Dynex Agility Automated ELISA System User manual

Agility®Automated ELISA System
Operator’s Manual
Part Number 91001040
IMPORTANT
Please read carefully before using the System

Revision History
DYNEX Technologies, Inc.
14340 Sullyfield Circle
Chantilly, VA 20151 USA
Dynex Technologies Limited
Unit B2
Yeoman Gate, Yeoman Way
Worthing, West Sussex
BN13 3QZ UK
Manual Version Revision Date:
Revision E For operation with Agility software November 2014
This publication is for the operators of the DYNEX Agility Automated Microplate
Processing System. Due to continuing software improvement, dialog boxes displayed in
this manual may differ from those actually seen in the software screens. Every effort has
been made to ensure the information in this manual is accurate, updated and consistent
with the product it describes. DYNEX reserves the right to make technical improvements to
the system and documentation without prior notice as part of a continuous program of
product development.
The information in this manual is of a proprietary nature. No part of this publication may be
reproduced, stored in a retrieval system, translated, transcribed, or transmitted in any form
or by any means without prior written permission of DYNEX.
DYNEX does not assume liability for the use of this manual. If the system is not used
according to the description in this manual DYNEX does not assume responsibility for any
consequent effects.
This manual supersedes all previous editions and is published by DYNEX Technologies,
Inc.
Questions or comments regarding the content of this manual can be directed to the
address below or to your supplier.
© 2009, Dynex Technologies, Inc.

Table of Contents
Agility System Operator’s Manual 3
Table of Contents
Table of Contents..................................................................................................................................3
About This Manual................................................................................................................................7
Chapter 1 Overview...........................................................................................................................9
1.1 Introduction .........................................................................................................9
1.2 SmartKitTM .........................................................................................................10
1.3 Sample Rack.....................................................................................................11
1.4 Microplates........................................................................................................11
1.5 Consumable Supplies.......................................................................................12
1.6 Waste................................................................................................................15
1.7 Setting up for LIS-Link.......................................................................................15
Chapter 2 Safety..............................................................................................................................21
2.1 Warning Labels .................................................................................................21
2.2 Warnings and Safety Precautions.....................................................................22
Chapter 3 System Design...............................................................................................................25
3.1 Overview ...........................................................................................................25
3.2 Workspaces ......................................................................................................25
3.2.1 Lower Workspace ................................................................................25
3.2.2 Upper (Reagent) Workspace ...............................................................26
3.3 Transport Arm ...................................................................................................27
3.4 Sample Pipettor Arm.........................................................................................28
3.4.1Overview ..............................................................................................28
3.4.2 Tip Detection........................................................................................29
3.4.3 Liquid Level Detection..........................................................................29
3.5 Reagent Pipettor Arm........................................................................................30
3.5.1Overview ..............................................................................................30
3.5.2 Reagent Dilution...................................................................................32
3.5.3 Reagent Mixing ....................................................................................32
3.6 Sample Loading Module ...................................................................................33
3.7 Consumable Drawers........................................................................................34
3.8 Microplate Washer............................................................................................35
3.9 Microplate Reader.............................................................................................39
3.10 Temperature Incubators....................................................................................40
3.10.1 Ambient Incubators ..............................................................................40
3.10.2 Elevated Temperature Incubators........................................................40
3.11 Front Doors .......................................................................................................41
Chapter 4 Operating the Agility System.......................................................................................43
4.1 Overview ...........................................................................................................43
4.2 Powering up the Instrument..............................................................................45
4.3 The Home Screen and the Instrument Self Test Procedure.............................46
4.4 Filter Setup........................................................................................................47
4.5 System Dashboard............................................................................................48
4.6 Preparing the System for Operation .................................................................49
4.6.1 Empty Waste Liquids and Used Tip Containers ..................................49
4.6.2 Start-of-Day Assays .............................................................................50
4.7 Loading Samples and Consumables ................................................................54
4.7.1 Loading Samples .................................................................................54

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4 Agility System Operator’s Manual
4.7.2 Load Consumables..............................................................................63
4.7.3 Load SmartKits.....................................................................................65
4.7.4 Load Reagent Tip Racks .....................................................................66
4.7.5 Load Microplates..................................................................................66
4.8 Performing an Assay.........................................................................................67
4.9 Viewing Data.....................................................................................................75
4.10 Aborting Plates/Stopping the System/Shutting the System Down....................78
4.10.1 Aborting Plates/Stopping the System ..................................................78
4.10.2 System Shutdown................................................................................80
Chapter 5 Maintenance and Troubleshooting..............................................................................83
5.1 Routine Maintenance Procedures ....................................................................83
5.2 Cleaning and Decontamination.........................................................................85
5.2.1 Cleaning the System............................................................................85
5.2.2 Decontaminating the System:.............................................................86
5.2.3 Components.........................................................................................86
5.3 Replacing the Lamp Assembly and Filters .......................................................88
5.3.1 Accessing the Lamp and Filters...........................................................88
5.3.2 Replacing the Lamp.............................................................................89
5.3.3 Replacing the Filter..............................................................................91
5.4 Replacing Tubing..............................................................................................92
5.4.1 Removal of the Fluidics Panel Assembly.............................................93
5.5 Replacing Tubing on the Fluidics Panel ...........................................................95
Chapter 6 The Graphical User Interface .......................................................................................97
6.1 Introduction .......................................................................................................97
6.2 The Administrator Screen .................................................................................97
6.3 The Home Screen.............................................................................................99
6.4 The Dashboard ...............................................................................................103
6.5 Worklist ...........................................................................................................106
6.6 The Timeline ...................................................................................................108
6.6.1 Overview of the Timeline ...................................................................108
6.6.2 Icons on the Timeline Screen ............................................................110
6.6.2.1 Samples Rack Status Screen.............................................111
6.6.2.2 SmartKit Screen..................................................................112
6.6.2.3 Plate Status Screen............................................................113
6.6.2.4 Consumables Status Screen ..............................................114
6.6.2.5 Incubator Screen.................................................................115
6.6.2.6 Wash Bottle Status Screen.................................................116
6.7 The Timeline Screen and Status Screens ......................................................117
6.7.1 The Timeline Screen..........................................................................117
6.9 Results............................................................................................................119
6.9.1 Result Lot Table.................................................................................122
6.9.2 OD Results Table...............................................................................123
6.9.3 Threshold Table.................................................................................124
6.9.4 Ratio Table.........................................................................................125
6.9.5 Curve Fit Table...................................................................................126
6.9.6 Curve Graph.......................................................................................127
6.9.7 Spreadsheet.......................................................................................128
6.10 Pause/Stop/Abort............................................................................................129
6.11 Utilities Screens ..............................................................................................131
Chapter 7 Error Handling .............................................................................................................143
7.1 Introduction .....................................................................................................143

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Agility System Operator’s Manual 5
Appendix A Specifications..............................................................................................................145
A.1System Specifications.....................................................................................145
A.2 Sample Pipetting Specifications......................................................................145
A.3 Reagent Pipetting Specifications ....................................................................145
A.4 Reader Specifications.....................................................................................146
A.5Washer Specifications.....................................................................................146
A.6 Incubator Specifications..................................................................................146
A.7 Regulatory Compliance...................................................................................147
A.8System Dimensions ........................................................................................147
A.9 Power Requirements.......................................................................................147
Appendix B Consumables and Spare Parts ..................................................................................149
Limited Warranty...............................................................................................................................151
Warranty and Special Provisions....................................................................151
Index 153
DYNEX Technologies Contact Information...................................................................155

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About this Manual
Agility System Operator’s Manual 7
About This Manual
This manual is designed to provide information about operating and maintaining the Agility
Automated ELISA Processing System and includes the following information:
Introduction (Chapter 1) -describes the system and discusses the overall method of
operation.
Safety (Chapter 2) -discusses the safety considerations involved in the operation of the
system.
System Design (Chapter 3) - discusses the various components of the system from an
operational point of view.
Analyzing Samples (Chapter 4) - discusses the steps involved in loading samples,
reagents, and consumables, generating a worklist and obtaining analytical results.
Maintenance and Troubleshooting (Chapter 5) - includes a list of activities that should
be performed on a periodic basic to ensure optimum operation and explains what to do
when there is a problem.
Details of the User Interaction Scheme (Chapter 6) - provides a detailed discussion of
the user interaction scheme for the Agility Automated ELISA Processing System.
System Specifications (Appendix A) - lists the formal specifications for the system
Disposables and Spare Parts (Appendix B) - a list of commonly used components to
support the system.

About this Manual
8 Agility System Operator’s Manual
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Chapter 1 Overview
Agility System Operator’s Manual 9
Chapter 1Overview
1.1 Introduction
The Agility Automated ELISA Processing System (Figure 1-1) is a flexible, high capacity
system to perform a broad range of automated ELISA assays. The operator simply inserts
packaged SmartKitsTM that contain all of the reagents, standards and related fluids as well as
assay information (Section 1.2) that are required for the assay into the ports on the front panel.
Similarly, the operator places samples (Section 1.3), microplates (Section 1.4) and disposables
such as pipette tips and mixing wells (Section 1.5) into compartments that are accessible from
the front of the system. A straightforward worklist (Section 1.6) on the built in touch screen
interface is used to indicate the desired operation of the system to analyze the samples. If
desired, multiple assays can be performed on a given sample.
Figure 1-1: The Agility Automated ELISA Processing System
In normal operation, all materials are inserted into the system and waste is removed via the
ports shown in Figure 1-1. The status of each port is indicated by a multi-colored LED (see
Section 4 for detailed information).
This chapter introduces the various components that are placed in the system for routine
operation. The internal design of the system includes a sample pipetting arm, a sample
loading module, a transport arm to move items around the system, a reagent pipetting arm,
two workspaces, a microplate heater, a microplate washer, cameras and an absorbance reader
that are all described in detail in Chapter 3. A detailed discussion of preparing the system for
operation and generating a worklist is presented in Chapter 4.

Chapter 1 Overview
10 Agility System Operator’s Manual
1.2 SmartKitTM
The heart of the Agility Automated ELISA Processing System is the SmartKit™, which is a
reagent pack that is designed to hold bottles that contain the fluids that are required to perform
the assay. A SmartKit™includes a two-dimensional barcode label that includes the details of
the assay, data reduction and reporting as well as lot information, usage volumes and pack
layout.
Typically, a complete SmartKit™is provided by a supplier of ELISA assay kits and is simply
placed into the Agility Automated ELISA Processing System. As an alternative, a generic
pack design can be used to hold standard fluid containers that the laboratory user fills from
the bottles of a manufacturers test kit. The pack is fitted into a reagent pack holder to be
loaded on the system through the reagent pack load position. A typical SmartKit™and
reagent pack holder is shown in Figure 1-2.
Figure 1-2: A SmartKit and Reagent Pack Holder
The SmartKitTM pack and pack holder are loaded on the system and the label is read with a
transport arm camera, the transport arm also grips and moves the SmartKitTM around the
system workspace locations with the transport arm where required.