Labtech LT-4500 User manual

Instructions for Use for
Absorbance Reader
Document Name: LT-4500 IFU
Document Revision No.: 1.0

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WARNING
CAREFULLY READ AND FOLLOW THE INSTRUCTIONS FOR USE
BEFORE OPERATING THE INSTRUMENT.
Notice
Every effort has been made to avoid errors in text and diagrams; however,
labtech.com assumes no responsibility for any errors, which may appear in this
document.
It is the policy of labtech.com to improve products as new techniques and
components become available. Therefore, labtech.com reserves the right to
change specifications at any time with appropriate verification, validation, and
approvals.
We would appreciate any comments on this document.
Manufacturer
labtech.com
Unit 2 Birch House
17 Brambleside
Bellbrook Ind Estate
Uckfield
TN22 1QQ
United Kingdom
Copyright Information
The contents of this document are the property of labtech.com and are not to be
copied, reproduced, or transferred to another person or persons without prior
written permission.
Copyright labtech.com
All rights reserved.
About the Instructions for Use
Original instructions. This document is intended as Instructions for Use (IFU) for
the labtech.com LT-4500 absorbance reader, which is designed to measure the
light absorbance (optical density) of samples in 96-well microplates. It is intended
as reference and instruction for the user.
This document instructs how to:
•Install the instrument
•Operate the instrument
•Clean and maintain the instrument
Remarks on Screenshots
The version number displayed in screenshots may not always be the one of the
currently released version. Screenshots are replaced only if the content related to
application has changed.

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Warnings, Cautions, and Notes
The following types of notices are used throughout this publication to highlight
important information or to warn the user of potentially dangerous situations:
Note
Gives helpful information.
CAUTION
INDICATES A POSSIBILITY OF INSTRUMENT DAMAGE OR DATA
LOSS IF INSTRUCTIONS ARE NOT FOLLOWED.
WARNING
INDICATES THE POSSIBILITY OF SEVERE PERSONAL INJURY, LOSS
OF LIFE OR EQUIPMENT DAMAGE IF THE INSTRUCTIONS ARE NOT
FOLLOWED.
WARNING
INDICATES THE POSSIBLE PRESENCE OF BIOLOGICALLY
HAZARDOUS MATERIAL. PROPER LABORATORY SAFETY
PRECAUTIONS MUST BE OBSERVED.
WARNING
THIS SYMBOL INDICATES THE POSSIBLE PRESENCE OF
FLAMMABLE MATERIALS AND A RISK OF FIRE. PROPER
LABORATORY SAFETY PRECAUTIONS MUST BE OBSERVED.
ATTENTION
DIRECTIVE 2002/96/EC ON WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE)
NEGATIVE ENVIRONMENTAL IMPACTS ASSOCIATED WITH THE
TREATMENT OF WASTE.

DO NOT TREAT ELECTRICAL AND ELECTRONIC EQUIPMENT
AS UNSORTED MUNICIPAL WASTE.

COLLECT WASTE FROM ELECTRICAL AND ELECTRONIC
EQUIPMENT SEPARATELY.

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Table of Contents
1. Safety .................................................................................................. 9
1.1 Instrument Safety ....................................................................9
2. General.............................................................................................. 11
2.1 Intended Use / Introduction ..................................................11
2.2 User Profile ............................................................................12
2.2.1 Professional User - Administrator Level...................................12
2.2.2 End User or Routine User........................................................12
3. Getting Started ................................................................................. 13
3.1 Unpacking and Inspection ....................................................13
3.1.1 Inspection of Delivered Packaging ..........................................13
3.1.2 Unpacking Procedure ..............................................................13
3.2 Power Requirements.............................................................14
3.3 Environmental Requirements............................................... 14
3.4 System Requirements...........................................................15
3.4.1 Hardware requirements ...........................................................15
3.4.2 Software Requirements ...........................................................15
3.5 Switching ON the Instrument ...............................................16
3.6 Software .................................................................................17
3.6.1 Introduction..............................................................................17
3.6.2 Installation Procedure..............................................................17
3.6.3 Installation Qualification...........................................................18
3.6.4 Start Working with LT-com ......................................................19
3.7 LT-com - Measurement Parameter Editor............................ 21
3.7.1 Control Bar ..............................................................................22
3.7.2 Workflow Pane ........................................................................27
3.7.3 Info Pane .................................................................................28
3.8 LT-com - Defining Measurements ........................................29
3.8.1 Defining Endpoint Measurements............................................ 29
3.8.2 Defining Multilabel Measurements...........................................30
3.8.3 Defining Kinetic Measurements ...............................................31
3.8.4 Indenting and Releasing Program Elements ...........................32
3.9 Optimizing for Best Performance.........................................34
3.9.1 Instrument Location .................................................................34
3.9.2 Operating Procedure ...............................................................34
4. Instrument Features ........................................................................ 35
4.1 Instrument Features ..............................................................35
4.1.1 Microplate Shaking ..................................................................35
4.2 Instrument Description .........................................................36

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4.3 Filter Wheel Description........................................................38
4.4 Instrument Specifications .....................................................39
4.4.1 General Specifications.............................................................39
4.4.2 Measurement Specifications....................................................40
4.4.3 Microplates ..............................................................................41
4.5 Available Option for LT-4500 ................................................42
4.5.1 LIS Option – Handheld Barcode Scanner................................42
4.6 Instrument Accessories ........................................................43
5. Quality Control ................................................................................. 45
5.1 Introduction............................................................................45
5.2 Self Check Procedure............................................................45
5.3 Operational Qualification (OQ) .............................................45
5.3.1 MultiCheck Test .......................................................................45
5.3.2 Microplate Test ........................................................................46
5.3.3 Instrument Precision with Liquid Samples ...............................46
5.3.4 Instrument Linearity with Liquid Samples.................................47
6. Application Example........................................................................ 49
6.1 Introduction............................................................................49
6.2 Step-by-Step Example: Quantitative ELISA.........................49
6.2.1 Test Kit Description..................................................................49
6.2.2 Create a Method ......................................................................51
6.2.3 Organize Printed Report ..........................................................61
6.2.4 Run the Method .......................................................................65
6.2.5 Evaluate the Result..................................................................66
6.2.6 Summary of Definition of Quantitative ELISA in LT-com..........68
7. Cleaning, Maintenance, and Disposal ........................................... 69
7.1 Introduction............................................................................69
7.2 Cleaning the Instrument........................................................70
7.3 Instrument Disinfection.........................................................70
7.3.1 Disinfection Solutions...............................................................71
7.3.2 Disinfection Procedure.............................................................71
7.3.3 Safety Certificate......................................................................73
7.4 Preventive Maintenance Plan for LT-4500 ...........................74
7.4.1 Monthly ....................................................................................74
7.4.2 Every 4 Years ..........................................................................74
7.5 Filter Replacement and Installation......................................74
7.5.1 Filter Switching Procedure .......................................................75
7.5.2 Defining Filters.........................................................................78
7.6 Disposal..................................................................................78
7.6.1 Introduction ..............................................................................78

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7.6.2 Disposal of Packing Material ...................................................78
7.6.3 Disposal of Operating Material ................................................79
7.6.4 Disposal of the Instrument.......................................................79
8. Troubleshooting............................................................................... 81
8.1 Introduction............................................................................81
8.1.1 Table of Error Messages and Troubleshooting........................81
8.1.2 Definition of ‘Overflow’ .............................................................82
8.1.3 Power Failure ..........................................................................82
9. Abbreviations, Trademarks, and Symbols .................................... 83
9.1 Abbreviations......................................................................... 83
9.2 Trademarks ............................................................................84
9.3 Symbols..................................................................................85
Index ..................................................................................................... 87

1. Safety
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1. Safety
1.1 Instrument Safety
1. Always follow basic safety precautions when using this product to reduce
the risk of injury, fire, or electrical shock.
2. Read and understand all information in the Instructions for Use (IFU).
Failure to read, understand, and follow the instructions in this document
may result in damage to the product, injury to operating personnel, or
poor instrument performance. labtech.com is not responsible for
damage or injuries resulting from incorrect handling of the device.
3. Observe all WARNING and CAUTION statements in this document.
4. Always disconnect the device from the main power supply prior to
cleaning and disinfection.
5. Never open the instrument’s housing.
6. Observe proper laboratory safety precautions such as wearing protective
clothing (e.g. gloves, lab coat, and safety glasses) and the application of
approved laboratory safety procedures.
CAUTION
IF THE INSTRUCTIONS GIVEN IN THIS PUBLICATION ARE NOT
CORRECTLY FOLLOWED, THE INSTRUMENT MAY BECOME
DAMAGED OR PROCEDURES MAY NOT BE CORRECTLY
PERFORMED AND THE SAFETY OF THE INSTRUMENT CANNOT BE
GUARANTEED.
It is assumed that the instrument operators, because of their vocational
experience, are familiar with the necessary safety precautions for handling
chemicals and bio-hazardous substances.
Adhere to the following laws and guidelines:
•National industrial protection law
•Accident prevention regulations
•Safety data sheets of the reagent manufacturers
WARNING
DEPENDING ON THE APPLICATIONS, PARTS OF THE LT-4500 MAY
COME IN CONTACT WITH BIOHAZARDOUS/INFECTIOUS MATERIAL.
MAKE SURE THAT ONLY QUALIFIED PERSONNEL OPERATE THE
INSTRUMENT. IN CASE OF SERVICE OR WHEN RELOCATING OR
DISPOSING OF THE INSTRUMENT, ALWAYS DISINFECT THE
INSTRUMENT ACCORDING TO THE INSTRUCTIONS GIVEN IN THIS
DOCUMENT.
OBSERVE PROPER LABORATORY SAFETY PRECAUTIONS SUCH
AS WEARING PROTECTIVE CLOTHING WHEN WORKING WITH
POTENTIALLY INFECTIOUS SUBSTANCES.

1. Safety
10
WARNING
THE INSTRUMENT COMPLIES WITH THE EMISSION AND IMMUNITY
REQUIREMENTS DESCRIBED IN IEC 61326-2-6; HOWEVER, THE
ELECTROMAGNETIC ENVIRONMENT SHOULD BE EVALUATED
PRIOR TO THE OPERATION OF THE INSTRUMENT.
IT IS THE OPERATOR'S RESPONSIBILITY TO ENSURE THAT A
COMPATIBLE ELECTROMAGNETIC ENVIRONMENT FOR THE
INSTRUMENT IS MAINTAINED, SO THAT THE INSTRUMENT
PERFORMS AS INTENDED.
DO NOT OPERATE THE INSTRUMENT IN CLOSE PROXIMITY TO
SOURCES OF STRONG ELECTROMAGNETIC RADIATION (E.G.
UNSHIELDED INTENTIONAL RF SOURCES) AS THIS MAY
INTERFERE WITH THE PROPER FUNCTION OF THE
INSTRUMENT AND MAY ALSO LEAD TO INCORRECT RESULTS.

2. General
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2. General
2.1 Intended Use / Introduction
The labtech.com LT-4500 instrument is a 96-well absorbance reader for the
measurement of light absorbance (optical density) of liquid media. The instrument
is intended to be used primarily in in-vitro diagnostic analysis of samples from the
human body to obtain information on physiological and pathological states.
For applications in human medicine, only the LT-com software is intended for the
use with the instrument. Software and instrument have been validated for
measurement and for the evaluation of qualitative and quantitative Enzyme-linked
Immunosorbent Assays (ELISA) according to the scheduled diagnostic
parameters and instrument specifications; they are therefore intended for
professional use in in-vitro diagnostics.
Note
If the LT-4500 absorbance reader or the LT-com software is modified in
any way, the warranty will no longer be valid and the instrument will lose
regulatory conformity.
Note
The operating authority must use only CE-labeled test kits for clinical
diagnostic applications. The operating authority must assure that the
combination of a particular CE-labeled test kit used with the CE-labeled
LT-4500 absorbance reader and its options have been validated to meet
the IVD directive 98/79/EC or other relevant national or local regulations.
If the LT-4500 absorbance reader is used differently from the ‘Intended Use’
mentioned above or if it is used with other software than LT-com, the instrument
is no longer IVD conform and the user is responsible for the respective use and
the necessary validation.
Note
Results obtained using the LT-4500 are influenced by the proper use of
the instrument and microplates, according to the instructions given in
this document, as well as the liquid compounds used (reagents,
chemistry). The instructions for use, storage, and applications involving
samples or reagents must be followed strictly. Results must therefore be
interpreted carefully.

2. General
12
Note
Never open the housing of the instrument or the warranty will be
rendered null and void.
The obtained transmission values are converted into optical density (OD) values
according to the following formula:
oI
I
TonTransmissi =
I0= intensity of the incident light
I = intensity of the transmitted light
The OD is the logarithm of the reciprocal transmission.
T
1
LogOD =
2.2 User Profile
2.2.1 Professional User - Administrator Level
The administrator is a person who has suitable technical training and
corresponding skills and experiences. If the product is used as intended, the
person is able to recognize and avoid dangers.
The administrator has extensive skills and is able to instruct the end user or the
routine user in assay protocols in connection with a Labtech product within the
bounds of the intended use.
Computer application skills and good English skills are required.
2.2.2 End User or Routine User
The end user or routine user is a person who has suitable technical training and
corresponding skills and experiences. If the product is used as intended, the
person is able to recognize and avoid dangers.
Computer application skills and good language skills for the respective national
language at the installation site and English are required.

3. Getting Started
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3. Getting Started
3.1 Unpacking and Inspection
3.1.1 Inspection of Delivered Packaging
The delivered instrument includes:
•External power supply
•Power cable
•USB cable for connection to external computer
•Instructions for Use (IFU), printed
•USB stick
oSoftware (LT-com)
oInstructions for Use (IFU), PDF files
oTools (e.g. Adobe Reader)
Note
To avoid undesired loss of data or virus/malware attack, never remove
the write protection from the USB stick.
CAUTION
THE READER HAS BEEN TESTED WITH THE SUPPLIED USB CABLE.
IF ANOTHER USB CABLE IS USED, THE CORRECT PERFORMANCE
OF THE INSTRUMENT CANNOT BE GUARANTEED.
3.1.2 Unpacking Procedure
1. Visually inspect the packaging for damage before it is opened.
Report any damage immediately.
2. Select a location to place the instrument. The location should be flat,
vibration free, away from direct sunlight, and free from dust, solvents, and
acidic vapors. Ensure that the distance between the instrument and the
wall or other equipment is at least 5 cm.
3. Lift the instrument out of the carton and place it in the selected location.
Take care when lifting the instrument.
4. Visually inspect the instrument for loose, bent, or broken parts.
Report any damage immediately.
5. Compare the instrument's serial number on the bottom plate of the
instrument with the serial number on the packing slip.
Report any discrepancy immediately.
6. Check the instrument accessories against the packing note.
7. Save packing materials for further transportation purposes.

3. Getting Started
14
3.2 Power Requirements
The instrument is auto-sensing for the supplied voltage. Therefore, it is not
necessary to make any changes to the voltage range. Check the voltage
specifications and ensure that the voltage supplied to the instrument is correct
according to the following specifications:
Voltage:
Basic instrument with AC adapter: 100 – 240 V AC, 50/60 Hz
Basic instrument without AC adapter: 24 V DC
If the above mentioned voltage is not available in your country, please contact
your local supplier.
Connect the instrument only to an electrical supply system with protective earth.
CAUTION
DO NOT USE THE INSTRUMENT IN AN INCORRECT VOLTAGE
RANGE. IF THE INSTRUMENT IS SWITCHED ON WITH THE
INCORRECT VOLTAGE IT WILL BE DAMAGED.
3.3 Environmental Requirements
The instrument should be placed on a flat, level surface that is free from dust,
solvents, and acidic vapors.
Vibration and direct sunlight must be avoided to ensure correct results.
Ambient Temperature:
Operation 15 °C to 35 °C (59 °F to 95 °F)
Storage -30 °C to 60 °C (-22 °F to 140 °F)
Relative Humidity: 20 % to 80 % non condensing at operation
temperature

3. Getting Started
15
3.4 System Requirements
3.4.1 Hardware requirements
The following requirements have to be met for using LT-com:
Hardware Minimum Recommended
Memory 512 MB 1024 MB
CPU Pentium III or Atom Pentium IV
Resolution 1024 x 600 1280 x 1024
USB ports 1 (USB 2.0 or
higher)
2 (USB 2.0 or
higher)
3.4.2 Software Requirements
The following requirements have to be met for using LT-com:
Operating System:
Microsoft Windows
Windows XP Professional x86 SP2
Windows Vista Professional x86 SP1
Windows7 Professional 32 Bit, 64 Bit
Additionally supported software: Microsoft Excel 2000
Microsoft Excel XP
Microsoft Excel 2003
Microsoft Excel 2007

3. Getting Started
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3.5 Switching ON the Instrument
The following procedures detail the necessary steps required before switching on
the instrument.
CAUTION
BEFORE THE INSTRUMENT IS INSTALLED AND SWITCHED ON, IT
SHOULD BE LEFT TO STAND FOR AT LEAST THREE HOURS, SO
THERE IS NO POSSIBILITY OF CONDENSATION CAUSING A SHORT
CIRCUIT.
When the requirements mentioned above have been met, installation is carried
out using the following procedure:
1. Connect the instrument to the external computer with the USB cable.
2. Ensure that the main power switch on the left side of the instrument is in
the OFF position.
3. Insert the power cable into the main power socket in the left panel.
4. Switch the instrument on using the main power switch in the left panel.
The instrument is ready to measure microplates upon software installation.
Note
Before starting measurements make sure that the microplate position A1
is inserted correctly.
Microplates can only be measured without lids.
Close the plate transport cover before starting a measurement to avoid
ambient light influencing the results.

3. Getting Started
17
3.6 Software
3.6.1 Introduction
The instrument control and data analysis software LT-com is delivered with the
instrument. This version of LT-com is only compatible with the LT-4500
absorbance reader.
LT-com is a universal reader control and data analysis software for analyzing
data generated by microplate tests using the labtech.com LT-4500.
LT-com offers all necessary functionality to become compliant with the FDA
Regulation 21 CFR part 11 and with the European in vitro diagnostic directive
98/79/EC.
Note
It is important to note that the proper installation of the instrument and
the LT-com software alone will not ensure compliance with laws and
requirements. Corresponding policies concerning processes and
standard operating procedures, including validation and quality control,
must also be established.
3.6.2 Installation Procedure
To install the software, insert the USB stick to the USB port and proceed as
follows:
1. LT-com installation wizard should start automatically and guide you
through the installation process. If it does not, please run the file
‘E:\Labtech.exe’ (where E is the drive letter of the USB stick).
2. Select ‘LT-com software’ and - depending on the version you have
ordered - ‘Install LT-com’ to start the installation procedure and follow the
wizard.
3. Click Install to start the software installation procedure.
4. Click I acceptthe terms of the license agreement and Next to
continue.
5. The Customer Information page appears: please enter user name and
organization.
6. The Configuration page appears: choose the language.
7. Use for regulated environments page: click Next to continue.
8. Click Install to start the installation.
9. Click Finish to end the installation and to close the setup program.

3. Getting Started
18
The software can be started via the Windows Start menu by selecting LT-com in
the program group ‘Labtech’.
Note
It is very important that the person who installs the software has
administrator rights on the computer.
By default, all file types associated with LT-com for LT-4500 are stored in
corresponding subdirectories in the following directory:
...\All Users\Documents\Labtech\LT-com
3.6.3 Installation Qualification
Check successful installation of LT-com with the automatic installation
qualification program:
Start TecanIQ.exe from the Windows Start menu: Start > Programs > Labtech
> LT-com IQ.
Click Check to start the installation qualification. All installed components should
have status OK. Please contact your local supplier if any potential problem is
reported.
To close the installation qualification program, click Cancel or Exit.
Note
The installation qualification should be repeated each time LT-com is
installed or updated to a newer version.

3. Getting Started
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3.6.4 Start Working with LT-com
The main type of the user interface in LT-com is the wizard.
Standard LT-com wizards represent workflow modules, which are step-by-step
guides for performing complex procedures.
Occasionally, menus are available in the heading bar. The Menu offers a
conventional way of using the software: the relevant menu item is selected from
the main menus. All subsequent actions are started instantly, or a dialog box is
displayed where further selections or entries can be made.
User Interface – Wizard List
After launching LT-com, the Wizard List appears:
Each wizard can be started either by double-clicking or by selecting it and clicking
the Next button.
Start Measurement Wizard
The Start Measurement wizard includes the following options:
•Obtain Raw Data is used to generate raw data quickly and easily by
setting the required measurement parameters and starting a
measurement.
•Run Strip Layout is used to collect strips from different methods,
combine the strips to one method and run this method.
•Use Predefined Method is used to perform measurements based on
previously defined methods.
•Start Favorite is used to select one of the most frequently used methods
from the list of numbered icons.
After the measurement is finished a workspace file is created.

3. Getting Started
20
Evaluate Results Wizard
The Evaluate Results wizard is used to view the raw data and to evaluate the
results. The evaluation parameters can be viewed and data can be re-evaluated.
Attach Signature Wizard
The Attach Signature wizard is used to sign method and workspace files.
Create/Edit a Sample ID List Wizard
The Create/Edit a Sample ID list wizard is used to create new and to edit
existing sample ID lists.
Create/Edit a Method Wizard
The Create/Edit a method wizard is used to define or edit methods.
Note
For detailed information about the software please refer to the LT-com
Instructions for Use.
Please note that some features (e.g. demo mode, licensing) described in the LT-
com Instructions for Use might not be relevant (available). However, all
necessary information is described in this IFU.
Note
Please find a detailed example of an ELISA measurement in chapter 6.