Biotek ELx808, ELx808IU Operator's Manual

Operator’s Manual
Absorbance Microplate Reader
ELx808
ELx808™
Absorbance Microplate Reader, All Models Operator’s Manual
April 2013 © 2013 Part Number 7341000 Revision P BioTek® Instruments, Inc.
ii | Preface

Notices

BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2013, BioTek® 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 BioTek Instruments, Inc.
Trademarks
BioTek® is a registered trademark, and ELx808™, 4-Zone™ and Gen5™ are trademarks of BioTek Instruments, Inc. Microsoft trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.
®
, Windows®, and Excel® are either registered
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 BioTek Instruments, Inc. Changes made to the information in this document will be incorporated in new editions of the publication. No responsibility is assumed by BioTek for the use or reliability of software or equipment that is not supplied by BioTek or its affiliated dealers.
BioTek Instruments, Inc.

Contents

Notices ........................................................................................... ii
All Rights Reserved ...................................................................... ii
Trademarks ................................................................................ ii
Restrictions and Liabilities ............................................................ ii
Contents ........................................................................................ iii
Contact Information ...................................................................... viii
Customer Service and Sales ....................................................... viii
Service/TAC ............................................................................ viii
European Coordination Center/Authorized European Representative viii
Revision History .............................................................................. ix
Document Conventions ................................................................... xii
Intended Use Statement ................................................................. xii
Quality Control .............................................................................. xii
Warranty & Product Registration ...................................................... xiii
Repackaging and Shipping .............................................................. xiii
Warnings ..................................................................................... xiii
Hazards ....................................................................................... xiv
Precautions ................................................................................... xv
CE Mark ....................................................................................... xvi
Directive 2004/108/EC: Electromagnetic Compatibility ................... xvi
Directive 2006/95/EC Low Voltage (Safety) .................................. xvi
Directive 2002/96/EC: Waste Electrical and Electronic Equipment ... xvii
Directive 98/79/EC: In Vitro Diagnostics (if labeled for this use) .... xvii
Electromagnetic Interference and Susceptibility ................................ xvii
USA FCC CLASS A ................................................................... xvii
Canadian Department of Communications Class A ........................ xvii
User Safety ................................................................................. xviii
Safety Symbols ............................................................................. xix
Chapter 1: Introduction ....................................................................... 1
Introducing the ELx808 Absorbance Microplate Reader ......................... 2
Reader Variations ....................................................................... 2
Hardware Features .......................................................................... 2
Software Features ........................................................................... 3
Package Contents ............................................................................ 3
Optional Accessories ........................................................................ 3
Specifications ................................................................................. 4
Microplates ................................................................................ 4
Electrical ................................................................................... 4
Physical .................................................................................... 4
Environmental ........................................................................... 5
Hardware .................................................................................. 5
Reading Speeds ......................................................................... 5
Contents | iii
ELx808 Operator’s Manual
iv | Preface
Product Support & Service ................................................................ 7
Chapter 2: Installation ........................................................................ 9
Product Registration ....................................................................... 10
1: Unpack and Inspect the Instrument .............................................. 10
2: Select the Operating Environment ................................................ 11
3: Install the Filter Wheel ................................................................ 12
4: Check/Adjust the Power Input Voltage Setting ................................ 14
5: Connect Power ........................................................................... 14
6: (Optional) Connect Printer ........................................................... 15
7: Turn on Reader and Run System Test............................................ 16
8: Check/Adjust the Reader’s Filter Table .......................................... 17
9: Configure Reader Settings ........................................................... 18
10: Install Software/Connect to a Computer (Optional) ........................ 21
11: Verify Performance ................................................................... 23
Before Repackaging the Instrument .................................................. 24
Chapter 3: Operation ......................................................................... 25
Getting Started with Gen5 ............................................................... 27
Introduction .................................................................................. 28
Defining Assays ............................................................................. 32
Standard Model: ELx808 ............................................................. 5
Ultraviolet/Incubator Model – ELx808IU ......................................... 6
Contacting the Technical Assistance Center .................................... 7
Returning Instruments for Service/Repair ...................................... 7
Printers .................................................................................... 16
SETUP Options .......................................................................... 18
OUTPUT Options ........................................................................ 19
REPORT Type ............................................................................ 19
READ Options ........................................................................... 20
Read Speed .............................................................................. 21
Attach the Cable ....................................................................... 21
Install Gen5 Software on the Host Computer ................................. 21
Establish Communication ............................................................ 22
Changing the Baud Rate on the ELx808 ........................................ 22
The Keypad .............................................................................. 29
The Startup Screen.................................................................... 30
The Main Menu Screen
Quick Read ............................................................................... 31
Selecting an Assay .................................................................... 32
Assay Name ............................................................................. 32
Defining the Method, Map, Formula, and Curve .............................. 33
METHOD .................................................................................. 34
Read Type ........................................................................... 34
Delay in First Read ............................................................... 34
Incubation Temperature ........................................................ 35
Single or Dual Wavelength ..................................................... 35
............................................................... 30
BioTek Instruments, Inc.
Contents | v
MEAS Selection .................................................................... 36
Number of Kinetic Reads/Kinetic Duration Selection .................. 36
Kinetic Interval ................................................................... 36
Kinetic Number of Reads ....................................................... 37
Kinetic Duration ................................................................... 37
Shake Mode Selection ........................................................... 37
Shake Time ......................................................................... 38
Shake Speed ....................................................................... 38
Kinetic Data Analysis Selection ............................................... 38
Number of Kinetic Points Selection .......................................... 39
Onset OD Selection ............................................................... 39
Linear Scanning ................................................................... 39
MAP ........................................................................................ 40
Map Generation .................................................................... 41
Mapping Direction ................................................................ 42
Replication Direction ............................................................. 42
Examples of Mapping & Replication Directions .......................... 43
Start Mapping at Well Location ............................................... 44
Selecting a Blank Map ........................................................... 44
Blank Map Definitions............................................................ 45
Constant Blank Value Entry .................................................... 46
Number of Blanks ................................................................. 46
Selecting a Blank Location ..................................................... 46
Number of Standards ............................................................ 47
Number of Standard Replicates .............................................. 47
Average Standards ............................................................... 47
Standard Concentration ......................................................... 48
Reuse of Standard Curves ..................................................... 49
Number of Controls .............................................................. 50
Control Type ........................................................................ 50
Number of Control Replicates ................................................. 51
Location of Controls .............................................................. 51
Valid Well Locations .............................................................. 51
Number of Samples .............................................................. 52
Number of Sample Replicates ................................................. 52
Sample Location ................................................................... 52
FORMULA ................................................................................. 53
Validation Formula Examples .................................................
Formul
a
Type ...................................................................... 53
Validation Type Selection ....................................................... 55
Formula Entry ...................................................................... 55
Number of Required Controls/Blanks ....................................... 57
Cutoff Formulas ................................................................... 58
Greyzone Entry .................................................................... 59
Positive/Negative Calls for Cutoff ............................................ 59
53
ELx808 Operator’s Manual
vi | Preface
Reading a Microplate ...................................................................... 70
Printing Reports and Assay Lists ....................................................... 73
Recommendations for Optimum Performance ..................................... 76
Chapter 4: Instrument Qualification .................................................. 79
Overview ...................................................................................... 80
Recommended Qualification Schedule ............................................... 80
Test Descriptions ........................................................................... 81
Perform the Tests
Examples ............................................................................ 60
Transformation Formulas ....................................................... 61
Transformation Formula Definition .......................................... 61
Transformation Scope Variable ............................................... 62
Another Transformation Example ............................................ 63
CURVE ..................................................................................... 64
Curve Fit ............................................................................. 64
Edit Standard Outliers ........................................................... 65
Axis Selection ...................................................................... 66
Extrapolation of Unknowns .................................................... 66
Panel Assays ............................................................................ 67
Select Assay ............................................................................. 70
Run-Time Prompts ..................................................................... 70
Enter Number of Samples ........................................................... 71
Enter Plate ID ........................................................................... 71
Enter Sample ID ....................................................................... 71
Prompts for Well Location ........................................................... 72
Beginning the Plate Read ............................................................ 72
Result ...................................................................................... 74
Editing Standard Outliers ............................................................ 74
Printing Results ......................................................................... 75
Map ......................................................................................... 75
Assay ...................................................................................... 76
List ......................................................................................... 76
System Test ............................................................................. 81
Incubator Self Test ............................................................... 84
Checksum Test ......................................................................... 84
Absorbance Plate Test ................................................................ 85
Empty Carrier Test .................................................................... 88
Liquid Tests .............................................................................. 88
........................................................................... 89
System Tes
Checksum Test ......................................................................... 89
Absorbance Plate Test ................................................................ 89
Define the Test Plate Parameters ........................................... 89
Run the Plate Test ............................................................... 90
Empty Carrier Test .............................................................. 91
Liquid Tests .............................................................................. 92
Prepare Test Solutions ......................................................... 92
t
............................................................................. 89
BioTek Instruments, Inc.
Contents | vii
Stock Solution Formulation ......................................................... 92
Solution A ........................................................................... 92
Solution B ........................................................................... 93
Perform Liquid Test 1 ................................................................. 94
Calculations ......................................................................... 94
Accuracy Specifications ......................................................... 95
Perform Liquid Test 2 ................................................................. 95
Perform the Linearity Test (Test A) ......................................... 96
Calculate Repeatability (Test B) .............................................. 97
Channel-to-Channel Variation and Alignment (Test C) ................ 97
Perform Liquid Test 3 (“UV” Models Only) ..................................... 98
Perform the Test .................................................................. 99
Calculate Repeatability .......................................................... 99
Calculate Linearity .............................................................. 100
Chapter 5: Preventive Maintenance ................................................. 101
Recommended Maintenance Schedule ............................................. 102
Warnings and Precautions ............................................................. 102
Clean Exposed Surfaces ................................................................ 103
Inspect and Clean the Wavelength Filters ........................................ 104
(Optional) Lubricate Robotic Components ........................................ 105
Robotic Motor Adjustment Procedure .......................................... 107
Replace the Lamp and Clean the Contacts ........................................ 107
Decontamination .......................................................................... 111
Purpose ................................................................................. 111
Tools and Supplies .................................................................. 112
Decontamination Procedure ...................................................... 112
Chapter 6: Troubleshooting and Error Codes ................................... 115
Overview .................................................................................... 116
Diagnostics ............................................................................ 116
Terms Used in the Error Codes Tables ........................................ 116
Error Codes (General) ................................................................... 117
Error Codes (Fatal) ....................................................................... 121
Appendix A: Sample Reports ........................................................... 123
Appendix B: Instructions for Programming a New Assay ................ 131
Appendix C: Adjusting the Power Input Voltage Setting ................. 141
ELx808 Operator’s Manual
viii | Preface

Contact Information

See also Product Support and Service on page 7.
BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
Customer Service and Sales
Internet: www.biotek.com
Phone: 888-451-5171 (toll free in the U.S.) 802-655-4740 (outside the U.S.)
Fax: 802-655-7941
E-Mail: customercare@biotek.com
Service/TAC
Phone: 800-242-4685 (toll-free in the U.S.) 802-655-4740 (outside the U.S.)
Fax: 802-654-0638
E-Mail: tac@biotek.com
European Coordination Center/Authorized European Representative
BioTek® Instruments GmbH Kocherwaldstrasse 34 D-74177 Bad Friedrichshall Germany
Internet: www.biotek.de
Phone: +49 (0) 7136 9680
Fax: +49 (0) 7136 968 111
E-Mail: info@biotek.de
BioTek Instruments, Inc.
Revision History | ix

Revision History

Rev Date Changes
A 1/96 First Release B 5/96 Revised reader specifications. Added Scanning method to software. C 1/97
D 2/98
E 8/98 Added printer information. Updated Appendix B: Computer Control. F 3/99
G 7/99
H 5/00
I 7/02
J 11/03
J 11/03
Added Panel and Reuse of Standard Curve, and rev ised serial port pin-out description.
Changed Chapter 4, Performance Verification to r eflect changes to the Universal Test Plate. Added Liquid Tests 1 and 2. Changed Appendix C: Error Codes.
Changed European address. Corrected p rinter compatibility. Corrected the sequence of steps for processing a curve-fit method.
Added comment about blanking, P-Down and P-Across being inactive in this version of software. Clarified the need for at least one sample to be defined on a plate. Added scanning computer control commands.
Updated Chapter 4- Performance Verification to include a Liquid Test 3 to verify 340 nm instruments. Corrected the voltage range for Range 2 in the Introduction. Corrected Incubation Temperat ure Control range to 6 deg above ambient. Changed Note on page 4-7 dealing with air readings during Self-Test. Clarified Liquid Test 1. Changed Table 4-1 to include additional maintenance items. Reworked Liquid Test 2.
Updated contact information (pages iii, 1-8, 1-9, 2-8, 2-20, and 4-13). Added IQ/OQ/PQ procedures and updated liqu id testing information (Chapter 4). Revised lamp replacement procedure (page 2-15).
Preface: Updated contact information in Notices (page iii). Added Document Conventions (page vi). Updated Warnings section (pages vii and viii). Updated Electromagnetic Compatibility section (pages ix and x). Added the following safety symbols and text: “Consult instructions for use” (page xii) “In vitro diagnostic medical device” (page xii) “Separate col lec tion for (disposal of) electrical and electronic equipment” (page x iii). Expanded the Intended Use Statement (page xiv).
Chapter 1: Updated contact information in Technical Support. Removed About This Manual section (page 1-5). Added “Absorbance Test Plate” to the Optional Accessories list (page 1-8). Clarifie d lamp replacement procedure (Chapter 2, pages 2-14 to 2-16). Clarified description of cutoff formulas (Chapter 3, pages 3­42 to 3-44).
Chapter 4: Changed title to “Performance Verification and IQ , PQ , OQ Tests.” Added IQ/PQ/OQ test procedure information. Clarified procedures for liquid tests.
Revised decontamination instructions and added cleaning procedure (Appendix A). Added KC4 startup information to Append ix B. Added new Appendix E with two examples of assay kit instructions and directions for programming an assay.
General: Edited and formatted text. Modified appearance of display screens. Standardized the presentation of significant digits. Changed “Abs” to “OD” throughout.
ELx808 Operator’s Manual
x | Preface
Rev Date Changes
K 4/05
L 4/06
M 3/08
Updated the cover with a current photo of the instrument. Updated contact information and warranty. Changed “Automated Microplate Reader” to “Absorbance Microplate Reader” throughout. Changed “Universal Test Plate” to “Absorbance Test Plate” throughout. Removed references to internal barcode scanner and “R” models. Removed references to Genera l For m ulas with respect to open assays. Updated specifications to match product spe c rev D. Added text from rev J1 insert (Fuse Installation/Replacement). Updated the installation instructions in Chapter 2 to better reflect actual practice. Updated the IQ/OQ/PQ/PM steps in Chapter 4 to better reflect actual practice. Created Appendix F to provide instructions for adju sting the line input voltage range and replacing fuses for instruments with an older-style power input module than the one described in Chapter 2.
Updated the manual primarily to support the in troduction of Gen5™ software. In general, changed ‘Bio-Tek’ to ‘B ioTek,’ and added Gen5 instructions wher ever KCjunior™ and KC4™ instructions were present.
Cover: Updated BioTek logo to new graphic. Preface: Added Contact Information section, updated Hazards, Precautions, and
safety standards. Removed Registration Card and Warranty (these items ship separately).
Chapter 1: Added external power supply to Hardw are Features, Package Contents, and Specifications. Also added ‘Reading Speeds’ section to specs. Replaced Technical Support section with one-page Product Support & Service section.
Chapter 2: Added instructions for connecting the external power supply in Connect Power section. Moved instructions in Check/Adjust the Power Input Voltage Setting section to Appendix F.
Chapter 4: Changed chapter title from ‘Performance Verification, Pe riodic Maintenance, and IQ, PQ, OQ Tests’ to ‘Inst rument Verification’. Moved maintenance instructions to new Chapter 5, Preventive Maintenance (see below). For Liquid Tests 1, 2, and 3, added recommendation to shake the plate for four minutes (or wait for 20 minutes) after pipetting the diluted test solution, before reading the plate.
Chapter 5 (new chapter): In Recommended Maintenance table, removed 3­month interval for cleaning the lamp contacts and changed ‘Replace the Lamp’ to ‘Replace the Lamp and Clean the Contacts.’ Added cleaning instructions from Appendix A, Decontamination.
Appendix B: Added new section: ‘Controlling the Reader with Gen5’. General: Applied the BioTek template to the manual. Changed “Bio- Tek” to
“BIOTEK” in startup screens to reflect this change in the reader’s basecode software.
Preface: Added Microsoft®, Windows®, Windows XP, Windows 2000, Windows Vista™, and Excel® to the “Trademarks” section. In the “Contacting BioTe k Instruments” section, updated the TAC fax number and added “Authorized European Representative” to the “European Coordination Center” heading.
Chapter 1: Added part number disclaimer to “Package Contents” and “Optional Accessories” and updated the TAC fax number i n the “ Product Support and Service” section.
Chapter 2: Added a packaging disclaimer to the section “Unpack and Inspect the Instrument.”
Chapter 3: Enhanced section on the keypad with graphics that illustrate components of the ELx808™keypad/ display. Updated “Panel Assays” section. In
BioTek Instruments, Inc.
Revision History | xi
Rev Date Changes
the “Printing Reports and Assay Lists” section, added a note containing an explanation of the OUT of range indication on report s.
Chapter 4: Clarified the description of the System Test Report to stat e that the incubation test is done ‘separately’ and that the overall system test results given at the bottom of the test report refer only to the Optics portion of the test. Capitalized the “l” in “μl” and “ml.”
Chapter 5: Merged this chapter with Appendix A, Decontamination. Reformatted and renamed Appendix C, Error Codes, as “Chapter 6, Error Codes”.
Added a “Fatal Errors” section, and added information on Error Codes 2311 to
2386. Renamed Appendix B, Computer Control, as Appendix A. Renamed Appendix D, Reports, as Appendix B, Sample Reports. In the
“Overview,” added a note containing an explanation of the OUT of range indication on reports.
Renamed Appendix E, Programming a New Assay as Appendix C. Renamed Appendix F, Adjusting the Power I nput Voltage Setting as Appendix D.
N 6/11 Throughout: Removed references to outdated software KC4 and KCjunior.
Preface: Updated Trademark. Updated Warnings and Precautions. Updated Intended Use statement.
Chapter 2: Removed Parallel and Serial Port Pinout charts. Added Install Software/Connect to Computer.
Chapter 3: Added “Getting Started with Gen5”. Gave Baud Rate information for Gen5. Removed references to outdated software Extensions.
Chapter 4: Removed Installation Qualification. Updated Autocal Analysis. Updated sample Absorbance Test Plate Results. Updated Stock Solution Formulation for Liquid Tests 1 and 2. Removed outdated instructions for creating former Solution A: 10x Concentrate PBS from Liquid Test 3. Simplified test procedure as a result.
Chapter 5: Updates lamp replacement instructions (added text from former revision M1 insert).
Chapter 6: Added error code 1201. Appendices: Removed former Appendix A: Computer Control.
O 9/12
General: Updated Gen5 instructions to reflect terminology in Gen5 v2.x. Preface: Updated the Intended Use Statement and the heading for the In
Vitro Diagnostics directive to refer to the instrument’s IVD label (if one exists). Added ‘Service’ and ‘Accessories’ hazard warnings. Added ‘Spare
P 4/13
Parts’ precaution.
Chapter 1, Introduction: Updated part number for the power supply. Chapter 2, Installation: Added note that improper packaging that results in
damage to the instrument may lead to additional charges. Chapter 4, Qualification: Added a note to the Absorbance Test Plate section
stating that the test tests the accuracy and repeatab ility of the reader to 2.500 OD. It does not indicate a PASS or FAIL above 2.500 OD.
Preface: Added EN 61010-2-081 and EN 61010-2-010 to Directive 2006/95/EC Low Voltage (Safety) and EN 61010-2-101 to Directive 98/79/EC In Vitro Diagnostics.
ELx808 Operator’s Manual
xii | Preface

Document Conventions

See also Safety Symbols on page xix.
This icon calls attention to important safety notes.
Warning!
Caution
Note:
A Warning indicates the potential for bodily harm and tells you how to avoid the problem.
A Caution indicates potential damage to the instrument and tells you how to avoid the problem.
Bold text is primarily used for emphasis.
This icon calls attention to important information.

Intended Use Statement

The ELx808 is an absorbance microplate reader. The performance characteristics of the
data reduction software have not been established with any laboratory diagnostic assay. The user must evaluate this instrument and (if used) PC-based software in conjunction with their specific assay(s). This evaluation must include the confirmation that performance characteristics for the specific assay(s) are met.
If the instrument has an “IVD” label it may be used for clinical and non-clinical
purposes, including research and development. If there is no such label the instrument may only be used for research and development or other non-clinical 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.
BioTek Instruments, Inc.
Warranty & Product Registration | xiii
Warranty & Product Registration
Take a moment to review the warranty information that shipped with your product. Please also register your product with BioTek to ensure that you receive important information and updates about the product(s) you have purchased. You can register online through the Customer Resource Center (CRC) at www.biotek.com or by calling 888-451­5171 or 802-655-4740.

Repackaging and Shipping

If you need to ship the instrument to BioTek for service or repair,
contact BioTek for a Return Materials Authorization (RMA) number, and be sure to use the original packing materials. Other forms of commercially available packaging are not recommended and can void the warranty. If the original packing materials have been damaged or lost, contact BioTek for replacement packing.

Warnings

Operate the instrument on a level, stable surface away from excessive humidity.
Bright light or strong incandescent light can reduce the linear performance range of the instrument.
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. See
Precautions.
Hazards and
ELx808 Operator’s Manual
xiv | Preface

Hazards

The following hazard warnings are provided to help avoid injury:
Warning! Internal Voltage
. Always turn off the power switch and unplug the power cord or power supply before cleaning the outer surface of the instrument or removing its top case.
Warning! Power Rating
. The instrument’s power supply or power cord must be connected to a power receptacle that provides voltage and current within the specified rating for the system. Use of an incompatible power receptacle may produce electrical shock and fire hazards.
Warning! Electrical Grounding
. Never use a plug adapter to connect primary power to the external power supply. Use of an adapter disconnects the utility ground, creating a severe shock hazard. Always connect the power cord directly to an appropriate receptacle with a functional ground.
Warning! Service.
procedures on internal components.
Warning! Accessories.
specifications shall be used with the instrument.
Warning! Liquids
Only qualified technical personnel should perform service
Only accessories that meet the manufacturer’s
. Avoid spilling liquids on the reader; fluid seepage into internal components creates a potential for shock hazard or instrument damage. Wipe up all spills immediately. Do not operate the instrument if internal components have been exposed to fluid.
Warning! Unspecified Use
. Failure to operate this equipment according to the guidelines and safeguards specified in this manual could result in a hazardous condition.
Warning! Software Quality Control
. The operator must follow the
manufacturer’s assay package insert when modifying software parameters and establishing reading methods. Failure to conduct quality control checks could result in erroneous test data.
Warning! Reader Data Reduction Protocol
. When the reader is operated in standalone mode the onboard assay software will flag properly defined controls when they are out of range. The software will present the data with the appropriate error flags for the operator to determine control and assay validity. When operated via computer control, no limits are applied to the raw measurement data. All information exported via computer control must be thoroughly analyzed by the operator.
Warning! Hot Surface
. The lamp is hot when the instrument is turned on. Turn off the reader and allow the lamp to cool for at least 15 minutes before attempting to replace it.
BioTek Instruments, Inc.
Precautions | xv
Warning! Potential Biohazards
. Some assays or specimens may pose a biohazard. Adequate safety precautions should be taken as outlined in the assay’s package insert. Always wear safety glasses and appropriate protective equipment, such as chemically resistant rubber gloves and apron.

Precautions

The following precautions are provided to help avoid damage to the instrument:
Caution: Service. The instrument should be serviced by BioTek-authorized
personnel. Only qualified technical personnel should perform service procedures on internal components.
Caution: Spare Parts. Only approved spare parts should be used for
maintenance. The use of unapproved spare parts and accessories may result in a loss of warranty and potentially impair instrument performance or cause damage to the instrument.
Caution: Environmental Conditions. Do not expose the system to temperature
extremes. For proper operation, ambient temperatures should remain within the range listed in the
Specifications section. Performance may be adversely affected
if temperatures fluctuate above or below this range. Storage temperature limits are broader.
Caution: Sodium Hypochlorite. Do not expose any part of the instrument to the
recommended diluted sodium hypochlorite solution (bleach) for more than 20 minutes. Prolonged contact may damage the instrument surfaces. Be certain to rinse and thoroughly wipe all surfaces.
Caution: Power Supply. Use only the power supply shipped with the
instrument. Operate the power supply within the range of line voltages listed on it.
Caution: Warranty. Failure to follow preventive maintenance protocols may
void the warranty.
Caution: Disposal. This instrument contains printed circuit boards and wiring
with lead solder. Dispose of the instrument according to Directive 2002/96/EC, “on waste electrical and electronic equipment (WEEE)” or local ordinances.
Caution: Electromagnetic Environment. Per IEC 61326-2-6 it is the user’s
responsibility to ensure that a compatible electromagnetic environment for this instrument is provided and maintained in order that the device will perform as intended.
Caution: Electromagnetic Compatibility. Do not use this device in close
proximity to sources of strong electromagnetic radiation (e.g., unshielded intentional RF sources), because these may interfere with the proper operation.
ELx808 Operator’s Manual
xvi | Preface

CE Mark

Based on the testing described below and information contained herein, this instrument bears the CE mark.
See the Declaration of Conformity for more information.
Directive 2004/108/EC: Electromagnetic Compatibility
Emissions—Class A
The system has been type-tested by an independent, accredited testing laboratory and found to meet the requirements of EN 61326-1: Class A for Radiated Emissions and Line Conducted Emissions. Verification of compliance was conducted to the limits and methods of EN 55011 – CISPR 11, Class A. In a domestic environment it may cause radio interference, in which case you may need to mitigate the interference.
Immunity
The system has been type-tested by an independent, accredited testing laboratory and found to meet the requirements of EN 61326-1 and EN 61326-2-6 for Immunity. Verification of compliance was conducted to the limits and methods of the following:
EN 61000-4-2 Electrostatic Discharge EN 61000-4-3 Radiated EM Fields EN 61000-4-4 Electrical Fast Transient/Burst EN 61000-4-5 Surge Immunity EN 61000-4-6 Conducted Disturbances from RFI EN 61000-4-11 Voltage Dips, Short Interruptions and Variations
Directive 2006/95/EC Low Voltage (Safety)
The system has been type-tested by an independent testing laboratory and was found to meet the requirements of this Directive. Verification of compliance was conducted to the limits and methods of the following:
EN 61010-1, “Safety requirement for electrical equipment for measurement, control and laboratory use. Part 1, General requirements.”
EN 61010-2-081, “Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes.”
EN 61010-2-010, “Particular requirements for laboratory equipment for the heating of materials.”
BioTek Instruments, Inc.
Electromagnetic Interference and Susceptibility | xvii
Directive 2002/96/EC: Waste Electrical and Electronic Equipment
Disposal Notice: This instrument contains printed circuit boards and wiring with
lead solder. Dispose of the instrument according to Directive 2002/96/EC, “on waste electrical and electronic equipment (WEEE)” or local ordinances.
Directive 98/79/EC: In Vitro Diagnostics (if labeled for this use)
Product registration with competent authorities
Traceability to the U.S. National Institute of Standards and Technology (NIST)
EN 61010-2-101, “Particular requirements for in vitro diagnostic (IVD) medical
equipment.”

Electromagnetic Interference and Susceptibility

USA FCC CLASS A
RADIO AND TELEVISION INTERFERENCE
NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. Like all similar equipment, this equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause interference, in which case the user will be required to correct the interference at their own expense.
In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and television reception.
Canadian Department of Communications Class A
This digital apparatus does not exceed Class A limits for radio emissions from digital apparatus set out in the Radio Interference Regulations of the Canadian Department of Communications.
Le present appareil numerique n'émet pas du bruits radioelectriques depassant les limites applicables aux appareils numerique de la Class A prescrites dans le Reglement sur le brouillage radioelectrique edicte par le ministere des Communications du Canada.
ELx808 Operator’s Manual
xviii | Preface

User Safety

This device has been type-tested by an independent laboratory and found to meet the requirements of the following:
Underwriters Laboratories UL 61010-1, “Safety requirements for electrical
equipment for measurement, control and laboratory use; Part 1: General requirements.”
Canadian Standards Association CAN/CSA C22.2 No. 61010-1, “Safety
requirements for electrical equipment for measurement, control and laboratory use; Part 1: General requirements.”
EN 61010 Standards, see
CE Mark starting on page xvi.
BioTek Instruments, Inc.

Safety Symbols

Some of these symbols may appear on the instrument or accessories:
Safety Symbols | xix
Alternating current Courant alternatif Wechselstrom Corriente alterna Corrente alternata
Direct current Courant continu Gleichstrom Corriente continua Corrente continua
On (Supply) Marche (alimentation) Ein (Verbindung mit dem Netz) Conectado Chiuso
Off (Supply) Arrêt (alimentation) Aus (Trennung vom Netz) Desconectado Aperto (sconnessione dalla
rete di alimentazione)
Both direct and alternating current Courant continu et courant alternatif Gleich - und Wechselstrom Corriente continua y corriente alterna Corrente continua e corrente alternata
Earth ground terminal Borne de terre Erde (Betriebserde) Borne de tierra Terra (di funzionamento)
Protective conductor terminal Borne de terre de protection Schutzleiteranschluss Borne de tierra de protección Terra di protezione
Caution (refer to accompanying documents) Attention (voir documents
d’accompanement) Achtung siehe Begleitpapiere Atención (vease los documentos incluidos) Attenzione, consultare la doc annessa
Warning, risk of electric shock Attention, risque de choc
électrique Gefährliche elektrische schlag Precaución, riesgo de sacudida
eléctrica Attenzione, rischio di scossa
elettrica
Warning, hot surface Attention, surface chaude Warnen, heiße Oberfläche Precaución, superficie caliente Attenzione, superficie calda
ELx808 Operator’s Manual
Warning, risk of crushing or pinching Attention, risque d’écrasement et
pincement Warnen, Gefahr des Zerquetschens und
Klemmen Precaución, riesgo del machacamiento y
sejeción Attenzione, rischio di schiacciare ed
intrappolarsi Warning, potential biohazards
Attention, risques biologiques potentiels Warnung! Moegliche biologische Giftstoffe Atención, riesgos biológicos Attenzione, rischio biologico
xx | Preface
In vitro diagnostic medical device
Dispositif médical de diagnostic in vitro
Medizinisches In-Vitro­Diagnostikum
Dispositivo médico de diagnóstico in vitro
Dispositivo medico diagnostico in vitro
Consult instructions for use Consulter la notice d’emploi Gebrauchsanweisung beachten Consultar las instrucciones de
uso Consultare le istruzioni per uso
Separate collection for electrical and electronic equipment
Les équipements électriques et électroniques font l’objet d’une collecte sélective
Getrennte Sammlung von Elektro- und Elektronikgeräten
Recogida selectiva de aparatos eléctricos y electrónicos
Raccolta separata delle apparecchiature elettriche ed elettroniche
Laser radiation: Do not stare into beam Rayonnement laser: Ne pas regarder
dans le faisceau Laserstrahlung: Nicht in den strahl
blicken Radiación de láser: No mire fijamente al
rayo Radiazione di laser: Non stare nel fascio
BioTek Instruments, Inc.
Chapter 1
Introduction
This chapter introduces the ELx808 Absorbance Microplate Reader and describes its hardware and software features, and technical specifications. Instructions for contacting BioTek are provided on page 7.
ELx808 Absorbance Microplate Reader .................................. 2
Reader Variations .......................................................... 2
Hardware Features ............................................................. 2
Software Features .............................................................. 3
Package Contents .............................................................. 3
Optional Accessories........................................................... 3
Specifications .................................................................... 4
Microplates ................................................................... 4
Electrical ...................................................................... 4
Physical ....................................................................... 4
Environmental .............................................................. 5
Hardware ..................................................................... 5
Reading Speeds ............................................................ 5
Standard Model: ELx808 ................................................ 5
Incubator/Ultraviolet Model: ELx808IU ............................. 6
Product Support and Service ............................................... 7
Contacting the Technical Assistance Center ....................... 7
Returning Instruments for Service/Repair ......................... 7
2 | Chapter 1: Introduction

ELx808 Absorbance Microplate Reader

BioTek’s ELx808 is an eight-channel reader-assay system. The reader can serve as a standalone system, or can be controlled via BioTek’s Gen5 software.
Designed to automatically perform endpoint and kinetic analysis, the reader can measure the optical density of solutions in 96-well microplates between 380 nm and 900 nm. The UV option measures down to 340 nm.
The reader features superior optical specifications, with an extended dynamic range of up to 4.000 absorbance units.
The instrument’s onboard processor, 2-line x 24-character LCD screen, and membrane keys allow easy definition and management of assay protocols, templates, formulas, and data. Results can be output in a printed report format, or exported for use in a variety of ELISA-based data manipulation applications.

Reader Variations

ELx808: Absorbance Microplate Reader (standard model).
ELx808IU: Reader with incubation and UV capability. The ELx808IU has a four-
zone incubation chamber that controls temperatures up to 50°C, and is capable of reading plates between 340 nm and 900 nm wavelengths.

Hardware Features

Eight optics channels, with an additional reference channel
A wavelength range of 380-900 nm (ELx808), 340-900 nm (ELx808IU)
A user-accessible, 6-position filter wheel
A 2-line x 24-character LCD display
A membrane keypad with alphanumeric keys
Adjustable plate shake frequency and times
Reads 96-well microplates with 0.355" (9.017 mm) well centers
Internal, four-voltage range power input module that can be adjusted for 100, 120,
230, or 240 V~ @ 50-60 Hz (readers manufactured before December 2005)
24-volt external power supply compatible with 100-240 V~ ± 10% @ 50-60 Hz
(readers manufactured after December 2005)
One serial COM port (25-pin male) and one parallel port (25-pin female)
4-Zone incubation chamber option (ELx808IU)
BioTek Instruments, Inc.
Software Features | 3

Software Features

Easy-to-use, menu-driven interface
Endpoint, Kinetic, and Linear Well scanning calculations
Curve fitting, with 4-parameter, cubic, quadratic, linear, 2-P, cubic-spline and
point-to-point methods
Transformation and formula calculations for more complex mathematical
operations, including validation and cutoff formulas
55 assays are available onboard; up to 75 custom assays can be preprogrammed
and exported to the reader using BioTek’s Define Protocol software.
Automatically stores results for the last 10 plates.

Package Contents

Package contents and part numbers are subject to change. Please
contact BioTek Customer Care with questions.
ELx808 Absorbance Microplate Reader
Power cord (PN varies according to country of use)
Power supply for readers manufactured after December 2005 (PN 01281)
Filter wheel with four standard filters: 405 nm, 450 nm, 490 nm, 630 nm and two
blank filters. The ELx808IU also includes a 340 nm filter.
Operator’s Manual (PN 7341000)
Serial cable (PN 75053)
Dust cover (PN 7342066)

Optional Accessories

Accessory availability and part numbers are subject to change. Contact
BioTek Customer Care with questions, or visit www.biotek.com and use the Accessories search tool.
Additional filters (please inquire for availability):
¾ 340 to 630 nm, PN 3100XXX (XXX is wavelength in nanometers) ¾ 640 to 900 nm, PN 3404XXX (XXX is wavelength in nanometers)
ELx808 Operator’s Manual
4 | Chapter 1: Introduction
Replacement lamp assembly (PN 3400508)
Filter wheel plug (PN 3122037)
Absorbance Test Plate (PN 9000547 or PN 7260522)
ELx808 IQ/OQ/PQ Package (PN 7340543)
Gen5 Software (visit biotek.com or contact your local dealer for details)
Absorbance Liquid Test Solutions:
¾ BioTek QC Check Solution No. 1 (PN 7120779, 25 mL; PN 7120782, 125 mL) ¾ BioTek wetting agent (PN 7773002)
Adapter to connect the reader to a USB-only printer (PN 75135)

Specifications

Microplates

Standard 96-well, flat- or round-bottom plates

Electrical

Power source and voltage range:
¾
Readers manufactured after December 2005: 24-volt external power
supply compatible with 100-240 V~ ± 10% @ 50-60 Hz
¾
Readers manufactured before December 2005: Internal, adjustable
power input module with four voltage ranges accommodated by the voltage selection switch:
Range 1 100 V~ 90 to 110 V~, 50 to 60 Hz Range 2 120 V~ 108 to 132 V~, 50 to 60 Hz Range 3 230 V~ 207 to 253 V~, 50 to 60 Hz Range 4 240 V~ 216 to 264 V~, 50 to 60 Hz
Power consumption: 100 VA

Physical

Dimensions: 16.0" D x 15.5" W x 8.75" H (40.6 cm x 39.37 cm x 22.2 cm)
Weight: 35 lb. maximum (15.87 kg maximum)
BioTek Instruments, Inc.
Specifications | 5

Environmental

Operating temperature: 18° to 40°C (64° to 104°F)
Humidity: 10% to 85% noncondensing

Hardware

• Light source: Tungsten halogen-filled bulb
Display: 2-line x 24-character LCD

Reading Speeds

Single wavelength: 8 seconds rapid mode; 12 seconds normal/regular mode
Dual wavelength: 13 seconds rapid mode; 20 seconds normal/regular mode
Single wavelength higher than 400 nm: 6-second minimum kinetic interval,
rapid mode

Standard Model: ELx808

The following specifications apply only to standard 96-well, flat- or
round-bottom microplates.
Wavelength Range: 380 to 900 nm
Filters: 10 nm half-bandwidth interference filters. User-accessible filter wheel.
Up to 6 filters may be installed on the instrument at one time. Filters supplied: 405 nm, 450 nm, 490 nm, 630 nm, and two blank filters.
Absorbance Measurement Range: 0.000 to 4.000 OD
Optical specifications for single-wavelength endpoint measurements with a 12­second read (normal/regular read mode):
Accuracy: ± 1.0% ± 0.010 OD from 0.000 to 2.500 OD @ 405 nm Linearity: ± 1.0% from 0.000 to 2.500 OD at 405 nm
± 2.0% from 2.500 OD to 3.500 OD @ 405 nm
Repeatability: ± 0.5% ± 0.005 OD from 0.000 to 2.500 OD @ 405 nm
± 1.5% ± 0.005 OD from 2.500 to 3.500 OD @ 405 nm ± 2.5% ± 0.005 OD from 3.500 to 4.000 OD @ 405 nm
ELx808 Operator’s Manual
6 | Chapter 1: Introduction
Optical Specifications for single-wavelength kinetic measurements with read intervals of less than 12 seconds:
Accuracy: ± 2.0% ± 0.010 OD from 0.000 to 2.500 OD @ 405 nm Linearity: ± 2.0% from 0.000 to 2.500 OD @ 405 nm Repeatability: ± 1.0% ± 0.010 OD from 0.000 to 2.500 OD @ 405 nm
The plate can be read at 6-second intervals (rapid mode) with
wavelengths higher than 400 nm.

Incubator/Ultraviolet Model: ELx808IU

The following specifications apply only to standard 96-well,
flat- or round-bottom microplates.
Wavelength Range: 340 to 900 nm
Filters: 10 nm half-bandwidth interference filters. User-accessible filter wheel.
Up to 6 filters may be installed on the instrument at one time. Filters supplied: 340, 405, 450, 490, 630 nm.
Absorbance Measurement Range: 0.000 to 4.000 OD for 400 to 900 nm range,
0.000 to 3.000 OD for 340 to 400 nm range
Optical specifications for the 400 to 900 nm range (12-second read in normal/ regular read mode):
Accuracy, Linearity, Repeatability: Same as Standard Model.
Optical specifications for the 340 to 400 nm range (12-second read in normal/ regular mode):
Accuracy: ± 1.0% ± 0.010 OD from 0.000 to 2.000 OD @ 340 nm Linearity: ± 1.0% from 0.000 to 2.000 OD @ 340 nm Repeatability: ± 1.0% ± 0.005 OD from 0.000 to 2.000 OD @ 340 nm
Incubation: The following specifications apply to a 96-well sealed plate with
200 μL of liquid in all wells:
Temperature Control: Temperature controlled to 50°C
¾
Temperature Variation: ± 0.50°C @ 37°C with the plate sealed
¾
BioTek Instruments, Inc.
Product Support and Service | 7

Product Support and Service

If your instrument or software fails to function properly, if you have questions about how to use or maintain your products, or if you need to send an instrument to BioTek for service or repair, please contact our Technical Assistance Center (“TAC”).

Contacting the Technical Assistance Center

TAC is open from 8:30 AM to 5:30 PM (EST), Monday through Friday, excluding standard U.S. holidays. You can send a fax or an e-mail any time.
Phone: 800-242-4685 (in the U.S.) or 802-655-4740 (outside the U.S.) Fax: 802-654-0638 E-Mail: tac@biotek.com Web: www.biotek.com
Please be prepared to provide the following information:
Your name and company information
A daytime phone or fax number, and/or an e-mail address
The product name, model, and serial number
The onboard software part number and version (available via the keypad
by selecting
Gen5 software version information (
UTIL > TESTS > CHKSUM)
Help > About Gen5).

Returning Instruments for Service/Repair

If you need to return an instrument to BioTek for service or repair, please contact the TAC for a Return Materials Authorization (RMA) number and the shipping address. Repackage the instrument according to the instructions at the end of
Installation
.
Chapter 2:
ELx808 Operator’s Manual
8 | Chapter 1: Introduction
BioTek Instruments, Inc.
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