Operator Manual

For

Semi-Automated Clinical Chemistry Analyzer

Document Version: 2013.00.03

Last Updated: August 04, 2014

Operator Manual LisaScan EM

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.

Use of the analyzer with proper knowledge will ensure quality test results and trouble free
analyzer operation with optimum performance.

This operation manual is prepared based on the assumption that the user has knowledge
of clinical chemistry.

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.

NOTE: Keep this manual in an easily accessible place.

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Operator Manual LisaScan EM

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.

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Operator Manual LisaScan EM

Contact Us
We welcome your feedback about the product. You can reach us at the following.

Address Erba Diagnostics Mannheim GMBH, Mallaustrasse 69 – 73, 68219,

Mannheim, Germany
Phone 49-621- 8799770
Fax 49-621- 8799688
Website www.erbamannheim.com
Email sales@erbamannheim.com

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CONTENTS

1. Overview of Analyzer ................................................................................................ 1-1

1.1. Introduction .......................................................................................................... 1-1
1.2. Analyzer View ...................................................................................................... 1-2
2. Safety ......................................................................................................................... 2-1
3. Analyzer Features ..................................................................................................... 3-1
3.1. Hardware Specifications ...................................................................................... 3-1
3.2. Software Specifications ....................................................................................... 3-3
3.3. Keyboard Description .......................................................................................... 3-4
4. Installation ................................................................................................................. 4-1
4.1. Inspection ............................................................................................................ 4-1
4.2. Unpacking............................................................................................................ 4-1
4.3. Installation Requirements .................................................................................... 4-1
4.4. Electrical Requirements ....................................................................................... 4-2
4.5. Installation Procedure .......................................................................................... 4-2
4.6. Printer Housing and Printer Paper Installation ..................................................... 4-3
4.6.1. Internal Printer Installation.......................................................................................... 4-3
4.7. COM Port Settings............................................................................................... 4-3
4.8. USB Driver Installation......................................................................................... 4-4
5. Types of Analysis...................................................................................................... 5-1
5.1. Modes of Operation ............................................................................................. 5-1
5.1.1. Quantitative Mode ...................................................................................................... 5-1
5.1.2. Qualitative Mode ........................................................................................................ 5-1
5.1.3. Semi quantitative Mode.............................................................................................. 5-1
6. Settings ...................................................................................................................... 6-1
6.1. Hardware Check .................................................................................................. 6-1
6.2. Main Menu ........................................................................................................... 6-2
6.2.1. RUN Test.................................................................................................................... 6-2
6.2.2. Test Parameters......................................................................................................... 6-2
6.2.3. Patient Reports........................................................................................................... 6-3
6.2.4. Service Check ............................................................................................................ 6-3
6.2.5. System Setup ............................................................................................................. 6-3
6.2.6. Demo RUN ................................................................................................................. 6-3
6.3. System Setup ...................................................................................................... 6-3
6.3.1. Lab Information .......................................................................................................... 6-4
6.3.2. Setting the Time ......................................................................................................... 6-4
6.3.3. Setting the Date.......................................................................................................... 6-5
6.3.4. Setting the Data Output Mode.................................................................................... 6-6
6.3.5. Mixing ......................................................................................................................... 6-7
7. Test Parameters ........................................................................................................ 7-1
7.1. Create/Edit Test................................................................................................... 7-2
7.1.1. Quantitative Assay ..................................................................................................... 7-3
7.1.2. Qualitative Assay...................................................................................................... 7-11
7.1.3. Semi quantitative Assay ........................................................................................... 7-25
7.2. Delete Test ........................................................................................................ 7-39

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Operator Manual LisaScan EM
7.3. Print Params ...................................................................................................... 7-39
8. RUN Test .................................................................................................................... 8-1
8.1. Plate Definition..................................................................................................... 8-1
8.1.1. Result After RUN........................................................................................................ 8-8
8.1.2. Errors Before & After RUN ....................................................................................... 8-10
8.2. Read Absorbance .............................................................................................. 8-11
8.3. Current Result.................................................................................................... 8-15
9. Patient Report............................................................................................................ 9-1
9.1. Collated report by Date ........................................................................................ 9-1
9.2. Collated Report by ID .......................................................................................... 9-2
9.3. Collated Report by Date and ID ........................................................................... 9-2
9.4. Collated Report by Test ....................................................................................... 9-3
9.5. Collated Report on External Printer ..................................................................... 9-3
9.6. Collated Report by Plate ID ................................................................................. 9-4
9.7. Collated Report by Plate ID & Date ..................................................................... 9-4
10. Service Check........................................................................................................ 10-1
10.1. Voltages........................................................................................................... 10-2
10.2. Plate Settings................................................................................................... 10-2
10.3. Photometer ...................................................................................................... 10-3
10.4. Keyboard Test ................................................................................................. 10-4
10.5. Printer Check ................................................................................................... 10-4
10.6. Download Params ........................................................................................... 10-5
11. Demo RUN.............................................................................................................. 11-1
12. PC Interface through ELI-LIMS............................................................................. 12-1
13. Maintenance and Analyzer Care .......................................................................... 13-1
13.1. Daily Maintenance ........................................................................................... 13-1
13.2. Quarterly Maintenance..................................................................................... 13-2
13.2.1. Replacement of the paper roll ................................................................................ 13-2
14. Trouble Shooting Guide........................................................................................ 14-1
15. List of Consumables ............................................................................................. 15-1
16. Appendix ................................................................................................................ 16-1
16.1. Revision History............................................................................................... 16-1

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Operator Manual LisaScan EM

1. Overview of Analyzer
1.1. Introduction
The LisaScan EM is an 8-channel Micro well plate reader for quantitative,
qualitative and Semi Quantitative (mixture of both) determination of wide range of
analytes in body fluids.
Unique features of the analyzer are:
 It is a 96 well micro plate reader with a large built-in graphic LCD display
and Thermal Printer.
 Operation is through a non-tactile keyboard with quick shift from one
function to another without going through complex sequential operations.
 It is provided with memory of 100 programmable tests and 480 well’s (5
plates) results.
 The analyzer is provided with a 320x240 dots backlight liquid crystal display
with alphanumeric and graphic capabilities.
 User can take a Printout of Collated Report by Date wise or ID wise or both
by Date & ID wise or Test wise or Plate ID wise or by both Plate ID & Date
wise and ID wise with Demographic.
The software is complete with the device diagnostics self-test function capable of
providing timely flag / error messages related to Test results or analyzer
malfunctioning.

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1.2. Analyzer View

TRAY COVER THERMAL PRINTER

DISPLAY KEYBOARD LEGEND

RUN TEST LED INDICATOR

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PARALLEL PORT FOR

SERIAL PLATE
EXTERNAL PRINTER

USB PORT FOR PC EXTERNAL (PS2 PC)

COMMUNICATION KEYBOARD

POWER SUPPLY INPUT DC JACK ON/OFF SWITCH

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2. Safety
This section provides safety information about analyzer. Use this product properly
and safely to prevent injuries and or damage to property. User must read these
safety precautions before installation/use and follow the directions.
 Only qualified personnel should use the analyzer.
 While operating, maintaining, servicing or repairing the analyzer, follow all
the procedures described in this manual.
 Always ensure that mains switch is OFF while connecting or removing or
servicing the analyzer.
 Observe all WARNINGS and CAUTIONS posted on the system or
described in this manual.
 Avoid contact with all electrical circuits of analyzer; observe CAUTIONS
posted on the analyzer.
 Never use substitute parts on the analyzer or modify it in any way.
 Keep the analyzer out of the rain and any other water splash. Pay attention
to inclination, vibration, shock etc.
 During the operation photometric lamp becomes extremely hot. DO NOT
look directly into the light path of the lamp when it is ON. DO NOT touch the
lamp when it is ON.
 If the lamp needs to be changed, always switch off the lamp by switching off
the analyzer and then wait for minimum 10-minutes, until lamp has cooled
down.
 Avoid using dangerous flammable material around the analyzer. Fire or
explosion may be caused by ignition.
 Avoid areas that are adversely affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust and air containing salt,
sulfur, etc.
 Operator is responsible for taking all necessary precautions against hazards
associated with the use of clinical laboratory chemicals. Specific
recommendations for each reagent used with the analyzer are normally
found on the manufacturer’s package inserts or on product information
sheets for each chemical. Wipe up any reagent spillage on the analyzer
immediately.
 Pay attention not to exceed time and volume necessary for diagnosis. Keep
monitoring the behavior of whole system in order to detect any malfunction.
 Take immediate corrective measures including shutdown of operation when
any malfunction is detected in the analyzer.

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 In the event of trouble, do not play with the analyzer and leave any repair
work to an authorized expert.
Caution: NEVER OPERATE ON A WET OR DAMP SURFACE.

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3. Analyzer Features
3.1. Hardware Specifications
1 SYSTEM TYPE Open system
Reagent from any manufacturer can be
programmed and run
2 MEASUREMENT Vertical photometry
PRINCIPLE
3 SETUP Bench top.
4 PLATE TYPES 96 well micro plates
User Selectable well mapping
5 WELLS TYPE Flat wells
U wells
6 OPERATING MODE Absorbance
Quantitative
Qualitative
Semi-quantitative
Kinetic mode
7 MEASUREMENT MODES Continuous
Step
8 SHAKING MODES Three Linear Speeds
9 WAVELENGTH SELECTION Monochromatic(Single)
Bichromatic(Dual)
Four Filters(Quad) available only in READ Absorbance
mode
10 CALCULATION MODES Non-linear Standard
Cut-off
Index Formula
Column Subtraction
Cubic Spline
Point to Point
Linear Regression.
Linear – Log
Blank, Control, Assay Validation equations with facility of
accurate flagging.
Multi-standard calibration as well as cut-off equation
programmable in the same test.
11 BLANK OPTIONS Against Air / Water, Well, Plate, Column, Column Mean,
Row, Row Mean.
12 NUMBER OF Up to 10 standards
PROGRAMMABLE Storage/ display/ printing of multi standard curves and cut-
STANDARDS off equations for all parameters.

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Operator Manual LisaScan EM
13 100 TOTALLY “OPEN” TEST Selectable through keypad. Parameters can be viewed/
PROGRAMS changed / printed and permanently deleted / stored. All
positions can be open for qualitative as well as
quantitative assays or mixed.
14 PHOTOMETER Optical system 8 VERTICAL measurement channels with
8 photodiode array, using Fiber optics cable for light
transmission.
Number of Filters: 6
Available filters: 405 nm, 450 nm, 492 nm, 578nm, 630
nm, 700nm
Light Source: 13.8V/50W Quartz Halogen Lamp.
Photometric Resolution : 0.001OD
Wavelength Range : 400 to 750 nm
Measurement Range : (0 to 3 OD)
Accuracy :
0.0 ~ 3.0 OD/492 nm: better than ±5%
Linearity : 400 to 750 nm - VIS model:
0.0 ~ 2.0 OD/492 better than ±1 %
2.0 ~ 3.0 OD/492 better than ±1.5 %
Precision :
0.0 ~ 2.0 OD/492 nm: better than 5% CV
2.0 ~ 3.0 OD/492 nm: better than 5% CV
15 READ MODE NORMAL : 17 Seconds
SPEED : 8 Seconds (for single wavelength)
16 DISPLAY(Monochrome) High resolution Graphics LCD 320x240 pixels, CCFL
Backlight, View area: 120x92 mm
17 Display Backlight Supply Inverter PCB – I/P: + 5 V DC; O/P: 110 V AC, 400 Hz
18 KEYBOARD Rugged waterproof & membrane panel
19 PC COMMUNICATION Serial (RS232) Based
Protocol compatible with Eli-LIMS and TNW
20 PRINTER INTERFACE Built in High resolution, 384 dots per line, thermal Type
with full graphics facility printer and option for connecting
External Parallel Printer (or USB Printer using External
Adaptor).
21 COMPUTER INTERFACING Windows Based Software with data management
SOFTWARE (OPTIONAL) capabilities to store patient results, store/display
calibration curve / QC curves.
22 PATIENT REPORT Report generation for last (480) Sample’s is
viewed/printed/stored.
Lab name in Print-out
Lab name in Display
Collated reports
Print-out of Normal Range along with the result (on
external printer only).
Sorted by:
Date

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Operator Manual LisaScan EM
I.D.
Both by Date and I.D.
Test
Plate ID
Both by Plate ID and Date
23 ONLINE HELP At each step on-line help in each menu. Beeps and online
instructions on erroneous entry.
24 OPERATING 20 – 40 Degree Celsius
TEMPERATURE
25 STORAGE TEMPERATURE -10 to + 50 Degree Celsius.
26 HUMIDITY Max.80% RH, non-condensing.
27 MAINS SUPPLY 18V DC using External Auto ranging SMPS adapter
115/230VAC ±10%, 50/60Hz., Max. 100 Watt. (CE & UL
certified)
28 SIZE: 502 X 369 X 216mm
29 WEIGHT: 7Kg
30 CE Certification IEC 61010-1/EN 61010-1
NOTE:
 Above specifications subject to change without prior notice. Screens shown
in this manual are meant for demonstration purpose and may differ from
actual.

3.2. Software Specifications

1. Following analytical modes of operation are available:
a. Absorbance
b. Qualitative
c. Quantitative
d. Semi quantitative
e. Kinetic
2. 100 totally “OPEN” test programs selectable through keyboard.
3. Parameters can be viewed, edited, printed and deleted.
4. Report: Report generation for last 480 samples are stored and obtained by
a. Date
b. I.D.
c. Both by date and I.D.
d. Test wise
e. Plate ID wise

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Operator Manual LisaScan EM
f. Plate ID and Date wise
5. Graphic presentation of Non Linear calibration curves.
6. Provision to run at least 5 external controls with each test.
7. Non-linear calibration (10 standards).First standard is zero standard.
8. Monochromatic as well as bichromatic measurements possible.
9. On-line help.
10. Self-diagnostics.
11. Help messages on erroneous entry.

3.3. Keyboard Description

KEY DESCRIPTION
These are multifunctional keys. Each key is used for
entering a number seen on the key and three alphabets in
upper and lower case .E.g. The numeric key <1> is used
to select an alphabet or the number in the following
sequence 1, A, B, C, a, b, c following each press.

Decimal point is used to enter the concentration and

absorbance value in calibration table. It is also used to
enter appropriate value in cutoff equations for qualitative
assays.

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Operator Manual LisaScan EM
Negative sign is used to enter the absorbance value in
calibration table. It is also used for cutoff equations for
qualitative assays.

 Paper feed key is used to Advance the paper when

new paper roll is inserted.
 It also used to advance the paper whenever printing
is functional.

This key is used to reset the instrument without resetting

the memory. Reset key is not active while test Run is in
progress. But it is active while editing the parameters for
the test.

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Operator Manual LisaScan EM

4. Installation
4.1. Inspection
The analyzer is tested before shipment and is packed carefully to prevent any
shipping damage. It is user’s responsibility to inspect all cartons upon arrival and
notify the carrier for any apparent damage. Follow the steps described in the
paragraphs below to install the analyzer.

4.2. Unpacking
The main unit and accessories like power adapter, power cord is packed in single
cartons. The representative is responsible for unpacking, installing and initial
setting up of the analyzer.
Following is the list.
Serial Item Description Quantity
Number Code
1 114585 Operator Manual for LisaScan EM (Export)_version 1 NO.
2013.00.03
2 100343 TYPE E / F PLUG - M2511 / U16CS3 V1625 HO5 VVF 1 NO.
3 X 1SQ.MM 2MTR. LENGTH.
3 101508 ALLEN KEY WHITE BIT HEX BALL SIZE: 1.5 MM 1 NO.
4 101510 ALLEN KEY WHITE BIT HEX BALL SIZE: 2.5 MM 1 NO.
5 101511 ALLEN KEY WHITE BIT HEX BALL SIZE: 3.0 MM 1 NO.
6 103217 DUST COVER 1 NO.
7 110309 THERMAL PAPER ROLL FOR PRINTER (57mm X 30M) 1 NO.
8 111067 AC POWER ADAPTER ( O/P : 18 VDC ; 100 W ) 1 KIT
PPS100A-13 (00A) L – TYPE
104891 EliLIMS SOFTWARE KIT FOR LISASCAN EM 1 NO.
(Optional)
1 101421 CABLE ASSEMBLY OF USB JUMPER USBC-AM-BM-B- 1 NO.
B-S-2/USB2.0 AM/BM-1.8M 33-2 x 0160-101
2 150664 "TBM-Eli-LIMS" HASP SRM basic dongle 1 NO.
3 104873 Eli-LIMS Software for Lisa Scan EM - CD 1 NO.
NOTE: Please refer to dispatch note for detailed checklist. ***

4.3. Installation Requirements

The proper location is an important consideration; a poor location can lead to
malfunction of the analyzer. Please follow our environmental and electrical
suggestions to ensure the accuracy and precision of the analyzer and to maintain
high level of safety for your personnel.

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Operator Manual LisaScan EM
Since the analyzer is comparatively smaller, it can be comfortably accommodated
on any standard sized table.
Remember that a minimum 30cm space is maintained between the Rear, Left
panel and the wall to allow for heat dissipation.
PROBLEMS resulting from the relocation of the analyzer done by
unauthorized service representative are not covered under warranty.

4.4. Electrical Requirements

Voltage and Single phase continuous stabilized AC 230/115 volts ±10%, 50 / 60
Frequency Hz.
Grounding Perfect earthing must be provided at power source with all applicable
local requirement (A grounded, power plug only should be used. The
voltage between earth and neutral should not exceed 5 V).
Plug Points 3 Nos. of 5 Amps sockets should be available near the mounting
desks. (Normally only one socket is required per analyzer and 2 extra
sockets are recommended for using any measuring equipment and
engineering tool if required while servicing.) Failure to properly
ground the analyzer bypasses important safety features and may
result in an electrical hazard. Heavy duty electrical devices like Air-
conditioners, Refrigerators, Oven, Centrifuge etc., should not be
operated on the same electrical lines as the analyzer.

4.5. Installation Procedure

1. Unpack the analyzer and other accessories from the box.
2. Check for any physical damage. In case of any damage, report it to your
local branch immediately. If everything is found OK then, continue to step 3.
3. The Analyzer is equipped with an external AC power adapter (also referred
as SMPS) and the power cord for the External AC adapter.
4. Proper use of the appropriate power cord assures adequate grounding for
the system. Failure to properly ground the analyzer bypasses important
Safety features and may result in an electrical hazard.
5. Connect the power cord of the external SMPS to the mains socket & check
the output of the SMPS; it should be 18V ± 5% DC.
6. Put the output end of the Power cord in the socket provided at the rear of
the instrument.
7. Switch ON the mains supply and then switch ON the instrument by ON/OFF
switch provided on the SMPS.

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Operator Manual LisaScan EM

4.6. Printer Housing and Printer Paper Installation

4.6.1. Internal Printer Installation
The thermal printer is housed inside the chassis. It is an extremely low noise
printer. When an improper installation (printer lever is not pressed downward) of
paper is detected, an audible alarm in the form of beeps is sounded and the
message “-TP-” is displayed on the screen.
Warning: BEFORE REMOVING THE COVER, SWICTH OF THE
POWER SUPPLY.

Refer below Figure 1 for proper routing of Thermal Printer Paper roll.

NOTE: The thermal paper used must match the specification of the original one,
since the calibration of the working temperature is optimized for that kind of paper.
Failure to use proper quality of paper may permanently damage the printer.

Caution: DO NOT TOUCH THE PRINTER PAPER CUTTER.

For details refer section 13.2.1 REPLACEMENT OF THE PAPER ROLL

4.7. COM Port Settings

The COM Port settings for the HyperTerminal are:
a. Baud rate 9600 bps
b. Data Bits 8
c. Parity None
d. Stop Bits 1
e. Flow control None

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Operator Manual LisaScan EM

4.8. USB Driver Installation

Install the USB driver from provided CD, follow the below steps-
1. Start the driver installation Setup program

2. Click Next

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Operator Manual LisaScan EM
3. Click Next

4. Select Install

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Operator Manual LisaScan EM
5. Select ‘Launch the CP210xVCP Driver installer’ and click ‘Finish’

6. Select ‘Install’

7. Select ‘OK’

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Operator Manual LisaScan EM
8. Connect the USB Cable between PC port & Analyzer’s USB port.

9. Close all applications. Right click on ‘My Computer’ -> ‘Properties’. ->
‘Hardware’ -> ‘Device manager’

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Operator Manual LisaScan EM
10. Check the ‘Ports’(COM & LPT), Silicon Labs CP210x USB to UART
Bridge’ to be listed

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Operator Manual LisaScan EM

5. Types of Analysis
5.1. Modes of Operation
The analyzer is capable of performing analysis using the following modes:
11. Quantitative
12. Qualitative
13. Semi quantitative

5.1.1. Quantitative Mode

5.1.1.1. ENDPOINT
Results are directly obtained after the analyzer has been calibrated using a
standard /calibrator of known concentration.

5.1.2. Qualitative Mode

On the basis of cutoff equation and grey zone equation the results are flagged as
positive or negative, so the actual value of the sample is not known and hence it is
a relative measurement.

5.1.3. Semi quantitative Mode

Based on the index formula the results of samples are calculated if it is to run
qualitatively and based on curve type the results of samples are calculated if it is to
run quantitatively. Results are flagged as High Positive, Positive, Negative and
Low Negative depending upon the range defined by the user.

5.1.3.1. Result Calculation

If smp/co  no. of standards = 0, result will be based on index formula. CO will be
based on cut off equation.
If multi standard mode  no. of standards will be more than 0 as per curve type.
Result will be sample concentration calculated based on current curve type. In
multi-standard mode cut off equation and Index formula will not be printed since it
is not considered during the result calculation.
Concentration will be calculated for each sample without check of out of calibration
table.
Negative sample concentration will be 0.
For infinity (or invalid), CONCENTRATION will be SHOWN “INVALID!”
Flag will be based on Interpretation values.

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Operator Manual LisaScan EM

6. Settings
6.1. Hardware Check
Turn ‘ON’ the analyzer. It will automatically check all the important devices and will
show the status on display.

In case of one or multiple parameters are showing NOT O.K, then the analyzer will
display message PRESS <YES> TO PROCEED, asking user to proceed by
pressing <YES> key.

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Operator Manual LisaScan EM

Note: - With any of the hardware check is NOT OK, the instrument performance is
not guaranteed. Hence, it is recommended only to use the machine for referring &
printing previous data
If all the hardware tests are OK then the Home Screen will be displayed
automatically.

6.2. Main Menu

Switch ON the analyzer by following the instructions as mentioned in the
installation section. Ensure that the voltage between earth and neutral should not
exceed 5V. The following display appears after Hardware Check:

This screen is also referred to as the "Home screen" of the analyzer. Select any
option by pressing any one of the alphanumeric keys (1-6) corresponding to the
desired option.
The options on the opening screen are described below:

6.2.1. RUN Test

Measurement of the different tests can be performed using this menu. The last
measurement results can be viewed in this menu.

6.2.2. Test Parameters

This menu is for creating protocol for different assays. The other functions in this
menu include the editing, deleting or printing the existing test parameters.

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Operator Manual LisaScan EM
6.2.3. Patient Reports
Patient reports can be viewed and printed using this menu. The patient reports for
printing can be sorted (by the date, I.D. No. or date and I.D. both, by the Test, by
the Plate ID, both by Plate ID and Date) as per the requirement.

6.2.4. Service Check

Service Check mode is a self-diagnostic mode. It is used by the Service Personnel
to check different voltages, plate setting, printer test, keypad check, checking
readings of Pre-channel for every filter and offset storage and downloading default
parameters.

6.2.5. System Setup

To set the laboratory information, system date, time and the data output mode,
mixing speed and mixing time.

6.2.6. Demo RUN

This menu is used to run a plate to obtain Water OD counts with all filters.

6.3. System Setup

The system setup menu allows the user to set the system date, time and the data
output mode.
The “SYSTEM SETUP” screen is as follows:

The numeric keys 1, 2, 3, 4 and 5 are used to select the Laboratory Information,
Set Time, Set Date, Data Output Mode and mixing speed/time respectively.
Following sections cover each of the above options in detail.

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Operator Manual LisaScan EM
6.3.1. Lab Information
Select the numeric <1> key to enter the LAB INFO menu. The screen displayed is
as follows:

Follow the instruction provided in the lower box of this screen display, for entering
the lab information. First two lines of LABORATORY INFORMATION will be
printed.

6.3.2. Setting the Time

Choose the option 2 from the System Setup menu and SET TIME. The display
screen appears as shown below.
The cursor is positioned on the TIME field on the SYSTEM SETUP > TIME screen.
Enter an appropriate time in the format as stated below.

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Operator Manual LisaScan EM
HOUR: Enter an hour from 00 to 23.
MINUTE: Enter minutes from 00 to 59.
SECONDS: Enter seconds from 00 to 59.
Each entry is separated by a ‘:’ sign, which appears automatically after the entry of
the 2nd digit.
Left/Right Navigation keys are provided for entering the date and time.
After appropriate entry is made, press the SAVE key to save and return to the
System Setup screen.
Press GO BACK to quit without saving and go back to the System Setup screen.
User will be prompted if the date or time is entered wrong.
Note: If an inappropriate Time entry is made, the user will be prompted with the
message, “INVALID TIME. PLEASE ENTER AGAIN.”

6.3.3. Setting the Date

The analyzer incorporates a built-in calendar function, which is maintained by a
battery, and once set, the Date and Time will be printed every time the analyzer
prints result data on the printer.
Press numeric key '3' and the following screen appears:

The cursor is positioned on the DATE field on the SYSTEM SETUP: DATE
screen. Enter an appropriate data in the following format:
DAY : Enter a day from 01 to 31
MONTH : Enter a month from 01 to 12
YEAR : The last 2 digits of any year from 00 to 99

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After appropriate entry is made, press the <fn> key to save date and return to the
System Setup screen or press < PREV > to quit without saving and return to the
System Setup screen.
Note: If an inappropriate Date entry is made, the user will be prompted with the
message, "INVALID DATE. PLEASE ENTER AGAIN.".

6.3.4. Setting the Data Output Mode

Choose numeric key 4 on the SYSTEM SETUP screen to select the data output
mode.

AUTO PRINT
The auto print function can be enabled for any or both printers.
Select <YES> key against the required printer selection. If auto print is enabled,
test results are automatically printed on respective printers after test completion.
<PRINT> KEY
<PRINT> key allows the user to take the print out of the test data displayed on
LCD.
TRANSMISSION
When the transmission is selected, results taken in read absorbance mode can be
transmitted to PC using <SEND> key.
If mapping at PC is enabled, patient report data can also be transmitted to PC
using <SEND ALL> key.

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MAPPING AT PC
This option enables the user to control the instrument through a PC (Protocol
compatible with Eli-LIMS /TNW / Microbe). The test parameter menu and the plate
definition menu of the instrument are deactivated in this mode & can be edited via
PC only.
When the user tries to access test parameter or plate definition menu, the following
message is displayed: “MENU DEACTIVATED, AS MAPPING PC OPTION IS
ENABLED”.
READ MODE
Every test can be run in either of the 2 modes: Normal & speed.
This selection offers a precision v/s time trade off.
By default, the READ Mode is selected as ‘NORMAL’ on every power on.
Note: At every power on the read mode will take default value & needs to be
edited always if speed mode is required.
ZERO INITIALIZATION
If zero initialization is selected, negative absorbance value obtained for Sample,
EC (Extra Control), HC (High Control), and LC (Low Control) is rounded off to zero.
Zero Initialization does not affect value of cutoff controls, Standards & Blank.
If zero initialization is deselected, all negative values are kept unchanged.

6.3.5. Mixing
This option is used for mixing of the contents of well of the micro plate before start
of the run. Choose the mixing speed option as displayed in the help window. Press
the <TEST> key to verify the selected speed. The time required for mixing can also
be entered.

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7. Test Parameters

The analyzer is preprogrammed for test codes. The test code for any chemistry
can be created, changed or viewed by the operator. A test code can have a
maximum of four characters which could be an abbreviation of the chemistry name
as per the convenience of the operator e.g. TSH, FSH, PRL etc. or alphanumeric
such as CO2 (all vacant positions are identified by the ‘xxxx’ code).
Select the PARAMETER MENU from the MAIN MENU by pressing the numeric
key ‘2’. Test Parameters menu is used to change the parameters including test
name and its description.
Note: When “MAPPING AT PC” option is selected as YES, the parameter menu is
not accessible. So when the parameter menu is selected, the screen appears as
shown in figure:

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Operator Manual LisaScan EM

7.1. Create/Edit Test

The Test Page screen is displayed on pressing numeric key “1” in PARAMETER
MENU.

In the parameter menu, up to100 tests can be programmed.

By pressing the numeric key, the particular test can be selected.
Entering number & pressing <SELECT>, displays the following screen:
e.g. Enter Test number as 38 and press <SELECT> key.

When the cursor is placed on TYPE, following options are displayed:

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TYPE: Select the required type from amongst the qualitative, quantitative and the
semi-quantitative options based on the type of assay.

7.1.1. Quantitative Assay

7.1.1.1. Measurement Type
In Quantitative, Measurement Type – End Point is included in Test Parameter
Module. While Absorbance Mode is included in Run Test Read Absorbance
module.

7.1.1.2. LAG Time

When the cursor is placed at lag time, message appears “Wait time before the
test starts. Enter time in the specified format”.

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7.1.1.3. Normal Min & Normal Max
For quantitative mode the normal min and normal max value of the test to be
carried out can be entered between 0 – 99999
For Sample concentration greater than NORMAL.MAX value, generates “H” Flag.
The sample concentration less than NORMAL.MIN value will generate the “L” flag,
along with the concentration in results.

7.1.1.4. Curve Type

Curve type is applicable for quantitative & semi quantitative mode. For quantitative,
when the cursor is placed at the curve type, the following screen will be displayed:

Select the curve type by pressing the appropriate numeric key.

Enter the no. of standards by placing the cursor at “NUMBER OF STANDARDS”.
No. of standards that can be programmed for each curve type is as follows:
CURVE TYPE NO. OF STANDARDS TO BE
PROGRAMMED
Linear Regress 2 – 10
Point – to – Point 1 – 10
Spline 3 – 10
Lin – Log 3 – 10
The concentration for each standard can be entered using < CALB TABLE> key.

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7.1.1.5. Calibration Table
Press the key <CALIB TABLE> and the following screen will appear (if number of
standards selected is 3):

After entering concentration for all standards, press <SAVE> key.

Press <YES> key to save the entries, if <NO> key pressed the entries will not be
saved. The <GRAPH> key will be displayed in place of <YES>, and the <GO
BACK> key in place of <NO>. Graph can be viewed by pressing key <GRAPH>.
User can exit from this menu by pressing <GO BACK>.
Note: In the CALIBRATION TABLE screen, only CONC field is editable & ABS is
non-editable. ABS can automatically get updated if standard is defined in well map
& then run has finished.

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7.1.1.6. Calibration Curve
After pressing <GRAPH> key, the following screen will appear (assuming
Concentration for the 3 Standards are entered by the user and the Plate is run to
obtain the corresponding Absorbance)

The printout of the graph can be obtained by pressing the <PRINT> Key
The key <SELECT POINTS> facilitates the user for selecting/deselecting the
points which are appropriate/inappropriate. By default all the points are selected
and the graph plotted is of all the points. To deselect a point, go to the undesired
point using <> or <> arrow key and press key <NO>.

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7.1.1.7. Sample Flags
For Quantitative Tests flags will be displayed as per the following criteria:
Sample Value Flags
Sample Concentration > NORMAL.MAX H (High)
Sample Concentration < NORMAL MIN L (Low)
Sample Absorbance > 3.5 Abs O (Out of Range) &
Absorbance displayed as “>3.5”
Sample Absorbance > Maximum absorbance in C (Out of Curve Range)
Calibration table
Sample Absorbance < Minimum absorbance in C (Out of Curve Range)
Calibration table

7.1.1.8. Wavelength
After selection of test type in quantitative mode, the type of wavelength required for
test needs to be selected. When the cursor is placed on wavelength, the following
screen appears:

NOTE: QUAD mode is only available in READ ABSORBANCE module.

Select the corresponding numeric key based on the specific requirement, from the
options provided and press <DEFINE> key. The following screen will be displayed:

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Select the type of wavelength required using the numeric keys corresponding to
options provided in the help window.
Note: When ELISA mode is selected position 1 and 5 have BLK filter; however
when instrument is in MICROBIOLOGY mode, position 1 has 700 and position 5
has 578 filters.

7.1.1.9. Units
When the cursor is placed on units, the following screen appears:

Select the units by pressing the corresponding numeric key as shown in the help
window provided. Blank Space is also acceptable as a Unit. The units for 6, 7, 8,
and 9 on UNIT PAGE 2 are editable.

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Operator Manual LisaScan EM
On Unit Page 2, <HELP> key is provided. On pressing <HELP>, the following
message will be displayed – “Highlighted Units Are Editable Press the Unit &
Enter New Unit”.
UNIT PAGE 2 screen will appear again by pressing <HELP> once again.

7.1.1.10. Blanking
The next step after the selection of units is to set the blanking options for the
desired test.

Select the blanking option by pressing the corresponding numeric key, in the help
window provided.
In case of Qualitative & Semi Quantitative Test Types, if any of the Blank Option is
selected, the ‘BLK’ Control in Cutoff Control’s screen will get auto selected.

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7.1.1.11. Measurement Mode
Select the measurement mode by pressing the numeric key corresponding to the
help window provided. For example, continuous mode is selected by pressing the
numeric key <2> below,

After Pressing <SAVE> Key, the selected option will be memorized & <RUN
TEST> key will appear.

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7.1.2. Qualitative Assay
To perform qualitative assay, go to CREATE/EDIT TEST from PARAMETER
MENU by pressing numeric key <1>. The screen will be displayed as follows:

Entering 2-digit number & pressing <SELECT>, displays the following screen:

Select the type of assay i.e. qualitative by pressing the numeric key <1>, then
press the command button <DEFINE>. The screen appears as follows:

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7.1.2.1. CUT OFF Controls

In order to select the type of control and the no. of replicates for the control, place
the cursor on cutoff control and press the command button <DEFINE>. The
Screen appears as follows:

Place the cursor on the control to be run and press <SELECT> Button to select the
control and the replicates.

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Operator Manual LisaScan EM

By default on selection of the control the no of replicates is shown as 1.

The no. of replicates can be increased to more than 1 by entering the appropriate
numeric key. Maximum 9 replicates can be entered.
For de-selection of the control the <DESELECT> key is used. When the control is
selected the Deselect key is visible and when control is deselected the select key
is visible.
Note: Once user enters in Cutoff Control screen & exits, automatically Validation
Equation & Cutoff Equation screen will be opened so that user can enter new
equation.

7.1.2.2. Validation Equation

Validation and Cutoff equation screen opens automatically after entering controls.

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Using the down <> arrow key, place the cursor on validation equation and press
the <DEFINE> key. The screen will appear as follows, if no validation equation is
stored (New Test):

User can navigate on the Validation Equation Screen for the required numbered
equation using <NEXT> and <PREV> keys.
Equation Counter is given so that the user is able to enter till Equation Counter >
0.
After each parameter entry this counter gets decremented as per the internal
memory required. Decrementing of counter is not proportional to no. of parameters
in the entered equation but it depends on what parameter is entered.
Initially, the Equation Counter is 18 which will decrease by one on every entry.
Equation counter is shown so that once limit is over, LIMIT OVER message will be
displayed and Equation Counter will become zero and equation entry will be
blocked.
If user can delete any equation using <CANCEL> key to delete it from the
memory.
Equation can be saved by using either <SAVE> or <NEXT> key.
Incomplete equation cannot be saved in memory. If incomplete equation is entered
and the user tries to save it, equation will automatically get erased and equation
Counter becomes 18. After entering incomplete equation if user presses <NEXT>
key, cursor will move to next equation and in place of incomplete equation,
previously stored equation from memory will be displayed.
<PREV> key has dual function. While entering equation it will act as <VALUE>
and while navigating through equation, it will act as <PREV> key.

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Operator Manual LisaScan EM
Incomplete equation cannot be saved considering following 4 cases:
1. Only control or opening/left bracket
2. Decimal point at the end
3. If last parameter is math sign or other than closing/right bracket
4. If parenthesis/brackets are not closed.
Design constraint: No check for at least one control compulsion in validation
equation.

Press <CUTOFF CTRL> to view the controls selected. The screen appears as
follows:

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Operator Manual LisaScan EM
Note: The letter <m> indicates the mean of the control values as the number of
replicates selected for the control is 2 or more.
Press the down <> arrow key to select the control for which the validation
equation is to be defined. After selecting control, the validation equation for the
same control needs to be set. Press <ENTER> key to set the validation equation.
The screen appears as follows:

To enter mathematical operators press the soft key <MATH SIGN>. The screen
appears as follows:

Select the mathematical sign as per the requirement by using the right arrow key.
Press <ENTER> key and the screen appears as follows:

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Operator Manual LisaScan EM

Press key <VALUE> in order to enter the values for the control in the equation.
After pressing the <VALUE> key, the screen appears as follows:

After entering the numeric value in the equation, press <ENTER> key. The screen
appears as follows:

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Operator Manual LisaScan EM

To enter the validation equation for the next control, press <NEXT> key. After
entering the validation equation, press <SAVE> key.
When <SAVE> is pressed, the screen appears as follows:

Using <GO BACK> key it is possible to go back to the qualitative test screen.

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7.1.2.3. Cut OFF Equation
After entering the validation equations, the cut off control should be defined. Press
<DEFINE> key to define the cutoff equation.

Next press the soft key <CUTOFF CTRL> the screen appears as follows:

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Operator Manual LisaScan EM

Select the control for which the cut off equation needs to be entered by using the
down <> arrow key.
Press the <ENTER> key and the screen appears as follows:

Press the soft key <MATH SIGN>

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Operator Manual LisaScan EM

Choose the mathematical operator as desired by using the right arrow key and
press <ENTER>.

Press the Key <VALUE> to enter an appropriate value for the control and then
press <ENTER> key. The screen appears as follows:

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Operator Manual LisaScan EM

After entering the equation for the control selected press <SAVE> key once the
equation is saved then press <GO BACK> key.

7.1.2.4. Grey Zone

Grey zone is used to indicate inconclusive results as determined by the equations
programmed as per the reagent manufacturer’s recommendations.

When grey zone is defined as <NO>, the parameters need not be defined and the
sample flag is based on the cutoff value.

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Operator Manual LisaScan EM

When grey zone is set as <YES >, press the <DEFINE> key to add the Upper &
Lower Limits. On pressing <DEFINE> key, the following screen will appear:

Type the limits using the keypad and press <SAVE>. Then press <GO BACK> to
return to the qualitative menu screen.

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7.1.2.5. Sample Flags
By using down arrow key, select the key from the options displayed in help
window. Sample flags can be based on Sample absorbance or on Sample/CO.

For grey zone entered as YES & sample flags are based on SAMPLE ABS,
Positive sample can be defined as follows:
1. ABS. > UL
2. ABS. >= UL
3. ABS. < LL
4. ABS. <= LL
If grey zone is entered as YES & sample flags are based on SMP/CO (SMP/UL &
SMP/LL), Positive sample can be defined as follows:
1. SMP/UL > 1
2. SMP/UL >= 1
3. SMP/LL < 1
4. SMP/LL <= 1
For Grey Zone Option ‘NO’ UL = CO
For Sample Absorbance > 3.5 ABS, “O” (Out of Range) flag will be displayed and
absorbance will be displayed as “>3.5”

7.1.2.6. Wavelength
Refer section 7.1.1.8 for details.

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7.1.2.7. Units
For Qualitative, test units are not applicable.

7.1.2.8. Blanking
Refer section 7.1.1.10 for details.

7.1.2.9. Measurement Mode

Refer section 7.1.1.11 for details.

7.1.3. Semi quantitative Assay

To perform semi quantitative assay, go to CREATE/EDIT TEST from
PARAMETER MENU, by pressing numeric key <1>. The screen will be displayed
as follows:

Entering number & pressing <SELECT> and then Numeric Key <3> displays the
following screen:

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Operator Manual LisaScan EM

Then press the command button <DEFINE>, the screen appears as follows:

7.1.3.1. Cut OFF Controls

In order to select the type of control and the number of replicates, place the cursor
on cutoff control, and press the command button <DEFINE>. The screen appears
as follows:

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Operator Manual LisaScan EM

Place the cursor on the control to be run and press <SELECT> key, to select the
control and the replicates.

By default, the number of replicates is shown as 1, when <SELECT> key is

pressed. The number of replicates can be increased to more than 1 by entering the
appropriate numeric key.
For de-selection of the control, the <DESELECT> key is used. When the control is
selected, the Deselect key is visible and when control is deselected, the Select key
is visible.
Note: Once user enters in Cutoff Control screen & exits automatically Validation
Equation & Cutoff Equation & Index Formula screen will be opened so that user
can enter new equation.

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7.1.3.2. Validation Equation
Refer section 7.1.2.2 for details.

7.1.3.3. Cut OFF Equation

Refer section 7.1.2.3 for details.

7.1.3.4. Index Formula

Result of samples based on smp/co mode will be calculated by using Index
Formula. While there is no use of Index formula for the STD based semi
quantitative mode.
If current no. of standards is equal to 0 it indicates that one has to enter Index
Formula since result calculation will be smp/co mode based.
And if current no. of standards is other than 0 (within range), result will be based
on curve type; hence there is no necessity to enter index formula as well as cutoff
equation.
By using the down <> arrow key place the cursor on Index Formula and then
press the soft key <DEFINE>. The screen will appear as follows:

Next press the soft key <CUTOFF CTRL> the screen appears as follows:

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Operator Manual LisaScan EM

Select the control for which the Index Formula needs to be entered by using the
down <> arrow key. Press the <ENTER> key and the screen appears as follows:

Press the soft key <MATH SIGNS>

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Operator Manual LisaScan EM

Choose the desired sign by using the right arrow key and press <ENTER>.

Press the key <VALUE> to enter an appropriate value & then press <ENTER>
key. The screen appears as follows:

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Operator Manual LisaScan EM

After entering the Factor Expression press <SAVE> key once, then the <SAVE>
key acts as <GO BACK>key.

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7.1.3.5. Interpretation of Result
By using the Down arrow key place the cursor on INTERPRETATION and then
press the soft key <DEFINE>. The screen will appear as follows:

After entering Concentration values for all press <SAVE> key once, it will ask for
<YES>/<NO>, After Pressing Key <YES> the values are saved & <SAVE> key
acts as <GO BACK> key & screen appears as follows:

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Operator Manual LisaScan EM
Sample flags will be based on Concentrations entered. For example:
SAMPLE VALUE INTERPRETATION FLAGS

SAMPLE VALUE <= 10 LN (LOW NEGATIVE)

10 >SAMPLE ABS <=20 N (NEGATIVE)

20 >SAMPLE ABS < 50 EQ (EQUIVOCAL)

50 >=SAMPLE ABS < 100 P (POSITIVE)

SAMPLE VALUE >= 100 HP (HIGH POSITIVE)

7.1.3.6. Curve Type

Press <1 to 4> numeric key to select the Curve Type.

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7.1.3.7. Current Number of Standards

Press <1 to 9> Numeric key to enter no of standards.

No. of Standards According to Curve Type:
Linear Regress 2-10
Point to Point 1-10
Cubic Spline 3-10

Lin Log 3-10

Note: ‘0’ entry is available only for Semi Quantitative Test Type. If user has
entered current no. of standards = 0; it indicates that user wants to run Semi
Quantitative type test using smp/co mode i.e. user wants to run it Qualitatively.
Then it is mandatory to enter both Cutoff Equation and Index Formula. It is user’s
responsibility confirm entered equation or to enter required valid eqns. before run
(to save that wastage of run).

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7.1.3.8. Calibration Table
Enter the no. of standards by placing the cursor at “NUMBER OF STANDARDS”.
Press the key <CALIB TABLE> and the following screen will appear:

After entering concentration for all standards, press <SAVE> key. If ABS has
nonzero value, graph can be viewed by pressing key <GRAPH>.
In Calibration Table, only CONC. field is editable while ABS has kept non editable.
ABS will automatically get updated in calibration table if & only if Standard has
defined in well map as well as STD has included in Index formula.
Note: If no. of Standards = 1, then graph will be plotted against origin (0, 0) if
blank is not defined If Blank is defined it will be plotted against (Blank ABS, 0).
Calibration Table will be updated after run if and only if STD is defined in well map
as well as if STD is included in Index Formula.

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7.1.3.9. Calibration Curve
After pressing <GRAPH> key, the following screen will appear (assuming
Concentration for the 3 Standards are entered by the User and the Plate is run to
obtain the corresponding Absorbance):

The printout of the graph can be obtained by pressing the <PRINT> key. The key
<SELECT POINTS> facilitates the user for selecting / deselecting the points which
are appropriate / inappropriate. By default all the points are selected and the graph
plotted is of all the points. To deselect a point, go to the undesired point using <>
or <> arrow key and press key <NO>.

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7.1.3.10. Sample Flags
Sample Flags will be based on Concentrations entered in Interpretation.
SAMPLE VALUE INTERPRETATION FLAGS

SAMPLE VALUE <= 10 LN (LOW NEGATIVE)

10 >SAMPLE ABS <=20 N (NEGATIVE)

20 >SAMPLE ABS < 50 EQ (EQUIVOCAL)

50 >=SAMPLE ABS < 100 P (POSITIVE)

SAMPLE VALUE >= 100 HP (HIGH POSITIVE)

For Sample Absorbance > 3.5 ABS, “O” (Out of Range) flag will be displayed and
absorbance will be displayed as “>3.5”

7.1.3.11. Wavelength
Refer section 7.1.1.8 for details.

7.1.3.12. Units
Refer section 7.1.1.9 for details.

7.1.3.13. Blanking
Refer section 7.1.1.10 for details.

7.1.3.14. Measurement Mode

Refer section 7.1.1.11 for details.
Flow chart of Events in Test Parameter Menu:

 If grey zone is not defined and flagging is done on sample abs. Positive
samples is defined as
 Abs>cutoff
 Abs>= Cutoff
 Abs< cutoff

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 Abs<=cutoff
 If grey zone is not defined and flagging is based on smp/co positive
samples are defined as follows:
 SMP/Co>1
 SMP/Co>=1
 SMP/Co<1
 SMP/Co<=1
 If grey zone is defined and flagging is based on sample abs, positive
samples are defined as follows:
 Abs>UL
 Abs>=UL
 Abs< LL
 Abs<=LL
 If grey zone is defined and flagging is based on SMP/Co positive samples
are defined as follows:
 SMP /Co>UL
 SMP /Co>=UL
 SMP /Co<LL
 SMP /Co<=LL

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7.2. Delete Test

The display will show the parameter screen of the selected test. The cursor can be
shifted to the required position using the arrow keys and the selected test can be
deleted.

7.3. Print Params

The cursor can be shifted to the required position using the arrow keys and the
selected test parameters can be printed using <Print> key.
If there is any problem related to Thermal Printer, beep will be sounded & error
message will pop up at the right upper corner of LCD.
If there is any problem related to Parallel Printer, it will not print anything but no
error message will pop up.

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8. RUN Test
To measure the test, once the assay parameters are programmed. Run test
includes:
1. Plate Definition
2. Read Absorbance
3. Current Result

The ELISA micro plate consists of 96 wells in which the samples are to be
dispensed hence it is necessary to define the controls and samples correctly in
order to interpret the results accurately.

8.1. Plate Definition

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Operator Manual LisaScan EM

After entering the test no. press <SELECT> to go that particular test .The screen is
displayed as follows:

Press edit and the screen appears as follows:

Controls or standards selected for the test will all appear in the well map, by using
<PREV ASSIGN> / <NEXT ASSIGN> key, the desired control can be selected.
Each well position can be assigned by using the <NEXT WELL> key, to get the
desired plate mapping.

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Enter the no. of samples that are required for the test to be performed and press
<DONE> key. For e.g. if the no. of samples entered are 10 followed by <DONE>
key then at whichever position the cursor is placed all 10 positions after that will be
assigned as SMP. The screen appears as above. The Sample ID of the sample
appears in the text box as above.
If no. of samples entered are more than 96, warning message appears, no. of
samples will be erased and cursor goes to 1st position so that user can enter no. of
samples less than or equal to 96.

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Operator Manual LisaScan EM

Key <CHANGE ALL> is used to assign NU (not used) wells to all positions, which
are vacant. Also if a particular ID is assigned to the sample E.g. 00001 and
<change all> is pressed then the IDs are automatically alphanumerically
incremented for the rest of the samples depending on the number of samples
assigned. User can also edit IDs required.
For Mapping at PC ‘NO’ option, the test for which, well map has been defined, can
be run.
Before starting the test, instrument checks the status of tray movement, & test is
started only if tray movement status is OK. In case, tray movement status is NOK,
following screen will appear:

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Operator Manual LisaScan EM
If paper roll is inserted in the machine, the same warning will be printed on thermal
paper also.
If tray movement status is OK, test is started.
If Mixing is OFF (in SYSTEM SETUP > MIXING menu) then on pressing <RUN
TEST> the following screen is displayed

The instrument will then display the Lag Time screen and proceed for Run Test.
However if Mixing is selected (in SYSTEM SETUP > MIXING menu) then on
pressing <RUN TEST> the following screen is displayed,

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The user has the option of skipping the Mixing before proceeding for Run Test by
pressing <NO> key. When one of the options is selected and the requisite
operation takes place, the analyzer proceeds for Run Test after displaying the Lag
time screen. The red LED glows indicating that the plate is being read. After the
plate is read, the Glow of the LED also stops.
Note: If any error occurs related to plate mapping again plate definition screen will
open.
If replicates related error occur user can proceed for RUN without editing well
mapping.

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Flow for modes other than Absorbance,

8.1.1. Result After RUN

After the Run is complete the result screen is displayed on the LCD as follows:
If “READ ABSORBANCE” (Mapping PC YES/NO)

Note: Printout will be possible only on Thermal Printer if it has selected in system
setup menu Mapping at PC option ‘YES’.

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Operator Manual LisaScan EM
Result can be transmitted to PC by pressing <SEND> key if Transmission option is
selected in SYSTEM SETUP > OUTPUT MODE
If Mapping At PC ‘NO’: e.g. Quantitative – End Point Chemistry

Flagging:
For Quantitative:
Quantitative Type
Mode Condition Flag
End Point OD > 3.5 O
CONC
>NORMAL MAX H
CONC
<NORMAL MIN L
OD out of
Calibration Table C
For Qualitative:
Flagging for OD > 3.5: O
For Sample Flags refer section 7.1.1.7 for details.
For Semi Quantitative:
Flagging for OD > 3.5: O
For Sample Flags refer section 7.1.1.7
User has the option of saving the Result in Memory for future reference by
pressing <SAVE> key. Following screen is displayed,

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On pressing <YES> key the result is stored in the memory and can be accessed
by the user at a later time for reference. Also the result is transmitted to PC if
Transmission option is selected in SYSTEM SETUP > OUTPUT MODE.
While, if <NO> key is pressed the Result will not be stored.
Note: Result will be loaded in Memory for valid or invalid results of Samples.
For Invalid Results, <Result> key will be available, only ABS will be displayed.
For the valid results, the Flag & Concentration will be displayed along with ABS.

8.1.2. Errors Before & After RUN

8.1.2.1. Errors after RUN
Based on the validation criteria, the message <VALID> or <FAILED> is displayed
after run.
In case the STD has not been defined in well map, message displayed is "GRAPH
WILL BE BASED ON OLD MEMORISED STD ABS DATA."
In Qualitative and Semi quantitative, if defined control fails, <RESULT> key will
appear and message “CONTROL HAS FAILED” will be displayed and printed (only
on thermal printer) to alert the user.

8.1.2.2. Errors before RUN

1. Crosscheck before run test:
If ALL WELLS ARE MARKED AS NU, message will be displayed “ALL
WELLS ARE MARKED AS NU PLEASE PRESS <EDIT> KEY TO EDIT
WELL MAP.”

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2. If control not found in well map “CONTROL NOT DETECTED, PLEASE
ASIGN CONTROL IN THE WELL MAP”
In case of points 1 & 2; after displaying message, cursor will automatically
go to edit well map screen.
3. If replicate of controls in control screen & those in well map are different, the
message displayed is “DIFFERENCE IN DEFINED AND ASSIGNED
REPLICATES”
CONTROL REPLICATES DEFINED REPLICATES IN THE WELL MAP
NC1 2 NOT USED
PRESS RUNTEST TO PROCEED.”
If cutoff equation is absent, “CUTOFF EQUATION IS ABSENT. ENTER
CUTOFF EQUATION PRESS RESET TO START” is displayed
4. Semi Quantitative: For smp/co mode only cut off equation error will be
considered. For multi standard mode validation check error will be given
only if any validation equation is present.

8.2. Read Absorbance

This mode is To Read ABS in Mapping PC ‘YES’ / ‘NO’ options.
The optical density reading in the range of 0 – 3.5 ABS. can be obtained directly
on the analyzer selecting appropriate wavelength.
For Mapping at PC ‘YES’ / ‘NO’ option. On pressing <RUN TEST> the LED glows
indicating that the plate is being read. After the plate is read, the Glow of the LED
also stops.
If Mapping At PC ‘NO’:
For Mapping at PC ‘NO’, user can set Lag Time, Wavelength & Measurement
Mode in this screen. Sub screen for Wavelength is same as in Mapping at PC ‘NO’
option for other test mode with addition of QUAD mode (option to read absorbance
with 4 filters).
If Mapping At PC ‘YES’:
For Mapping at PC is ‘YES’, user can set Lag Time, Wavelength & Measurement
Mode in this screen. Sub screen for Wavelength is as it is in Mapping at PC ‘NO’
option.
NOTE: Wavelength Option available in READ mode,
1. Single (1 filter)
2. Dual (2 filters)
3. QUAD (4 filters); however in this mode, Results will be transferred to PC (at
9600bps) after each filter reading and not be displayed on the LCD.

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Operator Manual LisaScan EM
For Read Absorbance mode, the measurement type displayed is Absorbance as
default.

The user can change the default measurement type from Absorbance to Kinetic by
pressing F3 key.
NOTE: Kinetic mode is available only for Single and Dual filter option.

Now press “-” button on keyboard. Following screen will be displayed.

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Operator Manual LisaScan EM

Press <EDIT> to set parameter for kinetic mode. Following screen will be
displayed.

Press “GO BACK”

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Operator Manual LisaScan EM

Press “RUN TEST”. Following screen will be displayed.

Again, press “RUN TEST” to start the test. After the completion of Kinetic test,
following screen will be displayed.

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8.3. Current Result

The latest Result can be viewed by the user by selecting RUN TEST > CURRENT
RESULT. The screen is displayed as follows:
If Mapping At PC ‘NO’: e.g. Quantitative – End Point Chemistry

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Flagging:
For Quantitative:
Quantitative Type
Mode Condition Flag
End Point OD > 3.5 O
CONC
>NORMAL
MAX H
CONC
<NORMAL
MIN L
OD out of
Calibration
Table C

For Qualitative:
Flagging for OD > 3.5: O
For Sample Flags refer section 7.1.2.5 for details.
For Semi Quantitative:
Flagging for OD > 3.5 : O
For Sample Flags refer 7.1.2.5

If Mapping At PC ‘YES’ or ‘NO’ (ABSORBANCE)

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Operator Manual LisaScan EM

READ ABSORBANCE(Mapping AT PC ‘NO’

Mode Condition Flag

Absorbance OD > 3.5 O

Note:
ABS will be loaded in Memory for all the 96 wells.
For Mapping PC ‘NO’ Plate ID, DATE & ABS with Flag will be loaded and for
Mapping PC ‘YES’ only Plate ID, DATE & ABS will be loaded.

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Operator Manual LisaScan EM

9. Patient Report
There are total 7 options for Collated Reports, out of which 5 options will be visible
for Quantitative (End Point), Qualitative & Semi Quantitative Test Types, while 6th
& 7th option will be visible only if Mapping At PC ‘NO’ ABS Mode & Mapping At PC
‘YES’ option.

Place the cursor at the required option of patient report and press <Enter> to go to
that option.

9.1. Collated report by Date

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Operator Manual LisaScan EM
After entering the date for which the report is to be generated press <ENTER> to
confirm the date and all reports for the particular date entered will be displayed.

9.2. Collated Report by ID

After entering the Sample I.D. for which the report is to be generated press
<ENTER> to confirm, all reports for the particular Sample I.D. entered will be
displayed.

9.3. Collated Report by Date and ID

Press Select key to toggle between Date and ID of patient. After entering the
Sample I.D. & Date for which the report is to be generated press <ENTER> to
confirm. All reports for the particular Sample I.D. & Date entered will be displayed.

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Operator Manual LisaScan EM

9.4. Collated Report by Test

After entering the Test name for which the report is to be generated press
<ENTER> to confirm, all reports for the particular Test. entered will be displayed.

9.5. Collated Report on External Printer

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Operator Manual LisaScan EM

9.6. Collated Report by Plate ID

9.7. Collated Report by Plate ID & Date

For Mapping at PC ‘YES’, the main screen will be as follows

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Operator Manual LisaScan EM

By pressing <SEND ALL> key, the entire 5 x 96 well’s offline results will be sent to
PC.

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Operator Manual LisaScan EM

10. Service Check

This menu includes 6 submenus:
1. Voltages
2. Plate settings
3. Photometer
4. Keyboard test
5. Printer check
6. Download Params

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Operator Manual LisaScan EM

10.1. Voltages
Go to SERVICE CHECK menu in the home screen and then press <1> numeric
key to go the submenu VOLTAGES. The screen is displayed as,

10.2. Plate Settings

Press numeric key <2> in service check menu to go to plate setting options. There
are two modes of setting. They are:
1. Step
2. Continuous
The user can define the desired option by pressing either <1> or < 2> numeric key.

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Operator Manual LisaScan EM

The Next key can be used to advance the plate from Home position to 12th position
i.e. when next key is pressed the plate moves from home to 1st position. When
next key is pressed again the plate is aligned at the second position and so on.
The position 1 to 12 denotes the strip numbers A1-A12.

10.3. Photometer
Pre-channel counts of the selected filter based on the position of the plate will be
displayed on the screen. The counts of all eight channels can be viewed on the
screen. For e.g. if numeric key <2> is pressed the filter 405 will be selected and if
plate is at second position the screen will appear as follows:

NOTE: - When ELISA mode is selected position 1 and 5 have BLK filter; however
when instrument is in MICROBIOLOGY mode, position 1 has 700 and position 5
has 578 filters.

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Operator Manual LisaScan EM
Printout of gains will be printed only on Thermal Printer if and only if “Thermal
Printer Select with Print Key” is selected in system setup menu.

10.4. Keyboard Test

When the keys on the legend are pressed the corresponding key symbol
disappears which is an indication that the keys are functioning properly.

10.5. Printer Check

This check is for thermal printer and when the key ‘5’ is pressed a printer test page
is printed, which contains following information:
1. Instrument Logo
2. Instrument name
3. Current date & time
4. Machine Serial Number
5. Software version
6. Printer Type
7. Read Mode of the instrument : Normal or Speed
8. Zero initialization : Selected or deselected
9. Thermal printer for Auto Print : Enabled or disabled
10. Lamp Voltage
11. Photometer counts for all filters & all channels.

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Operator Manual LisaScan EM
If the paper lever is lifted up or if paper is not loaded, the printer gives an error.
An audible alarm is sounded, along with visual error message that is displayed on
the screen.

10.6. Download Params

The user can download the default parameters of the 100 tests by this menu.

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Operator Manual LisaScan EM

11. Demo RUN

This menu is used to run a plate to obtain OD counts of sample with all filters. On
pressing <6> key for Demo Run in the main menu, the following screen will be
displayed:

Once the requisite Micro wells are filled up, the user should then press <RUN>
key. The analyzer will read the absorbance of the micro wells and display the
result as follows:

This menu is only for illustration purpose. The results are neither stored in memory
nor can be transmitted to PC.

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Operator Manual LisaScan EM

12. PC Interface through ELI-LIMS

There is a provision to perform READ ABSORBANCE through PC by means of Eli-
LIMS software (For details refer Eli-LIMS User Manual).
In this mode, the patient entry, assay parameters, plate scheduling is done with
help of Eli-LIMS software. The command for Start Run is given by Eli-LIMS to the
instrument. Instrument performs the run and sends back the results to Eli-LIMS.
NOTE: For PC interface through Eli-LIMS,
1. Instrument needs to be in Home Screen.
2. MAPPING AT PC option needs to be selected in SYSTEM SETUP > DATA
OUTPUT mode
3. Interface requirements (i.e. COM Port selection, Baud Rate) needs to be
fulfilled.
Results will not be stored in the instrument.

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Operator Manual LisaScan EM

13. Maintenance and Analyzer Care

Due to the use of various chemicals in the reagents, a compatible cleaning and
decontaminating fluid must be used. Consult the reagent manufacturer for
recommended fluids. Secondly, to avoid any potential shock when performing
preventive maintenance on the system, turn ‘OFF’ the power switch of the
instrument.
Though air conditioning is not a must, it is advisable to keep the instrument in a
dust free, cool atmosphere, away from direct sunlight.

13.1. Daily Maintenance

Handle the instrument with care and keep it clean.
1. The instrument’s power supply is capable of handling ± 10% fluctuations.
However, it is necessary to use a servo controlled voltage stabilizer or a
constant voltage transformer in cases of larger fluctuation.
2. Wipe off the outside surfaces of the instrument using a clean, soft cloth
dampened with an appropriate cleaning and decontaminating solution in
accordance with safe laboratory practices.
3. Discard all used wells from the plate at the end of each day.
4. Wipe off any spilled liquid on the holder with decontaminating liquid.
5. Close the lid of the Reader.
6. Switch off the Reader at the end of the day.
7. When not in use, cover the instrument with the dust cover to avoid
accumulation of dust.

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Operator Manual LisaScan EM

13.2. Quarterly Maintenance

13.2.1. Replacement of the paper roll
For any error, the printer displays the following text:
“-TP-“
To replace the paper roll, follow the procedure as stated below:
1. Open the Printer Cover.

2. Cut the end of the paper roll so that it is squared off.

3. Slide the ‘Plastic Pin’ into the new paper roll.

4. Place the paper roll along with the Plastic Pin on the support provided in the
housing.

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Operator Manual LisaScan EM
5. Lift up the Printer lever to unlock.

6. Slip the paper into the opening below the printer motor.

7. Press down the Printer Lever to lock.

8. Press [PAPER FEED] several times so that the paper now comes out.

9. See if the paper is properly aligned.

10. Close the printer cover.

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Operator Manual LisaScan EM

14. Trouble Shooting Guide

Note: The Trouble Shooting of LisaScan EM must be performed only by qualified
service personnel who are familiar with the operation of the instrument.
SERIAL PROBLEM CAUSE ACTION
NUMBER
1 Instrument does 1. Mains Supply 1. Check Mains Supply
not start. 2. Power adaptor 2. Check loose connection of mains cord / DC
jack pin.
3. Call service engineer
2 Printer does not 1. Paper 1. Reinsert printer paper. (Shiny side of paper
function. positioned should be on cutter side)
improperly. 2. Carefully remove foreign material without
2. Foreign material scratching / damaging surface of printer.
jammed in 3. Press leaver
printer
4. Check for Thermal Printer in service check.
3. Printer leaver
open
4. Printer setting in
service check
3 Key press and Damaged keypad Call service engineer.
LCD assembly

4 Tray does not 1. Plate placed 1. Check placement of plate.

move improperly. 2. Clear the path of tray.
2. Foreign object
in path of tray.

5 Tray rattles Tray home Call service engineer.

detector
improperly
aligned.
6 Time and/or Time and/or date Set Time/Date
date Installed for were not set at
is incorrect. initialization.
7 Time and /or Damaged clock Call a service engineer
date does not chip on main PCB.
display, does
not save, or is
frequently
incorrect.
8 No illumination 1. Lamp is Call a service engineer
of lamp inoperative.
2. Lamp / light
path is out of
alignment.

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Operator Manual LisaScan EM

15. List of Consumables

For continuous and trouble free working of the analyzer, it is recommended to
keep certain spare consumables handy.
One set of the items mentioned below is also supplied along with the instrument as
standard accessories. It is recommended to store the consumables/spare in the
OEM packing until the actual use.
SERIAL ITEM CODE DESCRIPTION QUANTITY
NUMBER
1 110309 Thermal Paper Roll For Printer (57mm X 01 NO.
30M)

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Operator Manual LisaScan EM

16. Appendix
16.1. Revision History
Revision Date Revision Description Author
2012.01 29 Mar 2012 First release Prasad Patil
Updated section Service check for Prasad Patil
2012.02 29 May 2012
Voltages & Photometer
Updated section Service check for Prasad Patil
2012.03 25 July 2012
Voltages
2012.04 -- Not used --
Introduced section wise page numbering Pramila Sawant
2012.05 23 Nov 2012 & added note for compatible software
version number
Following list of changes updated in the Pramila Sawant
manual
 Setting for Hardware check
 Data Output mode for Zero
2013.00.01 6 June 2013 initialization
 Test Parameters for Sample
Absorbance OD
 Run test for Plate definition
 Printer check for thermal printer
 Hardware Specification updated Pramila S
2013.00.02 10 Sept 2013 for Photometer details.
 Accessories check list updated.
 USB driver installation procedure PS
2013.00.03 04 Aug 2014 added
 Accessories check list updated

*
Compatible Software Version: 2013.00.xx

*
NOTE: xx denotes intermediate software releases having no impact on this Operator Manual.

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