Bio-Tek ELx800 User manual

ELx800™
Absorbance Microplate Reader
Operator’s Manual

BIO-TEK INSTRUMENTS, INC., P.O. BOX 998, HIGHLAND PARK, WINOOSKI, VERMONT 05404 USA
COPYRIGHT © 2005 TEL: [phone] FAX: [phone] Outside the USA: [phone] E-mail: [e-mail]
www.biotek.com
Creating Solutions for the Future of Science™
This Manual Update contains changes to the ELx800™ Operator’s Manual.
These changes will be incorporated in the next full revision (Rev O) of the Manual.
Page 43, System Startup
Addition:
L
Important! Some ELx800 readers have custom programmed
software installed. Not all features of the software discussed
in this Operator’s Manual are available on custom instruments.
Please contact Bio-Tek’s Technical Assistance Center at 800-242-4685
if you have any questions about the software on your reader.
Page 119, Liquid Test 1
Recommendation:
After pipetting the diluted test solution into the microplate (step 3) and
before reading the plate, we strongly recommend shaking the plate for
four minutes. This will allow any air bubbles in the solution to settle and
the meniscus to stabilize. If a plate shaker is not available, wait 20 minutes
after pipetting the diluted test solution before reading the plate.
7331000 Rev N2
July 2005

.

ELx800™
Absorbance Microplate Reader
Operator’s Manual
October 2004
2004
Part Number 7331000
Revision N
Bio-TekInstruments, Inc.

ii | Preface
Notices
Bio-TekInstruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2004, Bio-Tek® Instruments, Incorporated. No part of this publication may be
reproduced, transcribed, or transmitted in any form, or by any means electronic
or mechanical, including photocopying and recording, for any purpose other
than the purchaser’s use without written permission of Bio-Tek Instruments,
Inc.
Trademarks
Bio-Tek® is a registered trademark, and ELx800™, KC4, KCjunior, and EL800
are trademarks of Bio-Tek Instruments, Inc. Microsoft®, Windows®, and the
Windows logo are registered trademarks of Microsoft Corporation in the
United States and other countries. All other trademarks are the property of
their respective holders.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a
commitment by Bio-Tek Instruments, Inc. Changes made to the information in
this document will be incorporated in new editions of the publication. No
responsibility is assumed by Bio-Tek for the use or reliability of software or
equipment that is not supplied by Bio-Tek or its affiliated dealers.
Bio-Tek Instruments, Inc.

Contents | iii
Contents
Notices ............................................................................................. ii
All Rights Reserved ................................................................................. ii
Trademarks ........................................................................................... ii
Restrictions and Liabilities ........................................................................ ii
Contact Information ................................................................................. xi
Customer Service and Sales .................................................................... xi
Service/TAC.......................................................................................... xi
European Coordination Center ................................................................. xi
Document Conventions .............................................................................xii
Revision History......................................................................................xiii
Intended Use Statement .......................................................................... xv
Quality Control ....................................................................................... xv
Repackaging and Shipping........................................................................ xv
Warnings ...............................................................................................xvi
General ...............................................................................................xvi
Readers...............................................................................................xvi
Hazards and Precautions ......................................................................... xvii
Hazards.............................................................................................. xvii
Precautions........................................................................................ xviii
Directive 89/336/EEC:Electromagnetic Compatibility..................................xix
Directive 73/23/EEC Low Voltage ............................................................xix
Directive 2002/96/EC: Waste Electrical and Electronic Equipment ................xix
Directive 98/79/EC: In Vitro Diagnostics ..................................................xix
Electromagnetic Interference and Susceptibility........................................... xx
User Safety ............................................................................................ xx
Safety Symbols.......................................................................................xxi
Warranty ............................................................................................. xxiii
Registration Card .................................................................................. xxiv
ELx800 Operator's Manual

iv | Preface
Chapter 1: Introduction .................................................................... 1
Introducing the ELx800 Automated Microplate Reader .................................... 2
Hardware Features .................................................................................... 3
Software Features ..................................................................................... 3
Package Contents ..................................................................................... 4
Optional Accessories.................................................................................. 5
Specifications ........................................................................................... 6
Standard Model ...................................................................................... 6
Ultraviolet/UV Model ............................................................................... 7
Narrow Beam/NB Model........................................................................... 8
Technical Support ................................................................................... 10
Phone Support ..................................................................................... 10
Electronic Communication ...................................................................... 11
Facsimile Support ................................................................................. 11
Written Communication ......................................................................... 11
Shipping Address .................................................................................. 11
Chapter 2: Installation ................................................................... 13
Unpacking and Inspecting the ELx800™ ..................................................... 14
Unpacking the Instrument and Its Accessories .......................................... 15
Setting Up the ELx800 ............................................................................. 19
Operating Environment.......................................................................... 19
Electrical Connections............................................................................ 19
Power-Up and System Test .................................................................... 20
ELx800 Main Menu................................................................................ 20
Configuring Global Default Options .......................................................... 21
Connecting a Printer to the ELx800 ......................................................... 22
Setting Up the Serial Port for Communications With Other Devices................. 24
Attaching the Cable............................................................................... 24
Setting Communication Parameters......................................................... 24
Installing Additional Filters ....................................................................... 26
Bio-Tek Instruments, Inc.

Contents | v
Repackaging and Shipping the ELx800 ....................................................... 30
Before Repackaging the Instrument......................................................... 30
Repackaging the ELx800 and Its Accessories ............................................ 31
Preparing the Shipping Container ............................................................ 37
Chapter 3: Operation ...................................................................... 39
ELx800 Front Panel ................................................................................. 40
Overview ............................................................................................... 42
Recommendations for Achieving Optimum Performance................................ 42
System Startup ...................................................................................... 43
Main Menu ............................................................................................. 44
Define ................................................................................................... 46
Programming Note................................................................................ 47
Selecting an Assay to Define .................................................................. 48
Editing the Assay Name ......................................................................... 48
Define (Method, Map, Formula and Curve) .................................................. 49
Defining METHOD ................................................................................. 49
Defining MAP ....................................................................................... 53
Defining FORMULA ................................................................................ 69
Defining CURVE .................................................................................... 81
Reading a Microplate ............................................................................... 88
Selecting an Assay to Run...................................................................... 89
Printing Reports ...................................................................................... 93
Editing Standard Outliers ....................................................................... 94
Printing Results .................................................................................... 96
Using the Utility Options........................................................................... 97
Setting the Date and Time ..................................................................... 97
Viewing/Editing the Filter Table............................................................... 98
Specifying Data Output and Reporting Options.......................................... 99
Selecting Read Options........................................................................ 101
ELx800 Operator's Manual

vi | Preface
Chapter 4: Performance Verification and IQ/OQ/PQ Procedures.. 103
Recommendations for Achieving Optimum Performance.............................. 104
Recommended Test Schedule ................................................................. 105
Qualification Procedures ......................................................................... 106
System Test....................................................................................... 107
Checksum Test................................................................................... 109
Absorbance Plate Test ......................................................................... 110
Entering the Absorbance Plate Specifications .......................................... 113
Test Failures ...................................................................................... 115
Liquid Testing ....................................................................................... 116
Stock Solution Formulation .................................................................. 117
Liquid Test 1 ...................................................................................... 119
Liquid Test 2 ...................................................................................... 121
Liquid Test 3 (for “UV” Models Only)...................................................... 125
Chapter 5: Maintenance and Decontamination ............................. 129
Maintenance......................................................................................... 130
Routine Cleaning Procedure .................................................................... 130
Purpose............................................................................................. 130
Tools and Supplies .............................................................................. 131
Procedure .......................................................................................... 131
Replacing the Bulb ................................................................................ 132
Decontamination Procedure .................................................................... 135
Tools and Supplies .............................................................................. 136
Procedure .......................................................................................... 136
Bio-Tek Instruments, Inc.

Contents | vii
Chapter 6: Troubleshooting and Error Codes ................................ 139
Overview ............................................................................................. 140
System Test Description......................................................................... 140
Glossary of Terms............................................................................... 140
Error Codes.......................................................................................... 141
General Errors.................................................................................... 142
Fatal Errors........................................................................................ 148
Appendix A: Controlling the Reader With KCjunior™ or KC4™ ...... 149
Overview ............................................................................................. 150
Controlling the Reader With KCjunior™ .................................................... 151
Problems ........................................................................................... 152
Getting Started With KCjunior™............................................................ 152
Controlling the Reader With KC4™........................................................... 153
Problems ........................................................................................... 154
Getting Started With KC4™ .................................................................. 154
Appendix B: Using 384-Well Geometry ......................................... 155
KCjunior™............................................................................................ 156
KC4™.................................................................................................. 159
Appendix C: Report Format........................................................... 163
Appendix D: Comparison of the ELx800 and the EL800................. 171
ELx800 Operator's Manual

viii | Preface
Appendix E: Instructions for Programming a New Assay.............. 173
Sample ANA Screen Enzyme Immunoassay Kit.......................................... 174
Intended Use ..................................................................................... 174
Background ....................................................................................... 174
Principle of the Assay .......................................................................... 174
Materials ........................................................................................... 175
Quality Control and Results .................................................................. 176
Expected Values ................................................................................. 176
Programming the ANA Screen Enzyme Immunoassay Kit ............................ 177
Sample Human Anticardiolipin IgG Enzyme Immunoassay Kit...................... 179
Intended Use ..................................................................................... 179
Background ....................................................................................... 179
Principle of the Assay .......................................................................... 179
Materials ........................................................................................... 180
Quality Control and Results .................................................................. 181
Expected Values ................................................................................. 183
Programming the Human Anticardiolipin IgG Enzyme Immunoassay Kit ........ 184
Bio-Tek Instruments, Inc.

List of Figures | ix
List of Figures
Figure 1: Removing the Power Supply and Shelf..................................... 15
Figure 2: Removing the Foam End Caps ................................................ 16
Figure 3: Removing the Top Cover Mounting Screws............................... 17
Figure 4: Removing the Shipping Block ................................................. 18
Figure 5: Global Configuration Options Available Under UTIL.................... 21
Figure 6: Connectors for Printer (Parallel), Computer (Serial), and Power
Supply ........................................................................................ 23
Figure 7: Filter Wheel Assembly........................................................... 26
Figure 8: Securing the Carrier ............................................................. 31
Figure 9: Hooking the Shipping Straps Around the Shaft ......................... 32
Figure 10: Installing the Shipping Block ................................................ 33
Figure 11: Reinstalling the Top Cover ................................................... 34
Figure 12: Reattaching the End Caps .................................................... 35
Figure 13: Placing the Unit in the Box ................................................... 36
Figure 14: Keyboard .......................................................................... 40
Figure 15: Options Available from the Main Menu ................................... 44
Figure 16: Sample Output for the System Test (Sheet 1 of 2) ................ 108
Figure 17: Sample Output for the System Test – Autocal Analysis
(Sheet 2 of 2) ............................................................................ 109
Figure 18: Sample Absorbance Test Plate Data Sheet ........................... 112
Figure 19: Sample Test Plate Analysis Report ...................................... 112
Figure 20: Lamp Assembly ................................................................ 133
Figure 21: KCjunior Main Menu, Setup|Reader 1 Dialog......................... 156
Figure 22: Reader Setup 1 Dialog ...................................................... 156
Figure 23: Read Plate Dialog ............................................................. 157
Figure 24: Protocol Definition (General Information) Dialog ................... 157
Figure 25: Protocol Definition (Read Method) Dialog ............................. 158
Figure 26: KC4 Main Menu, System|Readers........................................ 159
Figure 27: Reader Selection Dialog..................................................... 159
Figure 28: Data|New Plate Dialog....................................................... 160
Figure 29: New Data File Dialog ......................................................... 160
Figure 30: Reading Parameters Dialog ................................................ 161
ELx800 Operator's Manual

x | Preface
List of Figures (Continued)
Figure 31: Samples With Calls on Matrix Report ...................................... 164
Figure 32: Curve Fit Report .................................................................. 165
Figure 33: Samples With Calls on Column Report .................................... 166
Figure 34: Column Report Without Samples............................................ 167
Figure 35: Panel Report ....................................................................... 168
Figure 36: Assay Detail Report (Sheet 1 of 2) ......................................... 169
Figure 37: Assay Detail Report (Sheet 2 of 2) ......................................... 170
List of Tables
Table 1: Recommended Test Schedule................................................... 105
Table 2: Typical Enzyme-Substrate Combinations and Stopping Solutions ... 116
Table 3: Test Tube Dilutions ................................................................. 121
Table 4: PBS 10X Concentrate Solution.................................................. 126
Bio-Tek Instruments, Inc.

Contact Information | xi
Contact Information
Bio-TekInstruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
Customer Service and Sales
Internet: www.biotek.com
Phone: [phone] (toll free in the U.S.)
802-655-4040 (outside the U.S.)
Fax: [phone]
E-Mail: [email protected]
Service/TAC
Phone: [phone] (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: [phone]
E-Mail: [email protected]
European Coordination Center
Bio-TekInstruments GmbH
Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany
Internet: www.biotek.de
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
ELx800 Operator's Manual

xii | Preface
Document Conventions
This manual uses the following typographic conventions:
Example Description
This icon calls attention to important safety notes.
Warning! A Warning indicates the potential for bodily harm and tells you
how to avoid the problem.
Caution A Caution indicates potential damage to the instrument and tells
you how to avoid the problem.
DEFINE Text in COURIER font represents menu options as they appear on
the instrument’s display.
Note:Bold text is primarily used for emphasis.
 This icon calls attention to important information.
Bio-Tek Instruments, Inc.

Revision History | xiii
Revision History
Revision Date Changes
A 3/95 First Release
B 7/95 Generic
C 9/95 Add Errata sheet
D 10/95 Incorporate Errata: cal plate PN cover text to UV
E 11/96 Added Panel Assay info. Added TVar parameter. Added
Appendix D to include all reports.
F 2/97 Added Notes including info on 384-well format. Updated Reuse
of Standard Curves and Panel sections. Added Appendix E –
KcJr for 384-well format.
G 03/98 Added Liquid Test 1 and 2 to Chapter 4 –Performance
Verification. Added Appendix F – Comparison, to show the
differences between the ELx800 and the EL800.
Added printer information.
Changed plate type information to include
384-well and 72-/96-well Terasaki plate formats. Added
reference to Quick Read on display.
H 09/98 Modified Appendix B - Computer Control. Updated Elx800 and
EL800 model comparison table in Appendix F.
I 2/99 Incorporated Manual Updates.
Changed European addresses.
J 9/99 Changed printer-compatible description. Changed the number
of samples necessary if there aren't controls, standards or blanks
defined. Corrected the number of stored plates to 8. Corrected
the positions for re-use of standard curves. Removed the "M"
command from Appendix B- Computer Control.
K 1/00 Added Liquid Test 3 to test 340 nm filters. Updated screens in
Chapter 3. Updated chart in Appendix F.
L 5/03 Preface:
- Updated contact information in Notices
(page iii).
- Added Document Conventions (page v).
- Corrected errors in Safety Symbol text
(page ix).
Removed "screwdriver" from Package Contents, and added "Bio-
Tek QC Check Solutions for 405 nm" to Optional Accessories list
(page 1-7).
Removed About This Manual section (page 1-5).
Updated contact information in Technical Support (Chapter 1).
Modified appearance of display screens throughout.
Revised lamp alignment section in Chapter 2.
ELx800 Operator's Manual

xiv | Preface
Revision History (Continued)
L 5/03
(Cont.)
Chapter 4:
- Changed title to "Performance Verification and
IQ/PQ/OQ Tests."
- Added IQ/PQ/OQ test procedure information.
- Clarified procedures for liquid tests.
Replaced outdated Appendix E with instructions for using KCjunior
to read 384-well microplates.
Added new Appendix G with two examples of assay kit instructions
and directions for programming an assay.
Made editorial and formatting changes throughout.
M 9/03 Preface:
- Updated Warnings section (pages vii and viii).
- Updated Electromagnetic Compatibility section (page x).
- Added “Consult instructions for use” and “In vitro diagnostic
medical device” safety symbols (page xii).
- Expanded Intended Use Statement (page xiii).
Added Absorbance Test Plate to Optional Accessories list (Chapter 1,
page 1-8).
Changed callout in Figure 2-2 from “Place unit in bag” to “Unit in
plastic bag” (Chapter 2, page 2-2).
Added KC4 startup information to Appendix E.
Removed references to ELx800UV and EL800UV from Appendix F.
Standardized the presentation of significant digits throughout.
Changed “Abs” to “OD” throughout.
N 10/04 Restructured manual according to new template.
Removed references to “General Formula” throughout.
Updated Chapter 4, Performance Verification and IQ-OQ-PQ
Procedures.
Added new Chapter 5, Maintenance and Decontamination.
Added new Chapter 6, Troubleshooting and Error Codes.
Removed Computer Control portion of Appendix A; renamed
Appendix to “Controlling the Reader With KCjunior™ or KC4™.”
Added new Appendix B, Using 384-Well Geometry.
Updated sample reports in Appendix C, Report Format (formerly
Appendix D).
Removed previous Appendix A, Decontamination.
Removed previous Appendix C, Error Codes.
Added new Appendix E, Instructions for Programming a New Assay.
Bio-Tek Instruments, Inc.

Intended Use Statement | xv
Intended Use Statement
The intended use of this instrument is dependent on the instrument’s rear panel label. If
there is an IVD label, then the instrument may be used for clinical, research and
development, or other nonclinical purposes. If there is no such label, then the instrument
may only be used for research and development, or for other nonclinical purposes.
Quality Control
It is considered good laboratory practice to run laboratory samples according to
instructions and specific recommendations included in the assay package insert for the
test to be conducted. Failure to conduct Quality Control checks could result in erroneous
test data.
Repackaging and Shipping

If you need to ship the instrument to Bio-Tek for service
or repair, contact Bio-Tek for a Return Materials
Authorization (RMA) number, and be sure to use the
original packing. Other forms of commercially available
packing are not recommended and can void the warranty.
If the original packing materials have been damaged or
lost, contact Bio-Tek for replacement packing.
ELx800 Operator's Manual

xvi | Preface
Warnings
General
• Operate the instrument on a flat surface away from excessive humidity.
Readers
• Excessive Ambient Light: Bright sunlight or strong incandescent light
can reduce the linear performance range of the instrument.
• Dust: Measurement values may be affected by extraneous particles (such as
dust) in the microplate wells. A clean work area is necessary to ensure
accurate readings.
• When operated in a safe environment according to the instructions in this
document, there are no known hazards associated with the instrument.
However, the operator should be aware of certain situations that could
result in serious injury; these may vary depending on the instrument
model.
Bio-Tek Instruments, Inc.