Strips.
On clicking OK, the run will proceed.
If tip is already present on the tip position 1, it will be asked to
remove the tip which is indicated by a following message.
9.5.7. Placing Strips

When you click on the Location of Strips as shown in figure below.
You can click on the Click button next to the strip which will bring Strip Tray on the
front side that is at its loading position. You must place the strip carefully such that
the strip rests properly on the Tray. In case if all 8 wells are not be used then you
can break the strip (minimum 2 wells) and place a dummy broken strip and should
9-14
have the remaining wells (dummy strip should be of same size as of the actual
strip).
For example, if only three wells are required then user needs to break the actual
strip which 3 wells and place a dummy strip of same type that has 5 wells. It
should be noted that whenever a broken strip is used then it should have at least
one side of the strip (i.e. holding position) intact.
9.5.7.1. Strip Fitment

IMPORTANT: Before placing the strips on the Strip tray, you must follow the
necessary instructions:
If you are using the broken strip, then make sure all the wells (New wells and
dummy wells) should be at a same level. If all wells are not in the same level,
then washer will not wash the wells properly and there are chances that
Washer will leave high residual volume which may affect the result.
9-15
One well should not be used on the tray positions. There should be at least 2
wells (along with 6 dummy wells).
Washer is 8 needle manifold and during washing process, it will wash all 8
wells simultaneously. In case, if number of wells are less than 8, then for any
of the strips, ensure that the dummy wells (preserved or used strips, which
can be used as dummy wells when patient samples are not in multiples of 8)
are placed in the empty position. If this is not done, then this may cause
spillage and may damage the instrument.
9.5.8. Starting the Run

After placing all the required consumables for the test at their suitable position, you
can start the run using Run button provided in the Reagent Layout screen.
Before starting the batch run, make sure that Waste can is emptied.
A confirmation message will be displayed if you clicked on the
Run.
In case, during the batch run, if Waste can is full to its capacity,
then batch run will be terminated automatically.
On clicking the Run button message will be displayed for asking the user to empty
the waste bottle.
9-16
When you click on the Start button, he will be prompted to clean the Tip bin, in
case, if Tips are going to be used for the Test.
You need to remove the Tip bin, clean it, and place it again into its location. A
buzzer will be sounded when Tip Bin is placed in its position. Refer section 9.5.6
Placing Tips.
A level scan will be performed which will check the adequacy of Reagent and
controls/Calibrators / Standards required for the Test, it will also scan for the
number of tips placed on SRGT.
9-17
To avoid contamination due to carryover, level scan operation is

performed in the following sequence;
 Diluent
 Substrate
 Stop Solution
 Conjugate
 Stop Solution
In case of reagent/control volume is less than required volume or it exceeds
maximum capacity of bottle(less than 6 ml for small bottle and less than 12 ml for
large bottle) following message is displayed along with the position.
Increase/decrease the volume at required position and click OK. However, in case
if you fill the bottle, then make sure that the solution is from the same kit. It is not
advisable to mix the Reagents from different kits.
Also, if the numbers of tips are not adequate for the RUN, a message box will pop
up indicating the error.
If room temperature is out of range following error will occur. Click Yes to continue
or No to cancel the run.
On clicking Yes, AGC and Gain during run is checked. After completing the
checking of AGC and Gain during run, user will be prompted to perform strip
checking of the Strip Tray.
9-18
This message will not be displayed if option Perform Strip

Checking is checked.
See section 13.3.5.2 Perform Strip Checking for more details.
Click Yes to perform strip checking. In case of error, following message will be
displayed.
On clicking OK, you will be directed back to Run screen. Replace the dirty strips
(wells) with new strips. The analyzer will perform all the above steps again and ask
the user to perform strip checking. Click No to proceed with the Run.
On completion of Run, Batch Completed message is displayed.
9-19
On clicking OK, a message box will be displayed.
Pending sample is shown in Yellow color.
9.5.9. Calibration (for Quantitative tests)

After the “Batch Completed” message is displayed, click OK.
Use the following procedure for calibration:
1. Click View Results button. Following screen will be displayed.
9-20
2. Click on any particular test to display the results with calibration curve for
that particular test.
9-21
3. Click View Print button. The results can be viewed/printed with two options:
a. PrintTablewiseResults
b. PrintStripwiseRawData
You can also view the TableWise and StripWise report using
Search options after completing the batch run. Refer section 11
Search for more details.
4. By default, calibration curve is saved automatically with default test name.
The saved calibration curve can be viewed clicking Curve Calibration
button. Select check box to display the curve.
9-22
5. The curve can also be saved manually with another name. Click on
Memorise Curve button. Give the desired name to the curve and click OK.
9-23
6. Following message will appear. Click OK.
7. The new curve name will now be displayed in Memorized Curves grid.
9-24
9.5.9.1. Result Calculation Using Earlier Saved Calibration

Use the following procedure to calculate results using earlier saved calibration in
case a Test is run without standards (i.e. if Standards check box is not ticked in
WorkBench screen)
9-25
If standards are not selected, screen will appear as follows.
9-26
1. After the completion of tests, click on View Results button. In this case,
only O.D. is displayed and no data is displayed in Standard Details, Conc,
and Result field in the grid.
2. Click Curve Calibration button.
9-27
3. Select any calibration curve from the saved calibration curves for that
particular test. Click Using Selected Calibration button. Following
message will appear. Click OK.
9-28
4. Click OK button in main window.
9-29
5. On clicking OK button, the previous screen is displayed with calculated

results (using earlier saved calibration). Standard details, Conc, Results will
also be displayed.
6. It is mandatory to save the calculated results by clicking Save Selected

Results button.
7. Following message will appear. Click OK.
9-30
Click View Print button. In this case (results calculated using earlier
saved calibration), PrintStripwiseRawData option is disabled.
Click OK to display table wise results. Error! Reference source not

found.
9.5.9.2. Viewing Batch Results

Once the Run of a particular test in a Batch is completed successfully, the color of
the respective test will to Green.
When all the tests are completed, you can view the batch results by clicking the
View Results button.
Results:
In the Test Result section, a complete description of the results for all the samples
is displayed in a concise manner.
It consists of following sections:
1. Test Details: In this section, the details pertaining to the test are displayed.
These include Test Code & Units.
2. Blank Details: In this section, the details pertaining to the Blank are displayed.
These include Concentration, O.D., C.V. % and Observed C.V. %.
3. Standard Details: In this section, the details pertaining to the Standards are
displayed. These include Concentration, O.D., C.V. % and Observed C.V. %.
4. Control Details: In this section, the details pertaining to the Controls are
displayed. These include Concentration, O.D., C.V. % and Observed C.V. %.
5. Calculations: In this section, the calculation details of the test are displayed.
For Quantitative test it displays Calibration Curve (is selectable from the list of
curves. Once the changes are saved for the selection of curves, the result values
changes dynamically)
For Qualitative test it displays List of Curves.
 Cut-off value
 GrayZone value
Values greater than Cut-off are considered as > Positive/Negative.
 Cut-off Formula
9-31
For Semi-Qualitative test it displays.

 Cut-off value
 GrayZone value
Values greater than Cut-off are considered as > Positive/Negative.
 Cut-off Formula
 Index Formula
 Index Value
Results: In this section, the sample results for a particular test will be listed, which
includes information like:
 Patient I.D.
 Patient Name
 Result - (Depending on the interpretation Type selected in the Tests
Programming module).
 Absorbance measured (in terms of O.D.)
 Co-efficient of Variation (in %)
 Replicates (if present).
 Fitting Curve
 Quality Control
 Validation Conditions
 Tests
 Add / Edit Test’s
New: Whenever you want to add a new test to analyzer three options are
available.
 Copy: Copy the test details from the CD- provided by TBM.
 Download: To download all the test details from the TBM site.
 Manual Entry: By seeing the manual.
Open: You can view / modify the existing test details. Options to view / modify the
existing details are
 Test Details: You can view/modify the selected test details.
 Calculation: You can view/modify the selected test calculation values.
 Interpretation: You can view/modify the Interpretation of the selected test.
 Validation : You can view/modify the validation of the selected test
9-32
Profile: You can make new profiles here.
9.6. Common Reagents

If any tests in a batch, shares the same or common reagent, in this case you can
keep that particular common reagent in a single reagent position on the tray.
For example: Three tests are defined in a batch ID that is T3EM, T4EM, and TSH
EM. While saving the tests, a message box will be displayed as shown in the
following figure:
Now, click on Yes. On clicking, the following screen will be displayed.
9-33
Common
Reagents with
common position
Enter the reagent position manually in the RgtPosition column for those tests
having the common reagents. As shown in above screen, same reagent positions
are defined 1, 2, 3 for the tests T3 EM and TSH EM for common reagents.
After entering the positions click Save. This will displayed the Reagent Layout
screen as follows:
9-34
Common Reagents
Alternately, it can also be defined in the following way.(for position 4,5,6)
Common
reagent with
common position
9-35
Common Reagents
Make sure that the reagent name should be same for defining the common
reagent. In case, if it not same, a error message will be displayed. See the
following screen.
9.7. Test Details

Test are divided in to 2 types based on results:
 Quantitative
 Qualitative
Collecting test details are divided into three types:
 Test details
 Selecting test sequence
 Calibration
9-36
9.8. Details of the Qualitative Test

1. Test details
 Test details
 Reagent Details
 Blank details
 Cut off formula
 Control details
 Sample details
 Wave length
 Kit details
 Tips for probe
 Washing incubation
2. Test Sequence
 Dispense
 Incubation
 Washing
 Read
3. Calibration
 Validations
4. Reagents:
 Make Workbench:
Work bench is used to select the tests for a Batch. Here he can program
any number of work benches.
 Reagent Table
After programming the work bench we have all the Batch details and
tests to be performed. Now we have to specify the position of the
Reagents and control and controls and total strips required and volume
of the wash liquid required for that particular Batch. This will guide the
User to place the Reagents and control and controls in particular
positions and number of strips to be placed torn the Batch and volume of
the wash liquids.
9-37
5. Run:
Here you can select the Batch and perform Run.
All validations are checked before going to Run a Batch.
Validation to be checked:
a. Initialize robotic arm
b. Checking Bottle placement
c. Checking tips quantity
d. Initialize photo meter
e. Checking strip placements
f. Checking wash fluids
g. Checking Reagent volumes
If there are no errors then analyzer will continue with the Run.
9-38
10. Results
The Result screen available on the main screen is used for viewing and printing
the patient’s result. On clicking the Report, the following screen will be displayed.
There are four different options available to generate the patient result. They are:
 Test wise Results
 Batch wise Results
 Sample wise Results
 Batch wise Results with Date
The options are explained below:
10-1
10.1. Test wise Results

If you select this option, then patient results related to that test can be viewed
depending on the type of test selected from the Select Test dropdown list. After
selecting the test, click on the View Results to display the report in the grid.
Figure 10-1
The following report will be generated on clicking Print Results.
10-2
Figure 10-2
Click the Export Report button to save the report in *.rpt, pdf, xls, doc or rtf format.
In the Patient results, “NA” will be displayed in the ODValue and

ConcValue column and the Result column is displayed as Invalid
(invalid due to Sample absent, VOD or clot).
When the OD is found to be outside the calibration curve, in this

case, “NA” will be displayed in the ConcValue column with OD
values and the Result column is displayed as “Out of Range”.
10-3
10.2. Batch wise Results

Using this option, the patient’s results can be viewed batch wise. There are three
options to view the reports in batch wise.
 Last Batch Results
 Today Total Batches
 Total Batch Results
Figure 10-3
10.3. Sample wise Results

This option is used to view and print the patient’s results in sample ID wise. On
clicking this option, you have to enter the desired sample ID number in the
Sample ID text box. After entering the sample ID click View Result. The report
will be displayed in the grid as shown below.
10-4
Figure 10-4
The following report will be generated on clicking Print Results
Figure 10-5
10-5
10.4. Batch wise Results with Date

The patient results can be viewed batch wise as per desired date. To print the
result, first you have to select the date from the Select Date field and then select
the batch number from the BatchID field. The batch ID will be automatically listed
on selecting the appropriate date. Once the date and batch id is selected, click on
View Result to display the report in the grid. Alternatively, without selecting the
date you can only enter the BatchID in the text box and click View Results to view
the reports in the grid.
Figure 10-6
The following report will be generated on clicking Print Results.
10-6
Figure 10-7
10-7
This page is Intentionally Left Blank
10-8
11. Search
This screen is used to search the Patient and Sample details. Three options are
available for selection:
 Patient /Sample
 Test Details
 Doctor
 TableWise Report
 StripWise Report
To open this screen, click on the Search from the main screen. The following
window will be displayed:
11.1. Patient / Sample

This option is used to search the patient and sample details by using Patient ID,
Patient Name, and Sample ID.
The following are the searching options performed in Patient / Sample.
11-1
 Using only Patient ID

 Using only Patient Name
 Using only Sample ID
 Using only From Date and To Date
 Using Patient ID, From Date and To Date
 Using Patient Name, From Date and To Date
 Using Sample ID, From Date and To Date
Use the following step to search the details:
1. Select the option Patient / Sample.
2. Select the checkbox, and enter the Patient ID or Patient Name or Sample ID,
as appropriate.
The Patient ID, Patient Name, and Sample ID can be entered

one at a time.
3. Select the check box to select the From Date and To Date, if required.
4. Then click View Result.
On clicking, the details will be displayed in the grid.
11-2
 If the Patient ID or Patient Name or Sample ID is selected, then

only the single particular record will be searched and displayed,
which contains information of Patient ID/Patient Name/Sample ID.
 If the From Date and To Date are selected, then the sample and
patient records between those two dates will be searched and
displayed.
 If the Patient ID or Patient Name or Sample ID is selected with
From Date and To Date then only the records between the selected
dates will be searched and displayed.
11.2. Test Details

This option is used to search the records according to the type of Test selected.
1. Select the option Test Details.
2. Select the checkbox, and select the appropriate test from the available tests.
3. Click on the check box to select the dates, if required.
4. Click on View Results.

11-3
 If you select the test from the Select Test fields, then only the
records which are related with that Test will be searched and
displayed.
 If you select the dates from the From Date and To Date fields,
then the records between those two dates will be searched and
displayed.
 If you select the tests along with From Date and To Date, then the
records of that test between those two dates will be displayed.
11.3. Doctor
This option is used to search the record of all patients referred by the doctor.
1. Select the option Doctor.
2. Select both checkboxes if required, and enter the name of the doctor in
Enter Doctor Name and select the dates in From Date and To Date text
box.
3. Click on View Results.

11-4
 If you only select Doctor then the records of all Patients referred
by that Doctor will be searched and displayed.
 If you select only From Date and To Date then the records of
Patients between those dates will be searched and displayed.
 If you select Doctor with From Date and To Date then the records
of Patients referred by that particular Doctor between those dates
will be displayed.
11.4. TableWise Report

This option is used to search the records according to the type of Test selected in
Selected Batch.
Use the following step to search the details :
1. Select the option Tablewise Report.
2. Select the appropriate Test & select the Batch.
3. Click on Print Reports.

On clicking, print will be displayed in the TableWise Format as shown in
below screen.
11-5
11-6
11-7
For all negative OD values, a fixed value of 0.0001 OD will be

displayed and printed in test reports.
11-8
11.5. StripWise Report

This option is used to search the records according to the type of Test selected in
Selected Batch.
Use the following step to search the details :
1. Select the option StripWise Report.
2. Select the appropriate Test & select the Batch.
3. Click on Print Reports.

On clicking, print will be displayed in the Stripwise Format as shown in
below screen.
11-9
11-10
For all negative OD values, a fixed value of 0.0001 OD will be

displayed and printed in test reports obtained.
11-11
11-12
12. Quality Control

“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).
To open, click on the Quality Control from the main screen.
The Quality Control screen is useful for viewing the results in Graphical format.
The user should either rerun the controls again or recalibrate the test and run the
controls.
Following are the steps to view the results and chart:
1. Select required test from the Test dropdown list.
2. Select the option By OD/Conc. or By Index.
12-1
 For Qualitative test types both this options are available.

 For Quantitative test types only OD/Conc option is available and
selected by default.
 For Semi-Quantitative test types no options are available for the
user.
3. Select the Control Name from drop down list.
4. Search Interval option to select the Lot ID.
5. Select QC data & Click on Plot Graph
6. Graph will be displayed on screen with respective LJ Chart entry in Validation
criteria.
12-2
13. Maintenance
This section provides the necessary and minimal maintenance procedures in order
to ensure that the analyzer operates correctly and provides the accurate
measurement results.
It is recommended that the analyzer be maintained by the user with proper
instructions from the service personal to get the optimum output and to avoid any
possible damage to the analyzer.
Voltages present in the ELAN 30s can produce severe
electrical shocks. Place the analyzer and the computer in the
OFF (0) position and disconnect all line chords before
attempting any maintenance procedure.
Follow the laboratory’s safety protocol for cleaning and

decontaminating the analyzer and surrounding work surface.
Do not perform any maintenance procedure other than those

described in this manual.
Electrostatic sensitive components present on the PC

boards in the ELAN 30s require you to ground yourself even
when the Analyzer is in the OFF (0) position, otherwise
damage to the Analyzer electro-sensitive components and
PC boards can occur.
13.1. Maintenance Intervals

The analyzer has been designed to require very little user maintenance compared
to the other analyzers of the same class. Regular cleaning and periodic
maintenance as per the schedule keeps the analyzer in good working condition
without any trouble.
This section provides the necessary and minimal maintenance procedures in order
to ensure that the analyzer operates correctly and provides the accurate
measurement results.
Maintenance is a set of operations that are carried out at regular intervals in order
to preserve the functionality and reliability of the ELAN 30s.
13-1
There are various types of Maintenance operations. Some of them are very easy
and may be performed by the OPERATOR. Others, however, should only be
carried out by the authorized QUALIFIED TECHNICIAN only.
Among the operations that are carried out by the OPERATOR are those of
checking, cleaning, and decontamination of the equipment.
13.1.1. Daily Maintenance

Start of the day procedure
Serial Number Description
1 Fill the de-ionized water bottle.
2 Fill the Buffer bottles as per the tests that are to be programmed
3 Perform the Probe & Washer Priming.
4 Replace the printer paper if necessary.
End of the day Procedure
1 Remove and discard all sample / standard and controls tubes from the
sample tray.
2 Perform Empty Strip operation after completion of test; this is required to
remove off the solutions from the strips.
3 Take a backup of all patient reports.
4 Turn off the main switch located on the right hand side of the analyzer.
5 Empty the disposable tip bin container.
6 Empty the bio-hazardous waste bottle.
7 Clean analyzer external surface, to remove residues of serum, reagents
etc.
13.1.2. Weekly Maintenance

1 Clean and fill the de-ionized water bottle.
2 Clean the disposable tip bin container.
3 Empty the Bio-Hazardous Waste bottle.
4 Clean the computer, trolley, monitor, keyboard, and printer external
surface.
5 Clean the area around the analyzer, and discard any unwanted item.
(Maintain proper room cleanliness).
6 Clean the Sample & Reagent Tray.
7 Clean the Strip Tray.
8 Perform an auto span check and note down the gain values for all the
wavelengths.
9 Perform washer prime and check the flow of liquid from all the tubes.
13-2
13.1.3. Quarterly Maintenance

3 Empty the Bio-Hazardous Waste bottle.
4 Clean the computer, monitor, keyboard, and printer external surface.
5 Clean the area around the analyzer, and discard any unwanted item
(maintain proper room cleanliness).
6 Clean the Sample & Reagent Tray
7 Clean the Strip Tray
8 Clean the fans.
9 Clean the bar code reader.
10 Perform the auto span check and note down the gain values for all the
wavelengths.
11 Carry out site verification for temperature, line voltage, electrical ground,
ventilation, external interferences, room lighting, and laboratory
cleanliness practice.
12 Make a detailed entry of the maintenance carried out and site
verifications performed in the error log book.
13.1.4. Annual Maintenance

1 Clean the Bio-Hazardous waste bottle.
4 Replace External Tubing Bio-Hazardous Waste, Buffer Solution And
Deionizer Water Bottles.
5 Clean the analyzer external surface.
6 Clean the computer, monitor, keyboard, and printer external surface.
7 Clean the area around the analyzer, and discard any unwanted item
(maintain proper room cleanliness).
8 Check and replace the sample or reagent probe if necessary.
9 Clean the fans.
10 Clean the bar code readers.
11 Perform the auto span check and note down the gain values for all the
wavelengths.
12 Replace the lamp.
13 Carry out site verification for temperature, line voltage, electrical
ground, ventilation, external interferences, room lighting, and laboratory
cleanliness practice.
14 Make a detailed entry in the error log book, of the maintenance carried
out and site verifications.
13-3
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.
13.2. Preventative Maintenance

13.2.1. Actions 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 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 by your own and call for service at our
customer service department.
13.2.1.1. 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.
 Trouble in assembly.
 Serial number of analyzer in use.
 Method code in question.
 Explanation of encountered trouble.
 Serial number and lot number of reagent, calibrator, and QC sample in
use.
 A few calibration results that were carried out recently.
 A few measurement results of QC sample, that were carried out
recently.
 Measurement results.
 Trouble in analyzer.
 Serial number of analyzer in use.
13-4
 Software version numbers in use (PC, Mechanical, and Sub-CPU).

 Explanation of the relevant alarm and problem, and any other
information about the analyzer in use and maintenance.
13.2.1.2. 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 right hand side 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.
13.2.1.3. Randomly Derived Erroneous Measurement Results

Serial Number Cause Corrective action
Fibrin clots formed on specific sample Clean the Probe nozzle.
1
tube.
Check if the tip of water or
solution tube is positioned below
Insufficient water or solution supply the water or solution level. Call
2
from respective external tank. for service at our customer
service department in case of
trouble.
Perform Auto-Maintenance and
check whether the liquid is
dispensed equally from all
3 Improper Washing
dispensing needles and is
aspirated properly by the
aspirating needles
13-5
13.2.2. Equipment Malfunction

It may be difficult for the user to deal with the problem, the troubleshooting of
which is beyond this limited extent. In this case, call for service at our customer
service department.
13.2.2.1. 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.
The Maintenance > Error Display screen can be used to view all the errors
occurred on the analyzer during the Run, Service, or Maintenance. This data is
generally useful for servicing/diagnostic purposes.
The date of Error List can be selected by selecting the check box and Date from
the calendar.
Remedial actions for all error conditions are given below in section 14 Error Codes.
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 damage to the analyzer or erroneous outcome of
measurements.
13.3. Maintenance Screen

Maintenance is divided into tabs. They are Routine, Records, Backup, User
Authentication, Configuration, Span, and Error Display in the Maintenance screen.
Refer following sections for greater details.
13.3.1. Routine
Routine tab is used for performing analyzer’s routine maintenance. To open this
screen, Click on the Maintenance menu, and then click on Routine tab.
13-6
The following are the commands available in the screen:

Empty Strips: This command is used to empty the strips after running the tests.
For washing, first and last strip number can be selected by the user. By default the
strips are washed with distilled water filled in bottle 1 for 1 cycle.
Prime Washer: This option can be used for priming the washer. By default distilled
water bottle 1 and 1 cycle is selected.
Probe Wash: This option can be used to prime the washer. By default distilled
water bottle 1 and 1 cycle is selected.
Probe Decontamination: This command is used to deproteinize the probe to
prevent the buildup of contaminants. This is an automatic service action that does
not require manual intervention.
Reconnect: This command is used to reconnect the communication between the
analyzer and PC, if it is disconnected.
Auto Startup: This command is used to perform the auto startup activities such as
probe cleaning, washer cleaning.
On clicking Auto Startup option following message is displayed.
13-7
Auto Shutdown: This command is used to perform the auto shutdown activities
such as probe cleaning, washer cleaning and software shutdown.
On clicking Auto Shutdown option following message is displayed.
Flush: Following screen is displayed.
13-8
Follow the on screen instructions to flush out water from all tubing before
transportation of analyzer.
Washer Decontamination: Following screen is displayed.
1. Prepare Hypochlorite solution with 0.01% concentration.

2. Place Wash Buffer -1 Bottle cover (along with float sensor & tubing) in a
bottle containing 0.01% hypochlorite solution.
Note: Do not use DI Bottle / tube for decontamination, if decontamination
solution gets into the DI line / tubing then this will damage the degasser.
3. Perform washer priming by using Service Menu > Washer > Priming >
Select Buffer B1 > select 3 cycles > click Start.
4. Remove Wash Buffer - 1 Bottle cover from the hypochlorite solution and
place it in a clean buffer bottle containing at least 1 L of DI water.
6. Replace the DI water used in step 4 with fresh DI water and repeat step 5.
7. Repeat the above steps for Buffer bottle 2 & 3 (for wash buffer 3 connect an
extra tubing).
13-9
13.3.2. Records
This tab is used to maintain the records. You can save the Date of change and
write the comments or reason for Probe, Lamp, Plunger, Syringe, Filter, or any
other Change. User can view the previously saved records by using the Display
option.
The following screen will be displayed on clicking Maintenance > Records.
Following are the buttons available on the screen:

Save: This button is used to save the comments. After entering the comments for
the appropriate module, click on this button.
Display: This button is used to display the previously saved records. Records can
be displayed module wise or all records.
To display the records for a module, use the following steps:
1. Click on the Display Records for Module option, and choose the appropriate
module from the dropdown list.
13-10
2. Now click on Display to display the records.

To display all records for all module, use the following steps:
1. Click on the Display All Records for All Module option.
2. Now click on Display.
On clicking, it will display the records entered on the same date.
3. If you want to view the records between the particular dates, then click on
the checkbox provided, and select the appropriate date into the From Date
and To Date fields as shown below.
4. After entering the dates, click on Display.
13.3.3. Backup
The backup tab is used to take the backup of the installed database. The following
screen will be displayed on clicking Maintenance > Backup.
13-11
Method to take a backup data:

1. Backup Mode: Two options are available for taking the backup.
 Full
Select this option to take full database backup.
 Selective
Select this option to take selective database backup. Use Backup
Option field to select your requirement.
2. Backup Format: This drop down list is used to select the mode of backup
only if the Backup Mode is selected as Selective. The available options
are Text, XML, Xls, and CSV.
 XML: This mode of backup stores the Backup Parameters in XML
format.
 Text: This mode of backup stores the Backup Parameters in Text format.
 Xls: This mode of backup stores the Backup Parameters in Excel format.
13-12
 CSV: This mode of backup stores the Backup Parameters in CSV

format.
3. Backup Path: Click on the Browse button to select the path or directory
where the database to be backed up.
4. Backup Option: A list of backup option will be enabled, if the Backup
Mode is selected as Selective Backup. The user can either check all the
parameters at once by clicking on the Backup All Option checkbox or can
make the selections individually.
5. Once the above details are entered, click on the Backup button.
13.3.4. User Authentication

This screen allows the administrator to create new user and can provide access
rights to new user and the existing users. The following screen will be displayed on
clicking Maintenance > User Authentication.
Administrator of the system can create, edit, and delete the user ids as required,
and also provide access rights to new and existing users.
13-13
13.3.4.1. To Create a New User ID

Use the following steps:
1. Click on the ADD button.
2. Enter the required details in the following fields:
 User Name
 Password
 User Type (select option Admin or Analyst, as appropriate)
 Password
 Address
 City
 State
 Country
 Zip/Postal Code
 TelNo (Telephone number)
 Email
3. In the Access rights frame, select the required checkbox to give screen
access to the user.
4. After entering all the details, click on SAVE.

On clicking, the new user id will be created and displayed in the grid.
13.3.4.2. To Edit the Existing User ID

1. Double click on the appropriate user ID to be edited.
On clicking, the previous details of the user will be displayed on the screen.
2. Click on EDIT.
13-14
3. Now, you can enter the new details in the required fields.
4. After entering the details, click on SAVE to save the settings.
13.3.4.3. To Provide Access Rights to the Existing User

Access rights can be given to the user while creating the new user ID. Refer
section 13.3.4.1 To Create a New User ID.
Use the following steps to provide access to the existing user ID:
1. Double click on the appropriate user ID to be edited.
The previous details of the user will now be displayed on the screen.
2. Click on EDIT.
3. In the Access rights frame, select the required checkbox to give screen
access to the user.
4. After entering the details, click on SAVE to save the settings.
13.3.4.4. To Delete the Existing User ID

Use the following steps to delete the existing user ID:
1. Double click on the appropriate user ID to be deleted.
2. Now click on DELETE.
On clicking, a confirmation message will be displayed.
3. Click OK.
This will delete the user ID from the grid.
13.3.5. Configuration
The Configuration screen allows you to configure the behavior of the analyzer
hardware and software. This screen is grouped into three parameters:
 ASTM settings
 Report Header Settings
 Reader Settings
13-15
 System Settings
To open this screen, click on the Maintenance > Configuration.
13.3.5.1. ASTM Settings
Click on Settings.
A new window named Settings will open which is used to establish
communication between the analyzer and the host.
The host communicates with LIMS (Interfacing Laboratory Information
Management System) only from the PC where the ELAN 30s software is installed.
Separate serial port is required to enable the communication through serial cable.
13-16
To enable the communication with Host, the analyzer PC where the

Host is installed should be connected to Internet or to local
network.
Two communication mediums are available in the ASTM Settings window for
communicating with the host. They are:
 TCP/IP
 COM
To enable communication through serial cable, select the COM option in the
Settings > Connectivity, and enter the appropriate parameter in the following
fields:
 COM Port
 Baud rate
After entering the details, click on OK.

To enable the communication through TCP/IP, select the TCP/IP option, and enter
the following fields:
 IP Address
 Port Number
13-17
After entering the details, click on OK.
13.3.5.2. Perform Strip Checking
When Perform Strip Checking option is checked, during batch run, system will
perform strip checking without asking user confirmation. See page number 9-19.
While performing strip check, if the detected OD <=0.01 then it is considered as
no/missed well and if the OD>=3 then the well is considered to be dirty.
NOTE: ‘Strip Checking’ option is enabled by default..
13.3.5.3. Auto Startup
When Auto Startup option is selected, analyzer will perform the auto startup
activities after initializing.
13-18
13.3.5.4. Tip Eject Type
This option is used to set the tip eject mechanism. Two types of eject mechanism
are provided.
 At Arm
 At Eject Location
By default, option At Arm is selected. This option is factory set and can be
changed depending upon the tip eject mechanism.
13.3.5.5. Report Header Settings

The parameter under the Report Header Settings is used to display the header
information on the patient reports. To do this, enter the required details in the fields
provided under this option. See figure below:
After entering the required information, click on Save.

If Online Printing option is selected, then batchwise results will be generated
during run. If you print the patient reports through the Search/Results screen, the
following information will be printed on the header.
13-19
Click on Clear to clear the entered text, as required.
13.3.5.6. Reader Settings

This option is used to work analyzer as a reader mode only. Click On Use As
Reader & Save
Follow the steps to work analyzer as a reader mode:

1. Select the tests to be performed. Refer the section 7.5 Test Selection for
more details.
2. If “Use As Reader“option is selected, then user can perform only single test.
13-20
3. If selected tests are exceed more than one following message will be
displayed
4. Select the single test & click Save. This will displayed the reagent Layout
screen as shown below:
13.3.5.7. System Settings

Using this option, you can change the language of your choice from the available
list of languages. ELAN 30s user interface uses this language in dialog boxes,
menus, captions, header in the screen, and other items in the user interface.
13-21
Changing the language is as follows:
1. Click on the three dotted button .

2. Select the desired language from the Set Language drop down list.
3. Click OK.
4. On clicking, the captions on the screen will appear in the selected
language.
13.3.6. Span
This screen is used to check the gain of the photometer for 405,450, 492 and 630
wavelengths. The range is 1.0 to 2.0. Click on Start button to start. ON clicking
Show Log button, the log details will be displayed on the screen.
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.
The following screen will be displayed on clicking Maintenance > Span > Show
Log.
13-22
13.3.7. Error Display

This screen is used to display the errors occurred during run or after completing
the run. This data is generally useful for service and diagnostic purposes. The
following screen will be displayed on clicking Maintenance > ErrorDisplay.
13-23
 The date can be selected by changing the date from the dropdown list by
selecting the checkbox provided.
 You can select the operation (Run, Service, Maintenance) during which
the errors occurred.
 Select the batch id by selecting the BatchId dropdown list.
 Once the above selection is done, click on Show button. The error
messages will be displayed according to the operation selected.
 In the grid following are the different column present:
 ErrorCode – This column displays the error code number to identify the
type of error occurred.
 ErrorMessage – This column displays the error code description.
 ErrorDateAndTime – This column displays the date and time of the
occurrence of error.
 BatchId – This column displays the batch id in which the error occurred.
Refer section 14 Error Codes list for error description and there corrective actions in
more details.
13-24
13.3.8. Raw Data

This option is used to display the data with respect to selected Date & Batch ID as
shown in below screen.
a. Select the Date & Batch ID for which data to be printed.

b. Click on Raw Data Print. Following screen will be displayed as shown
below
13-25
13.4. Washer Calibration

13.4.1. Volume Calibration
13.4.1.1. Dispensing Time
This time is used to calibrate the amount of fluid to be dispensed in wells
during a wash cycle.
a. Place an Empty clean strip at position 1.
b. Select the Type of Strip from the dropdown menu.
c. Select the strip position and click on check.
d. After performing an internal prime user will be asked to observe the
dispensing cycle. For Dispensing time user needs to observe the
dispensing of liquid in the wells.
e. The amount of liquid should be such that at the end of the dispensing
only a small amount of liquid should be sucked back by the big
aspirating needles.
13-26
f. In case if there is no suction after dispensing then increase the time and
incase if there is a high amount of liquid being sucked back then
decrease the time and click on save.
g. Repeat step 4 – 6 till a point such that all the wells are filled properly and
min amount of liquid is sucked back by the aspirating needles.
13-27
13.4.2. Strip Height Calibration
13.4.2.1. Washer Calibration till Strip

Before starting the calibration make sure that the Mask Error Code
Checkbox is ticked (as indicated by Red Circle in above figure) This is used
to perform a coarse calibration of the washer and change in this calibration
will affect all the strips simultaneously i.e. if this calibration value is
decrease by 1 unit then the individual calibration of all the strips will get
reduced by one unit.
a. Place an empty clean strip at position 31 that is used for washer priming.
b. Select strip number 31.
c. Click on start.
d. Now try to gently lift the strip from its side.
e. It should be possible to lift the strip by 1.5mm (equally from both the
sides).
f. In case if this is not as per the above requirement then increase or
decrease the calibration values accordingly and then click on save.
g. Repeat step 2- 6 till it meets the requirement as specified in step 5.
13.4.2.2. Calibration By residual Volume

This is used for calibrating the individual strips for residual volume.
13-28
a. Place an empty clean strip at position 31, this strip should be of the type
for which calibration is to be done.
b. Click on start.
c. The washer will perform a wash cycle and will ask to check the residual
volume.
d. If residual volume is Ok (as per the volume specified in the message
box) then click on Yes.
e. After this user will be asked whether he wants to, save the calibration,
click Yes to save and No to discard.
f. In case if residual volume is not OK then click on No when it asks to
check the residual volume in step 3.
g. Repeat the above steps till the residual volume is obtained.
This calibration is to be performed for all the strips that are going to be used
in the analyzer.
13.4.2.3. Calibration By steps

This is a very fine adjustment of calibration steps and is used for fine tuning.
a. Select the Strip Type for which calibration is to be done.
b. Click on Up /Down arrow as per the requirement and click on save.
This is to be used only for fine tuning and it will increase /
Decrease from the steps that were save previously (either
using calibration By steps procedure OR Calibration by
residual volume procedure)
13.5. Decontamination Procedure

At the end of the day, it is mandatory to perform the following decontamination
operations, in case, if infectious ELISA test is performed on the machine.
13.5.1. Washer Decontamination

1. Prepare Hypochlorite solution with 0.01% concentration.
2. Place WASH BUFFER-1 Can containing hypochlorite solution at position
1.
3. Close the Can with cover (along with float sensor & tubing).
Do not use DI Bottle / tube for decontamination, if
decontamination solution gets into the DI line / tubing then
this will damage the degasser.
13-29
5. Remove hypochlorite solution from WASH BUFFER-1 Can and replace it

with DI water.
7. Replace the DI water used in step 5 with fresh DI water and repeat step 6.
8. Repeat the same procedure for WASH BUFFER-2 and WASH BUFFER-3
(for wash buffer 3 connect extra tubing).
13.5.2. Probe Decontamination

1. Take 4 ml of Isopropyl Alcohol (IPA) in a Sample Tube.
2. Using Maintenance > Routine > Probe Decontamination > select Sample
and respective sample position > select 200 µl volume > select 10 Cycles >
and click Start.
3. Perform Probe Priming using Maintenance > Routine > Probe Wash.
13.5.3. Waste Bottle Decontamination

1. Rinse the WASTE bottle with 1% Hypochlorite solution and fill completely
with 1% hypochlorite solution, and keep it for at least 15 minutes.
2. Discard the hypochlorite solution and fill the waste bottle with DI water and
keep it for at least 5 minutes.
3. After 5 minutes discard the DI water and let it dry.
Even after performing decontamination procedure, you
should strictly follow the laboratory safety guidelines as
instructed in section 1.1 Safety Instruction.
13-30
14. Error Codes

14.1. Interpretation of the Error Codes
The error codes are generated in the following format.
CC RR SS W
Each code is of two digit number. Following are the code and its description:
Code Description
CC (2 Digits) Current state in which error has occurred
RR (2 Digits) Module / Type of Error
SS (2 Digits) Strip Number
W (1 Digit) Well Number
 CC - Current state in which error has occurred
The CC is a single digit number and if the error code value is less than 10, this will
take the following values which indicates the following possible cause:
Value Possible Cause
Error generated during Sample / Control /
1/2/3/4/5/6/7
Reagent Dispensation
8/9 Error generated during RUN / Service.
10 Error generated during shaking of strip tray.
11 Error generated during Washing of strips.
12 Error generated during calibration.
15 Error generated during Probe Priming
16 Error generated during Liquid Level Check
18 Error generated during Photometer Read
 RR - Module / Type of Error
Errors related to Robotic Arm
10 Not Initialized
11 Positional error
12 Probe Not at Home (Interlock)
Errors Related to Probe

20 Not Initialized
21 Positional error
22 VOD
23 Dead Volume Reached
24 Tip Bin Not Present
14-1
25 LLD Error (this code is generated by Driver)

Bottle Absent (FPGA steps exhausted
generated when probe goes 3mm below the
26
previous sensed level - this code is generated
by Driver)
27 LLS Air Aspiration error
Errors Related to SRGT

30 Not Initialized
31 Positional error
Errors Related to ST
40 Not Initialized
41 Positional error
43 Washer Not at Home (Interlock)
Errors Related to Washer

50 Not Initialized
51 Positional Error
52 ST Not In Position
Errors Related to Photometer

60 Not Initialized
61 Positional error
Errors related to Syringe

70 Not Initialized
In case of Sample -- Clot Detected
71
In case of Reagent – Tip Blocked
72 LLS froth Error
Misc Errors
80 Tip Exhausted
81 Unable to Dispose Tip
82 Proper Tip Fixing Failed
 SS - Strip Number
Strip Number 1 01
Strip Number 30 30
14-2
 W - Well Number
Well Number 1 01
Well Number 8 08
14.2. List of Error Codes

14.2.1. Probe and Robotic Arm
Possible Check
Serial Error Error Cause/Causes of
Flag Points/Remedies
Number Code Message
Error Generation
1 110SSW Robotic Arm  If while aspirating 1. Check for any
210SSW Initialization / dispensing or obstructions to
Error during Tip Fix / Robotic Arm
310SSW Tip eject the movement
410SSW Robotic Arm is 2. If there is no
510SSW not able to obstruction but still
initialize then this it is generating this
610SSW error is error then please
710SSW generated call service
810SSW engineer.
910SSW
1510SSW
1610SSW
2 120SSW Probe  If while aspirating 1. Check for any
220SSW Initialization / dispensing or obstructions to
Error during Tip Fix / Probe movement
320SSW Tip eject the 2. If there is no
420SSW Probe is not able obstruction but still
520SSW to initialize then it is generating this
this error is error then please
620SSW generated call service
720SSW engineer.
820SSW
920SSW
1520SSW
1620SSW
3 323SSW S* Sample 1. Once Sample
absent / Test Absent is detected,
Tube absent software will
Or automatically skip
the sample for the
LLS cannot rest of the Test/s
sense liquid and this error
as volume is cannot be
less than corrected during
dead volume the ongoing RUN.
2. Make sure that
during start of RUN
14-3
the total sample

volume is more
than the Required
Volume + Dead
Volume.
4 323SSW C* Controls/Stan  If while 1. Check for the
dards/Reage dispensing quantity of the
nt Absent Controls/Standar Reagent in the
Or ds/Reagent LLS Reagent Bottle and
is not able to if it is sufficiently
LLS cannot detect any more than the
sense liquid solution then this Dead Volume level
as volume is error is then there is
less than generated. possibility of
dead volume electronics failure.
Please call service
engineer.
5 372SSW -- Froth Error  If there is 1. Check for physical
872XXX presence of froth presence of froth.
on liquid surface. Wait for froth to
 If probe senses settle or use
in air. another bottle.
2. If froth is not
actually present
then it is false
sensing of froth.
Please call service
engineer.
6 327SSW LLS air  If probe senses 1. There is possibility
827XXX aspiration in air. of electronics
error failure. Please call
service engineer.
7 322SSW !R Vertical  Obstruction 1. Check for any

obstruction detected when obstructions to
error during probe goes for Probe movement
Reagent aspirating 2. If there is no
aspiration Reagent obstruction but still
its detecting VOD
(Vertical
Obstruction Detect
error) then call
service engineer
8 322SSW !C Vertical  Obstruction 3. Check for any
error during probe goes for Probe movement.
Standards/Co aspirating 4. If there is no
ntrols Standards / obstruction but still
aspiration Controls it’s detecting VOD
(Vertical
14-4
Obstruction Detect
error) then please
call service
engineer.
9 322SSW !S Vertical  Obstruction 1. Check for any
Sample aspirating 2. If there is no
aspiration Sample obstruction but still
it’s detecting VOD
(Vertical
Obstruction Detect
error) then please
call service
engineer.
10 422SSW R! Vertical  Obstruction 1. Check for any
Reagent dispensing 2. If there is no
dispense Reagent obstruction but still
(Vertical
Obstruction Detect
error) then please
call service
engineer.
11 422SSW C! Vertical  Obstruction 1. Check for any
Standards/Co dispensing 2. If there is no
ntrols Sample obstruction but still
dispensation it’s detecting VOD
(Vertical
Obstruction Detect
error) then please
call service
engineer.
12 422SSW S! Vertical  Obstruction 1. Check for any
Sample dispensing 2. If there is no
dispense Sample obstruction but still
(Vertical
Obstruction Detect
error) then please
call service
engineer.
13 1522SSW PW! Vertical  Obstruction 1. Check for any
Probe Wash priming 2. If there is no
obstruction but still
14-5
(Vertical
Obstruction Detect
error) then please
call service
engineer.
14 1622XXX Vertical  Obstruction 1. Check for any
liquid level liquid level check 2. If there is no
check obstruction but still
(Vertical
Obstruction Detect
error) then please
call service
engineer.
15 280SSW !T Error during  This error may 1. If there are
281SSW Tip Fixation get reported sufficient Tips and
when Tip is used still this error was
282SSW for Sample / reported then
Control / Reagent service engineer
dispensing needs to be
consulted.
16 581SSW T! Error during  Error when the 1. Open the Robotic
Tip eject Tip is not arm cover section
properly ejected and check for any
after dispensing obstructions for
of Sample / Probe movement.
Control / Reagent 2. If no obstructions
is observed then
service engineer
needs to be
consulted.
17 422SSW S! Vertical  Obstruction 1. Check for any
Sample dispensing 2. If there is no
dispense Sample obstruction but still
it is detecting VOD
(Vertical
Obstruction Detect
error) the please
call service
engineer.
18 422SSW R! Vertical  Obstruction 1. Check for any
Reagent dispensing 2. If there is no
dispense Reagent obstruction but still
it is detecting VOD
(Vertical
Obstruction Detect
error) then service
engineer needs to
14-6
be consulted.
19 422SSW C! Vertical  Obstruction 1. Check for any

Standards/Co dispensing 2. If there is no
ntrols Sample obstruction but still
dispensation it’s detecting VOD
(Vertical
Obstruction Detect
error) then please
call service
engineer.
20 581SSW T! Error during  Error when the 1. Open the Robotic
Tip eject Tip is not arm cover section
properly ejected and check for any
after dispensing obstructions for
of Sample / Probe movement.
Control / Reagent 2. If no obstructions
is observed then
please call service
engineer.
21 311SSW @S Arm  Error generated if 1. Check for any
Rotational required position obstructions to
Error during Opto slots are Robotic Arm
Sample not detected movement.
Aspiration when RA moves 2. If there is no
for aspirating obstruction but still
sample it’s generating this
error then service
engineer needs to
be consulted.
22 311SSW @RX Arm  Error generated if 1. Check for any
Reagent not detected movement.
Aspiration when RA moves 2. If there is no
for aspirating obstruction but still
Reagent it’s generating this
error then service
engineer needs to
be consulted.
23 311SSW @C Arm  Error generated if 3. Check for any
Controls/Stan not detected movement.
dards when RA moves 4. If there is no
Aspiration for aspirating obstruction but still
Controls/Standar it’s generating this
ds error then service
engineer needs to
be consulted.
24 411SSW S@ Arm  Error generated if 1. Check for any
14-7

Sample not detected movement.
Dispensation when RA moves 2. If there is no
for dispensing obstruction but still
sample it’s generating this
error then service
engineer needs to
be consulted.
25 411SSW R@ Arm  Error generated if 1. Check for any
Reagent not detected movement.
for dispensing obstruction but still
Reagent it’s generating this
error then service
engineer needs to
be consulted.
26 411SSW C@ Arm  Error generated if 1. Check for any
Controls/Stan not detected movement.
dards when RA moves 2. If there is no
Dispensation for dispensing obstruction but still
Controls/Standar it’s generating this
ds error then service
engineer needs to
be consulted.
27 ?? T@ Arm  Error generated if 1. Check for any
Tip not detected movement.
for ejecting the obstruction but still
Tip it’s generating this
error then service
engineer needs to
be consulted.
28 1511SSW @PW Arm  Error generated if 1. Check for any
Probe Wash not detected movement.
when RA moves 2. If there is no
for Probe wash obstruction but still
it’s generating this
error then service
engineer needs to
be consulted.
29 1611XXX Arm  Error generated if 1. Check for any
Error during opt slots are not Robotic Arm
liquid level detected when movement.
check RA moves for 2. If there is no
14-8
liquid level check obstruction but still

it’s generating this
error then service
engineer needs to
be consulted.
30 132SSW Arm  Error generated 1. Check for any
232SSW Rotational in case if probe obstructions to
Error when has not initialized Probe movement
332SSW Probe is Not and RA gets a 2. If there is no
432SSW at Home command to obstruction but still
532SSW move. This is an its generating this
interlock used to error then service
632SSW prevent any engineer needs to
732SSW damage to probe be consulted
832SSW
932SSW
1532SSW
1632SSW
31 371SSW CD Clot Error  Error generated 1. Try to clean the
when Clot is probe using Probe
detected during Wash feature
Sample available in
aspiration Maintenance.
2. If problem persists
contact Service
engineer.
32 371SSW @RTB Tip blocked  Error generated 1. Check the quality
when blockage in of Tips.
tip is detected 2. If problem persists
during Reagent contact Service
aspiration engineer.
33 329 Bottle Absent  Error is 1. Check the sense
generated when level
probe goes 3mm 2. If problem persists
below the contact Service
previous sensed engineer.
level
14.2.2. SRGT
Serial Error Error
Flag Possible Failure Corrective Actions
Number Code Message
1 130SSW @SRGT SRGT  This error is 1. Check for any
230SSW Initialization generated if obstructions in
Error SRGT is not SRGT movement.
330SSW able to 2. If there is no
430SSW initialize obstruction but
530SSW still its generating
630SSW this error then call
service engineer.
730SSW
830SSW
930SSW
14-9
1530SSW
1630SSW
2 831SSW @SRGT SRGT  Error 1. Check for any
931SSW Rotational generated if obstructions in
Error during required SRGT movement.
1231SSW aspiration position opto 2. If there is no
slots are not obstruction but
detected still its generating
when SRGT this error then call
moves for service engineer.
aspiration
3 332SSW @PSRGT SRGT  Error 1. Check for any
832SSW Rotational generated in obstructions to
Error during case if probe Probe movement
932SSW aspiration has not 2. If there is no
1232SSW when probe initialized and obstruction but
is not at SRGT gets a still its generating
HOME command to this error then
move. This is service engineer
an interlock needs to be
used to consulted
prevent any
damage to
probe
4 1631XXX @SRGT SRGT  Error 1. Check for any
Rotational generated if obstructions to
Error during required SRGT movement
LONGREAD position opto 2. If there is no
slots are not obstruction but
detected still its generating
when SRGT this error then
moves for service engineer
Liquid Level needs to be
Check consulted
14.2.3. Strip Tray

Serial Error Error
Number Code Message
1 840SSW @ST Strip Tray  This error is 1. Check for any
940SSW Initialization generated if obstructions to ST
Error ST is not able movement.
1040SSW to initialize 2. If there is no
1140SSW obstruction but
1840SSW still it’s generating
this error then
service engineer
needs to be
consulted.
2 441SSW @ST Strip Tray  Error 1. Check for any
841SSW Rotational generated if obstructions to ST
Error during required movement.
941SSW dispensation position opto 2. If there is no
1041SSW / during slots are not obstruction but
14-10
1141SSW washing / detected still it’s generating

during this error then
1241SSW Photometer service engineer
1841SSW Read needs to be
consulted.
3 442SSW @PST Strip Tray  Error 1. Check for any
Error during case if probe Probe movement
942SSW dispensation has not
1042SSW when initialized and 2. If there is no
1142SSW washer is ST gets a obstruction but still
not at command to its generating this
1242SSW HOME move. This is error then service
1842SSW an interlock engineer needs to
used to be consulted
prevent any
damage to
probe
4 443SSW @WST Strip Tray  Error 1. Check for any
Error during case if Washer
943SSW dispensation Washer has movement
1043SSW when not initialized
1143SSW washer is and ST gets a 2. If there is no
not at command to obstruction but
1243SSW HOME move. This is still its generating
1643SSW an interlock this error then
1843SSW used to service engineer
prevent any needs to be
damage to consulted
probe
14.2.4. Heater
Serial Error Error
Number Code Message
1 2000001 @TMP Heater Cancel Batch and
Communicat report the Results
ion Error with the Flag.
2 2000002 @TMP Heater Cancel Batch and
Sensor Error report the Results
with the Flag.
14.2.5. Washer
Serial Error Error
Number Code Message
1 850SSX @W Washer This error is 1. Check for any
950SSX Initialization generated if Washer obstructions to
Error (can't is not able to Washer
1150SSX get to home initialize movement
1250SSX position) 2. If there is no
obstruction but
still its generating
this error then
14-11
service engineer
needs to be
consulted
14.2.6. Photometer
Serial Error Error
Number Code Message
1 860SSX @PH Photometer  This error is 1. Check for any
960SSX Initialization generated if obstructions to
Error Photometer is Photometer
1260SSX not able to movement
1860SSX initialize 2. If there is no
obstruction but
still its generating
this error then
service engineer
needs to be
consulted
2 861SSX @PH Photometer  Error 1. Check for any
961SSX Linear generated if obstructions to
Movement required Photometer
1261SSX Error position opto movement
1861SSX slots are not 2. If there is no
detected obstruction but
when still its generating
Photometer this error then
moves for service engineer
reading needs to be
consulted
3 ?? L-FAIL Photometer --
Lamp OFF
during
Photometer
Reading.
14.2.7. Syringe
Serial Error Error
Number Code Message
1 670SSW @SYG Syringe  This error is Call service engineer.
770SSW Initialization generated if
Error Syringe is not
870SSW Initialization able to
970SSW Error initialize
1570SSW
1670SSW
14-12
14.2.8. Fluid Level Sensing

Serial Error
Flag Error Message Possible Failure Corrective Actions
Number Code
Either DI Can is 1. Check for the
1 1500003 Buffer Empty empty or Buffer amount of liquid in
Bottle is empty the bottle, if it is
2 1500002 Waste Can Full Waste Can is Full found to be OK,
and then check
the connections of
Float Sensors.
Either DI Can is
Waste Can Full empty or Buffer 2. If problem still
3 1500001 persists then
and Buffer empty Bottle is empty or
Waste Can is Full service engineer
needs to be
consulted.
14-13
14-14
15. Measurement Error Flag List

The flags printed out together with the measurement result are shown in the
following list.
Serial
Flags Cause
Number
This flag is displayed with control results to indicate that the
1 -1SD
result is below 1SD limit
2 +1SD
result is above 1SD limit
3 -2SD
4 +2SD
5 -3SD
6 +3SD
Measured value is larger than upper limit set for normal value
7 H
range for the corresponding age, sample type and category.
Measured value is smaller than lower limit set for normal value
8 L
range for the corresponding age, sample type and category.
This flag indicates that a clot has been detected during
9 CD
sampling for that test.
10 High-OOR This flag is displayed when the O.D. is out of range i.e. >3
15-1
15-2
16. Appendix
16.1. TBM Image Installation
This section explains you the procedure of installing the TBM image (Windows
Embedded 7 Operating System) into the analyzer PC.
The analyzer PC comes with preinstalled TBM image.
For any reason, if the TBM image is not installed or you want to upgrade the
existing operating system (OS) into TBM image, please read the following
information carefully for installing the TBM image to analyzer PC.
16.1.1. Scenario
There could be two scenarios under installing the TBM image:
 New (Clean Installation)
 Upgrade/ Reinstall
16.1.1.1. New (Clean Installation)

It is the first installation of TBM image on a fresh computer having no data.
In this installation, the TBM image setup will clean the entire hard disk and create
two drives that is C and D drive, with C drive as the active primary partition. In this
case, it will delete all the existing data and OS. Therefore, this type of
installation must be used exclusively on newly acquired PC.
16.1.1.2. Upgrade/Re-installation
It is kind of an upgrade installation in which the analyzer PC already has some
operating system (for example: previous TBM image) installed. In this case, the
TBM image setup will only format the C: drive and install the TBM image on the
same. This type of installation must be used if you want to install TBM image
on C: drive but want to keep the data on other drives untouched.
16.1.2. Installing TBM Image into Analyzer PC

The installation procedure should be performed by the trained
service engineer. Improper installation may result in loss of
data.
Before we start installing the TBM image, you must verify that the analyzer PC
allows booting from DVD by checking the boot options.
To check the boot options:
16-1
1. Restart the PC and continuously press F12 (or key that is mentioned on the
screen to go to boot menu) to go to boot menu. Select system setup in the
boot menu to find all the options for the system setup.
2. Find the boot sequence option in the system setup and make sure that the
sequence of boot for CD-ROM is higher than hard drive.
3. If any changes are made to the existing sequence, click Apply to save the
changes and restart the PC.
16.1.2.1. Installing TBM image - New (Clean Installation)

In this installation, all the existing data on target computer will be
deleted and clean installation of TBM image will be performed.
Use the following steps to install the TBM image available on DVD to the analyzer
PC:
1. Insert the DVD containing TBM image setup into the DVD drive and restart
the PC.
2. It will show a message “Press any key to boot from CD or DVD”. As
suggested, press any key so as to boot from the DVD we entered.
3. Now, the PC will boot from the DVD containing TBM image. It will show the
Loading Windows... progress bar message on the screen.
4. After loading windows, wait till it shows command prompt window i.e.
X:\Windows\System32>.
5. Now, you need to get to the DVD and existing OS drive letter so that we can
start the TBM setup.
(Refer section 16.1.3 Identifying Various Drives for details on finding the
DVD and OS drive letter on the analyzer PC. Note down DVD drive letter
and Drive on which you want to install TBM image of OS).
6. Type the appropriate DVD drive letter followed by colon ‘:’ to enter into the
DVD drive.
For example, if E is the DVD drive letter then type the following command
and press Enter key.
X:\Windows\System32> E:
7. Now, type the following command in the command prompt window and press
Enter key.
TBMSetupWithClean
This will delete all the data from the PC.
A message will be asked to confirm the TBM image installation.
16-2
Type y for yes to continue with the installation or type n to cancel the
installation.
On clicking n, the installation will be canceled and the command prompt will
be displayed.
8. After confirmation, it will clean the entire hard disk and then create two
partitions i.e. C and D drive with C drive size as 35 GB approximately, and
the remaining as D drive. It will then start applying the TBM image on the
PC. This process may take few minutes depending on the configuration of
PC.
9. Once the installation of TBM image is completed, a confirmation message
for the same will be provided on the screen and then the target computer will
restart automatically as shown below.
16-3
10. After restart, it might again ask to boot from DVD. Do not press any key and
let the PC continue to load the windows automatically. It is ok to take the
boot DVD out.
11. It will apply the required settings and may boot again.
12. Finally, it will ask to enter the product key. Enter the product key and click
Next button.
13. Follow and accept the remaining instructions to complete the TBM image
setup on the target computer.
TBM setup image contains driver for specific hardware
configuration, especially for Network Interface and Display. If
the analyzer PC has different hardware components, you may
need to install the corresponding drivers from the PC’s
motherboard utility CD.
16.1.2.2. Installing TBM image - Upgrade/Reinstall

Use the following steps to install the TBM image available on DVD to the analyzer
PC:
1. Insert the DVD containing TBM image setup into the DVD drive and then re-
start the computer.
2. It will show a message “Press any key to boot from CD or DVD”. As
suggested, press any key so as to boot from the DVD we entered.
3. Now, the PC will boot from the DVD containing TBM image. It will show the
Loading Windows... Progress bar message on the screen.
4. After loading windows, wait till it shows command prompt window that is
5. Now, you need to get to the DVD and existing OS drive letter so that we can
start the TBM setup.
(Refer section 16.1.3 Identifying Various Drives for details on finding the
DVD and OS drive letter on the analyzer PC. Note down DVD drive letter
and Drive on which you want to install TBM image of OS)
6. Type the appropriate drive letter followed by colon ‘:’ to enter into the DVD
drive.
For example, if E is the DVD drive letter then type the following command
and press Enter key
X:\Windows\System32> E:
Be absolutely sure about the drive where you want to install
the TBM Image. Next step will format the provided drive and
all data on that drive will be lost.
16-4
7. Now, type the following command in the command prompt window and
press Enter key.
TBMSetup
A message will be asked to type the OS drive letter followed by colon.
For example, if C is the OS drive letter then type C: in the command
prompt and press Enter key. If you do not want to continue with the
installation then type exit and press Enter key.
After drive letter is entered in the command prompt, it will ask to confirm
the TBM image installation on the specified drive, type y for yes in the
command prompt to continue with the installation. If you do not want to
continue with the installation type n to exit and return to command prompt.
The same has been shown in the figure.
8. This will format the drive that was provided in step above and then start
installing the TBM image on the PC. This process may take few minutes
depending on the configuration of analyzer PC.
9. Once the installation of TBM image is completed, a confirmation message
for the same will be provided on the screen and then the analyzer PC will
restart automatically as shown below.
16-5
10. It might again ask to boot from DVD. Do not press any key and let the PC
continue to load the windows automatically. It is ok to take the boot DVD
out.
11. It will apply the required settings and may boot again.
12. Finally, it will ask to enter the product key. Enter the product key and click
Next button.
13. Follow and accept the remaining instructions to complete the TBM image
setup on the target computer.
In the upgrade installation scenario, if the previous
installation is Windows 7, it is possible that after
installing TBM image, it will show one extra volume
which was the hidden partition in previously installed
Windows 7 OS. The typical size of this partition or
volume is normally 100 to 200 MB.
TBM setup image contains driver for specific hardware
configuration, especially for Network Interface and
Display. If the analyzer PC has different hardware
components, you may need to install the corresponding
drivers from the PC’s motherboard utility CD.
16.1.3. Identifying Various Drives

Use the following steps to find the DVD/OS drive letter from the command prompt
on the analyzer PC:
16.1.3.1. Finding the DVD Drive Letter

Use the following steps to find the drive letter pertaining to DVD drive. You can
skip the steps (1 to 3) if already done:
16-6
1. Boot the PC from the DVD containing the TBM image.

2. Now, the PC will boot from DVD containing TBM image. It will show the
4. To know the DVD drive letter, just type notepad in the command prompt
window.
It will open the Notepad window. Click on the Save option from the file
menu and then click on the Computer tab on the left to view all the drives
information on the right for the analyzer PC. Note the drive letter for the
DVD drive.
For example, if it is showing CD Drive (E :) or DVD Drive (E :) then, it
means that the drive letter is E.
5. Note down the drive letter.
The following figure shows the graphical representation of the
same.
6. Cancel and Close the Notepad window after confirming the DVD
drive letter.
16.1.3.2. Finding the Existing Operating System (OS) Drive Letter
Use the following steps to find the drive letter pertaining to DVD drive. You can
skip the steps (1 to 3) if already done:
16-7
1. Boot the PC from the DVD containing the TBM image

2. Now, the PC will boot from DVD containing TBM image. It will show the
4. To know the DVD drive letter, just type notepad in the command prompt
window.
It will open the Notepad window. Click on the Save option from the file
menu and then click on the Computer tab on the left to view all the drives
information on the right for the analyzer PC. Browse each drive to find the
following folders:
 Program Files
 Windows
1. Generally these folders are expected to be in OS drive.
However, you will find these folders in multiple drives in
case the target computer has multiple operating
systems.
2. These folders will not be available on a clean PC.
5. Note the drive letter containing the above folders because these folders are
expected to be in OS drive.
6. Note down the drive letter.
The following figure shows the graphical representation of the same.
16-8
Cancel and Close the Notepad window after confirming the DVD drive letter.
16-9
16-10
17. Revision History

Revision Date Revision Description Author
First release.
2012.01 29-Dec-2012 Updated as per ASW version 2012.01 PP/PS/SD
Addendum release.
2012.01.01 1-Jan-2013 Accessories checklist updated with new item SD
code and description for Reagent bottle
2013.01 -- Not used --
2013.02 -- Not used --
2013.03 7-June-2013 Updated as per ELAN30s software version SD
2013.03.
Following are the brief description:
 Message to view results after batch
completion is added.
 Provision to keep reagents on sample tube
using adaptor
 Edit button removed from the Workbench
screen.
 After saving the test, extra column will be
displayed that is Use Sample Tube. It
indicates small bottle is selected for the
reagent.
 DI water requirement added
 Decontamination procedure added
 Accessories checklist
 Strip fitment instructions
2013.04 16-Dec-2013 Updated as per software version 2013.04 PS
 Common Reagent
 Accessories list updated
2014.01 09-Jan-2014 Updated as per software version 2014.01 PS
 Sample positions (41-48) for reagents
2014.01.06 05-May-2014 Following changes are as per software version PS
2014.01.06
 Raw data in maintenance.
 On line printing & Analyzer as a reader
mode in configuration.
 Tablewise & Stripwise report with date.
2014.01.11 10-September- Following changes are as per software version SD

2014 2014.01.11.
 Soak time with variable wash cycle.
 Kit lot and kit expiry number in table wise
and strip wise report.
17-1
Revision Date Revision Description Author

2016.00.01 03-August-2016 Updated as per latest software version PS/MB
v2016.00.06
 30s soak time & mix up control
 Error code 329
 Strip Checking & Tip ejection in
maintenance
 Removed eppendorf 1.5ml
 Eppendorf 2ml rename to Micro
Centrifuge Tube
 Consumable details in table wise report
 Start time & end time in report
 Validation Criteria
 Removed suck back time, Priming time
 Removed external controls
 Available Photometry Wavelengths
 Updated unpacking procedure.
 Accessories checklist
 Added ORR
 Added user selectable interpretation for
Qualitative tests in Calculation
 Display and print fixed value of 0.0001
OD for all negative OD in tablewise and
stripwise reports.
 Added no well and dirty well OD range
while performing strip checking
 Added SMP/CO for Qualitative Test
 Auto Startup in Maintenance
 LJ chart Implemented
 Updated New Test creation menu
 Added Lot No. for control(As Mandatory)
 Added Blank Volume dispense in test
parameters with specific limit
 Updated Raw data screen
2016.00.02 19-January-2017 Updated as per latest software version MB
v2016.00.12
 SD flag added in Quality Control
 Added Semi-Quantitative test using
Standard curve
 Added 4PL curve
 Added CValue in Results
 Level scan sequence changes added
17-2
Contact Us
We welcome your feedback about the product. You can reach us at the following.
Address Transasia Bio-medicals Limited, Transasia House, 8 Chandivali

Studio Road, Andheri (East), Mumbai-400072, India
Phone 022 - 40309000
Fax 022 - 28573030
Web site www.transasia.co.in
Email transasia@transasia.co.in
Transasia Bio-medicals Limited, Transasia House, 8 Chandivali Studio Road, Andheri (East),
Mumbai-400072, India

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Operator Manual

Fully Automated ELISA Microwell Strip Batch

Document Version: 2016.00.02

Last Updated: January 19, 2017

Before operating the analyzer, user should:

1. Read and understand this manual.

2. Be trained by authorized person.

3. Be familiar with the operation of the analyzer.

Keep this manual in an easily accessible place.

Manufacturer is the copyright owner of this document.

This document cannot be modified, reproduced, translated, or transmitted in any form or

4.8.2. Pre-requisite ............................................................................................................. 4-20

8. Test Programming......................................................................................................... 8-1

12. Quality Control .......................................................................................................... 12-1

Icons Warning About

Warnings and Caution

Notes, Usage, Tips, and

1.1. Safety Instructions

Never touch patients' samples and analyzer components with

1.2. Warning Labels

On the 5-piece Top Cover Plates

On the 5-piece Top Cover Plates

On top of the front side of SMPS.

On the top cover.

On top of the power entry module

On the Bio-hazardous waste can

On DI Water Can (4 liter)

On wash buffer can (1 liter)

On wash buffer can (1 liter)

On wash buffer can (1 liter)

1.3. Precautionary Warning

Washing & reusing of the TIPs is not recommended.

This Page is Intentionally Left Blank

2. Introduction to the Analyzer

Advantages of the ELAN 30S analyzer:

2.1.1. Operating Principle

2.1.1.2. Principles of Absorption Photometry

2.1.2. Sequence of Operation

2.2. Analyzer Overview

2.2.1. Front View with Dome Closed

2.2.2. Front View with Dome Open

2.2.3. Left Side View

2.2.4. Right Side View

2.3. Technical Specification

2.3.1. General Specifications

2.3.2. Reader Specification*

Wavelengths 4 standard (405nm, 450nm, 492nm, 630nm) and 3 Optional

Linearity At 405nm & 450nm:

2.3.3. Washer Specification

2.3.4. Incubator Specification

2.3.5. Product Specification

2.3.6. Sample Pipetting

Sample Pipetting Precision With Probe:

2.3.7. Reagent Pipetting

Lab temperature is recommended to be in the range of 25-28°C.

3.1. Installation Conditions

danger to the analyzer or human body when the analyzer in conjunction

3.2. Site Requirements