This Manual Update contains changes to the ELx800™ Absorbance Microplate Reader
Operator’s Manual. These changes will be incorporated in the next full revision of the
manual, revision Q.
Replacing and Aligning the Bulb
Chapter 5, Maintenance and Decontamination contains instructions for replacing and
aligning the bulb. These instructions do not contain enough information to help you
properly align the bulb in all cases.
When it becomes necessary to replace the bulb*, replacement kits are available from
BioTek. PN 7330513 is required for standard models, and PN 7330516 is required for
ELx800UV and ELx800NB models. The kit contains complete instructions for replacing
and aligning the bulb. Please ignore the replacement/alignment instructions currently
supplied in this manual in Chapter 5.
If you have any questions or require further assistance, please contact BioTek’s Technical
Assistance Center (TAC). Contact information is provided on page x.
* The lamp is rated for an average life of 600 hours. The intensity of the lamp will slowly
drop over time until the run-time self check detects a low signal level. The reader will
display an error code at this time, indicating that it is time to replace the bulb.
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.
BioTek
and EL800™ are trademarks of BioTek Instruments, Inc. Microsoft
®
is a registered trademark, and ELx800™, Gen5™, KC4™, KCjunior™,
®
, 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 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 | iii
Contents
Notices ............................................................................................. ii
All Rights Reserved ................................................................................. ii
Trademarks ........................................................................................... ii
Restrictions and Liabilities ........................................................................ ii
Contact Information .................................................................................. x
Customer Service and Sales ..................................................................... x
Service/TAC........................................................................................... x
European Coordination Center .................................................................. x
Document Conventions ............................................................................. xi
This manual uses the following typographic conventions:
Example Description
Document Conventions | xi
Warning!
Caution
DEFINE
Note:
This icon calls attention to important
A Warning indicates the potential for bodily harm and tells you
how to avoid the problem.
Caution indicates potential damage to the instrument and tells
A
you how to avoid the problem.
Text in COURIER font represents menu options as they appear on
the instrument’s display.
Bold text is primarily used for emphasis.
This icon calls attention to important information.
safety notes.
ELx800 Operator's Manual
xii | Preface
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
F 2/97 Added Notes including info on 384-well format. Updated Reuse
G 03/98 Added Liquid Test 1 and 2 to Chapter 4 –Performance
H 09/98 Modified Appendix B - Computer Control. Updated Elx800 and
I 2/99 Incorporated Manual Updates.
J 9/99 Changed printer-compatible description. Changed the number
K 1/00 Added Liquid Test 3 to test 340 nm filters. Updated screens in
L 5/03 Preface:
Appendix D to include all reports.
of Standard Curves and Panel sections. Added Appendix E –
KcJr for 384-well format.
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.
EL800 model comparison table in Appendix F.
Changed European addresses.
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.
Chapter 3. Updated chart in Appendix F.
- 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
"BioTek 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.
BioTek Instruments, Inc.
Revision History (Continued)
L 5/03
(Cont.)
M 9/03 Preface:
N 10/04 Restructured manual according to new template.
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.
- 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.
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.
Revision History (Continued) | xiii
ELx800 Operator's Manual
xiv | Preface
Revision History (Continued)
O 4/06
General:
- Changed “Bio-Tek” to “BioTek,” and “ELx800 Automated
Microplate Reader” to “ELx800 Absorbance Microplate Reader.”
- Added Gen5 references and instructions wherever KC4 and
KCjunior references and instructions were present.
Cover: Updated BioTek logo to new graphic.
Preface: Revised Hazards and Precautions, and removed Warranty
and Registration Card.
Chapter 1: Updated Package Contents, Optional Accessories, and
Specifications. Replaced 3-page Technical Support with 1-page
Product Support and Service section.
Chapter 2: Updated unpacking/packing instructions. Added new
section, “Installing Software on the Host PC,” for Gen5, KC4, and
KCjunior users.
Chapter 3: In System Startup, incorporated information from Manual
Update Rev. N2 that not all software features discussed in the manual
are available on ELx800 readers with custom programmed software.
Chapter 4:
- Changed title from “Performance Verification and IQ/OQ/PQ
Procedures” to “Instrument Qualification.”
- Add Gen5 instructions for System Test and Absorbance Plate Test.
- In Recommended Qualification Schedule, changed PQ frequency
from monthly and semiannually to monthly and quarterly, and
clarified criteria for running Liquid Tests 1, 2, or 3.
- In Absorbance Plate Test section, added a sample test plate report
(and explanatory note) illustrating that values higher than the
specified 0.000 to 2.000 OD range may not have “PASS”/”FAIL”
indications.
- For Liquid Tests 1, 2, and 3, incorporated recommendation from
Manual Update N2 to shake the plate or wait between pipetting
and read steps.
Appendix A: Changed title of appendix from “Controlling the Reader
With KCjunior or KC4” to “Computer Control.” Added new section,
“Controlling the Reader with Gen5.”
Appendix B: Added Gen5 instructions for preparing and running a
384-well plate protocol with the ELx800NB. Updated KC4 and
KCjunior sections by specifying that the ELx800NB model must be
used for running 384-well plates, and added screen shots that
illustrate selection of the ELx800NB.
BioTek Instruments, Inc.
Revision History (Continued)
P 10/06 Ch 3 Operation, clarified instructions for running Panel assays via the
keypad.
Ch 4 Instrument Qualification, replaced incorrect sample System Test
report with a report run using an ELx800.
Ch 5 Maintenance and Decontamination, added tips for storing and
handling filters.
Appx B, Using 384-Well Geometry, inserted step 13 to select a Read
Type when using Gen5.
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.
Revision History (Continued) | xv
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 BioTek for service or
repair, contact BioTek for a Return Materials
Authorization (RMA) number, and be sure to use the
original packaging. Other forms of commercially available
packaging are not recommended and can void the
warranty. If the original packaging materials have been
damaged or lost, contact BioTek for replacement
packaging.
ELx800 Operator's Manual
xvi | Preface
Warnings
Operate the instrument on a flat surface away from excessive
humidity.
Bright sunlight 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.
Hazards and Precautions
Hazards
Warning! Power Rating.
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.
adapter to connect primary power to the external power supply. Use
of a two-prong adapter disconnects the utility ground, creating a
severe shock hazard. Always connect the power cord directly to a
three-prong receptacle with a functional ground.
Warning! Internal Voltage.
and unplug the power cord before cleaning the outer surface of the
instrument.
Warning! Liquids.
seepage into internal components creates a potential shock hazard.
Wipe up all spills immediately. Do not operate the instrument if
internal components have been exposed to fluid.
Avoid spilling liquids on the instrument; fluid
The instrument’s power supply or power
Never use a two-prong plug
Always turn off the power switch
BioTek Instruments, Inc.
(Hazards, continued)
Hazards and Precautions | xvii
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.
Warning! Hot Surface.
The lamp is hot when the instrument is
turned on. Turn off the reader and allow the lamp to cool down
before attempting to replace it.
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, using the instrument’s
onboard software.
could result in erroneous test data
Warning! Reader Data Reduction Protocol.
Failure to conduct quality control checks
.
For readers with
onboard assay software, the 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. For readers operated via computer control,
no limits are applied to the raw absorbance data. All information
exported via computer control must be thoroughly analyzed by the
operator.
Precautions
The following precautions are provided to help avoid damage to the instrument:
Caution: Service.
service personnel. Only qualified technical personnel should perform
troubleshooting and service procedures on internal components.
Caution: Environmental Conditions.
instrument to temperature extremes. For proper operation, ambient
temperatures should remain between 18°-40°C. Performance may be
adversely affected if temperatures fluctuate above or below this
range. Storage temperature limits are broader.
ELx800 Operator's Manual
The ELx800™ should be serviced by authorized
Do not expose the
xviii | Preface
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.
Only use the power supply shipped with
the instrument. Operate this power supply within the range of line
voltages listed on it.
Caution: Shipping Hardware.
Shipping straps and a shipping
block must be removed before operating the reader. They must be
reinstalled before repackaging the reader for shipment. See
, Installation.
2
Caution: Disposal.
This instrument contains printed circuit boards
Chapter
and wiring with lead solder. Dispose of the instrument according to
Directive 2002/96/EC, “on waste electrical and electronic equipment
(WEEE).”
Caution: Warranty.
protocols may
and Decontamination
void the warranty. See Chapter 5, Maintenance
Failure to follow preventive maintenance
.
BioTek Instruments, Inc.
Hazards and Precautions | xix
Based on the testing described below and information contained
herein, this instrument bears the CE mark.
EN 55022:2000 Class A, CISPR 16-1:1993, CISPR 16-2:1999
Immunity
EN 61326-1:2002
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
EN 61000-4-11: Voltage Dips, Short Interruptions and Variations
Directive 73/23/EEC Low Voltage
IEC 1010: “Safety requirement for electrical equipment for measurement, control
and laboratory use. Part 1, General requirements”.
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).”
Directive 98/79/EC: In Vitro Diagnostics
• Product registration with competent authorities
• Traceability to the U.S. National Institute of Standards and Technology
(NIST):
Optical density measurements, and if equipped, incubator
Specific data for a particular serial number is available on request from BioTek
Instruments. See page x for contact information.
ELx800 Operator's Manual
temperature readings, are traceable to NIST.
xx | Preface
Electromagnetic Interference and Susceptibility
USA FCC CLASS A
Warning: Changes or modifications to this unit not expressly approved by
the manufacturer could void the user's authority to operate the equipment.
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 his/her
expense.
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'met 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.
User Safety
This device has been type tested by an independent laboratory and found to meet the
requirements of the following:
North America
• Canadian Standards Association CAN/CSA C22.2 No. 1010.1-92
“Safety Requirements for Electrical Equipment for Measurement, Control,
and Laboratory Use, Part 1: General Requirements”
• UL 61010A-1, 1st Edition
“Safety Requirements for Electrical Equipment for Measurement, Control,
and Laboratory Use, Part 1: General Requirements”
International
• IEC 1010
“Safety Requirements for Electrical Equipment for Measurement, Control,
and Laboratory Use, Part 1: General Requirements”
BioTek Instruments, Inc.
Safety Symbols
Some of the following symbols will appear on the instrument.
Alternating current
Courant alternatif
Wechselstrom
Corriente alterna
Corrente alternata
Courant continu et courant alternatif
Gleich - und Wechselstrom
Corriente continua y corriente alterna
Corrente continua e corrente alternata
Safety Symbols | xxi
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
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)
ELx800 Operator's Manual
xxii | Preface
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, 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, hot surface
Attention, surface chaude
Warnen, heiße Oberfläche
Precaución, superficie caliente
Attenzione, superficie calda
Consult instructions for use
Consulter la notice d’emploi
Gebrauchsanweisung beachten
Consultar las instrucciones de uso
Consultare le istruzioni per uso
In vitro diagnostic medical device
Dispositif médical de diagnostic in vitro
Medizinisches In-Vitro-Diagnostikum
Dispositivo médico de diagnóstico in vitro
Dispositivo medico diagnostico in vitro
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
BioTek Instruments, Inc.
Chapter 1
Introduction
This chapter introduces the ELx800™ Absorbance Microplate Reader
and describes its hardware and software features. Also included is
contact information if technical assistance is needed.
Introducing the ELx800 Absorbance Microplate Reader ................. 2
Standard Model.................................................................. 6
Ultraviolet/UV Model ........................................................... 7
Narrow Beam/NB Model ...................................................... 8
Product Support & Service ....................................................... 10
Contacting the Technical Assistance Center ........................... 10
Returning Instruments for Service/Repair .............................. 10
2 | Chapter 1: Introduction
Introducing the ELx800 Absorbance Microplate
Reader
The ELx800™ Absorbance Microplate Reader is a single-channel reader-assay system,
designed to automatically perform endpoint analysis for a variety of ELISA-based
applications. The reader can measure the optical density of solutions in 6-, 12-, 24-, 48-,
or 96-well microplates. The “NB” reader models can measure 384-well microplates and
60-, 72-, 96-well Terasaki trays as well as 6-, 12, 24-, 48-, or 96-well plates. The reader
features superior optical specifications, with an extended dynamic range of up to 3.000
absorbance units in some read modes. The wavelength range is from 400 nm to 750
nm. “UV” instruments have an extended range from 340 nm to 750 nm. Kinetic
analysis can be performed using computer control (e.g., via Gen5™, KC4™ , or
KCjunior™ running on a host PC).
Assay definitions (consisting of protocols, templates and formulas) and the data they
produce are managed by an onboard processor, via a 2-line x 24-character LCD screen
and membrane switch. Data can be stored onboard, printed, and/or uploaded to
controlling software on a host PC.The ELx800 is designed to serve as a stand-alone
system, or as part of a larger laboratory data network, sending, receiving, and
manipulating assay data as needed.
The ELx800 is backed by a superior support staff. If the ELx800 ever fails to work
perfectly, please call the Technical Assistance Center, or visit BioTek’s Web site. Refer
to the end of this chapter for contact information.
BioTek Instruments, Inc.
Hardware Features| 3
Hardware Features
The ELx800’s hardware features include:
• Single optics channel
Wavelength range of 400-750 nm
•
ELx800UV model provides extended wavelength range of
340 to 750 nm
A 5-position filter wheel
•
A 2-line x 24-character LCD display
•
A membrane keypad with alphanumeric keys
•
X-Y carrier movement
•
Capability of reading 6-, 12-, 24-, 48- and 96-well microplates.
•
ELx800NB model extends read capability to include 384-well and
60-/72-/96-well Terasaki microplates.
External 24-volt power supply, compatible with 100-240 V~ ± 10.0%
•
@ 50 to 60 Hz
One serial COM port, 25-pin male connector
•
One parallel port, 25-pin female connector
•
Software Features
• An easy-to-use, menu-driven interface
Endpoint 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 validations
Up to 75 assays can be programmed into memory and recalled instantly
•
Up to 10 results can be stored in memory
•
ELx800 Operator's Manual
4 | Chapter 1: Introduction
Package Contents
The contents of the ELx800™ package include:
• ELx800 Absorbance Microplate Reader
• Power cord (part number varies according to country of use)
• Power supply (PN 61062)
• Filter wheel with 4 standard filters: 405 nm, 450 nm, 490 nm, 630 nm and one
blank filter. The UV model includes a 340 nm filter.