Bio-Tek ELx405 Manual

ELx405™
Microplate Washer
Operator’s Guide
For all models:
ELx405
ELx405 Select
ELx405 Magna
ELx405 HT
ELx405 Select CW

.

ELx405™
Microplate Washer
Operator’s Guide
January 2005
2005
7101000
Revision I
Bio-TekInstruments, Inc.

ii |Preface
Bio-Tek Instruments, Inc.

Notices | iii
Notices
Bio-TekInstruments, Inc.
P.O. Box 998, Highland Park
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2005, 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 ELx405, Bio-Stack, and Ultrasonic
Advantage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. Bio-Tek
assumes no responsibility for the use or reliability of software or equipment
that is not supplied by Bio-Tek or its affiliated dealers.
ELx405 Operator's Guide

iv |Preface
Bio-Tek Instruments, Inc.

Table of Contents | v
Table of Contents
Notices .....................................................................................iii
Table of Contents ......................................................................v
List of Figures .........................................................................xii
Contact Information...............................................................xiii
Customer Service and Sales........................................................................................ xiii
Service/TAC................................................................................................................. xiii
European Coordination Center.................................................................................. xiii
Document Conventions .......................................................... xiv
Revision History ...................................................................... xv
Intended Use Statement ...................................................... xviii
Quality Control ..................................................................... xviii
Repackaging and Shipping ................................................... xviii
Warnings................................................................................xix
Hazards and Precautions........................................................ xix
Hazards ..........................................................................................................................xix
Precautions......................................................................................................................xx
Directive 89/336/EEC: Electromagnetic Compatibility........................................xxii
Directive 73/23/EEC: Low Voltage (Safety)...........................................................xxii
Directive 2002/96/EC: Waste Electrical and Electronic Equipment ...................xxii
Directive 98/79/EC: In Vitro Diagnostics (some models)................................... xxiii
Electromagnetic Interference and Susceptibility.................. xxiv
USA FCC CLASS A.................................................................................................... xxiv
Canadian Department of Communications Class A............................................. xxiv
User Safety........................................................................... xxiv
Safety Symbols ..................................................................... xxv
ELx405 Operator's Guide

vi |Preface
Warranty ............................................................................. xxvii
Bio-Tek Instruments Warranty Policy ................................................................... xxvii
Hardware Warranty ................................................................................................. xxvii
Registration Card ............................................................... xxviii
Registration Online ............................................................ xxviii
Chapter 1: Introduction............................................................1
Introducing the ELx405................................................................................................... 2
ELx405 Washer Variations..............................................................................................3
Compatibility With the Bio-Stack System .................................................................... 4
Hardware Features ..........................................................................................................6
Software Features............................................................................................................. 7
Package Contents............................................................................................................. 8
Optional Accessories ....................................................................................................... 9
Specifications ..................................................................................................................10
Performance Specifications........................................................................................... 11
Technical Support .......................................................................................................... 12
Phone Support ......................................................................................................... 13
Electronic Communication.....................................................................................13
Facsimile Support.................................................................................................... 13
Written Communication.........................................................................................13
Shipping Address.................................................................................................... 13
Applications Support .................................................................................................... 14
Phone Support ......................................................................................................... 14
Electronic Communication.....................................................................................14
Chapter 2: Installation ...........................................................15
Unpacking and Inspecting the Instrument ................................................................16
To unpack the washer and its accessories............................................................ 16
Unpacking the Valve Module................................................................................ 19
Removing the Manifold Shipping Bracket .................................................................21
Setting Up the Washer...................................................................................................22
Operating Environment.......................................................................................... 22
Bio-Tek Instruments, Inc.

Table of Contents | vii
Installing the Microplate Carrier........................................................................... 22
Connecting the Tubes and Bottles.........................................................................26
Attaching the Mist Shield....................................................................................... 33
Connecting the Power Cord................................................................................... 34
Serial Port for Communication With Other Devices ..........................................34
Verifying Performance ..................................................................................................35
Installation of the Washer for Operation With the Bio-Stack .................................. 36
Repackaging and Shipping........................................................................................... 37
Before Repackaging the Instrument ..................................................................... 38
Repackaging the ELx405 and Its Accessories ......................................................39
Repackaging the External Valve Module (if equipped)..................................... 39
Chapter 3: Operation..............................................................41
ELx405 Front Panel ........................................................................................................42
Keypad Description....................................................................................................... 43
Entering Program Names ............................................................................................. 44
System Startup................................................................................................................ 45
Main Menu...................................................................................................................... 46
Programs .........................................................................................................................47
Operation With the Bio-Stack.......................................................................................48
General Usage Guidelines ............................................................................................ 49
Before Running Any Program ...............................................................................49
Maintenance .............................................................................................................50
Programming Considerations ...............................................................................51
Wash ................................................................................................................................52
Run Wash Program .................................................................................................52
Define Wash Program............................................................................................. 53
Edit Wash Program ................................................................................................. 71
Copy Wash Program...............................................................................................71
Delete Wash Program .............................................................................................72
Prime................................................................................................................................73
Run Prime Program ................................................................................................73
Define Prime Program ............................................................................................ 74
ELx405 Operator's Guide

viii |Preface
Recommended Prime and Low Flow Prime Volumes....................................... 76
Edit Prime Program ................................................................................................76
Copy Prime Program .............................................................................................. 77
Delete Prime Program.............................................................................................77
Default Prime Program: Prime_200 ...................................................................... 78
Default Prime Program: Prime_CW .....................................................................78
Dispense .......................................................................................................................... 79
Run Dispense Program........................................................................................... 79
Define Dispense Program ......................................................................................80
Edit Dispense Program........................................................................................... 81
Copy Dispense Program.........................................................................................81
Delete Dispense Program....................................................................................... 82
Aspiration .......................................................................................................................83
Run Aspiration Program ........................................................................................83
Define Aspiration Program.................................................................................... 84
Edit Aspiration Program ........................................................................................ 84
Copy Aspiration Program......................................................................................85
Delete Aspiration Program .................................................................................... 85
Soak..................................................................................................................................86
Define Soak Program .............................................................................................. 86
Edit Soak Program................................................................................................... 86
Copy Soak Program ................................................................................................ 87
Delete Soak Program............................................................................................... 87
Linking Programs ..........................................................................................................88
Run Link Program................................................................................................... 88
Define Link Program............................................................................................... 89
Delete Link Program...............................................................................................90
Setup Utilities .................................................................................................................91
RS-232 Settings (RS232) .......................................................................................... 91
Sensor System (SENSOR)....................................................................................... 91
Adjust Utility (ADJUST).........................................................................................92
Park Utility (PARK)................................................................................................. 93
Bio-Stack Utilities (BIOSTACK) ............................................................................ 93
Bio-Tek Instruments, Inc.

Table of Contents | ix
Delay After Dispense (DISP)..................................................................................94
Plate Clearance Height (PLATE)...........................................................................94
Vacuum Dissipation Delay (VACUUM).............................................................. 94
Manifold Selection (MANIFOLD)......................................................................... 95
ELx405 Washer Menu Maps.........................................................................................96
Main Menu (DEFINE function path for Create and Edit) ................................. 97
Main Menu (DEFINE function path for Copy and Delete) ............................... 98
Main Menu (RUN function path).......................................................................... 99
Main Menu (MAINT, UTIL function path) .......................................................100
Chapter 4: Preventive Maintenance......................................101
Overview....................................................................................................................... 102
Schedule.................................................................................................................. 102
Recommended Maintenance Schedule .....................................................................103
Required Materials.......................................................................................................104
Warnings & Precautions ............................................................................................. 105
Maintenance Programs ............................................................................................... 106
Prime Programs............................................................................................................107
Rinse/Soak the Fluid Path..........................................................................................109
Daily Maintenance ................................................................................................ 109
Overnight/Multi-Day Maintenance ................................................................... 111
Clean Components.......................................................................................................114
Periodic Maintenance ...........................................................................................114
Decontaminate the Washer......................................................................................... 128
Decon Procedure for External Surfaces of the Instrument .............................. 129
Decon Procedure for Tubing and Manifold.......................................................130
Alternate Decontamination Procedure for Tubing and Manifold.................. 132
Prepare for Storage or Shipment................................................................................134
Long_Shutdown ....................................................................................................134
Storing the Washer................................................................................................ 135
Replace Components...................................................................................................136
Replacing the O-Rings and Channel-End Seals ................................................136
ELx405 Operator's Guide

x|Preface
Chapter 5: Performance Verification/Qualification Tests .....139
Overview....................................................................................................................... 140
Verification Schedule................................................................................................... 141
Installation Qualification (IQ) .................................................................................... 142
Operational Qualification (OQ) .................................................................................142
Performance Qualification (PQ).................................................................................143
System and Checksum Tests ......................................................................................144
System Self Test .....................................................................................................144
Checksum Test....................................................................................................... 145
Liquid Tests ..................................................................................................................146
Evacuation Efficiency Test (Overview) .............................................................. 146
Dispense Precision Test (Overview)................................................................... 146
Valve Module Test (Overview) ........................................................................... 147
Which Tests to Perform?.......................................................................................147
Materials .................................................................................................................148
Evacuation Efficiency Test (96)............................................................................ 150
Dispense Precision Test (96).................................................................................153
Evacuation Efficiency Test (192).......................................................................... 157
Dispense Precision Test (192)...............................................................................160
Worksheets ............................................................................................................. 164
Appendix A: Troubleshooting ...............................................171
Overview....................................................................................................................... 172
Troubleshooting Checklist .................................................................................. 172
Troubleshooting Charts ..............................................................................................173
Washer Start-Up ....................................................................................................173
Fluid Aspiration..................................................................................................... 175
Fluid Delivery ........................................................................................................ 178
Fluid Leakage.........................................................................................................181
Microplate Carrier Movement............................................................................. 182
Washer Manifold Movement............................................................................... 182
Microplate Scratches .............................................................................................183
Bio-Tek Instruments, Inc.

Table of Contents | xi
Appendix B: Error Codes.......................................................185
Error Codes...................................................................................................................186
Bio-Stack Errors (Overview) ................................................................................ 186
General Errors .............................................................................................................. 187
Fatal Errors.................................................................................................................... 200
Bio-Stack Errors............................................................................................................ 203
Appendix C: Chemical Compatibility .....................................205
Components and Materials Composition.................................................................206
Appendix D: Default Programs .............................................207
Default Programs .........................................................................................................208
Appendix E: Changing the Manifolds ....................................209
Changing Manifolds in HT Models With the 96-Tube Manifold.......................... 210
Index ....................................................................................213
ELx405 Operator's Guide

xii |Preface
List of Figures
Figure 1: The ELx405™ Microplate Washer With the Bio-Stack ........................................................ 5
Figure 2: Removing the Inner Shipping Box ....................................................................................... 17
Figure 3: Removing the Carrier and Other Accessories .................................................................... 17
Figure 4: Removing the End Caps ........................................................................................................ 18
Figure 5: Manifold Shipping Bracket ................................................................................................... 18
Figure 6: Removing the Valve Module From the Shipping Container............................................ 20
Figure 7: Removing the Wire Holders, Supply Bottles, and Other Accessories ...........................20
Figure 8: Removing and Storing the Manifold Shipping Bracket ....................................................21
Figure 9: Installing the Microplate Carrier for the ELx405 Model ................................................... 23
Figure 10: Installing the Microplate Carrier for the Select, Select CW, and all HT Models .........24
Figure 11: Installing the Microplate and Magnet Plate Carriers for the Magna Model................ 25
Figure 12: Rear Panel ..............................................................................................................................27
Figure 13: Washer With Vacuum Pump and Waste Tubing Connections......................................29
Figure 14: Washer With Supply Tubing Connections (Without External Valve Module) ........... 31
Figure 15: Washer With External Valve Module................................................................................32
Figure 16: Attaching the Mist Shield ....................................................................................................33
Figure 17: ELx405 Front Panel With LCD and Keypad.....................................................................42
Figure 18: Dispense and Aspirate Heights for the ELx405 and Magna Models ............................ 68
Figure 19: Dispense and Aspirate Heights for the Select, Select CW, and HT2/HTV2
Models With Dual/96 Manifold ...........................................................................................................69
Figure 20: Dispense and Aspirate Heights for the HT Model .......................................................... 70
Figure 21: Using the Adjust Utility.......................................................................................................93
Figure 22: Position of the Transport Arm on the Plate Carrier....................................................... 116
Figure 23: Removing the Screws and Washers From the Transport Arm ....................................117
Figure 24: The Transport Arm Removed From the Carrier ............................................................ 117
Figure 25: Carrier and Manifold Placement in the ELx405 Model................................................. 120
Figure 26: Carrier and Manifold Placement in the Select, Select CW, and HT Models .............. 121
Figure 27: Carrier and Manifold Placement in the Magna Model .................................................122
Figure 28: Cleaning the Fluid Inlet Filter...........................................................................................127
Figure 29: Replacing the Channel-End Seals.....................................................................................137
Figure 30: Storing the 96- or 192-Tube Dual Manifold in the Shipping Case...............................212
Bio-Tek Instruments, Inc.

Contact Information | xiii
Contact Information
Bio-TekInstruments, Inc.
P.O. Box 998, Highland Park
Winooski, Vermont 05404-0998 USA
Customer Service and Sales
Internet: www.biotek.com
Phone: [phone] (toll free in the U.S.)
802-655-4740 (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]
ELx405 Operator's Guide

xiv |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.
Note:Bold text is primarily used for emphasis.
 This icon calls attention to important information.
Bio-Tek Instruments, Inc.

Revision History | xv
Revision History
Rev Date Changes
A12/98 • Release to Production.
B3/99 • Replaced graphic of the Magna carrier placement to clarify position. Added
defaults and ranges for Method, Dispense, Aspirate, Prime and Soak
parameters.
C02/00 • Updated contact information under Notices. Added “patented” to all
references to the “dual-manifold design.” Enhanced the Maintenance and
Instrument Verification chapters.
D6/00 • Corrected default prime dispense volume. Added new error code A900.
Added info on pump for testing 384-well plates.
E 3/03 • Updated contact information, standards, and safety symbols in Preface.
Added Cautions to Precautions section: Chemical Compatibility, Bovine
Serum Albumin, Shipping Bracket, Waste Monitor Sensor Connector.
• Revised hardware/software features, package contents, optional
accessories, and specifications in Ch. 1. Moved Technical Support section
from App. A to Ch. 1, and updated TAC addresses, phone numbers, etc.
Included information about compatibility of ELx405Auto Plate and Select
models with Bio-StackMicroplate Stacking System in Ch. 1.
• Added brief paragraphs in Ch. 2 & 3, App. A & B regarding installation,
operation, troubleshooting, error codes when operating with Bio-Stack;
referenced Bio-Stack Operator’s Manual.
• Updated Ch. 3 screens, descriptions of program options, and menu maps to
reflect New/Repeat options at program completion and additional 4 aspirate
rates (for Aspiration and Wash programs); added new sections to Setup
Utilities about the Bio-Stack, delay after dispense, plate clearance height,
and vacuum dissipation delay options.
• Updated maintenance and IQ-PQ-OQ chapters.
ELx405 Operator's Guide

xvi |Preface
Revision History, Cont’d
Rev Date Changes
F 10/03 • Added information about new ELx405HT model throughout manual.
• Updated TAC information in Preface and Ch. 1, and Customer Service
contact information, Hazards, Safety Symbols, Intended Use Statement,
and Warranty in Preface.
• Updated Introduction, Variations, Hardware and Software Features,
Package Contents, Optional Accessories, and Specifications in Ch. 1.
• Enhanced Unpacking/Repackaging and Installation sections in Ch. 2;
added new sections on unpacking/repackaging the optional valve module,
and new Fig. 2-2A, Removing the valve module from the shipping
container, and Figure 2-2B, Removing the wire holders, buffer bottles and
other accessories from the shipping container.
• Corrected menu screens, program options, and menu maps in Operation,
Ch. 3. Included new ELx405 HT version and additional Bio-Stack
information; added new Fig. 3-2C: Dispense and aspirate heights for the
ELx405 HT (384-well) washer.
• Updated Ch. 4 and Ch. 5. Added information from revised ELx405 IQ-OQ-
PQ Manual (PN 7100567) to liquid testing section of Ch. 5, including new
section on liquid testing for ELx405 HT model.
• Updated App. A, Troubleshooting, and App. B, Error Codes; added several
Bio-Stack error codes that appear on the ELx405.
• Added new Appendix C, Chemical Compatibility.
• Replaced previous artwork of microplate carriers with revised artwork of
the latest, robotic compatible and Bio-Stack compatible carriers in figures
throughout manual.
G 5/04 • Re-formatted manual in new template and according to format designated
in latest Revision D of TP01, Structure for Operator Manuals/User Guides.
• Added information on new cell washer model ELx405Select CW
throughout manual, including the Low Flow Prime Volume, Dispense Flow
Rates 10 and 11, Vacuum on Volume, prime program Prime_CW, and cell
washer defaults in Maintenance and AutoPrime prime programs.
• Revised Technical Support section and added new sections on Depot
Service Contracts and Applications Support in Ch. 1.
• Enhanced installation instructions in Ch. 2, and General Usage Guidelines in
Ch. 3.
• Updated Liquid Testing sections and added Valve Module Dispense Precision
Test in Ch. 4.
• Enhanced cleaning, decon, and long-term storage sections of Ch. 5.
• Revised Troubleshooting and Error Codes sections.
• Added new Appendix D, Default Programs.
Bio-Tek Instruments, Inc.

Revision History | xvii
Revision History, Cont’d
Rev Date Changes
H 7/04 • Edited Chemical Compatibility caution in Preface and Components and
Materials Composition table in Appendix C concerning use of acetic acid.
• Replaced section in Chapter 1 on Depot Service Contracts with reference to
the Bio-Tek website, where this information may be found.
• Revised Maintenance chapter with updated cleaning procedure for removal
of Bovine Serum Albumin (BSA) residue from washer.
• Updated ELx405 product name to reflect latest product name configuration.
I 1/05 • Added text throughout manual about new models:
− HT2/HTV2 (HT models with the accessory 96-tube dual manifold)
− Ultrasonic Advantage™ (ELx405, Select, Select CW, or HT models
equipped with the ultrasonic cleaner)
• Updated accessories and specs in Chapter 1, Introduction.
• Revised artwork in Chapter 2, Installation, Chapter 3, Operation, and
Chapter 4, Preventive Maintenance.
• Revised instructions in Chapter 3 for the following:
− Clarified use of the Select CW Dispense Flow Rates 10 and 11 (not
recommended for 384-well plates).
− Revised description of rapid Aspirate Rates 7 to 10.
− Added more information about Magna soak/shake options.
− Recommended a range of 12-175 (current range is 12-180) in Dispense
Height, Bottom Dispense Height, Aspirate Height, Crosswise Aspirate
Height, Plate Clearance Height sections.
− Revised sections on recommended Prime and Low Flow Prime Volumes
for the Select CW models.
• Updated Chapter 4, and Chapter 5, Performance Verification/Qualification
Tests with revisions from latest ELx405 IQ-OQ-PQ procedures.
• Enhanced Appendix B, Error Codes with descriptions of the codes and new
AUTOCLEAN codes.
• Added new Appendix E, Changing the Manifolds (for HT2/HTV2 models).
ELx405 Operator's Guide

xviii |Preface
Intended Use Statement
• The ELx405Microplate Washer provides microplate priming, washing,
dispensing, and aspiration for ELISA™, fluorescence and chemiluminescence
immunoassays, cellular and agglutination assays.
• The washer can operate as a stand-alone instrument or with standard robotic
systems, such as Bio-Tek’s Bio-Stack Microplate Stacker.
• 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 non-clinical purposes. If there is no
such label, then the instrument may only be used for research and
development, or for 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.
Repackaging and Shipping

Important! 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.
Bio-Tek Instruments, Inc.