Echo Lumena Operator Manual PDF

Operator Manual
English version
Copyrights and Disclaimers
Echo Lumena Operator Manual
©2016, Immucor, Inc. Echo Lumena™ is a trademark of Immucor, Inc. (hereinafter
“Immucor”).
The contents of this manual are protected by copyright. The Immucor name, logos,
related trademarks, and service marks are owned and used in commerce by
Immucor and are protected by U.S. and international trademark laws.
No part of this publication may be reproduced, transmitted, transcribed, stored in a
retrieval system, or translated into any human or computer language in any form by
any means without written permission from the copyright holder.
Unauthorized copying of this publication may not only infringe copyright but also
reduce the ability of Immucor to provide accurate and up-to-date information to
customers.
No warranties of any nature are extended by this document. You should be very
careful to ensure that the use of this information and/or hardware and software
material complies with the laws, rules, and regulations of the jurisdictions with
respect to which it is used.
All operating instructions must be followed. In no event shall Immucor be held
responsible for failures, errors, or other liabilities resulting from a customer’s
noncompliance with the procedures and precautions outlined in this manual.
The sample screen displays and sample printouts in this Echo Lumena Operator
Manual are for information and illustration purposes only. Immucor makes no
representations or warranties about the accuracy or reliability of the information
presented on the screen displays, and this information is not to be used for clinical
or maintenance evaluation.
Immucor reserves the right to make changes to the product to improve reliability,
function or design, or to discontinue any product at any time without notice or
obligation. The material contained in this manual is subject to change without
notice. Immucor will not be liable for any consequences resulting from the use of
this publication.
Any comments or suggestions regarding this publication should be forwarded to
Immucor, Inc., 3130 Gateway Drive, P.O. Box 5625, Norcross, GA 30091-5625.
Microsoft, Windows, and the Windows logo are registered trademarks or
trademarks of Microsoft Corporation in the United States and other countries. All
third-party trademarks, service marks, and trade names are the property of their
respective owners and are hereby acknowledged.
No responsibility is assumed by Immucor for the use or reliability of software or
equipment that is not supplied by Immucor or its affiliated dealers. All warnings and
cautions must be reviewed by the operator prior to using the Echo Lumena for the
first time.
Table of Contents
ABOUT THIS MANUAL .................................................................. About This Manual-1
Organization of Manual .............................................................. About This Manual-2
Format .................................................................................... About This Manual-2
Notational Conventions ........................................................... About This Manual-2
Limitations of Use and Warnings.............................................. About This Manual-2
Use of Symbols ....................................................................... About This Manual-2
Front Pages ............................................................................ About This Manual-3
Chapters ................................................................................. About This Manual-3
CHAPTER 1: INTRODUCTION TO THE ECHO LUMENA ...........................................1-1
Intended Use ........................................................................................................1-2
Principles of Operation ..........................................................................................1-2
Instrument Appearance .........................................................................................1-3
Basic System Concepts ........................................................................................1-4
Indicator LED Signals .........................................................................................1-4
Barcodes ...........................................................................................................1-5
Reagent .............................................................................................................1-7
Racks ................................................................................................................1-7
Continuous Access ............................................................................................1-8
Expected Results ..................................................................................................1-9
CHAPTER 2: SYSTEM SOFTWARE NAVIGATION .....................................................2-1
Navigation Options ...............................................................................................2-2
Keyboard and Mouse .........................................................................................2-2
Touch Screen.....................................................................................................2-2
Confirmation Dialog Boxes ....................................................................................2-3
Common Buttons .................................................................................................2-3
Logging In and Out ...............................................................................................2-3
Logging In ..........................................................................................................2-3
Logging Out .......................................................................................................2-4
Screen Layout ......................................................................................................2-6
Pull-down Menu .................................................................................................2-6
Toolbar ..............................................................................................................2-9
Results Bar and Results Panel ..........................................................................2-11
Progress Bar ....................................................................................................2-12
Instrument Map ................................................................................................2-13
Status Bar ........................................................................................................2-13
Instrument Map ..................................................................................................2-14
Event Log Entry ..................................................................................................2-20
Maintenance .......................................................................................................2-20
Print ...................................................................................................................2-20
Help ...................................................................................................................2-20
CHAPTER 3: INSTRUMENT TESTING OPERATION ..................................................3-1
Preparing for Sample Processing ..........................................................................3-2
Starting Up.........................................................................................................3-2
Filling the PBS Supply Container.........................................................................3-4
Emptying the Waste Container ...........................................................................3-4
Initialization ...........................................................................................................3-5
Initializing the Echo Lumena................................................................................3-5
Sample Requirements ...........................................................................................3-6
Processing Tests ..................................................................................................3-8
Loading the Samples..........................................................................................3-8
Echo Lumena Operator Manual EC2-001-100 i

Loading Reagents and Controls ....................................................................... 3-19
Loading Micro-well Strips ................................................................................. 3-25
Downloading Requests from LIS ...................................................................... 3-29
Using the Run Test Wizard ............................................................................... 3-31
Starting Processing .......................................................................................... 3-36
Emergency Stop ................................................................................................. 3-37
Turn On/Off Rack Scanners ................................................................................. 3-38
Continual Loading during Operation..................................................................... 3-39
Loading Additional Samples or Requesting Additional Assays ........................... 3-39
Reloading Micro-well Strips .............................................................................. 3-39
Replenishing Reagents and Controls ................................................................ 3-39
Replenishing System Liquid .............................................................................. 3-39
Removing System Liquid Waste ....................................................................... 3-40
CHAPTER 4: TEST RESULTS ................................................................................... 4-1
Results Panel and Results Bar ............................................................................... 4-2
Results Panel ..................................................................................................... 4-2
Results Bar ........................................................................................................ 4-2
Commonly Used Symbols ..................................................................................... 4-3
Viewing Test Results ............................................................................................. 4-4
Example of a Report........................................................................................... 4-4
Viewing Results .................................................................................................. 4-5
Approving Results .............................................................................................. 4-5
Exporting Results ............................................................................................... 4-6
Editing Results ................................................................................................... 4-7
Alternative Method to View, Edit, Approve, and Export Results ........................... 4-8
Configuration of Printed Result Reports ................................................................. 4-8
Viewing Test Well Scores and Sample Event Logs ................................................. 4-8
Viewing Test Well Scores ................................................................................... 4-9
Viewing Sample Based Test Event Logs ............................................................. 4-9
Finding Samples .................................................................................................. 4-10
To Find a Sample Using Sample Identification................................................... 4-10
To Find a Collection of Samples Using Common Reagents ............................... 4-11
To Find a Collection of Samples Using Common Strips..................................... 4-12
CHAPTER 5: MAINTAINING THE ECHO LUMENA .................................................... 5-1
Maintenance Tasks Interval Summary Table........................................................... 5-3
Accessing the Maintenance Window ..................................................................... 5-4
Daily Maintenance ................................................................................................. 5-7
Refilling the PBS Supply Container ..................................................................... 5-7
Emptying the Waste Container ......................................................................... 5-10
Initializing the Instrument .................................................................................. 5-13
Cleaning the Instrument ................................................................................... 5-16
Checking the Probe Alignment ......................................................................... 5-17
Checking the Probe Vertical Position ................................................................ 5-19
Performing the Washer Residual Volume Test (Visual) ....................................... 5-21
Performing Quality Control on the Echo Lumena ............................................... 5-22
Weekly Maintenance ........................................................................................... 5-25
Shutting Down the Instrument and Computer ................................................... 5-25
Archiving Results and Deleting from the Database ............................................ 5-26
Monthly Maintenance .......................................................................................... 5-29
Decontamination (Decontaminate/Flush/Purge/Prime)....................................... 5-29
Wiping Down the Probe Splash Guard ............................................................. 5-33
Performing the Washer Residual Volume Test (Measured) ................................. 5-34
Performing the Washer Dispense Accuracy Test ............................................... 5-36
As Needed Maintenance ..................................................................................... 5-38
ii EC2-001-100 Echo Lumena Operator Manual

Cleaning the Probe...........................................................................................5-38
Priming the Probe ............................................................................................5-39
Performing the Probe Accuracy Test ................................................................5-40
Calibrating the Probe ........................................................................................5-43
Performing the Fluidics Test .............................................................................5-44
Performing the Washer Basic Test ....................................................................5-46
Priming the Washer ..........................................................................................5-48
Unlocking the Strip Trays..................................................................................5-49
Retrieving the Strip Holders ..............................................................................5-50
Installing the Priming Strip Holder .....................................................................5-51
Cleaning of Barcode Scanner Mirrors ...............................................................5-53
Calibrating the Camera .....................................................................................5-54
Checking the Camera Alignment ......................................................................5-55
Calibrating the Centrifuge .................................................................................5-56
System Shutdown ............................................................................................5-58
Field Service Preventative Maintenance ...............................................................5-60
CHAPTER 6: ECHO LUMENA REPORTS ..................................................................6-1
Accessing the Categories of Reports ....................................................................6-2
Categories of Reports ...........................................................................................6-3
Camera ..............................................................................................................6-3
Event Log...........................................................................................................6-6
Instrument Status ...............................................................................................6-8
Maintenance History .........................................................................................6-10
QC Information .................................................................................................6-12
Reagent Usage ................................................................................................6-13
Statistics ..........................................................................................................6-14
System ............................................................................................................6-19
Test History ......................................................................................................6-20
Users ...............................................................................................................6-22
HIS/LIS Transmission Log ................................................................................6-23
Printing Reports ..................................................................................................6-24
CHAPTER 7: TROUBLESHOOTING ..........................................................................7-1
Technical Support.................................................................................................7-2
Help .....................................................................................................................7-2
Error Codes and Recovery ....................................................................................7-5
Error Codes .......................................................................................................7-5
Recovery............................................................................................................7-6
Audible Alarms......................................................................................................7-7
Situations and Error Conditions that Generate an Audible Alarm .........................7-7
Motor Controller Functional Processing Error Codes .............................................7-8
Board and Axis Identifiers ...................................................................................7-8
Troubleshooting Common Errors ..........................................................................7-9
Software Errors ..................................................................................................7-9
Clot Detection Recovery Process .....................................................................7-11
Recovery from Initialization Failure ....................................................................7-12
Prime Strip Holder/Washer Errors .....................................................................7-18
Transport System Errors...................................................................................7-20
Pipetting System Errors ....................................................................................7-22
Fluidics Errors ..................................................................................................7-26
Camera Errors ..................................................................................................7-31
Centrifuge Errors ..............................................................................................7-34
Scanner Errors .................................................................................................7-35
Archive Errors...................................................................................................7-40
QC Failure ........................................................................................................7-42
Echo Lumena Operator Manual EC2-001-100 iii

Interpreting Echo Lumena Images ....................................................................... 7-45
Atypical Echo Lumena Images ............................................................................. 7-46
Atypical Hemagglutination Images ....................................................................... 7-49
CHAPTER 8: CUSTOMER COMPONENT REPLACEMENT ....................................... 8-1
Component Maintenance Table ............................................................................. 8-3
Removing and Replacing the Probe ....................................................................... 8-4
Purpose ............................................................................................................. 8-4
Required Interval ................................................................................................ 8-4
Tools.................................................................................................................. 8-4
Instructions to Remove the Probe....................................................................... 8-4
Instructions to Replace the Probe ....................................................................... 8-7
Removing and Replacing the Wash Manifold ......................................................... 8-9
Purpose ............................................................................................................. 8-9
Required Interval ................................................................................................ 8-9
Tools.................................................................................................................. 8-9
Instructions ...................................................................................................... 8-10
Removing and Replacing Syringes ....................................................................... 8-12
Purpose ........................................................................................................... 8-12
Required Interval .............................................................................................. 8-12
Tools................................................................................................................ 8-12
Instructions ...................................................................................................... 8-12
Removing and Replacing the Peri-Pump .............................................................. 8-14
Purpose ........................................................................................................... 8-14
Tools................................................................................................................ 8-14
Instructions ...................................................................................................... 8-14
Removing and Replacing the Centrifuge .............................................................. 8-16
Purpose ........................................................................................................... 8-16
Tools................................................................................................................ 8-16
Instructions ...................................................................................................... 8-16
Replacing the Echo Lumena Incubator Assembly................................................. 8-18
Purpose ........................................................................................................... 8-18
Tools................................................................................................................ 8-18
Instructions ...................................................................................................... 8-18
Replacing the Echo Lumena Skin Micro-Switch ................................................... 8-20
Purpose ........................................................................................................... 8-20
Tools................................................................................................................ 8-20
Instructions for Removal ................................................................................... 8-20
Instructions for Replacement ............................................................................ 8-21
Replacing the Echo Lumena Washer Syringe Cap and Seal ................................. 8-22
Purpose ........................................................................................................... 8-22
Tools................................................................................................................ 8-22
Instructions for Removal ................................................................................... 8-23
Instructions for Installation and Replacement .................................................... 8-24
Replacing the Top and Bottom Lamp in the Camera ............................................ 8-25
Purpose ........................................................................................................... 8-25
Tools................................................................................................................ 8-25
Instructions for Top Lamp Assembly Removal .................................................. 8-25
Instructions for Top Lamp Assembly Replacement ........................................... 8-27
iv EC2-001-100 Echo Lumena Operator Manual

Instructions for Bottom Lamp Assembly Removal .............................................8-28
Instructions for Bottom Lamp Assembly Replacement ......................................8-30
Cleaning, Removing, and Installing the Rinse Station ...........................................8-31
Purpose ...........................................................................................................8-31
Required Interval ..............................................................................................8-31
Tools ................................................................................................................8-31
Instructions for Cleaning ...................................................................................8-32
Instructions for Removal ...................................................................................8-33
Instructions for Installation ................................................................................8-35
Removing and Replacing the Probe Rinse and Waste Pumps .............................8-36
Purpose ...........................................................................................................8-36
Required Interval ..............................................................................................8-36
Tools ................................................................................................................8-36
Instructions to Remove the Probe Rinse and Waste Pumps ..............................8-37
Instructions to Replace the Probe Rinse and Waste Pumps ..............................8-37
CHAPTER 9: SOFTWARE AND HARDWARE COMPONENTS ...................................9-1
General Data ........................................................................................................9-2
Power Requirements ..........................................................................................9-2
Dimensions ........................................................................................................9-2
Weight ...............................................................................................................9-3
Connections.......................................................................................................9-3
Personal Computer (PC) .......................................................................................9-3
Description .........................................................................................................9-3
Safety Features of the PC ...................................................................................9-4
Software ............................................................................................................9-4
Main Instrument ....................................................................................................9-4
Sample and Reagent Loading Bays ......................................................................9-4
Description .........................................................................................................9-4
Safety Features of the Sample and Reagent Loading Bays .................................9-5
Sample Loading Bay ..........................................................................................9-5
Reagent Loading Bay .........................................................................................9-5
Sample/Reagent Barcode Scanner.....................................................................9-6
Strip Loading Bay .................................................................................................9-6
Description .........................................................................................................9-6
Safety Features of the Strip Loading Bay ............................................................9-7
Incubators ............................................................................................................9-7
Description of the Elevated Temperature Incubator .............................................9-7
Safety Features of the Elevated Temperature Incubator ......................................9-8
Description of the Ambient Incubator ..................................................................9-8
Safety Features of the Ambient Incubator ...........................................................9-8
Fluidics Module .....................................................................................................9-9
Description .......................................................................................................9-10
Safety Features of the Fluidics Module ..............................................................9-10
Pipetting System.................................................................................................9-11
Description .......................................................................................................9-12
Safety Features of the Pipetting System ............................................................9-12
Transport System ...............................................................................................9-13
Description .......................................................................................................9-14
Safety Features of the Transport System ..........................................................9-14
Washer ...............................................................................................................9-14
Description .......................................................................................................9-14
Safety Features of the Washer ..........................................................................9-15
Centrifuge ...........................................................................................................9-15
Description .......................................................................................................9-15
Echo Lumena Operator Manual EC2-001-100 v

Safety Features of the Centrifuge ...................................................................... 9-15
Camera Reader ................................................................................................... 9-16
Description....................................................................................................... 9-16
Safety Features of the Camera Reader ............................................................. 9-16
CHAPTER 10: CONFIGURATION ........................................................................... 10-1
Barcode Options ................................................................................................. 10-2
General Tab ..................................................................................................... 10-2
Samples Tab .................................................................................................... 10-3
Donors Tab ...................................................................................................... 10-4
General Options .................................................................................................. 10-6
General Tab ..................................................................................................... 10-6
Date/Time Tab ................................................................................................. 10-6
HIS/LIS Tab ..................................................................................................... 10-7
Language Tab ................................................................................................ 10-13
Reports Tab ................................................................................................... 10-14
Results Tab .................................................................................................... 10-18
System Tab.................................................................................................... 10-21
Security Tab ................................................................................................... 10-23
Service Tab .................................................................................................... 10-26
Test Options ..................................................................................................... 10-27
General Tab ................................................................................................... 10-28
Reflex Tests Tab ............................................................................................ 10-28
Menu Tab ...................................................................................................... 10-29
Profiles Tab .................................................................................................... 10-30
QC Tab .......................................................................................................... 10-32
CHAPTER 11: SECURITY ....................................................................................... 11-1
Assigning Passwords and User Access Rights ..................................................... 11-2
Defining Users with Associated Access Rights .................................................. 11-2
CHAPTER 12: LIMITATIONS OF USE AND WARNINGS .......................................... 12-1
Limitations of Use ................................................................................................ 12-2
Chapter 1 – Introduction................................................................................... 12-2
Chapter 3 – Instrument Testing Operation ........................................................ 12-2
Chapter 5 – Maintaining the Echo Lumena ....................................................... 12-4
Chapter 7 – Troubleshooting ............................................................................ 12-4
Chapter 9 – Hardware Components ................................................................. 12-5
Chapter 10 – Configuration .............................................................................. 12-5
Chapter 11 – Security ...................................................................................... 12-5
Appendix A – Echo Lumena Installation ............................................................ 12-6
Warnings ............................................................................................................. 12-7
About This Manual ........................................................................................... 12-7
Chapter 3 – Instrument Testing Operation ........................................................ 12-7
Chapter 5 – Maintaining the Echo Lumena ..................................................... 12-10
Chapter 8 – Customer Component Replacement ........................................... 12-10
Chapter 9 – Hardware Components ............................................................... 12-11
Chapter 10 – Configuration ............................................................................ 12-12
Chapter 11 – Security .................................................................................... 12-12
Appendix A – Echo Lumena Installation .......................................................... 12-12
APPENDIX A: ECHO LUMENA INSTALLATION ........................................................ A-1
Verifying That All Parts Are Present ....................................................................... A-2
Environmental Conditions and General Safety Features ......................................... A-3
USA FCC CLASS A ........................................................................................... A-6
Canadian Department of Communications Class A ............................................ A-6
User Safety .......................................................................................................... A-6
North America ...................................................................................................... A-6
vi EC2-001-100 Echo Lumena Operator Manual

International ...................................................................................................... A-6
EC Directive 73/23/EEC Low Voltage (Safety) .................................................... A-7
EMC EC Directive 89/336/EEC Electromagnetic Compatibility ........................... A-7
Making the Connections ...................................................................................... A-8
Instrument Connections .................................................................................... A-8
PC Connections ................................................................................................ A-8
Installing the Software .......................................................................................... A-9
Setting up the System.......................................................................................... A-9
General Options Configuration Default Settings .................................................... A-9
Date/Time Tab .................................................................................................. A-9
HIS/LIS Tab .................................................................................................... A-10
Reports Tab .................................................................................................... A-10
Results Tab ..................................................................................................... A-10
System Tab ..................................................................................................... A-10
Service Tab ..................................................................................................... A-11
Completing the Post-installation Check .............................................................. A-11
Validating the Installation .................................................................................... A-11
Repackaging Before Shipment ........................................................................... A-11
APPENDIX B: MAINTENANCE RECORDS ............................................................... B-1
Echo Lumena Maintenance Record ..................................................................... B-2
Washer Residual Volume Test and Washer Dispense Accuracy Test Maintenance
Record ................................................................................................................ B-3
Probe Accuracy Test Maintenance Record ........................................................... B-4
QUICK START GUIDE ........................................................................................ QSG-1
GLOSSARY .................................................................................................. Glossary-1
INDEX ............................................................................................................... Index-1
REGIONAL ATTACHMENT .................................................................................. ATT-1
Echo Lumena Operator Manual EC2-001-100 vii

About This Manual
About This Manual

In This Chapter:
ABOUT THIS MANUAL ............................................................... About This Manual-1
Organization of Manual ........................................................... About This Manual-2
Format ................................................................................. About This Manual-2
Notational Conventions ........................................................ About This Manual-2
Limitations of Use and Warnings........................................... About This Manual-2
Use of Symbols .................................................................... About This Manual-2
Front Pages ......................................................................... About This Manual-3
Chapters .............................................................................. About This Manual-3
Echo Lumena Operator Manual EC2-001-100 About This Manual-1

About This Manual Organization of Manual
Note: The Echo Lumena Operator Manual is designed to guide the Echo Lumena operator through
all procedures required to use and maintain the Echo Lumena, including operating procedures,
maintenance, and troubleshooting.
Warning: Failure to follow the instructions within this manual or to comply with the warnings and
limitations of use may result in inaccurate or invalid results, delay of treatment for the patient,
exposure to biohazardous materials, or injury.
Organization of Manual
Format
This manual is divided into chapters that describe specific aspects of the Echo Lumena structure or functionality.
Notational Conventions
This manual uses a page numbering system that includes a prefix of the chapter number hyphenated with the page
number. Sequential lists within the text that describe step-by-step procedures are included as numbered lists.
The footer of each page contains the current manual version identified using a nine character hyphenated format.
The first three characters (EC2) identify the instrument. The second set of three characters identifies this document
as the operator manual (001). The final set of three characters identifies the version of the operator manual. The
number 100 designates version 1, 200 designates a full version 2 update, and so on.
If changes are made to individual chapters in between full manual version updates, then chapter version numbers
are incremented by single digits. For example, 101 is the first update of a chapter falling between a full manual
update from version 1 to version 2.
Limitations of Use and Warnings

Limitations of use and warnings are located throughout this manual, specifically in the body of the text where they
are most relevant to the information. An icon draws your attention to limitations of use and warnings. Chapter 12 –
Limitations of Use and Warnings contains a complete list of all of the limitations of use and warnings in this manual.
Use of Symbols
Some of the following safety symbols may be displayed on the instrument or may appear in the manual to alert you
of warnings or limitations of use. The following symbols are examples:
Symbol Meaning
Laser beam safety warning: These comments alert you to laser beam-related safety
issues.
Alternating current: Related to power supply.
Direct current: Related to power supply.
Protective conductor terminal: Related to power supply.
On (supply): Related to power supply.
About This Manual-2 EC2-001-100 Echo Lumena Operator Manual

Organization of Manual About This Manual
Symbol Meaning
Off (supply): Related to power supply.
Warning or limitation: These comments alert you to potentially damaging or dangerous

outcomes if certain critical procedural steps are ignored or incorrectly executed.
Warning, risk of electric shock: This symbol represents a potential hazard related to the
power supply.
Warning, risk of crushing or pinching: This symbol represents a potential hazard resulting
in possible injury.
Avoid exposure to direct sunlight
Ambient Temperature should be within 18°C and 30°C
Relative humidity range is 10% to 80%
Consult instructions for use
Biohazard
Manufacturer
Separate collection for electrical and electronic equipment: Disposal information.
Authorized Representative in the European Community
Front Pages
The front pages of this manual include the Copyrights and Disclaimers page and the Table of Contents.
Chapters
The Table of Contents sequentially lists all chapter contents. The first page of each chapter lists the contents of that
chapter.
Echo Lumena Operator Manual EC2-001-100 About This Manual-3

About This Manual Organization of Manual
About This Manual-4 EC2-001-100 Echo Lumena Operator Manual

Chapter 1: Introduction to the Echo Lumena
Chapter 1: Introduction to the Echo Lumena

In This Chapter:
CHAPTER 1: INTRODUCTION TO THE ECHO LUMENA ........................................ 1-1
Intended Use ..................................................................................................... 1-2
Principles of Operation ....................................................................................... 1-2
Instrument Appearance ...................................................................................... 1-3
Basic System Concepts ..................................................................................... 1-4
Indicator LED Signals ...................................................................................... 1-4
Barcodes ........................................................................................................ 1-5
Reagent .......................................................................................................... 1-7
Racks ............................................................................................................. 1-7
Continuous Access ......................................................................................... 1-8
Expected Results ............................................................................................... 1-8
Echo Lumena Operator Manual EC2-001-100 1-1

Chapter 1: Introduction to the Echo Lumena Intended Use
Intended Use
The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro
diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data
management functions. The Echo Lumena is designed to automate standard immunohematology assays using a
micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell
antibodies, compatibility testing, and red blood cell phenotyping.
The Echo Lumena is intended for use only with the reagents described in Regional Attachments.
Principles of Operation
The Echo Lumena is designed to automate standard immunohematology assays and to operate as a walk-away
system, meaning you can leave the Echo Lumena to operate independently for periods of time. Several unified
principles have been integrated into the Echo Lumena system to support and simplify the system’s overall
operation.
The Echo Lumena is a closed system and can only be used with specified Immucor products. The Echo Lumena is
a robotic instrument programmed to move micro-well strips, liquid reagent fluids, and blood sample fluids to
different processing areas for a given assay in the correct sequence, such as the incubator, the micro-well washing
station, the centrifuge, and the reader.
The Echo Lumena micro-well reader uses a CCD camera to capture an image of the micro-well. The Echo Lumena
software calculates a reaction value for each well based on a multi-feature image analysis. The Echo Lumena then
assigns a result and interpretation to the well based on predefined criteria associated with the calculated reaction
value. Some assay protocols require multiple test wells for a given blood sample interpretation, such as ABO and
Rh (D) typing.
The Echo Lumena uses software to drive its mechanics and data processing. The operator uses hardware in
combination with the software to operate and maintain the Echo Lumena.
1-2 EC2-001-100 Echo Lumena Operator Manual

Instrument Appearance Chapter 1: Introduction to the Echo Lumena
Instrument Appearance
The following photograph shows the Echo Lumena as it is viewed from the front. The computer monitor and
keyboard are supported by the fluidics module. The operational components of the main instrument are protected
by an instrument cover. The instrument cover slides into place at the front of the main instrument, and two screws
at the bottom of the cover secure it.
Note: The Echo Lumena software does not allow operation of the instrument without the instrument
cover in place.
Echo Lumena

Chapter 1: Introduction to the Echo Lumena Basic System Concepts
Basic System Concepts

This section describes the basic system concepts of the Echo Lumena. This section includes the following
subsections:
X Indicator LED signals
X Barcodes
X Reagent
X Racks
X Continuous access
Indicator LED Signals

There are several safeguards incorporated into the system in order to improve process control when loading or
unloading the Echo Lumena. To indicate when it is safe to use a component, the Echo Lumena uses light-emitting
diodes (LEDs) to indicate the status of specific components.
For example, the sample and reagent loading bays on the main instrument use LEDs to indicate the status of rack
loading lanes. The strip tray loading bays also use LEDs to indicate the status of strip loading trays.
This table describes the LED signals.
Color State Meaning
Continuous You can safely add or remove racks or trays.

(no light)
Solid You must not add or remove the rack or tray. The rack or
tray is in use.
Flashing Error occurred or action required.

Note: For example, initialization requires
action as indicated by the flashing LEDs in
the strip loading bay.
By following the indicator LED signals, you can continually load and unload samples, strips, and reagents onto the
Echo Lumena during operation. Continual loading results in improved sample throughput efficiency.

Basic System Concepts Chapter 1: Introduction to the Echo Lumena
Barcodes
The Echo Lumena uses barcodes to identify reagents and samples in the loading modules. Using barcode
technology increases the number of steps that can be automated, thus decreasing handling errors. Concatenated
barcodes are not supported.
The Echo Lumena supports the use of the following barcode symbologies:
• Codabar
• Code 128 (including the ISBT 128 standard)
• Code 39
• Interleaved 2 of 5 (fixed at 12 characters)
• Two-dimensional barcode on micro-well strips only
Note: To increase data security, Immucor recommends that you use a check digit in conjunction
with sample barcodes
Limitation: Barcodes should be between three and 18 characters in length.
Limitation: Barcodes must have a module size larger than 0.2 mm and a bar width ratio between
2.25:1to 3:1.
Decodability grade (grading system of A to F; A being best, F being failing) of C or better is required for consistent
reading of barcodes on the instrument. This grade measures the bar width consistency throughout the barcode
label. It is usually an indication of print quality of the barcode label.
The minimum number of barcode characters is three.
The length of the barcode is variable but must be completely visible with a quiet zone (white space on each end of
the label) of 2.5 mm when placed on the sample or donor rack.
Depending on barcode symbology, the barcode height, including quiet zones, must be between 10.25 and 16.5
mm.
For correct reading of sample barcodes in the loading bay, the sample barcodes must be positioned between 0.5
and 3.9 inches (12.7 and 99.1 mm) from the bottom of the tube.
If barcodes have parameters outside of these specifications, then barcode misreads can occur on the instrument.
The following characters are not permitted as part of sample barcode identification:
• ,;$%^&*()+\:‘“<.>/?|
• Leading or trailing spaces
Reagent Barcodes
Reagent barcodes are used to identify reagents.
The following information is encoded in the reagent barcode:
• Reagent ID – The type of reagent
• Expiration date – The last date that the reagent may be used
• Lot number – Batch identifier
• Serial number – Unique identifier for each vial

Chapter 1: Introduction to the Echo Lumena Basic System Concepts
Sample Barcodes
Sample barcodes are located on sample tubes, and they encode the sample ID. The sample ID can be mapped to
information downloaded from the host Laboratory Information System (LIS).
Micro-well Strip Barcodes

Two-dimensional barcodes are located on the micro-well strips only (as shown in the following photographs).
Barcode identification includes:

• Product ID – A three-digit ID that corresponds to the product code
• Expiration date – The last date that the strip may be used
• Lot number – Batch identifier
• Serial number – Unique identifier for each strip
The opposite tab on the strip includes the product code and the lot number in an eye-readable format. The
instrument reads each strip after being loaded and verifies that the strip has not been previously used. The
instrument monitors on-board strip storage time.
Two-dimensional barcode located on the bottom of micro-well strip tab

Basic System Concepts Chapter 1: Introduction to the Echo Lumena
Reagent
The Echo Lumena accesses all reagents such as antisera, reagent red blood cells, specimen diluent, and LISS
using vials with lot-numbered barcodes. The operator loads these vials into reagent racks, which are slotted into the
Echo Lumena. For more information, refer to the Racks section.
The barcodes identify each vial individually so that the system can electronically monitor the fill level when the
reagents are removed from the Echo Lumena and then reused later. When using barcoded reagents, the system
automatically registers the position of the reagent so the reagent can be placed in any accessible position.
Note: For more information about loading test reagents, refer to Chapter 3 – Instrument Testing
Operation.
Racks
The Echo Lumena uses racks for loading and unloading samples and reagents.
There are two sizes of Echo Lumena racks:

• Racks for reagent vial loading (four vials per rack)
• Racks for sample tube loading (five samples per rack)
There are four reagent and four sample rack positions. You must place reagent vials and sample tubes into an
appropriate rack and then slide the rack onto the appropriate Echo Lumena location. You can continuously load or
unload racks from the Echo Lumena during operation according to the consistent color code.
Echo Lumena racks are equipped with a guide rail underneath to position them correctly in the loading modules, a
handle at the front to facilitate handling, and a pin at the back that triggers a sensor to inform the system that the
rack is loaded into position.
Note: Sample racks include racks dedicated to patient, donor, and pediatric categories of blood
sample tubes. These racks can be readily identified by the icons on the finger tabs of the racks
themselves. For example, the pediatric rack has an icon illustrating a baby (as shown in the following
photographs).
Collection of rack icons

Chapter 1: Introduction to the Echo Lumena Expected Results
Selection of racks
Continuous Access
The Echo Lumena is designed so that resources can be replenished and new assays can be started without
interrupting the processing of in-progress or scheduled assays.
New samples, reagents, buffer, and micro-well strips can be added during test processing. You can also remove
completed samples, used reagent containers, micro-well strips, and liquid waste during test processing.
The Echo Lumena has STAT capability for processing of urgent samples. STAT samples will begin processing
ahead of routine samples that have been scheduled but have not started processing. Any sample other than WB
corQC can be scheduled as a STAT sample.
Instructions for replenishing resources and scheduling STAT samples during Echo Lumena operation are included
in Chapter 3 – Instrument Testing Operation.
Expected Results
The specific performance characteristics are described in the package inserts of each reagent or test well. The
expected results are specific to the reagent or test wells in use.

Chapter 2: System Software Navigation

In This Chapter:
CHAPTER 2: SYSTEM SOFTWARE NAVIGATION .................................................. 2-1
Navigation Options ............................................................................................ 2-2
Keyboard and Mouse ...................................................................................... 2-2
Touch Screen.................................................................................................. 2-2
Confirmation Dialog Boxes ................................................................................. 2-3
Common Buttons .............................................................................................. 2-3
Logging In and Out ............................................................................................ 2-3
Logging In ....................................................................................................... 2-3
Logging Out .................................................................................................... 2-4
Screen Layout ................................................................................................... 2-6
Pull-down Menu .............................................................................................. 2-6
Toolbar ........................................................................................................... 2-9
Results Bar and Results Panel ....................................................................... 2-11
Progress Bar ................................................................................................. 2-12
Instrument Map ............................................................................................. 2-13
Status Bar ..................................................................................................... 2-13
Instrument Map ............................................................................................... 2-14
Event Log Entry ............................................................................................... 2-20
Maintenance .................................................................................................... 2-20
Print ................................................................................................................ 2-20
Help ................................................................................................................ 2-20

Chapter 2: System Software Navigation Navigation Options
Navigation Options
Software navigation can be performed using the keyboard, mouse, or touch screen.
Keyboard and Mouse

Use of the keyboard and mouse is based on basic Windows® functionality.
The Echo Lumena PC uses a standard keyboard and mouse. You can use the keyboard to type alphanumeric
characters into a field and to navigate through the software.
To navigate through the software using the keyboard, press the Tab key on the keyboard to move from one field in
the dialog to the next. Press Enter to execute the action of the currently selected element.
Hot keys can also be used to start certain functions from the keyboard. These keys are accessed by pressing the
Ctrl key plus an action key, such as I, or the Alt key plus an action key. Function keys, such as F8, can also be
used. Instructions for the use of hot keys are provided on the screen for specific tasks.
Buttons are displayed on the screen as either the suggested default selection (button displayed with a prominent
bolded border) or alternate offered selections.
Selection Example of
Description Button
Display
Default Option
Selection
Alternate Option
Selection
You can use the mouse to position the pointer over a selection within a window. Click the mouse button to select
that option.
Touch Screen
The touch screen enables you to interact directly with the software. Most selections that you can access using the
keyboard and mouse can also be accessed using the touch screen.
To use the touch screen, simply touch the item or button on the screen that you want to use, such as the Log in
button.
If selected items or fields require alphanumeric input, use of the keyboard is required.

Confirmation Dialog Boxes Chapter 2: System Software Navigation
Confirmation Dialog Boxes

Confirmation dialog boxes are standard safety features in the operating software. The system displays these dialog
boxes after you request certain actions.
For all confirmation dialog boxes, you must either click the Yes button to continue the action or click the No button
to discontinue the action. For example, when shutting down the Echo Lumena computer, a confirmation dialog box
is displayed prior to the actual shutdown asking if this is the action you wish to take.
Example of confirmation dialog box: computer shutdown
Common Buttons
The following buttons are standard command buttons used throughout the software. They always have the same
function.
Button Description
Click OK to close the dialog box and to save any

changes made.
Click Cancel to close the dialog box without saving

any changes.
Click Close to close the dialog box.
Logging In and Out

To access the instrument software, you must log in. Only one operator can be logged in at a time. You can exit the
software by logging out.
Logging In
After starting the system, you must log in using the Log in window. You can access the Log in window by clicking
the Log in button on the toolbar. This section describes how to log on to the Echo Lumena.
Note:The Echo Lumena software is password protected to prevent unauthorized access to the
computer operating system. This further prevents configuration changes by unauthorized personnel.
To log in:
1. Click the Log in button from the toolbar.

Chapter 2: System Software Navigation Logging In and Out
Log in button
Toolbar
Note: If logging in is part of a start-up from powering up the computer, then the Log in
dialog box automatically displays.
2. Enter your valid User name and Password into the Log in window in order to use the Echo Lumena. Only
one operator can be logged in at a time. Click OK to access the Echo Lumena software or Shut down to
turn off the PC.
Log in window
To access the Echo Lumena software, you must enter a valid user name and password. For more information
about user names and passwords, refer to Chapter 11 – Security.
Note: Your password is case sensitive, but your user name is not. You must take care to accurately
input your password to account for capital letters, lowercase letters, numbers, and special
characters.
Logging Out
Note: To prevent unauthorized use of the instrument by another operator under your user name,
you are advised to click the Log in button from the toolbar when you leave the vicinity of the Echo
Lumena. After confirming your wish to log off by clicking Yes in the confirmation box, the monitor
displays the Log in window and requires a user name and password entry to be able to access the
Echo Lumena. This security action should be taken to protect your user name from abuse. Assays
will continue to run if they are in progress when you log out, even if no operator is currently logged
in.
To log out:
1. By clicking the Log in button from the toolbar during Echo Lumena activity, a confirmation dialog box is
then displayed asking the question: Are you sure you want to log off? (if the Instrument Map is closed).
Additional text appears in this dialog if the Instrument Map is open.

Logging In and Out Chapter 2: System Software Navigation
Log off confirmation dialog box with Instrument Map closed
Click Yes to log off. Click No to cancel the log-off process. After you click the Yes button to log off, the Log
in window is displayed and ready for the next operator to log in.
Additional text appears in this dialog box if the instrument map or documents are open on the screen. This
additional text alerts you to the closing of any open documents if you log off. The dialog box reads: Are you
sure you want to log off? Any open documents will be closed when you log off.
Log off confirmation dialogbox with Instrument Map open

Chapter 2: System Software Navigation Screen Layout
Screen Layout
The Echo Lumena graphical user interface reflects the structure of the Echo Lumena. This feature makes it easy to
navigate through the software and provides important information when relevant.
Echo Lumena screen layout
The screen is divided into six areas:

• Pull-down menu
• Toolbar
• Results panel and Results bar
• Progress bar
• Instrument map – a Multiple Document Interface (MDI) window
• Status bar
Pull-down Menu
The pull-down menu at the top of the screen provides access to functional parts of the software. Most of these
software functions are also accessible through the toolbar.
Pull-down menu
The following table lists the software features accessed from the pull-down menu.

Screen Layout Chapter 2: System Software Navigation
Pull-down Menu Item Submenu of Pull-down Secondary Submenu

Item Item
File Print
Initialize
Log in
Run Test
Stop
File management
Shut down
Restart
Edit Find Find sample
Find reagent
Find strip
Reagents
Samples
Strips
Sample names
View Toolbar
Results bar
Status bar
Instrument
Notes
Camera
Instrument log
Scheduler log
Worklist

Item Item
Reports Camera
Event log
Instrument status
Maintenance


Item Item
QC information
Reagent usage
Statistics Statistics
Result summary
Reagent performance
Strip performance
System
Test history Summary
Details
Users
Tools Initialize
Log in
Event log entry
File management
Maintenance
Security
Reset password
Barcode options
General options
Test options
Window Close
Close all
Cascade
Tile horizontal
Tile vertical
Arrange icons
Help Help
About

File
The Print, Initialize, Log in, Run Test, Stop, and File management functions can also be accessed through the
toolbar, and they are discussed later in this chapter.
Shut down and Restart are used to shut down and restart the Echo Lumena, respectively.
When Shut down is selected, a confirmation dialog is displayed asking: Are you sure you wish to shut down the
computer? You must click Yes to proceed or No to cancel.
When Restart is selected, a confirmation dialog is displayed asking: Are you sure you wish to restart the computer?
You must click Yes to proceed or No to cancel.
View
The on-screen display can be customized by activating or deactivating each screen component. For example, if not
already visible, the Instrument Map can be made visible by accessing the View submenu from the pull-down menu
and activating the Instrument submenu item.
Reports
Refer to Chapter 6 –Echo Lumena Reports in this manual for information about Echo Lumena reports.
Tools
Refer to Chapter 11 – Security for information about security and resetting passwords and Chapter 5 – Maintaining
the Echo Lumena for information about maintenance. Configuration options are described in Chapter 10 –
Configuration.
Window
The Window submenu list from the pull-down menu gives the option to close all open windows using the Close all
submenu item. Four options for the screen display of multiple open windows are also available in the submenu.
The first option is Cascade, where multiple on-screen windows overlap each other. The second option is Tile
horizontal, where multiple on-screen windows extend horizontally above and below each other (without
overlapping). The third option is Tile vertical, where multiple on-screen windows extend vertically side by side
(without overlapping). The fourth option is Arrange icons, where multiple on-screen windows (in the minimized
position) are arranged in a linear fashion starting at the bottom left of the screen.
Help
Refer to Chapter 7 –Troubleshooting for more information about the Help submenu item.
About is a submenu item of the Help drop-down list. The About Immucor Echo Lumena window is displayed if you
click the About submenu item. This window displays the software version number, the instrument software version
number, the instrument name, the Instrument ID, and more.
Toolbar
The toolbar, just below the pull-down menu, provides buttons with graphics to depict the function that clicking the
button invokes. If any buttons appear dimmed, then the function is not currently available until other processes
(current processes that would conflict with the dimmed process) become inactive.
Toolbar

The following table describes the toolbar buttons and their functions.
Button Description
Log in – Controls access to the operating software
Initialize – Initializes the instrument
Worklist – Displays the list of samples and assays that are pending from
the reflex testing and LIS download
Run Test Wizard – Manages the process of running assays
Emergency stop – Allows operator to stop or abort instrument processing.
Turn on/off rack scanners – Activates/deactivates barcode scanners for

reagent and samples bays
Find a sample – Allows operator to search for a sample in database files
Print – Prints selected reports
File management – Archives results to other media source
Help – Provides access to an electronic copy of the Echo Lumena

Operator Manual and access to blud_direct
Note: Most of these features are also available through the pull-down menu.

Results Bar and Results Panel

The Results panel, below the toolbar on the left side of the screen, displays results arranged by date in descending
order, so that the most recent dates appear first. To view test results, use the Results panel and the Results bar.
Results Bar
The Results bar is located above the Results panel, and it has four software access buttons.
Results bar above the Results panel with four software access buttons
The following table describes the actions of the four software access buttons.
Button Description
Display Results – Used to select a batch or sample ID from the menu.

Clicking the button displays results.
Edit Results – Used to view and edit reactions on equivocal results.
Approve Results – Used to approve results for export.
Export Results – Used to export results to LIS.
Results Panel
The Results panel is located below the Results bar.
Results panel and Results bar

Sample IDs appear on the Results panel immediately when they are scheduled, and the results are displayed with
the sample ID as soon as they are available.
Results can be printed by viewing them first and then clicking the Print button.
Progress Bar
A Progress bar is displayed at the bottom of the Results panel for each sample when it is ready for processing.
STAT sample Progress bars are highlighted in red, and QC Progress bars are highlighted in yellow on the screen.
Progress bar: sample processing not started
When each sample begins processing, a black bar expands from left to right within the Progress bar for the
sample, gradually filling the initial bar and indicating how far the processing has progressed. A digital clock is
displayed in minutes and seconds on the right side of the Progress bar for samples currently being processed. This
clock counts down to the estimated completion of sample processing. The expanding black bar and clock only
appear for a sample when that sample processing is started.
Progress bar: Sample processing started

Instrument Map
The Instrument Map, to the right of the Results panel, is the user interface that reflects the structure of the Echo
Lumena. The Instrument Map is an MDI window. For complete information about the Instrument Map, refer to the
Instrument Map section later in this chapter.
Instrument Map
Status Bar
A Status bar is located on the bottom of the screen, and the display includes:
• Initialization status
• Log in status detailing which operator is currently logged in
• Date and time
Status bar

Chapter 2: System Software Navigation Instrument Map
Instrument Map
The Instrument Map is the user interface that reflects the structure of the Echo Lumena. The Instrument Map allows
you access to all of the micro-well strip, reagent, and sample position information, as well as the waste, system
liquid buffer, incubator, and general instrument information. Detailed information is provided for a specific position
when the mouse is pointed over a specific screen position (information displayed in a tool tip).
If not already visible, the Instrument Map can be made visible by accessing the View submenu from the pull-down
menu and activating (√) the Instrument submenu item. The Instrument Map can be closed by clickingthe close (X)
button in the top right-hand corner of the Instrument Map window (if the Instrument Map is either minimized or at
half screen). If the Instrument Map is at full screen, it can be removed from display by accessing the View submenu
from the pull-down menu and canceling the Instrument submenu item selection or by clicking the close (X) button in
the top right-hand corner of the screen.
A B C
Instrument Map
A: Sample loading bay

B: Reagent loading bay
C: Strip loading bay
D: Waste
E: Buffer
F: Incubators
G: Instrument

Instrument Map Chapter 2: System Software Navigation
A. Sample Loading Bay
By pointing to the boxes within the Samples area with the mouse, a tool tip is displayed. This provides an overview
of the sample loading status for a given sample position. Individual sample positions can be accessed by clicking
one box in the four columns above Samples.
Each column (representing one sample rack) has five sample positions. Each sample rack is color coded according
to the rack type used. A pediatric rack is displayed on the screen as pink, a donor rack is displayed as yellow, and
a sample rack is displayed as white when these racks are inserted into the bay.
Each tool tip display shows detailed information regarding the sample in that position. The number of samples
currently loaded on the Echo Lumena is numerically displayed on the screen as x (where x is the number of
samples). The tool tip information includes the instrument sample position, sample identification, and the rack type
that contains the sample. The following is an example.
Sample status information

B. Reagent Loading Bay
By pointing to the boxes within the Reagents area with the mouse, a tool tip is displayed. This tip provides an
overview of the reagent loading status. Individual reagent rack positions can be accessed by clicking one box in the
four columns above Reagents.
Each column (representing one reagent rack) has four reagent positions and displays on the screen as white when
the rack is in the bay. Each tool tip display shows detailed information regarding the reagent in that position. The
number of reagents currently loaded on the Echo Lumena is numerically displayed on the screen as x (where x is
the number of reagents). The tool tip information includes reagent type, barcode identification, on-board time,
remaining QC time, and expiration date. The following is an example.
Reagent status information

Instrument Map Chapter 2: System Software Navigation
C. Strip Loading Bay
By pointing to the boxes within the Strips area with the mouse, a tool tip is displayed. This provides an overview of
the strip loading module status. Individual micro-well strip positions can be accessed by clicking each box
(representing one micro-well strip). Each micro-well strip has eight micro-well positions.
Each one of the four rows of eight micro-well strips (above Strips) represents one micro-well strip tray. Each tool tip
display shows detailed information regarding the strip in that position. The number of strips currently loaded on the
Echo Lumena is numerically displayed on the screen as x (where x is the number of strips).
The tool tip information includes the strip type, position and identification, on-board time, remaining QC time,
expiration, and if any samples are assigned to this strip. The following is an example.
Strip status information

D. Waste
By pointing to Waste with the mouse, a tool tip is displayed showing the current status of the waste container. The
following is an example.
Waste status information
E. Buffer
By pointing to Buffer with the mouse, a tool tip is displayed showing the current status of the system liquid
container. The following is an example.
Buffer status information

F. Incubators
By pointing to Incubators with the mouse, a tool tip is displayed showing the current status of the incubators. The
information displayed includes the actual temperatures of the incubators. The following is an example.
Incubator status information
G. Instrument
By pointing to Instrument with the mouse, a tool tip is displayed showing the current status of the Echo Lumena.
The following is an example.
Instrument status information

Chapter 2: System Software Navigation Event Log Entry
Event Log Entry

Event log entry is a component of the Tools pull-down menu. A field for event log data entry is displayed when you
select Event log entry. You can type in the text you wish to save as part of an event log. This can be used to record
any troubleshooting events. You must then click OK to save or Cancel to cancel the action. An example of the
dialog box is shown in the following image with the resulting event log entry.
Event log entry dialog manual entry
The above example of Event log entry as documented in the event log at 15:52
Maintenance
Maintenance is a component of the Tools menu.
From the pull-down menu, click Tools, and then click Maintenance from the Tools submenu.
Pull-down menu
Refer to Chapter 5 – Maintaining the Echo Lumena for details regarding maintenance.
Print
By clicking the Print button from the toolbar, you can print the current reports.
Print button on the toolbar
Refer to Chapter 6 –Echo Lumena Reports for more information regarding the printing of reports.
Help
By clicking the Help button from the toolbar, you can view an electronic copy of the Echo Lumena Operator
Manual. Insert the Echo Lumena Operator Manual disk to view the electronic copy of the manual. This electronic
copy of the manual has hyperlinked sections. You can also access blud_direct through the Help window.
Help button on the toolbar
Refer to Chapter 7 – Troubleshooting for details of the help function.

Chapter 3: Instrument Testing Operation
Chapter 3: Instrument Testing Operation

In This Chapter:
CHAPTER 3: INSTRUMENT TESTING OPERATION ............................................... 3-1
Preparing for Sample Processing ....................................................................... 3-2
Starting Up...................................................................................................... 3-2
Filling the PBS Supply Container...................................................................... 3-4
Emptying the Waste Container ........................................................................ 3-4
Initialization ........................................................................................................ 3-5
Initializing the Echo Lumena............................................................................. 3-5
Sample Requirements ........................................................................................ 3-6
Processing Tests ............................................................................................... 3-8
Loading the Samples....................................................................................... 3-8
Loading Reagents and Controls .................................................................... 3-19
Loading Micro-well Strips .............................................................................. 3-25
Downloading Requests from LIS.................................................................... 3-29
Using the Run Test Wizard ............................................................................ 3-31
Starting Processing ....................................................................................... 3-36
Emergency Stop .............................................................................................. 3-37
Turn On/Off Rack Scanners ............................................................................. 3-38
Continual Loading during Operation ................................................................. 3-39
Loading Additional Samples or Requesting Additional Assays ........................ 3-39
Reloading Micro-well Strips ........................................................................... 3-39
Replenishing Reagents and Controls ............................................................. 3-39
Replenishing System Liquid ........................................................................... 3-39
Removing System Liquid Waste .................................................................... 3-40

Chapter 3: Instrument Testing Operation Preparing for Sample Processing
Warning: Only officially trained Echo Lumena operators are permitted to operate the Echo Lumena.
If untrained personnel operate the Echo Lumena and, as a result, generate technical problems, the
operating site is held responsible for erroneous sample results that may be generated.
Preparing for Sample Processing

This section describes the tasks related to preparing the Echo Lumena for processing samples. This section
includes the following subsections:
X Starting up
X Filling the PBS supply container
X Emptying the waste container
Starting Up
Warning: Blood samples, liquid waste, used micro-well strips, and consumed liquid
reagent vials contain potentially biohazardous material.
Always wear protective gloves and clothing when handling blood samples, liquid waste,
used micro-well strips, or consumed liquid reagent vials. All blood samples, liquid waste,
used micro-well strips, and consumed liquid reagent vials must be discarded following
the standard practice of the laboratory.
All blood products must be treated as potentially infectious. No known test methods can
offer assurance that products derived from human blood will not transmit infectious
agents.
Warning: Follow all of the necessary precautions to prevent exposure to and potential
injury from electrical current, mechanical movement, and barcode laser scanners.
Warning: Follow basic electrical hazard awareness to reduce the risk of injury due to
potentially hazardous electrical exposure. To avoid spills do not place containers of
liquids from any source on the Echo Lumena. Fluid 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.
Warning: Keep all Echo Lumena protective covers in place when operating the Echo
Lumena to reduce the risk of operator injury due to Echo Lumena mechanical movement.
Laser Beam Safety Warning: The Echo Lumena utilizes two internal visible light lasers
and one handheld scanner to scan barcodes of reagent vials and sample tubes. Do not
look directly into the laser beam of scanners or at any reflections of the beam from a
mirror-like surface. Exposure to the laser beam light can cause eye damage and
permanent injury.

Preparing for Sample Processing Chapter 3: Instrument Testing Operation
If the instrument has been previously shut down, to use the Echo Lumena, you must turn on the Echo Lumena PC
and the Echo Lumena instrument. This section describes how to start the Echo Lumena.
To start the Echo Lumena:
1. Plug the Echo Lumena AC power into the UPS.
2. Power up the Echo Lumena by turning on the power supply unit.

3. Press the power switch on the front panel of the PC to turn on the computer. Allow enough time for the
computer to start up and the Echo Lumena program to load. The monitor displays the Echo Lumena main
screen (including the Instrument Map, if configured).
Note: Viewing of the instrument map at start-up is a configurable option. Refer to Chapter 10 –
Configuration for more information regarding this configurable option.
Echo Lumena screen layout with Instrument Map
Warning: The Echo Lumena must be powered on long enough to allow the elevated temperature
incubators to reach acceptable temperature range prior to the first assay being run.

Chapter 3: Instrument Testing Operation Preparing for Sample Processing
Filling the PBS Supply Container

The PBS supply container is located in the fluidics module. The filling of the PBS supply container is a daily
maintenance item. Refer to Chapter 5 – Maintaining the Echo Lumena.
Emptying the Waste Container

The waste container is located in the fluidics module. The emptying of the waste container is a daily maintenance
item. Refer to Chapter 5 – Maintaining the Echo Lumena.

Initialization Chapter 3: Instrument Testing Operation
Initialization
This section describes how to initialize the Echo Lumena. The initialization of the Echo Lumena is a daily
maintenance item. Refer to Chapter 5 – Maintaining the Echo Lumena.
Initializing the Echo Lumena

Prior to performing initialization, you must make sure that the following conditions are met. If any of these conditions
are not met, the software will display alert messages instructing you to perform certain tasks before proceeding with
initialization. The conditions are the following:
• The PBS supply container must be installed correctly in the fluidics module and contain enough system
liquid so that the warning for low level of system liquid is not displayed.
• The waste container must be installed correctly in the fluidics module and not contain an excessive amount
of liquid waste so that the warning for waste full is not displayed.
• The main instrument cover must be in place.
• No instrument error flags must be displayed.
• The instrument must not be currently running any assays, identifying strips, or performing an automated
scheduled rinse cycle.
Note: Initialization must be performed before any assay processing is attempted and after any
instrument errors. Error messages are generated if assay processing is prematurely attempted (prior
to performing initialization) or if errors occur during initialization. These error messages must be
addressed and a successful initialization must be performed before assay processing can occur.
Note: Initialization is used to perform critical equipment verifications and resets prior to allowing the
Echo Lumena to be used for assay processing
Refer to Chapter 5 – Maintaining the Echo Lumena for details on initialization. Refer to Chapter 7 – Troubleshooting
the Echo Lumena for information regarding error messages and error recovery in the event of failure of any of the
components during initialization.

Chapter 3: Instrument Testing Operation Sample Requirements
Sample Requirements
Warning: At least 250 μL of packed red blood cells need to be present in a sample tube to ensure
that the probe picks up red blood cells and not plasma (only for those assays that require red blood
cells).
At least 500 μL of plasma or serum needs to be present in a sample tube to ensure that the probe
picks up plasma or serum, respectively.
Samples run with the red blood cell antibody identification assays require approximately 1 mL of
plasma or serum.
Note: If plasma or serum is removed from a whole blood tube and added to an empty sample tube,
the plasma/serum volume requirements will change
The following table describes volume requirements according to tube size.
Tube Size Assay Volume of Serum or Plasma Required
12-13 mm Screen 750 μL or 0.75 ml
12-13 mm Ready ID 1.5 ml
16 mm Screen 1.0 ml
16 mm Ready ID 1.75 ml
Warning: Red blood cell samples collected with the following anticoagulants and additives can be
tested on the Echo Lumena: EDTA, ACD, CPD, CPDA-1, CP2D, heparin, AS-1, AS-3, AS-5, and
the combinations of CPD with AS-1, CPD with AS-3, and CPD with AS-5.
Anticoagulated samples containing clots must not be used. Serum samples can also be tested on
the Echo Lumena for tests that do not require red blood cells. Samples obtained from tubes
containing neutral gel separators may produce falsely positive results and should therefore not be
tested on the Echo Lumena.
Warning: When inserting a sample test tube into a rack, the contents of the test tube must not
exceed a liquid height of 3.2 inches (8.1 cm), otherwise a fluidics error can be generated. Exceeding
this liquid height is usually the result of overfilling sample tubes.
Note: Prior to use on the instrument, centrifuge blood samples so that the red cells are adequately
separated from the plasma. Immucor studies have shown that centrifuging the blood samples at
speeds up to 2115 xg for a minimum of three minutes is acceptable. When sample tube stoppers
are removed for testing and are intended to be used to re-stopper the tubes after testing, remove
any dried blood on the rim of the sample tube and the stopper. This prevents dried blood from
entering the sample tube.

Sample Requirements Chapter 3: Instrument Testing Operation
Note: Red blood cell donor unit segments can be tested on the Echo Lumena. You must remove
segments from blood donor units and cut them, so that the contents can be dispensed into a test
tube with a diameter of between 12 and 16 mm (maximum height is 100 mm). It is recommended
that you label the test tube with a unit ID-barcoded label taken from the correct blood donor unit.
Centrifuge the donor segment contents before testing to separate the red cells from the plasma.
Failure to centrifuge the donor segment contents can cause inaccurate results to occur. The
minimum centrifugation time for donor segments is 30 seconds. You must then insert the test tube
into the donor rack for testing on the Echo Lumena.
Note: The pediatric rack is used to process capillary collection tubes (inserted into a 12 x 75 mm
test tube or acceptable adapter as a support). Acceptable tubes include: BD Microtainer™, BD
Microtainer MAP, Greiner MiniCollect®, and Terumo™ CapiJect®. If using BD Microtainer MAP,
Immucor personnel must reconfigure the pediatric rack to adjust probe position within the tube prior
to use on the Echo Lumena.
Note: We require that you select one tube and adapter type from one manufacturer to be used on
the instrument. If different types of capillary collection tubes are mixed in the pediatric rack, it is likely
that a probe crash will occur.
Warning: Samples that exhibit excessive hemolysis or lipemia or are icteric should not be tested on
the Echo Lumena. Samples that exhibit a hemolysis grade of 3+ or greater must not be tested on
the Echo Lumena because they may generate invalid or indeterminate results. Refer to the following
photograph for a hemolysis grade of 3+ (color guide). For assays using Capture-R® Select, do not
use hemolyzed samples for creating a monolayer. Fragmented red blood cell membranes will
interfere with monolayer formation.
0 1+ 2+ 3+ 4+
Hemolysis grading chart
Warning: Echo Lumena studies have demonstrated that the probe washes are not sufficient to
prevent carryover of samples that have an atypical red blood cell antibody titer of 5120 or greater
(not typical of those samples encountered in a blood bank setting). It is important to note that these
studies apply only to routine patient or donor samples. Sample material that is provided in surveys
has been shown to occasionally cause carryover at lower titers (a result of the manufacturing
process for these materials).

Chapter 3: Instrument Testing Operation Processing Tests
Processing Tests
This section describes all procedures necessary for sample assay processing. You can manually select assays
using the Echo Lumena touch screen. This is further explained in Using the Run Test Wizard in this chapter.
For information about the available assays and the reagents used for each assay, refer to Regional Attachments.
You must prepare all of the necessary reagents and samples according to the reagent package insert requirements
before you can choose the assay. The Run Test Wizard allows the operator to run assays.
This section describes the tasks related to processing sample assays with the Echo Lumena. This section includes
the following subsections:
X Loading the samples
X Loading reagents and controls
X Loading micro-well strips
X Downloading requests from LIS
X Using the Run Test Wizard
X Start Processing
Loading the Samples

This section provides sample requirements and describes how to load samples onto the Echo Lumena.
Note: Echo Lumena racks are equipped with a guide rail underneath to position them correctly in
the loading bay modules, a handle at the front to facilitate handling, and a pin at the back that
triggers a sensor to inform the system that the rack is loaded into position.
Warning: Do not insert or remove a rack when the indicator LED is lit, as this can damage the
pipetting system and invalidate all test results for samples in the rack.
Note: Use the correct sample and reagent racks with the appropriately sized sample tubes and
reagent vials. The use of an inappropriately sized tube or vial can result in improper volume tracking,
inadequate fluid volume aspirations, and possible probe crashes.
Warning: Open field access is required to provide continuous access for sample and reagent
loading during full-system operation.
Inappropriate, unauthorized access to the loading bays (outside of those methods described in this
manual) is strictly prohibited and could cause injury.
• Racks for the reagent vial loading (four vials per rack)
• Racks for the sample tube loading (five samples per rack)
Note: Sample racks include racks dedicated to patient, donor, and pediatric categories of blood
sample tubes. These racks can be readily identified by the icons on the finger tabs of the racks
themselves. For example, the pediatric rack has an icon illustrating a baby (as shown in the following
table).
Warning: In the event of biological material spillages such as blood or testing reagents onto the
instrument cover, you should immediately clean the spill using an alcohol-based cleaning method to
prevent unnecessary prolonged operator exposure to biohazardous materials.

Processing Tests Chapter 3: Instrument Testing Operation
To load samples:
1. The correct samples must be loaded into the appropriate racks (as identified by the rack icons). The
following table details the acceptable tube sizes for all racks.
Note: It has been determined that the use of 10 x 75 mm tubes is associated with a high
rate of clot detection errors. We recommend the use of 12 x 75 mm, 13 x 100 mm, or 16 x
100 mm tubes only. Contact Immucor when implementing a new tube type on the Echo
Lumena after initial installation to ensure the Echo Lumena is configured for its use.
Rack Acceptable Tube Sizes
Test tube with a diameter of between 12 mm and 16

mm inclusive (maximum height is 100 mm).
For example:
12 x 75
13 x 100
16 x 100
Test tube with a diameter of between 12 mm and 16

mm inclusive (maximum height is 100 mm).
For example:
12 x 75
13 x 100
16 x 100
The pediatric rack is used to process capillary

collection tubes. Acceptable tubes include:
• BD Microtainer™
• BD Microtainer™ MAP
• Greiner MiniCollect®
• Terumo™ CapiJect®
• Sarstedt Microvette® 500
Reagent vials as supplied by the manufacturer.
Sarstedt tubes as supplied by the manufacturer.

Selection of racks
Warning: Assays that require the use of plasma or serum must not be run from donor or
pediatric racks. Use of incorrect tubes can cause pipetting errors.

The following table lists all of the capillary collection tubes currently supported on the Echo Lumena.
Capillary Collection System Highlights
Microtainer™ with Microguard™ by BD (Refer to This tube has been used successfully on the
manufacturer for catalog number) Echo Lumena. The inner diameter is sufficient
for probe sampling and the outer diameter
holds the tube in the Echo Lumena Pediatric
rack. The maximum sample volume is 500μl.
9
MiniCollect® by Greiner bio-one (Refer to manufacturer This tube has been used successfully on the
for catalog number) Echo Lumena. The inner diameter is sufficient
for probe sampling. Due to the small outer
diameter and short height, MiniCollect® sample
tubes must be placed in a 12 X 75 mm test
9 tube, and then placed in the Echo Lumena
Pediatric rack. The maximum sample volume is
500μl.
CapiJect® by Terumo™ (Refer to manufacturer for This tube has been used successfully on the
catalog number) Echo Lumena. The inner diameter is sufficient
for probe sampling. Due to the small outer
diameter and short height, CapiJect sample
tubes must be placed in a 12 X 75 mm test
9 tube, and then placed in the Echo Lumena
Pediatric rack. The maximum sample volume is
500μl.
BD Microtainer® MAP (Refer to manufacturer for catalog This tube has been used successfully on the
number) Echo Lumena. The inner diameter is sufficient
for probe sampling and the outer diameter
holds the tube in the Echo Lumena Pediatric
rack. The maximum sample volume is 500μl.
9
This tube has been used successfully on the
Sarstedt Microvette® 500 (Refer to manufacturer for
Echo Lumena. The inner diameter is sufficient
catalog number)
for probe sampling. Due to the short height,
Microvette sample tubes must be placed in a
carrier tube and then placed in the Echo
9 Lumena Pediatric rack. The maximum sample

volume is 500μl.
Microtainer tube extender (Refer to manufacturer for It is recommended that the tube extender be
catalog number) used with the Microtainer™ with Microguard™
when tested on the Echo Lumena. The tube
extender allows the sample tubes to fit in the
9 Echo Lumena Pediatric racks at the correct
height.

The following table shows the capillary collection tube that is not currently supported on the Echo Lumena.
Capillary Collection System Highlights

Microtainer™ by BD (Refer to manufacturer for catalog Not Acceptable
number)
This tube has a smaller inner diameter than
recommended. Use of this tube has been
associated with increase instances of probe
crashes.
2. The samples must be inserted into the racks so that the barcode of the sample is visible to the barcode
reader in the sample loading bay (barcode facing left). Insert the appropriate prepared rack with samples
into one of the available lanes of the sample loading bay (when the lane LED is not illuminated), as shown in
the following photograph.
Operator loading samples into the sample loading bay
Sample and reagent loading bay modules (rack in sample position 2 is pediatric rack)

Warning: When a sample rack is partially removed after testing is complete and another rack is
inserted into an adjacent position, it is possible for the partially removed rack to be inadvertently
loaded ahead of the second rack. In this instance, there is a possibility that the sample IDs from the
second rack will also be assigned to the original rack. A message that there are duplicate barcodes
in the second rack is generated.
If, when loading samples on the Echo Lumena, a warning message appears indicating that duplicate sample IDs
have been detected, no samples should be selected for testing. All sample racks should be removed and inspected
for duplicate sample IDs. If no duplicate sample IDs are noted then all sample racks removed can be reloaded and
sample scheduling resumed. If duplicate sample IDs are identified, then only one of these sample IDs should be
loaded and scheduled.
Note: It is also possible for sample IDs to be incorrectly assigned without generating a duplicate
sample ID message. This happens when the operator fails to fully insert the rack.
To avoid incorrect sample IDs, when loading sample racks onto the Echo Lumena:
1. Load one rack at a time.
2. Ensure that the rack is fully inserted by viewing the instrument map for confirmation that
the rack has been recognized by the instrument.
When samples with Codabar identification labels are encountered and the prompt to convert Codabar labels option
has been selected under the barcode option configuration, then a screen allowing you to select alpha conversion of
the scanned Codabar labels appears after the rack insertion. Click Yes to convert the data or No to not convert. If
configured, the prefix prompt subsequently appears. Refer to Chapter 10 – Configuration for details on this
configurable option.
Example of barcode conversion confirmation dialog box
When donor racks are loaded and the prompt for prefix when donor racks are inserted option has been selected
under barcode option configuration, then a screen allowing you to enter a donor prefix appears after the rack
insertion. Enter a donor prefix that is listed on the donor unit label and click OK to continue. If no donor prefix is on
the donor unit label, then click Cancel to continue.
Example of donor prefix prompt

Manual Sample ID Data Entry

If a sample rack is inserted into the loading bay and a sample barcode is unreadable, then the Samples window will
be displayed. The rack in question should be removed from the loading bay and the barcode information
subsequently entered into the software.
Samples Window
As a manual method, the same Samples window can be displayed by selecting Edit on the pull-down menu and
then subsequently selecting the Samples item. The Select Sample Rack window is then displayed where you must
select the appropriate rack for editing (Rack 1, Rack 2, Rack 3 or Rack 4) followed by pressing the OK button. The
Samples window is then displayed for the selected rack. Press the Cancel button to cancel the rack selection
process.
Select Sample Rack window
If sample IDs are not automatically read by the sample loading bay barcode scanner, those misread barcode IDs
can be manually scanned in using the handheld scanner. The sample rack must be removed from the sample
loading bay for you to be able to scan the barcode from the sample tube into the relevant field position. Once the
sample rack is removed, any manually entered sample IDs will be removed.

Each rack position has its own tab (Rack 1, Rack 2, Rack 3, and Rack 4) on the Samples window, and each tab
has five sample data input positions. You can edit sample IDs from this window. By clicking the Close button, you
can close the Samples window. This window can be accessed from the pull-down menu.
For security purposes, double entry of sample IDs is required when the Samples window is displayed. Both entries
must be identical for access. If a sample is in a rack position, then the sample ID number of that sample is
displayed in the data field. R09658 is shown as an example.
Second entry of sample ID
Note: You can also manually enter data into the sample ID fields of the Samples window using the
keyboard; however, the use of the handheld scanner can prevent possible typographical errors that
may be incurred by manually typing using the keyboard. Another potential problem with using the
keyboard is that the eye-readable portion of a barcode is not necessarily the same as the encoded
barcode data—for example, those barcodes utilizing alphanumeric conversion. In these cases,
erroneous information could be entered using the keyboard.
If sample barcodes are unable to be read after the initial insertion of the rack into the bay, the following window is
automatically displayed.
Samples window indicating unread barcodes
This window indicates that the barcode was unable to be read, and you must manually enter the information. It is
necessary to remove the rack at this point. In doing so, the Samples window updates on the screen to the following
version (ready for your manual entry). You can then enter the barcode information (see following example).

Note: The window indicates that No rack is present.
Samples window with fields for manual entry
When the rack is re-inserted, the Samples window updates on the screen to the following version, indicating that
the data has been entered. The sample position barcode data is grayed out (see following example).
Samples window with samples in Rack 2

Note: If the rack is reinserted into the wrong lane, then a warning message will appear indicating the
wrong lane was selected. The incorrect lane will be highlighted on the instrument map to indicate an
invalid insertion.
Example of warning message when rack is reinserted into wrong lane
If a sample or reagent barcode is hand-scanned or manually entered for a given rack position, and if that rack is not
the next one to be inserted, then the edited data will be erased. For example, if a sample ID for position 2 of rack 1
is hand-scanned or manually entered into the software, and then sample rack 3 is the next rack to be inserted, then
the edited information for sample rack 1 will be erased.

Sample Name Data Entry Using Sample Names

If you wish to assign unique sample names in addition to the sample IDs, then you can access the Sample names
window through the pull-down menu. Each rack position has its own tab (Rack 1, Rack 2, Rack 3, and Rack 4),
and each tab has five sample data input positions.
By clicking the Close button, you can close the Sample names window. You can add sample names into this
window. If a sample is in a rack position, then the sample ID (as identified by the Echo Lumena software) of that
sample is displayed above the data field, and the name of the sample can be entered into the data field.
You can type or scan in (using the handheld scanner if the name is accessible in barcode format) the name you
wish to assign to the relevant sample ID. Rack 2: R09658 is shown as an example. If no sample is present in a
particular position, (No sample) appears above that data field (as shown in the following screen). Once the rack is
removed, the manually entered name is also removed. If the sample is reloaded the name will need to be re-
entered. In order for the sample name to be included in the result report, the sample name must be entered prior to
assay scheduling.
Sample names window

Loading Reagents and Controls

This section describes how to load reagents and controls onto the Echo Lumena.
Note: Echo Lumena racks are equipped with a guide rail underneath to position them correctly in
the loading bay modules, a handle at the back to facilitate handling, and a pin at the front that
triggers a sensor to inform the system that the rack is loaded into position.
To load reagents and controls:
1. Load the reagents and controls required for the planned assays into the Echo Lumena reagent racks.
Reagent racks accommodate up to four vials per rack and are identifiable by the presence of the reagent
vial icon label. Other Echo Lumena racks are listed in Appendix A – Echo Lumena Installation.
Reagent racks
Warning: Inspect all reagents and controls for the presence of foam before placing them on
the instrument. Do not vigorously agitate blood grouping anti-sera or controls. Shaking will
produce foam in the vial that can cause the liquid level detection (LLD) feature of the
pipetting system to aspirate foam rather than reagent. This will produce incorrect results or
an error.
Warning: Before placing reagents on the Echo Lumena, you must remove the bottle caps.
You are advised to remove and discard the dropper by pulling the dropper from the bulb.
When you remove the reagents from the Echo Lumena for storage, you must place the
caps back on the bottles. To avoid cross-contamination of reagents, it is important that you
place the caps on the correct bottles. Mixing caps can result in erroneous test results
Warning: In the event of biological material spillages such as blood or testing reagents onto
the instrument cover, you should immediately clean the spill using an alcohol-based
cleaning method to prevent unnecessary prolonged operator exposure to biohazardous
materials
2. Add one stir ball into each vial containing cellular reagents, such as Referencells® and Capture R® Indicator
Cells.

Note: The stir balls are used to keep cellular reagents in suspension during testing.
Warning: If you do not add the stir balls to the cell suspensions, the results may be invalid
or incorrect. Do not touch the stir balls. You should add them directly to the cellular reagent
vials using the dispenser provided. Contamination and neutralization of cellular reagents can
occur if the stir balls are touched.
You must only add one stir ball per vial of cellular reagent. Do not add more than one stir
ball per vial
3. The reagent vials must be inserted into the racks so that the barcode of the vial is visible to the barcode
reader in the reagent loading bay (vial barcodes must be facing right). Insert the appropriate prepared rack
with reagents into one of the available lanes of the reagent loading bay (when the rack light is not
illuminated).
Operator loading reagents into the reagent loading bay
Sample and reagent loading bay modules (rack in reagent positions 1–4 are reagent racks: note vial icon)

Warning: If you are using multiple Immucor instruments or other test methodologies, the specific
reagent vials for each instrument must be dedicated for use on that single instrument or method to
ensure correct reagent volume tracking. If the actual reagent volume (less than the software numeric
volume) is not sufficient for the number of tests scheduled, the Echo Lumena can produce invalid
results, and samples will need to be rescheduled for testing.
Warning: Pooling of liquid reagent from multiple vials into one vial will cause inaccuracies in volume
tracking and risk contamination, as well as consequent erroneous results. Therefore, the practice of
reagent pooling is strictly prohibited.

Manual Reagent ID Data Entry

If a reagent rack is inserted into the loading bay and a reagent barcode is unreadable, then the Reagents window
will be displayed. The rack in question should be removed from the loading bay and the barcode information
subsequently entered into the software.
Reagents window
As a manual method, the same Reagents window can be displayed by selecting Edit on the pull-down menu and
then subsequently selecting the Reagents item. The Select Reagent Rack window is then displayed where you
must select the appropriate rack for editing (Rack 1, Rack 2, Rack 3 or Rack 4) followed by pressing the OK
button. The Reagents window is then displayed for the selected rack. Press the Cancel button to cancel the rack
selection process.
Select Reagent Rack window
If reagent IDs are not automatically read by the reagent loading bay barcode scanner, then those missing barcode
IDs can be manually entered using the handheld scanner. The reagent rack must be removed from the reagent
loading bay for you to be able to scan the barcode from the reagent vial into the relevant field position. Once the
reagent rack is removed, any manually entered reagent IDs will be removed.

Each rack position has its own tab on the Reagents window (Rack 1, Rack 2, Rack 3, and Rack 4), and each tab
has four reagent data fields. You can edit reagent IDs from this window, which is accessed from the pull-down
menu (Edit sub-menu item: Reagents). For security purposes, double entry of reagent IDs is required when they are
input into the Reagents window. Both entries must be identical for acceptance.
For security purposes, double entry of reagent IDs is required when the Reagents window is displayed. Both entries
must be identical for access. If a reagent is in a rack position, then the sample ID number of that reagent is
displayed in the data field. Anti-D Series 5 (505055126000219613) and A1 Reference Cells
(111197107610363908) are shown as examples.
Second entry of reagent ID
When the rack is re-inserted, the Reagents window updates, indicating that the data has been entered. If a reagent
vial is in a rack position, then the ID number of that vial is displayed in the data field, and the name of the reagent is
displayed above the data field. The following example shown is Rack 1: Capture LISS (211044086480337417).
Reagents window: Rack 2 with Capture LISS
Note: If the rack is reinserted into the wrong lane, then a warning message will appear indicating the
wrong lane was selected. The incorrect lane will be highlighted on the instrument map to indicate an
invalid insertion.

Warning message that appears when rack is re-inserted into wrong lane
Note: You can also manually enter data into the reagent ID fields of the Reagents window using the
keyboard; however, the use of the handheld scanner can prevent possible typographical errors that
may be incurred by manually entering these values using the keyboard.
Each reagent position inside the Reagents window also has a Measure button associated with it. The Measure
button is only enabled if the instrument is initialized and idle and has a reagent vial in that loading bay position. If No
reagent is located at a particular position or the instrument requires initialization or is active, then the Measure
button is disabled.
Under the conditions stated previously, if a reagent vial is in position, then you can perform a liquid level detection
check on the contents of the vial by clicking the Measure button. The probe descends into the vial and detects the
reagent liquid level. The software then calculates the volume of liquid, and that value is displayed above the
Measure button for that vial.
The above example shown for Capture LISS is 2436 μL. This volume display is also maintained as a current value
for a vial in a given position during its routine use. This information can be useful to determine if you have sufficient
reagent to run a collection of samples with a particular assay, before viewing the Supplies window of the Run Test
Wizard. If No reagent is located at a particular position, then there is no volume display.
By clicking the Close button, you can close the Reagents window.
If a sample or reagent barcode is hand-scanned or manually entered for a given rack position, and if that rack is not
the next one to be inserted, then the edited data will be erased. For example, if a sample identification for position 2
of rack 1 is hand-scanned or manually entered into the software, and then sample rack 3 is the next rack to be
inserted, then the edited information for sample rack 1 will be erased.

Loading Micro-well Strips

This section describes how to load micro-well strips into the Echo Lumena.
You can load and remove micro-well strips onto and from the Echo Lumena. The portal entry is located in the
center of the instrument and accessed from the front. You must load the micro-well strips onto strip holders before
placing them into the Echo Lumena using the strip trays. These strip holders (two strips per holder) allow the
transport system to move the micro-well strips and load them into the various instrument modules required to
complete the assays.
To load micro-well strips:
1. You must insert a pair of strips with the two-dimensional barcodes next to each other into a strip holder (at
the end of the holder identified by the holder protrusions). The strip 2-D barcodes must be nearest the
handle of the strip tray. The strips also have eye-readable text on the top strip tab (identified by unique
characters for each strip type).
Refer to Regional Attachments for a list of unique strip eye-readable characters. Refer to the following
photograph that shows correctly loaded strips in a strip holder. The strips must be completely pushed
down to be level with the top of the holder. Incorrect loading of strips into holders can cause processing
errors.
Two-dimensional barcode located on bottom of micro-well strip tab
Strip holder with a pair of strips (two-dimensional barcodes next to each other at end of holder with protrusions)
Warning: Two of the same strip type, or a balance strip along with a single strip of any type,
must be loaded into a given strip holder. Empty strip holders must not be stored on the
instrument.

2. Insert the holders into the strip tray with the two-dimensional barcodes nearest to the handle of the strip
tray (with the end of the holder identified by the holder protrusions nearest to the handle of the strip tray).
Diagrams of the correct holder orientation are imprinted onto the strip tray.
Four strip holders in a strip tray
3. Load the strip tray into an available strip loading bay when the tray light is not illuminated (see the following
photograph). The instrument must be initialized. Once the strip tray is loaded on the instrument, the color of
the strip tray location on the instrument map will change from grey to pink. Once the strip holders are read
for each position the color will revert back to grey.
Loading a strip tray
Warning: After you load the strip trays, the Echo Lumena reads the two-dimensional
barcode of each loaded micro-well strip to be used prior to their use in assay runs. If this
barcode is unreadable, you can use the attached handheld scanner to scan the linear
barcode on the white frame from which the strips were taken. Details of this process are
described in the next section. This information is scanned into the manual barcode Strips
window and can require a separate entry of the expiration date of the micro-well strip in
question.

Manual Strip ID Data Entry

If strip IDs are not automatically read by the strip tray loading bay barcode scanner, then those misread barcode
IDs can be manually entered using the handheld scanner. The barcode that must be scanned is imprinted on the
side of the strip frame from which the strip came.
You can enter strip IDs into the Strips window, which is accessed from the Edit menu of the pull-down menu. For
security purposes, double entry of strip IDs is required when they are put into the Strips window. Both entries must
be identical for acceptance.
Second entry of strip ID
Each strip tray position has its own tab (Tray 1, Tray 2, Tray 3, and Tray 4) on the Strips window, and each tab has
four strip holder data fields. Each strip holder section (Strip holder 1, Strip holder 2, Strip holder 3, and Strip holder
4) has two fields for the two strips that can be accommodated within a strip holder.
If a micro-well strip is in a strip holder position, then the ID number of that micro-well strip is displayed in the data
field and the name of the micro-well strip is displayed above the data field. Tray 1: Strip holder 1: Capture-R RS (3)
(0191210701400265) is shown as an example.
Strips window with data entry fields filled

Once the plate barcode is scanned, you are prompted by a pop-up window to enter the strip expiration date.
Expiration date window
Warning: Entering an incorrect expiration date can result in the use of expired strips, which can lead
to inaccurate results.
By clicking the Close button, you can close the Strips window.
Warning: Incorrectly placing a micro-well strip into a strip holder or incorrectly placing a holder onto
a tray can cause damage to the pipetting system and other modules on the Echo Lumena.
Warning: Loading a micro-well strip with an incorrect strip orientation can result in invalid results and
can create a biohazardous spill on the Echo Lumena. Incorrect orientation includes strips inserted
upside-down in a micro-well strip holder
Note: The micro-well strip barcode indicates the type of micro-well strip, such as blood grouping or
Capture-R Ready-Screen (3), and that determines the assays for which the strip may be used.

Downloading Requests from LIS

The Worklist is the window where assays that have been automatically assigned to samples (via an LIS interface or
reflex processing) can be viewed and selected. Worklist entries must first be selected (scheduled) before they can
be run on the instrument.
By clicking the Worklist button from the toolbar, you can display all of the assays requested through the LIS
bidirectional interface (if active) or through reflex processing.
Refer to Regional Attachments for more information about reflex processing.
The Worklist window can also be launched by pressing the Worklist bar at the bottom of the screen.
The Worklist bar will only appear if there are any entries on the worklist and will provide a count of the number of
entries that exist.
Worklist button on the toolbar
Worklist bar
The Worklist window is then displayed, and it shows the sample ID and the assays requested.
Worklist window
Assays can be scheduled according to assays for a matching sample ID or according to samples for a matching
assay.
To process assays according to sample ID, select the first instance of the desired sample ID entry in the list, and
then click the Samples button in the Check all matching field. Individual assays for the matching sample ID can be
selected or deselected by clicking the check box next to the desired worklist entry.

To process samples according to matching assays, select the first instance of the desired assay entry in the list,
and then click the Tests button in the Check all matching field. This will select all of the samples in the worklist that
are assigned the matching assay. Individual samples for the matching assay can be selected or deselected by
clicking the check box next to the desired worklist entry.
Note: The Next button is available once all matching sample criteria or all matching test criteria are
met.
The list of samples and assays can be updated within the Worklist window by clicking the Refresh list button.
Selected samples and tests can be deleted from the Worklist by first selecting the entries and then clicking Delete
checked items. All samples can be selected or deselected at the same time by clicking the All button.
If the bidirectional LIS interface is active, the Worklist window is populated with LIS-generated assay assignments,
as well as reflex processing entries. If the bidirectional LIS interface is not active, the Worklist window is populated
with reflex processing entries. The Confirm test window of the Run Test Wizard (described later in this chapter) is
opened by clicking the Next button (if all of the necessary supplies are present on the instrument).
The Worklist window replaces the Select tests and Select samples windows from the Run Test Wizard. All Worklist
activity (prior to opening this window) can be cancelled by pressing the Cancel button.

Using the Run Test Wizard

This section describes how to use the Run Test Wizard to begin processing the sample assays.
Note: The physical loading of micro-well strips, reagents, and samples is described earlier in this
chapter.
Press the Run Test Wizard button on the toolbar.
Run Test Wizard button on the toolbar
Select Tests
The Echo Lumena displays the Select tests window of the Run Test Wizard.
Select Tests window
The Select tests window presents you with a list of all defined assays plus any custom created profiles. You can
select the assay required by clicking the check box adjacent to the name of the assay. Selection cannot be made
by clicking the assay name.
The window also details instrument QC status. The Back, Next, and Cancel buttons are used for navigational
purposes:
• The Back button returns you to the Worklist window.
• The Next button advances you to the next window (the Select samples window, in this example).
• The Cancel button closes the Run Test Wizard.
Note: If the Worklist is accessed from the Select tests window by clicking the Back button, the Next
button in the Worklist is disabled. You must click Cancel and access the Worklist either through the
toolbar or Worklist bar if it is displayed at the bottom of the screen.

Select Samples
Select samples window
The Select samples window shows all of the samples loaded on the Echo Lumena. The page shows the sample ID,
rack location, sample position, and rack type—for example, Sample 001 (Rack 2 #1) – Patient. Only samples from
a selected assay appear in the window—for example, donor samples are not shown for a Group assay.
All samples can be selected or cleared by using the Select all or Select none buttons at the top of the window.
Samples can also be selected or cleared from a given rack using the Select a rack feature.
Donor or pediatric samples only appear on the Select samples window if donor or pediatric assays, respectively,
are selected from the Select tests window.
STAT and Priority Selection

The STAT tests window and the Priorities test window only appear if selected on the General page of the Test
options menu. Refer to Chapter 10 – Configuration for additional information on configuring the STAT and Priorities
windows.
STAT tests window

All previously selected samples appear in the STAT tests window and can be selected for STAT processing by
checking the adjacent check boxes.
Priorities window
The Priorities window displays all selected Normal samples and STAT samples. The sample IDs can be arranged
on-screen by moving the sample IDs using the Up or Down buttons within the selection windows.
The order of samples can also be modified by clicking and dragging the sample IDs on the screen using the mouse.
However, the samples will not be processed in the selected order because the priority functionality is not currently
available for use. Click the Next button to display the Supplies window. If running the Crossmatch assay, the
Crossmatch selection window will be displayed next.
Crossmatch Selection
The Crossmatch setup window is displayed only when the Crossmatch assay is selected on the Select tests
window. The instructions for use of this window are displayed in the top left-hand section of the window.
The Crossmatch assay can be used to match one patient sample with up to 15 donor samples.
Note: When running the Crossmatch assay, each patient/donor combination is considered to be a
separate test. For example, if one patient sample is crossmatched with three donor samples, then
this scenario is considered to be three separate tests.
Checked donors can be applied to all patients by checking the Apply checked donors to all patients check box.
Individual donors can be assigned to a given patient (highlighted by a blue line) by checking the boxes next to the
donor IDs intended to be crossmatched. The Back, Next, and Cancel buttons are used for navigational purposes.

Crossmatch setup window
Supplies
The Supplies window appears when the number of reagents or strips is not adequate for processing the selected
tests, or when the buffer volume is low or the waste container is full. Once adequate supplies are loaded onto the
Echo Lumena, the reagent or strip is removed from the list (on the Supplies window).
The Echo Lumena monitors the volume of reagent in each vial. The software performs a liquid level check and
recalculates the overall volume based on the current level. The instrument also flags any reagents that have an
unexpected volume discrepancy, which may have occurred, for example, if different reagent vials were pooled or if
a vial of reagent was used for test tube bench testing between uses on the Echo Lumena. The instrument also
monitors on-board time to verify that the reagents are not left on the instrument for extended time periods.
Warning: Capture-R® Ready Indicator Red Cells can be used no more than 24 hours after a stir ball
has been added to the vial. Refer to the appropriate Regional Attachment for on-board expiration
information for vials of reagents other than Indicator Red Cells. Results can be adversely affected if
reagents are used beyond the recommended on-board time.
Reagents listed in the Supplies window in red text are for assays that require QC. Reagents listed in the Supplies
window in green text are for assays that do not require QC or for assays that have WB corQC scheduled.
• Add QC’d Reagent or Strip (red text) – An assay that requires QC has been scheduled and QC has not
been performed on the reagent or strip lot that is loaded. QC needs to be performed before continuing.
• Add QC’d Reagent or Strip (red text) – A reagent or strip lot has already been QC’d, but additional supplies
need to be loaded.
• Add Reagent or Strip (green text) – An assay that does not require QC has been scheduled and additional
supplies need to be loaded.
• Add Reagent or Strip (green text) – WB corQC is scheduled and additional supplies need to be loaded.

Supplies window
The Supplies window updates and items disappear from the list as you load the requested items onto the
instrument. The Next button becomes available when all items are loaded and cleared from the list. Click the Next
button to display the Confirm test window.
If you try to schedule processing for more than 40 sample tests concurrently, a message will be displayed in the
Supplies window stating: Too many tests. Please go back and select fewer tests. In this instance, the Next button
will be inactive, and the only two button options available will be Back or Cancel.

Starting Processing
The Supplies window is replaced with the Confirm test menu when all of the supplies are loaded onto the
instrument. The Confirm test menu displays all of the selected samples and tests. By clicking the Begin Tests
button on the Confirm test menu, processing of the selected tests begins.
Confirm test menu

Emergency Stop Chapter 3: Instrument Testing Operation
Emergency Stop
To display the Stop window, click the Emergency Stop button on the toolbar.
Emergency Stop button on the toolbar
The system displays the Stop window.
The Emergency Stop button allows the operator to choose from three options: Abort, Stop, or Close.
• By clicking the Abort button, you can immediately stop all processing and void all tests that are running.
• By clicking the Stop button, any tests that are currently processing will run to completion and any tests that
have not started processing will be cancelled and the results will be reported as invalid.
• By clicking the Close button, you can close this window without any further action.
Stop window
Echo Lumena Operator Manual ECO-001-200 3-37

Chapter 3: Instrument Testing Operation Turn On/Off Rack Scanners
Turn On/Off Rack Scanners

By clicking the Turn on/off rack scanners button from the toolbar, you can turn the rack scanners on or off. When
switching on using the Toolbar button, the scanners turn on after a brief delay of about five to ten seconds.
Sliding a rack onto the instrument automatically switches the scanners on. The length of time that must expire
before the scanners automatically switch off (after a period of inactivity) is a configurable option.
Refer to Chapter 10 – Configuration for details of this option.
Turn on/off rack scanners button on the toolbar
3-38 ECO-001-200 Echo Lumena Operator Manual

Continual Loading during Operation Chapter 3: Instrument Testing Operation
Continual Loading during Operation

To maintain optimal throughput, you can access the Echo Lumena at any time to continually load samples,
replenish reagents or buffer, or empty waste while the Echo Lumena is processing.
This section describes the operational procedures that you can perform while the Echo Lumena processes assays.
This section describes:
X Loading additional samples or requesting additional assays
X Reloading micro-well strips
X Replenishing reagents and controls
X Replenishing system liquid
X Removing system liquid waste
Warning: Removing racks while the probe is accessing the tubes or vials results in damage to the
probe and invalidated results. Only remove racks when the LED is not illuminated.
Loading Additional Samples or Requesting Additional Assays

You can load more samples if free loading lane positions are available, or you can request additional tests at any
time on samples that are already loaded.
Refer back to information provided earlier in this chapter for instructions regarding the loading of samples.
Reloading Micro-well Strips

After the Echo Lumena has completely used a micro-well strip, remove the micro-well strip from the Echo Lumena
and insert a new one as needed.
Refer back to information provided earlier in this chapter for instructions regarding the loading of micro-well strips.
Warning: Used micro-well strips contain potentially biohazardous material. Wear protective gloves
and clothing at all times when handling used micro-well strips. If any liquid is spilled, clean it up
immediately, adhering to standard laboratory practice.
Replenishing Reagents and Controls

After the Echo Lumena has completely used reagents, remove the reagents from the Echo Lumena, and insert
additional vials as needed.
Refer back to information provided earlier in this chapter for instructions regarding the loading of reagent vials.
Replenishing System Liquid

To replenish the system liquid, follow the procedure for refilling the PBS supply container in Chapter 5 – Maintaining
the Echo Lumena.

Chapter 3: Instrument Testing Operation Continual Loading during Operation
Removing System Liquid Waste

All liquid waste is collected in the instrument waste container. You can empty the liquid waste container at any time
by draining its contents into the shuttle container.
To drain the waste container, follow the procedure for emptying the waste container in Chapter 5 – Maintaining the
Echo Lumena.
Warning: Blood samples, liquid waste, used micro-well strips, and consumed liquid reagent vials
contain potentially biohazardous material.
Always wear protective gloves and clothing when handling blood samples, liquid waste, used micro-
well strips, or consumed liquid reagent vials. All blood samples, liquid waste, used micro-well strips,
and consumed liquid reagent vials must be discarded, adhering to the standard practice of the
laboratory.
All blood products must be treated as potentially infectious. No known test methods can offer
assurance that products derived from human blood will not transmit infectious agents.
Warning: Disconnecting the waste container during Echo Lumena operation will abort all tests in
progress and can cause a waste spill
Note: Waste can be drained during instrument operation.
Warning: The liquid waste is potentially biohazardous material. Always wear protective gloves and
clothing when handling liquid waste. If any liquid waste is spilled, clean it up immediately, adhering
to standard laboratory practice

Chapter 4: Test Results
Chapter 4: Test Results

In This Chapter:
CHAPTER 4: TEST RESULTS ................................................................................ 4-1
Results Panel and Results Bar ........................................................................... 4-2
Results Panel .................................................................................................. 4-2
Results Bar ..................................................................................................... 4-2
Commonly Used Symbols .................................................................................. 4-3
Viewing Test Results .......................................................................................... 4-4
Example of a Report ........................................................................................ 4-4
Viewing Results ............................................................................................... 4-5
Approving Results ........................................................................................... 4-5
Exporting Results ............................................................................................ 4-6
Editing Results ................................................................................................ 4-7
Alternative Method to View, Edit, Approve, and Export Results ........................ 4-8
Configuration of Printed Result Reports .............................................................. 4-8
Viewing Test Well Scores and Sample Event Logs.............................................. 4-8
Viewing Test Well Scores ................................................................................ 4-9
Viewing Sample Based Test Event Logs .......................................................... 4-9
Finding Samples .............................................................................................. 4-10
To Find a Sample Using Sample Identification ................................................ 4-10
To Find a Collection of Samples Using Common Reagents ............................ 4-11
To Find a Collection of Samples Using Common Strips .................................. 4-12

Chapter 4: Test Results Results Panel and Results Bar
Results Panel and Results Bar

To view the test results, use the Results panel and the Results bar.
Note: The capacity for data storage on the Echo Lumena PC is approximately 433,000 test results.
Results Panel
The Results panel is located below the Results bar.
Results panel and Results bar
To print results, view the results, and then click the Print button. Refer to Chapter 6 – Echo Lumena Reports for
more information regarding printing reports.
Results Bar
The Results bar is located above the Results panel, and it has four software access buttons.
Results bar above the Results panel with four software access buttons

Commonly Used Symbols Chapter 4: Test Results
The following table describes the actions of the four software access buttons.
Button Description
Display Results – Used to select a batch or sample ID from the menu.

Clicking the button displays results.
Edit Results – Used to view and edit reactions on equivocal results.
Approve Results – Used to approve results for export.
Export Results – Used to export results to LIS.
Commonly Used Symbols

Some symbols are commonly used (in conjunction with the results of samples and the Results panel) to indicate the
status of actions taken with particular results.
The following icon legend illustrates some of the commonly used symbols seen in the Results panel. The diagram
includes a description of the meaning of the symbols.
Symbol Meaning
Pending assay
Pending reflex assay
NTD
Edited
Approved
Edited and approved
Result transmission pending acknowledgement by LIS
Edited and result transmission pending acknowledgement

by LIS
Received by LIS
Edited and received by LIS
Not received by LIS

Chapter 4: Test Results Viewing Test Results
Viewing Test Results

Note: This section is designed only for basic operator access to the results database.
To view test results, use the Results panel and the Results bar. Results are displayed in the Results panel according
to assay scheduling and sample priority.
Note: The order of sample results can be configured to be displayed in the Results panel either in
processing order or alphanumeric order. Refer to Chapter 10 – Configuration for details.
This section describes:

X An example of a report
X Viewing results
X Approving results
X Exporting results
X Editing results
X Alternative method to view, edit, approve, and export results
Example of a Report
Select a sample from the Results panel to display its report by double-clicking the sample ID listed in the Results
panel (or by using the Display Results button on the Results bar, as described in the next section).
The following image displays an example of a report. For more details on reports, refer to Chapter 6 – Echo
Lumena Reports.
Example of a result report

Viewing Test Results Chapter 4: Test Results
Note: When an invalid test result is encountered, clicking that sample ID on the report brings up its
event log, which displays the reason why the test result was invalid. The event logs of valid test
results can also be displayed by the same method.
Viewing Results
This section provides an overview of viewing test results.
To view test results:
1. Double-click the sample ID listed in the Results panel to display the report for that sample. Alternatively,
proceed with step 2.
Note: Batch results can only be viewed using the Display Results button or by the
alternative method described later in this chapter.
2. Click the sample (or batch) ID in the Results panel, and then click the Display Results button on the Results
bar to display the report for that sample or batch.
Display Results button
Approving Results
This section provides an overview of approving test results.
Note: The intended use of the approval process is to provide a method of result authorization. A
result can no longer be edited after approval has been performed on that result.
Note: Results for combination assays cannot be edited or approved until both portions of the assay
are completed. A warning message is displayed if you attempt to edit or approve the results for a
given sample before all processing for that sample is complete.
To approve test results:
1. Click the Approve Results button on the Results bar to approve the selected results.
Approve Results button
An information balloon message is displayed briefly to indicate that the selected result was approved.

Chapter 4: Test Results Viewing Test Results
Information balloon message showing approval for a selected result
The approve symbol appears next to the approved results in the Results panel.
Approved Result symbol
2. You can click the Approve Results button on the Results bar for a second time to deselect results that
were erroneously approved initially.
Exporting Results
This section provides an overview of exporting test results.
Note: Automatic export of results is a configurable option. Refer to Chapter 10 – Configuration for
details of this option.
To export test results:
1. Select the result or batch from the Results panel.
2. With the LIS switched on and active, click the Export Results button on the Results bar to export results.
Export Results button
The export symbol appears next to the exported results in the Results panel.
Once the results are exported, the export symbol is updated based on the export transmission status. The
export transmission status of results is indicated by five icons. Examples of the icons are shown in the table
of commonly used symbols described earlier in this chapter.
Exported results symbols
QC results can also be exported, but it is dependent on how the receiving LIS is configured as to whether the
exported QC result is accepted or not, and whether any error messages are generated.
Results can be exported more than once. However, if the export is performed more than once, you will be required
to respond to a confirmation dialog box asking if you wish to export the result again.

Viewing Test Results Chapter 4: Test Results
Repeat export confirmation dialog box
Editing Results
This section provides an overview of editing test results. Only equivocal results can be edited.
Note: Results for combination assays cannot be edited or approved until both portions of the assay
are completed. A warning message is displayed if you attempt to edit or approve the results for a
given sample before all processing for that sample is complete.
To edit test results:
1. Select the result in question from the Results panel, and then click the Edit Results button on the Results
bar to edit result.
Edit Results button
2. The Edit results window appears for the sample in question. You can then modify the result by first
selecting the well result in question (by highlighting with the blue line) and then selecting the new grade
from the Revised grade drop-down list.
A comment is required when a result is edited, and this must be entered into the Comment for revised
grade field. Click the Close button to close and save. Only equivocal (?) results can be edited.
Edit results window

Chapter 4: Test Results Configuration of Printed Result Reports
Note: Control wells and QC results cannot be edited.
3. The edit symbol appears next to the edited results in the Results panel.
Edited Result symbol
Alternative Method to View, Edit, Approve, and Export Results

An alternative method to view, edit, approve, and export results can be used that requires steps taken within the
results tree of the Results panel:
1. To select the sample ID in the results tree of the Results panel, hover the cursor over that required ID, and
then right-click over that sample ID.
2. Click to select View, Edit, Approve, or Export when the submenu is displayed. The View, Edit, Approve, or
Export results function for the selected sample ID is accessed by selecting the appropriate submenu item.
Display of alternative method to view, edit, approve, and export results
Refer to Chapter 7 – Troubleshooting for details regarding Event log and Result file functions (as shown in the
previous screen image).
Configuration of Printed Result Reports

Refer to Chapter 10 – Configuration for details regarding configuration of test results
Viewing Test Well Scores and Sample Event Logs

The viewing and documentation of test well scores can be used as a troubleshooting tool. This score information
can be useful when troubleshooting unexpected negative, positive, or equivocal reactions.
The sample based test event logs can be used as a troubleshooting tool to investigate problems that occur during
sample processing.
This section contains information on how to:

X View test well scores
X View sample based test event logs

Viewing Test Well Scores and Sample Event Logs Chapter 4: Test Results
Viewing Test Well Scores

The following instructions describe how to view test well scores:
then right-click over that sample ID.
2. Click to select Result file when the submenu is displayed. A list of information is then displayed to the right
of the Results panel.
3. Scroll down the information list to find the section labeled [Reactions] where the test well scores are
displayed.
Display of test well scores
4. You can either make a note of the test well scores or print a paper copy using the Print button on the
toolbar or clicking the Print submenu item from the File item on the pull-down menu.
5. After viewing or printing the result file, you can close the file using the red (X) close button (if the file is
minimized or at half screen) or by using the black (X) close button (if the file is at full screen).
Note: The assay threshold value scores (in relation to graded results) are tabled in Regional
Attachments.
Viewing Sample Based Test Event Logs

The following instructions describe how to view sample based test event logs:
then right-click over that sample ID. Click to select Event log when the submenu is displayed. The test
event log for that sample is then displayed to the right of the Results panel.
2. You can either make a note of the event log information or print a paper copy using the instructions
described in Chapter 6 – Echo Lumena Reports. You can also right-click over the log and select Print from
the displayed submenu.

Chapter 4: Test Results Finding Samples
3. After viewing or printing the event log, you can close the log using the red (X) close button (if the log is
minimized or at half screen) or by using the black (X) close button (if the log is at full screen). You can also
right-click over the log and select Close from the displayed submenu.
Note: The test event log can also be accessed using the Event log link in the sample report.
In this case, you can return from the test event log back to the sample report using the
Back link. This link is also displayed on the log when accessed via this Results panel
method. However, in this method, the Back link is inactive.
Display of Test event log
Finding Samples
This section describes how to find a specific sample or a collection of samples (categorized by the use of a
common reagent or strip) in the Results panel, including how to:
X Find a sample using sample identification
X Find a collection of samples using common reagents
X Find a collection of samples using common strips
To Find a Sample Using Sample Identification

By clicking the Find a Sample button from the Toolbar, you can search for a sample in the database files.
Find a Sample button on the toolbar
The Find a sample window can be used to highlight all test results for a selected sample ID in the Results Panel.
This window can also be accessed through the Edit function of the pull-down menu (using the Find sample menu
item). The list of samples is displayed in barcode-derived numerical and alphabetical order.
The selected sample ID in the Find a sample window is highlighted with a blue background. When the window is
opened, the top item in the list is the default selected item. You can change that selection as needed by using the
keyboard, using the handheld scanner, or scrolling down the list of sample IDs.
The keyboard can be used to search for a sample in the Find a sample window. As the sample ID is typed, the first
matching sample ID is highlighted with a blue background. Once the sample ID is found in the list, click OK to
select the sample.

Finding Samples Chapter 4: Test Results
The handheld scanner can be used to search for a sample in the Find a sample window. When a sample barcode is
scanned by hand and is successfully found on the list, the sample ID is then highlighted in bold in the Results panel,
and the Find a sample window automatically closes.
The mouse or touch screen monitor can be used to scroll through the list of sample IDs in the Find a sample
window. Once the sample ID is found in the list, click OK to select the sample.
Only one sample ID can be searched for at a time. The sample ID is then highlighted in bold in the Results panel
when it is selected, and the Find a sample window automatically closes.
Find a sample window
Click Cancel to close the Find a sample window.
To Find a Collection of Samples Using Common Reagents

The Find a reagent window can be used to highlight a collection of sample IDs in the Results panel that have the
use of a reagent in common.
This window can only be accessed through the Edit function of the pull-down menu (using the Find reagent menu
item). The list of reagents is displayed in barcode-derived numerical order. The selected reagent in the Find a
reagent window is highlighted with a blue background.
When the window is opened, the top item on the list is the default selected item. You can change that selection as
needed. Only one reagent can be selected at one time. Details of the selected reagent are displayed in the Selected
reagent area of the window.
The search criteria can be expanded to include samples within the collection that were tested with a common
reagent type or lot number. You can do this by selecting one of the three radio buttons for Reagent type, Lot
number, or Barcode within the Match area of the window. Only one of the radio buttons can be selected at one
time. The default radio button is Barcode.

You can then click OK to select the collection of samples that have the reagent usage in common. The collection of
samples is then highlighted in bold in the Results panel when the common reagent is selected, and the Find a
reagent window automatically closes.
Find a reagent window
Click Cancel to close the Find a reagent window.
To Find a Collection of Samples Using Common Strips

The Find a strip window can be used to highlight a collection of sample IDs in the Results panel that have the use of
a strip in common.
This window can only be accessed through the Edit function of the pull-down menu (using the Find strip menu
item). The list of strips is displayed in barcode-derived numerical order. The selected strip in the Find a strip window
is highlighted with a blue background. When the window is opened, the top item on the list is the default selected
item. You can change that selection as needed. Only one strip can be selected at one time. Details of the selected
strip are displayed in the Selected strip area of the window.
The search criteria can be expanded to include samples within the collection that were tested with a common strip
type or lot number. You can do this by selecting one of the three radio buttons for Strip type, Lot number, or
Barcode within the Match area of the window. Only one of the radio buttons can be selected at one time. The
default radio button is Barcode.
You can then click OK to select the collection of samples that have the strip usage in common. The collection of
samples is then highlighted in bold in the Results panel when the common strip is selected, and the Find a strip
window automatically closes.

Finding Samples Chapter 4: Test Results
Find a strip window
Click Cancel to close the Find a strip window.


Chapter 5: Maintaining the Echo Lumena
Chapter 5: Maintaining the Echo Lumena

In This Chapter:
Chapter 5: Maintaining the Echo Lumena ............................................................... 5-1
Maintenance Tasks Interval Summary Table ........................................................ 5-3
Accessing the Maintenance Window................................................................... 5-4
Daily Maintenance .............................................................................................. 5-7
Refilling the PBS Supply Container .................................................................. 5-7
Emptying the Waste Container ...................................................................... 5-10
Initializing the Instrument ............................................................................... 5-13
Cleaning the Instrument................................................................................. 5-16
Checking the Probe Alignment ...................................................................... 5-17
Checking the Probe Vertical Position ............................................................. 5-19
Performing the Washer Residual Volume Test (Visual) .................................... 5-21
Performing Quality Control on the Echo Lumena ............................................ 5-22
Weekly Maintenance......................................................................................... 5-25
Shutting Down the Instrument and Computer ................................................ 5-25
Archiving Results and Deleting from the Database ......................................... 5-26
Monthly Maintenance ....................................................................................... 5-29
Decontamination (Decontaminate/Flush/Purge/Prime).................................... 5-29
Wiping Down the Probe Splash Guard........................................................... 5-33
Performing the Washer Residual Volume Test (Measured) .............................. 5-34
Performing the Washer Dispense Accuracy Test ............................................ 5-36
As Needed Maintenance .................................................................................. 5-38
Cleaning the Probe........................................................................................ 5-38
Priming the Probe ......................................................................................... 5-39
Performing the Probe Accuracy Test ............................................................. 5-40
Calibrating the Probe ..................................................................................... 5-43
Performing the Fluidics Test .......................................................................... 5-44
Performing the Washer Basic Test ................................................................. 5-46
Priming the Washer ....................................................................................... 5-48
Unlocking the Strip Trays............................................................................... 5-49
Retrieving the Strip Holders ........................................................................... 5-50
Installing the Priming Strip Holder .................................................................. 5-51
Cleaning of Barcode Scanner Mirrors ............................................................ 5-53
Calibrating the Camera .................................................................................. 5-54
Checking the Camera Alignment ................................................................... 5-55
Calibrating the Centrifuge .............................................................................. 5-56
System Shutdown ......................................................................................... 5-58
Field Service Preventative Maintenance............................................................. 5-60

Chapter 5: Maintaining the Echo Lumena Maintenance Tasks Interval Summary Table
Warning: Maintenance tasks for the Echo Lumena verify that specific modules of the instrument are
functioning at the required specifications or they are preventative maintenance tasks. The tasks
described in this chapter are critical to the Echo Lumena assay performance.
If software-driven maintenance tasks are not successfully performed within the required time interval
that you have configured, then assays will not run.
For example, the initialize instrument task is required to be performed daily. If you do not perform
the daily initialize instrument task, then all assays are locked down and no assays can be run.
Note: You can log documentation of maintenance tasks onto the maintenance form: Echo Lumena
Maintenance Record. The master copy of this record sheet is located in Appendix B – Maintenance
Records of this manual.
You can configure the Echo Lumena software to define monthly as 31 or 30 days (or a more
frequent time period). You can successfully perform any maintenance task before the required time
interval date you have configured. If you do, the next required time interval date for that task remains
automatically calculated from that last task date.
For example, if you performed a weekly task after only four days, then the next required date is
calculated as weekly from this latest task date. Daily is defined as a 24-hour period such as 9 a.m.
to 9 a.m.
Information pop-up dialog boxes are often displayed after you perform a manual task or subtask.

Maintenance Tasks Interval Summary Table Chapter 5: Maintaining the Echo Lumena
Maintenance Tasks Interval Summary Table

Maintenance Task Required Interval
Refill PBS supply container Daily
Empty waste container Daily
Initialize instrument Daily
Clean instrument Daily
Check probe alignment Daily
Check probe vertical position Daily
Washer residual volume test (visual) Daily
Reagent QC Daily
Instrument and computer shutdown 7 days
Archive results and delete from database 7 days
Decontamination Monthly
(decontaminate/flush/prime/purge)
Wipe down probe splash guard Monthly
Washer residual volume test (measured) Monthly (and as needed)
Washer dispense accuracy test Monthly (and as needed)
Clean probe As needed
Prime probe As needed
Probe accuracy test As needed
Calibrate probe As needed
Fluidics test As needed
Washer basic test As needed
Prime washer As needed
Unlock strip trays As needed
Retrieve strip holders As needed
Install priming strip holder As needed
Clean barcode scanner mirrors As needed
Calibrate camera As needed
Check camera alignment As needed
Calibrate the centrifuge As needed

Chapter 5: Maintaining the Echo Lumena Accessing the Maintenance Window
Note: Immucor recommends that you completely shut down the Echo Lumena computer every
week to prevent potential long-term memory leakage.
Accessing the Maintenance Window

The Maintenance window (Schedule tab) lists all of the software-driven maintenance tasks (under the Item column)
that are available on the Echo Lumena, along with the Frequency, the date the Last task was performed, and the
date the Next task is required.
There are some non-software-driven maintenance tasks, such as refilling the PBS supply container, that are not
listed in the Maintenance window. As the operator, it is your responsibility to perform and track these non-software-
driven tasks. These non-software-driven tasks are listed on the Echo Lumena Maintenance Record in Appendix B –
Maintenance Records, and they are also described in this chapter.
This section describes how to access the Maintenance window.
To access the maintenance window:
1. From the pull-down menu, click Tools, and then click Maintenance from the Tools submenu.
Pull-down menu
The system displays the Maintenance window (Schedule tab).
Maintenance window (Schedule tab)
A maintenance activity is selected by highlighting (clicking) the required line. That selected line will then be
highlighted in blue. The previous image is an example of highlighting Check camera alignment.

Accessing the Maintenance Window Chapter 5: Maintaining the Echo Lumena
By clicking the Close button in the Maintenance window Schedule tab, you can close the Maintenance window and
return to the Echo Lumena main screen display.
By clicking the Run button on the Maintenance window Schedule tab, the software displays on-screen instructions
(Maintenance window Run tab) for the selected maintenance task (highlighted in blue on the Schedule tab).
The Maintenance window Schedule tab lists the following information:
1. The task (Item) name.
2. The Frequency that the maintenance task (Item) is required to be performed. This interval can be set and
adjusted using the Perform selected item every field and the Up or Down arrow buttons. The maintenance
task (Item) interval that is being set must be highlighted in blue.
• If you configure the number of days at 1, the task is displayed as Daily under the Frequency
column.
• If you configure the number of days at 7, the task is displayed as Weekly under the Frequency
column.
• If you configure the number of days at any other number apart from 1 or 7, the task is displayed as
Every x days under the Frequency column (where x is the number of configured days).
• If you configure the number of days at 0, the item is displayed as Never under the Frequency
column. Under the Never configuration, there is no software control to mandate performance of
this task. This item can be completely ignored under the Never configuration. However, the tasks
that you are allowed to configure to Never are limited by preset frequency ranges within the
software.
Warning: You can configure each maintenance item to your own on-site requirements, but you are
limited by software-defined frequency ranges. If you click the Up or Down arrow buttons for a given
task, the number only increases or decreases to the preset limits for that particular task. If you try to
type in a number which is out of range, the number will change to the nearest allowed value to the
number that you typed in. The recommended frequency of performance for each maintenance task
is published in this chapter as part of product labeling.
If you configure a particular task to a fixed number of days, another operator (as long as they do not have the same
user access rights to also change maintenance frequency) cannot increase the interval above that value, but they
can perform those tasks more frequently than defined by you. This process is a method used to define a fixed
upper interval limit; for example, the fixed upper interval limit for Decontaminate instrument is Every 31 days. This is
equivalent to Monthly (based on the number of days equating to most calendar months).
In this instance, you cannot exceed 31 days, but you can perform this item more frequently, if required. This flexible
performance feature is useful to cover this task in February. In this instance, it is your responsibility to monitor the
monthly calendar. If you do not perform this task within the time interval limit and exceed the 31 days, then the task
is marked as Due under the Next column.
The date in the Last column is the date that the maintenance task (Item) was last performed.
The date in the Next column is the date that the selected maintenance task (Item) is Next required to be performed.
If the performance interval of a particular item is exceeded, the item is marked as Due under the Next column.
By clicking the Run button on the Maintenance window Schedule tab, the software displays on-screen instructions
(Maintenance window Run tab) for the selected maintenance task (highlighted in blue on the Schedule tab). You
must follow the on-screen instructions. The following example is for the decontaminate instrument task.

Chapter 5: Maintaining the Echo Lumena Accessing the Maintenance Window
Alternatively, software-driven maintenance items can be accessed by selecting the necessary item from the drop-
down list at the bottom of the Run tab. This is an alternative method to display the relevant on-screen instructions.
Example of a Maintenance window Run tab: Decontaminate instrument
The Maintenance window Run tab displays detailed instructions required to perform the maintenance task (Item)
that you selected. You can start the selected maintenance task by clicking the Start button.
Warning: Not all maintenance tasks described in this chapter are listed on the software Maintenance
window Schedule tab—for example, Refill PBS Supply Container and Removal and Replacement of
the Probe. Dates of such non-software-driven maintenance tasks can be documented and tracked
on the Echo Lumena Maintenance Record in Appendix B – Maintenance Records.
The system displays a message at the bottom of the screen if maintenance tasks are due. The Maintenance screen
can be directly accessed by clicking the message, so that maintenance can then be completed. The following
image is an example of a maintenance due message.
Example of a maintenance due message

Daily Maintenance Chapter 5: Maintaining the Echo Lumena
Daily Maintenance
Refilling the PBS Supply Container
This section describes how to refill the supply container.
Purpose
The purpose of refilling the PBS supply container is to ensure that there is sufficient PBS to process the sample
workload.
Required Interval
You must perform this task at least every day the instrument is in use and refill as needed. An alert message is
displayed on the bottom of the screen, signifying when the buffer container is low.
“The buffer container is low” alert message
Tools
• Funnel
Instructions
Warning: Immucor requires the use of phosphate-buffered saline (PBS) which is prepared by
using an Immucor approved commercially available product. Refer to Regional Attachment for
details.
Warning: The instrument cannot differentiate between water and system fluid. If deionized water
is mistakenly used as the system fluid, the test results are invalid.

Chapter 5: Maintaining the Echo Lumena Daily Maintenance
Follow this procedure to refill the PBS supply container:
Step Action
1 Lift the fluidics module lid to access the PBS supply container, and secure the lid in place by manually
locking the left-hand side support bracket. There is no need to reposition the keyboard, mouse, or
handheld scanner when lifting the lid, because these items nestle safely in the space between the
raised lid and the monitor.
Warning: To reduce the risk of operator injury, when either (a) lifting the fluidics module lid
or (b) returning the lid back to its horizontal position, confirm that either (1) the lid is
securely locked in place using the support bracket, or (2) gently lower the lid, respectively.
Note: PBS can be added during instrument operation.
2 Remove the cap from the PBS supply container.
3 Using the funnel, add PBS to the PBS supply container.
4 Remove the funnel, and securely replace the cap back onto the PBS supply container.
5 Return the fluidics module lid to the horizontal position by manually unlocking the left-hand side support
bracket and allowing the lid to gently return to the horizontal position. If the keyboard mouse or
handheld scanner has shifted, reposition them on the top of the fluidics module lid for your
ergonomically friendly use.
PBS supply container
Warning: It is not routinely necessary or recommended to disconnect the PBS supply container
from the fluidics module. All tests in progress will be aborted if the PBS supply container is
disconnected from the fluidics module during Echo Lumena operation. However, if this
disconnection does occur, there is only one correct sequence with which to reconnect the
container.
There are two labels adhered to the container instructing you how to reconnect.

Follow this procedure to reconnect the PBS supply container:
Step Action
1 You must reconnect the buffer fluid tubing.
Step 1 label: To reconnect the buffer fluid tubing of the PBS supply container
2 Reconnect the electrical sensor plug into the back of the Fluidics module. If the Echo Lumena is
powered on and initialized, the Echo Lumena performs an automatic PBS prime to remove all in-line
trapped air bubbles after this step is completed.
Step 2 label: To reconnect the electrical sensor plug into the Fluidics module
Three exceptions exist where disconnection of the PBS supply container is required, and they are when performing
three as-needed maintenance tasks—the removal and replacement of the 1000 μL and 100 μL syringes, the
removal and replacement of the peri-pump, and decontamination.

Emptying the Waste Container

This section describes how to empty the waste container.
Note: Based on your local regulations, the Echo Lumena can be setup to have waste disposed from
the waste container directly to a drain used for biohazardous waste.
Purpose
The purpose of emptying the waste container is to maintain empty space in the waste container for the collection of
waste fluids (into the waste container).
Required Interval
You must perform this task at least every day the instrument is in use or when the waste container is full. An alert
message is displayed on the bottom of the screen signifying when the waste container is full.
“The waste container is full” alert message
Tools
• Waste shuttle container and associated tubing

Instructions
Follow this procedure to empty the waste container:
Step Action
1 Attach the waste shuttle container (with associated tubing) to the waste container (using the draining
connector tubing linked to the waste container) to drain the waste container.
Note: This can be performed while the instrument is running.
2 After the waste fluid has drained from the waste container into the waste shuttle container, detach the
waste shuttle container.
Warning: Failure to disconnect the waste shuttle container after the waste container has
been drained can result in spillage of biohazardous material.
3 Discard the biohazardous waste fluid from the waste shuttle container according to your local onsite
regulations.
Instrument waste container

used micro-well strips, or consumed liquid reagent vials. All blood samples, liquid
waste, used micro-well strips, and consumed liquid reagent vials must be discarded
following the standard practice of the laboratory.
All blood products must be treated as potentially infectious. No known test methods
can offer assurance that products derived from human blood will not transmit infectious
agents.
Note: Waste can be drained during instrument operation using the shuttle container.
Disconnecting the waste container during operation will abort all tests in progress and
potentially cause a biohazardous spill.

Follow this procedure to remove and reconnect the waste container:
Step Action
1 Disconnect the electrical sensor plug on the waste container from the back of the Fluidics module.
2 Unscrew the waste container cap from the top of the waste container and remove the waste container
from the Fluidics module.
3 Discard the biohazardous waste fluid from the waste container according to your local onsite
regulations.
agents.
Note: Waste can be drained during instrument operation using the shuttle container.
Disconnecting the waste container during operation will abort all tests in progress and
potentially cause a biohazardous spill.
4 Place the waste container on the left side of the Fluidics module and screw the waste container cap on
the top of the waste container.
5 Reconnect the electrical sensor plug into the back of the Fluidics module.
Three exceptions exist where disconnection of the waste container is required, and they are the removal and
replacement of the 1000 μL and 100 μL syringes, the removal and replacement of the peri-pump, and
decontamination.

Initializing the Instrument

This section describes how to initialize the instrument.
Purpose
The purpose of initializing the instrument is to verify hardware modules and check modular functionality. Initialization
primes all of the tubing and self-tests the Echo Lumena processes.
Required Interval
You must perform this task every day the instrument is in use.
Tools
None

Instructions
Follow this procedure to initialize the Echo Lumena:
Step Action
1 Click the Initialization button on the toolbar.
Initialization button on the toolbar

The Initializing window is displayed. The Initializing window lists the sequence of the Echo Lumena
initializing tasks (as shown in the following window). Each task is highlighted with a blue line as it starts.
A Progress bar at the bottom of the window indicates the progress of the tasks.
Initializing window
During the initialization process, you will be prompted by an on-screen message to place two empty
strip trays into the top two positions of the strip loading bay. This following image displays the
message.
Initialization message to load empty strip trays

The LEDs for the top two strip loading tray positions will be flashing in conjunction with this message,
indicating that task is required in those two tray positions.

Step Action
2 After inserting the trays, you must then click the OK button of the message to proceed. The LEDs for
the top two positions will then stop flashing after clicking OK.
Before initialization finishes, you will also be prompted to remove the top two strip trays. The following
image displays this message.
Initialization message to remove top two strip trays
3 Once the trays are removed, you must then click the OK button in the message. Initialization is then
automatically completed.
Note: You must ensure that all strip holders on the instrument contain strips. An empty
strip holder on the instrument may cause a component of initialization to fail.
Refer to Chapter 7 – Troubleshooting for information regarding error messages and error recovery in the event of
failure of any of the components during initialization.

Cleaning the Instrument

This section describes how to clean the instrument.
Purpose
The purpose of cleaning the instrument is to maintain a clean instrument cover and instrument casings.
Required Interval
Tools
• Alcohol pads
Instructions
Follow this procedure to clean the instrument:
Step Action
1 Wipe down the external instrument casings, cover, and external surfaces with alcohol pads.

Checking the Probe Alignment

This section describes how to check the probe alignment.
Purpose
The purpose of checking the probe alignment is to ensure that the probe is correctly aligned. This maintenance task
must be performed each day of use, when a new probe is installed, when an existing probe is removed and
reinstalled, or when there is a reason to suspect that the probe may have been bent. This procedure allows you to
visually confirm that the probe is properly aligned with the probe alignment hole.
Required Interval
Tools
None

Instructions
Follow this procedure to check the probe alignment:
Step Action
1 Select Check probe alignment from the drop-down list on the Run tab of the Maintenance window and
then click Start to check the probe alignment. You must follow the on-screen instructions.
Maintenance window: Run tab: Check probe alignment

You can start the selected maintenance task by clicking the Start button.
2 The system displays a Check probe alignment information dialog box asking you: Is the probe aligned
with the alignment hole? After inspecting the probe alignment position, you must click Yes or No to
respond.
Note: As a corrective action, if the probe requires alignment correction, you can gently
rotate the probe to align it correctly.
Check probe alignment information dialog box

Checking the Probe Vertical Position

This section describes how to check the probe vertical position.
Purpose
The purpose of checking the probe vertical position is to ensure that the probe is in the correct vertical position.
This maintenance task must be performed each day of use, when a new probe is installed, when an existing probe
is removed and reinstalled, or after a probe crash is detected.
Required Interval
Tools
None

Instructions
Follow this procedure to check the probe vertical position:
Step Action
1 Select Check probe vertical position from the drop-down list on the Run tab of the Maintenance
window, and then click the Start button to check the probe’s vertical position.
Maintenance window > Run tab > Check probe vertical position
2 An information pop-up dialog box is displayed if the maintenance task was successful – The probe
vertical position check passed.
Check probe vertical position information dialog box

Note: You must visually observe the probe during this task. In the case of a failure, an error
message is generated indicating the probe vertical position check failed. The error
message does not specify if the probe is seated either too high or too low, so you must
visually observe the probe to determine where the probe is seated. The probe will crash if it
is seated too low. If this task fails, you must correct the problem before repeating this task
and processing any assays.
3 You must then click OK in the information dialog box to proceed.

Performing the Washer Residual Volume Test (Visual)

This section describes how to perform the washer residual volume test.
Purpose
The purpose of performing the visual washer residual volume test is to check that the washer residual volume does
not exceed the acceptable range.
You must investigate and correct the root cause of any washer residual volume test failures. An excessive volume
of residual saline that remains after a washing cycle can lead to neutralization of Capture Indicator Red Cells,
resulting in potentially false negative results and/or problems related to the reading of well reactions by the camera.
Note: Refer to Performing Washer Residual Volume (Measured) later in this chapter when
performing monthly maintenance or when removing and replacing the wash manifold or syringe cap
and seal or washer tubing.
Required Interval
You must perform this task every day the instrument is in use (visual check only and do not weigh).
Tools
• Two (2) Capture strips
• One (1) strip holder and one (1) strip tray
• Daily Worksheet
Note: Although strips may be reused for performing the daily visual check, it is recommended that
the Capture strips used be replaced once per week.
Instructions
Follow this procedure to perform the washer residual volume test if performed daily:
Step Action
1 Select the Washer residual volume test from the drop-down list on the Run tab of the Maintenance
window.
2 Place two (2) Capture strips into a strip holder, and then insert this holder into position 1 of a strip tray.
3 Load the strip tray from step 2 into strip tray position 1 of the strip tray loading bay.
4 Click the Start button on the Run tab to start the task.
5 Immediately remove the two (2) strips from strip tray and the holder (from steps 2 and 3) when the test
is complete, and visually verify the level of residual saline for all wells of both strips. The level of residual
volume for every well should present as a thin meniscus of fluid inside the bottom of the well.

Performing Quality Control on the Echo Lumena

This section describes how to perform quality control (QC).
Purpose
The purpose of QC is to:
• Verify that the reagents are reacting appropriately in case of deterioration of sensitivity or specificity,
through inappropriate shipping or storage conditions or microbial or chemical contamination.
• Verify that the instrument is performing correctly.
The Echo Lumena incorporates several types of serological and physical process controls to verify reagent and
instrument performance.
Process Controls
Color checks are performed using the analysis of images taken during the processing of ABO and Rh (D) grouping
tests to verify that reagents have been added to all of the required micro-wells. The system checks for the presence
of blue color after the addition of Anti-A and for the presence of yellow after the addition of Anti-B.
Similarly, image analysis is used to verify the presence of sample red cells in the test wells used for reverse group
reactions, the presence of the LISS and plasma mixture for antibody screening and identification, Weak D and
Crossmatch assays and to identify any test wells containing severely hemolyzed, lipemic, and icteric samples.
Color checks are also used to verify that an intact red blood cell monolayer was formed during assays using
®
Capture-R Select (Weak D, DAT, and Crossmatch).
Internal Assay Serological Controls

Antibody screen and identification assays employ the use of a positive control well to verify that the Capture-R®
Ready Indicator Red Cells were not neutralized during the assay process. The positive control well is coated with an
IgG Anti-D sensitized red blood cell membrane in the manufacturing process.
The antibody identification assays also use a negative control well manufactured as a non-sensitized red blood cell
membrane. The assays that include this type of QC are Screen, Ready ID, Extend I, and Extend II.
Additional reagent controls (DAT Positive Control Cell) are also used to verify Capture-R® Ready Indicator Red Cells
performance within assays utilizing Capture-R® Select micro-well strips. The DAT Positive Control Cell reagent is
manufactured as an IgG sensitized intact red blood cell suspension.
Assays that use these control cells are DAT, Crossmatch, and Weak D.
The process and internal assay control checks are performed automatically by the instrument and require no
operator intervention. Results are invalidated if the correct conditions are not found (for example, a positive control
well does not have a positive reaction, or an Anti-A well does not have the required blue color).
“Whole Blood” Run Controls

In addition to the control processes that occur automatically when each sample is tested, the Echo Lumena can
use WB corQC to perform a daily (or more frequently if desired) test of the hemagglutination and antibody screen
reagents and processes. This process using WB corQC is referred to as “QC” in this section of the manual.
Refer to the package insert for details of antigens and antibodies represented by WB corQC.
When QC is run successfully, all reagents in the assays in which it is run are “qualified” for the duration of the QC
interval. If these reagents are used in other assays, these assays may be run without running QC.

For example, after a successful run of group and screen including WB corQC tubes 1, 2, and 3, the confirm, donor,
or pediatric assays can be run because their reagents have been verified by running QC for group, but the
phenotyping assay Ag_CcEe requires QC because its reagents are not in the group assay, so QC must be run with
any samples that require phenotyping.
When running WB corQC, it must be run at the minimum interval configured (a maximum of 24 hours) and at a
minimum whenever a new lot of reagents is used for the first time. If QC becomes overdue, or reagents from an
unverified lot are loaded, you may be alerted to load a lot of reagent on which a QC has been run. This message
does not specify whether QC needs to be performed or if there is insufficient reagent volume to perform the testing.
The WB corQC tubes may be included in a run with patient/donor samples or tested separately. If the QC samples
are tested in the same run with other samples, they are prioritized and tested ahead of STAT and routine samples.
If the QC samples are included in a run with patient/donor samples and the QC fails, all results from all samples will
be invalidated.
Note: When using WB corQC, all reagents must pass QC prior to, or in conjunction with, assay
processing and must be performed within the specified time limits. The QC results are valid within
the specified time limit, up to a maximum of 24 hours. The specified time limits are configurable. For
more information about this configuration, refer to Chapter 10 – Configuration.
When running WB corQC, it must be processed successfully before sample processing can be completed and
before results can be released for these assay types. Should WB corQC fail, all sample processing relying on the
WB corQC controls will discontinue processing.
Quality Control (QC)

In the event of a QC failure, only those tests that concurrently utilized either the failed reagent in question or the strip
in question will be invalidated.
A QC failure will only cause the QC status of the reagents and strips actually used during the failed QC test to be
failed. For example, if a grouping assay was processing when a Weak D assay failed QC, only the Anti-D reagent
and not the other reagents from the grouping assay will fail.
A QC failure for one assay in a combination assay does not invalidate the other assay portions of the combination
assay.
Required Interval
You must perform this task at least every day the instrument is in use. QC can be configured to be performed on a
more frequent interval. Refer to Chapter 10 – Configuration for information on changing Reagent QC interval.
Tools
Refer to the Echo Lumena Assay Reagent Component Grid in Regional Attachments for the list of reagents used
with reagent QC (which includes the use of the WB corQC vials for each given assay).

Instructions
Follow this procedure to perform reagent QC:
Step Action
1 WB corQC tubes must be centrifuged before use to separate the red blood cells and the supernatant.
2 Load WB corQC into sample racks, and load rack into sample loading bay. Refer to Chapter 3 –
Instrument Testing Operation for proper loading of sample racks.
3 Use the Run Test Wizard to start a test run including WB corQC. Refer to Chapter 3 – Instrument
Testing Operation for navigation of the Run Test Wizard.
Warning: When performing reagent QC for group and screen assays, WB corQC
reagent tubes 1, 2, and 3 must be run together in order for reagent QC to pass.
Warning: When performing reagent QC for phenotyping assays, WB corQC reagent

tubes 1, 2, 3, and 4 must be run together in order for reagent QC to pass. If you run a
phenotyping assay specific for a single antigen, then you only are required to run the
appropriate WB corQC reagent tube as listed in Regional Attachments.
4 Refer to Regional Attachments for the list of assays that require WB corQC and procedural steps for
each assay.
5 After the assays have been completed, document on the Echo Lumena Maintenance Record whether
or not acceptable results were obtained for WB corQC.
Note: If WB corQC results were not acceptable, all of the samples included with the batch
of WB corQC will be invalidated. It will not be possible to schedule tests for grouping,
phenotyping, or antibody screening assays until QC has been run successfully; therefore,
you must troubleshoot the WB corQC results to determine the cause of the QC failure for
the assay that was performed, rectify the cause of the problem, and repeat the tests with
WB corQC.
• If the QC test results are accepted, the next required QC time for the reagents used is moved
forward by the specified QC interval. QC does not need to be repeated until this time unless a
new lot of reagent needs to be used or a new lot of reagent is loaded on the Echo Lumena.
• If the QC results are unacceptable (QC failure), results of all other tests included in the QC run
are invalidated. If QC fails, the cause of the failure must be identified and QC repeated. After a
QC failure, additional tests using the affected reagents may not be started unless the required
WB corQC tubes are included in the run.

Weekly Maintenance Chapter 5: Maintaining the Echo Lumena
Weekly Maintenance
Shutting Down the Instrument and Computer
This section describes how to shut down the instrument and computer.
Purpose
The purpose of shutting down the instrument and computer is to prevent potential long-term computer memory
leakage.
Required Interval
You must perform this task at least every seven days.
Tools
None
Instructions
Follow this procedure to shut down the instrument and computer:
Step Action
1 Shut down the computer and hardware modules. To shut down the computer, you must select the
Shut down submenu item from the File selection on the pull-down menu. When Shut down is selected,
a confirmation dialog box is displayed asking: Are you sure you wish to shut down the computer? You
must click Yes to proceed.
Shut down confirmation dialog box
Note: You can select No if you choose not to shut down the Echo Lumena at this time.
2 Switch off the instrument using the power button on the instrument power supply.
3 After the computer and hardware modules are completely shut down, switch all of the items back on.
4 Refer to Chapter 3 – Instrument Testing Operation for details regarding the correct method to switch
the instrument and computer back on.

Chapter 5: Maintaining the Echo Lumena Weekly Maintenance
Archiving Results and Deleting from the Database

This section describes how to archive results and delete them from the database.
Purpose
The purpose of archiving results and deleting them from the database is to maintain Echo Lumena PC drive space
at an acceptably high available space level, such that the PC continues to function at an acceptably fast speed.
The event log for the current month cannot be deleted during the archive process.
The result tree in the results panel automatically populates with the current results when an archive disk is ejected.
Required Interval
You must perform this task at least every seven days.
Note: The Archive procedure should not be attempted if the Echo Lumena is processing samples or
running any maintenance task.
Tools
• Approved archiving media
Warning: When archiving results once the batch number reaches 100,000 or larger, the Echo
Lumena is unable to copy the files of the 100,000 or larger files to the archive media. However, any
associated batch numbers of 99,999 or less within the same archive process will be archived
without problems. Contact Immucor Technical Support if archiving failure occurs and the batch
number is 100,000 or larger.

Weekly Maintenance Chapter 5: Maintaining the Echo Lumena
Instructions
Follow this procedure to archive results and delete them from the database:
Step Action
1 Insert an acceptable CD-R, DVD-R or DVD+R in the DVD drive of the Echo Lumena PC. Allow the PC
to recognize the disc before beginning the archive procedure (wait approximately 60 seconds after
insertion of the disc before accessing the file management menu option).
2 Log in to the Echo Lumena software (if needed). Select the File management button on the Toolbar or
go to File and select File management.
a. In the Results tab, select the month(s) or individual batches of data you wish to archive by placing
a check beside the month(s) listed.
b. Select the Event logs tab and select the months of event logs you wish to archive.
c. Select the Configuration files tab and select all the configuration files for archival.
d. Verify that the Copy files action item is checked. Verify that the Delete files action item is not
checked.
e. Select the Archive radio button. See screen shots below for guidance.
File management window with appropriate options selected

f. Select Yes to begin the Archive procedure.
Confirmation box displayed before archiving

Chapter 5: Maintaining the Echo Lumena Weekly Maintenance
Step Action
g. As the Archive procedure is in process, a series of progression bars and details for what is
occurring will appear on the screen. The list of messages and screen shot below are examples of
what will appear on the monitor.
• Preparing files
• Optimizing laser intensity…
• Writing files to disc…
• Finalizing writing…
• Verifying disc contents…
Archive window
3 Once all of the files have been copied to the disc, the disc is finalized and will be ejected. A
confirmation dialog will be displayed indicated all files are archived successfully. Click OK to continue.
Information box confirming that all files have been archived

Before deletion of the files, you should verify that the contents of the disc can be viewed. Refer to
Chapter 10 – Configuration for instructions to view archived results.
4 Once the contents of the disc have been verified, the result files can be deleted from the hard drive by
performing the following:
• Repeat step 2.
• For step 2d deselect the Copy files action item and select the Delete files action.

Monthly Maintenance Chapter 5: Maintaining the Echo Lumena
Monthly Maintenance
Decontamination (Decontaminate/Flush/Purge/Prime)
This section describes how to decontaminate the Echo Lumena.
Purpose
The purpose of decontamination is to prevent contamination of or remove contamination from the Echo Lumena. A
sequence of four maintenance items is used to first decontaminate then thoroughly remove all remnants of the
recommended cleaning solution from all areas of the Echo Lumena prior to the restart of routine assay procedures.
1. The decontaminate instrument task pumps the recommended cleaning solution through all fluidics tubing
and devices.
2. The flush instrument task pumps enough volume of deionized water through the Echo Lumena to replace
all fluid in the fluidics tubing and devices.
3. The purge instrument task allows you to purge all liquid from the Echo Lumena. A small amount of residual
fluid is normal.
4. The prime instrument task allows you to prime PBS throughout the Echo Lumena, in all fluidics tubing and
devices.
Required Interval
You must perform this task every month.
Note: Decontamination can be performed either immediately before or after the monthly wiping
down the probe splash guard maintenance task so that the same recommended cleaning solution
can be utilized, thereby improving this maintenance task’s efficiency.
Tools
• Recommended cleaning solutionEcho Lumena
• Deionized water or distilled water

Chapter 5: Maintaining the Echo Lumena Monthly Maintenance
Instructions
Follow this procedure to decontaminate the instrument:
Note: An alert message is displayed on the bottom of the screen signifying that buffer container is
low during the decontaminate instrument, flush instrument, and purge instrument tasks. The
maintenance tasks can be performed while this message displayed. If you leave the Maintenance
window, the Echo Lumena will require sufficient fluid levels to address the alert message before
returning to the Maintenance window or processing assays.
Step Action
1 Decontaminate instrument.
• Prepare a working solution of the recommended cleaning solution according to the
manufacturer’s directions.
Note: Before connecting the PBS supply container, swirl the recommended cleaning
solution inside the container so that it comes in contact with all surfaces. Make sure that
the tubing inside of the PBS supply container is fully extended to the bottom of the
container and not hooked on the inside shelf when reconnecting the container back onto
the instrument. You should perform this check when reconnecting the container during
the decontamination, flushing, purging, or priming of the instrument.
• Connect the PBS supply container with at least 1L of the recommended cleaning solution
• Connect an empty waste container to the system
• Begin the procedure by pressing the Start button
• Once the procedure is complete, allow the recommended cleaning solution to soak for 10
minutes
Maintenance window Run tab: Decontaminate instrument on-screen instructions

Step Action
2 Flush instrument.
• Connect the PBS supply container with at least 1L deionized or distilled water
• Connect an empty waste container
• Press the Start button to begin flushing the system
Maintenance window Run tab: Flush instrument on-screen instructions

Note: The flush instrument maintenance task can be used as a stand-alone task if you
wish to shut down the Echo Lumena for a prolonged period.
3 Purge instrument.
• Connect an empty PBS supply container
• Connect an empty waste container
• Press the Start button to begin purging the system
Maintenance window Run tab: Purge instrument on-screen instructions

Note: The purge instrument maintenance task can be used as a stand-alone task.

Step Action
4 Prime instrument.
• Connect the PBS supply container filled with PBS
• Press the Start button to begin priming the instrument
Maintenance window Run tab: Prime instrument on-screen instructions

Note: The prime instrument maintenance task can be used as a stand-alone task, if
required, as part of the post-replacement procedure for syringe, probe, manifold, or peri-
pump replacement processes.

Wiping Down the Probe Splash Guard

This section describes how to wipe down the probe splash guard.
Purpose
The purpose of wiping down the probe splash guard is to prevent contamination of or remove contamination from
the probe splash guard.
Required Interval
You must perform this task every month.
Note: This task can be performed either immediately before or after the monthly decontamination
maintenance task so that the same resource of the recommended cleaning solution working
solution can be utilized, thereby improving this maintenance task’s efficiency.
Tools
• Recommended cleaning solution
• Dry paper cloth/wipe
Instructions
Follow this procedure to wipe down the probe splash guard:
Step Action
1 Power off both the Echo Lumena and instrument computer.
2 Remove the cover from the instrument.

Note: It is not necessary to remove the probe, but you must take care not to bend it. If
you prefer to remove the probe, follow the instructions in Chapter 8 – Customer
Component Replacement.
3 Clean any crystallized PBS off the probe splash guard using the recommended cleaning solution.
4 Use a dry paper cloth to wipe off any excess cleaning solution from the bottom of the probe splash
guard.
5 If previously removed, reinstall the probe, taking care not to bend it. Perform the required probe
maintenance tasks after the probe is replaced.

Performing the Washer Residual Volume Test (Measured)

This section describes how to perform the measured washer residual volume test.
Purpose
The washer residual volume test should be performed when a new manifold or washer tubing line is installed or
when an existing manifold or washer tubing line is removed and reinstalled. The purpose of performing the washer
residual volume test is to check that the washer residual volume is within the acceptable range.
In addition, this task must be performed on a routine basis (as defined below).
You must investigate and correct the root cause of any washer residual volume test failures. An excessive volume
of residual saline that remains after a washing cycle can lead to neutralization of Capture Indicator Red Cells,
resulting in potentially false negative results and/or problems related to the reading of well reactions by the camera.
Note: The washer residual volume test should be performed in tandem with the washer dispense
accuracy test (method as described in this chapter).
Required Interval
You must perform this task:
• Every month (measure)
• As needed
Tools
• Copy of washer residual volume test maintenance record (master copy located in Appendix B –
Maintenance Records of this manual)
• Electronic balance
• Electronic calculator (optional)

Instructions
Follow this procedure to perform the monthly washer residual volume test:
Step Action
1 Record the serial number of the electronic balance, your initials, date of this task performance, facility
name, and instrument serial number on the washer residual volume test maintenance record.
2 Select Washer residual volume test from the drop-down list on the Run tab of the Maintenance
window.
Maintenance window: Run tab: Washer residual volume test
3 Weigh two (2) Capture strips, and record the weight on the washer residual volume test maintenance
record.
4 Place the two (2) strips from step 3 into a strip holder, and then place the holder in position 1 of a strip
tray.
5 Load the strip tray from step 4 into strip tray position 1 of the strip tray loading bay.
7 Re-weigh the two (2) strips from step 3 when the test is complete, and record the weight on the
washer residual volume test maintenance record.
8 Subtract the weight obtained in step 3 from the weight obtained in step 7, and record that value on the
washer residual volume test maintenance record.
9 Interpret the acceptability of the resulting value based on the published acceptable range, and record
this conclusion on the form.
Note: The acceptable range for washer residual volume is listed on the washer residual
volume test maintenance record.

Performing the Washer Dispense Accuracy Test

This section describes how to perform the washer dispense accuracy test.
Purpose
The washer dispense accuracy test should be performed when a new manifold or washer tubing line is installed or
when an existing manifold or washer tubing line is removed and reinstalled. The purpose of performing the washer
dispense accuracy test is to check that the dispensing of system liquid by the washer is within the acceptable
range.
In addition, this task must be performed on a routine basis (as defined below).
You must investigate and correct the root cause of any washer dispense accuracy test failures. Inadequate
dispensing of system liquid by the washer can lead to under-washing of Capture tests, causing neutralization of
Capture Indicator Red Cells, which can result in potentially false negative results.
Note: The washer dispense accuracy test should be performed in tandem with the washer residual
volume test (method as described in this chapter).
Required Interval
• Every month
• As needed
Tools
• Copy of washer dispense accuracy test maintenance record (master copy located in Appendix B –
Maintenance Records of this manual).

Instructions
Follow this procedure to perform the washer dispense accuracy test:
Step Action
name, and instrument serial number on the washer dispense accuracy test maintenance record.
2 Select Washer dispense accuracy test from the drop-down list on the Run tab of the Maintenance
window.
Maintenance window > Run tab > Washer dispense accuracy test
3 Weigh two (2) Capture strips, and record the weight on the washer dispense accuracy test
maintenance record.
4 Place the two (2) strips from step 3 into a strip holder, and then place the holder in position 1 of a strip
tray.
5 Load the strip tray from step 4 into position 1 of the strip loading bay.
7 Re-weigh the two (2) strips from step 3 when the test is complete, and record the weights on the
washer dispense accuracy test maintenance record.
8 Subtract the weights obtained in step 3 from the weights obtained in step 7, and record those values
on the washer dispense accuracy test maintenance record.
9 Interpret the acceptability of the resulting value based on the published acceptable range, and record
Note: The acceptable range for washer dispense volume is listed on the washer
dispense accuracy test maintenance record.

Chapter 5: Maintaining the Echo Lumena As Needed Maintenance
As Needed Maintenance
Cleaning the Probe
This section describes how to clean the probe.
Purpose
The purpose of cleaning the probe is to maintain the probe in a clean state such that it does not accumulate solid
biohazardous material and generate a situation where there is a risk of clogging the probe. This procedure positions
the probe at the probe rinse station and cleans the interior and exterior of the probe with a buffer solution.
Required Interval
You must perform this task on an as-needed basis.
Tools
None
Instructions
Follow this procedure to clean the probe:
Step Action
1 Select Clean probe from the drop-down list on the Run tab of the Maintenance window, and then click
Start to clean the probe. You must follow the on-screen instructions.
Maintenance window > Run tab > Clean probe

You must click the Start button on the Run tab with Clean probe selected from the drop-down list to
start the clean probe maintenance task.

As Needed Maintenance Chapter 5: Maintaining the Echo Lumena
Priming the Probe

This section describes how to prime the probe.
Purpose
The purpose of priming the probe is to expel any air from the probe to prevent possible dispensing of
sample/reagent and air mixture during pipetting, which could result in small volumes of sample/reagent being
dispensed and thereby yielding inaccurate or erroneous sample results.
This procedure pumps enough buffer solution from the buffer bottle through the probe to fully fill all of the probe
tubing with buffer solution. The prime probe task should be performed when a new probe, syringe, or tubing line is
installed or when an existing probe, syringe, or tubing line is removed and reinstalled.
Required Interval
Tools
None
Instructions
Follow this procedure to prime the probe:
Step Action
1 You can select Prime probe from the drop-down list on the Run tab of the Maintenance window, and
then click Start to prime the probe. You must follow the on-screen instructions.
Maintenance window > Run tab > Prime probe

You must click the Start button on the Run tab with Prime probe selected from the drop-down list to
start the prime probe maintenance task.

Performing the Probe Accuracy Test

This section describes how to perform the probe accuracy test.
Purpose
The probe accuracy test must be performed when a new probe or syringe is installed or when an existing probe or
syringe tubing is disconnected from the instrument. The purpose of performing the probe accuracy test is to check
that the dispensing of liquid by the probe is within the acceptable range.
You must investigate and correct the root cause of any probe accuracy test failures. Inadequate or excessive
dispensing of liquid by the probe can lead erroneous test results.
Note: The probe accuracy test must be performed in conjunction with the calibrate probe, check
probe alignment, and the check probe vertical position tasks (as described in this chapter).
Required Interval
You must perform this task on an as-needed basis and after there has been a probe or syringe replacement or an
existing probe or syringe has been removed and reinstalled on the instrument in order to verify that the correct
volumes of fluid are begin dispensed.
Tools
• Four (4) Capture strips
• Two (2) strip holders and one (1) strip tray
• Copy of the probe accuracy test maintenance record (master copy located in Appendix B – Maintenance
Records of this manual).

Instructions
Follow this procedure to perform the probe accuracy test:
Step Action
name, and instrument serial number on the probe accuracy test maintenance record.
2 Select Probe accuracy test from the drop-down list on the Run tab of the Maintenance window.
Maintenance window > Run tab > Probe accuracy test
3 Label four (4) Capture strips (identify these strips as 1, 2, 3, and 4), and weigh them using the
electronic balance. Record the weights on the probe accuracy test maintenance record.
4 Place the four (4) strips from step 3 into two (2) strip holders, and then place the holders in positions 1
and 2 of a strip tray (left two positions).
5 Load the strip tray from step 4 into strip tray position 1 of the instrument.
6 Place a reagent vial (without a barcode attached) half filled with PBS in position 1 (back position) of a
reagent rack, and then insert this rack into the reagent rack loading bay position 1 (left lane).
Note: The vial must not have a readable barcode on it. In this instance, the Reagents
window will appear when the rack is inserted. Click the Close button to exit the
Reagents window and continue with this task.
Note: Placing the reagent vial in the incorrect location or loading an empty vial will
generate an instrument error.
8 Re-weigh the four (4) strips from step 3 when the test is complete, and record the weights on the
probe accuracy test maintenance record.
9 Subtract the weights obtained in step 3 from the weights obtained in step 8, and record those values
on the probe accuracy test maintenance record.

Step Action
10 Interpret the acceptability of the resulting values based on the published acceptable ranges, and record
Note: The acceptable ranges for washer dispense volume are listed on the probe
accuracy test maintenance record.

Calibrating the Probe

This section describes how to calibrate the probe.
Purpose
The purpose of calibrating the probe is to reset the probe to the correct calibration position, in the event of a probe
replacement.
Required Interval
• On an as-needed basis
• When a probe is replaced or manually repositioned
Tools
None
Instructions
Follow this procedure to calibrate the probe:
Step Action
1 Select Calibrate probe from the drop-down list on the Run tab of the Maintenance window and then
click the Start button. You must follow the on-screen instructions.
Maintenance window > Run tab > Calibrate probe

Performing the Fluidics Test

This section describes how to perform the fluidics test.
Purpose
The purpose of performing the fluidics test is to check that the fluidics is functioning correctly. This procedure tests
the probe fluidics functionality and is additionally run as part of initialization. If this procedure fails during initialization,
you can run the fluidics test separately to clear the problems encountered during initialization.
If the fluidics test fails and you attempt to run tests through the Run Test Wizard, the system displays an error
dialog box stating that you cannot run tests. Click OK in this dialog box to acknowledge the message, and then
proceed to investigate and correct the root cause of the fluidics test failure.
Fluidics Test Steps and Expected Results

There are three main automatic sequential steps of the fluidics test:
1. The external rinse station is level sensed (volume must be zero).
2. The probe is rinsed with 4000 μL of PBS using the peristaltic pump (with the waste pump off), and the
external rinse station is then level sensed (volume must be 500 μL to 3500 μL).
3. The waste pump is run for one second and then turned off. The rinse pump is then run for 0.04 seconds,
and the external rinse station is then level sensed (volume must be from 500 μL to 3500 μL). The waste
pump is then run for one second.
Common Causes for Failure of the Automatic Steps

The table below details several common causes for failure of the three fluidics test steps:
Step Common Causes for Failure
1 The waste tubing is kinked.
The waste pump is not evacuating.
The filter in the rinse station is clogged.
The waste pump could have a vapor lock when the instrument is powered off for extended time
periods.
2 The peri-pump is leaking or failing.
The supply tubing is not connected or is leaking.
3 The rinse tubing is kinked.
The supply tubing is not connected or is leaking.
The rinse pump is not dispensing.
The rinse pump could have a vapor lock when the instrument is powered off for extended time periods.

Required Interval
Tools
None
Instructions
Follow this procedure to perform the fluidics test:
Step Action
1 Select Fluidics test from the drop-down list on the Run tab of the Maintenance window, and then click
Start to run the fluidics test. You must follow the on-screen instructions.
Maintenance window > Run tab > Fluidics test

You must click the Start button on the Run tab with Fluidics test selected from the drop-down list to
start the fluidics test maintenance task.

Performing the Washer Basic Test

This section describes how to perform the washer basic test.
Purpose
The purpose of performing the washer test is to check that the washer is functioning correctly. This procedure is
run as part of initialization. Should the procedure fail during initialization, you can run the washer basic test
independently to clear problems encountered during initialization.
If this procedure continues to fail, you should perform the removal and replacement of the wash manifold procedure
described later in this chapter. Following performance of removal and replacement of the wash manifold, you must
then repeat the washer basic test procedure.
If the washer basic test fails and you attempt to run tests through the Run Test Wizard, the system displays an error
dialog box stating that you cannot run tests. You must investigate and correct the root cause of the washer basic
test failure.
Common Causes for Failure

There are three common causes for a washer basic test failure:
1. The instrument is not primed.
2. One or more washer channels are blocked.
3. If the failure is on all channels, this can be due to the absence of a priming strip.
Required Interval
Tools
None

Instructions
Follow this procedure to perform the washer basic test:
Step Action
1 Select Washer basic test from the drop-down list on the Run tab of the Maintenance window, and then
click Start to begin the washer basic test. You must follow the on-screen instructions.
Maintenance window > Run tab > Washer basic test

You must click the Start button on the Run tab with Washer basic test selected from the drop-down list
to start the washer basic test maintenance task.

Priming the Washer

This section describes how to prime the washer.
Purpose
The purpose of priming the washer is to expel any air from the washer to prevent possible dispensing of PBS and
air mixture during micro-well strip washing, which could result in small volumes of PBS being dispensed and
thereby cause positive control failures on capture testing.
This procedure pumps enough PBS from the buffer bottle through the wash manifold to fully fill all wash manifold
tubing with PBS. Prime washer should be performed when a new manifold or washer tubing line is installed or
when an existing manifold or washer tubing line is removed and reinstalled.
Required Interval
Tools
None
Instructions
Follow this procedure to prime the washer:
Step Action
1 Select Prime washer from the drop-down list on the Run tab of the Maintenance window, and click
Start to prime the washer. You must follow the on-screen instructions.
Maintenance window > Run tab > Prime washer

You must click the Start button on the Run tab with Prime washer selected from the drop-down list to
start the prime washer maintenance task.

Unlocking the Strip Trays

This section describes how to unlock the strip trays.
Purpose
The purpose of unlocking the strip trays is to ensure that all strip trays are removable from the Echo Lumena after a
recovery process but before samples are loaded for routine assay usage.
Required Interval
Tools
None
Instructions
Follow this procedure to unlock the strip trays:
Step Action
1 Select Unlock strip trays from the drop-down list on the Run tab of the Maintenance window, and then
click Start to force the instrument to unlock the strip trays. You must follow the on-screen instructions.
Maintenance window > Run tab > Unlock strip trays

You can start the selected maintenance task by clicking the Start button. Once the strip trays have
been unlocked, you can remove them (as shown in the following photograph).
Removing a strip tray

Retrieving the Strip Holders

This section describes how to retrieve the strip holders.
Purpose
The purpose of retrieving the strip holders is to ensure that all strips are retrieved from the Echo Lumena after a
recovery process but before samples are loaded for routine assay usage. This procedure requires you to place two
empty strip trays into positions 1 and 2 of the strip loading bay. During the procedure, any strip holders held within
the instrument are retrieved and loaded onto predetermined positions on the two empty strip trays. This procedure
is useful after an instrument crash.
Required Interval
Tools
None
Instructions
Follow this procedure to retrieve the strip holders:
Note: You must perform the Unlock strip trays task before performing this task.
Step Action
1 Select Retrieve strip holders from the drop-down list on the Run tab of the Maintenance window, and
then click Start to force the instrument to retrieve the remaining strip holders from the instrument and
place them in one of the ambient incubator trays. You must follow the on-screen instructions.
Maintenance window > Run tab > Retrieve strip holders

You can start the selected maintenance task by clicking the Start button.

Installing the Priming Strip Holder

This section describes how to install the priming strip holder.
Purpose
The purpose of installing the priming strip holder is to replace used priming strips that have been inadvertently
removed from the instrument.
Note: The most common cause of inadvertent removal is if the priming strips were on the transport
during a rinse cycle or initialization and the instrument was powered off at the same time.
Required Interval
Tools
• A pair of CMT Plate strips to be used as priming strips (in the holder)
• One micro-well strip holder
Instructions
Follow this procedure to install the priming strip holder:
Step Action
1 Select Install priming strip holder from the drop-down list on the Run tab of the Maintenance window,
and then click the Start button. You must follow the on-screen instructions.
Maintenance window > Run tab > Install priming strip holder

Step Action
2 An information dialog box with additional instructions is displayed by clicking the Start button.
Information dialog box with instructions
Note: If this task is attempted and the priming strip holder is still present, then the
following error message is displayed. By clicking OK on the error message, the software
returns to the Run page of this maintenance task.
Error message with priming strip holder still in place

Cleaning of Barcode Scanner Mirrors

This section describes how to clean the barcode scanner mirrors.
Purpose
The purpose of cleaning the barcode scanner mirrors is to ensure that sample and reagent vial barcodes are read
by the scanners in the sample and reagent loading bays without the interference of dirt, dust, or smears on the
mirrors. Either one or both of the mirrors are cleaned on an as-needed basis. Reagent and/or sample barcode
scanning errors may indicate the need to clean the mirror(s).
The barcode scanner mirrors are located on either side of the sample and reagent loading bays.
Image of sample and reagent loading bays with mirrors
Required Interval
Tools
• Soft, absorbent wipe material
• Lens cleaner fluid
Instructions
Follow this procedure to clean barcode scanner mirrors:
Step Action
1 Power off both the Echo Lumena and instrument computer.
2 Remove the cover from the instrument.
3 Apply lens cleaner to a piece of soft, absorbent wipe material.
4 Using a single upward swipe, pull the wet absorbent wipe material firmly over the mirror(s). Repeat
until the mirror is clean.
Note: Wiping the mirror in a circular or side to side motion can cause scratches on the
mirror surface which can impact barcode reading by the scanners.
5 Reinstall the instrument cover.
6 Power on the Echo Lumena instrument and PC as described in Chapter 3 – Instrument Testing
Operation. Initialize the Echo Lumena.

Calibrating the Camera

This section describes how to calibrate the camera.
Purpose
The purpose of calibrating the camera is to check that the camera is functioning correctly. This procedure is run
during initialization. Should the procedure fail during initialization, you can run the calibrate camera task to clear
problems encountered during initialization.
Required Interval
Tools
None
Instructions
Follow this procedure to calibrate the camera:
Step Action
1 Select Calibrate camera from the drop-down list on the Run tab of the Maintenance window, and then
click Start to calibrate the camera. You must follow the on-screen instructions.
Maintenance window > Run tab > Calibrate camera

You must click the Start button on the Run tab with Calibrate camera selected from the drop-down list
to start the calibrate camera maintenance task.

Checking the Camera Alignment

This section describes how to check the camera alignment.
Purpose
The purpose of checking the camera alignment is to investigate the camera in the event of initialization or other
camera failures. This maintenance task homes the mirror, picks up the priming strips holder, and positions it to
wells D and E in the top camera chamber, checks the camera alignment, turns off the camera lamp, and then
replaces the priming strips holder. This process is also incorporated as a component of initialization.
Required Interval
Tools
None
Instructions
Follow this procedure to check camera alignment:
Step Action
1 You can select Check camera alignment from the drop-down list on the Run tab of the Maintenance
window, and then click the Start button. You must follow the on-screen instructions.
Maintenance window > Run tab > Check camera alignment

Calibrating the Centrifuge

This section describes how to perform the calibrate centrifuge task.
Purpose
The purpose of performing the calibrate centrifuge task is to enter the specific CENTC calibration value into the
software for a given centrifuge module. The calibrate centrifuge task must only be performed when a new centrifuge
is installed into the instrument.
Required Interval
Tools
• CENTC calibration value provided by Immucor

Instructions
Follow this procedure to calibrate the centrifuge:
Step Action
1 Select Calibrate centrifuge from the drop-down list on the Run tab of the Maintenance window.
Maintenance window > Run tab > Calibrate centrifuge
2 Click the Start button on the Run tab to start the task. The Centrifuge calibration data entry window is
then displayed.
Centrifuge calibration data entry window
3 Use the keyboard to type the Immucor-provided CENTC value into the data entry field.
Warning: Entering an incorrect CENTC value can lead to unexpected instrument errors.
4 Click the OK button of the Centrifuge calibration data entry window to input the CENTC value into the
software and calibrate the new centrifuge.
Note: You can abort the centrifuge calibration process by clicking the Cancel button of
the Centrifuge calibration data entry window.
5 Following calibration of the centrifuge, you must successfully run reagent QC.

System Shutdown
This section describes the operating procedures required to shut down the Echo Lumena system for long periods
of time.
Extended Shutdown for Long Periods

Follow the shutdown procedures listed here if you are taking the instrument out of routine use. Under this context,
shutdown incorporates decontamination and flushing and purging of pumps, manifold, and tubing to prevent
potential salt crystallization buildup and blockages.
Refer to the Decontamination section of this chapter for details.
The full shutdown procedure is divided into three stages described in this section:
• Remove all sample racks, reagent racks, and micro-well strips.
• Remove PBS system liquid by decontaminating, flushing, and purging the system.
• Shut down instrument, computer, and monitor.
The following sections describe the actions you must take to fulfill these steps.
Removing All Sample Racks, Reagent Racks, and Micro-well Strips

Follow this procedure to remove all sample racks, reagent racks, and micro-well strips:
Step Action
1 Remove all samples, reagents, and unused micro-well strips, and store them according to standard
laboratory practices and relevant package insert requirements.
agents.
Warning: Disconnecting the waste container during Echo Lumena operation will abort all
tests in progress.
Note: Waste can be drained during instrument operation.

Removing PBS System Liquid by Decontaminating, Flushing, and Purging the System
Follow this procedure to remove PBS system liquid by decontaminating, flushing, and purging the system:
Step Action
1 Decontaminate the instrument.
2 Flush the instrument.
3 Purge the instrument.
Refer to the Decontamination section of this chapter for details on how to decontaminate the instrument, flush the
instrument, and purge the instrument.
Shutting Down the Instrument, Computer, and Monitor

Follow this procedure to shut down the instrument, computer, and monitor:
Step Action
1 The File submenu list from the pull-down menu includes a Shut down option. You must use Shut down
to turn off the Echo Lumena software.
2 When Shut down is selected, a confirmation dialog box is displayed asking Are you sure you wish to
shut down the computer? You must click Yes to proceed or No to cancel.
Shut down confirmation dialog box
3 Following completion of the Purge instrument maintenance action and closing down the software, you
can switch off the Echo Lumena instrument (at the power supply unit) and the monitor.
Warning: When bringing the Echo Lumena back into service after a prolonged
shutdown, you must run the prime instrument maintenance action with the PBS supply
container filled with PBS prior to running assays on the instrument.

Chapter 5: Maintaining the Echo Lumena Field Service Preventative Maintenance
Field Service Preventative Maintenance

This section provides a list of activities for completing the scheduled annual Field Service Preventative Maintenance
(PM) site visit (only to be performed by Immucor Field Service personnel).
Note: The PM items below are not necessarily listed in the order in which they will be performed by
the Immucor Field Service personnel.
1. Software:
(1.1) Perform entire software backup.
2. Fluidics:
(2.1) Inspect for contamination and leaks (perform decontamination if necessary).
(2.2) Replace the peri-pump tubing.
(2.3) Replace check valves for the washer syringe pump tubing.
(2.4) Replace check valve for the probe rinse pump.
3. Barcode scanners:
(3.1) Inspect barcode scanners (clean if necessary).
4. Camera:
(4.1) Verify camera functionality.
5. Probe:
(5.1) Verify probe functionality.
6. Incubator:
(6.1) Verify incubator functionality.
7. Centrifuge:
(7.1) Verify centrifuge functionality.
8. Robot:
(8.1) Verify robot functionality.
9. Washer:
(9.1) Verify washer functionality.
10. Racks and trays:
(10.1) Inspect all racks and trays to verify ease of removal and insertion.
11. Qualifications:
(11.1) Perform all daily (including reagent QC) and weekly maintenance.
(11.2) Test a minimum of four samples with group screen assay.

Chapter 6: Echo Lumena Reports
Chapter 6: Echo Lumena Reports

In This Chapter:
CHAPTER 6: ECHO LUMENA REPORTS ............................................................... 6-1
Accessing the Categories of Reports ................................................................. 6-2
Categories of Reports ........................................................................................ 6-3
Camera ........................................................................................................... 6-3
Event Log........................................................................................................ 6-6
Instrument Status ............................................................................................ 6-8
Maintenance History ...................................................................................... 6-10
QC Information .............................................................................................. 6-12
Reagent Usage ............................................................................................. 6-13
Statistics ....................................................................................................... 6-14
System ......................................................................................................... 6-19
Test History ................................................................................................... 6-20
Users ............................................................................................................ 6-22
HIS/LIS Transmission Log ............................................................................. 6-23
Printing Reports ............................................................................................... 6-24

Chapter 6: Echo Lumena Reports Accessing the Categories of Reports
Accessing the Categories of Reports

You can access multiple categories of reports from the Reports submenu through the pull-down menu (on the main
Echo Lumena software screen). You can access a specific report by clicking the desired report item on the
submenu.
Reports submenu from the pull-down menu showing Statistics items
Reports submenu from the pull-down menu showing Test history items

Categories of Reports Chapter 6: Echo Lumena Reports
Categories of Reports
This section describes the multiple categories of reports accessed from the Reports submenu:
X Camera
X Event log
X Instrument status
X Maintenance history
X QC information
X Reagent usage
X Statistics (Statistics, Result summary, Reagent performance, Strip performance)
X System
X Test history (Summary, Details)
X Users
X HIS/LIS Transmission Log
Camera
The Camera report shows the most recent image used for camera alignment; the most recent five images that
produced an error, as well as the most recent top and bottom chamber test images; the image leveling statistics;
and the status of the flags for camera calibration, alignment, and bottom chamber test. Use the scroll bar to display
all of the items. Use the red X button in the top right corner to close this report.
Camera Report

Chapter 6: Echo Lumena Reports Categories of Reports
You can display the larger versions of the camera images by clicking one of the smaller versions of the images that
you wish to view (from the row of smaller images at the top of the report).
Alternatively, those larger images can be viewed by scrolling down the report.
The Calibration image displays the camera calibration values. The following image is an example.
Example of Calibration image

The software analyzes three values: Averages, Max diffs, and Deviation. The calibration values are listed in three
columns: Red, Green, and Blue, which is also referred to as RGB (an acronym for the colors). Each pixel within a
camera image has an RGB value. The software analyzes each pixel and calculates the RGB values to determine the
calibration range.
• The Average RGB must be 170 to 190.
• The Max diffs range is 0 to 90.
• The Deviation range is 0 to 20.
If the Averages value is less than 170 or greater than 190, the Max diffs value is greater than 90, or the Deviation
value is greater than 20, then this is classified as a camera calibration failure. In the event of a camera calibration
failure, the Echo Lumena software will automatically adjust the camera settings and retest the camera calibration.
Instrument processing will stop, and the Run Test Wizard will not open when a camera calibration failure occurs. An
error message is also displayed if you try to run tests, indicating that you cannot run tests now and that the most
recent camera calibration test failed. Refer to Chapter 7 – Troubleshooting the Echo Lumena for details of camera
warning and error messages.
You can use the Event Log Report to identify which values caused the camera calibration warning message or
failure. In the event log, Averages value is referred to as Average intensity; Max diffs value is referred to as Pixel
intensity; and Deviation value is referred to as Standard deviation.

The camera displays alignment wells. These alignment well images can be used in the diagnosis of some camera-
related issues.
Alignment well image
Refer to Chapter 5 – Maintaining the Echo Lumena for details of camera alignment.

Event Log
The Event Log report lists the types of events that occurred during a specified date range (with specific data
regarding the time of those events). The event log displays the sample, reagent, and strip identifications and their
locations as the racks and trays are loaded. The event log also records when sample racks, reagent racks and strip
trays are removed.
The date range of a report can be customized using the Starting date and Ending date fields on the Event log
report window.
The system displays a monthly calendar when changing the date range to allow you to easily select the date you
require. All suboptions can be checked by clicking All, and all options can be cleared by clicking None. Selected
event types can be checked using the check boxes of those items in the list.
Click OK to run the report, or click Cancel to cancel.
Event log report window
The available items in the item list box are as follows:

• Information
• Warnings
• Errors
• Log ins
• Maintenance
• QC
• Reports
• Result edits
• Supplies
• Updates
• Camera calibration
• LIS General
• LIS Exports
• LIS Imports
• LIS Queries

The following is an example of an Event Log Report.
Example of Event Log Report

Instrument Status
The Instrument Status report provides detailed information about samples, reagents, and micro-well strips currently
loaded on the Echo Lumena. The following is an example of an Instrument Status report.
Example of an Instrument Status report showing Sample racks, Samples, Reagent racks, Reagents, Strips, and Supplies

Example of an Instrument Status report (after scrolling down) showing Incubators and Instrument initialization status

Maintenance History
The Maintenance History report provides a log of all of the maintenance tasks that have been run. The date range
of the report can be customized using the Starting date and Ending date fields on the Maintenance history report
window. The system displays a monthly calendar when changing the date range to allow you to easily select the
date you require.
Maintenance history report window
Maintenance history report window showing the monthly calendar to change the selected date

The Maintenance History Report will be displayed by clicking OK.
Example of Maintenance History Report

QC Information
The QC (quality control) Information report provides a log of all of the QC tests that have been run. The following is
an example of a QC Information report. This report also describes all reagents that are loaded on the instrument.
Example of a QC Information report

Reagent Usage
The Reagent Usage report provides a log of all of the reagents used during a specified date range, and the
information is categorized according to lot number. The date range of the report can be customized using the
Starting date and Ending date fields on the Reagent usage report window.
The system displays a monthly calendar when changing the date range to allow you to easily select the date you
require. Lot numbers can be designated using the Lot number field.
Click OK to run the report, or click the Cancel button to cancel.
Reagent usage report window
The Reagent Usage report will be displayed by clicking OK.
Example of Reagent Usage report

Statistics
The Statistics report provides a further submenu of statistics items: Statistics, Result summary, Reagent
performance, and Strip performance. The following details all four of these submenu items.
Note: These reports will only display the result information that is currently present in the Results
panel. These reports cannot be used when accessing archived results.
Reports submenu from the pull-down menu showing Statistics items
Statistics
The Statistics report displays the number of tests run per assay type plus the number and percentage of No Type
Determined (NTD) results for each assay. The date range of the report can be customized using the Starting date
and Ending date fields on the Statistics report window. The system displays a monthly calendar when changing the
date range to allow you to easily select the date you require.
Statistics report window

The Statistics report will be displayed by clicking OK.
Example of Statistics report
Result Summary
The Result Summary report displays information about sample tests run during a selected period. The date range of
the report can be customized using the Starting date and Ending date fields on the Summary report window. The
system displays a monthly calendar when changing the date range to allow you to easily select the date you
require.
All samples can be selected by clicking the All button, and all samples can be cleared by clicking the None button.
Samples you wish to investigate can be selected using the check boxes of those samples in the list. Well images
can be included in the report by checking the Include well images check box.
Summary report window

The Result Summary report will be displayed by clicking OK.
Example of Result Summary report
Reagent Performance
The Reagent Performance report analyzes the performance of a reagent and displays a graph depicting the number
of test results within the reaction strength ranges. The date range of a report can be customized using the Starting
date and Ending date fields on the Reagent performance report window. The system displays a monthly calendar
when changing the date range to allow you to easily select the date you require.
All reagents can be selected by clicking the All button, and all reagents can be cleared by clicking the None button.
Reagents you wish to investigate can be selected using the check boxes of those reagents in the list. Files can be
listed by checking the List files check box.
Reagent performance report window

The Reagent Performance report will be displayed by clicking OK.
Example of Reagent Performance report
Strip Performance
The Strip Performance report analyzes the performance of strips and displays a graph depicting the number of test
results within the reaction strength ranges. The date range of the report can be customized using the Starting date
and Ending date fields on the Strip performance report window. The system displays a monthly calendar when
changing the date range to allow you to easily select the date you require.
All strips can be selected by clicking the All button, and all strips can be cleared by clicking the None button. Strips
you wish to investigate can be selected using the check boxes of those strips in the list. Files can be listed by
checking the List files check box.
Click the OK button to run the report, or click the Cancel button to cancel.
Strip performance report window

The Strip Performance report will be displayed by clicking OK.

Example of Strip Performance report

System
The System report provides detailed hardware and PC configuration information. The following is an example of a
System Report.
Example of a System Report (more information is available by scrolling down)

Test History
The Test History report provides a further submenu of test history items: Summary and Details. The following
describes both of these submenu items.
Reports submenu from the pull-down menu showing Test history items
Test History Summary

The Test History Summary report lists the number of tests run per assay within each given month. The following is
an example of a Test History Summary report.
Example of a Test History Summary report
Test History Details

The Test History Details report gives a detailed list of when a sample test was run and the status of that sample
test. The date range of the report can be customized using the Starting date and Ending date fields on the Test
history report window. The system displays a monthly calendar when changing the date range to allow you to easily
select the date you require.

Test history report window
The Test History Details report will be displayed by clicking OK.
Example of a Test History Details report

Users
The User Accounts report lists all of the user accounts and their current permissions. The following is an example of
a User Accounts report.
Example of a User Accounts report

HIS/LIS Transmission Log

An HIS/LIS transmission log can be generated from Reports to display details of the HIS/LIS activity. The HIS/LIS
log item on the pull-down menu must be selected to display the report.
Reports menu displaying HIS/LIS log item
The HIS/LIS Transmission log is displayed on the screen.
HIS/LIS Transmiassion log

The <ACK> abbreviation that is associated with log entries describes the fact that a given packet of results data
has been accepted by the LIS. <ACK> is the abbreviation for acknowledged.

Chapter 6: Echo Lumena Reports Printing Reports
Printing Reports
Based on the previous instructions, you must first display the desired report on the screen before printing a paper
copy. You then have a choice of three methods to print the report. The report will print to the default printer
connected to the Echo Lumena computer.
Note: Make sure the printer supplied with the Echo Lumena is connected to the Echo Lumena
computer, has an adequate supply of paper and is powered on before printing reports.
1. Click the Print button on the toolbar to print the active report.
Print button from the toolbar
2. Click the Print submenu item from the File item on the pull-down menu.
3. Right click on the active report that is displayed on the screen and select Print.

Chapter 7: Troubleshooting
Chapter 7: Troubleshooting
In This Chapter:
Chapter 7: Troubleshooting .................................................................... 7-1
Technical Support .............................................................................. 7-2
Help .................................................................................................... 7-2
Error Codes and Recovery.................................................................. 7-5
Error Codes ..................................................................................... 7-5
Recovery .......................................................................................... 7-6
Audible Alarms.................................................................................... 7-7
Situations and Error Conditions that Generate an Audible Alarm ...... 7-7
Motor Controller Functional Processing Error Codes .......................... 7-8
Board and Axis Identifiers................................................................. 7-8
Troubleshooting Common Errors ........................................................ 7-9
Software Errors ................................................................................ 7-9
Clot Detection Recovery Process ................................................... 7-11
Recovery from Initialization Failure .................................................. 7-12
Prime Strip Holder/Washer Errors .................................................. 7-18
Transport System Errors ................................................................ 7-20
Pipetting System Errors.................................................................. 7-22
Fluidics Errors ................................................................................ 7-26
Camera Errors................................................................................ 7-31
Centrifuge Errors ............................................................................ 7-34
Scanner Errors ............................................................................... 7-35
Archive Errors ................................................................................ 7-40
QC Failure ...................................................................................... 7-42
Interpreting Echo Lumena Images .................................................... 7-45
Atypical Echo Lumena Images .......................................................... 7-46
Atypical Hemagglutination Images .................................................... 7-49

Chapter 7: Troubleshooting Technical Support
Note: The Echo Lumena is designed to automate error-free processing of blood samples.
Nevertheless, errors can occur in practice.
Technical Support
For questions relating to Echo Lumena operational problems, contact Immucor Technical Support. Technical
Support is available 24 hours a day, 7 days a week. Please see Regional Attachments for contact information.
Note: When you encounter an on-screen error or a warning message, it is recommended that you
either make a note of the error or print the screen displayed on your monitor prior to calling
Technical Support so that an accurate diagnosis can be made. Press the Print Screen key on the
keyboard to print the screen using the printer.
Help
The Help submenu from the pull-down menu gives options to display both the Help window (using the Help
submenu item) or the instrument identifying data (using the About submenu item).
The Help window allows access to both the Online user manual link and the blud_directsm link.
The Online user manual link is used in conjunction with an Immucor-supplied disc that contains an electronic
version of the operator manual.
The blud_direct link is used to communicate electronically with Immucor Technical Support for help.
Help window
Note: This Help window can also be accessed by pressing the Help button from the toolbar.
Help button on toolbar

Help Chapter 7: Troubleshooting
Using Online Help Manual

You must click the Online user manual link to display the operator manual Table of Contents. The sections within
the Table of Contents are hyperlinked.
Online help displayed on the screen
You must ensure that the Immucor-supplied operator manual disc is inserted into the disc drive before attempting
to access the drive using the Online user manual link. If the disc is not inserted and you attempt to access the disc
drive, an error message displays stating: The page cannot be displayed. The online help information is displayed on
the screen if the disc is inserted correctly. You can use hyperlinks and scrolling to navigate the help information.
Note: The intended use for the online help CD is only for insertion into the Echo Lumena PC disc
drive and not with any other drive of any other PC type, such as a desk top PC.
You can right-click over an open on-screen operator manual chapter to display a selection menu (as shown in the
following image). You can then click the Back item on the menu to return your display to the Table of Contents
(without closing the manual). From there, you can open another chapter. Alternatively, you can click the Close item
to close the manual.
Example of Back function

Chapter 7: Troubleshooting Help
Using blud_direct Help

blud_direct is used to communicate electronically with Immucor Technical Support and is accessed via the
blud_direct link in the Help window.
blud_direct link
You must click the link to open the Enter session window. You must then enter the correct session ID (as
designated by Immucor Technical Support) into the Enter session field and click the Send button.
The session ID assigned to you by Immucor must be entered into your Enter session field and then sent within
fifteen (15) minutes of assignment, otherwise it will expire and a new session ID will have to be assigned to you.
Enter session window
An error message stating: Session not found is displayed if an incorrect session ID is entered. If the ID is correct,
then a line of communication with Technical Support is established.

Error Codes and Recovery Chapter 7: Troubleshooting
Error Codes and Recovery

Error Codes
This section is dedicated to the troubleshooting of problems and errors that may be generated with the Echo
Lumena instrument.
The message numbers and descriptions of the messages (with some recovery information) are described in the
following section:
X Information messages (1000 series)
X Information balloon messages (2000 series)
X Warning messages (3000 series)
X Warning balloon messages (4000 series)
X Error messages (5000 series)
X Instrument error messages (6000 series)
X Warning error balloon messages (7000 series)
X Yes or no messages (8000 series)
Information Messages (1000 series)

Information messages (or dialogs) are used to inform you of instrument status or to provide instruction on how to
proceed with instrument use. Information messages are generated by the instrument software in response to
particular instrument scenarios. The following is an example.
Example of information message: 1410: The probe vertical position check passed.
Information Balloon Messages (2000 series)

Information balloon messages are used to inform you of instrument status or provide instruction on how to proceed
with instrument use. The following is an example.
Example of information balloon message: 2400: Approval
Warning Messages (3000 series)

Warning messages are used to inform you of unacceptable situations or operator actions. Warning messages are
generated by the instrument software in response to unacceptable situations or operator actions.

Chapter 7: Troubleshooting Error Codes and Recovery
Warning Balloon Messages (4000 series)

Warning balloon messages are used to inform you of unacceptable situations or operator actions. Warning balloon
messages are generated by the instrument software in response to unacceptable situations or operator actions.
The following is an example.
Example of warning balloon message: 4450: No instrument detected.
Error Messages (5000 series)

Error messages are used to inform you of Echo Lumena errors. Error messages are generated by the
instrument software in response to Echo Lumena errors.
Instrument Error Messages (6000 series)

Instrument error messages are used to inform you of instrument errors. Instrument error messages are generated
by the instrument software in response to instrument malfunction.
Warning Error Balloon Messages (7000 series)

Warning error balloon messages are used to inform you of error situations and are generated by the instrument
software.
Yes or No Messages (8000 series)

Yes or no messages are confirmation of action dialogs requiring a Yes or No response by you. You must press the
Yes button to perform the stated action or press the No button to cancel the stated action. Yes or no confirmation
messages are generated by the instrument software in response to an instrument or operator action.
Recovery
After an error occurs, it is sometimes necessary to restart the instrument. Performing initialization is the first step of
recovery. Refer to Chapter 5 – Maintaining the Echo Lumena for details about the recovery process.
When a 5000 or 6000 series error occurs, the Echo Lumena will begin aborting all instrument level activities. Once
the abort process occurs, the Echo Lumena and Echo Lumena computer will need to be restarted. The Echo
Lumena computer is shut down by pressing the power button on the front of the computer. Refer to Chapter 3 –
Instrument Testing Operation for information on restarting the Echo Lumena.

Audible Alarms Chapter 7: Troubleshooting
Audible Alarms
Audible alarms are used by the instrument to alert you to many different situations and error conditions. The alarms
signal the completion of some operator tasks and also supplement visual on-screen messages.
A list of situations and error conditions that generate an audible alarm is provided in the following section.
Situations and Error Conditions that Generate an Audible Alarm

Note: This list of situations and error conditions that generate an audible alarm does not contain
comprehensive error recovery protocols.
Situations and Error Conditions
When all information messages are displayed on screen.
When all warning messages are displayed on screen.
When all error messages are displayed on-screen.
When all Yes / No prompts are displayed on-screen.
When all warning balloons are displayed on-screen.
When all error balloons are displayed on-screen.
The PBS level in the PBS supply container falls too low (measured by the level sensor), or the PBS
supply container is disconnected while tests are running.
The waste fluid level in the waste container fills too high (measured by the level sensor), or the waste
container is disconnected while tests are running.
Instrument initialization completes successfully.
A clot is detected while aspirating red blood cells from a sample.
A sample or reagent rack is removed while it is still in use (while the LED signal is on).
A sample or reagent rack; or strip tray is removed (when the option to play a sound with rack insertion
and removal is selected).
A sample or reagent rack; or strip tray is inserted (when the option to play a sound with rack insertion
and removal is selected).
A sample with an unreadable barcode is inserted (when the option to play a sound with rack insertion
errors is selected).
A test is completed for a sample (when the option to play a sound when samples are complete is
selected).
A test is completed for a batch (when the option to play a sound when a batch is complete is selected
and the option to play a sound when samples are complete is not selected).
One or more tests are aborted due to an instrument or software error.

Chapter 7: Troubleshooting Motor Controller Functional Processing Error Codes
Motor Controller Functional Processing Error Codes

Certain specific error messages can be generated from hardware-controlling software as a direct consequence of
hardware failures or problems. These motor controller functional processing error messages are saved in the event
logs. Such event log information can be used for the diagnosis of instrument hardware problems.
Note: The numeric identification of these motor controller error codes inside the event log is a
different population of error codes distinct from the general instrument software error codes
(described earlier in this chapter) that display or pop up on the monitor screen.
At least two (2) lines are listed in the event log for every single motor error. One line details the board in question
(numbered 2 to 7 inclusive) and the other line(s) detail the error(s) related to that board.
For example, an error status of TRANSPORT_HOLDER (STATUS=3102) associated with an Error (5150) Motor
failed positional verify (Board 2) indicates that the Transport Holder failed positional verify when moving in the Y axis.
Status=3102 (A 3100 error with an axis identifier of 2)
Using the error code, error code status, and axis identifier the exact movement that the transport arm was making
can be determined. The abort logs can be further used to identify the exact step that the transport arm was trying
to complete at the time of the error. This can assist in identifying the exact cause of the error.
Board and Axis Identifiers

The following table describes the general mapping of motor controller errors. One line in the event log specifies the
board in question (numbered 2 to 7 inclusive). These are described in the header row. The other line(s) in the event
log detail the error(s) related to that board. The axis identifier (in the first column of the table), numbered 1 to 5
inclusive, maps the general component or movement that had the error. This axis identifier is added to the four (4)-
digit motor control error code.
Axis Strip Transfer Fluidics Peri-Pump Reagent Incubator Centrifuge

Identifier (Board 2) (Board 3) (Board 4) (Board 5) (Board 6) (Board 7)
<motor id>
1 X (left/right) X (left/right) Probe Rinse X (left/right) Door Motor Lift Motor

Pump
2 Y (front/back) Y (front/back) Y (front/back)
3 Z (up/down) Z (up/down) Stir Motor
4 Mirror Large Syringe
5 Wash Syringe Small Syringe

Troubleshooting Common Errors Chapter 7: Troubleshooting
Troubleshooting Common Errors

Errors that occur on the Echo Lumena can also be viewed through the event log report. You are advised to only
select Errors and Warnings when you run this report to reduce the number of items listed. Refer to Chapter 6 –
Echo Lumena Reports for more details about the event log report.
Note: Always switch the instrument power off before removing the instrument cover and inspecting
the inside of the instrument in situations such as looking for obstructions or loose connections.
Software Errors
Software Assertion Errors
This section describes how to:
X Recognize a software assertion error
X Respond to the error
Recognizing a Software Assertion Error

Some unique and unpredictable combination of software circumstances give rise to errors characterized by the
name assertion errors. These software circumstances generate the on-screen display of an error message that
details the software file name and line number involved in the error. The following example highlights the
involvement of the file AssayFile.cpp and the line number of 41.
Example of assertion error: File name: “AssayFile.cpp” Line number: 41

Chapter 7: Troubleshooting Troubleshooting Common Errors
Responding to a Software Assertion Error

Before acknowledging the assertion error (by clicking the OK button), you should either print the screen display or
make note of the information contained in the error message so that it can be relayed to Immucor Technical
Support. This information will be a valuable tool to troubleshoot the root cause of the error. You may then
acknowledge the error.
After you click the OK button:

• The computer will automatically restart.
• Log in to the Echo Lumena software and perform initialization
Note: All assay processing occurring at the time of the error will be lost when the instrument
is again ready for use. Any samples included will need to be re-tested.
• After initialization is completed, you should view the event log report to access the error-related information.
You should select all fields in the event log setup so that all of the events leading up to the assertion error
can be seen. You should either print the event log or make note of the information contained in it related to
the assertion error so that it can be relayed to Immucor Technical Support. This information will be a
valuable tool to troubleshoot the root cause of the error. Refer to Chapter 6 – Echo Lumena Reports for
details of the event log report.
Emergency Restart of Software

If an error occurs where the Echo Lumena software is closed, resulting in the PC desktop being displayed on the
monitor, then you can restart the Echo Lumena software by double-clicking the emergency Restart icon found on
the desktop. This icon is located in the left hand side of the screen.
Note: Normally, you will never have access to the PC desktop.
Emergency Restart icon

Clot Detection Recovery Process

If the probe detects a clot during sample aspiration, the system displays an error message alerting you to the event,
and the probe remains stationary above the tube in question. This is your opportunity to inspect the tip of the probe
for any hanging clots.
You can select either (a) Continue processing or (b) Stop processing.
(a) If you choose Continue processing, then the instrument sends the probe to the wash station for cleaning
before processing the remaining on-board samples.
(b) If you choose Stop processing, you will lose all assay processing for samples being tested at that time. All
acceptable samples without clots currently being run will have to be retested. If a clot is present, remove
the cover from the instrument. You can carefully use a small piece of absorbent material to remove any
obvious clots. You must discard this material according to your standard laboratory practice relating to
biohazardous waste. You must reinstall the cover to the instrument and restart the system before
continuing processing.
If you do not acknowledge the error message, there is a two-minute period before all processing stops and a
system restart is required. The system counts down the number of seconds remaining, indicating with a progress
bar how much time is left.
Clot detection recovery process dialog box

Recovery from Initialization Failure

Initialization is composed of many steps to initialize and check the functionality of the instrument modules. An error
balloon will be displayed at the bottom of the screen if an initialization step fails. The error balloon will describe the
particular module, the step that failed, or both. If the error balloon goes unnoticed and you attempt to run assays,
then additional error messages will be displayed alerting you to your inability to run assays due to instrument
module(s) requiring investigation and/or error recovery. Refer to Chapter 5 – Maintaining the Echo Lumena for
details of any maintenance tasks that need to be retested when component(s) or step(s) fail during initialization (e.g.,
Prime instrument, Washer test, Install priming strip holder, etc.).
The following table lists the initialization steps, their likely causes of failure, what to check, and the recommended
actions.
Note: Some of the protocols described under the recommended actions may be beyond the scope
of your training. Technical support may be required to guide you through the necessary recovery
steps.
Initialization step Likely causes of failure What to check and recommended actions
Setting lights PCB connection loose View event log for instrument error.
Failed PCB Verify PCB connections are secure and
reconnect if necessary.
Testing strip Obstruction in the transport path View event log for instrument error.
transport
Failed opto-sensor Power off instrument, remove the
instrument cover, and look for possible
Failed transport motor
obstruction.
Testing incubator Opto-sensor cable disconnected Power off instrument, remove the
door instrument cover, and verify cable
Failed opto-sensor
connections. Reconnect if necessary.
Failed door motor
Testing probe and Data cables disconnected from back of Verify the data cables are securely
syringe pumps Fluidics module to Main instrument connected between the back of the Fluidics
Module and the side of the Main
Failed opto-sensor
Instrument. Reconnect if necessary.
Failed probe motor
Failed syringe motor
Checking robot for Strip holder is present on the transport Follow the on-screen instructions for
strip holder retrieving the strip holder.
Testing camera Failed opto-sensor Verify cable connections on PCB, which is

mirror located on the front of the reader module,
Failed mirror motor
and reconnect if necessary.
Obstruction in reader module that is
Check reader module for obstructions, and
preventing movement of the mirror
remove obstruction if necessary.

Testing washer Priming strip holder is missing Verify that the priming strip holder is
manifold and washer installed by using maintenance task: install
Wash manifold is not primed
syringe pump priming strip holder.
Wash manifold is clogged
Prime the manifold by using maintenance
Cable for syringe opto-sensor or drive task: prime washer.
motor are disconnected
Perform maintenance task: washer test.
Failed opto-sensor for syringe pump
Power off instrument, and remove the
Failed motor for syringe drive instrument cover. Remove the manifold
then stylus, and flush it. Replace the
manifold.
Verify cable connections for opto-sensor
and syringe motor, and reconnect if
necessary.
Testing washer well Priming strip holder is missing Verify that the priming strip holder is
sensors installed by using maintenance task: install
Wash manifold is not primed
priming strip holder.
Wash manifold is clogged
Prime the manifold by using maintenance
Well sensor cable is disconnected task: prime washer.
Failed well sensor PCB Perform maintenance task: washer test.
Well sensors dirty Power off instrument, and remove the
instrument cover. Remove the manifold
then stylus, and flush it. Replace the
manifold.
Verify cable connection for well sensor PCB
and reconnect if necessary.
Clean the well sensors.

Testing bottom Priming strip holder is missing Verify that the priming strip holder is
camera chamber installed by using maintenance task: install
Invalid strips are loaded in priming strip
holder
Check the Camera report, and verify that
Bottom chamber lamp has burned out
the Bottom chamber test image displays
Camera has failed strips with 2-D barcodes.
Bottom chamber test image

the Bottom chamber test image is not
darkened or blacked out.
Replace bottom chamber lamp.

Checking camera Priming strip holder is missing Verify that the priming strip holder is
alignment installed by using maintenance task: install
Reader module top chamber lamp has
burned out
Camera has failed
the Top chamber test image is not
Mirror in reader module is out of alignment darkened or blacked out.
Check the Camera report, and verify that a
black bar is absent in the Alignment image.
The following example has no black bar
present:
Alignment image with no black bar

A black bar is present at the top of the
image in the following example:
Alignment image with black bar

Replace top chamber lamp.
Testing reagent Obstruction in path of reagent stirrer Look under reagent loading bay, and verify
stirrer that nothing is obstructing the path of the
Mechanical failure with reagent stirrer (belt,
reagent stirrer. Remove the obstruction, as
motor, etc.)
necessary.

Testing centrifuge lift Obstruction in path of centrifuge lift Look under centrifuge, and verify that
nothing is obstructing the path of the
Mechanical failure with centrifuge lift motor
centrifuge lift. Remove the obstruction as
necessary.
Testing centrifuge Instrument not level Verify instrument is placed on a level

surface.
Centrifuge not installed properly
Verify centrifuge is installed and securely
Centrifuge cables not connected
connected.
Mechanical failure with centrifuge (motor,
bearings, etc.)
Testing centrifuge Obstruction in path of transport Remove obstruction from transport path.
door
Centrifuge not aligned properly Verify centrifuge alignment pegs are within
the alignment holes.
Transport not aligned properly with
centrifuge door
Calibrating camera Top chamber lamp has burned out Check the Camera report, and verify
and testing top calibration values from Calibration image.
Camera color settings are not set correctly
chamber
Camera has failed
Calibration image
Note: Refer to Chapter 6 –

Echo Lumena Reports for
details of the expected
calibration values.
Replace top chamber lamp.
Testing fluidics Instrument is not primed with system liquid Run the prime instrument maintenance
task.
Supply or waste tubing are kinked
Verify the supply and waste tubing are
Supply or waste tubing are not securely
securely connected to the Main Instrument
connected
and Fluidics Module.
Leak in supply or waste tubing
Verify the supply and waste tubing are not
Failed peristaltic pump leaking.
Failed membrane pump for rinse or waste Check the peri-pump, and verify it is
lines working properly and is not leaking.
The waste and/or rinse pump has a vapor Verify the membrane pumps are working.
lock (Is fluid traveling through the connected
lines?)
The filter in the rinse station is clogged

Unlocking strip Obstruction in path of transport Remove obstruction from path of transport.
holder trays
Transport not aligned with tray locks
Checking load Obstruction in path of transport Remove obstruction from path of transport.
station for strip
Transport not aligned with load station
holders
Checking centrifuge Obstruction in path of transport Remove obstruction from path of transport.
for strip holder
Transport not aligned with centrifuge Check position of centrifuge rotor table.
Centrifuge home position not set correctly
Checking incubators Obstruction in path of transport Remove obstruction from path of transport.
for strip holders
Transport not aligned with incubators
Setting lights PCB connection loose Verify PCB connections are secure and
reconnect if necessary.
Failed PCB

Prime Strip Holder/Washer Errors

The prime strip holder is located above the wash manifold and is used during initialization and the timed automatic
rinse to verify the wash function. In some instances washer errors occur and further troubleshooting is required. The
following is a table of common errors with the prime strip holder and wash manifold.
Problem Possible Cause Steps to Resolve
6900-Washer Fill Test Failed for Wells__
Fluid is not dispensed Washer manifold needle(s) is(are) • Prime washer manifold and repeat the
into the well(s) dirty or clogged washer basic test.
• Remove the washer manifold.
• Stylus all washer needles.
• Soak the washer manifold in warm tap water
for 10-15 min.
• Flush the washer manifold with DI or distilled
water.
• Repeat the washer residual volume and
washer dispense accuracy maintenance
tasks.
Washer manifold tubing is • Remove the instrument cover and inspect

kinked/ pinched/loose washer manifold tubing.
• Replace instrument cover using care not to
kink the washer manifold tubing or pinch the
tubing with the bottom of the instrument
cover.
Priming strips are not properly in • View the camera bottom chamber image or
place remove the instrument cover and verify the
priming strips are in place.
• Replace if necessary.
PBS supply container is not • Inspect connection to PBS supply container.

properly connected
Q Cup Check valve is clogged • Inspect connection to PBS supply

containers.
Syringe cap and seal is leaking • Remove instrument cover and inspect
syringe cap and seal.
Fluid is not being Well sensor(s) are dirty • Inspect and clean the well sensor(s).
detected by well
sensors PBS has been replaced with DI • Replace instrument liquid with new PBS.
water

6950 – Washer Aspirate Test Failed for Wells ___
Fluid is not being Washer manifold needle(s) is(are) • Prime washer manifold and repeat the
aspirated by washer dirty or clogged washer basic test.
manifold • Remove the washer manifold.
• Stylus all washer needles.
• Soak the washer manifold in DI water or
recommended cleaning solution for 10-15
min.
• Flush the washer manifold with DI water.
• Repeat the washer residual volume and
dispense accuracy.
Washer manifold tubing is • Remove the instrument cover and inspect

kinked/pinched/loose washer manifold tubing.
• Replace instrument cover using care not to
kink the washer manifold tubing or pinch the
tubing with the bottom of the instrument
cover.
Leaking Washer Manifold
Fluid is leaking from Leaking washer manifold • Check all manifold connections and tubing.
the washer manifold • Check the manifold plugs.
onto priming strips, or
fluid is seen in the • Check all cap and seal connections.
white overflow tray • Replace the manifold tubing and probe
supply tubing from fluidics to main
instrument (see Image below).
• Replace top manifold check valve.
Tubing from Fluidics to Main Instrument Part Descriptions
Manifold Check Valves

Fluidics to Main Instrument Tubing
Note: Contact Immucor Technical
Support for part numbers.

Transport System Errors

The Echo Lumena uses multiple opto-sensors and instrument firmware to track and verify the position of the
transport system. The table below lists the common errors that occur with the transport system.
Echo Lumena transport arm showing the opto-sensors and robot fork
Close-up of Y opto-sensor Close-up of Z opto-sensor

Transport_Holder (Status=3000), Transport_Holder (Status=3100), Transport_Holder (Status=3200)
Customer cannot pass Transport arm is obstructed by a • Check the instrument for stuck or
initialization without stuck or misplaced strip misplaced strips (typically found in
getting a 3000, 3100, or camera, incubator, or washer overflow
3200 error tray.
Robot arm cannot home due to • Move the transport arm to the back
current position right corner of the instrument before
initializing.
Opto-Sensor is Dirty • Using a soft, absorbent wipe material

clean the inside of the opto-sensor.
Opto-Sensor is Defective • Contact Immucor Technical Support
Robot forks are bent or damaged • Contact Immucor Technical Support
Transport arm is not properly aligned • Contact Immucor Technical Support
5150 Motor Failed Positional Verify (Board 2)
Customer reports Improperly loaded strip trays/strip • Advise customer to use care when
intermittent 3102 errors holders loading the strip holders on the black
after loading strips strip trays and when loading the black
strip trays into the instrument.
Robot forks are dirty • Clean any crystallization off the robot
forks using Immucor approved cleaning
solution.

5150 Instrument Error (Board 2)
Intermittent 3000, 3100, Transport arm is obstructed by a • Check the instrument for stuck or
or 3200 error stuck or misplaced strip misplaced strips (typically found in
camera, incubator, or washer overflow
tray.
Robot forks are dirty • Clean any crystallization off the robot
forks using Immucor approved cleaning
solution.


Pipetting System Errors

The Echo Lumena uses multiple opto-sensors and instrument firmware to track and verify the position of the probe
and probe arm. The table below lists the common errors that occur with the pipetting system.
Probe arm (top view) Probe arm (side view)

5150 Probe Crash (Status=5700)
Probe Crash Sensor is Probe is Bent • Run Check Probe Alignment.

Being Tripped • Replace probe.
• Run required probe maintenance.
Probe is Not Seated Correctly • Run Check Probe Vertical Position.

• Reseat probe.
• Run Calibrate probe.
Buildup of crystallized PBS on • Clean any salt off the probe, probe arm, and
and behind probe splash guard probe guide.
• Verify that the probe crash sensor can move
freely.
• Refer to Chapter 5 – Maintaining the Echo
Lumena for instructions on cleaning the
probe splash guard.
Probe is Not Installed Correctly • Verify that the probe is correctly installed and
no tubing is interfering with probe movement
and that no magnets have been
disconnected. Refer to Chapter 8 –
Customer Component Replacement for
correct installation of probe.
Probe is not Calibrated • Reseat probe.

• Re-calibrate probe.
Crash Sensor is Defective • Probe crash sensor leaf spring is loose.

(Service.)
• Probe LLD/Crash Sensor board is defective.
(Service.)

Level sense reference error (8110)" "Level sense error, possibly caused by bubble or vibration. (7120)" "Probe
went to its lowest position, but no fluid was found. (7130)" "Fluid level too high (7140)" "Fluid level too low
(7150)"
Probe Cannot Probe is Dirty • Clean any salt off the probe, probe arm, and
Properly probe guide.
Detect/Measure Fluid • Verify that the probe crash sensor can move
freely.

• Reseat probe.
Probe is leaking • Inspect probe and probe connections for salt

or leaking.
• Inspect probe supply tubing for salt or
leaking.
• Perform the probe dispense accuracy test.
• Replace the probe.
Sample/Reagent Sample/Regent Volume Issues • Foam or bubbles in reagent vial or sample.

• Low/High sample/reagent volume.
5150 Instrument Error (Status=3100)
Probe failed positional Probe is Not Installed Correctly • Verify that the probe is correctly installed and
verify no tubing or magnets are interfering with
probe movement.

• Reseat probe.
Probe is Bent • Run Check Probe Alignment.

• Replace probe.
freely.
probe splash guard.

5150 Instrument Error (Status=5e00)
Wet level-sense found Rinse station is clogged • Clean rinse station with a cotton swab.
in rinse tube at purge • Replace rinse station.
height
Waste pump is defective • Swap rinse pump and waste pump.
• If the Echo Lumena is now giving 6630
fluidics step 3 or 3 failed volume too low
errors the rinse (formerly waste) pump needs
to be replaced.
Probe is leaking • Inspect probe and probe connections for salt

or leaking.
• Inspect probe supply tubing for salt or
leaking.
Probe is making contact with • Run Check Probe Alignment.

the side of the rinse station • Run clean probe and check to make sure the
probe is not contacting the side of the probe
rinse hole on the probe rinse station.
• Replace probe.

Fluidics Errors
During initialization the Echo Lumena performs the Fluidics test to verify the function of the rinse station, rinse and
waste pumps and the peri-pump. The fluidics test can also be performed as a maintenance task. The table below
lists the common errors that occur during the fluidics test.
6620 – Fluidics Test: Step 1 of 3 failed
Fluid cannot drain Probe rinse station is clogged • Clean the probe rinse station using a cotton
properly from the swab.
probe rinse station • Remove and soak the probe rinse station in
recommended cleaning solution.
• Replace probe rinse station.
Waste pump is not working • Check connections to waste pump.

• Replace waste pump.
Rinse station check valve is • Flush or replace rinse station check valve.
clogged

6630 – Fluidics Test: Step 2 of 3 failed (volume too low)
Fluid is not properly Peri-pump is leaking or defective • Prime Instrument (at least 3 times).
being dispensed into • Inspect peri-pump.
the probe rinse station
• Replace peri-pump.

properly connected
Probe tubing or probe supply is • Inspect the probe supply tubing.

pinched/kinked/leaking • Inspect the probe tubing.
Fluid is not being Probe is seated incorrectly • Reseat probe.

detected by the probe
Probe cannot detect fluid (level • Measure a reagent vial to determine if the
sense) probe can level sense.
• Inspect probe for crystallization around base
of probe block.
• Clean probe with alcohol swab remove any
detected crystallization.
• Partially remove and reseat probe.
• Replace probe.
PBS has been replaced with DI • Replace instrument liquid with new PBS.
water
freely.
probe splash guard.

6640 – Fluidics Test: Step 2 of 3 failed (volume too high)

clogged
Fluid is being Probe is seated incorrectly • Reseat probe.

incorrectly detected
by the probe
Probe is leaking • Inspect probe.

• Inspect probe supply tubing.

6650 – Fluidics Test: Step 3 of 3 failed (volume too low)
Fluid is not properly Rinse pump is leaking, defective, • Prime Instrument (x 3).
being dispensed into or vapor locked • Inspect rinse pump.
the probe rinse station
• Replace rinse pump.

properly connected
Rinse pump/station tubing is • Inspect the rinse station tubing.

pinched/kinked/leaking • Inspect the rinse pump tubing.
Fluid is not being Probe is seated incorrectly • Reseat probe.

detected by the probe
Probe cannot detect fluid (level • Measure a reagent vial to determine if the
sense) probe can level sense.
• Inspect probe for crystallization around base
of probe block.
• Clean probe with alcohol swab remove any
detected crystallization.
• Partially remove and reseat probe.
• Replace probe.
PBS has been replaced with DI • Replace instrument liquid with new PBS.
water
freely.
probe splash guard.

6660 – Fluidics Test: Step 3 of 3 failed (volume too high)

clogged
Fluid is being Probe is seated incorrectly • Reseat probe.

incorrectly detected
by the probe Probe is leaking • Inspect probe.
• Inspect probe supply tubing.

Camera Errors
During initialization camera calibration is performed to verify the camera is operating within acceptable limits.
Camera calibration can also be performed as a maintenance task. The table below lists the most common warning
and error messages reported during camera calibration.
6360 – Camera Calibration failed for the top chamber
Camera calibration Top chamber lamp has burned • Check Camera report and verify calibration
failed during out values from Calibration image.
initialization • Check Camera report and verify no strips or
Strips present in top camera
chamber after unexpected debris present in Top Chamber image.
instrument error • Perform Calibrate Camera maintenance
Camera mirror is dirty task.
• Repeat Initialization.
Camera calibration is out of
range for average intensity, pixel • Replace top chamber camera lamp.
intensity or standard deviation
Camera is failing
6361 – Camera Calibration failed for the bottom chamber
Camera calibration Bottom chamber lamp has • Check Camera report and verify calibration
failed during burned out values from Calibration image.
initialization • Check Camera report and verify no strips or
Strips present in bottom camera
chamber after unexpected debris present in Bottom Chamber image.
Camera auto-calibration is out of
range • Replace bottom chamber camera lamp.
Camera is failing
6500 – Camera calibration failed for the top chamber
Camera calibration Top chamber lamp has burned • Check Camera report and verify calibration
failed through out values from Calibration image.
Maintenance window • Check Camera report and verify no strips or
Strips present in top camera
chamber after unexpected debris present in Top Chamber image.
range for average intensity, pixel • Replace top chamber camera lamp.
Camera is failing

6501 – Camera calibration failed for the bottom chamber
failed through burned out values from Calibration image
Maintenance window • Check Camera report and verify no strips or
chamber after unexpected debris present in Bottom Chamber image
instrument error • Perform Calibrate Camera maintenance task
Camera mirror is dirty • Repeat Initialization
Camera auto-calibration is out • Replace bottom chamber camera lamp
of range
Camera is failing
6100 – Manual camera calibration failed for the top chamber
Camera calibration Top chamber lamp has burned Check Camera report and verify calibration values
failed through View- out from Calibration image.
Camera window
Strips present in top camera Check Camera report and verify no strips or debris
chamber after unexpected present in Top Chamber image.
instrument error
Perform Calibrate Camera maintenance task.
Camera mirror is dirty
Repeat Initialization.
Replace top chamber camera lamp.
range for average intensity, pixel
Camera is failing
6101 – Manual camera calibration failed for the bottom chamber
failed through View- burned out values from Calibration image.
Camera window • Check Camera report and verify no strips or
chamber after unexpected debris present in Bottom Chamber image.
Camera auto-calibration is out
of range • Replace bottom chamber camera lamp.
Camera is failing
3300 – The top chamber camera lamp is nearing its limits.

Processing can continue but please replace the top chamber lamp at your earliest convenience.
Refer to the maintenance chapter of the operator manual for camera lamp replacement instructions.
Top chamber camera Top chamber camera lamp is • Replace top chamber camera lamp.
lamp needs nearing its end of life
replacement

3301 – The bottom chamber camera lamp is nearing its limits.

Processing can continue but please replace the bottom chamber lamp at your earliest convenience.
Bottom chamber Bottom chamber camera lamp • Replace bottom chamber camera lamp.
camera lamp needs is nearing its end of life
replacement
5108 – The top chamber camera lamp has exceeded its limit.
Assay processing will not be permitted until the top chamber lamp is replaced.
Please power off the instrument and PC before lamp replacement
Top chamber lamp Top chamber camera lamp has • Replace top chamber camera lamp.
exceeded its limit failed
5109 – The bottom chamber camera lamp has exceeded its limit.
Assay processing will not be permitted until the top chamber lamp is replaced.
Please power off the instrument and PC before lamp replacement
Bottom chamber Bottom chamber camera lamp • Replace bottom chamber camera lamp.
camera has exceeded has failed
its limits

Centrifuge Errors
During instrument operation, the centrifuge operation is verified through opto-sensors and the centrifuge firmware.
The table below lists the common centrifuge errors that can occur.
5150 Board 7 (Status=91a4)
Centrifuge control J11 power cable is not • Verify that the J11 connection has not been
error connected correctly connected upside down.
Centrifuge is failing • Contact Immucor Technical Support to
replace the centrifuge.
5150 Board 7 (Status=9201)
Centrifuge move timed Strip holder is stuck in the • Check centrifuge for any stuck strip holders.
out before completion centrifuge • Verify all centrifuge cables are connected
Centrifuge cables (J9, J10, J11) correctly.
are not connected correctly • Contact Immucor Technical Support to
Centrifuge is failing replace the centrifuge.
Centrifuge move did Strip holder is stuck in the • Check centrifuge for any stuck strip holders.
not clear the home centrifuge • Verify all centrifuge cables are connected
sensor correctly.
Centrifuge cables (J9, J10, J11)
Centrifuge move did Strip holder is stuck in the • Check centrifuge for any stuck strip holders.
not find the home centrifuge • Verify all centrifuge cables are connected
sensor correctly.
Centrifuge cables (J9, J10, J11)
Centrifuge home Strip holder is stuck in the • Check centrifuge for any stuck strip holders.
position not defined centrifuge • Verify all centrifuge cables are connected
Centrifuge cables (J9, J10, J11) correctly.

Scanner Errors
Besides the sample and reagent barcodes there are several other barcodes that the Echo Lumena scanner expects
to see when a sample or reagent rack is loaded on the Echo Lumena. The first barcode is the bracket label, which
is located on the divider post between the sample and reagent loading bays. The next barcodes are the vessel
labels that are located on the sample and reagent racks. Depending on the type of rack, the vessel label will include
an eye-readable two digit number (for example, the patient rack is 11, 12, 13, 14, and 15). The last barcode on the
rack is called the end label. When a rack is inserted, the Echo Lumena scanner expects to see the following
sequence:
Bracket label Æ Vessel label Æ Sample/reagent label (repeat for number of positions in rack) Æ End label Æ
Bracket label
If this sequence is not seen correctly a scanner error will be generated.
The error code “Warning (4100): The rack could not be successfully scanned. Please check the barcodes and try
again,” is a general error code. It does not give the details of the error. To determine the error code details the error
status must first be determined. The instrument event log can be used to determine the error status associated with
the error code. Below are several of the most common scanner errors.

Warning (4100) GET_BARCODES (STATUS=7000)

Scanner error
General error, sample Rack inserted too quickly or • Verify scanner lasers are on prior to loading
or reagent barcodes unevenly rack.
or rack barcodes • Remove rack and reinsert the rack in a
Rack inserted prior to scanners
could not be read smooth motion.
turning on
Rack was not inserted • Hold rack by handle and insert rack.
completely • Verify rack was inserted completely and
barcode information is present on
An obstruction was in the path instrument map.
of the scanner laser
• Verify scanner laser is seen across loading
Scanner or scanner mirrors are bay and on bracket label.
dirty
• Clean scanner and mirrors. Refer to
Scanner is not operational Chapter 5 – Maintaining the Echo Lumena
for instructions.

Scanner didn't find bracket label
Scanner could not Rack inserted too quickly or • Verify scanner lasers are on prior to loading
read bracket label unevenly rack.
Rack was not inserted • Remove rack and reinsert the rack in a
completely smooth motion.
An obstruction was in the path • Hold rack by handle and insert rack.
of the scanner laser • Verify rack was inserted completely and
Scanner or scanner mirrors are instrument map.
dirty
bay and on bracket label.
Chapter 5 – Maintaining the Echo Lumena
for instructions.


Scanner bracket label out of sequence
Scanner read bracket Rack inserted too quickly or • Verify scanner lasers are on prior to loading
label on divider post unevenly rack.
out of sequence • Remove rack and reinsert the rack in a
Rack inserted prior to scanners
turning on smooth motion.
dirty
for instructions.

Scanner didn’t find last bracket label
read last bracket label unevenly rack.
Rack inserted prior to scanners • Remove rack and reinsert the rack in a
dirty
for instructions.


Scanner didn't find end label
read end label on rack unevenly rack.
Rack inserted prior to scanners • Remove rack and reinsert the rack in a
dirty
for instructions.

Vessel label longer than allowed
Scanner read invalid Invalid sample or reagent • Verify sample or reagent contains between
barcode label barcode label 3-18 characters for ISBT 128, Code 128,
Code 39 and Codabar barcodes.
Sample or reagent barcode
contains too many characters • Verify Interleave 2 of 5 barcodes contain 12
than what can be read by the characters. Contact Immucor Technical
scanner support if barcodes are not 12 characters
and scanners have not been previously
reprogrammed for new character length.
• Verify sample barcodes contain valid
barcode characters.
• Verify 18 character reagent barcode is
facing outward when loaded in rack.

Racks pushed in too close together time wise
Scanner read multiple Two or more sample or reagent • Remove all racks and reinsert one at a
racks too close racks were inserted too quickly time. Verify barcodes are read by the
together in succession scanner and barcode information is present
on instrument map.

Warning (4610) or Warning (4750)

The scanner was not able to read the rack. Please wait until the scanners turn on and then re-insert rack
The sample or reagent Scanners were not turned on • Verify scanner lasers are on prior to loading
rack is inserted in the prior to loading sample or rack.
loading bay and no reagent rack • Verify scanner laser is seen across loading
barcodes are read by bay and on bracket label.
Scanner or scanner mirror is
the scanner
dirty • Clean scanner and mirrors. Refer to
Scanner is not operational Chapter 5 – Maintaining the Echo Lumena
for instructions.
• Contact Immucor Technical Support for
additional assistance.
Warning (4770)
Invalid barcode(s)
The scanner reads an Sample barcode includes • Verify sample or reagent contains between
invalid barcode invalid characters 3-18 characters for ISBT 128, Code 128,
Code 39 and Codabar barcodes.
Unsupported sample barcode
symbology is used • Verify Interleave 2 of 5 barcodes contain 12
characters. Contact Immucor Technical
Incorrect reagent barcode is support if barcodes are not 12 characters
used and scanners have not been previously
reprogrammed.
• Verify sample barcodes contain valid
barcode characters.
• Verify 18 character reagent barcode is
facing outward when loaded in rack.
Warning (4790)
Duplicate sample IDs detected. Duplicate sample IDs cannot be used.
A sample ID is loaded More than one sample is • Remove all sample racks from the Echo
and the Echo Lumena loaded on the Echo Lumena Lumena and inspect for duplicate sample
identifies the sample with the same sample ID IDs. If no duplicate IDs are noted then
ID as already loaded reload the sample racks and verify barcode
information is present on the instrument
map. If duplicate sample IDs are identified
then only one of these sample IDs should
be loaded on the Echo Lumena.

Archive Errors
During archiving, the Echo Lumena software and the operating system on the Echo Lumena PC performs various
checks to ensure the data is archived to the DVD-ROM drive successfully. The table below lists the most common
errors during the archiving process.
Information (1042) Archive location on C: drive not allowed
Archive cannot be Archive location was changed to the C: • Press the Cancel button to exit the
completed in C: drive drive. The D: (DVD-ROM) drive should File Management window and access
be used during archiving. File Management again so the default
archive location is used.
By selecting the Browse button, the
• Press the Browse button and select
archive location was changed to the C:
the D: (DVD-ROM) drive for archiving.
drive.
Information (1043) Invalid archive location
Archive cannot be Archive location was changed to a • Press the Cancel button to exit the
completed in current different drive location. The D: (DVD- File Management window and access
location ROM) drive should be used during File Management again so the default
archiving. archive location is used.
By selecting the Browse button, the • Press the Browse button and select
archive location was changed to the C: the D: (DVD-ROM) drive for archiving.
drive.
Information (1044) Disc appears to contain data. Please insert a blank disc and try again.
Archive cannot be A disk that was previously used for • Remove the disk from the DVD drive
completed on the archiving was in the DVD drive when and load an unused disk prior to
current disc archiving was selected. After archiving is archiving.
complete the disk is finalized and
cannot be reused.
Information (1045) No disc (or unsupported disc) detected.
Archive cannot be No disk was loaded in the DVD drive • Verify a disk is loaded in the DVD drive
completed because prior to archiving prior to starting the archive process.
the drive contains an • Verify the disk being used for archiving
An invalid or unsupported disk was
incorrect disc or no is CD-R, DVD-R or DVD+R.
loaded in the DVD drive prior to
disc.
archiving • Verify the DVD drive can read a
DVD drive is not operational and cannot previously archived disk to determine
read the disk if DVD drive is operational. Contact
Immucor Technical Support for further
assistance.

Information (1046) There is not enough disc space for all selected files! Please insert a blank disc and try again.
Archive cannot be There are too many files selected for • Select fewer files to archive by using
completed due to archiving to fit on one disk the Select All, Select None and the
inadequate storage checkboxes next to the batch file
space on current disc names prior to starting the archive.
• Use a supported disk that can
manage greater storage capacity.
Error (5900) Error occurred during archiving! Please check event log for details.
Archive cannot be Archive was started before the PC and • Verify light on DVD drive is off prior to
completed due to an DVD drive recognized the disk accessing File Management to start
error archive.
Disk was scratched or damaged and
files could not be written to disk during • Verify disk is not scratched or
archive damaged and try a different disk.
DVD drive is not operational and cannot • Verify the DVD drive can read a
write files to the disk previously archived disk to determine
if DVD drive is operational. Contact
Immucor Technical Support for further
assistance.
Warning: ArchiveManager cannot delete file (C:\G3\Results\xxx.htm) because the archive bit is on.
Archive bit is used by the software to verify the result files are copied before they are deleted.
Cannot delete Result file was edited, approved or • Repeat archive procedure to set the
information (Archive exported after a Copy Files archive was archive bit to off. Once archive is
bit is used by the performed and before a Delete Files completed successfully, perform
software to verify the archive is performed archive with Delete Files selected.
result files are copied
Prior to performing the Delete files
before they are
archive, the result files are verified on
deleted)
the archive disk and left in the DVD
drive. The Delete Files action is not
selected or the Copy Files action is not
deselected prior to Archiving

QC Failure
In order to better assist our customers, Immucor is taking this opportunity to provide additional guidance for
interpreting QC failures on the Echo Lumena.
Test Results page

Steps for Interpreting QC Failure on the Echo Lumena

Step Action
1 From the results window on the main instrument page, right click any one of the failed WB corQC
samples and select Event Log. Towards the bottom of the Test event log, verify that the red batch
number (failed QC batch) matches the batch number at the top of the Test event log report (scroll up
on the Test event log to see this number).
Note: If multiple QC batches are running at the same time and QC fails for a single
batch, all other batches running with reagents in common will fail as well. Locating the
failed batch number on the event log assures that you are reviewing the QC batch
responsible for the QC failure.
2 Once the failed QC batch is located, right click on the failed WB corQC beginning with WB corQC 1
and select Result file.
3 Scroll down on the Result file until [Reactions] is displayed.
Result file shown in menu and on screen

Step Action
4 Match the reactions with those listed on the WB corQC reaction charts. Refer to Regional Attachments
for the WB corQC reaction charts for the corresponding assay and determine the well(s) responsible for
the QC failure.
Example: Under Reactions in the result file above, Strip 1, Well 5 has a result of 19. According to
the Group WB corQC Reaction Chart, this value is out of range. WB corQC 2, Well 5 (Anti-D1)
should have a result between 0-2.
Note: There may be no reactions listed if the strip was invalid or images were not analyzed
by the camera.
Note: For combined assays such as Group Screen, Strip 1 is the Group reactions and Strip
2 is the Screen reactions.
5 Review the well image on the Test Results Report to assist in determining why QC may have failed.
Test Results report
6 Repeat steps 2-5 for each level of WBcorQC to locate or determine additional well(s) responsible for
QC failure.

Interpreting Echo Lumena Images Chapter 7: Troubleshooting
Interpreting Echo Lumena Images

This section provides guidance for identifying typical well reactions for Capture-R® Ready-Screen® and Capture-
R® Ready-ID®. The table below describes typical well reactions seen on the Echo Lumena.
Warning: The grading of reactions on the Echo Lumena must only be regarded as an approximation
when compared to off-line visual grading by laboratory technical staff.
Typical Capture-R Reaction Appearance Grades Negative to 4+
Image Grade Description
Negative No to very slight degree of red cell

adherence, tightly defined red cell button
Equivocal Very slight to small degree of adherence,

adhering to approximately ¼ or less of
monolayer surface, slightly diffuse or less
defined red cell button margin
1+ Small degree of adherence adhering to

Positive approximately ¼ of monolayer surface,
diffuse cell button margin
2+ Moderate to strong degree of adherence,

Positive adhering to approximately ½ to ¾ of
monolayer surface, loosely formed red cell
button with hole or tear
3+ Moderate to strong degree of adherence,

Positive adhering to approximately ½ to ¾ of
monolayer surface, loosely formed red cell
button with hole or tear
4+ Adherence is strong, covering entire

monolayer, very slight to no gathering of
Positive red cells in center of well

Chapter 7: Troubleshooting Atypical Echo Lumena Images
Atypical Echo Lumena Images

This section provides guidance for identifying and troubleshooting atypical well reactions for Capture-R® Ready-
Screen® and Capture-R® Ready-ID®. The table below provides examples of atypical well reactions seen on the
Echo Lumena.
When grading reactions, keep in mind that the degree of Capture-R Indicator Cell adherence is key in assigning
grades for positive reactions. Aside from absence of adherence, judging the size and margin of an Indicator Cell
button relative to the negative control is important for negative interpretations.
Atypical Echo Lumena® Capture-R® Images
Under-Pipetted Indicator Cells

A lower concentration or smaller than expected volume of
indicator cells was added to the well. Typically this is due to no
stirball in the Indicator Cell vial. The first several runs may pass
as expected, then, as red cells settle out, the buttons will
appear smaller and smaller.
Some Possible Cause(s):
No stirball added to the Indicator Cell vial, leaking probe,
leaking syringe, loose/leaking probe supply tubing, stir motor
not properly functioning
Common Troubleshooting:
• Verify the presence of a stirball in the Indicator Cell vial.
• Verify that the stir motor is re-suspending the Indicator
Cells.
• Check all connections to the syringes, probe and PBS
container for loose or leaking tubing.
• Run the Probe Accuracy Test maintenance task.
• Replace the probe and run all required probe maintenance.
• Check for hemolysis in Indicator Cell vial.

Atypical Echo Lumena Images Chapter 7: Troubleshooting
No Indicator Cells Added

No indicator cells were added to the well. Typically this is due
to no stirball in the indicator cell vial. The first several runs will
pass as expected, then as red cells settle out only diluent will
be added to the wells.
No stirball added to the indicator cell vial, stir motor not
properly functioning
• Verify the presence of a stirball in the Indicator Cell vial.
• Verify that the stir motor is re-suspending the Indicator
Cells.
Balance Strip used for Testing

Manually scanning the strips and loading them in the wrong
position resulted in the balance strip being used for testing.
Improperly manually scanning or loading strips on the
instrument.
• Follow proper procedure when manually scanning or
loading strips on the instrument.
Capture-R® Artifacts
Reaction patterns that appear atypical may be artifacts. These
reaction patterns should be investigated further to consider
potential instrument issues, patient diagnosis, donor history, or

Chapter 7: Troubleshooting Atypical Echo Lumena Images

reagent and sample integrity. If you need further guidance
please contact Immucor Technical Support.
Improper washing, improper pipetting, sample factors, reagent
factors, residual recommended cleaning
solution/Compromised PBS
• Repeat the sample on the Echo Lumena and/or in an
alternative method to identify any sample or reagent
factors that may be causing the artifacts.
• Verify the washer is performing as expected (Washer
Residual Volume and Washer Dispense Accuracy tests
are passing).
• Verify that the probe is performing as expected (Check
Probe Alignment, Check Probe Vertical Position, and
Probe Accuracy Test is passing).
• Replace the PBS in the PBS supply container and prime
the instrument.
• Verify stir motor is re-suspending the Indicator Cells.

Atypical Hemagglutination Images Chapter 7: Troubleshooting
Atypical Hemagglutination Images

This section provides guidance for identifying and troubleshooting atypical well reactions for hemagglutination
assays. The following table provides examples of atypical well reactions seen on the Echo Lumena.
Atypical Hemagglutination Final Read Images
Under Aspirated Control/Test well

Some Grouping assays and Phenotype assays use the mixing well as a test well. It is
possible for inadequate aspiration of red cells from the mix well.
Possible Causes:
Improperly seated probe, leaking probe, leaking syringe, loose/leaking probe supply
tubing
• Reseat the probe and run all required probe maintenance.
• Check all connections to the syringes, probe and PBS container for loose or leaking
tubing.
• Run Probe Accuracy Test maintenance task.
Over-Pipetted Well (Anti-A)

Too many red cells added to well.
Possible Causes:
Leaking probe, leaking syringe, loose/leaking probe supply tubing
tubing.
Under-Pipetted Well (Anti-B)

Too few red cells added to well.
Possible Causes:
Low sample volume, sample not spun down, leaking probe, leaking syringe, loose/leaking
probe supply tubing, partially clogged probe
• Verify sample was centrifuged and red cells are separated from plasma/diluents.
• Verify sample has sufficient red cell volume.
tubing.

Chapter 7: Troubleshooting Atypical Hemagglutination Images
Clotted Sample (Anti-B)

Sample was clotted slightly, but not enough to trigger the clot detection warning
Possible Causes:
Clotted sample
• Use applicator stick and check sample for clots.
Antisera not Added to Well (Anti-D)

Since the Monoclonal and Rh control and anti-D are clear, there is no color check on
these wells. The Echo Lumena cannot detect the absence of these reagents like it can for
the anti-A and anti-B. It is possible for the antisera not to be added to well and the diluted
red cells to be added normally.
Possible Causes:
Bubbles/foam in the reagent, low reagent volume, improperly seated probe, leaking
probe, leaking syringe, loose/leaking probe supply tubing
• Verify all bubbles are removed from reagent vial.
tubing.
Bubbles in Well (Anti-D)

Since the Monoclonal and Rh control and Anti-D are clear there is no color check on these
wells. The Echo Lumena cannot detect the absence of these regents like it can for the
anti-A and anti-B. It is possible for the antisera not to be added to well and with bubbles
present.
Possible Causes:
Bubbles/foam in the reagent, leaking probe, leaking syringe, loose/leaking probe supply
tubing
• Verify all bubbles are removed from reagent vial.
tubing.

Atypical Hemagglutination Images Chapter 7: Troubleshooting
Atypical Hemagglutination Final Read Images
Mixed Field Reaction (Anti-B)

This reaction was scored equivocal due to the presence of non-agglutinated cells resulting
in a pink rather than yellow background. The Echo Lumena will not interpret this reaction
as mixed field, but rather as positive, equivocal or negative depending on the agglutinate(s)
present in the well. Refer to Regional Attachment for limitation regarding mixed field
results.
Possible Causes:
Transfusion, bone marrow or stem cell transplant, sub-groups, hemolysis in test well
• Verify patient’s transfusion history.
• Verify patient’s diagnosis and medical history.
• Check sample tube for hemolysis.
Debris in Well (Anti-B)

Debris is seen in image that does not appear to be red cell agglutinates.
Possible Causes:
Debris in or on strip wells, debris in antisera
• Inspect strips for debris prior to loading.
• Inspect reagent vial for debris.

Chapter 7: Troubleshooting Atypical Hemagglutination Images

Chapter 8: Customer Component Replacement
Chapter 8: Customer Component

Replacement
In This Chapter:
Chapter 8: Customer Component Replacement .................................................... 8-1
Component Maintenance Table ......................................................................... 8-3
Removing and Replacing the Probe ................................................................... 8-4
Purpose .......................................................................................................... 8-4
Required Interval ............................................................................................. 8-4
Tools ............................................................................................................... 8-4
Instructions to Remove the Probe .................................................................... 8-4
Instructions to Replace the Probe .................................................................... 8-7
Removing and Replacing the Wash Manifold ...................................................... 8-9
Purpose .......................................................................................................... 8-9
Required Interval ............................................................................................. 8-9
Tools ............................................................................................................... 8-9
Instructions ................................................................................................... 8-10
Removing and Replacing Syringes ................................................................... 8-12
Purpose ........................................................................................................ 8-12
Required Interval ........................................................................................... 8-12
Tools ............................................................................................................. 8-12
Instructions ................................................................................................... 8-12
Removing and Replacing the Peri-Pump .......................................................... 8-14
Purpose ........................................................................................................ 8-14
Tools ............................................................................................................. 8-14
Instructions ................................................................................................... 8-14
Removing and Replacing the Centrifuge ........................................................... 8-16
Purpose ........................................................................................................ 8-16
Tools ............................................................................................................. 8-16
Instructions ................................................................................................... 8-16
Replacing the Echo Lumena Incubator Assembly ............................................. 8-18
Purpose ........................................................................................................ 8-18
Tools ............................................................................................................. 8-18
Instructions ................................................................................................... 8-18
Replacing the Echo Lumena Skin Micro-Switch................................................ 8-20
Purpose ........................................................................................................ 8-20
Tools ............................................................................................................. 8-20
Instructions for Removal ................................................................................ 8-20
Instructions for Replacement ......................................................................... 8-21
Replacing the Echo Lumena Washer Syringe Cap and Seal.............................. 8-22
Purpose ........................................................................................................ 8-22
Tools ............................................................................................................. 8-22
Instructions for Removal ................................................................................ 8-23
Instructions for Installation and Replacement ................................................. 8-24
Replacing the Top and Bottom Lamp in the Camera ........................................ 8-25

Purpose ........................................................................................................ 8-25

Required Interval ...........................................................................................8-25
Tools ............................................................................................................. 8-25
Instructions for Top Lamp Assembly Removal ................................................8-25
Instructions for Top Lamp Assembly Replacement .........................................8-27
Instructions for Bottom Lamp Assembly Removal ..........................................8-28
Instructions for Bottom Lamp Assembly Replacement ...................................8-30
Cleaning, Removing, and Installing the Rinse Station ........................................8-31
Purpose ........................................................................................................ 8-31
Tools ............................................................................................................. 8-31
Instructions for Cleaning ................................................................................ 8-32
Instructions for Removal ................................................................................8-33
Instructions for Installation ............................................................................. 8-35
Removing and Replacing the Probe Rinse and Waste Pumps ...........................8-36
Purpose ........................................................................................................ 8-36
Tools ............................................................................................................. 8-36
Instructions to Remove the Probe Rinse and Waste Pumps ...........................8-37
Instructions to Replace the Probe Rinse and Waste Pumps ...........................8-37

Component Maintenance Table Chapter 8: Customer Component Replacement
Component Maintenance Table

The table below lists the maintenance tasks that are required once the instrument component has been replaced.
Washer Dispense Accuracy

Washer Residual Volume
Check Probe Alignment
Check Probe Vertical
Probe Accuracy Test
Calibrate Centrifuge
Washer Basic Test
Calibrate Camera
Calibrate Probe
Prime Washer
Prime Probe
Fluidics Test
Initialization
Position
Replaced Module and
Required Maintenance
Remove and replace the

X X X X X X
probe
Remove and replace the wash

X X X X X
manifold

X X X
100μL and 1mL syringes
Remove and replace the Peri-

X X X
pump

X X X X X
Rinse station

X X
centrifuge
Remove and replace the rinse

X X X
and waste pumps

X
incubator

X
instrument cover micro-switch

X X X X X
syringe cap and seal

X X X X X
probe splash guard
Remove and replace the top

X X
and bottom camera lamp

Chapter 8: Customer Component Replacement Removing and Replacing the Probe
Removing and Replacing the Probe

This section describes how to remove and replace the probe.
Purpose
The purpose of removing and replacing the probe is to allow inspection of the probe if a blockage is suspected or
when a probe must be replaced if it is bent beyond repair.
Required Interval
Note: Following completion of this maintenance task, you must perform Initialization followed by the
Prime Probe maintenance tasks. You must then perform the Calibrate Probe, Check Probe
Alignment, Check Probe Vertical Position, and Probe Accuracy Test maintenance tasks.
Tools
None
Instructions to Remove the Probe

Follow this procedure to remove the probe:
Step Action
1 Switch off the power to the instrument and the PC, remove the instrument cover, and then position the
probe over the wash station before removing it to collect any drained fluid (once the fluid tension is
released).
2 Unscrew the probe fitting from the block on the rear wall below the probe coil (location indicated as
step 2 in the following diagram).
3 Uninstall the probe coil bracket from under the rear wall (location indicated as step 3 in the following
diagram).
4 Uninstall the tubing bracket farthest from you (location indicated as step 4 in the following diagram).
5 Uninstall the tubing bracket nearest to you (location indicated as step 5 in the following diagram).
6 Unclip the probe tubing from the clip (location indicated as step 6 in the following diagram).

Removing and Replacing the Probe Chapter 8: Customer Component Replacement
Step Action
7 Remove the probe from the probe housing.
Probe removal
Note: To prevent bending of the probe leaf spring, you must hold it down while removing
the probe.
8 Inspect, flush (using a syringe) or discard the probe (as appropriate).

Note:
• To eliminate any blockages, use PBS to flush the probe.
• Never stylus the probe; in doing so, you can damage the tubing inside the probe
tip.

Diagram of steps 2 and 6 to remove the probe
Diagram of steps 3, 4, 5, and 7 to remove the probe

Removing and Replacing the Probe Chapter 8: Customer Component Replacement
Instructions to Replace the Probe

Follow this procedure to replace the probe:
Step Action
1 Install the probe coil bracket under the rear wall and align it to the pins.
Probe coil bracket installation
2 Install the first tubing bracket as shown.
Tubing bracket installation
3 Remove the plastic cover from the probe tip.
4 Insert the probe into the probe housing until it snaps into place. The probe must be pushed past
some resistance until it fits into place. No metal should be visible at the top of the entrance hole. A
small click will be felt and heard.
Probe housing
Note: No metal should be showing.

Step Action
5 Install the second tubing bracket.
Tubing bracket installation
6 Clip the probe tubing into the black clip above the probe housing.
7 Remove the plastic cover from the fitting (located at the end of the probe coil tubing attached to the
metal plate) by gently wiggling it from side to side, then screw the fitting into the block on the rear
wall below the probe coil.
8 Ensure that the probe housing can move to each corner of the pipetting station to verify correct
installation of the probe and magnets.
9 Put the instrument cover back on the main instrument. Power on the main instrument and PC
according to the instructions in Chapter 3 – Instrument Testing Operation.
10 Perform the required maintenance tasks: Initialize, Calibrate Probe, Check Probe Vertical Position,
Check Probe Alignment, Prime Probe and Probe Accuracy Test.

Removing and Replacing the Wash Manifold Chapter 8: Customer Component Replacement
Removing and Replacing the Wash Manifold

This section describes how to remove and replace the wash manifold.
Purpose
The purpose of removing and replacing the wash manifold is to allow for inspection of the manifold if blockages are
suspected and to allow access for any subsequent cleaning of the manifold.
Note: This task should be performed if the Washer Basic Test maintenance task (described in
Chapter 5 – Maintaining the Echo Lumena) continues to fail. After completion, instrument
Initialization must be performed, followed by the Prime Washer maintenance task. Repeat the
Washer Basic Test maintenance task. If the Washer Basic Test passes, proceed with the Wash
Residual Volume and Wash Dispense Accuracy maintenance tasks.
Required Interval
Tools
• Flathead screwdriver
• Styluses (2)
• Tap water
• Syringe

Chapter 8: Customer Component Replacement Removing and Replacing the Wash Manifold
Instructions
Note: The wash manifold consists of two sets of eight needles—the dispense needles and aspirate
needles. The transport holder positions the micro-well strips below the manifold during the washing
process. Sensor needles are located above the manifold to check for the fluid level in the micro-strip
wells during initialization and the washer basic test.
Follow this procedure to remove and replace the wash manifold:
Step Action
1 Power off the instrument and PC and remove the cover of the Echo Lumena.
2 The manifold can be removed by releasing the flathead screw in the center of the front of the manifold
using the flathead screwdriver (as shown in the following diagram).
Images showing wash manifold
3 The manifold can now be pulled out. Remove the tubing by disconnecting the luer locks on the end of
the manifold. Be careful to leave the connectors inside the wash manifold, and make sure that they are
tight.
Note: Do not remove the bumpers from the body of the manifold. There is a risk of
damaging some associated washers, the function of which is to prevent leakage, if the
bumpers are removed. Loss of one or more washers can result in manifold leakage.
4 Inspect the wash manifold. If necessary, use the two styluses provided to clean out all of the metal
aspirating and dispensing probes. The two styluses are stored in a clear plastic cylinder and gripped by
a clip located in the inside upper back right corner of the main instrument.
The smaller diameter stylus is used for the relatively narrower dispensing probes. The larger diameter
stylus is used for the wider aspirating probes. You can soak the manifold in warm tap water for 20
minutes. After soaking, flush the manifold with warm tap water through the luer connection (using a
syringe), and reinsert it back into the Echo Lumena.

Removing and Replacing the Wash Manifold Chapter 8: Customer Component Replacement
Step Action
5 Following inspection (and cleaning, if necessary), the manifold can be reconnected to its tubing (as
shown in the previous diagram). The two pieces of tubing can only be connected to their matching luer
locks.
6 Slide the manifold back into the groove, and secure it with the flathead screw in the front of the
manifold.
8 Perform the required maintenance tasks: Initialize, Prime Washer, Washer Basic Test, Washer Residual
Volume, and Washer Dispense Accuracy.

Chapter 8: Customer Component Replacement Removing and Replacing Syringes
Removing and Replacing Syringes

This section describes how to remove and replace the 1000 μL and 100 μL syringes.
Purpose
The purpose of removing and replacing the 1000 μL and 100 μL syringes is to allow for inspection of the 1000 μL
and 100 μL syringes if a leak (through breakage) is suspected and to allow replacement thereafter (if necessary).
Required Interval
Note: Following completion of this maintenance task, you must then perform the initialization
followed by the prime instrument and the probe accuracy test maintenance tasks.
Tools
None
Instructions
Note: The syringe assembly consists of two syringes driven by separate syringe motors that turn a
lead screw. One syringe is 100 μL in volume and the other is 1000 μL in volume. The larger 1000 μL
syringe is used to aspirate and dispense most sample and reagent volumes. The smaller 100 μL
syringe is used to insert air gaps between sample and reagents and the system liquid. The 100 μL
syringe is also used to aspirate the smallest volumes for preparation of red blood cell suspensions.
The 100 μL syringe is mounted to the left pump, and the 1000 μL syringe is mounted to the right
pump.
Syringe assembly

Removing and Replacing Syringes Chapter 8: Customer Component Replacement
Follow this procedure to remove and replace syringes:
Step Action
1 Power off the instrument and the PC.
2 Remove both the PBS liquid container and the waste container from the fluidics module.
3 Remove the black bracket that protects the bottom of the syringes by removing the four (4)
thumbscrews that secure the bracket.
Note: A pinch hazard warning label is adhered onto the front of the black bracket.
Pinch hazard label on black bracket
4 Loosen the thumb screw on top of each syringe.
5 Remove the thumb screw (at the bottom of each syringe) that mounts the syringe plunger to the pump
lead screw.
6 Disconnect the tubing from both sides of the top of the syringe.
7 The syringe is now free to be removed and replaced. To replace the syringe:
• Connect the tubing to both sides of the top of the syringe.
• Mount the syringe plunger to the pump lead screw, and use the thumb screw (at the bottom of
the syringe) to secure it.
• Tighten the thumb screw on the top of the syringe to secure it into its slot.
8 After you have installed the new syringe, you must then replace the black bracket that protects the
bottom of the syringes (using the thumbscrews).
9 Reconnect both the PBS liquid container and the waste container using the methods described in
Chapter 5 – Maintaining the Echo Lumena.
10 Power on the main instrument and PC according to the instructions in Chapter 3 – Instrument Testing
Operation.
11 Perform the required maintenance tasks: Initialize, Prime Probe and Probe Accuracy Test.

Chapter 8: Customer Component Replacement Removing and Replacing the Peri-Pump
Removing and Replacing the Peri-Pump

This section describes how to remove and replace the peri-pump.
Purpose
The purpose of removing and replacing the peri-pump is to allow inspection of the peri-pump if a leak (through
breakage) is suspected and to allow replacement thereafter (if necessary).
Required Interval
Note: The tubing will be changed by an Immucor representative as part of the annual preventative
maintenance.
Following the completion of this maintenance task, you must perform the Initialization followed by
the Prime Instrument and Fluidics Test maintenance tasks.
Tools
• Flathead screwdriver
Instructions
Note: The peri-pump is used to rinse the probe after reagent and sample addition. It consists of a
peristaltic pump wheel driven by a stepper motor. The pump pushes system liquid through the tops
of the syringes and out the main tubing line to the probe.
Peri-pump

Removing and Replacing the Peri-Pump Chapter 8: Customer Component Replacement
Follow this procedure to remove and replace the peri-pump:
Step Action
1 Power off the instrument and the PC, and lift the lid of the fluidics module.
2 Remove the PBS liquid container.
3 Disconnect the peri-pump tubing from the inlet fitting and the outlet fitting to the syringes.
4 Using the flathead screwdriver, remove the three flathead screws that hold the pump assembly in place
(note the two on the left side and one in the bottom right corner).
Note: There is one nut in the top-right corner that keeps the wheel and housing together.
Do not remove this nut.
5 The peri-pump can now be removed and inspected. To remove the peri-pump, you must disconnect
both ends of the peri-pump tubing connected to the back wall of the fluidics module (the inlet fitting
and the syringe connection fitting). If the peri-pump requires replacement, obtain a new peri-pump for
attachment, and proceed to step 6. If the peri-pump does not require replacement, proceed to step 6
to reattach it.
6 Attach the peri-pump to the fluidics module by using the three flathead screws from step 4, and ensure
that the key (covered by the plastic noise buffer) on the wheel matches the gear on the motor.
Note: Reuse the same plastic noise buffer from the removed peri-pump on the newly
installed peri-pump.
7 Attach the tubing to the inlet fitting and the syringe fitting.
8 Reconnect the PBS liquid container using the method described earlier in this chapter, and close the
lid of the fluidics module.
10 Perform the required maintenance tasks: Initialize, Prime Probe and Fluidics Test.

Chapter 8: Customer Component Replacement Removing and Replacing the Centrifuge
Removing and Replacing the Centrifuge

This section describes how to remove and replace the centrifuge.
Purpose
The purpose of removing and replacing the centrifuge is to replace a non-functioning centrifuge with a working
module.
Required Interval
Note: Following completion of this maintenance task, you must then perform Initialization followed
by the Calibrate Centrifuge maintenance task.
Tools
None
Instructions
Follow this procedure for removing and replacing the centrifuge:
Step Action
2 Remove the cover from the main instrument.
3 Remove the four (4) springs from the two (2) pins on the front and the two (2) pins on the back of the
centrifuge assembly.
Centrifuge module with springs attached to pins

Removing and Replacing the Centrifuge Chapter 8: Customer Component Replacement
Step Action
4 Disconnect the centrifuge motor power connection from the centrifuge controller PCB (J11
connection).
Centrifuge J9, J10, J11 connections
5 Disconnect the centrifuge motor encoder connection from the centrifuge controller PCB (J10
connection).
6 Disconnect the centrifuge motor home sensor from the centrifuge controller PCB (J9 connection).
7 Remove the thumbscrew that secures the cables to the instrument.

Note: Do not discard the thumbscrew clip. It will be used for the new centrifuge.
8 Remove the old centrifuge module from the instrument.
9 Install the new centrifuge module by securing the springs back on the pins.
10 Connect the J9, J10 and J11 cables so that they do not interfere with the operation of the centrifuge.
11 Attach the thumbscrew clip to the new centrifuge cables and secure the thumbscrew to the
instrument.
12 Secure the cover back onto the main instrument.
Operation.
14 Perform the required maintenance tasks: Initialization, Calibrate Centrifuge.

Chapter 8: Customer Component Replacement Replacing the Echo Lumena Incubator Assembly
Replacing the Echo Lumena Incubator Assembly

This section describes how to replace the incubator assembly.
Purpose
The incubator assembly is used for ambient and elevated temperature incubation during assay processing. The
ambient incubator is also used for strip loading. The reason for repairing and replacing the incubator is that the
thermistors are failing and reporting false temperatures, the elevated temperature incubator is out of temperature
range, or the incubator door is not closing or sealing adequately.
Required Interval
Tools
• Incubator Assembly
• 5/32” Allen wrench
Instructions
Follow this procedure to replace the incubator assembly:
Incubator

Replacing the Echo Lumena Incubator Assembly Chapter 8: Customer Component Replacement
Step Action
1 Remove any strips or strip holders from the instrument.
3 Remove the instrument cover.
4 Remove the 2 hex nuts at the bottom of the ambient incubator using the 5/32” Allen wrench. Be
careful not to lose the washer on each nut.
5 Remove the 2 hex nuts at the right edge of the elevated temperature incubator using the 5/32” Allen
wrench. Be careful not to lose the washer on each nut.
6 Disconnect the blue cable at the top of the ambient incubator by pushing it in to remove. This
connection resembles a telephone jack.
7 Disconnect the cable connector that contains the red and black cables at the top of the ambient
incubator.
8 Disconnect by untwisting the fastener that anchors these two cables to the top of the elevated
temperature incubator.
9 Remove the blue cable and the red and black cables completely from the incubator module by
unlatching the gray door on the outside of the incubator. Push the gray latch as far left as possible to
release.
10 Remove the entire incubator module from the instrument.

Note: There are 2 pegs on the underside of the incubator module, one on either side of
the centrifuge, which help secure and position the module on the instrument. If these fall
out while removing the module, replace them into their respective holes before loading
the new incubator module.
11 Place the new incubator module on the instrument, using the pegs and holes for the hex screws for
reference.
12 Secure the 4 hex screws using the 5/32” Allen wrench.
13 Secure the blue cable and the red and black cables under the gray latch.
14 Connect the blue cable and the red and black cables to their respective outlets.
Remember, the blue cable must be compressed before inserting into the jack.
15 Twist the fastener around the blue, red, and black cables to secure them to the top of the elevated
temperature incubator.
16 Put the instrument cover back on the main instrument.
Operation.
18 Perform the required maintenance tasks: Initialization.
19 Contact Immucor Technical Support to perform post-installation verification.

Chapter 8: Customer Component Replacement Replacing the Echo Lumena Skin Micro-Switch
Replacing the Echo Lumena Skin Micro-Switch

This section describes how to replace the skin micro-switch.
Purpose
The micro-switch may need to be repaired or replaced if the instrument cover error continues to occur even when
the cover is secured correctly.
Note: The skin micro-switch is located in the bottom right corner of the main instrument. The micro-
switch is used to indicate whether the instrument cover has been removed during instrument
operation.
Required Interval
Tools
• Skin micro-switch
• #1 Phillips head screwdriver
Instructions for Removal

Follow this procedure to remove the skin micro-switch:
Step Action
3 Remove the two screws on the side of the micro-switch with a #1 Phillips head screwdriver.
Remove these
screws
Side of the micro-switch showing screws to remove
4 Disconnect the micro-switch from the instrument by gently pressing and pulling the cable
connector.

Replacing the Echo Lumena Skin Micro-Switch Chapter 8: Customer Component Replacement
Instructions for Replacement

Follow this procedure to replace the skin micro-switch:
Step Action
1 Connect the cable connector from the instrument to the replacement micro-switch. The open
portion of the sensor on the micro-switch should be facing downward.
2 Secure the micro-switch by inserting the two screws through the micro-switch and tighten them to
the instrument.
3 Replace the instrument cover.
4 Power on the main instrument and PC according to the instructions in Chapter 3 – Instrument
Testing Operation
5 Initialize the instrument.
Note: If instrument cover removed errors continue to be observed, make sure the micro-switch was
installed correctly by repeating the steps described above. If the errors continue, contact Immucor
Technical Support for further assistance.

Chapter 8: Customer Component Replacement Replacing the Echo Lumena Washer Syringe Cap and Seal
Replacing the Echo Lumena Washer Syringe Cap and Seal

This section describes how to replace the syringe cap and seal.
Note: This procedure applies to Echo Lumena instruments that have received the retro-fitted
bracket on the washer syringe cap and seal. This procedure also requires a Phillips head
screwdriver in place of a flat head screwdriver.
Purpose
The washer syringe opens and closes within the washer syringe cap to dispense PBS to the washer. The purpose
of replacing the syringe cap is to ensure dispensing of PBS and to stop leaks.
Required Interval
You must perform this task as required.
Tools
• Washer Syringe Cap and Seal
• Phillips head screwdriver
Note: Before removing the washer syringe cap and seal, the Purge Instrument maintenance task
should be performed to prevent leakage. Purge Instrument can be accessed from the toolbar by
going to Tools and then Maintenance.

Replacing the Echo Lumena Washer Syringe Cap and Seal

Follow this procedure to remove the syringe cap and seal:
Step Action
3 Loosen the screws on the bracket and place the bracket to the side.
4 Disconnect the two pieces of tubing from the front of the syringe cap and seal.
Disconnect
Syringe tubing
5 Remove the two screws from the syringe cap and seal with the Phillips head screwdriver.
6 Remove the syringe cap and seal by pulling it straight out from the syringe head and off of the
instrument.

Chapter 8: Customer Component Replacement Replacing the Echo Lumena Washer Syringe Cap and Seal
Instructions for Installation and Replacement

Follow this procedure to install or replace the syringe cap and seal:
Step Action
1 Insert the syringe cap and seal into the instrument by sliding it straight forward onto the syringe head.
2 Replace the two screws on the syringe cap and seal, but do not tighten them until the bracket has
been put into place as stated in step 3.
3 Replace the bracket by holding it against the cap and seal and then tighten the screws.
4 Connect the two pieces of tubing from the instrument to the front of the syringe cap and seal, ensuring
the arrows on the plastic connectors remain aligned with each other.
5 The tubing from the wash manifold should attach to the top nipple on the syringe cap and seal. The
tubing from the instrument should attach to the bottom nipple on the syringe cap and seal.
Operation.
8 Perform the required maintenance tasks: Initialization, Prime Washer, Washer Basic Test, Washer
Residual Volume, and Washer Dispense Accuracy.

Replacing the Top and Bottom Lamp in the Camera

This section describes how to replace the camera lamp assemblies.
Note: There are two camera lamps located on the front of the reader module, which is located in the
front center of the main instrument. The top camera lamp illuminates the reader module during
image analysis. The bottom camera lamp illuminates the reader module during strip identification.
Purpose
The camera lamps illuminate the reader module during image analysis and strip identification. The purpose of
replacing the camera lamps is to resolve camera calibration warning or error messages.
Required Interval
You must perform this task as required.
Tools
• Echo Lumena Top Lamp Assembly
• Echo Lumena Bottom Lamp Assembly
Instructions for Top Lamp Assembly Removal

Follow this procedure to remove the top lamp assembly:
Step Action
3 Disconnect the top right black cable connector (labeled TOP-LAMP) from the PC board on the front of
the reader module by pressing the connector and pulling.
Disconnect here
PC board showing top lamp assembly

Chapter 8: Customer Component Replacement Replacing the Top and Bottom Lamp in the Camera
Step Action
4 Remove the thumbscrew that holds the top lamp assembly to the reader module.
Remove
Top lamp assembly and reader module
5 Remove the top lamp assembly.
Top lamp assembly

Instructions for Top Lamp Assembly Replacement

Follow this procedure to replace the top lamp assembly:
Step Action
1 Insert the top lamp assembly into position on the reader module.
2 Connect the top lamp assembly to the reader module by inserting the thumbscrew and tightening.
3 Connect the cable connector from the top lamp assembly into position on the PC board on the front of
the reader module.
Operation.
6 Initialize the instrument. During Initialization, Camera Calibration is performed. If the Camera Calibration
fails during Initialization, check the camera report by accessing Reports and then Camera from the
toolbar and verify the camera calibration values per Chapter 6 – Echo Lumena Reports. If the
calibration values are out of range, contact Technical Support for further assistance.

Instructions for Bottom Lamp Assembly Removal

Follow this procedure to remove the bottom lamp assembly:
Step Action
3 Disconnect the bottom right cable connector (labeled BOT-LAMP) from the PC board on the front of
the reader module by pressing the connector and pulling.
Disconnect here
PC board showing bottom lamp assembly
4 Remove the two thumbscrews that hold the bottom lamp assembly to the reader module.
Remove
Reader module

Step Action
5 Remove the bottom lamp assembly by holding the PC board.
Bottom lamp assembly
Note: Do not handle bottom lamp assembly by the light bulb. This can cause the lamp to
overheat and fail sooner than expected.

Instructions for Bottom Lamp Assembly Replacement

Follow this procedure for replacing the bottom lamp assembly:
Step Action
1 Insert the bottom lamp assembly into position on the reader module by holding the PC board.
Note: Do not handle bottom lamp assembly by the light bulb. This can cause the lamp
to overheat and fail sooner than expected.
2 Connect the bottom lamp assembly to the reader module by inserting the two thumbscrews and
tightening.
3 Connect the cable connector from the bottom lamp assembly into position on the PC board on the
front of the reader module.
Operation.
6 Initialize the instrument. During Initialization, Camera Calibration is performed. If the Camera Calibration
fails during Initialization, check the camera report by accessing Reports and then Camera from the
toolbar and verify the camera calibration values per Chapter 6 – Echo Lumena Reports. If the
calibration values are out of range, contact Technical Support for further assistance.

Cleaning, Removing, and Installing the Rinse Station

This section describes how to clean, remove, and install the probe rinse station.
Purpose
The probe rinse station provides a location for the probe to dispense waste and wash the outside of the probe, and
for the probe to rinse itself. The purpose of removing and replacing the probe rinse station is to clean it, to clear any
blockages or to replace a damaged unit with a new station.
Note: After removing and replacing the station you must then perform the prime instrument
maintenance task followed by the fluidics test, check probe vertical position, and check probe
alignment. All of these maintenance tasks must pass to ensure that the rinse station has correctly
been installed.
Required Interval
You must perform this task as needed.
Note: Signs of a blocked or damaged probe rinse station are a failed fluidics test or an overflowing
of rinse station fluids onto the internal Main Instrument deck.
Tools
• Allen wrench (9/64”)
• Disposable, soft, and absorbent material
• Cotton applicator stick
• Warm tap water
• Recommended cleaning solution

Chapter 8: Customer Component Replacement Cleaning, Removing, and Installing the Rinse Station
Instructions for Cleaning

Follow this procedure to clean the rinse station:
Step Action
1 Power off the instrument and PC and remove the instrument cover.
2 Lift up on the bottom of the probe block and move the probe assembly to the far right of the
instrument.
3 Insert cotton applicator stick into the external rinse tube (front center hole) of the probe rinse station.
Cotton applicator stick and external rinse tube
4 Clean the bottom of the probe rinse station with the cotton applicator stick. Ensure the rinse station is
free of clots and blockages (the cotton applicator stick should be clean when removed).
If the cotton applicator stick is dirty or the rinse station is still clogged, remove the probe rinse station to
rinse or soak with warm tap water or recommended cleaning solution.
Cleaning the probe rinse station


Follow this procedure to remove the rinse station:
Step Action
2 Remove the cover of the instrument.
3 Position the probe assembly as far to the right as possible to avoid damage to the probe.
4 Loosen the four (4) Allen screws at the base of the rinse station using the Allen wrench (9/64”). The
screws will be removed in step 5.
Note: The probe rinse station is located at the left-back corner of the internal Main
Instrument deck.
Removing Allen screws at the probe rinse station
5 Lift the rinse station with the loosened screws hanging from the bottom corners of the rinse station
until the rinse station is free of the deck. Remove the screws and washers from the bottom of the
probe rinse station.
6 Remove the rinse tubing from the fitting on the side of the rinse station. Rinse tubing is equipped with
blue tape.
Removal of rinse tubing

Chapter 8: Customer Component Replacement Cleaning, Removing, and Installing the Rinse Station
Step Action
7 Remove the waste tubing at the bottom back side of the probe rinse station. Waste tubing is equipped
with yellow tape.
Removal of waste tubing
8 Use the disposable soft and absorbent material to clean up any liquid waste spilled onto the internal
Main Instrument deck as a result of removing the waste pump tubing. Discard the contaminated
disposable materials according to your local site regulations.
Warning: Liquid waste from the rinse station contains potentially biohazardous material
and must be treated as potentially infectious.
Always wear protective gloves and clothing when handling liquid waste. All liquid waste
must be discarded following the standard practice and local site regulations of the
laboratory.
9 Inspect the station for damage or blockages. You can flush or soak the station with warm tap water or
a working solution of the recommended cleaning solution if the station is blocked or grossly
contaminated. Alternatively, if the station is damaged beyond use, you can install a new rinse station.

Instructions for Installation

Follow this procedure to install the rinse station:
Step Action
1 Connect the waste tubing onto the bottom back side of the probe rinse station. Waste tubing is
equipped with yellow tape.
2 Connect the two pieces of rinse tubing to each side of the probe rinse station. Rinse tubing is
equipped with blue tape.
3 Insert the 4 sets of Allen screws and washers into the bottom corners of the probe rinse station.
4 Place the probe rinse station in the bottom of the main instrument with the waste tubing facing the
back of the instrument. Ensure the waste tubing is behind the probe rinse station and is not kinked so
that it does not interfere with probe movement.
Note: Press firmly on the rinse station to ensure that it is secured onto the alignment
pins.
5 Tighten the four screws on the bottom of the probe rinse station with the 9/64” Allen wrench.
Note: Be careful not to over tighten the screws, as this could damage the rinse station.
6 Install the instrument cover. Power on the main instrument and PC according to the instructions in
Chapter 3 – Instrument Testing Operation.
7 Perform the required maintenance tasks: Initialization, Prime Probe, Fluidics Test, Check Probe
Alignment and Check Probe Vertical Position.
Note: It is not advised to remove the bottom of the rinse station to clean or replace the internal filter
of the rinse station. Incorrect replacement of this filter can lead to excess leaking from the rinse
station and possible damage to the rinse station or other parts of the instrument.

Chapter 8: Customer Component Replacement Removing and Replacing the Probe Rinse and Waste Pumps
Removing and Replacing the Probe Rinse and Waste Pumps

This section describes how to remove and replace the probe rinse and waste pumps.
Purpose
The probe rinse and waste pumps are used in conjunction with the rinse station to rinse the probe and remove
waste from the rinse station. Some indications that the pumps may need to be repaired or replaced are listed
below.
· The fluidics test fails.

· The rinse station is overflowing.
· The external rinse of the probe is not functioning.
Probe Rinse Pump
Probe Waste Pump
Required Interval
Note: Following completion of this maintenance task, you must perform Initialization followed by the
Prime Probe maintenance tasks. You must then perform the Fluidics Test maintenance tasks.
Tools
None

Removing and Replacing the Probe Rinse and Waste Pumps
Instructions to Remove the Probe Rinse and Waste Pumps

Follow this procedure to remove the probe rinse and waste pumps:
Step Action
1 Switch off the power to the instrument and the PC, remove the instrument cover, and then position the
probe to the farthest position to the right in the instrument
2 Unscrew the two thumb screws that hold the cover that houses the probe rinse and waste pumps and
slide the cover to the right so it is out of the way.
3 Disconnect the two pieces of tubing attached to the pump by grasping the tubing and pulling the
tubing away from the pump.
4 Disconnect the cable connector between the pump and the instrument by pressing the wire connector
and pulling
5 Remove the pump
Instructions to Replace the Probe Rinse and Waste Pumps

Follow this procedure to replace the probe rinse and waste pumps:
Step Action
1 Place the pump in the back left corner of the instrument. The rinse pump is seated in the forward
location and the waste pump is located in the back location. The wiring on the pump should be
facing to the left.
2 Connect the cable from the pump to the instrument
3 Connect the tubing from the instrument to the pump according to the diagram that is located on the
top of the rinse and waste pump cover.
5 Perform the required maintenance tasks: Initialize, Prime Probe and Fluidics Test.

Chapter 8: Customer Component Replacement Removing and Replacing the Probe Rinse and Waste Pumps

Chapter 9: Software and Hardware Components
Chapter 9: Software and Hardware

Components
In This Chapter:
CHAPTER 9: SOFTWARE AND HARDWARE COMPONENTS ................................ 9-1
General Data ..................................................................................................... 9-2
Power Requirements ....................................................................................... 9-2
Dimensions ..................................................................................................... 9-2
Weight ............................................................................................................ 9-3
Connections.................................................................................................... 9-3
Personal Computer (PC) .................................................................................... 9-3
Description ...................................................................................................... 9-3
Safety Features of the PC ................................................................................ 9-4
Software ......................................................................................................... 9-4
Main Instrument ................................................................................................. 9-4
Sample and Reagent Loading Bays ................................................................... 9-4
Description ...................................................................................................... 9-4
Safety Features of the Sample and Reagent Loading Bays .............................. 9-5
Sample Loading Bay ....................................................................................... 9-5
Reagent Loading Bay ...................................................................................... 9-5
Sample/Reagent Barcode Scanner.................................................................. 9-6
Strip Loading Bay .............................................................................................. 9-6
Description ...................................................................................................... 9-6
Safety Features of the Strip Loading Bay ......................................................... 9-7
Incubators ......................................................................................................... 9-7
Description of the Elevated Temperature Incubator .......................................... 9-8
Safety Features of the Elevated Temperature Incubator ................................... 9-8
Description of the Ambient Incubator ............................................................... 9-8
Safety Features of the Ambient Incubator ........................................................ 9-9
Fluidics Module ................................................................................................ 9-10
Description .................................................................................................... 9-10
Safety Features of the Fluidics Module ........................................................... 9-11
Pipetting System.............................................................................................. 9-12
Description .................................................................................................... 9-12
Safety Features of the Pipetting System ......................................................... 9-13
Transport System ............................................................................................ 9-14
Description .................................................................................................... 9-14
Safety Features of the Transport System ....................................................... 9-14
Washer ............................................................................................................ 9-14
Description .................................................................................................... 9-14
Safety Features of the Washer ....................................................................... 9-15
Centrifuge ........................................................................................................ 9-15
Description .................................................................................................... 9-15
Safety Features of the Centrifuge ................................................................... 9-15
Camera Reader ............................................................................................... 9-16
Description .................................................................................................... 9-16
Safety Features of the Camera Reader .......................................................... 9-16

General Data
This section describes the general technical data for the Echo Lumena:
X Power requirements
X Dimensions
X Weight
X Connections
Power Requirements
Voltage 100–240 +/- 10% volts
Frequency 50–60 Hz
Power consumption 250 watts or VA
Dimensions
Main instrument (with instrument cover in 28 inches wide x 19.5 inches deep x 19
place) inches high (71 cm wide x 49.5 cm deep x
48.5 cm high)
Fits on a 24-inch (61-cm) deep bench
This allows for 2.75 inches (7 cm) of cable
space on the right end and 2 inches (5 cm)
of space in the rear for tubing, cables, and
air flow.
Fluidics module (without monitor in place) 17 inches wide x 23 inches deep x 13.5
inches high (43.2 cm wide x 58.4 cm deep
x 34.3 cm high)
Fits on a 24-inch (61-cm) deep bench
Side clearance between the fluidics module
and the main instrument should be 0.5 inch
to 1 inch (1.3 cm to 2.5 cm).
Power supply 4.5 inches wide x 11 inches deep x 3

inches high (11.4 cm wide x 27.9 cm deep
x 7.6 cm high)

Personal Computer (PC) Chapter 9: Software and Hardware Components
Weight
Maximum dry weight of main instrument 84 lbs (38.1 kg)
(with cover in place)
Maximum dry weight of fluidics module 20 lbs (9.1 kg)

(without monitor or containers)
Connections
LIS to PC Serial RS232 or TCP/IP socket transfer
(network LAN adaptor)
PC to instrument Serial RS232
Instrument internal Serial RS232
Monitor to PC USB
Personal Computer (PC)

This section describes the PC and its safety features.
Description
The PC hardware consists of a keyboard, touch screen monitor, mouse, and handheld barcode scanner for entry of
information into the Echo Lumena software. The Echo Lumena software, installed on a stand-alone PC, controls the
Echo Lumena. The touch screen PC monitor and keyboard reside on top of the fluidics module.
The PC workstation
This PC is connected to the Echo Lumena and can also be linked through a serial or network (LAN) Ethernet
connection to a host computer or an external Laboratory Information System (LIS). This enables you to download
test selections (worklists) to the Echo Lumena and export test results from it to the LIS.

Chapter 9: Software and Hardware Components Main Instrument
Note: Do not install additional software or add-on hardware. This will void your warranty and service
contract. The installation of unapproved software may affect the performance of the Echo Lumena
and provide a means of introducing computer viruses.
The computer provides the hardware environment for the PC-based software, the interface for the
instrument, and the interface for the LIS, Charged Coupled Device (CCD) camera port, printer port,
and fixed DVD disk drive.
For more information about the Echo Lumena software, refer to Chapter 2 – System Software
Navigation.
Safety Features of the PC

This PC is equipped with the following safety features:
• The computer is attached to an uninterruptible power supply (UPS) with an integral power conditioner to
provide a consistent source of electricity and to provide short periods of backup power.
• This UPS is supplied to you with the purchase of the Echo Lumena.
Software
Operating system Windows® 7 Professional
Echo Lumena install set Loaded with current software version
Data storage capacity Approximately 433,000 test results
Antivirus Immucor approved Antivirus solution
Optional Software Safety Features

The Echo Lumena software is equipped with the following optional safety features:
• Antivirus virus definitions and security updates will be released on a scheduled basis through Immucor
• Windows security updates will be released on a scheduled basis through Immucor
Main Instrument
The main instrument consists of the following modules which will be described in detail in this chapter.
• Sample and reagent loading bays
• Strip loading bay
• Incubators
• Pipetting system
• Transport system
• Washer
• Centrifuge
• Camera reader
Sample and Reagent Loading Bays

This section describes the sample and reagent loading bays and their safety features.
Description
The sample and reagent loading bays both operate the same way. The loading bays are composed of rack lanes,
indicator LEDs, and a barcode laser scanner. The reagent and sample loading bays are not interchangeable.

Sample and Reagent Loading Bays Chapter 9: Software and Hardware Components
The sample and reagent loading bays are equipped to contain the samples and reagents required for pipetting. The
loading bays are accessible from the front of the instrument, allowing the operator continuous access during
instrument operation.
Up to four racks can be loaded into each of the sample and reagent loading bays at one time.
The sample and reagent loading bays are in the center of the instrument, and they both have an associated laser
scanner. The barcode laser scanners are located within the loading bays. They read the rack, tube, and vial
barcodes as a rack slides into the loading module.
The reagent loading bay has a magnetic stirrer located below the reagent bay floor to stir the stir balls added to
cellular reagent vials.
A table loading station is located directly behind the sample and reagent loading bays where the micro-well strips
are loaded. The samples and reagents are pipetted into the micro-well strip wells from this location.
Sample and reagent loading bays
Safety Features of the Sample and Reagent Loading Bays

The sample and reagent loading bays are equipped with the following safety features:
• Integrated sensors continuously monitor the presence of racks in the lanes and flag any rack removal or
exchange.
• LEDs indicate the status of each lane at all times.
• Positional barcodes on the rack prevent the mix-up of sample or reagent barcodes and positions during
rack loading.
• Laser barcode scanners in the loading bays read sample tube and reagent vial barcodes as a method of
maintaining positive identification of those items.
Sample Loading Bay

Dimensions 4 inches wide x 4 inches high (10.2 cm
wide x 10.2 cm high)
Lanes 4
Reagent Loading Bay

Dimensions 4.3 inches wide x 2.5 inches high (10.9 cm

Chapter 9: Software and Hardware Components Strip Loading Bay
wide x 6.4 cm high)
Lanes 4
Sample/Reagent Barcode Scanner

Barcode types Refer to Chapter 1 – Introduction to the
Echo Lumena for list of barcode
specifications
Maximum fraction of reading failures <1 failure per 500 reads
Strip Loading Bay

This section describes the strip loading bay and its safety features. The Strip Loading Bay is also referred to as the
Ambient Incubator.
Description
Dimensions 8 inches wide x 4.3 inches high (20.3 cm
wide x 10.9 cm high)
Tray positions 4
Capacity 32 strips (4 trays of 4 strip holders with 2

strips per holder)
Safety locks In use strip trays are locked so that the

operator cannot remove the tray,
regardless of the status of the indicator
lights.
The strip loading bay is a self-contained module that enables you to load and unload micro-well strips.
The micro-well strip positions are designed for easy and safe insertion of the micro-well strips.
You must load the micro-well strips into strip holders before placing them into the Echo Lumena using the strip
loading trays. These strip holders (two strips per holder) allow the transport system to move the micro-well strips
and load them into the various instrument modules required to complete the assays.
Up to four strip loading trays can be loaded at one time. Up to four strip holders can be loaded onto each strip
loading tray.

Incubators Chapter 9: Software and Hardware Components
Strip holder
Loading a strip tray
Note: Ensure that the micro-well strips are fully pushed down into the recess of the strip holder. A
mechanical stop at the rear of each position ensures that you cannot insert the micro-well strip too
far.
The strip loading bay acts as the location for the incubation of assays requiring incubation at room
temperature. An instrument thermistor is set to monitor ambient room temperature. If ambient
temperature exceeds the acceptable limit for a given assay incubating in the strip loading bay, then
the sample results are flagged as invalid.
Warning: Laboratory ambient temperature and humidity affect the room temperature incubation
process, and an elevated ambient room temperature may disrupt assays that need to be incubated
at specified temperature ranges as per the package insert.
Safety Features of the Strip Loading Bay

The strip loading bay is equipped with the following safety features:
• Integrated sensors continuously monitor the presence of strip trays in each position.
• LEDs indicate the status of each strip tray position at all times.
• Strip loading trays are locked while in use.
• Strips are tracked and monitored throughout the instrument by the use of two-dimensional barcodes.
Incubators
This section describes the incubators and their safety features.

Chapter 9: Software and Hardware Components Incubators
Description of the Elevated Temperature Incubator

The incubators provide the appropriate environment for the incubation steps of the assays performed on the
instrument. The elevated temperature incubator is located inside the instrument.
The elevated temperature incubator has a capacity of three strip holders. There is a motor-driven door with a seal
to prevent excessive mixing of incubated air and ambient air to minimize evaporation.
Thermistors and a temperature control circuit maintain the incubator temperature.
There are three incubator bays—two are still-air and one is forced-air. Strips are loaded first into the forced-air bay
for five minutes to rapidly heat the strips to the desired temperature. These preheated strips are then moved to one
of the two still-air heated bays for completion of the incubation. The temperature is monitored in all positions.
Safety Features of the Elevated Temperature Incubator

The incubator is equipped with the following safety features:
• Integrated sensors monitor the temperature in each position.
• The instrument software monitors and controls incubation time.
• The temperature distribution within an elevated temperature chamber during incubation is less than 1°C
from average. All tests in progress will be aborted if temperatures are outside the acceptable range (37.5 -
39.5°C).
Description of the Ambient Incubator

The Ambient Incubator acts as the location for the incubation of assays that require a room temperature incubation
temperature range. The Ambient Incubator is also referred to as the Strip Loading Bay.
Ambient incubator position slots
An instrument thermistor is set to monitor the ambient room temperature. If the ambient temperature is outside the
acceptable limit for a given assay incubating in the strip loading bay, the sample results are flagged as invalid.
in specified temperature ranges as per the package insert.

Incubators Chapter 9: Software and Hardware Components
Safety Features of the Ambient Incubator

The incubator is equipped with the following safety features:
• An instrument thermistor is set to monitor ambient room temperature. If ambient temperature is outside the
acceptable limit for a given assay incubating in the strip loading bay, then the sample results are aborted
and flagged as invalid.
• The instrument software monitors and controls the incubation time.
• The instrument software does not permit the start of an assay that requires ambient temperature incubation
if the ambient incubator is too hot or too cold.

Chapter 9: Software and Hardware Components Fluidics Module
Fluidics Module
This section describes the fluidics module and its safety features.
Description
The fluidics module is an integral part of the Echo Lumena. It is a compartment into which the Echo Lumena PBS
supply container and waste container are safely placed.
Fluidics module
The compartment houses two syringes, a peri-pump, the waste container, and the PBS supply container.
The two syringes and peri-pump are part of the system liquid delivery method to the main instrument.
One waste container – This container collects all fluid waste from the Echo Lumena.
One PBS supply container – This container houses the system liquid used by the pipettors, the probe rinse station,
and the washer.
For more information about the pipettors, refer to Pipetting System in this chapter.
Containers Waste container

PBS supply container
Waste container capacity 7.5 liters
PBS system liquid container capacity 7.5 liters
Peri-pump One pump
Syringes Two syringes

Fluidics Module Chapter 9: Software and Hardware Components
Waste (left side) and system liquid (right side) containers
Safety Features of the Fluidics Module

The compartment is equipped with the following safety features:
• The system monitors system liquid levels and alerts you when the volume is low and the container needs to
be filled.
• The system monitors waste liquid levels and alerts you when the volume is high and the container needs to
be emptied.
• The Echo Lumena will not operate if the PBS supply container or waste container is not connected.
“The waste container is full” alert message
“The buffer is low” alert message
Buffer disconnected alert message
Waste disconnected alert message

Chapter 9: Software and Hardware Components Pipetting System
Pipetting System
This section describes the pipetting system and its safety features.
Description
The pipetting system aspirates liquids from a defined source and dispenses them into a defined destination. Both
loading bays can be defined as a source location for the aspiration of fluids. The pipetting system also aspirates
and dispenses fluids from and into micro-wells.
The pipetting system is composed of the probe and the wash station.
Probe
The system has one probe mounted on a pipetting arm. The probe is used to pipette samples and reagents. The
probe assembly tubing is attached to the instrument using magnetic plates. Teflon tubing is fitted through the probe
to avoid sample and reagent carryover.
The probe assembly is fitted with a steel needle. A primed probe can dispense liquid volumes in single or multiple
deliveries.
The probe is equipped with both liquid level detection (LLD) and clot detection. If the probe detects no liquid or not
enough liquid, or if it detects a clot, the system issues a warning and, depending on assay-defined settings, waits
for your correction or aborts (invalidates) the run. The system makes an entry in the log.
Note: If the system detects a clot, it is important to check that the pipettor is not blocked, as this
inhibits further pipetting and leads to operational failures. For more information, refer to Chapter 7 –
Troubleshooting.
During instrument initialization, the pipettor arm and the pipettor mechanics undergo a full motion
check. The PBS supply container must be filled with pHix buffered (Immucor, Inc. saline buffering
concentrate product) commercial isotonic saline to yield PBS.
Note: Regular maintenance of the pipettor system is critical to the accuracy and precision of the
Echo Lumena’s pipetting performance. Refer to Chapter 5 – Maintaining the Echo Lumena.
Probe Rinse Station

To prevent contamination due to carryover between samples, the probe needle is washed in the rinse station after
every dispensing step. The rinse station is used for internal and external probe rinsing as well as probe alignment
verification.
You can also use the rinse station to prime the liquid system prior to its first use.
Probe washing is a two-step process, as follows:
1. The probe moves to the waste position over the rinse station, where the remaining contents of the probe
are emptied by flushing system liquid through and out of the probe.
2. The probe moves over and into the rinse cup, and the Echo Lumena pumps system liquid through the
pipettor tubing. This action washes the inside and the lower outside end of the probe simultaneously.
The system actively pumps waste liquid from the rinse station to the waste container in the fluidics module.

After sampling red blood cells from the bottom of sample tubes, the system performs a special external rinse in the
external rinse position.
The probe moves to the bottom of the external rinse well. The wash pump rinses the outside of the probe by
pumping system liquid through the tube.
The probe moves slowly out of the external rinse well to achieve complete rinsing of the outside of the probe.
Modes of function Aspirating

Dispensing
Priming
Washing
Channels 1 x 1 needle
Volume range 5–1000 μL
Dispensing accuracy +/- 10% accuracy
Liquid viscosity Aqueous solutions
System liquid container capacity 7.5 liters
Reagent vial dead volume 850 μL
Safety Features of the Pipetting System

The pipetting system is equipped with the following safety features:
• Integrated sensors monitor the position of the probe, as well as probe movement. If something hinders
probe movement, the system displays an error message and movement stops.
• LLD, clot detection, and aspiration tracking ensure accurate aspiration of liquids or adequate flagging of
results.
• Software controls limit the collision of the pipetting probe with other Echo Lumena components.
• If the Echo Lumena instrument cover is opened while the instrument is processing, any pipettor arm
movement in process will complete prior to stopping.
• Software controls monitor the addition of sample red blood cells, sample plasma or serum, and reagents to
test wells.
• The software reminds you to clean and decontaminate the pipetting system based on when the system
was last cleaned.
• After sampling red blood cells from the bottom of sample tubes, the system performs a special external
rinse in the external rinse position. The system also rinses the inside of the probe to remove plasma, red
blood cells, and reagents in order to prevent cross-contamination.
• A filter in the liquid supply prevents the system from aspirating particulate material into the fluidics system.

Chapter 9: Software and Hardware Components Transport System
Transport System
This section describes the transport system and its safety features.
Description
The transport system is composed of a robotic arm that moves micro-well strips between the various locations or
modules of the instrument, such as the loading (pipetting) station, centrifuge, washer, incubator, and reader. The
transport system moves the micro-well strips without interfering with any of the other modules of the analyzer. The
transport system positions micro-well strips in the camera reader. The robot positions the strips under the washer.
The robot arm also performs the shake function for assays performed by the instrument.
The transport system is not visible from the outside of the Echo Lumena, and it moves the micro-well strips without
interfering with any of the other modules.
Safety Features of the Transport System

The transport system is equipped with the following safety features:
• Integrated sensors monitor all movements of the transport system and verify that the programmed steps
are executed successfully. These sensors detect any obstruction in the transport system.
• Software controls limit the collision of the transport system with other Echo Lumena components.
• The transport system only operates when the Echo Lumena instrument cover is on.
• If the Echo Lumena instrument cover is opened while the instrument is processing, any transport system
movement in process will complete prior to stopping.
• The transport system moves strips to the camera reader for positive strip identification.

Warning: Never attempt to remove the instrument cover or reach the internal mechanical areas while
the Echo Lumena is operating. You may disrupt the Echo Lumena or injure yourself.
Washer
This section describes the washer and its safety features.
Description
The washer performs all micro-well strip washing cycles required for an assay protocol.
The washer is divided into two components—the washer module and the fluidics module (previously described).
Dimensions 2 inches wide x 6 inches deep x 4 inches high (5.1 cm

wide x 15.2 cm deep x 10.2 cm high)
Modes of operation Strip mode
Aspiration time Programmable
Dispense volume range 50–1100 μL per channel
Dispensing accuracy +/- 10% accuracy +/- 5% precision

Centrifuge Chapter 9: Software and Hardware Components
Washer Module
The washer, located inside the instrument, comprises the wash manifold assembly, the wash syringe, the wash
syringe cap and seal, the well sensor pins and the overflow and prime troughs. The washing process is not visible
from the outside of the Echo Lumena when the instrument cover is in place.
The transport system positions micro-well strips into the washer.
The wash manifold assembly dispenses PBS into the micro-well strip wells and aspirates PBS from them as
required by the assay protocol. Micro-well strips are raised to the wash manifold for each aspiration step.
Fluidics Module
The wash waste pump is located in the back of the fluidics module.
Safety Features of the Washer

The washer is equipped with the following safety feature:
• Integrated sensors that monitor the aspiration and the dispensing step to ensure correct operation.
Centrifuge
This section describes the centrifuge and its safety features.
Description
The centrifuge module is located inside the Echo Lumena and it has a safety containment barrier. Its function is to
perform centrifugation of micro-well strips and their contents during assays, as required by the assay protocol.
The transport system positions micro-well strips into the centrifuge and removes strips from the centrifuge following
centrifugation.
Dimensions 6 inches wide x 7.5 inches deep x 5.5 inches high (15.2
cm wide x 19.1 cm deep x 14 cm high)
Modes of operation Spinning
G-force (RPM) 0 – 745 RCF (0 – 3500 RPM)
Safety Features of the Centrifuge

The centrifuge is equipped with the following safety features:
• The centrifuge is entirely enclosed within a containment barrier during operation.
• The centrifuge rotor housing withstands complete rotor disintegration at full speed with only minor dents.
No parts will leave the housing.
• The software monitors centrifuge speed. It flags too-high and too-low speed conditions.

Chapter 9: Software and Hardware Components Camera Reader
Camera Reader
This section describes the camera reader and its safety features.
Description
The reader module is located inside the instrument.
The reader uses a Charged Coupled Device (CCD) camera to record an image of the micro-well strip wells. The
system software calculates an agglutination or solid phase red cell adherence value for each well based on multi-
feature image analysis algorithms.
The camera also reads the two-dimensional barcodes (used to identify micro-well strips) and performs assay in-
process safety reads of reagent and sample addition color checks.
Dimensions Camera assembly: 4.5 inches wide x 7 inches deep x

5.5 inches high (11.4 cm wide x 17.8 cm deep x 14
cm high)
Connection USB
Modes of operation Image capture
Type of camera CCD
Type of micro-well strip barcode read Two-dimensional barcodes
Optimum reading distance Adjust focus per instrument
Safety Features of the Camera Reader

The camera reader is equipped with the following safety features:
• The reader operates without the need for operator intervention.
• The reader performs color checks on micro-well strips to check for the presence of Anti-A and Anti-B when
performing ABO-related assays.
• The reader performs color checks on micro-well strips to check for the absence of red blood cells when
performing ABO-related assays.
• The reader checks for the addition of LISS and plasma and the absence of red blood cells in micro-well
strips when an antibody screen or identification is performed.
• The reader checks for air bubbles and foaming in the wells when performing ABO-related assays and
phenotype assays.

Camera Reader Chapter 9: Software and Hardware Components

Chapter 10: Configuration

In This Chapter:
CHAPTER 10: CONFIGURATION......................................................................... 10-1
Barcode Options ............................................................................................. 10-2
General Tab .................................................................................................. 10-2
Samples Tab ................................................................................................. 10-3
Donors Tab ................................................................................................... 10-4
General Options ............................................................................................... 10-6
General Tab .................................................................................................. 10-6
Date/Time Tab .............................................................................................. 10-6
HIS/LIS Tab .................................................................................................. 10-7
Language Tab ............................................................................................. 10-13
Reports Tab ................................................................................................ 10-14
Results Tab ................................................................................................. 10-18
System Tab ................................................................................................. 10-21
Security Tab ................................................................................................ 10-23
Service Tab ................................................................................................. 10-26
Test Options .................................................................................................. 10-27
General Tab ................................................................................................ 10-28
Reflex Tests Tab ......................................................................................... 10-28
Menu Tab ................................................................................................... 10-29
Profiles Tab ................................................................................................. 10-30
QC Tab ....................................................................................................... 10-32

Chapter 10: Configuration Barcode Options
Note: There are multiple categories of configuration options that can be accessed from the Tools
submenu. You can access the various options by clicking the item on the Tools submenu.
Accessibility is dependent on the access rights assigned to your user ID. Refer to Chapter 11 –
Security for details on access rights.
Barcode Options
The Barcode options window is a component of the Tools submenu. This option sets the barcode interpretation
options for patient and donor samples. There are three tabs within the Barcode options window:
• General tab
• Samples tab
• Donors tab
General Tab
Under the General tab of the Barcode options window, you can configure four features by checking or clearing
check boxes. By checking a box, you make that particular feature active.
Play a sound on rack and tray insertion and removal – This feature activates an audio signal when a rack or tray is
inserted or removed.
Play a sound on rack scanning errors – This feature activates an audio signal when a rack barcode has a scanning
error.
Display the Edit Barcodes property page on scanning errors – This feature activates the Edit Barcodes property
window when a barcode scanning error occurs.
Prompt for conversion on all Codabar samples – This feature activates a reminder dialog box regarding the
conversion of Codabar samples when sample or donor racks are inserted. This does not convert the barcodes.
Actual barcode conversion is configured on the Samples or Donor tab, described later in this chapter.
You can close the Barcode options window by clicking the Close button at the bottom of the window.
Barcode options: General tab

Barcode Options Chapter 10: Configuration
Samples Tab
Samples are defined as tubes inserted into either Sample or Pediatric racks. Under the Samples tab of the Barcode
options window, you can configure five features by checking or clearing check boxes. By checking a box, you
make that particular feature active.
Convert Codabar from numeric to alpha – This feature activates the alphanumeric conversion for Codabar
barcodes. This conversion replaces the first two digits (of seven) of the barcode with designated alphas using a
software-embedded truth table.
Convert day prefix from numeric to alpha – This feature activates the alphanumeric conversion for Sunquest day-of-
the-week prefixes. This conversion replaces the first digits of the barcode with designated alphas using a
configurable software truth table.
Strip Codabar prefix and postfix – This feature activates the stripping of the prefix and postfix characters from
Codabar barcodes (when recognized).
Strip equals sign from ISBT barcodes – This feature activates the stripping of the equal sign (=) at the beginning of
the sixteen-character ISBT 128 barcodes, thereby leaving characters numbered between two and sixteen inclusive.
Strip checksum from ISBT barcodes – This feature activates the stripping of the last two digits at the end of the
sixteen-character ISBT 128 barcodes, thereby leaving characters numbered between one and fourteen inclusive
(including the beginning equal sign).
By combining the Strip equals sign from ISBT barcodes and Strip checksum from ISBT barcodes features, you can
strip the equal sign (=) at the beginning and the last two digits at the end, thereby leaving characters numbered
between two and fourteen.
The Mask field is used to define how a barcode is manipulated and governed by how characters from the legend
are combined. Masking is an alternative, flexible method to manipulate the barcodes.
? – Ignore a barcode character.
# – Use a barcode character if it is a digit.
& – Use any character.
* – Use all remaining characters.
2-9 – An example of a numeric range that defines which characters are to be used. This number range can be
customized.
The following ISBT 128 barcode data is an example of masking. If the mask was set at ?2-14, then the ISBT 128
barcode of =G07359931656200 would be masked to G073599316562.

Chapter 10: Configuration Barcode Options
Barcode options: Samples tab
Warning: The instrument does not support the use of special characters as characters embedded in
patient or donor barcodes. The instrument software will issue a warning alerting you to the presence
of invalid barcodes on the instrument if you use a barcode embedded with a special character, and
it will list the actual invalid barcode data as part of the warning message. Additionally, no tube will be
recognized as being present by the software at that rack location. Refer to Chapter 1 – Introduction
to the Echo Lumena for the list of special characters that are not permitted on the Echo Lumena.
Donors Tab
Donors are defined as tubes inserted into the Donor rack. Under the Donors tab of the Barcode options window,
you can configure five features by checking or clearing check boxes. By checking a box, you make that particular
feature active.
Convert Codabar from numeric to alpha – This feature activates the alphanumeric conversion for Codabar
barcodes. This conversion replaces the first two digits (of seven) of the barcode with designated alphas using a
software-embedded truth table.
Convert day prefix from numeric to alpha – This feature activates the alphanumeric conversion for Sunquest day-of-
the-week prefixes. This conversion replaces the first digits of the barcode with designated alphas using a
configurable software truth table.
Strip Codabar prefix and postfix – This feature activates the stripping of the prefix and postfix characters from
Codabar barcodes (when recognized).
Strip equals signs from ISBT barcodes – This feature activates the stripping of the equal sign (=) at the beginning of
the sixteen-character ISBT 128 barcodes, thereby leaving characters numbered between two and sixteen inclusive.
Strip checksum from ISBT barcodes – This feature activates the stripping of the last two digits at the end of the
sixteen-character ISBT 128 barcodes, thereby leaving characters numbered between one and fourteen inclusive
(including the beginning equal sign).
By combining the Strip equals sign from ISBT barcodes and Strip checksum from ISBT barcodes features, you can
strip the equal sign (=) at the beginning and the last two digits at the end, thereby leaving characters numbered
between two and fourteen.

Barcode Options Chapter 10: Configuration
The Mask field is used to define how a barcode is manipulated and is governed by how characters from the legend
are combined. Masking is an alternative, flexible method to manipulate the barcodes.
? – Ignore a barcode character.
# – Use a barcode character if it is a digit.
& – Use any character.
* – Use all remaining characters.
2-9 – An example of a numeric range that defines which characters are to be used. This number range can be
customized.
The following ISBT 128 barcode data is an example of masking. If the mask was set at ?2-14, then the ISBT 128
barcode of =G07359931656200 would be masked to G073599316562.
The Prefix field is used to enter a prefix to barcode data that is not embedded in the barcode. You can add the
prefix to the barcode data by entering the desired prefix into the Prefix field.
Note: Only one prefix per donor rack can be added at any one time.
If blood unit donations that have different prefixes are tested on the Echo Lumena, you can activate a prompt for
every time a donor rack is inserted. The prompt requests the specific prefix to be used for that collection of donor
samples in that rack. Select Prompt for prefix when donor racks are inserted to activate this feature.
Warning: You must make sure that the donor samples in one given donor rack are of a single prefix
type. It is your responsibility to check this data. If you have mixed donor samples of different
prefixes, all donor samples will be given the same prefix that you entered on the prompt. Therefore,
identification errors could occur if the operator fails in this tube data check.
Barcode options: Donors tab

Chapter 10: Configuration General Options
General Options
The General options window is a component of the Tools submenu. This option configures the general system
settings. There are eight tabs within the General options window (the Service tab is only visible under the Service
user access):
• General tab
• Date/Time tab
• HIS/LIS tab
• Language tab
• Reports tab
• Results tab
• System tab
• Security tab
• Service tab (password protected – only for use by Immucor personnel)
General Tab
Under the General tab of the General options window, there are three data entry fields. The fields are Facility name,
Facility location, and Instrument name.
General options: General tab
You can close the General options window by clicking the Close button at the bottom of the window.
Date/Time Tab
Under the Date/Time tab in the General options window, there are fields and drop-down lists to customize the local
date and time format settings. When the Date/Time tab is opened, it displays the Current date and time (if it was
previously configured). Date and time formats can be configured using the Long date format, Short date format,
and Time format drop-down lists.
Defaults can be set using the Defaults button. This button is common to several other tabs on the General options
window. Refer to Appendix A – Echo Lumena Installation for a list of the default values.

General Options Chapter 10: Configuration
General options: Date/Time tab
Warning: The calculated elapsed times for reagent on-board time, QC expiration time, initialization
interval, and other instrument-related time monitoring functions that coincide with the end and
beginning of Daylight Saving Time (DST) may not accurately reflect the actual elapsed times. In this
instance, you are responsible for ensuring that the instrument is run according to your local
procedures, including the monitoring of elapsed times of these instrument time-related functions.
HIS/LIS Tab
Purpose
HIS/LIS configuration is provided so that site specific HIS/LIS configurations can be applied as required by the local
site rules, regulations, and standards. HIS/LIS connectivity can be configured using the HIS/LIS tab under General
options. Operators who have been granted authority to change the HIS/LIS setting have full access to the tab.
Operators who have not been granted authority to change the HIS/LIS settings can still access the tab, but with
extremely limited usage. The two (2) different levels of HIS/LIS tab accessibility are defined by different user rights,
as listed in the table below.
Access level Requires user rights ability to:
Full Change General options and administer security.
Limited Change General options but not administer

security.
HIS/LIS Tab with Full Access

A range of configurable features are available to you if you have the authority to change the HIS/LIS settings. The
restricted functions available under limited access, described later in this section, are also included with full access.
You must have the authority to change General options and also administer security to be able to gain full access.

General options window
The category selections in the Connection Type area that dictate areas of configuration are:
• Socket (which displays the Socket Options)
• Serial (which displays the Serial Options)
• Off (this selection disables the LIS interface)
Connection Type categories
The LIS interface settings can only be changed when the Interface Status is Stopped.
Interface Status stopped to change LIS settings
Pressing the Stop button will stop the LIS interface connection.
Stop button
The Instrument ID and Instrument Name are displayed for information as read-only. LIS ID is available for both
Socket and Serial options.

Inactive Instrument ID and Instrument Name fields
The Instrument ID consists of the instrument serial number and can only be edited by Immucor personnel. The
Instrument ID is used in the result messages to indicate the serial number of the instrument that performed the
testing.
The Instrument Name can be edited on the General tab of General options. The information stored in this field will
be used in outbound interface messages from the instrument to note the Sender ID (i.e., the sender of the
message).
The LIS ID is a free text field to enter the ID of the LIS system. The information stored in this field will be used in
outbound interface messages from the instrument to note the Receiver ID (i.e., the intended message recipient).
You can choose to Display the worklist notification bar when there are worklist entries by checking the
corresponding box. This option can be switched off by not checking the box.
Note: This worklist option should normally be selected.
Worklist option selected
Socket Options
If the Socket connection type is selected, the Socket Options area is open for configuration, but the Serial Options
area is closed.
Socket Options area
Within the Socket Options area, you can configure three (3) properties for the socket communication.
You can set the Host IP Address. This is the address identifying the IP address for the system that is listening for
the socket connection. The listening system is referred to as the LIS system.

You can set the Host Port Number. This is the port that is listening for connection on the LIS system identified
under the Host IP Address setting.
The KeepAlive checkbox is displayed to show whether the LIS interface has been configured to maintain an active
connection. You can enable whether the socket connection will utilize a KeepAlive packet. When this setting is
checked, a KeepAlive packet will be sent periodically to the LIS system in order to prevent a network idle timeout
situation with the established socket connection.
When the LIS interface communication is started, the instrument will attempt to establish a TCP Socket connection
to the Host IP Address and on the port number listed in the Host Port Number field.
Serial Options
If the Serial connection type is selected, the Serial Options area is open for configuration, but the Socket Options
area is closed. The five (5) items (shown in the image below) in the Serial Options area have drop-down lists where
various options are available to be selected.
Serial Options area
You can set the COM Port. This is the communication port recognized by the operating system. The default is set
as COM2.
You can set the Baud Rate. This is the speed at which the serial port will communicate. The default is set as 9600.
You can set the Byte Size. This is the number of data bits per character used in the serial connection. The default is
set as 8.
You can set the Stop Bits. This setting determines the number of stop bits used to indicate when the data byte has
been transferred. The default is set as 1.
You can set the Parity. This setting determines the parity bit to use in the serial communication. The default is set as
None.
By pressing the Defaults button, the interface is stopped and the socket and serial default values are reset.
Defaults button

Applying the Configuration

All interface configurations can be saved by pressing the Close button of the General options window.
Once all configured parameters are set for the desired connection type, you can press the Start button to initiate
LIS interface connectivity.
Start button
The interface status will update accordingly to display the current status of the interface connection. The possible
statuses are:
Stopped means that the instrument is not attempting an LIS interface connection.
Stopped interface status
Starting… means that the instrument is attempting to establish connection. For serial communication, this indicates
that the instrument software is attempting to bind with the serial COM port hardware. For socket communication,
this indicates that the instrument software is attempting to establish the socket connection with the LIS system.
Starting… interface status
Running means that the connection has been successfully established and the interface is running. For serial
communication, this indicates that the instrument software is bound with the serial COM port hardware. For socket
communication, this indicates that the instrument software has successfully established a socket connection with
the LIS system.
Running interface status
Not Connected means that the instrument was unsuccessful in establishing a connection. Troubleshooting the
connection settings may need to occur if a persistent problem exists with the inability to establish a connection.
Not Connected interface status

HIS/LIS Tab with Limited Access

If you do not have the authority to change HIS/LIS settings, you can still access the HIS/LIS tab to use the interface
Start button, if the interface needs to be started, and to use the Stop button, if the interface needs to be stopped,
as long as you have the authority to change General options.
HIS/LIS tab
When the Start button is pressed, the Interface Status changes from Stopped to Starting…, and then subsequently
to Running if the connection is successful.
Start button
The interface status displays as Not Connected if the interface is unable to establish a connection. The interface
can be stopped with the Stop button and attempted to start again with the Start button. If a problem persists in
getting the interface to advance to the Running state, troubleshooting the connection settings may need to occur.
Not Connected interface status
The interface status displays as Stopped if the interface is stopped and needs to be started with the Start button.
Stopped interface status
Pressing the Stop button will stop the LIS interface connection if the interface is currently active, which is indicated
by the interface status of Running.
HIS/LIS tab with Running interface status

Scenarios that could suggest the use of the Stop button include when the LIS is on downtime or when validation of
the interface is being performed.
Start button
You can also choose to Display the worklist notification bar when there are worklist entries by checking the box.
This option can be switched off by not checking the box.
Note: The worklist option should normally be selected.
Selected worklist option
All other information displayed on the HIS/LIS tab is displayed for information only for operators with limited access.
Language Tab
Under the Language tab in the General options window, the language options for the Echo Lumena are listed.
You can select the appropriate language by highlighting the language line in blue. Languages are listed in both
English and language-local spellings (with the exception of English).
General options: Language tab

Reports Tab
Under the Reports tab in the General options window, you can customize the information that you want to be
displayed on your reports.
General options: Reports tab
All assay reports display standard information—the Test name, Software version, Operator, Assay version, Batch
number, Instrument ID, Profile name, and Instrument name. The following is an example.
Example of standard information on assay reports
By selecting the check box for a given item in the Include in reports section, you can select which optional items will
be displayed on your reports. The list of available items includes:
• Test summary
• Well images
• Supplies
• Signature line
• Sample status
• Legend
The Test summary option is only available for group and screen assays so that all results can be seen together.
You can configure the well image size by using the Up and Down buttons (or by entering a number using the
keyboard) in the Well image size field (32 pixels is displayed in the previous example). The minimum pixel value is
16, and the maximum is 64.

Note: If a pixel value greater than the default of 32 is configured, the efficiency of printing reports
can be detrimentally affected.
Well results can be reported as positive and negative or graded by selecting either the Pos or neg or Grade option
in the Well results section.
Defaults can be set using the Defaults button. Refer to Appendix A – Echo Lumena Installation for a list of the
default values.
The following examples illustrate the different components of printed result reports.
The Test summary option is only available for group and screen combination assays, so that all results can be seen
together.
Example of Results test summary information on Group and Screen report
Example of Results Group information with well images on assay reports
Example of Results Screen information with well images on assay reports
Each sample listed on the on-screen report has an Event log link. You can link to the event log to view sample
processing events by clicking the sample identification number in the Sample ID column of the report.
Example of sample Event log link

You can display an enlarged image of a well by clicking a selected well image on an assay report. The system then
displays a Reaction image report (shown in the following example). You can return to the previous display by
clicking the Back to report link located below the enlarged image.
Example of enlarged Reaction image
The Supplies option displays a table of the reagents and strips used to perform the assay. The Supplies table will
display the product ID, Lot number, serial number of reagent vials, the date QC was last performed, the expiration
of the reagent or strip, and any flags associated with the reagent or strip.
Example of Supplies information on assay reports
The Signature line option provides a line for the signature of the person reviewing the printed report and the date
reviewed (when a copy of the report is printed).
Example of Signature line on assay reports
The Sample Status option displays a table of when sample testing started and finished and the operator that
performed the testing. The Sample Status table also displays the date, time and operator if the sample was Edited,
Approved or Exported.
Example of Sample status information on assay reports

The Legend option displays a table of commonly used flags that can be found on the Results report.
Example of Legend information on assay reports
The following image is an example of a report with various informational components displayed (including well
images).
Example of an on-screen report
Sort Sequence for Test Result Reports

The sort sequence of test result reports can be configured so that result reports can be presented in either
alphabetic or processing sequence. This configuration option is located on the Reports tab of General options.
The Sort order of results area has two (2) options (Alphanumeric by sample ID and Processing sequence). Either,
but not both of the options can be selected.
Sort order of results options
Pressing the Defaults button allows multiple values to be configured at one time. The default values for the Reports
tab are all selections made to Include in reports, Pos or neg (+ / 0) for Well results, Alphanumeric by sample ID for
Sort order of results, and 32 pixels for Well image size.

Defaults button
Refer to Chapter 4 – Test Results for more information regarding the structure and printing of results reports.
Results Tab
Under the Results tab in the General options window, various options are provided when the results are completed.
General options > Results tab
The file location to view archived results can be designated using the Location of results field. The ellipsis (…)
button is used for selecting the file location.
By clicking the ellipsis (…) button, the Browse for folder window will display. Select the location of the results to
view and click the OK button.
Example of Browse for folder window

By clicking the Close button on the General options window, the archived results will load into the Results panel. An
alert message will display indicating it may take up to 15 minutes for the files to load.
Example of warning message
In order to return to the default location, use the ellipsis button and select C:\G3\Results as the location of results or
click on the Defaults button to automatically populate the default location.
Note: By clicking the Defaults button, the result bar options and result export options will also reset
to the default options. Refer to Appendix A – Echo Lumena Installation for list of default options.
The software will prevent performing assays or maintenance if the location of results is changed from the default
location.
You can activate pop-up summaries in the Results bar by selecting the Show pop-up summaries in results bar
check box in the Results bar options section. An example of an on-screen pop-up summary is shown in the
following image.
An example of an on-screen pop-up summary
You can activate action notifications in the Results bar by checking the Show action notifications in results bar
check box in the Results bar options section. An example of an on-screen action notification (information balloon
message) is shown in the following image.

Example of an information balloon message
You can configure the system so that results must be approved prior to export by checking the Results must be
approved before they can be exported check box in the Result export options section.
The automatic exporting of results is configured using the Result export options area of the Results tab under
General options.
If Results must be approved before they can be exported (which can be selected by checking the box), then the
results are not automatically exported. The two (2) button options shown below are not accessible if this box is
checked.
Result export options area
If results do not need to be approved before exporting, the two (2) button options located below When a test
completes… become accessible when the check box is not checked. Results can be automatically exported by
selecting Automatically export results or not automatically exported by selecting Do not automatically export results.
Result export options with Automatically export results selected
Result export options with Do not automatically export results selected

Note: Edited or updated sample results can be exported to the HIS/LIS.
When results are manually exported, the operator identification field will populate with the identification of the
operator who exported the result. When results are automatically exported, the operator identification field will
populate with the identification of the operator who scheduled the assay.
You can configure the system so that invalid results can be exported by checking the Export invalid results check
box in the Result export options section.
You can configure the system so that NTD results can be exported by checking the Export NTD results check box
in the Result export options section.
default values.
System Tab
Under the System tab in the General options window, various options are provided to configure the Echo Lumena.
General options > System tab
You can configure the number of minutes that the rack barcode scanners stay on after the last scanner activity. To
do this, use the Up or Down buttons of the Keep scanners on for field to adjust the time. You can also type in a
number.
You can configure the frequency of the probe and manifold auto-flush with the Rinse probe and manifold every
field. This time can be adjusted using the Up or Down buttons of the Rinse probe and manifold every field (in
increments of hours). The auto-flush function can be configured to run every one to four hours. The default value is
every four hours.

Warning: If the value is set at 4 and you observe a pattern of repeated failures of the washer basic
test during initialization, or if you visually observe salt crystalline build up on the manifold needles or
instrument probe, then the time interval should be decreased to increase the frequency of flushing.
Under routine operating conditions, the probe and manifold would be expected to undergo flushing
during sample processing, and the likelihood of a blocked probe and/or a blocked wash manifold
due to salt crystallization would be reduced.
You can select whether the Echo Lumena shows the Instrument Map at startup by selecting or clearing the Show
instrument map at startup check box in the Startup options section.
default values.
If you select the Align touch screen button, an error message will be produced indicating that the touch screen
alignment functionality is not currently available for your use (as shown).
Image of no touch screen alignment error message
The Volume Control window can be accessed by clicking the Set speaker volume button. This window can be used
to set the speaker auditory volume to the desired level, as well as make other sound refinements. You can save any
changes you have made by closing the Volume Control window using the red X button. The Volume Control
window is shown in the following image.
Volume Control window
Warning: If the speaker volume is muted (by selecting Mute all) or lowered, audible alarms for certain
conditions may not be audible or would not be available to the operator. A delay in results may
occur if certain audible alarms are generated and not heard.

Security Tab
The Security tab is located under General options.
Security tab under General options
Any changes to the security settings will be applied to existing operator identifications proactively. For example, if
you set the option to require passwords to expire after 90 days, all existing passwords will expire in 90 days from
the day each individual password was last modified. If you choose to require the password to include numbers, all
operators will have to meet that requirement the next time they reset their password. The existing password will be
accepted until that time.
The range of length for an operator name can be set using the Minimum length and Maximum length number
selections in the User name area. The allowable range for both number selections is between five (5) and forty (40)
inclusive.
Minimum and Maximum length options in User name area
If you select a Minimum length value which is greater than the selected Maximum length value, then these values
cannot be saved as a configuration and an error message is generated that must be acknowledged by pressing the
OK button. The minimum value must be equal to or less than the maximum value.
Error displayed when user name Minimum length is set higher than Maximum length

The range of length for a password can be set using the Minimum length and Maximum length number selections
in the Password area. The allowable range for both number selections is between five (5) and forty (40) inclusive.
If you select a Minimum length value which is greater than the selected Maximum length value, then these values
cannot be saved as a configuration and an error message is generated that must be acknowledged by pressing the
OK button. The minimum value must be equal to or less than the maximum value.
Error displayed when password Minimum length is set higher than Maximum length
A requirement to include certain characters in the password can be defined in the Password area by checking or
not checking the selections of Uppercase alphabetic, Lowercase alphabetic, Numbers, or Special characters. A
rule can be applied to require the use of 1 or more of these character types by using the number selection for Must
include at least…of the following. The allowable range for this number selection is between one (1) and four (4)
inclusive.
Password area options
If you select a number of character types which is less than the number selection for Must include at least…of the
following, then these values cannot be saved as a configuration and an error message is generated that must be
acknowledged by pressing the OK button. The error message states that the correct number of character types
must be selected for the password requirements.
Error displayed when the number of selected character types is less than the required amount according to settings

Expiration of passwords can be set by checking the box for Enabled under the Password expiration area. In doing
so, you can select a day range of 30, 60, or 90 days. By using the number selection for Password expiration
warning: …days, you can select the number of days prior to expiration that an operator will receive a warning
message indicating how long is left before their password will expire. The allowable range for this expiration number
selection is between three (3) and fourteen (14) inclusive. You can also limit repeat usage of previous passwords by
selecting the number for Cannot use…most recent passwords. The allowable range for this number selection is
between three (3) and ten (10) inclusive. If the Password expiration area is not enabled by not checking the Enabled
box, then all of the options for configuration are inaccessible.
Password expiration area
Auto-logoff of operators can be set by checking the box for Enabled under the Auto-logoff area. You can then
select the length of inactivity time that will cause an operator to be automatically logged off. You can select 15, 30,
45, or 60 minutes of inactivity. If the Auto-logoff area is not enabled by not checking the Enabled box, then all of the
options for configuration are inaccessible.
Auto-logoff area
Locking out of operators after a sequence of failed log in attempts can be set by checking the box for Enabled
under the User lockout area. You can then select the number for Lock out user after…failed login attempts. The
allowable range for this number selection is between three (3) and five (5) inclusive. If the User lockout area is not
enabled by not checking the Enabled box, then the option for this configuration is inaccessible.
User lockout area
All configurations can be saved by pressing the Close button of the General options window.

Service Tab
The Service tab in the General options window is only available for use by Immucor personnel; therefore, the tab is
only displayed when the necessary Immucor personnel user ID and password are entered in the Log in window.
The access rights to this tab are password protected.
The detail described in this section is only provided for your information.
General options > Service tab
Note: The Service tab provides authorized Immucor personnel access to the operating system.
The instrument serial number can be configured using the Instrument ID field.
The computer run-time limit can be configured using the Up and Down buttons of the Run time limit field. The
maximum limit is 240 hours (10 days), and the minimum limit is 1 hour. The default value is 168 hours (7 days). This
configuration determines the time period after which you are required to restart the computer before being allowed
to proceed with any testing or maintenance on the Echo Lumena.
The computer warning interval can be configured using the Up and Down buttons in the Run time warning field.
The maximum limit is 24 hours, and the minimum limit is 1 hour.
The transparency of dialog boxes on the screen can be adjusted so that underlying information can still be seen
(when a dialog box is displayed) by adjusting the percentage number of the Dialog transparency field using the Up
and Down arrow buttons. The range of adjustment is limited to between 0 percent and 15 percent inclusive.
The font size of the results in the Results panel can be configured to larger or smaller sizes, depending on the
required ease of reading. The font size can be configured by adjusting the number of the Result font size field using
the Up and Down arrow buttons. The range of adjustment is limited to between 8 and 18 inclusive.
The KeepAlive time is the duration between two KeepAlive transmissions in idle condition. The socket KeepAlive
period is required to be configurable and by default is set to no less than two (2) hours.
The KeepAlive interval is the interval duration between two successive KeepAlive retransmissions, if
acknowledgement to the previous KeepAlive transmission is not received.

Used or dirty strips can be checked for by selecting the Check for used / dirty strips check box.
Note: The Echo Lumena is configured to perform a clean strip check as part of the strip
identification process when micro-well strips are loaded on the instrument. This is a valuable tool to
ensure they are free from particulate matter and gross contamination and to prevent the reuse of
micro-well strips, especially if they are transferred from one Echo Lumena to a second Echo
Lumena. This option should remain active due to potential adverse effects to results.
Recovery of strip holders at initialization can be performed by selecting the Always perform strip holder recovery at
initialization check box.
Note: The Echo Lumena is configured to perform a recovery of strip holders as part of initialization.
This is a valuable tool to ensure all strip holders are removed from the Echo Lumena prior to assay
processing. This option should remain active due to potential instrument errors.
Run in Demo Mode can be used to run the Echo Lumena instrument without performing fluidics functions. When
running in Demo Mode the following will occur:
• Demo Mode will be displayed in the title and status bars.
• The instrument will not perform any activities involving fluidics.
• The instrument while running assays will not skip to the DR step if an error is detected.
• The automatic rinse is disabled.
• “Demo Mode” will be displayed on all reports.
• An event log entry of when the instrument is placed in and brought out of Demo Mode will be recorded.
default values.
The General options window can be closed by clicking the Close button at the bottom of the window.
Test Options
The Test options field is a component of the Tools submenu. These options configure the test system settings.
There are five tabs within the Test options window:
• General tab
• Reflex tests tab
• Menu tab
• Profiles tab
• QC tab

Chapter 10: Configuration Test Options
General Tab
The General tab of the Test options window defines actions that occur when a sample or batch is completed.
Test options > General tab
When a sample is complete, there are two options available within the When sample is complete section of the
General tab: Play a sound and Generate sample report. You must check the box or boxes for those features to
activate them.
When a batch is complete, there are two options available within the When batch is complete section of the
General tab: Play a sound and Generate batch report. You must check the box or boxes for those features to
activate them.
The Run Test Wizard has two options available within the Run Test Wizard options section of the General tab:
Display the STAT page and Display the Priorities page. You must check the box or boxes for those features to
activate them. Refer to Chapter 3 – Instrument Testing Operation for details on these options.
The Test options window can be closed by clicking the Close button at the bottom of the window.
Reflex Tests Tab

You can use the Reflex tests tab of the Test options window to configure two options related to reflex testing.
Test options > Reflex tests tab

Test Options Chapter 10: Configuration
You can reflex an antibody ID test for samples after a positive antibody screen result by checking the Antibody ID
reflex test after positive Screen result check box.
You can make the status of reflex tests STAT if the initial test was STAT by checking the Make reflex tests STAT if
initial test is STAT check box. This option only applies to Weak D testing and not to red blood cell antibody screens.
Menu Tab
You can use the Menu tab of the Test options window to select which assays can be run on the Echo Lumena.
This is a method used to customize which assays are available to operators in the Run Test Wizard.
Warning: If assays are used as part of a profile, a software error can occur if assays are deselected
from the menu.
Test options > Menu tab
You can check the box or boxes for your chosen assays within the Include the selected tests on the assay
selection menu list.
You can choose any one assay to be the default assay for samples loaded onto the Echo Lumena by selecting an
assay from the Default test drop-down list. For a full list of all assays, refer to Regional Attachments.

Profiles Tab
You can use the Profiles tab of the Test options window to create custom assay profiles with up to four assays.
Test options > Profiles tab
You can add, edit, or delete assay profiles by clicking the Add, Edit, or Delete buttons, respectively, on the Profiles
tab. The assay profile must be highlighted in blue prior to editing or deletion.
You can add assay profiles by clicking the Add button on the Profiles tab. As a result, the Test profile dialog box is
displayed.
Test profile dialog box with example of Cord profile
You can create the new assay profile by entering your chosen profile name into the Name field of the Test profile
dialog box.
You can then add up to a maximum of four assays to the new assay profile using the drop-down lists Test 1, Test
2, Test 3, and Test 4. You must then click OK on the Test profile dialog box to save the new assay profile. You can
click Cancel to abort the assay profile creation process.

Test Options Chapter 10: Configuration
Test profile dialog box with example of Cord profile
If the new assay profile is saved, it will be saved in Profiles, and it will be available for use when assays are assigned
for sample testing during the routine running of the Echo Lumena (through the Run Test Wizard). The following is an
example of the Cord profile.
Select tests window from Run Test Wizard with example of Cord profile selection
You can edit or delete a test profile by using the Edit and Delete buttons, respectively.
A confirmation dialog box is displayed if you attempt to delete a profile using the Delete button (the following is an
example of Cord deletion).
Example of confirmation dialog box: deletion of Cord profile

QC Tab
You can use the QC tab of the Test options window to define the QC requirements for the Echo Lumena.
Test options > QC tab

Reagent QC can be configured to be performed either by lot or by reagent vial. To do this, you must select one of
the two options within the QC reagents section of the QC tab. You must select either the By lot number or the
Every vial option.
You can configure the frequency of QC using the Up and Down buttons of the Instrument and Supplies fields
(independent of each other) within the QC time section. You can also type a number into these fields.
Note: Daily Initialization can be referred to as Instrument QC.
You can purge data from the QC and reagent files that is two or more years old by clicking the Purge old data
button on the QC tab. The following are examples of data that can be purged.
• Date and time reagents are loaded
• Date and time strips are loaded
• Remaining reagent volumes from used reagent vials (will purge any reagent IDs that have an expiration date
of two or more years old)
• Strips used on the Echo Lumena (will purge any strip IDs that have an expiration date of two or more years
old)
Note: This data is purged during the startup process of the Echo Lumena software.

Chapter 11: Security
Chapter 11: Security

In This Chapter:
CHAPTER 11: SECURITY .................................................................................... 11-1
Assigning Passwords and User Access Rights ................................................. 11-2
Defining Users with Associated Access Rights ............................................... 11-2

Chapter 11: Security Assigning Passwords and User Access Rights
Assigning Passwords and User Access Rights

The Echo Lumena uses User names and Passwords (through the Log in window) to track which operator is
currently operating the system and to restrict access to areas of the system by unauthorized operators.
Only one operator can be logged in at a time. The use and assignment of user names allows for operator tracking
in an instrument activity audit trail. For example, if any results are edited, the identification of the operator who
performed the edit is captured in an event log.
Log in window
Each operator has a unique User name and Password with corresponding access rights. This section describes
how to define users with associated access rights, including adding a new operator and editing and deleting current
operators.
Note: Your User name is case insensitive and Password is case sensitive. You must take care to
accurately input your User name and Password to account for capital letters, lowercase letters,
special characters, and numbers.
Defining Users with Associated Access Rights

Initial user names, passwords, and access rights are defined at instrument installation.
Following installation, you can administer user names, passwords, and access rights from the User Accounts
window (if you have the necessary administrator access rights). The User Accounts window (shown in the following
screen shot) is accessed through the Tools submenu Security item on the pull-down menu.
Add, Delete, or Edit a User or Reset Password
User Accounts window
The User Accounts window lists all existing user identifications numerically and alphabetically.

Assigning Passwords and User Access Rights Chapter 11: Security
Note: Any security profile modifications are documented in the event log.
Add a New User

To add a new user to the system, click Add on the User Accounts window. This opens the Add User Account
window. From here, the new user ID can be created.
Assign User Name, Password, and Access Rights
Add User Account window
The Add User Account window is automatically opened after the Add button in the User Accounts window is
clicked.
When adding a new user, the User name, Password, and Confirm password fields will be empty. You must type in
this information for the new user.
Passwords and user names must be a minimum of five characters in length. Restrictions regarding the mixing of
upper case and lower case alpha characters, numeric characters, and special characters can be configured. Refer
to Chapter 5 – Configuration.

The system displays an error message if you attempt to create a password of less than five characters (shown in
the following screen shot). You must click OK in the error message to proceed.
Error message indicating the password is too short
Duplicate entry of a password using the Password and Confirm password fields is required for accuracy purposes.
If you do not type the password identically in both fields, an error message (shown in the following screen shot) is
displayed. You must click OK in the error message to proceed.
Error message indicating the duplicate password entries do not match
Warning: Because manual entry of passwords in Log in dialog box is case-sensitive, passwords
must be entered exactly as they were set up for successful entry into the Echo Lumena software.
User names are not case-sensitive.
The system displays an error message (shown in the following screen shot) if you attempt to create a new user with
a user name that already exists in the software. You must click OK in the error message to proceed.
Error message indicating that a chosen user name is already in use
The saved password content configurations and user name configurations are subsequently displayed in the Add
User Account window under the Confirm password field. This information is displayed for instructional purposes to
be used when creating user names and passwords. The following is an example.

Saved password content configurations and user name configurations
Once a user name and password are created, select the appropriate security profile and access rights for the
operator. Refer to Edit a user section later in this chapter for the description of security profiles and list of access
rights.
After the access rights, password, and user ID are entered as required, all of the data can be saved by clicking OK
in the Add user account window.
If the access rights, password, and user ID are entered, but are not yet saved, then all of the changes can be
eliminated by clicking Cancel in the Add User Account window.
Delete a User
To delete a user ID from the system, click the Delete button in the User Accounts window. The user ID to be
deleted must be highlighted in blue. Clicking the Delete button removes the selected user from the list. Prior to the
actual deletion of the user account, a confirmation dialog box is displayed to confirm that you wish to delete the
user account.
Example of confirmation dialog box to confirm that you wish to delete a user account
Note: The Service user ID cannot be deleted.
As a precaution to prevent inadvertent removal of overall site access to the administration of security, if you attempt
to delete an operator with Administer security rights and that person is the only operator at that given site with
those rights, you will generate an error message indicating that you cannot delete that operator account. You must
press the OK button to clear the error message.

Error message indicating that you cannot delete an operator account
Click the Close button in the User Accounts window to close the window.
Edit a User
To edit a user ID in the system, click the Edit button in the User Accounts window. The user ID to be edited must
be highlighted in blue. This opens the Edit User Account window. From here, the user access rights can be edited.
Edit User Account window
Warning: It is important to consider the needs of each operator when assigning access rights.
Setting access rights too low may prevent an operator from performing job activities. Setting access
rights too high may permit an operator to gain access to portions of the instrument software he or
she is unfamiliar with. Incorrectly assigning access rights can result in operator software changes
that may negatively impact the performance of the Echo Lumena.
As with attempting to delete access to the administration of security, if you attempt to edit an operator with those
administration rights, you will be unable to access the Administer security item.
Example of being unable to access Administer security item

If you are editing an existing user, the User name field will display the existing information for the selected user when
the Edit User Account window appears. You can then edit the access rights for the existing user.
Clicking the Profile 1 button assigns user level access to the selected user.
Clicking the Profile 2 button assigns supervisor level access to the selected user.
The following table lists the designated access right items for both Profile 1 and Profile 2.
Perform file management
Change barcode options
Change general options

Perform maintenance
Change test options

Approve test results
Enter/edit barcodes
Administer Security
Edit sample names

Export test results
Shut down/restart
Generate reports
View test results
View event logs

Edit test results
Print reports
Run tests
Profile
Number
Profile 1 X √ √ X √ √ √ √ √ √ √ √ √ X X X √
Profile 2 √ √ √ √ √ √ √ √ √ √ √ √ √ X X X √
Key: X = No, 9 = Yes
Clicking All assigns all user rights to the designated user, including configuration options.
Clicking None assigns no user rights to the designated user.
The scrolling Rights for this user list box displays all of the access right components, such as Edit test results. Each
individual access right component can be checked or cleared, as required, using the relevant check box.
After the access rights, password, and user ID are entered as required, all of the data can be saved by clicking OK
in the Edit user account window.
If the access rights are edited, but have not yet been saved, then all of the changes can be eliminated by clicking
Cancel in the Edit User Account window.
Reset a User’s Password

The saved password content configurations are displayed in the Change Password window under the Confirm field
when the Reset Password… button is pressed within the area for setting up operator security and access rights, or
when the Reset Password option is selected in the Tools drop-down menu.

Tools drop-down menu
The saved password content configuration is displayed for instructional purposes to be used when changing
passwords. An example is shown below.
Change Password window
Enter the new password in the New field, then re-enter the new password in the Confirm field. Click the OK button
to save the changes. By clicking the Cancel button, you can close the window without saving changes.
Note: Refer to Add a New User section earlier in this chapter for minimum requirements and
restrictions related to password creation.

Chapter 12: Limitations of Use and Warnings
Chapter 12: Limitations of Use and Warnings

In This Chapter:
CHAPTER 12: LIMITATIONS OF USE AND WARNINGS ....................................... 12-1
Limitations of Use ............................................................................................ 12-2
Chapter 1 – Introduction ................................................................................ 12-2
Chapter 3 – Instrument Testing Operation ..................................................... 12-2
Chapter 5 – Maintaining the Echo Lumena..................................................... 12-4
Chapter 7 – Troubleshooting ......................................................................... 12-4
Chapter 9 – Hardware Components .............................................................. 12-5
Chapter 10 – Configuration............................................................................ 12-5
Chapter 11 – Security.................................................................................... 12-5
Appendix A – Echo Lumena Installation ......................................................... 12-6
Warnings ......................................................................................................... 12-7
About This Manual ........................................................................................ 12-7
Chapter 3 – Instrument Testing Operation ..................................................... 12-7
Chapter 5 – Maintaining the Echo Lumena..................................................... 12-9
Chapter 8 – Customer Component Replacement ........................................ 12-10
Chapter 9 – Hardware Components ............................................................ 12-10
Chapter 10 – Configuration.......................................................................... 12-11
Chapter 11 – Security.................................................................................. 12-11
Appendix A – Echo Lumena Installation ....................................................... 12-11

Chapter 12: Limitations of Use and Warnings Limitations of Use
Limitations of Use
This section lists the limitations of use of the Echo Lumena that are contained in the following chapters:
X Chapter 1 – Introduction
X Chapter 3 – Instrument Testing Operation
X Chapter 5 – Maintaining the Echo Lumena
X Chapter 7 – Troubleshooting
X Chapter 9 – Hardware Components
X Chapter 10 – Configuration
X Chapter 11 – Security
X Appendix A – Echo Lumena Installation
Chapter 1 – Introduction
Limitation: Barcodes should be between three and 18 characters in length.
Limitation: Barcodes must have a module size larger than 0.2 mm and a bar width ratio between
2.25:1 and 3:1.
Chapter 3 – Instrument Testing Operation

Warning: Only officially trained Echo Lumena operators are permitted to operate the Echo Lumena. If
untrained personnel operate the Echo Lumena and, as a result, generate technical problems, the
operating site is held responsible for erroneous sample results that may be generated.
Warning: The Echo Lumena must be powered on long enough to allow the elevated temperature
incubators to reach acceptable temperature range prior to the first assay being run.
Warning: At least 250 μL of packed red blood cells need to be present in a sample tube to ensure
that the probe picks up red blood cells and not plasma (only for those assays that require red blood
cells).
At least 500 μL of plasma or serum needs to be present in a sample tube to ensure that the probe
picks up plasma or serum, respectively.
Samples run with the red blood cell antibody identification assays require approximately 1 mL of
plasma or serum.
Warning: Red blood cell samples collected with the following anticoagulants and additives can be
tested on the Echo Lumena: EDTA, ACD, CPD, CPDA-1, CP2D, heparin, AS-1, AS-3, AS-5, and the
combinations of CPD with AS-1, CPD with AS-3, and CPD with AS-5.
Anticoagulated samples containing clots must not be used. Serum samples can also be tested on
the Echo Lumena for tests that do not require red blood cells. Samples obtained from tubes
containing neutral gel separators may produce falsely positive results and should therefore not be
tested on the Echo Lumena.
Warning: When inserting a sample test tube into a rack, the contents of the test tube must not
exceed a liquid height of 3.2 inches (8.1 cm), otherwise a fluidics error can be generated. Exceeding
this liquid height is usually the result of overfilling sample tubes.

Limitations of Use Chapter 12: Limitations of Use and Warnings
Warning: Samples that exhibit excessive hemolysis or lipemia or are icteric should not be tested on
the Echo Lumena. Samples that exhibit a hemolysis grade of 3+ or greater must not be tested on the
Echo Lumena because they may generate invalid or indeterminate results. Refer to the following
photograph for a hemolysis grade of 3+ (color guide). For assays using Capture-R® Select, do not
use hemolyzed samples for creating a monolayer. Fragmented red blood cell membranes will
interfere with monolayer formation.
0 1+ 2+ 3+ 4+
Hemolysis grading chart
Warning: Echo Lumena studies have demonstrated that the probe washes are not sufficient to
prevent carryover of samples that have an atypical red blood cell antibody titer of 5120 or greater
(not typical of those samples encountered in a blood bank setting). It is important to note that these
studies apply only to routine patient or donor samples. Sample material that is provided in surveys
has been shown to occasionally cause carryover at lower titers (a result of the manufacturing
process for these materials).
Warning: Do not insert or remove a rack when the indicator LED is lit, as this can damage the
pipetting system and invalidate all test results for samples in the rack.
Warning: Open field access is required to provide continuous access for sample and reagent loading
during full-system operation.
Inappropriate, unauthorized access to the loading bays (outside of those methods described in this
manual) is strictly prohibited and could cause injury.
Racks for the reagent vial loading (four vials per rack)
Racks for the sample tube loading (five samples per rack)
Warning: Assays that require the use of plasma or serum must not be run from donor or pediatric
racks. Use of incorrect tubes can cause pipetting errors.
has been added to the vial. Refer to the appropriate Regional Attachment for on-board expiration
information for vials of reagents other than Indicator Red Cells. Results can be adversely affected if


Warning: Maintenance tasks for the Echo Lumena verify that specific modules of the instrument are
functioning at the required specifications or they are preventative maintenance tasks. The tasks
described in this chapter are critical to the Echo Lumena assay performance.
If software-driven maintenance tasks are not successfully performed within the required time interval
that you have configured, then assays will not run.
For example, the initialize instrument task is required to be performed daily. If you do not perform the
daily initialize instrument task, then all assays are locked down and no assays can be run.
Warning: You can configure each maintenance item to your own on-site requirements, but you are
limited by software-defined frequency ranges. If you click the Up or Down arrow buttons for a given
task, the number only increases or decreases to the preset limits for that particular task. If you try to
type in a number which is out of range, the number will change to the nearest allowed value to the
number that you typed in. The recommended frequency of performance for each maintenance task
is published in this chapter as part of product labeling.
Warning: Immucor requires the use of phosphate-buffered saline (PBS) which is prepared by using
an Immucor approved commercially available product. Refer to Regional Attachment for details.
Warning: When performing reagent QC for group and screen assays, WB corQC reagent tubes 1, 2,
and 3 must be run together in order for reagent QC to pass.
Warning: When performing reagent QC for phenotyping assays, WB corQC reagent tubes 1, 2, 3,
and 4 must be run together in order for reagent QC to pass. If you run a phenotyping assay specific
for a single antigen, then you only are required to run the appropriate WB corQC reagent tube as
listed in Regional Attachments.
Warning: When archiving results once the batch number reaches 100,000 or larger, the Echo
Lumena is unable to copy the files of the 100,000 or larger files to the archive media. However, any
associated batch numbers of 99,999 or less within the same archive process will be archived without
problems. Contact Immucor Technical Support if archiving failure occurs and the batch number is
100,000 or larger.
Warning: Entering an incorrect CENTC value can lead to unexpected instrument errors.
Chapter 7 – Troubleshooting

Limitations of Use Chapter 12: Limitations of Use and Warnings
Chapter 9 – Hardware Components

at specified temperature ranges as per the package insert.
in specified temperature ranges as per the package insert.
Chapter 10 – Configuration
Warning: The instrument does not support the use of special characters as characters embedded in
patient or donor barcodes. The instrument software will issue a warning alerting you to the presence
of invalid barcodes on the instrument if you use a barcode embedded with a special character, and it
will list the actual invalid barcode data as part of the warning message. Additionally, no tube will be
recognized as being present by the software at that rack location. Refer to Chapter 1 – Introduction
to the Echo Lumena for the list of special characters that are not permitted on the Echo Lumena.
Warning: The calculated elapsed times for reagent on-board time, QC expiration time, initialization
interval, and other instrument-related time monitoring functions that coincide with the end and
beginning of Daylight Saving Time (DST) may not accurately reflect the actual elapsed times. In this
instance, you are responsible for ensuring that the instrument is run according to your local
procedures, including the monitoring of elapsed times of these instrument time-related functions.
Warning: If assays are used as part of a profile, a software error can occur if assays are deselected
from the menu.
Chapter 11 – Security
Warning: Because manual entry of passwords in Log in dialog box is case-sensitive, passwords
must be entered exactly as they were set up for successful entry into the Echo Lumena software.
User names are not case-sensitive.

Appendix A – Echo Lumena Installation

Environmental Conditions Warning: Do not expose the instrument to temperature extremes. For
proper instrument operation, ambient temperatures should remain between 18°C and 33°C.
However, for proper assay performance using approved Immucor reagents, ambient temperature
should remain between 18°C and 30°C. Performance may be adversely affected if temperatures
fluctuate above or below this range.
Shipping and storage temperatures range from -25°C to 50°C.
Relative humidity range is 10 percent to 80 percent at 18°C to 31°C and 10 percent to 74 percent at
33°C (noncondensing).
The instrument is for use at altitudes up to 2,000 meters.
Warning: Changes or modifications to this unit, which includes hardware or software modifications
and updates, not expressly approved by the manufacturer could void the user's authority to operate
the equipment.
Warning: The printer power cable must not be connected to the UPS. This can cause electrical
supply problems.

Warnings Chapter 12: Limitations of Use and Warnings
Warnings
This section lists warnings of the Echo Lumena that are contained in the following chapters:
X About This Manual
X Chapter 3 – Instrument Testing Operation
X Chapter 5 – Maintaining the Echo Lumena
X Chapter 8 – Customer Component Replacement
X Chapter 9 – Hardware Components
X Chapter 10 – Configuration
X Chapter 11 – Security
X Appendix A – Echo Lumena Installation
About This Manual

Warning: Failure to follow the instructions within this manual or to comply with the warnings and
limitations of use may result in inaccurate or invalid results, delay of treatment for the patient,
exposure to biohazardous materials, or injury.
Chapter 3 – Instrument Testing Operation

and consumed liquid reagent vials must be discarded following the standard practice of the
laboratory.
Warning: Follow all of the necessary precautions to prevent exposure to and potential injury from
electrical current, mechanical movement, and barcode laser scanners.
Warning: Follow basic electrical hazard awareness to reduce the risk of injury due to potentially
hazardous electrical exposure. To avoid spills do not place containers of liquids from any source on
the Echo Lumena. Fluid 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.
Warning: Keep all Echo Lumena protective covers in place when operating the Echo Lumena to
reduce the risk of operator injury due to Echo Lumena mechanical movement.
Laser Beam Safety Warning: The Echo Lumena utilizes two internal visible light lasers and one
handheld scanner to scan barcodes of reagent vials and sample tubes. Do not look directly into the
laser beam of scanners or at any reflections of the beam from a mirror-like surface. Exposure to the
laser beam light can cause eye damage and permanent injury.

Chapter 12: Limitations of Use and Warnings Warnings
Warning: When a sample rack is partially removed after testing is complete and another rack is
inserted into an adjacent position, it is possible for the partially removed rack to be inadvertently
loaded ahead of the second rack. In this instance, there is a possibility that the sample IDs from the
second rack will also be assigned to the original rack. A message that there are duplicate barcodes
in the second rack is generated
Warning: Inspect all reagents and controls for the presence of foam before placing them on the
instrument. Do not vigorously agitate blood grouping anti-sera or controls. Shaking will produce foam
in the vial that can cause the liquid level detection (LLD) feature of the pipetting system to aspirate
foam rather than reagent. This will produce incorrect results or an error.
Warning: Before placing reagents on the Echo Lumena, you must remove the bottle caps. You are
advised to remove and discard the dropper by pulling the dropper from the bulb. When you remove
the reagents from the Echo Lumena for storage, you must place the caps back on the bottles. To
avoid cross-contamination of reagents, it is important that you place the caps on the correct bottles.
Mixing caps can result in erroneous test results.
Warning: If you do not add the stir balls to the cell suspensions, the results may be invalid or
incorrect. Do not touch the stir balls. You should add them directly to the cellular reagent vials using
the dispenser provided. Contamination and neutralization of cellular reagents can occur if the stir
balls are touched.
You must only add one stir ball per vial of cellular reagent. Do not add more than one stir ball per vial.
Warning: If you are using multiple Immucor instruments or other test methodologies, the specific
reagent vials for each instrument must be dedicated for use on that single instrument or method to
ensure correct reagent volume tracking. If the actual reagent volume (less than the software numeric
volume) is not sufficient for the number of tests scheduled, the Echo Lumena can produce invalid
results, and samples will need to be rescheduled for testing.
Warning: Pooling of liquid reagent from multiple vials into one vial will cause inaccuracies in volume
tracking and risk contamination, as well as consequent erroneous results. Therefore, the practice of
reagent pooling is strictly prohibited.
Warning: Two of the same strip type, or a balance strip along with a single strip of any type, must be
loaded into a given strip holder. Empty strip holders must not be stored on the instrument.
Warning: After you load the strip trays, the Echo Lumena reads the two-dimensional barcode of each
loaded micro-well strip to be used prior to their use in assay runs. If this barcode is unreadable, you
can use the attached handheld scanner to scan the linear barcode on the white frame from which
the strips were taken. Details of this process are described in the next section. This information is
scanned into the manual barcode Strips window and can require a separate entry of the expiration
date of the micro-well strip in question.
Warning: Entering an incorrect expiration date can result in the use of expired strips, which can lead
to inaccurate results.
Warning: Incorrectly placing a micro-well strip into a strip holder or incorrectly placing a holder onto a
tray can cause damage to the pipetting system and other modules on the Echo Lumena.

Warning: Loading a micro-well strip with an incorrect strip orientation can result in invalid results and
can create a biohazardous spill on the Echo Lumena. Incorrect orientation includes strips inserted
upside-down in a micro-well strip holder.
Warning: Removing racks while the probe is accessing the tubes or vials results in damage to the
probe and invalidated results. Only remove racks when the LED is not illuminated.
Warning: Used micro-well strips contain potentially biohazardous material. Wear protective gloves
and clothing at all times when handling used micro-well strips. If any liquid is spilled, clean it up
immediately, adhering to standard laboratory practice.
and consumed liquid reagent vials must be discarded, adhering to the standard practice of the
laboratory.
progress and can cause a waste spill.
Warning: The liquid waste is potentially biohazardous material. Always wear protective gloves and
clothing when handling liquid waste. If any liquid waste is spilled, clean it up immediately, adhering to
standard laboratory practice.

Warning: Not all maintenance tasks described in this chapter are listed on the software Maintenance
window Schedule tab—for example, Refill PBS Supply Container and Removal and Replacement of
the Probe. Dates of such non-software-driven maintenance tasks can be documented and tracked
on the Echo Lumena Maintenance Record in Appendix B – Maintenance Records.
Warning: The instrument cannot differentiate between water and system fluid. If deionized water is
mistakenly used as the system fluid, the test results are invalid.
Warning: To reduce the risk of operator injury, when either (a) lifting the fluidics module lid or (b)
returning the lid back to its horizontal position, confirm that either (1) the lid is securely locked in
place using the support bracket, or (2) gently lower the lid, respectively.
Warning: It is not routinely necessary or recommended to disconnect the PBS supply container from
the fluidics module. All tests in progress will be aborted if the PBS supply container is disconnected
from the fluidics module during Echo Lumena operation. However, if this disconnection does occur,
there is only one correct sequence with which to reconnect the container.
Warning: Failure to disconnect the waste shuttle container after the waste container has been
drained can result in spillage of biohazardous material.

laboratory.
laboratory.
laboratory.
progress.
Warning: When bringing the Echo Lumena back into service after a prolonged shutdown, you must
run the prime instrument maintenance action with the PBS supply container filled with PBS prior to
running assays on the instrument.
Chapter 8 – Customer Component Replacement

Warning: Liquid waste from the rinse station contains potentially biohazardous material and must be
treated as potentially infectious.
Always wear protective gloves and clothing when handling liquid waste. All liquid waste must be
discarded following the standard practice and local site regulations of the laboratory.
Chapter 9 – Hardware Components

Warning: Never attempt to remove the instrument cover or reach the internal mechanical areas while
the Echo Lumena is operating. You may disrupt the Echo Lumena or injure yourself.

Chapter 10 – Configuration
Warning: You must make sure that the donor samples in one given donor rack are of a single prefix
type. It is your responsibility to check this data. If you have mixed donor samples of different prefixes,
all donor samples will be given the same prefix that you entered on the prompt. Therefore,
identification errors could occur if the operator fails in this tube data check.
Warning: If the value is set at 4 and you observe a pattern of repeated failures of the washer basic
test during initialization, or if you visually observe salt crystalline build up on the manifold needles or
instrument probe, then the time interval should be decreased to increase the frequency of flushing.
Under routine operating conditions, the probe and manifold would be expected to undergo flushing
during sample processing and the likelihood of a blocked probe and/or a blocked wash manifold due
to salt crystallization would be reduced.
Warning: If the speaker volume is muted (by selecting Mute all) or lowered, audible alarms for certain
conditions may not be audible or would not be available to the operator. A delay in results may occur
if certain audible alarms are generated and not heard.
Chapter 11 – Security
Warning: It is important to consider the needs of each operator when assigning access rights.
Setting access rights too low may prevent an operator from performing job activities. Setting access
rights too high may permit an operator to gain access to portions of the instrument software he or
she is unfamiliar with. Incorrectly assigning access rights can result in operator software changes that
may negatively impact the performance of the Echo Lumena.
Appendix A – Echo Lumena Installation

Warning: Adequate space must be provided for accessing the instrument, both during operation and
in the event of servicing. There must be a gap of at least 10 cm behind the instrument for access and
ventilation.
Power Rating Warning: The instrument’s external power supply 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.
Electrical Grounding Warning: Never use a two-prong plug adapter to connect primary power to an
instrument’s external power supply. Use of a two-prong adapter disconnects the utility ground,
creating a severe shock hazard. Always connect the system power cord directly to a three-prong
receptacle with a functional ground.
Internal Voltage Warning: Always turn off the power switch and unplug the power supply before
cleaning the outer surface of the instrument.
Potential Biohazards Warning: 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. Dispose of waste in an approved manner.
Decontaminate the instrument per the guidelines given in Chapter 5 – Maintaining the Echo Lumena.
Unspecified Use Warning: Failure to operate this equipment according to the guidelines and
safeguards specified in this manual could result in a hazardous condition.

Qualified Personnel Warning: Some maintenance procedures must be performed with the
instrument’s front cover removed. Only qualified personnel—trained in the hazards involved when
operating the instrument while open—are allowed to conduct these procedures, as moving parts
may pose pinch or crush hazards.
Service Warning: The Echo Lumena should be serviced by Immucor authorized service personnel.
Only qualified technical personnel should perform troubleshooting and service procedures on internal
components.
Excessive Humidity Warning: Operate the instrument on a flat surface away from excessive humidity.
Excessive Ambient Light Warning: Avoid instrument exposure to direct sunlight, as it can reduce the
performance range of the instrument.
On/Off Switch Accessibility Warning: Do not block the right side of the instrument, as the on/off
switch must be easily accessible at all times.
Recommended Cleaning Solution Warning: Do not expose any part of the instrument to the
recommended cleaning solution for more than the prescribed amount of time. Prolonged contact
may damage the instrument surfaces. Be certain to rinse and thoroughly wipe all surfaces after
decontamination.
Warranty Warning: Failure to follow preventive maintenance protocols may void the warranty. Refer
to Chapter 5 – Maintaining the Echo Lumena.
Warning: Do not install additional software on the PC. This will void your warranty and service
contract. Third-party software can interfere with the controlling software and result in a loss of
sample data.
Warranty Caution: You must save all of the packaging materials. If you need to ship the Echo
Lumena to Immucor for repair or replacement, the original packing must be used. Other forms of
commercially available packing are not recommended and can void your warranty.
Disposal Caution: This instrument must be fully decontaminated prior to 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.

Appendix A: Echo Lumena Installation
Appendix A: Echo Lumena Installation

In This Appendix:
APPENDIX A: ECHO LUMENA INSTALLATION ......................................................A-1
Verifying That All Parts Are Present ....................................................................A-2
Environmental Conditions and General Safety Features ......................................A-3
USA FCC CLASS A .........................................................................................A-5
Canadian Department of Communications Class A ..........................................A-5
User Safety ........................................................................................................A-5
North America .................................................................................................A-5
International ....................................................................................................A-5
EC Directive 73/23/EEC Low Voltage (Safety) ..................................................A-6
EMC EC Directive 89/336/EEC Electromagnetic Compatibility .........................A-6
Making the Connections ....................................................................................A-7
Instrument Connections ..................................................................................A-7
PC Connections ..............................................................................................A-7
Installing the Software ........................................................................................A-8
Setting up the System........................................................................................A-8
General Options Configuration Default Settings ..................................................A-8
Date/Time Tab ................................................................................................A-8
HIS/LIS Tab ....................................................................................................A-9
Reports Tab ....................................................................................................A-9
Results Tab .....................................................................................................A-9
System Tab .....................................................................................................A-9
Service Tab ...................................................................................................A-10
Completing the Post-installation Check ............................................................A-10
Validating the Installation ..................................................................................A-10
Repackaging Before Shipment .........................................................................A-10
Echo Lumena Operator Manual EC2-001-100 A-1

Appendix A: Echo Lumena Installation Verifying That All Parts Are Present
Note: Qualified Immucor personnel must unpack and install the Echo Lumena system, because the
instrument contains sensitive electrical equipment and requires correct handling, adjustment, and
testing before use. This appendix only provides the unpacking, installation, and setup information
that is of interest to the operator. Contact Immucor for more information about the Echo Lumena
installation.
Verifying That All Parts Are Present

The following is a list of all of the parts that should have been delivered. The Immucor representative will verify that
all parts are present during the installation process.
Item Quantity
Echo Lumena, including main instrument and fluidics 1

module
Echo Lumena power supply 1
Personal computer (PC): 1

Application software installed by manufacturer, including all
applicable licenses
Touch screen monitor: 1

17 inch size (minimum)
TFT active matrix panel
Keyboard 1
Mouse 1
Uninterruptible Power Manager (with incorporated power 1

conditioner) or Uninterruptible Power Supply
Barcode hand scanner and scanner cable 1
Printer 1
System liquid container 1
Waste container 1
Waste shuttle container and tubing 1
Stylus 1 small diameter

1 large diameter
(both contained in a clear plastic cylinder found inside
the Main Instrument body)
Echo Lumena tool kit 1
Reagent racks 6
Customer can order additional racks (number
determined by specific on-site requirements)
A-2 EC2-001-100 Echo Lumena Operator Manual

Environmental Conditions and General Safety Features Appendix A: Echo Lumena Installation
Item Quantity
Sample racks 4 patient sample racks

4 donor sample racks
1 pediatric sample rack
Customer can order additional racks (number
determined by specific on-site requirements)
Strip loading trays 5
Strip holders 21 (1 used as prime strip holder)
Operator Manual 1
Validation Guide 1
Training Guide 2
Power cords and USB cables Number determined by specific instrument

requirements
Replaceable parts kit 1
Environmental Conditions and General Safety Features

The Echo Lumena must be located in an appropriate environment. This section describes the necessary
environment for the Echo Lumena.
X For indoor use only
X Ventilation (non-drafting environment): Installation Category per IEC 61001-1 Pollution Degree 2
X For use in areas where there is normally nonconductive pollution; however, temporary conductivity caused
by condensation can occur
This instrument meets the requirements of IEC 61010-4-4 and IEC 61010-4-5 with regard to transient over-
voltages.
Warning: Adequate space must be provided for accessing the instrument, both during operation
and in the event of servicing. There must be a gap of at least 10 cm behind the instrument for
access and ventilation.
Power Rating Warning: The instrument’s external power supply 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.
Electrical Grounding Warning: Never use a two-prong plug adapter to connect primary power to an
instrument’s external power supply. Use of a two-prong adapter disconnects the utility ground,
creating a severe shock hazard. Always connect the system power cord directly to a three-prong
receptacle with a functional ground.
Internal Voltage Warning: Always turn off the power switch and unplug the power supply before
cleaning the outer surface of the instrument.

Appendix A: Echo Lumena Installation Environmental Conditions and General Safety Features
Potential Biohazards Warning: 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. Dispose of waste in an approved manner.
Decontaminate the instrument per the guidelines given in Chapter 5 – Maintaining the Echo
Lumena.
Unspecified Use Warning: Failure to operate this equipment according to the guidelines and
safeguards specified in this manual could result in a hazardous condition.
Qualified Personnel Warning: Some maintenance procedures must be performed with the
instrument’s front cover removed. Only qualified personnel—trained in the hazards involved when
operating the instrument while open—are allowed to conduct these procedures, as moving parts
may pose pinch or crush hazards.
Service Warning: The Echo Lumena should be serviced by Immucor authorized service personnel.
Only qualified technical personnel should perform troubleshooting and service procedures on
internal components.
Excessive Humidity Warning: Operate the instrument on a flat surface away from excessive
humidity.
Excessive Ambient Light Warning: Avoid instrument exposure to direct sunlight, as it can reduce the
performance range of the instrument.
Environmental Conditions Warning: Do not expose the instrument to temperature extremes. For
proper instrument operation, ambient temperatures should remain between 18°C and 33°C.
However, for proper assay performance using approved Immucor reagents, ambient temperature
should remain between 18°C and 30°C. Performance may be adversely affected if temperatures
fluctuate above or below this range.
Shipping and storage temperatures range from -25°C to 50°C.
Relative humidity range is 10 percent to 80 percent at 18°C to 31°C and 10 percent to 74 percent
at 33°C (noncondensing).
The instrument is for use at altitudes up to 2,000 meters.
On/Off Switch Accessibility Warning: Do not block the right side of the instrument, as the on/off
switch must be easily accessible at all times.
Recommended Cleaning Solution Warning: Do not expose any part of the instrument to the
recommended cleaning solution for more than the prescribed amount of time. Prolonged contact
may damage the instrument surfaces. Be certain to rinse and thoroughly wipe all surfaces after
decontamination.
Warranty Warning: Failure to follow preventive maintenance protocols may void the warranty. Refer
to Chapter 5 – Maintaining the Echo Lumena.
Warranty Warning: Changes or modifications to this unit, which includes hardware or software
modifications and updates, not expressly approved by the manufacturer could void the user's
authority to operate the equipment.

User Safety Appendix A: Echo Lumena Installation
USA FCC CLASS A

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; if not installed and used in accordance with the operator manual, it may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely to cause
interference, in which case you will be required to correct the interference at your own 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.
User Safety
This device has been type tested by an independent laboratory, and it was found to meet the requirements of the
following:
North America
• Underwriters Laboratories UL 61010-1:2008
o “Electrical Equipment for Laboratory Use; Part 1: General Requirements”
• Canadian Standards Association CAN/CSA C22.2 No. 61010-1-04
o “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part
1: General Requirements”
• Also see other standards listed under CE Mark
International
• EN 60825-1:2001
o “Safety of Laser Products, Part1"
• IEC 61010-1 (2010) 3rd Edition (Including Japanese variations)
o “Safety Requirement for Electrical Equipment for Measurement, Control, and Laboratory Use, Part
1: General Requirements”
• IEC 61010-2-10 (2009)
o “Safety Requirement for Electrical Equipment for Measurement, Control, and Laboratory Use, Part
2-010: Particular requirements for the heating of materials”
• Also see other standards listed under CE Mark
Based on the testing described below and information contained herein, this
instrument bears the CE mark.

Appendix A: Echo Lumena Installation User Safety
EC Directive 73/23/EEC Low Voltage (Safety)

The system has been type tested by an independent testing laboratory and was found to meet the requirements of
EC Directive 73/23/EEC for Low Voltage. Verification of compliance was conducted to the limits and methods of
the following:
• EN 61010-1 (2010) 3rd Edition
o “Safety requirement for electrical equipment for measurement, control, and laboratory use. Part 1,
General requirements”
• EN 61010-2-20 (2006) 1st Edition + Amendment 1 (2006)
o “Particular requirements for laboratory centrifuges”
• EN 61010-2-081 (2009) 1st Edition + Amendment 1 (2003)
o “Particular requirements for automatic and semi-automatic laboratory equipment for analysis and
other purposes”
• EN 61010-2-101 (2002) 1st Edition
o “Particular requirements for in vitro diagnostic (IVD) medical equipment”
EMC EC Directive 89/336/EEC 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 61326-1:1998 for Radiated Emissions and Line Conducted Emissions. Verification of
compliance was conducted to the limits and methods of the following:
• CISPR 16-1:1993
• CISPR 16-2:1999
• EN 55022:2000
Immunity
The system has been type tested by an independent, accredited testing laboratory and found to meet the
requirements of EN 61326-1:1998 for Immunity. Verification of compliance was conducted to the limits and
methods of the following:
• EN 61000-3-2
• EN 61000-3-3
• EN 61000-4-2: 2001 Electrostatic Discharge
• EN 61000-4-3: 2002 Radiated EM Fields
• EN 61000-4-4: 2004 Electrical Fast Transient/Burst
• EN 61000-4-5: 2001 Surge Immunity
• EN 61000-4-6: 2001 Conducted Disturbances
• EN 61000-4-11: 2004 Voltage Dips, Short Interruptions, and Variations
Directive 2004/108/EC: Electromagnetic Compatibility Directive
Directive 2006/95/EC: Low Voltage Directive
Directive 93/68/EEC: CE Marking Directive
Directive 94/62/EC: European Parliament and Council Directive on Packaging and Packaging Waste

Making the Connections Appendix A: Echo Lumena Installation
Directive 98/79/EC: In Vitro Diagnostics
The system is in compliance with the requirements of the Directive, including Risk Assessment, Quality System
Certification, and Product registration with competent authorities.
Directive 2002/95/EC: RoHS, Reduction of the use of certain Hazardous substances
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).”
Making the Connections

This section describes the process required to connect the Echo Lumena and PC, as well as how to prepare the
software for operation.
This section also outlines the connections required for the operation of the Echo Lumena, including:
X Instrument connections
X PC connections
Instrument Connections
This section describes the Echo Lumena instrument connections.
Descriptions
The Echo Lumena connects to its external power supply through a round electrical connector located at the lower
right-hand side of the instrument.
A serial connection transfers data between the PC and the Echo Lumena.
A Universal Serial Bus (USB) connection connects the PC directly to the CCD camera in the Echo Lumena reader
module.
The connections for the liquid system link the system liquid container and waste container in the fluidics module to
the pipetting and washer system of the instrument.
PC Connections
This section describes the Echo Lumena PC connections.
Descriptions
A standard PC power cord connects the PC to the main voltage supply. A serial connection transfers data between
the PC and the Echo Lumena.
The network (LAN) adaptor provides an alternative means of connecting to an LIS or a second serial connection.
The monitor, mouse, and keyboard (via the barcode hand scanner) are connected in the same manner as a
standard PC. The touch screen electronics of the monitor are connected to the USB connection.
A standard PC power cord connects the display monitor to a main voltage supply.
The power cords of the monitor, PC, and instrument are connected into the UPS.

Appendix A: Echo Lumena Installation Installing the Software
Warning: The printer power cable must not be connected to the UPS. This can cause electrical
supply problems.
Using an Uninterruptible Power Supply (UPS)

The Echo Lumena system is a computer-controlled analyzer that electronically stores both test requests and test
results. You can lose the current run data (but not the data that has previously been generated) if the power supply
to the system is interrupted. Using an Uninterruptible Power Supply (UPS) with an incorporated power conditioner is
required to operate the Echo Lumena, and Immucor provides an UPS. Approximately 15 minutes of battery power
is available from the UPS to run the Echo Lumena in the absence of wall outlet power.
Installing the Software

The software for the Echo Lumena is preinstalled on the PC.
Warning: Do not install additional software on the PC. This will void your warranty and service
contract. Third-party software can interfere with the controlling software and result in a loss of
sample data.
Setting up the System

The Echo Lumena system is dedicated for use with Immucor reagents. Nevertheless, you can configure several
functions according to the specific needs of the laboratory. You can configure the following parameters:
• User name and access rights
• User password
For more information about user configuration, refer to Assigning Passwords and User Access Rights in Chapter 11
– Security.
General Options Configuration Default Settings

A number of software configurable options can be set as the default values by clicking the Defaults buttons (under
General options). Refer to Chapter 10 – Configuration for details regarding the configurable options. The default
values are listed below.
Date/Time Tab
Long date format Day, month and day number, year (yyyy)
Short date format Month (mm)/day (dd)/year (yyyy)
Time format 12-hour time

General Options Configuration Default Settings Appendix A: Echo Lumena Installation
HIS/LIS Tab
Interface Status Stopped
Connection Type Off
Serial Options Com2, 9600, 8, 0, 0
Socket Options Keep Alive Selected
Display the worklist notification bar when Selected

there are worklist entries
Reports Tab
Include in reports (Test summary, Well All selected
images, Supplies, QC information,
Signature line, Sample status, Legend)
Well results Pos or Neg (+ / -)
Sort Order of results Alphanumeric by sample ID
Well image size 32 pixels
Results Tab
Location of results C:\G3\Results
Results bar options: All selected

• Show pop-up summaries in
results bar
• Show action notifications in results
bar
Result export options: All selected

• Results must be approved before
they can be exported.
• Export invalid results
• Export NTD results
System Tab
Keep scanners on for xx minutes 30 minutes
Rinse probe and manifold every xx hours 4 hours
Startup options: Selected

• Show instrument map at startup

Appendix A: Echo Lumena Installation Completing the Post-installation Check
Service Tab
Note: The Service tab is only accessible to Immucor personnel.
Run time limit 168 hours
Run time warning 4 hours
Dialog transparency 0%
Result font size 12 points
KeepAlive Time 30 minutes
KeepAlive Interval 3 seconds
Local Port 1080
Check for used / dirty strips Selected
Always perform strip holder recovery at Selected

initialization
Run in DEMO MODE Unselected
Completing the Post-installation Check

After the Immucor representative has finished the installation, check all of the components of the Echo Lumena
system for proper functioning. To check the components, you must follow the procedures described in Chapter 5 –
Maintaining the Echo Lumena.
Validating the Installation

An installation and operational qualification process must be completed after the Echo Lumena has been installed.
The installation and operational qualification process confirms that:

• The operating environmental conditions are met.
• The Immucor documentation and manuals are supplied.
• The mechanical safety features are active.
• All calibration results are acceptable.
• The necessary instrument modules function correctly.
• The assays that have been configured for laboratory requirements are correctly prepared and interpreted.
Repackaging Before Shipment

If it is necessary to remove the Echo Lumena from the laboratory, an Immucor representative must repackage it in
the original packaging.
Warranty Caution: You must save all of the packaging materials. If you need to ship the Echo
Lumena to Immucor for repair or replacement, the original packing must be used. Other forms of
commercially available packing are not recommended and can void your warranty.

Repackaging Before Shipment Appendix A: Echo Lumena Installation
You must decontaminate the Echo Lumena before it is repackaged. Follow the procedures in Chapter 5 –
Maintaining the Echo Lumena to decontaminate the instrument. The responsible laboratory authorities must state
on the shipping documents that the instrument has been decontaminated and provide a signature for verification.
Immucor reserves the right to refuse to accept an instrument that does not have such a decontamination
statement.
Disposal Caution: This instrument must be fully decontaminated prior to 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.

Appendix A: Echo Lumena Installation Repackaging Before Shipment

Appendix B: Maintenance Records
Appendix B: Maintenance Records

In This Appendix:
Appendix B: Maintenance Records ....................................................................... B-1
Echo Lumena Maintenance Record .................................................................. B-2
Washer Residual Volume Test and Washer Dispense Accuracy Test Maintenance
Record ............................................................................................................. B-3
Probe Accuracy Test Maintenance Record ........................................................ B-4
Use a copy of these master forms to record results of the maintenance procedures, as described in Chapter 5 –
Maintaining the Echo Lumena.
Echo Lumena Operator Manual EC2-001-100 B-1

Appendix B: Maintenance Records Echo Lumena Maintenance Record
Echo Lumena Maintenance Record

Instructions for use: Operator(s) must perform the maintenance requirement at the specified time. The date of each activity must be entered in the
table. Write the initials of the operator in the designated box(es) to signify successful completion of the task(s). Refer to Chapter 5 – Maintaining the
Echo Lumena for written information about maintenance requirements.
Facility: Instrument Serial Number: Month/Year:

Daily Maintenance Requirement
Date: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1. Refill PBS supply container.
2. Empty waste container.
3. Initialize instrument.
4. Clean instrument.
5. Check probe alignment.
6. Check probe vertical position.
7. Washer residual volume test (visual).
8. Reagent QC.
Weekly Maintenance Requirement Week 1 Week 2 Week 3 Week 4 Week 5

Operator notation: Operator Date Operator Date Operator Date Operator Date Operator Date
1. Instrument and computer shutdown.
2. Archive results (at least weekly) and delete from database.
Monthly Maintenance Requirement

Operator notation: Operator Date
1. Decontamination (Decontaminate/Flush/Purge/Prime).
2. Wipe down probe splash guard with recommended cleaning solution.
3. Washer residual volume test (refer to washer residual volume test and washer
dispense accuracy test Maintenance Record for results).
4. Washer dispense accuracy test (refer to washer residual volume test and washer
dispense accuracy test Maintenance Record for results).
B-2 EC2-001-100 Echo Lumena Operator Manual

Washer Residual Volume Test and Washer Dispense Accuracy Test Maintenance Record Appendix B: Maintenance Records
Washer Residual Volume Test and Washer Dispense Accuracy Test Maintenance Record
Instructions for use: Operator(s) must perform the maintenance task at the required interval. The date of each activity must be entered in the table.
Write the initials of the operator in the designated box(es) to signify performance of the task(s). Refer to Chapter 5 – Maintaining the Echo Lumena for
written information about the maintenance tasks.
Facility: Instrument Serial Number:

Washer residual volume test Item descriptor
Operator notation: Operator Date Weight Conclusion & Serial Number
A. Record operator initials and date of performance:
B. Record weight of strips before test process: g

C. Record weight of strips after test process: g
D. Subtract weight before test from weight after test: g
E. Record YES (acceptable) or NO (not acceptable) for final
weight (from line D): Acceptable?:
Acceptable range: 0.06 g–0.16 g
F. Record serial number of electronic balance:
Washer dispense accuracy test Item descriptor

Operator notation: Operator Date Strip 1 Weight Strip 2 Weight Conclusion & Serial Number
B. Record weight of strips before test process: g g

C. Record weight of strips after test process: g g
D. Subtract weight before test from weight after test: g g
E. Record YES (acceptable) or NO (not acceptable) for final
weights (from line D): Acceptable?:
Acceptable range: 1.92 g–2.08 g for each strip
F. Record serial number of electronic balance:
Echo Lumena Operator Manual EC2-001-100 B-3

Appendix B: Maintenance Records Probe Accuracy Test Maintenance Record
Probe Accuracy Test Maintenance Record

Instructions for use: Operator(s) must perform the maintenance task at the required interval as well as after there has been a probe or syringe
replacement or an existing probe or syringe has been removed and reinstalled on the instrument. The Probe Accuracy Testis performed to verify the
correct volumes of fluid are being dispensed. The date of the activity must be entered in the table. Write the initials of the operator in the designated
box to signify performance of the task. Refer to Chapter 5 – Maintaining the Echo Lumena for written information about this maintenance task.
Facility: Instrument Serial Number:
Probe accuracy test identifying data Item descriptor

Operator notation: Operator Date Electronic Balance Serial Number
B. Record serial number of electronic balance:
Probe accuracy test results Item descriptor

Operator notation: Strip 1 Strip 2 Strip 3 Strip 4 Conclusion
Weight Weight Weight Weight
C. Record weight of strips before test process: g g g g
D. Record weight of strips after test process: g g g g
E. Subtract weight before test from weight after test: g g g g
F. Record YES (acceptable) or NO (not acceptable) for
final weights (from line E): Acceptable?:
Acceptable ranges:
0.14 g–0.18 g for strip 1
B-4 EC2-001-100 Echo Lumena Operator Manual

Regional Attachment – Europe
Regional Attachment – Europe

In This Attachment:
REGIONAL ATTACHMENT – EUROPE................................................................ EU-1
Copyrights and Disclaimers ............................................................................. EU-2
Manufacturer .................................................................................................. EU-3
Authorized Representative ............................................................................ EU-3
Technical Support........................................................................................... EU-3
Markings......................................................................................................... EU-3
Main Instrument ........................................................................................... EU-3
Fluidics Module ............................................................................................ EU-3
Power Supply............................................................................................... EU-4
System Liquid ................................................................................................. EU-5
Echo Assay Reagents and Cutoffs .................................................................. EU-5
Assay Descriptions ....................................................................................... EU-5
Reflex Testing .............................................................................................. EU-8
Control of Strip Usage Time.......................................................................... EU-9
Control of Reagent Usage Time .................................................................. EU-10
Strip Identification ....................................................................................... EU-10
Assay Cutoffs ............................................................................................. EU-12
Assay Reagent Component Grid ................................................................ EU-14
Assay Procedural Steps ............................................................................. EU-17
Interpretation of Tests ................................................................................... EU-27
WB corQC Reaction Charts .......................................................................... EU-32
Echo LIS Interface Specification .................................................................... EU-34
Detailed List of Contents ............................................................................ EU-34
Scope ........................................................................................................ EU-35
Definitions .................................................................................................. EU-35
Connectivity ............................................................................................... EU-35
Communication .......................................................................................... EU-37
Echo ASTM Message Structure .................................................................. EU-38
Echo ASTM Record Structure .................................................................... EU-40
Examples ................................................................................................... EU-57
References ................................................................................................. EU-58
Echo Lumena Operator Manual EC2-001-100 (A1 – EU) EU-1

Regional Attachment – Europe Copyrights and Disclaimers
Copyrights and Disclaimers

Echo Lumena Operator Manual
©2016, Immucor, Inc. Echo Lumena™ is a trademark of Immucor, Inc. (hereinafter “Immucor”).
The contents of this manual are protected by copyright. The Immucor name, logos, related
trademarks, and service marks are owned and used in commerce by Immucor and are protected by
U.S. and international trademark laws.
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system,
or translated into any human or computer language in any form by any means without written
permission from the copyright holder.
Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of
Immucor to provide accurate and up-to-date information to customers.
No warranties of any nature are extended by this document. You should be very careful to ensure
that the use of this information and/or hardware and software material complies with the laws, rules,
and regulations of the jurisdictions with respect to which it is used.
All operating instructions must be followed. In no event shall Immucor be held responsible for
failures, errors, or other liabilities resulting from a customer’s noncompliance with the procedures
and precautions outlined in this manual.
The sample screen displays and sample printouts in this Echo Lumena Operator Manual are for
information and illustration purposes only. Immucor makes no representations or warranties about
the accuracy or reliability of the information presented on the screen displays, and this information is
not to be used for clinical or maintenance evaluation.
Immucor reserves the right to make changes to the product to improve reliability, function or design,
or to discontinue any product at any time without notice or obligation. The material contained in this
manual is subject to change without notice. Immucor will not be liable for any consequences
resulting from the use of this publication.
Any comments or suggestions regarding this publication should be forwarded to Immucor, Inc.,
3130 Gateway Drive, P.O. Box 5625, Norcross, GA 30091-5625.
Microsoft, Windows, and the Windows logo are registered trademarks or trademarks of Microsoft
Corporation in the United States and other countries. All third-party trademarks, service marks, and
trade names are the property of their respective owners and are hereby acknowledged.
No responsibility is assumed by Immucor for the use or reliability of software or equipment that is not
supplied by Immucor or its affiliated dealers. All warnings and cautions must be reviewed by the
operator prior to using the Echo Lumena for the first time.
EU-2 EC2-001-100 (A1 – EU) Echo Lumena Operator Manual

Manufacturer Regional Attachment – Europe
Manufacturer
Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
USA
Authorized Representative
Immucor Medizinische Diagnostik GmbH

Adam-Opel-Strasse 26 A
63322 Rödermark, GERMANY
Technical Support
Europe
If you are in Europe, call Technical Support at +49 6074 842010 for assistance with questions relating to Echo
operational problems. (Technical support is available 24 hours a day, 7 days a week)?.
Markings
There are marking labels for the three main hardware components:
• Main instrument
• Fluidics module
• Power supply
These marking labels are illustrated next (not illustrated to scale).
Main Instrument
The following marking label is located on the main instrument:
Main instrument CE mark, serial number (prefix M), and manufacturer label
Fluidics Module

Regional Attachment – Europe Markings
The following marking label is located on the fluidics module:
Fluidics module CE mark, serial number (prefix F), and manufacturer label
Power Supply
The following marking labels are located on the power supply:
Label for Echo power supply listing electrical requirements
The following TÜV® Mark is applied to the main instrument, fluidics module, and power supply:
TÜV® Mark for: UL 61010-1; CAN/CSA C22.2 No. 61010-1; EN 61010-1; IEC 61010-1 including Japanese variations

System Liquid Regional Attachment – Europe
System Liquid
Immucor requires the use of commercially prepared phosphate-buffered saline (PBS), which may include the
addition of a commercially prepared buffer concentrate to commercially prepared unbuffered saline or Galileo
System Liquid Concentrate to DI water (contact Immucor for the Galileo System Liquid Concentrate product
ordering information).
Echo Assay Reagents and Cutoffs

Assay Descriptions
Assay Description Assay Abbreviation Micro-well Strips Used
ABO and Rh blood group ABD_Type CMT Plates

ABOD Full
ABO1D Full
ABOD Full NC
ABO1D Full NC
ABOD Long
ABO1D Long
ABOD Group
ABO and Rh blood group with reflex RfxABD_Type CMT Plates

capability
RfxABOD Full
RfxABO1D Full
RfxABOD Full NC
RfxABO1D Full NC
RfxABOD Long
RfxABO1D Long
RfxABOD Group
ABO and Rh blood group for pediatric Neonate CMT Plates

samples
ABO and Rh blood group for pediatric RfxNeonate CMT Plates

samples with reflex capability
Forward ABO and Rh blood group only ABOD Check CMT Plates
ABOD Check2
Forward ABO and Rh blood group only RfxABOD Check CMT Plates
with reflex capability
RfxABOD Check2
Forward ABO and Rh blood group only; ABOD Check Screen Capture-R® Ready-Screen® (3)
and red blood cell (RBC) antibody screen
ABOD Check2 Screen CMT Plates
(3-cell)

Regional Attachment – Europe Echo Assay Reagents and Cutoffs
Forward ABO and Rh blood group only; RfxABOD Check Screen Capture-R® Ready-Screen® (3)
and red blood cell (RBC) antibody screen
RfxABOD Check2 Screen CMT Plates
(3-cell) with built-in reflex capability for
group only
Auto control for agglutination Autocontrol CMT Plates
Phenotyping Ag_CcEe CMT Plates

Ag_CcEe2
Ag_CcEeK
Ag_CcEeK2
Ag_CEceK
Ag_CEceK2
Ag_cEK2
Ag_C RH2
Ag_c RH4
Ag_E RH3
Ag_e RH5
Ag_Kell
Auto_Kell
Kell1u2
ABO and Rh blood group; and red blood ABOD Full Screen Capture-R® Ready-Screen® (3)
cell (RBC) antibody screen (3-cell)
ABO1D Full Screen CMT Plates
ABOD Full NC Screen
ABO1D Full NC Screen
ABOD Long Screen
ABO1D Long Screen
ABOD Group Screen
ABO and Rh blood group; red blood cell RfxABOD Full Screen Capture-R® Ready-Screen® (3)
(RBC) antibody screen (3-cell) with built-in
RfxABO1D Full Screen CMT Plates
reflex capability for group only
RfxABOD Full NC Screen
RfxABO1D Full NC Screen
RfxABOD Long Screen
RfxABO1D Long Screen
RfxABOD Group Screen
Red blood cell antibody screen (3-cell) Screen Capture-R® Ready-Screen® (3)
RBC antibody panel Ready-ID assay Ready ID Capture-R® Ready-ID®

Echo Assay Reagents and Cutoffs Regional Attachment – Europe
RBC antibody panel Extend I assay Extend I Capture-R® Ready-ID® Extend I
RBC antibody panel Extend II assay Extend II Capture-R® Ready-ID® Extend II
Red blood cell crossmatch (IgG) Crossmatch Capture-R® Select
Direct Antiglobulin Test (IgG DAT) DAT Capture-R® Select
Red blood cell weak D testing Weak D Capture-R® Select
Warning: The red blood cell crossmatch (IgG) is intended only for the detection of incompatibilities
due to IgG antibodies. The red blood cell crossmatch (IgG) is not intended for the detection of
incompatibilities due to IgM antibodies, such as ABO incompatibilities.
Warning: The Monoclonal Control is used to control false positive results produced in the antisera
testing wells. The Monoclonal Control well can yield a positive result. If the Monoclonal Control well
produces a positive result, then the final interpretation will be Ctrl Fail and all well reaction grades will
be reported as C because the control well failed.
Warning: Certain blood sample factors have a high likelihood of causing no-type-determined (NTD)
ABO or Rh (D) interpretations. These include serological factors due to the inheritance of weakly
expressed gene products by certain diseases (such as leukemia) through the transfusion or
transplantation of ABO and Rh (D) allogeneic red blood cell products, or they could be due to the
patient's age. Instrument NTD results can also occur due to the interference caused by certain
sample conditions, such as higher-than-normal levels of lipid, bilirubin, free plasma hemoglobin,
clots, or aggregates.
It is possible that when two or more of these factors occur simultaneously, believable but erroneous
test results (that is, mistype) will occur. Forward-only ABO-Rh testing has a higher risk of mistype
due to the absence of the reverse type results. Hazardous mistypes may occur, such as an A
sample being interpreted as group AB or an Rh (D) negative sample being interpreted as Rh (D)
positive. For this reason, ABO-Rh results should always be compared to the patient or donor’s
history.
Additionally, sample preparation and exclusion instructions contained in the relevant reagent
package inserts should be followed precisely. Before decisions about medical treatment are made
or red blood cell products are released for transfusion, ABO and Rh (D) test results should be
verified. This verification can consist of an immediate spin crossmatch or a result comparison to a
second current or historical ABO and Rh (D) test by the same or an alternative method. This
limitation applies to all ABO-Rh assays, both with and without a reverse test.
Warning: The grading of reactions on the Echo must only be regarded as an approximation when
compared to visual grading by laboratory technical staff.
has been added to the vial. Refer to Control of Reagent Usage Time table below for on-board
expiration time of reagents other than Indicator Red Cells. Results can be adversely affected if
Warning: The Echo cannot reliably detect hemagglutination reactions that are graded as 1+ or less
in test tube methodology.
Warning: The Echo does not generate an interpretation of mixed-field reactions. Such a mixed-field
reaction will be interpreted as positive, negative, or equivocal.

Warning: If a positive sample result is obtained when running the Weak D assay, then as a follow up.
You must perform the DAT assay for that sample. The DAT assay is performed to qualify the Weak
D positive result.
Warning: If the strip washer fails to dispense PBS when washing strips for the Weak D assay, prior
to adding Capture-R® Ready Indicator Cells, then the associated well results can still appear as
expected reactions, due to red blood cell Rh (D) antigen bridging created by residual reagent Anti-D
IgM antibody molecules.
Warning: The Echo Lumena operational site is ultimately responsible for performing their own
reagent quality control (QC) testing according to the regulations, specifications and standards as
defined by the site requirements and local authorities.
Reflex Testing
This section describes the basic concepts of reflex testing and the features of the reflex assays.
Basic Concepts of Reflex Testing

Whenever a condition is met within a given assay that should require further sample testing before a result is
finalized, an automatic additional test request (or reflex test request) is generated. An example is the subsequent
Weak D testing of a sample if an initial D typing result is negative. This reflex process is used to streamline the work
flow process and make it as convenient for you as possible to complete all of the necessary testing in a timely
manner.
To accommodate different on-site and regional regulations, reflex testing is designed to be optional by having a
second version of some assays available for the reflexing of Rh (D) testing. The only difference between the two
versions is that one version has reflex capability to Weak D testing and one does not.
If the use of one or more reflex testing scenarios is preferred, then the preferred reflex assays can be used for
testing of samples.
Reflex testing for red blood cell antibody screen positive results is a configurable option. Refer to Chapter 10 –
Configuration for details about the antibody screen reflex configuration.
Features of the Reflex Assays

The table below lists the reflex tests generated with specific reflex assays when certain qualifying conditions are
met.
Reflex Assay Assay Qualifying Condition Reflex Test
RfxABD_Type Rh (D) negative result Weak D

RfxABODFull
RfxABO1DFull
RfxABODFullNC
RfxABO1DFullNC
RfxABODLong
RfxABO1DLong
RfxABODGroup

Reflex Assay Assay Qualifying Condition Reflex Test
RfxNeonate Rh (D) negative result Weak D
RfxCheck Rh (D) negative result Weak D

RfxCheck2
RfxABODFullScrn Rh (D) negative result Weak D

RfxABO1DFullScrn
RfxABODFullNCScrn Screen positive result (and Ready-ID®
screen reflex option
RfxABO1DFullNCScrn
configured)
RfxABODLongScrn
RfxABO1DLongScrn
RfxABODGroupScrn
RfxABODCheckScrn
RfxABODCheck2Scrn
General Reflex Features

Whenever the qualifying reflex condition is met while processing the original reflex assay, a reflex test request is
created in the Worklist queue. You are required to release the reflex test from the Worklist queue.
The reflex test is performed once. A repeated reflex test is not rescheduled if the initial reflex test result is invalid.
A portion of the results from the original assay are available before reflex processing is complete for the sample.
Screen Reflex Features

Results for the screen reflex are final. Results from the subsequent reflex Ready ID test are reported independently.
Weak D Reflex Test Features

The Weak D reflex test is performed as STAT if the original reflex assay was scheduled as STAT. Results for all
assays that reflex to the Weak D assay show the Rh (D) status as Reflex. Reflex indicates that the Rh (D)
interpretation from the original assay was negative, but the Weak D assay has not yet been performed to confirm
that the Rh (D) is negative. Once the Weak D assay has completed processing, the original test result is updated to
show the Rh (D) status from the Weak D assay, e.g., Neg.
Reflex Test Rules

Reflex Tests cannot be edited if an equivocal result is generated
Control of Strip Usage Time

The amount of time a strip can be used on the instrument is limited once it is recognized by the instrument. The
time limits are detailed in the following table.
Strip Time Limit (hours)
Capture R Select 16
Capture-R Ready-ID 8
Capture-R Ready-ID Extend I 8
Capture-R Ready-ID Extend II 8
CMT 72
Capture-R Ready-Screen (3) CW 8
Control of Reagent Usage Time

The amount of time a reagent can be used on the instrument is limited once it is recognized by the instrument. An
expiration warning will generate once the reagent is nearing its on-board expiration time. The time limits are detailed
in the table below.
Reagent Initial On-Board Days Prior to On-Board Expiration

Expiration Warning
DAT Positive 3 Days 7 Days

Control Cell
Indicator Cells N/A 24 hours
Warning: The on-board expiration time is based on intervening periods of refrigeration. The Echo
software does not monitor on-board expiration if reagents are left on-board for 72 hours of
continuous use. Vials of reagents, other than Indicator Red Cells, that have remained continuously
on the Echo for 72 hours (3 days) should be removed and replaced with fresh vials.
Strip Identification

Each type of micro-well strip used on the Echo has unique eye-readable identifying text on the top tab of each strip.
The information provided in the following table can be used to identify strip types.
Type of Strip Identifying Text Lot Prefix Numerical Code
CMT Plates NU NU 018
Capture-R® Ready- 020

RS3 E
Screen® (3) CW
Capture-R® Select SC SC 008
Capture-R® Ready-ID® RID ID ID 013
Capture-R® Ready-ID® DP 014

RID DP
Extend I
Capture-R® Ready-ID® DN 015

RID DN
Extend II
Balance Strip BL BL 016

Assay Cutoffs
Category of Assays Grade Lower Limit => Upper Limit <=
0 0 2
? 3 9
Hemagglutination based assays 1+ 10 30

(excluding the phenotype assays) 2+ 31 45
3+ 46 62
4+ 63 100
0 0 2
? 3 28
Forward Hemagglutination based 1+ 29 30
assays (excluding the phenotype
assays) 2+ 31 45
3+ 46 62
4+ 63 100
0 0 5
? 6 9
Capture-R® Ready-Screen® (excluding 1+ 10 39
those assays utilizing Capture-R®
Select) 2+ 40 59
3+ 60 93
4+ 94 100
0 0 6
? 7 9
1+ 10 39
Negative Control for ID Assays
2+ 40 59
3+ 60 93
4+ 94 100

Category of Assays Grade Lower Limit => Upper Limit <=
0 0 5
? 6 9
Capture-R® Ready-ID®, Extend I and 1+ 10 39

Extend II 2+ 40 59
3+ 60 93
4+ 94 100
0 0 4
? 5 9
1+ 10 39
Capture-R® Select based assays
2+ 40 59
3+ 60 93
4+ 94 100
0 0 5
? 6 28
1+ 29 30
Rh Phenotype assays
2+ 31 45
3+ 46 62
4+ 63 100
0 0 5
? 6 9
1+ 10 30
Kell Phenotype assays
2+ 31 45
3+ 46 62
4+ 63 100

Assay Reagent Component Grid
ABO1D Full NC
ABO1D Full NC
ABOD Check2
ABOD Check2
ABOD Full NC
ABOD Full NC
ABOD Check
ABOD Check
ABO1D Long
ABO1D Long
ABOD Group
ABOD Group
ABOD Long
ABOD Long
ABO1D Full
ABO1D Full
ABD_Type
ABOD Full
ABOD Full
Neonate
Screen
Screen
Screen
Screen
Screen
Screen
Screen
Screen
Screen
Screen
Reagents and
Microplates
immuClone Anti-A IgM X X X X X X X X X X X X X X X X

immuClone Anti-B IgM X X X X X X X X X X X X X X X X
immuClone Anti-A,B IgM X X X X X X
immuClone Rh-Hr
X X X X X X X X X X X X
Control
immuClone Anti-D Rapid
X X X X X X X X X X
IgM
NOVACLONE Diluent
X X X X
Control
NOVACLONE Anti-A X X X X
NOVACLONE Anti-B X X X X
NOVACLONE Anti-A,B X X X X
NOVACLONE Anti-D
X X X X X X X X X X X X X X X X X X
IgM/IgG
Referencells® A1 X X X X X X X X X X X X X X X
Referencells® B X X X X X X X X X X X X X X X
Referencells® A2 X X X X X X X
Referencells® O X X X X X
Specimen Diluent X X X X X X X X X X X X X X X X X X X X
CMT Plates X X X X X X X X X X X X X X X X X X X X
Capture-R® Ready-
X X X X X X X X X X
Screen® (3)
®
Capture LISS X X X X X X X X X X
Capture-R® Ready
X X X X X X X X X X
Indicator Red Cells
WB corQC 1 X X X X X X X X X X X X X X X X X X X X X
WB corQC 4
EU-14 EC2-001-100 (A1 – EU) Galileo Echo Operator Manual

RfxABOD Check2 Scrn

RfxABOD Full NC Scrn
RfxABOD Check Scrn

RfxABO1D Long Scrn
RfxABOD Group Scrn

RfxABOD Full Scrn
RfxABO1D Full NC
RfxABO1D Full NC
RfxABOD Check2
RfxABOD Check
RfxABO1D Long
RfxABOD Group
RfxABODFullNC
RfxABOD Long
RfxABOD Long
RfxABO1D Full
RfxABO1D Full
RfxABD_Type
RfxABOD Full
RfxNeonate
Reagents and
Scrn
Scrn
Scrn
Microplates
immuClone Anti-A IgM X X X X X X X X X X X X X X X X

immuClone Anti-B IgM X X X X X X X X X X X X X X X X
immuClone Anti-A,B IgM X X X X X X
immuClone Rh-Hr
X X X X X X X X X X X X
Control
immuClone Anti-D Rapid
X X X X X X X X X X
IgM
NOVACLONE Diluent
X X X X
Control
NOVACLONE Anti-A X X X X
NOVACLONE Anti-B X X X X
NOVACLONE Anti-A,B X X X X
NOVACLONE Anti-D
X X X X X X X X X X X X X X X X X X
IgM/IgG
®
Referencells A1 X X X X X X X X X X X X X X X
Referencells® B X X X X X X X X X X X X X X X
®
Referencells A2 X X X X X X X
Referencells® O X X X X X
Specimen Diluent X X X X X X X X X X X X X X X X X X X X
CMT Plates X X X X X X X X X X X X X X X X X X X X
Capture-R® Ready-
X X X X X X X X X
Screen® (3)
®
Capture LISS X X X X X X X X X
Capture-R® Ready
X X X X X X X X X
Indicator Red Cells
WB corQC 1 X X X X X X X X X X X X X X X X X X X X
WB corQC 4
Galileo Echo Operator Manual EC2-001-100 (A1 – EU) EU-15

Crossmatch
Ag_CcEeK2
Ag_CEceK2
Autocontrol
Ag_CcEeK
Ag_CEceK
Ag_C RH2
Ag_E RH3
Ag_c RH4
Ag_e RH5
Ag_CcEe2
Ag_cEK2
Ready ID
Auto_Kell
Ag_CcEe
Extend II
Extend I
Weak D
Ag_Kell
Kell1u2
Reagents and
DAT
Microplates
Capture® LISS X X X X X
Capture-R® Ready
X X X X X X
Indicator Red Cells
DAT Positive Control
X X X
Cell
Capture-R® Select X X X
® ®
Capture-R Ready-ID X
Capture-R® Ready-ID®
X
Extend I
® ®
Capture-R Ready-ID
X
Extend II
CMT Plates X X X X X X X X X X X X X X X
immuClone Rh-Hr
X X X X X X X X X X X X X X
Control
Specimen Diluent X X X X X X X X X X X X X X X
immuClone (1) Anti-C X X X X
immuClone (2) Anti-C X X X
immuClone (1) Anti-c X X X X
immuClone (2) Anti-c X X X X
immuClone (1) Anti-E X X X X
immuClone (2) Anti-E X X X X
ImmuClone (1) Anti-e X X X X
immuClone (2) Anti-e X X X
immuClone Anti-K X X X X X
Automated immuClone
X X X X X
Anti-K
WB corQC 1 X X X X X X X X X X X X
WB corQC 2 X X X X X X X X X
WB corQC 3 X X X X X X X X X X
WB corQC 4 X X X X X X X X X X X X X X

Assay Procedural Steps

Note: You must prepare all of the necessary reagents and samples for each assay according to the
detailed reagent package insert requirements. This brief synopsis of assay procedural steps relating
to sample and reagent preparation is intended only as a summary of the steps and is not intended
as a substitute for the detailed package insert.
Assay Abbreviation Brief Synopsis of Assay Procedural Steps
ABD_Type 1. Bring all reagents and blood samples to 18°C–30°C before testing.
ABOD Full 2. Centrifuge the blood samples to separate the plasma from the red blood
cells. Remove the caps from the blood sample tubes.
ABO1D Full
3. Remove the desired number of CMT Plate strips from the pouch.
ABOD Full NC
4. Remove reagent vial caps.
ABO1D Full NC
5. Add one stir ball to each new vial of Referencells® A1 and B (and A2 and
ABOD Long
O if applicable) to be used. Gently agitate each vial to re-suspend the
ABO1D Long red blood cells.
ABOD Group 6. Load reagents, micro-well strips, and blood samples onto the Echo
following the procedures in Chapter 3 – Instrument Testing Operation.
7. Assign the ABD_Type, ABOD Full (or ABO1D Full or ABOD Full NC or
ABO1D Full NC or ABOD Long or ABO1D Long or ABOD Group) assay
to the blood samples either manually or by following the upload worklist
procedure.
8. Start the ABD_Type, ABOD Full (or ABO1D Full or ABOD Full NC or
ABO1D Full NC or ABOD Long or ABO1D Long or ABOD Group) assay
The Echo automatically performs the ABD_Type, ABOD Full (or ABO1D
Full or ABOD Full NC or ABO1D Full NC or ABOD Long or ABO1D Long
or ABOD Group) assay and records and interprets the blood sample
results.
9. Access the blood sample results at the completion of the Echo
ABD_Type, ABOD Full (or ABO1D Full or ABOD Full NC or ABO1D Full
NC or ABOD Long or ABO1D Long or ABOD Group) assay.

RfxABD_Type 1. Bring all reagents and blood samples to 18°C–30°C before testing.
RfxABODFull 2. Centrifuge the blood samples to separate the plasma from the red blood
RfxABO1DFull
RfxABODFullNC
RfxABO1DFullNC
RfxABODLong
RfxABO1DLong red blood cells.
RfxABODGroup 6. Load reagents, micro-well strips, and blood samples onto the Echo
7. Assign the RfxABD_Type, RfxABODFull (or RfxABO1DFull or
RfxABODFullNC or RfxABO1DFullNC or RfxABODLong or
RfxABO1DLong or RfxABODGroup) assay to the blood samples either
manually or by following the upload worklist procedure.
8. Start the RfxABD_Type, RfxABODFull (or RfxABO1DFull or
RfxABO1DLong or RfxABODGroup) assay following the procedures in
Chapter 3 – Instrument Testing Operation. The Echo automatically
performs the RfxABD_Type, RfxABODFull (or RfxABO1DFull or
RfxABO1DLong or RfxABODGroup) assay and records and interprets
the blood sample results.
RfxABD_Type, RfxABODFull (or RfxABO1DFull or RfxABODFullNC or
RfxABO1DFullNC or RfxABODLong or RfxABO1DLong or
RfxABODGroup) assay.
Neonate 1. Bring all reagents and blood samples to 18°C–30°C before testing.
RfxNeonate 2. Centrifuge the blood samples to separate the plasma from the red blood
5. Load reagents, micro-well strips, and blood samples onto the Echo
6. Assign the Neonate (or RfxNeonate) assay to the blood samples either
7. Start the Neonate (or RfxNeonate) assay following the procedures in
performs the Neonate (or RfxNeonate) assay and records and interprets
8. Access the blood sample results at the completion of the Echo Neonate
(or RfxNeonate) assay.

ABOD Check 1. Bring all reagents, donor segment blood samples, and blood samples (if
applicable) to
ABOD Check2
18°C–30°C before testing.
RfxABODCheck
2. Centrifuge the blood sample collection tubes to separate the plasma
RfxABODCheck2 from the red blood cells and then remove the caps from those tubes.
Process the donor segment blood samples, which must include
centrifugation of these samples.
5. Load reagents, micro-well strips, and blood samples (and donor
samples) onto the Echo following the procedures in Chapter 3 –
Instrument Testing Operation.
6. Assign the ABOD Check (or ABOD Check2 or RfxABODCheck or
RfxABODCheck2) assay to the blood samples (and donor samples)
either manually or following the upload worklist procedure.
7. Start the ABOD Check (or ABOD Check2 or RfxABODCheck or
RfxABODCheck2) assay following the procedures in Chapter 3 –
Instrument Testing Operation. The Echo automatically performs the
ABOD Check (or ABOD Check2 or RfxABODCheck or RfxABODCheck2)
assay and records and interprets the blood sample (and donor samples)
results.
8. Access the blood sample results (and donor samples) at the completion
of the Echo ABOD Check (or ABOD Check2 or RfxABODCheck or
RfxABODCheck2) assay.

Ag_CcEe 1. Bring all reagents, donor segment blood samples, and blood samples (if
applicable) to
Ag_CcEe2
Ag_CcEeK
Ag_CcEeK2 from the red blood cells then remove the caps from those tubes.
Ag_CEceK
Ag_CEceK2
Ag_cEK2
Ag_C RH2
Ag_c RH4 samples) onto the Echo following the procedures in Chapter 3 –
Ag_E RH3
6. Assign the Ag_CcEe, Ag_CcEe2, Ag_CcEeK, Ag_CcEeK2, Ag_CEceK,
Ag_e RH5
Ag_CEceK2, Ag_cEK2, Ag_C RH2, Ag_c RH4, Ag_E RH3, Ag_e RH5,
Ag_Kell Ag_Kell, Auto_Kell or Kell1u2 assay to the blood samples (and donor
samples) either manually or by following the upload worklist procedure.
Auto_Kell
7. Start the Ag_CcEe, Ag_CcEe2, Ag_CcEeK, Ag_CcEeK2, Ag_CEceK,
Kell1u2
Ag_Kell, Auto_Kell or Kell1u2 assay following the procedures in Chapter
3 – Instrument Testing Operation. The Echo automatically performs the
Ag_CcEe, Ag_CcEe2, Ag_CcEeK, Ag_CcEeK2, Ag_CEceK,
Ag_Kell, Auto_Kell or Kell1u2 assay and records and interprets the blood
sample (and donor samples) results.
8. Access the blood sample results (and donor samples) at the completion
of the Echo Ag_CcEe, Ag_CcEe2, Ag_CcEeK, Ag_CcEeK2, Ag_CEceK,
Ag_Kell, Auto_Kell or Kell1u2 assay.

ABOD Full Screen 1. Bring all reagents and blood samples to 18°C–30°C before testing.
ABO1D Full Screen 2. Centrifuge the blood samples to separate the plasma from the red blood
ABOD Full NC Screen
4. Remove the Capture-R® Ready-Screen® (3) microplate frame and the
ABOD Long Screen
desired number of Capture-R® Ready-Screen® strips from the pouch.
ABO1D Long Screen
ABOD Group Screen
6. Add one stir ball to each new vial of Capture-R® Ready Indicator Red
ABOD Check Screen Cells to be used. Gently agitate each vial to re-suspend the red blood
cells.
ABOD Check2 Screen
red blood cells.
9. Assign the ABOD Full Screen (or ABO1D Full Screen or ABOD Full NC
Screen or ABO1D Full NC Screen or ABOD Long Screen or ABO1D
Long Screen or ABOD Group Screen) assay to the blood samples,
either manually or following the upload worklist procedure.
10. Start the ABOD Full Screen (or ABO1D Full Screen or ABOD Full NC
Long Screen or ABOD Group Screen) assay following the procedures in
performs the ABOD Full Screen (or ABO1D Full Screen or ABOD Full NC
Long Screen or ABOD Group Screen) assay and records and interprets
11. Access the blood sample results at the completion of the Echo ABOD
Full Screen (or ABO1D Full Screen or ABOD Full NC Screen or ABO1D
Full NC Screen or ABOD Long Screen or ABO1D Long Screen or ABOD
Group Screen) assay.

RfxABODFullScrn 1. Bring all reagents and blood samples to 18°C–30°C before testing.
RfxABO1DFullScrn 2. Centrifuge the blood samples to separate the plasma from the red blood
RfxABODFullNCScrn
RfxABO1DFullNCScrn
4. Remove the Capture-R® Ready-Screen® (3) microplate frame and the
RfxABODLongScrn
RfxABO1DLongScrn
RfxABODGroupScrn
RfxABODCheckScrn Cells to be used. Gently agitate each vial to re-suspend the red blood
cells.
RfxABODCheck2Scrn
red blood cells.
9. Assign the RfxABODFullScrn (or RfxABO1DFullScrn or
RfxABODFullNCScrn or RfxABO1DFullNCScrn or RfxABODLongScrn or
RfxABO1DLongScrn or RfxABODGroupScrn) assay to the blood
samples, either manually or following the upload worklist procedure.
10. Start the RfxABODFullScrn (or RfxABO1DFullScrn or
RfxABO1DLongScrn or RfxABODGroupScrn) assay following the
procedures in Chapter 3 – Instrument Testing Operation. The Echo
automatically performs the RfxABODFullScrn (or RfxABO1DFullScrn or
RfxABO1DLongScrn or RfxABODGroupScrn) assay and records and
interprets the blood sample results.
RfxABODFullScrn (or RfxABO1DFullScrn or RfxABODFullNCScrn or
RfxABO1DFullNCScrn or RfxABODLongScrn or RfxABO1DLongScrn or
RfxABODGroupScrn) assay.

Screen 1. Bring all reagents and blood samples to 18°C–30°C before testing.
2. Centrifuge the blood samples to separate the plasma from the red blood
3. Remove the Capture-R® Ready-Screen® microplate frame and the
Cells to be used. Gently agitate each vial to re-suspend the red blood
cells.
7. Assign the Screen assay to the blood samples either manually or by
following the upload worklist procedure.
8. Start the Screen assay following the procedures in Chapter 3 –
Screen assay and records and interprets the blood sample results.
9. Access the blood sample results at the completion of the Echo Screen
assay.
Ready ID 1. Bring all reagents and blood samples to 18°C–30°C before testing.
3. Remove the Capture-R® Ready-ID® microplate frame and the desired
number of Capture-R® Ready-ID® strips from the pouch.
cells.
7. Assign the Ready ID assay to the blood samples either manually or by
8. Start the Ready ID assay following the procedures in Chapter 3 –
Ready ID assay and records the blood sample results.
9. Access the blood sample results at the completion of the Echo Ready ID
assay. If any wells are reported positive, you must cross-reference this
data with the lot-specific Capture-R® Ready-ID® Master List to
determine the antibody identification (if any exist).

Extend I 1. Bring all reagents and blood samples to 18°C–30°C before testing.
3. Remove the Capture-R® Ready-ID® Extend I microplate frame and the
desired number of Capture-R® Ready-ID® Extend I strips from the
pouch.
cells.
7. Assign the Extend I assay to the blood samples either manually or by
8. Start the Extend I assay following the procedures in Chapter 3 –
Extend I assay and records the blood sample results.
9. Access the blood sample results at the completion of the Echo Extend I
data with the lot-specific Capture-R® Ready-ID® Extend I Master List to
Extend II 1. Bring all reagents and blood samples to 18°C–30°C before testing.
3. Remove the Capture-R® Ready-ID® Extend II microplate frame and the
desired number of Capture-R® Ready-ID® Extend II strips from the
pouch.
cells.
7. Assign the Extend II assay to the blood samples either manually or by
8. Start the Extend II assay following the procedures in Chapter 3 –
Extend II assay and records the blood sample results.
9. Access the blood sample results at the completion of the Echo Extend II
data with the lot-specific Capture-R® Ready-ID® Extend II Master List to

Crossmatch 1. Bring all reagents, donor segment blood samples, and blood samples to
from the red blood cells and then remove the caps from those tubes.
3. Remove the Capture-R® Select microplate frame and the desired
number of Capture-R® Select strips from the pouch.
Cells and DAT Positive Control Cell to be used. Gently agitate each vial
to re-suspend the red blood cells.
6. Load reagents, micro-well strips, blood samples, and donor segment
blood samples onto the Echo following the procedures in Chapter 3 –
7. Assign the Crossmatch assay to the blood samples either manually or
by following the upload worklist procedure.
8. Start the Crossmatch assay following the procedures in Chapter 3 –
Crossmatch assay and records and interprets the compatibility results.
Crossmatch assay.

DAT 1. Bring all reagents and blood samples to 18°C–30°C before testing.
samples) onto the Echo following the procedures in Chapter 3 –
7. Assign the DAT assay to the blood samples (and donor samples) either
8. Start the DAT assay following the procedures in Chapter 3 – Instrument
Testing Operation. The Echo automatically performs the DAT assay and
records and interprets the blood sample (and donor samples) results.
9. Access the blood sample results at the completion of the Echo DAT
assay.
Weak D 1. Bring all reagents and blood samples to 18°C–30°C before testing.
7. Assign the Weak D assay to the blood samples (and donor samples)
either manually or by following the upload worklist procedure. The Echo
software can automatically assign the Weak D assay to the necessary
blood samples if the software is configured to do so. The configuration
is optional.
8. Start the Weak D assay following the procedures in Chapter 3 –
Weak D assay and records and interprets the blood sample results.
9. Access the blood sample results at the completion of the Echo Weak D
assay.

Interpretation of Tests Regional Attachment – Europe
Autocontrol 1. Bring all reagents and blood samples to 18°C–30°C before testing.
6. Assign the Autocontrol assay to the blood samples either manually or by
7. Start the Autocontrol assay following the procedures in Chapter 3 –
Autocontrol assay and records and interprets the blood sample results.
Autocontrol assay.
Interpretation of Tests
The Echo generates a result for each well read by the instrument and an interpretation of the results. Each Echo
assay has predefined interpretations for the test well results.
A test well result is the reaction result for a given test well. Test well results can be reported as Negative, Positive, or
Equivocal. These results are determined by comparing the well reaction value to assay-specific cutoff values. Assay
cutoff values are listed in the Echo Assay Reagents and Cutoffs section earlier in this attachment.
Possible test well results for all assays include:
Positive + The reaction value is greater than or equal to the positive cutoff value.
Negative 0 The reaction value is less than or equal to the negative cutoff value.
Equivocal ? The Equivocal symbol indicates that the reaction well cannot be
definitively considered negative or positive. The reaction value is
greater than the negative cutoff value and less than the positive cutoff
value.
The operator can edit well results that the Echo identifies as equivocal (identified as “?”). Only equivocal results can
be edited. No positive or negative results reported by the Echo can be edited. Equivocal QC results cannot be
edited.
When results are edited, the Echo creates an audit trail. The operator is only able to edit test well results. The
operator cannot edit sample result interpretations.
The interpretation of the test well results is based on the reaction or reaction pattern of individual test well results,
applicable control results, and Echo process control monitoring. The possible well results used in the following
example are: 0, +, 1+, 2+, 3+, 4+, ?*, X, H, C, U, M, R, and Q. Table of Well Results and Test Interpretations by
Assay with the following Table Key:

Regional Attachment – Europe Interpretation of Tests
* Equivocal results that may be edited. Run controls for these assays cannot be edited.
+ or Pos Positive Q QC failure
0 or Neg Negative No Int No Interpretation
? Equivocal NTD No Type Determined
X Empty Well IgG Comp (Check ABO Compatible

Comp)
H Hemolyzed or other plasma R Reagent verification error

error (lipemic or icteric)
U Undetermined failure C Control failure (Ctrl Fail)
M Monolayer verification error
Possible interpretations generated by each assay are listed in the following table.
Assay Possible Test Interpretations
ABD_Type A Pos, A Neg, A NTD, B Pos, B Neg, B NTD, AB Pos,

AB Neg, AB NTD, O Pos, O Neg, O NTD, NTD Pos,
ABOD Full
NTD Neg, NTD NTD, Ctrl Fail, QC failure, Invalid
ABOD Full NC
ABOD Long
ABOD Group
ABOD Full Screen (ABOD Full portion)
ABOD Full NC Screen (ABOD Full NC portion)
ABOD Long Screen (ABOD Long portion)
ABOD Group Screen (ABOD Group portion)
ABO1D Full
ABO1D Full NC
ABO1D Long
ABO1D Full Screen (ABO1D Full portion)
ABO1D Full NC Screen (ABO1D Full NC portion)
ABO1D Long Screen (ABO1D Long portion)

RfxABD_Type A Pos, B Pos, AB Pos, O Pos, NTD Pos, A NTD, B NTD,

AB NTD, O NTD, NTD NTD, Ctrl Fail, QC failure, Invalid,
RfxABODFull
A Reflex, B Reflex, O Reflex, AB Reflex, NTD Reflex
RfxABODFullNC
Note: If a reflex Weak D assay is generated
RfxABODLong as a consequence of an initial Rh (D)
RfxABODGroup negative result, then the Rh (D) interim
result (prior to completion of the Weak D
RfxABODFullScrn (ABOD Full portion) assay) is recorded as Reflex. Reflex
RfxABODFullNCScrn (ABOD Full portion) describes a pending status. Interim results
waiting for reflex testing can be displayed,
RfxABODLongScrn (ABOD Long portion) approved, and exported, but not edited. If
RfxABODGroupScrn (ABOD Group portion) this interim result is exported, either by
manual or auto-export, the final updated
RfxABO1DFull result can be re-exported.
RfxABO1DFullNC Once the Weak D assay is completed, all of the
RfxABO1DLong interpretations from the group assay are applicable to
RfxGroup and RfxGroupScrn (group portion) when the
RfxABO1DFullScrn (ABOD Full portion) interim Reflex result is updated to a final result, including
RfxABO1DFullNCScrn (ABOD Full NC portion) those for a final Rh (D) negative result.
RfxABO1DLongScrn (ABOD Long portion)
Weak D Positive (Perform DAT Assay), Negative, No Int, Ctrl Fail,

Invalid, QC failure

Regional Attachment – Europe Interpretation of Tests
Screen Positive, Negative, No Int, Ctrl Fail, Invalid, QC failure

ABOD Full Screen (Screen portion)
ABOD Full NC Screen (Screen portion)
ABOD Long Screen (Screen portion)
ABO1D Full NC Screen (Screen portion)
ABO1D Full Screen (Screen portion)
ABO1D Long Screen (Screen portion)
ABOD Group Screen (Screen portion)
ABOD Check Screen (Screen portion)
ABOD Check2 Screen (Screen portion)
RfxABODFullScrn (Screen portion)
RfxABODFullNCScrn (Screen portion)
RfxABODLongScrn (Screen portion)
RfxABO1DFullScrn (Screen portion)
RfxABO1DFullNCScrn (Screen portion)
RfxABO1DLongScrn (Screen portion)
RfxABODGroupScrn (Screen portion)
RfxABODCheckScrn (Screen portion)
RfxABODCheck2Scrn (Screen portion)
Ready ID Complete, Ctrl Fail, Invalid

Extend I
Extend II
Neonate A Pos, A Neg, A NTD, B Pos, B Neg, B NTD, AB Pos,

AB Neg, AB NTD, O Pos, O Neg, O NTD, NTD Pos,
ABOD Check
NTD Neg, NTD NTD, Ctrl Fail, QC failure, Invalid
ABOD Check Screen (ABOD Check portion)
ABOD Check2
ABOD Check2 Screen (ABOD Check2 portion)

RfxNeonate A Pos, B Pos, AB Pos, O Pos, NTD Pos, A NTD, B NTD,

AB NTD, O NTD, NTD NTD, Ctrl Fail, QC failure, Invalid,
RfxABODCheck
A Reflex, B Reflex, O Reflex, AB Reflex, NTD Reflex
RfxABODCheckScrn (ABOD Check portion)
Note: If a reflex Weak D assay is generated
RfxABODCheck2 as a consequence of an initial Rh (D)
RfxABODCheck2Scrn (ABOD Check2 portion) negative result, then the Rh (D) interim
result (prior to completion of the Weak D
assay) is recorded as Reflex. Reflex
describes a pending status. Interim results
waiting for reflex testing can be displayed,
approved, and exported, but not edited. If
this interim result is exported, either by
manual or auto-export, the final updated
result can be re-exported.
Once the Weak D assay is completed, all of the
interpretations from the group assay are applicable to
RfxGroup and RfxGroupScrn (group portion) when the
interim Reflex result is updated to a final result, including
those for a final Rh (D) negative result.
Ag_CcEe C+, C-, c+, c-, E+, E-, e+, e-, K+, K-, combinations of
C+c+E+e+K+, combinations of phenotypic
Ag_CcEe2
interpretation, No Int, Ctrl Fail, Invalid, QC failure
Ag_CcEeK
Note: Examples of phenotypic
Ag_CcEeK2 interpretation include but are not limited to
Ag_CEceK CCEE, ccEE, CcEE, and CCee
Ag_CEceK2
Ag_cEK2
Ag_C RH2
Ag_c RH4
Ag_E RH3
Ag_e RH5
Ag_Kell
Auto-Kell
Kell1u2
Crossmatch IgG Comp (Check ABO Comp), Incompatible, No Int,

Ctrl Fail, Invalid
DAT Positive, Negative, No Int, Ctrl Fail, Invalid

Autocontrol

Regional Attachment – Europe WB corQC Reaction Charts
WB corQC Reaction Charts

The tables below list the expected reaction scores for each assay that requires WB corQC for daily reagent QC.
Refer to Chapter 7 – Troubleshooting for troubleshooting QC failures on the Echo.
ABOD Full
Strip 1 Control Anti-A Anti-B Anti-A,B Anti-D1 Anti-D2 A1 Cells B Cells

Reactions Well 1 Well 2 Well 3 Well 4 Well 5 Well 6 Well 7 Well 8
WBcorQC 1 0-2 31-100 0-2 31-100 31-100 31-100 0-2 31-100
WBcorQC 2 0-2 0-2 31-100 31-100 0-2 0-2 31-100 0-2
WBcorQC 3 0-2 0-2 0-2 0-2 31-100 31-100 31-100 31-100
ABOD Long
Strip 1 Anti-A Ant-B Anti-D1 Anti-D2 A1 Cells A2 Cells B Cells O Cells

Reactions Well 1 Well 2 Well 3 Well 4 Well 5 Well 6 Well 7 Well 8
WBcorQC 1 31-100 0-2 31-100 31-100 0-2 0-2 10-100 0-2
WBcorQC 2 0-2 31-100 0-2 0-2 31-100 31-100 0-2 0-2
WBcorQC 3 0-2 0-2 31-100 31-100 31-100 31-100 31-100 0-2
ABOD Group
Strip 1 Control Anti-A Anti-B Anti-D A1 Cells B Cells

Reactions Well 1 Well 2 Well 3 Well 4 Well 5 Well 6
WBcorQC 1 0-2 31-100 0-2 31-100 0-2 31-100
WBcorQC 2 0-2 0-2 29-100 0-2 31-100 0-2
WBcorQC 3 0-2 0-2 0-2 31-100 31-100 31-100
ABOD Check
Strip 1 Control Anti-A Anti-B Anti-D

Reactions Well 1 Well 2 Well 3 Well 4
WBcorQC 1 0-2 31-100 0-2 31-100
WBcorQC 2 0-2 0-2 31-100 0-2
WBcorQC 3 0-2 0-2 0-2 31-100

WB corQC Reaction Charts Regional Attachment – Europe
Neonate
Strip 1 Control Anti-A Anti-B Anti-A,B Anti-D1 Anti-D2

WBcorQC 1 0-2 31-100 0-2 31-100 31-100 31-100
WBcorQC 2 0-2 0-2 31-100 31-100 0-2 0-2
WBcorQC 3 0-2 0-2 0-2 0-2 31-100 31-100
Screen
Strip 1 Cell 1 Cell 2 Cell 3 Control

Reactions Well 1 Well 2 Well 3 Well 4
WBcorQC 1 0-5 60-100 60-100 60-100
WBcorQC 2 60-100 60-100 0-5 60-100
WBcorQC 3 0-5 0-5 0-5 60-100
Note: For combination assays, Screen results are reported as Strip 2 reactions.
Weak D
Strip 1 Anti-D Control

Reactions Well 1 Well 2
WBcorQC 1 60-100 60-100
WBcorQC 2 0-4 60-100
WBcorQC 3 60-100 60-100
Ag_CcEeK
Strip 1 Control C c E e K
WBcorQC 1 0-5 31-100 0-5 0-5 31-100 31-100
WBcorQC 2 0-5 0-5 31-100 0-5 31-100 0-5
WBcorQC 3 0-5 0-5 31-100 31-100 0-5 0-5
WBcorQC 4 0-5 31-100 31-100 31-100 31-100 0-5

Regional Attachment – Europe Echo LIS Interface Specification
Ag_CEceK
Strip 1 Control C E c e K
WBcorQC 1 0-5 31-100 0-5 0-5 31-100 31-100
WBcorQC 2 0-5 0-5 0-5 31-100 31-100 0-5
WBcorQC 3 0-5 0-5 31-100 31-100 0-5 0-5
WBcorQC 4 0-5 31-100 31-100 31-100 31-100 0-5
Red numerical values indicate an expected negative reaction score.
Green numerical values indicate an expected positive reaction score.
Additional Guidance:
Well scores must fall within this range to pass QC. Positive reactions at the lower limits or negative reactions at the
higher limits may indicate an emerging problem.
Note: All levels of WB corQC may not be required for specific assays. For example, WB corQC 4 is
not required for Group, Screen, or Weak D assays. The Assay Reagent Component Grid above lists
the WB corQC levels required for each specific assay.
Echo LIS Interface Specification

Detailed List of Contents
X Scope
X Definitions
X Connectivity
X Serial
X TCP/IP
X Communication
X Serial and TCP/IP Data Transfer
X Establishment Phase (Link Connection)
X Transfer Phase
X Termination Phase (Link Release)
X Data Characters
X Echo ASTM Message Structure
X Uploads
X Results
X Query
X Downloads
X Orders
X Echo ASTM Record Structure
X Header Record
X Patient Record
X Order Record
X Field 5.4 – Instrument Assay Code Table
X Field 6 – Priority Code Table
X Field 12 – Action Code Table

Echo LIS Interface Specification Regional Attachment – Europe
X Result Record
X Field 3.4 – Analyte Code Table
X Field 4 – Measurement Values Table
X Field 9 – Result Status Code Table
X Request Information Record
X Comment Record
X Terminator Record
X Field 3 – Termination Code Table
X Examples
X Group_Screen
X Crossmatch
X Donor
X Query
X Order
X References
Scope
This document describes the specifications for the transfer of data between the Echo instrument and a Laboratory
Information System (LIS). To ensure industry standardization, the Echo follows LIS1-A – Standard Specification for
Low-Level Protocol to Transfer Messages between Clinical Laboratory Instruments and Computer Systems
(formerly ASTM E1381-02) for electronic data transmission and incorporates LIS2-A2 – Specification for
Transferring Information between Clinical Laboratory Instruments and Information Systems (formerly ASTM E1394-
97) for the structure of the data being transferred.
Definitions
Field – One specific attribute of a record that may contain aggregates of data elements further refining the basic
attribute.
Component field – A single data element or data elements that express a finer aggregate or an extension of data
elements that precede it.
Message – A textual body of information consisting of a header (H) record through a message terminator (L) record.
Record – An aggregate of fields describing one aspect of the complete message.
Download – Data transmitted from a computer system (LIS) to a clinical instrument (Echo).
Upload – Data transmitted from a clinical instrument (Echo) to a computer system (LIS).
Connectivity
Two methods of connectivity are supported by the Echo—serial transfer and TCP/IP socket transfer. This section
describes both methods, each of which supports the LIS1-A low-level communication protocol.
Serial
Serial connection is made to the Echo instrument computer using a DB-9 pin connector. The following table
describes the connector contact assignments.

Direction
Contact No. EIA Circuit Description Instrument LIS
1 … Shield … No Connection
2 BB Received Data Input Output
3 BA Transmitted Output Input

Data
5 AB Signal Ground … …
The default serial communication port is COM2, and it uses the defaulted settings described in the following table.
Baud Rate 9600
Data Bits 8
Parity None
Stop Bits 1
The serial mode of operation is a one-way transfer of information with alternate supervision. Information flows in one
direction at a time. Replies occur after information is sent, never at the same time. It is a simple stop-and-wait
protocol.
TCP/IP
The Echo uses a standard RJ-45-style connector for TCP/IP communication. Detailed requirements of an
interconnecting cable are not defined, but good engineering practice should be followed in selecting the cable and
connectors. Low-capacitance cable and shielded connectors may be necessary to suppress electromagnetic
interface (EMI). Appropriate connector locking hardware should be used at the conforming connectors.
The data transmission rate for the Echo conforms to a speed of 100Mbps.
The standard framework for TCP/IP network implementation is generally referred to as “socket” implementation.
The normal implementation of a socket-based communication protocol is asymmetric.
One end is considered a “server” providing service to the other end, which is considered a “client.”
Under this client/server paradigm, the LIS is defined as the “server” and the Echo is defined as the “client.” Both
must initially create sockets and bind their local Internet addresses to their socket. The LIS, as the server, offers a
socket for connection. The Echo, as the client, is independently configurable for both socket and IP address (to
facilitate use of server-defined socket numbers and IP addresses) and requests a connection to the offered socket.
Due to the harmful nature of viruses, worms, and other network anomalies, it is required that a firewall device be
placed between the Echo instrument and the facility network to protect against the malicious threats of networking.
The Echo instrument connects to the firewall device, which in turn is connected to the facility network.
A firewall device is a hardware component that will restrict access between the Echo instrument and the facility
network to block unwanted use or abuse. The firewall device is only necessary for Ethernet (TCP/IP) connectivity.
The Cisco PIX® 501 firewall device is available from Immucor as part of the instrument setup.

Communication
Serial and TCP/IP Data Transfer
There are three distinct phases in transferring information between the Echo instrument and the LIS. In each phase,
one system directs the operation and is responsible for continuity of the communication. The three phases assure
that the actions of the sender and the receiver are coordinated. The three phases are establishment, transfer, and
termination. Although they are briefly described here as an overview, the LIS-1A specification should be reviewed
for complete details. Any variance of the LIS-1A specification is described in the following section.
Establishment Phase (Link Connection)

The establishment phase determines the direction of information flow and prepares the receiver to accept
information. The Echo will notify the LIS receiver that information is available under the following circumstances:
sample loading and result availability.
Upon loading samples onto the Echo, the instrument will initiate the establishment phase to notify the LIS that query
information is available. After the Echo determines that the link is in a neutral state, it will transmit the <ENQ>
transmission control character to the LIS. The Echo will ignore all responses other than <ACK>, <NAK>, and
<ENQ>. If the LIS responds with the <ACK> transmission control character, the establishment phase ends and the
transfer phase begins. The expectation is that LIS messages containing order information will follow as a reply to a
query from the Echo. The Echo will maintain the connection in an active state following a query to allow for the reply
or replies.
Upon result availability, the operator or the instrument may initiate the establishment phase to notify the LIS that
result information is available. After the Echo determines that the link is in a neutral state, it will transmit the <ENQ>
transmission control character to the LIS. The Echo will ignore all responses other than <ACK>, <NAK>, and
<ENQ>. If the LIS responds with the <ACK> transmission control character, the establishment phase ends and the
transfer phase begins.
Transfer Phase
During the transfer phase, the Echo transmits and receives messages to and from the LIS. The transfer phase will
continue until all messages are sent. Messages are sent and expected to be received in frames, with each frame
containing a maximum of 247 characters. Messages longer than 240 characters are divided between two or more
frames. Every message must begin a new frame. A frame is one of two types—an intermediate frame or an end
frame. The frame structure is illustrated in the following table; however, further explanation on the structure of the
frame, including how the frame number and checksum are calculated, can be found in the LIS1-A specification.

Intermediate Frame End Frame
<STX> FN text <ETB> C1 C2 <CR><LF> <STX> FN text <ETX> C1 C2

<CR><LF>
Where
<STX> Start of Text transmission control character
FN Single digit Frame Number 0 to 7
Text Data Content of Message
<ETB> End of Transmission Block transmission control character
<ETX> End of Text transmission control character
C1 Most significant character of check sum 0 to 9 and A to F
C2 Least significant character of checksum 0 to 9 and A to F
<CR> Carriage Return ASCII character
<LF> Line Feed ASCII character
The Echo follows the rules outlined for acknowledgements to each frame. An <ACK> signifies that the last frame
was received successfully and indicates readiness to receive another frame. A <NAK> signifies that the last frame
was not successfully received and indicates readiness to receive the frame again. An <EOT> signifies the last frame
was received successfully, but an interrupt is requested.
Termination Phase (Link Release)

The termination phase returns the data link to the clear or neutral state. The Echo will notify the LIS that all
messages have been sent by sending the <EOT> transmission control character. At this point, the Echo will regard
the data link to be in a neutral state. Upon receiving <EOT>, the LIS should also regard the data link to be in the
neutral state.
Data Characters
All data will be represented as eight-bit, single-byte, and coded graphic character values as defined in ISO 8859-
1:1987. The eight-bit values, within the range from 0 to 127 of ISO 8859-1987, correspond to the ASCII standard
character set. Values from 0 to 31 are disallowed with the exception of 7 (BEL), 9 (Horizontal Tab), 11 (Vertical Tab),
and 13 (CR), where 13 is reserved as a record terminator. Values from 32 to 126 and from 128 to 254 are allowed.
Values 127 and 255 are also not allowed.
Allowed characters: 7, 9, 11, 12, 13, 32-126, 128–254
Disallowed characters: 0–6, 8, 10, 14-31, 127, 255
All records are to be terminated with character 13 (CR).
The message structure and the record structure are detailed in the sections that follow.
Echo ASTM Message Structure

The Echo instrument supports both uploads to an LIS and downloads from an LIS. The following outlines the
records for uploads and downloads.

Uploads
Results
Messages will contain the Header (H) record, Patient (P) record, Order (O) record, Result (R) record, and the
Terminator (T) record. The records will appear in the following manner:
H
P|1
O|1
R|1
R|2
R|n…
O|n
R|n
L
Note: Result messages will contain one patient per message, but they may contain multiple order
and result records per patient record.
Query
Messages will contain the Header (H) record, Request for Information (Q) record, and the Terminator (T) record. The
records will appear in the following manner:
H
Q|1
Q|2
Q|n…
L
Downloads
Orders
Messages should contain the Header (H) record, Patient (P) record, Order (O) record, Comment (C) record (required
for XM orders), and the Terminator (T) record. The records should appear in the following manner:
H
P|1
O|1
C|1
O|2
C|1
O|n…
P|n
L
Note: Multiple orders per patient and multiple patient records per message can be received. Only
one comment record per order record is expected.

Echo ASTM Record Structure

For the tables in this section describing record structure, the following information applies:
• If a field is expected to contain multiple components, the Comp column will provide reference to the
component number.
• The Req column provides whether a field is required for uploads (U), downloads (D), both (B), or if it is
optional (O). If blank, then the field is not supported by the Echo.
Header Record
The interface ASTM record structure (header record fields 5 and 10) is adjusted to include 1.3 software features.
The table below describes the adjustments.
Note: The Req column indicates whether a field is required for uploads (U), downloads (D), both (B),
or if it is optional (O).
Field Comp Field/Component Name Req Description of use
1 Record type ID B H
The character H identifies the record as the header
record.
2 Delimiter Definition B | – field delimiter

\ – repeat delimiter
^ – component delimiter
& – escape character
Note: The five characters that
immediately follow the H (the header ID)
define the delimiters to be used
throughout the subsequent records of
the message. A field delimiter follows
these characters to separate them from
subsequent fields. The first six (6)
characters of the header record will
appear as follows: H|\^&|.
3 Message Control ID
4 Access Password
5 Sender Name or ID B Echo

Instrument user can configure this parameter for
outbound messages. Instrument will accept the ID that
the LIS sends on inbound messages.
6 Sender Street Address
7 Reserved Field
8 Sender Telephone

9 Characteristic of Sender
10 Receiver ID B Echo
Instrument will send the user configurable LIS ID for
outbound messages.
Instrument will expect Echo when receiving inbound
messages.
11 Special Instructions
12 Processing ID
13 ASTM Version No. B LIS2-A2
14 Date and time of message B YYYYMMDDHHMMSS
Patient Record
1 Record Type ID B P
The character P identifies the record as the patient
record.
2 Sequence Number B 1, 2, 3, n…
The number used defines the nth occurrence of the
patient record.
3 Practice Assigned ID O Medical Record Number
4 Laboratory Assigned ID
5 Patient ID No. 3
6 Patient Name O Last Name^First Name^Middle Name
6.1 Last Name O Patient Last Name
6.2 First Name O Patient First Name
6.3 Middle Name or Initial O Patient Middle Name (or Initial)
7 Mother’s maiden name
8 Birthdate O YYYYMMDD or YYYYMMDDHHMMSS
9 Patient Sex O M, F, or U
10 Patient Ethnic origin
11 Patient Address
12 Reserved Field
13 Patient Tel Number

14 Attending Physician
15 Special Field 1
16 Special Field 2
17 Patient Height
18 Patient Weight
19 Patient’s Diagnosis
20 Patient Active Medicines
21 Patient’s Diet
22 Practice Field No. 1
23 Practice Field No. 2
24 Admission & Discharge
25 Admission status
26 Location
27 Alt. Diagnosis
28 Alt. Diagnosis Code
29 Patient Religion
30 Marital Status
31 Isolation Status
32 Language
33 Hospital Service
34 Hospital Institution
35 Dosage category
Note: The Echo does not authenticate nor verify the Patient Demographics received in fields 3, 6, 8,
and 9. The instrument will simply return the values that were received from the LIS.
Order Record
1 Record type ID B O
The character O identifies the record as the order
record.

2 Sequence Number B 1, 2, 3, n…
order record at a particular hierarchical level and is
reset to 1 whenever a patient record of greater
hierarchical significance is transmitted.
3 Specimen ID B Sample Accession Number
4 Instrument Specimen ID
5 Universal Test ID ^^Âssay Code
5.1 Universal Test ID Reserved by standard
5.2 Universal Test ID Name Reserved by standard
5.3 Universal Test ID Type Reserved by standard
5.4 Instrument Code B Instrument Assay Code

See Instrument Assay Code Table
6 Priority B R (See Priority Code Table.)
7 Request Order Date
8 Specimen Collection Date
9 Collection End Time
10 Collection Volume
11 Collector ID
12 Action Code D N (See Action Code Table.)
13 Danger Code
14 Relevant Clinical Inf.
15 Date specimen received
16 Specimen Descriptor B Type^Source
16.1 Specimen Type B Blood
16.2 Specimen Source B Patient or Product

Note: Patient is used when sample is
from a patient; Product is used when
sample is from a donor unit or product.
17 Ordering Physician
18 Physician Tel No.
19 User Field 1
20 User Field 2

21 Laboratory Field 1
22 Laboratory Filed 2
23 Report Date Time
24 Instrument Charge
25 Instrument Section ID
26 Report Type O Y, Z (See Report Type Table.)
27 Reserved Field
28 Location or Ward
29 Infection Flag
30 Specimen Service
31 Specimen Institution
Field 5.4 – Instrument Assay Code Table

Note: Codes may be added, removed, or changed throughout the lifecycle of the instrument and
without systematically updating the list in the operator manual. LIS vendors should plan for this
flexibility when developing the LIS connection side of the interface.
Assay Codes Description
ABD_Type Forward and reverse blood type with Rh determination
ABOD Full Forward and reverse blood type with Rh determination
ABO1D Full Forward and reverse blood type with Rh determination
ABOD Full NC Forward and reverse blood type with Rh determination
ABO1D Full NC Forward and reverse blood type with Rh determination
ABOD Long Forward and reverse blood type with Rh determination
ABO1D Long Forward and reverse blood type with Rh determination
ABOD Group Forward and reverse blood type with Rh determination
RfxABD_Type Forward and reverse blood type with Rh determination
RfxABODFull Forward and reverse blood type with Rh determination
RfxABO1DFull Forward and reverse blood type with Rh determination
RfxABODFullNC Forward and reverse blood type with Rh determination

RfxABO1DFullNC Forward and reverse blood type with Rh determination
RfxABODLong Forward and reverse blood type with Rh determination
RfxABO1DLong Forward and reverse blood type with Rh determination
RfxABODGroup Forward and reverse blood type with Rh determination
Neonate Forward blood type
RfxNeonate Forward blood type
ABOD Check Forward blood type
ABOD Check Screen Forward blood type with Rh determination and 3-Cell screen
ABOD Check2 Forward blood type
ABOD Check2 Screen Forward blood type with Rh determination and 3-Cell screen
RfxABODCheck Forward blood type
RfxABODCheckScrn Forward blood type with Rh determination and 3-Cell screen
RfxABODCheck2 Forward blood type
RfxABODCheck2Scrn Forward blood type with Rh determination and 3-Cell screen
Ag_CcEe Detection of the C, c, E, and e antigens
Ag_CcEe2 Detection of the C, c, E, and e antigens
Ag_CcEeK Detection of the C, c, E, e, and Kell antigens
Ag_CcEeK2 Detection of the C, c, E, e, and Kell antigens
Ag_CEceK Detection of the C, c, E, e, and Kell antigens
Ag_CEceK2 Detection of the C, c, E, e, and Kell antigens
Ag_cEK2 Detection of the c, E and Kell antigens
Ag_C RH2 Detection of the C (RH2) antigen
Ag_c RH4 Detection of the c (RH4) antigen
Ag_E RH3 Detection of the E (RH3) antigen
Ag_e RH5 Detection of the e (RH5) antigen
Ag_Kell Detection of the Kell antigen

Auto_Kell Detection of the Kell antigen
Kell1u2 Detection of the Kell antigen
Forward and reverse blood type with Rh determination and 3-Cell

ABOD Full Screen
screen

ABO1D Full Screen
screen

ABOD Full NC Screen
screen

screen

ABOD Long Screen
screen

ABOD Long Screen
screen

ABOD Group Screen
screen

RfxABODFullScrn
screen

RfxABO1DFullScrn
screen

RfxABODFullNCScrn
screen

RfxABO1DFullNCScrn
screen

RfxABODLongScrn
screen

RfxABODLongScrn
screen

RfxABODGroupScrn
screen
Screen Three cell antibody screen
Ready ID Antibody identification panel
Extend I Extended antibody identification panel

Extend II Extended antibody identification panel
Crossmatch IgG crossmatch
DAT Direct Antiglobulin Test
Weak D Weak D determination
Autocontrol Autocontrol for agglutination
Note: Assay Codes are subject to change.

Field 6 – Priority Code Table

Code Description Echo Supported
S Stat
A As soon as possible
R Routine Y
C Callback
P Preoperative
Field 12 – Action Code Table

C Cancel request for the battery or tests named
A Add the requested tests or batteries to the existing

specimen with the patient and specimen identifiers and
date-time given in this record
N New requests accompanying a new specimen Y
P Pending Specimens
L Reserved
X Specimen or test already in process
Q Treat specimen as a Q/C test specimen
Field 26 – Report Type Table

O Order record; user asking that analysis be performed
C Correction of previously transmitted results
P Preliminary results
F Final results
X Order cannot be done, order cancelled
I In instrument pending
Y No order on record for this test (in response to query) Y
Z No record of this patient (in response to query) Y
Q Response to query (this record is a response to a

request-information query)

Result Record
1 Record type ID U R
The character R identifies the record as the result
record.
2 Sequence Number U 1, 2, 3, n…
result record at a particular hierarchical level and is
reset to 1 whenever an order record of a greater
hierarchical significance is transmitted.
3 Universal Test ID U ^^Ânalyte Code
3.1 Universal Test ID Reserved by standard
3.2 Universal Test ID Name Reserved by standard
3.3 Universal Test ID Type Reserved by standard
3.4 Instrument Analyte Code U Instrument Analyte Code

See Analyte Code Table
4 Measurement Value U Original ReactionÊdited Reaction^Measured Value

If providing well results, this field is divided into
components as described in 4.1, 4.2, and 4.3. If the
Analyte code indicates an interpretive value, only
component 4.1 will be populated.
See Measurement Value Table for possible values.
4.1 Original Result Value U Original instrument reaction
4.2 Edited Result Value U User edited reaction
4.3 Measured Value U Instrument measured reaction
5 Units
6 Reference Range
7 Result Abnormal Flags
8 Nature of Abnormality
9 Result Status U F (See Result Status Code Table.)
10 Date of Change in
Instrument
11 Operator Identification U Operator ID
12 Date/Time test started
13 Date/Time test completed U YYYYMMDDHHMMSS

14 Instrument Identification U Instrument serial number
Field 3.4 – Analyte Code Table

Assay Code Analyte Codes
Rh Ctrl, Anti-A, Anti-B, Anti-D1, Anti-D2, A1Cells, B Cells, O Cells, ABD_Type

ABD_Type
Interp
Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells, ABOD Full
ABOD Full
Interp
ABO1D Full Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells, ABO1D Full Interp
Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells, ABOD Full
ABOD Full NC
NC Interp
Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells, ABO1D Full NC

ABO1D Full NC
Interp
Anti-A, Anti-B, Anti-D1, Anti-D2, A1 Cells, A2 Cells, B Cells, O Cells, ABOD

ABOD Long
Long Interp
ABO1D Long Anti-A, Anti-B, Anti-D, A1 Cells, A2 Cells, B Cells, O Cells, ABO1D Long Interp
ABOD Group Rh Ctrl, Anti-A, Anti-B, Anti-D, A1 Cells, B Cells, ABOD Group Interp
Rh Ctrl, Anti-A, Anti-B, Anti-D1, Anti-D2, A1Cells, B Cells, O Cells,

RfxABD_Type
RfxABD_Type Interp
Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells,

RfxABODFull
RfxABODFull Interp
RfxABO1DFull Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells, RfxABO1DFull Interp
Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells,

RfxABODFullNC
RfxABODFullNC Interp
Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells, RfxABO1DFullNC

RfxABO1DFullNC
Interp
Anti-A, Anti-B, Anti-D1, Anti-D2, A1 Cells, A2 Cells, B Cells, O Cells,

RfxABODLong
RfxABODLong Interp
Anti-A, Anti-B, Anti-D, A1 Cells, A2 Cells, B Cells, O Cells, RfxABO1DLong

RfxABO1DLong
Interp
RfxABODGroup Rh Ctrl, Anti-A, Anti-B, Anti-D, A1 Cells, B Cells, RfxABODGroup Interp
Neonate Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, Neonate Interp
Neonate Rh Ctrl, Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, RfxNeonate Interp
ABOD Check Rh Ctrl, Anti-A, Anti-B, Anti-D, ABOD Check Interp
ABOD Check: Rh Ctrl, Anti-A, Anti-B, Anti-D, ABOD Check Interp

ABOD Check Screen
Screen: Screen 1, Screen 2, Screen 3, Pos Ctrl, Screen Interp

ABOD Check2 Rh Ctrl, Anti-A, Anti-B, Anti-D, ABOD Check2 Interp
ABOD Check2: Rh Ctrl, Anti-A, Anti-B, Anti-D, ABOD Check2 Interp

ABOD Check2 Screen
RfxABODCheck Rh Ctrl, Anti-A, Anti-B, Anti-D, ABOD RfxCheck Interp
ABOD Check: Rh Ctrl, Anti-A, Anti-B, Anti-D, RfxABODCheck Interp

RfxABODCheck Screen
RfxABODCheck2 Rh Ctrl, Anti-A, Anti-B, Anti-D, RfxABODCheck2 Interp
RfxABODCheck2 ABOD Check2: Rh Ctrl, Anti-A, Anti-B, Anti-D, RfxABODCheck2 Interp

Screen Screen: Screen 1, Screen 2, Screen 3, Pos Ctrl, Screen Interp
Ag_CcEe Rh Ctrl, Anti-C, Anti-c, Anti-E, Anti-e, Ag_CcEe Interp
Ag_CcEe2 Rh Ctrl, Anti-C(2), Anti-c(2), Anti-E(2), Anti-e(2), Ag_CcEe2 Interp
Ag_CcEeK Rh Ctrl, Anti-C, Anti-c, Anti-E, Anti-e, Anti-K, Ag_CcEeK Interp
Rh Ctrl, Anti-C(2), Anti-c(2), Anti-E(2), Anti-e(2), Automated Anti-K, Ag_CcEeK2

Ag_CcEeK2
Interp
Ag_CEceK Rh Ctrl, Anti-C, Anti-E, Anti-c, Anti-e, Anti-K, Ag_CEceK Interp
Rh Ctrl, Anti-C(2), Anti-c(2), Anti-E(2), Anti-e(2), Automated Anti-K, Ag_CEceK2

Ag_CEceK2
Interp
Ag_cEK2 Rh Ctrl, Anti-c(2), Anti-E(2), Automated Anti-K, Ag_cEK2 Interp
Ag_C RH2 Rh Ctrl, Anti-C, Ag_C RH2 Interp
Ag_c RH4 Rh Ctrl, Anti-c, Ag_c RH4 Interp
Ag_E RH3 Rh Ctrl, Anti-E, Ag_E RH3 Interp
Ag_e RH5 Rh Ctrl, Anti-e, Ag_e RH5 Interp
Ag_Kell Rh Ctrl, Anti-Kell, Ag_Kell Interp
Auto_Kell Rh Ctrl, Auto, Anti-Kell1, Anti-Kell2, Auto-Kell Interp
Kell1u2 Rh Ctrl, Anti-Kell, Automated Anti-K, Kell1u2 Interp
ABOD Full: Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells, ABOD
ABOD Full Screen Full Interp
ABO1D Full: Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells, ABO1D Full
ABO1D Full Screen Interp

ABOD Full NC: Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells,
ABOD Full NC Screen ABOD Full NC Interp
ABO1D Full NC: Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells, ABO1D Full
ABO1D Full NC Screen NC Interp
ABOD Long: Anti-A, Anti-B, Anti-D1, Anti-D2, A1 Cells, A2 Cells, B Cells, O

ABOD Long Screen Cells, ABOD Long Interp
ABO1D Long: Anti-A, Anti-B, Anti-D, A1 Cells, A2 Cells, B Cells, O Cells,

ABO1D Long Screen ABO1D Long Interp
ABOD Group: Rh Ctrl, Anti-A, Anti-B, Anti-D, A1 Cells, B Cells, ABOD Group
ABOD Group Screen Interp
RfxABODFull: Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells,

RfxABODFullScrn RfxABODFull Interp
RfxABO1DFull: Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells,

RfxABO1DFullScrn RfxABO1DFull Interp
RfxABODFullNC: Anti-A, Anti-B, Anti-AB, Anti-D1, Anti-D2, A1 Cells, B Cells,

RfxABODFullNCScrn RfxABODFullNC Interp
RfxABO1DFullNC: Anti-A, Anti-B, Anti-AB, Anti-D, A1 Cells, B Cells,

RfxABO1DFullNCScrn RfxABO1DFullNC Interp
RfxABODLong: Anti-A, Anti-B, Anti-D1, Anti-D2, A1 Cells, A2 Cells, B Cells, O

RfxABODLongScrn Cells, RfxABODLong Interp
RfxABO1D Long: Anti-A, Anti-B, Anti-D, A1 Cells, A2 Cells, B Cells, O Cells,

RfxABO1DLongScrn RfxABO1DLong Interp
RfxABOD Group: Rh Ctrl, Anti-A, Anti-B, Anti-D, A1 Cells, B Cells,

RfxABODGroupScrn RfxABODGroup Interp
Screen Screen 1, Screen 2, Screen 3, Pos Ctrl, Screen Interp

R-ID 1, R-ID 2, R-ID 3, R-ID 4, R-ID 5, R-ID 6, R-ID 7, R-ID 8, R-ID 9, R-ID 10,
Ready ID
R-ID 11, R-ID 12, R-ID 13, R-ID 14, Pos Ctrl, Neg Ctrl, Ready ID Interp
E-I 1, E-I 2, E-I 3, E-I 4, E-I 5, E-I 6, E-I 7, E-I 8, E-I 9, E-I 10, E-I 11, E-I 12, E-I
Extend I
13, E-I 14, Pos Ctrl, Neg Ctrl, Extend I Interp
E-II 1, E-II 2, E-II 3, E-II 4, E-II 5, E-II 6, E-II 7, E-II 8, E-II 9, E-II 10, E-II 11, E-II
Extend II
12, E-II 13, E-II 14, Pos Ctrl, Neg Ctrl, Extend II Interp
Crossmatch Donor, IgG XM, Ind Ctrl, Crossmatch Interp
DAT DAT Rxn, Ind Ctrl, DAT Interp
Weak D Anti-D, Ind Ctrl, Weak D Interp
Autocontrol Auto Rxn, Rh Ctrl, Auto Interp
Note: The sequence of the Analyte Codes in the Upload Messages is not fixed.
Analyte Codes are subject to change.
Field 4 – Measurement Values Table

Type Component 4.1 Component 4.2 Component 4.3
Reactions 0, 1+, 2+, 3+, 4+, ?, 0, 1+, 2+, 3+, 4+, ?, 0–100
C, H, Q, M, R, U, X C, H, Q, M, R, U, X
Value Legend:
? Questionable
C Control Failure
H Hemolyzed or Sample
Interference
Q QC Failure
M Monolayer Verification Error
R Reagent Verification Error
U Undetermined Failure
X Empty Well

Type Component 4.1
Grouping A Pos, A Neg, A NTD, A Reflex, B Pos, B Neg, B NTD, B Reflex,

Interpretations AB Pos, AB Neg, AB NTD, AB Reflex, O Pos, O Neg, O NTD, O
Reflex, NTD NTD, NTD Pos, NTD Neg, NTD Reflex, Ctrl Fail, QC
Failure, Invalid
Screen Positive, Negative, No Int, Invalid, Ctrl Fail, QC Failure

Interpretations
DAT Positive, Negative, No Int, Invalid, Ctrl Fail

Interpretations
Crossmatch IgG Comp (Check ABO Comp), Incompatible, No Int, Invalid, Ctrl
Interpretations Fail
Phenotyping C+, C-, c+, c-, E+, E-, e+, e-, K+, K-, combinations of C+c+E+e+,
Interpretations combinations of phenotypic interpretation, No Int, Invalid, Ctrl Fail,
QC Failure
Note: Examples of phenotypic interpretation
include but are not limited to CCEE, ccEE, CcEE,
and CCee
Weak D Positive (Perform DAT Assay), Negative, No Int, Invalid, Ctrl Fail,
Interpretations QC Failure
Antibody Panel Complete, Invalid, Ctrl Fail

Interpretations
Note: Result/Interpretation text is subject to change.
Field 9 – Result Status Code Table

Code Description Echo
Supported
C Correction of previously transmitted results
P Preliminary results
F Final results Y
X Order cannot be done
I In instrument, results pending
S Partial results
M This result is a MIC level
R This result was previously transmitted

N This result record contains necessary information to run a new order

Code Description Echo

Supported
Q This result is a response to an outstanding query
V Operator verified/approved result
W Warning: validity is questionable
Request Information Record

1 Record type ID U Q
The character Q identifies the record as the query
record.
2 Sequence Number U 1, 2, 3, n…
query record.
3 Starting Range ID U Accession Number
4 Ending Range ID
5 Universal Test ID U ALL
6 Nature of Request Time

Limits
7 Beginning Request
Results Date and Time
8 Ending Request Results

Date and Time
9 Requesting Physician
10 Physician Tel Number
11 User Field No. 1
12 User Field No. 2
13 Request Information
Status Codes
Comment Record
1 Record type ID D C
The character C identifies the record as a comment
record.
2 Sequence Number D 1, 2, 3, n…


query record.
3 Comment Source D L
4 Comment Text D DonorÂctual Unit Number
4.1 Comment Code D Donor
4.2 Comment Text D Actual donor or unit number identifier
5 Comment Type
Note: Comment record is required when ordering the crossmatch assay.
Terminator Record
1 Record type ID B L
The character L identifies the record as the terminator
record.
2 Sequence Number B 1
There will only be one terminator record per message.
3 Termination Code B N (See Termination Code Table.)
Field 3 – Termination Code Table

N Normal termination Y
T Sender aborted
R Receiver requested abort
E Unknown system error
Q Error in last request for information
I No information available from last query
P Last request for information processed

Examples
Result
ABOD Full Screen

H|\^&|||Echo|||||LIS|||LIS2-A2|20060306164429
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^ÂBOD Full|R||||||||||Blood^Patient
R|1|^^^Rh Ctrl|0^0^0|||||F||brentp||20060306164429|M0002
R|2|^^Ânti-A|0^0^0|||||F||brentp||20060306164429|M0002
R|3|^^Ânti-B|3+^3+^45|||||F||brentp||20060306164429|M0002
R|4|^^Ânti-AB|3+^3+^45|||||F||brentp||20060306164429|M0002
R|5|^^Ânti-D1|3+^3+^29|||||F||brentp||20060306164429|M0002
R|6|^^Ânti-D2|3+^3+^40|||||F||brentp||20060306164429|M0002
R|7|^^Â1 Cells|2+^2+^17|||||F||brentp||20060306164429|M0002
R|8|^^^B Cells|0^0^0|||||F||brentp||20060306164429|M0002
R|9|^^ÂBOD Full Interp|B Pos|||||F||brentp||20060306164429|M0002
O|2|0651439A||^^^Screen|R||||||||||Blood^Patient
R|1|^^^Screen 1|4+^4+^100|||||F||brentp||20060306164429|M0002
R|4|^^^Pos Ctrl|4+^4+^100|||||F||brentp||20060306164429|M0002
R|5|^^^Screen Interp|Pos|||||F||brentp||20060306164429|M0002
L|1|N
Crossmatch
H|\^&|||Echo|||||LIS|||LIS2-A2|20060309084558
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^^Crossmatch|R||||||||||Blood^Patient
R|1|^^^Donor|R02460|||||F||brentp||20060309084558|M0002
R|2|^^ÎgG XM|3+^3+^68|||||F||brentp||20060309084558|M0002
R|3|^^Înd Ctrl|4+^4+^94|||||F||brentp||20060309084558|M0002
R|4|^^^Crossmatch Interp|Incomp.|||||F||brentp||20060309084558|M0002
L|1|N
ABOD Check
H|\^&|||Echo|||||LIS|||LIS2-A2|20060310100612
P|1|||||||
O|1|FY72698||^^ÂBOD Check|R||||||||||Blood^Product
R|1|^^^Rh Ctrl|0^0^0|||||F||brentp||20060310100612|M0002
R|2|^^Ânti-A|0^0^0|||||F||brentp||20060310100612|M0002
R|3|^^Ânti-B|0^0^0|||||F||brentp||20060310100612|M0002
R|4|^^Ânti-D|3+^3+^24|||||F||brentp||20060310100612|M0002
R|5|^^ÂBOD Check Interp|O Pos|||||F||brentp||20060310100612|M0002
L|1|N
Query
H|\^&|||Echo|||||LIS|||LIS2-A2|20050222140243
Q|1|0651439A||ALL
Q|2|R02460||ALL
L|1|N

Order
H|\^&|||LIS|||||Echo|||LIS2-A2|20050222140243
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^^Crossmatch|R||||||N||||Blood^Patient
C|1|L|Donor^R02460
L|1|N
H|\^&|||LIS|||||Echo|||LIS2-A2|20050222140243
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^ÂBOD Full Screen|R||||||N||||Blood^Patient
L|1|N
H|\^&|||LIS|||||Echo|||LIS2-A2|20050222140243
P|1|
O|1|FY72698||^^^Donor Short|R||||||N||||Blood^Product
L|1|N
References
CLSI. Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Instruments and
Computer Systems. CLSI document LIS1-A [ISBN 1-56238-489-9]. CLSI, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2003.
CLSI. Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems;
Approved Standard—Second Edition. CLSI document LIS2-A2 [ISBN 1-56238-550-X]. CLSI, 940 West Valley
Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

Glossary
This glossary contains the definitions of the terms used in the Echo Lumena Operator
Manual, on the Echo Lumena hardware, and in the Echo Lumena software.
Echo Lumena Operator Manual EC2-001-100 Glossary-1

Glossary Barcode–Light Emitting Diode (LED)
Barcode
A barcode is a series of varying-width vertical lines (called bars) and spaces. There are different combinations of
bars and spaces that represent different characters. Unique barcode character sequences are used to uniquely
identify an item that the barcode is affixed to.
CCD Camera
CCD is the abbreviation for a Charged Coupled Device. The CCD camera consists of multiple photodiodes, and
when light is projected onto the photodiodes, an electrical charge proportional to the light intensity is generated.
The electrical charge mapped for each picture is processed (by binarization to “bright” or “dark”) to yield an overall
camera image.
Centrifuge
The on-board centrifuge is located inside of the Echo Lumena and is used to spin micro-well strips.
Event Log
The event log displays a list of event messages that have been generated.
Export Protocol
The export protocol describes the computer file structure used in the transfer of electronic data from the computer
to a Laboratory Information System (LIS).
Fluidics Module
The fluidics module is the area where the waste container and system liquid container (phosphate buffered saline)
are housed.
Echo Lumena
The Echo Lumena is an immunohematology device designed as a platform for in vitro diagnostic blood sample
testing.
Incubators
Incubators provide the necessary temperature environment for the incubation steps of the assays performed on the
Echo Lumena platform. Assays requiring ambient room temperature incubation are held at the strip loading bay for
incubation.
Initialization
Initialization is a Echo Lumena process whereby the whole Echo Lumena system is reset.
Instrument Map
The instrument map is an area of the onscreen graphical user interface (to the right of the results panel). The
instrument map reflects the mechanical structure of the Echo Lumena.
Light Emitting Diode (LED)

LEDs are diodes that contain a semi-conductor chip that emits light within a very narrow frequency range when
connected in a circuit. LEDs emit colored light.
Glossary-2 EC2-001-100 Echo Lumena Operator Manual

LIS–Pump Glossary
LIS
Laboratory Information System
Loading Bay (Sample and Reagent)

The sample and reagent loading bays are areas of the Echo Lumena main instrument equipped to contain the
blood sample tubes and reagent vials required for pipetting.
Login
The Login button is the portal button that allows access to the Login screen, thereby allowing an operator to log
into the software.
Maintenance
Maintenance actions for the Echo Lumena are performed on a scheduled basis to verify that specific modules of
the Echo Lumena are functioning at the required specifications. A record of these actions is documented by the
operator in a copy of the Echo Lumena Maintenance Record. A paper master copy of the Echo Lumena
Maintenance Record is in Appendix B – Maintenance Record.
Manifold
The manifold is the detachable wash head, which when correctly secured in the Echo Lumena, is used to physically
dispense clean wash fluid into the Capture test wells and also remove contaminated post-wash fluid out of the
Capture test wells.
Mouse
A mouse is a computer screen pointing device used to direct software activity across the computer monitor screen.
Multiple Document Interface (MDI) Window

An MDI window is an overlapping window that appears within the workspace of the program. MDI windows can
include reports, help windows, notepads, an instrument view, event logs, and more. MDI windows can be arranged
(cascaded, tiled, minimized, or maximized) using commands from the Window command on the Pull-down menu.
Passwords and User Access Rights

The Echo Lumena employs user names, passwords, and access rights to restrict access to various levels of the
Echo Lumena software to authorized operators only. Unauthorized operators are refused access.
Pipetting System
The pipetting system aspirates liquids from a defined source and deposits them in a defined destination.
Pull-Down Menu
The pull-down menu is an area of the onscreen graphical user interface (at the top of the screen) that provides
access to some functional parts of the software.
Pump
A pump is a machine or device for raising, compressing, or transferring fluids.

Glossary Rack–Touch Screen Monitor
Rack
Racks are used on the Echo Lumena for the loading and unloading of sample tubes and reagent vials in and out of
the loading bay area on the Echo Lumena.
Report
An Echo Lumena report is data organized in a logical sequence, such as by numeric sequence or by calendar
sequence.
Results Panel and Results Bar

The results panel and results bar is an area of the onscreen graphical user interface (below the tool bar) that
displays test results. Results can be viewed, edited, approved, and exported from this area.
Rinse Station
The rinse station for the probe is used to clean the probe after a pipetting procedure. This cleaning prevents cross-
contamination due to carryover of blood samples or reagents. The rinse station is also used to prime the liquid
system prior to its first use.
Run Test Wizard

The Run Test Wizard is the software user interface that guides the operator through the loading of the necessary
supplies and samples before starting an assay run.
Shut down
Shut down is a cessation of operations or activity. The Echo Lumena shutdown procedure closes down the Echo
Lumena.
Stop Button
If pressed, the Stop button will stop some of the Echo Lumena actions.
Strip Holders and Strip Loading Bay

All micro-well strips are transported on strip holders stationed on a strip loading tray. The strip loading trays are
inserted and removed from the strip loading bay.
Toolbar
The Toolbar is an area of the onscreen graphical user interface (below the pull-down menu) that provides access to
some functional parts of the software. This is displayed as buttons with graphics to depict the function that can be
invoked by pressing a particular button.
Transport System
The transport system moves strip holders between the different Echo Lumena modules located throughout the
Echo Lumena.
Touch Screen Monitor

The Echo Lumena monitor screen is pressure sensitive, such that by pressing the screen at a designated
coordinate, the operator can initiate a designated Echo Lumena action.

UPS (or UPM)–XYZ Movement Glossary
UPS (or UPM)

The Echo Lumena computer is connected to an Uninterruptible Power Supply (UPS) or Uninterruptible Power
Manager (UPM) with an integral power conditioner. The UPS (or UPM) provides a consistent source of electricity
(without excessive electrical noise output voltage) and provides short periods of backup power in the event of
power loss near the Echo Lumena.
Wash Buffer
Wash buffer fluid (phosphate-buffered saline) used on the Echo Lumena is stored in the PBS container. Phosphate-
buffered saline (PBS) is the only acceptable designated wash buffer used on the Echo Lumena.
Washer (Micro-well Strip)

The Echo Lumena micro-well strip washer is used to physically dispense clean wash fluid into the Capture test wells
and to remove contaminated post-wash fluid out of the Capture test wells for a predetermined volume of wash fluid
per well.
Waste Container
The waste container is located in the fluidics module and is used as a system collection vessel for liquid
biohazardous waste.
XYZ Movement
The transport system allows movement of the micro-well strip and its strip loading tray in the X, Y, and Z direction.
The X-direction is defined as being horizontal left to right (with the operator facing the Echo Lumena). The Y-
direction is defined as being horizontal front to back. The Z-direction is defined as being vertical top to bottom.

Glossary

Index
This index contains an alphabetical listing of subject matter referenced in the Echo
Lumena Operator Manual with associated page numbers. This enables you to quickly
locate specific information about the Echo Lumena within this manual.
Echo Lumena Operator Manual EC2-001-100 Index-1

Index access – camera
passwords, 11-2, 11-3

A
user access rights, 11-2, 11-3
access
user name, 11-3
continuous, 1-6
associated access rights
rights
defining users with, 11-2
assigning, 11-2
ASTM
editing, 11-7
message structure, NA-29, EU-37, JP-29
accessing
record structure, NA-30, EU-39, JP-30
reports
audible alarms, 7-6
categories, 6-2
error conditions that generate, 7-6
adding
situations that generate, 7-6
users, 11-3
axis
alarms
names and descriptions, 7-8
audible, 7-6
error conditions that generate, 7-6 B
situations that generate, 7-6 barcodes, 1-4
alignment micro-well strip, 1-5
camera options, 10-2
checking, 5-45, 7-13 donors tab, 10-4
ambient light general tab, 10-2
excessive, 12-9, A-4 samples tab, 10-3
approving reagent, 1-4
test results, 4-5 sample, 1-5
alternative method, 4-8 biohazards
archiving potential, 12-9, A-4
results, 5-20 blud_direct help, 7-2
assays using, 7-4
cutoffs, NA-5, NA-10, EU-5, EU-11, JP-5, JP-10 board
descriptions, NA-5, EU-5, EU-11, JP-5, JP-10 names and descriptions, 7-8
internal, 5-17 buffer
process controls, 5-17 instrument map, 2-13, 2-17
serological controls, 5-17
procedural steps, NA-14, EU-16, JP-13 C
reagent calibrating
component grid, NA-12, EU-13, JP-12 camera, 5-44
reagents, NA-5, EU-5, JP-5 centrifuge, 5-46
requesting additional, 3-32 probe, 5-35
assigning camera
access rights, 11-2 alignment
Index-2 EC2-001-100 Echo Lumena Operator Manual

Canadian department of communication class A – data Index
checking, 5-45, 7-13 general options, 10-6
calibrating, 5-44 confirmation
reader dialog boxes, 2-2
technical data, 9-14 connections, 9-3
report, 6-3 instrument, A-7
Canadian department of communications class A, descriptions, A-7

A-5 making, A-7
categories PC, A-7
of reports, 6-2 descriptions, A-7
accessing, 6-2 technical data, 9-3
centrifuge, 9-13 container
calibrating, 5-46 system liquid, 9-9, 9-11
description, 9-13 continual loading
removing, 8-13 during operation, 3-32
replacing, 8-13 continuous access, 1-6
safety features, 9-14 controls
technical data, 9-14 internal assay, 5-17
checking process, 5-17
camera alignment, 5-45 serological, 5-17
environmental conditions, A-3 loading, 3-16
probe replenishing, 3-32
alignment, 5-12 crossmatch
vertical position, 5-14 selection, 3-29
cleaning cutoffs
barcode scanner mirrors, 5-43 assay, NA-5, NA-10, EU-5, EU-11, JP-5, JP-10
instrument, 5-12
probe, 5-31
D
clot data
detection recovery process, 7-9 hardware technical, 9-2
comment record camera reader, 9-14
record structure, NA-41, EU-53, JP-41 centrifuge, 9-14
common buttons, 2-3 connections, 9-3
completing dimensions, 9-2
field service preventative maintenance, 5-49 fluidics module, 9-9
computer fluidics system, 9-9
personal, 9-3 general, 9-2
shutting down, 5-19, 5-48 incubation time, 9-7
configuration incubator, 9-7
Echo Lumena, 10-1 main instrument, 9-4

Index data entry – Echo Lumena
personal computer, 9-3 loading bays

pipetting system, 9-10 sample and reagent, 9-4
power requirements, 9-2 strip, 9-6
probe, 9-10 personal computer, 9-3
reagent loading bay, 9-5 pipetting system, 9-10
sample loading bay, 9-5 transport system, 9-12
sample/reagent barcode scanner, 9-6 washer, 9-13
software, 9-4 dialog boxes
strip loading bay, 9-6 confirmation, 2-2
transport system, 9-12 dimensions
washer, 9-13 technical data, 9-2
weight, 9-3 donors tab, 10-4
data entry downloading
manual requests from LIS, 3-25
reagent ID, 3-18 downloads
sample ID, 3-12 message structure, NA-29, EU-38, JP-29
strip ID, 3-23 orders, NA-29, EU-38, JP-29
sample name
using sample names, 3-15
E
Echo Lumena
date/time tab
concepts
default settings, A-8
basic system, 1-3
general options, 10-6
decomtaminating, 5-23, 5-48, A-11
decontaminating
initialization, 3-4
Echo Lumena, 5-23, 5-48, A-11
installing, A-8
instrument, 5-23
instrument map, 2-12
system, 5-48
intended use, 1-2
defining
logging in, 2-3, QSG-6
users, 11-2
logging out, 2-4, QSG-6
deleting
maintaining, 5-1
results
maintenance records, B-1
from the database, 5-20
markings, NA-3, EU-3, JP-3
users, 11-5
operation
descriptions
instrument testing, 3-1
assays, NA-5, EU-5, JP-5
principles of, 1-2
centrifuge, 9-13
parts
fluidics module, 9-8
verifying parts are present, A-2
incubators, 9-7
photograph, 1-3
ambient, 9-8
power supply, 12-9, A-3, A-6, A-8, QSG-5
elevated temperature, 9-7

editing – finding Index
principles of operation, 1-2 error codes, 7-4
repackaging before shipment, A-10 motor controller functional processing, 7-7
reports, 2-8, 4-4, 6-1 troubleshooting, 7-1
pull-down menu, 2-7 error messages (5000 series), 7-6
tab, 10-14 information balloon messages (2000 series),

7-5
safety
information messages (1000 series), 7-5
user, A-5
instrument error messages (6000 series), 7-6
security, 11-1
warning balloon messages (4000 series), 7-5
tab, 10-23
warning error balloon messages (8000 series), 7-6
shutting down, 5-19, 5-48
warning messages (3000 series), 7-5
for long periods, 5-48
yes or no messages (7000 series), 7-6
starting up, 3-2, QSG-4
errors
status bar, 2-12
software assertion, 7-8
system
recognizing, 7-8
basic concepts, 1-3
responding to, 7-9
troubleshooting, 7-1
establishing
editing
communication
access rights, 11-6
LIS interface, 10 -10
test results, 4-7
event logs, 6-5
alternative method, 4-8
entry, 2-18
user name, 11-6
report, 6-5
users, 11-6
sample based
electrical
viewing, 4-8, 4-9
grounding, 12-9, A-3
examples
requirements
power supply, NA-4, EU-4, JP-4
expected results, 1-7
emergency
exporting
restart of software, 7-9
test results, 4-6
stop, 3-31
button, 2-9
emptying F
waste container, 3-4, 5-8 FCC class A, A-5
environmental conditions, 12-9, A-3 filling
ambient light PBS supply container, 5-6
excessive, 12-9, A-4 finding
humidity samples, 4-10
excessive, 12-9, A-4 using common reagents, 4-11
specifications, A-4 using common strips, 4-12

Index fluidics – incubators
using sample identifcation, 4-10 centrifuge, 9-14
fluidics connections, 9-3
module dimensions, 9-2
description, 9-8 fluidics module, 9-9
markings, NA-4, EU-4, JP-4 fluidics system, 9-9
safety features, 9-10 general, 9-2
technical data, 9-9 incubation time, 9-7
test incubator, 9-7
performing, 5-35 main instrument, 9-4
flushing personal computer, 9-3
instrument, 5-23, 5-48 pipetting system, 9-10

power requirements, 9-2
G probe, 9-10
general options, 10-6 reagent loading bay, 9-5
date/time tab, 10-6, A-8 sample loading bay, 9-5
default settings sample/reagent barcode scanner, 9-6
configuration, A-8 software, 9-4
date/time tab, A-8 strip loading bay, 9-6
HIS/LIS tab, A-9 transport system, 9-12
reports tab, A-9 washer, 9-13
results tab, A-9 weight, 9-3
service tab, A-10 header record
system tab, A-9 record structure, NA-30, EU-39, JP-30
general tab, 10-6 help, 2-8, 2-19, 7-2
HIS/LIS tab, 10-7, A-9 button on the toolbar, 2-9
language tab, 10-13 submenu, 7-2
reports tab, 10-14, A-9 HIS/LIS tab, 10-7
results tab, 10-18, A-9 default settings, 10-7, A-9
service tab, 10-25, A-10 general options, 10-7
system tab, 10-21, A-9 humidity
volume control, 10-22 excessive, 12-9, A-4
general tab, 10-2, 10-6
grounding
I
electrical, 12-9, A-3 icons
rack, 1-6
H incubation time
hardware technical data, 9-7
technical data, 9-2 incubators, 9-7
camera reader, 9-14 ambient

initializing – LIS interface Index
description, 9-8 report, 6-6
safety features, 9-8 intended use
elevated temperature Echo Lumena, 1-2
description, 9-7 interface
safety features, 9-8 LIS
instrument map, 2-13, 2-17 communication, NA-27, EU-36, JP-27
technical data, 9-7 connectivity, NA-26, EU-34, JP-26
initializing definitions, NA-26, EU-34, JP-26
instrument, 5-10, QSG-14 scope, NA-25, EU-34, JP-25
installation specification
validating, A-10 LIS, NA-25, EU-33, JP-27
installing internal voltage, 12-9, A-3
Echo Lumena, A-1

K
priming strip holder, 5-42
keyboard, 2-2
rinse station, 8-24
software, A-8 L
instrument language tab
cleaning, 5-12 general options, 10-13
connections, A-7 laser beam
descriptions, A-7 safety, 3-2, QSG-4
decomtaminating, 5-23 layout
flushing, 5-23, 5-48 screen, 2-5
initializing, 5-10, QSG-14 common buttons, 2-3
main confirmation dialog boxes, 2-2
technical data, 9-4 instrument map, 2-12
map, 2-12 progress bar, 2-11
buffer, 2-13, 2-17 pull-down menu, 2-6
incubators, 2-13, 2-17 results bar, 2-10, 4-2
reagent loading bay, 2-13, 2-14 results panel, 2-10, 4-2
sample loading bay, 2-13 status bar, 2-12
strip loading bay, 2-13, 2-15 toolbar, 2-8
waste, 2-13, 2-16 LED
markings, NA-3, EU-3, JP-3 indicator signals, 1-3
priming, 5-23 limitations of use and warnings, 12-1
purging, 5-48 liquid waste
shutting down, 5-19, 5-48 removing system, 3-33
starting up, 3-2 LIS interface
status communication, NA-27, EU-36, JP-27

Index loading – module
data characters, NA-28, EU-37, JP-28 required intervals, 5-2

establishment, NA-27, EU-36, JP-27 window
terminating, NA-28, EU-37, JP-28 accessing, 5-3
transferring data, NA-27, EU-36, JP-28 markings, NA-3, EU-3, JP-3
connectivity, NA-26, EU-34, JP-26 fluidics module,
serial, NA-26, EU-34, JP-26 main instrument,
TCP/IP, NA-27, EU-35, JP-27 power supply, 12-9, A-3, A-6, A-8, QSG-5
data transfer menu
serial, NA-27, EU-36, JP-27 pull-down, 2-6
TCP/IP, NA-27, EU-36, JP-27 file, 2-6, 2-8
definitions, NA-26, EU-34, JP-26 help, 2-8, 7-2
scope, NA-25, EU-34, JP-25 reports, 2-7, 2-8
specification, NA-25, EU-33, JP-25 tools, 2-7, 2-8
loading tools submenu
continual barcode options, 10-2
during operation, 3-32 event log entry, 2-18
micro-well strips, 3-21 general options, 10-6
reagents and controls, 3-16 maintenance, 2-18
samples, 3-6 test options, 10-27
additional, 3-32 view, 2-6, 2-8
loading bays window, 2-7, 2-8
sample and reagent, 9-4 tab
description, 9-4 test options, 10-28
safety features, 9-5 message structure
strip, 9-6 ASTM, NA-29, EU-37, JP-29
description, 9-6 downloads, NA-29, EU-38, JP-29
safety features, 9-7 orders, NA-29, EU-38, JP-29
logging in, 2-3 uploads, NA-29, EU-38, JP-29
logging out, 2-4 query, NA-29, EU-38, JP-29
results, NA-29, EU-38, JP-29
M micro-well strips
maintenance
barcodes, 1-5
field service preventative
loading, 3-21
completing, 5-49
reloading, 3-32
history
mirrors
report, 6-7
barcode scanner
records, B-1
cleaning, 5-43
tasks
module
interval summary table, 5-2
fluidics, 9-8

monitor – personal computer (PC) Index
monitor menu tab, 10-28
shutdown, 5-19, 5-48 profiles tab, 10-29
motor controller error codes QC tab, 10-31
names and descriptions, 7-7 reflex tests tab, 10-28
mouse, 2-2 order record

N action code table, NA-36, EU-46, JP-36
navigation instrument assay code table, NA-34, EU-43,
JP-34
options, 2-2
priority code table, NA-35, EU-46, JP-35
keyboard, 2-2
mouse, 2-2
P
touch screen, 2-2
passwords
O assigning, 11-2
resetting, 11-7
on/off switch
patient record
accessibility, 12-9, A-4
online help manual, 7-2
PBS
using, 7-3
supply container
operation
refilling, 5-6
continual loading during, 3-32
system liquid
principles of
removing, 5-48
Echo Lumena, 1-2
performing
options
fluidics test, 5-35
barcode, 10-2
probe accuracy test, 5-33
donors tab, 10-4
reagent quality control (QC), 5-16
general tab, 10-2
washer basic test, 5-37
samples tab, 10-3
washer dispense accuracy test, 5-29
general, 10-6
washer residual volume test
date/time tab, 10-6
visual, 5-15
general tab, 10-6
measured, 5-27
HIS/LIS tab, 10-7
peri-pump
language tab, 10-13
removing, 8-12
reports tab, 10-14
replacing, 8-12
results tab, 10-18
personal computer (PC), 9-3
service tab, 10-25
connections, 9-3
system tab, 10-21
description, 9-3
volume control, 10-22
safety features, 9-4
test, 10-27
technical data, 9-3
general tab, 10-27

Index personnel – qualified personnel
personnel priming, 5-32

qualified, 12-9, A-4 removing, 8-4
pipetting system, 9-10 instructions, 8-4
description, 9-10 replacing, 8-4
probe, 9-10 instructions, 8-7
rinse station, 9-11 rinse station, 9-11
safety features, 9-12 splash guard
technical data, 9-10 wiping down, 5-26
post-installation check vertical position
completing, A-10 checking, 5-14
power processing
rating, 12-9, A-3 samples
requirements preparing for, 3-2
technical data, 9-2 tests, 3-6
supply profiles tab
power test options, 10-29
markings, NA-4, EU-4, JP-4 progress bar, 2-11
preventative maintenance pull-down menu, 2-6
completing file, 2-6, 2-8
field service, 5-49 help, 2-8, 7-2
priming reports, 2-7, 2-8
instrument, 5-23 tools, 2-7, 2-8
probe, 9-11 tools submenu
strip holder barcode options, 10-2
installing, 5-42 event log entry, 2-18
washer, 5-39 general options, 10-6
print button maintenance, 2-18
on the toolbar, 2-9, 2-19 test options, 10-27
printed result reports view, 2-6, 2-8
configuration, 4-8 window, 2-7, 2-8
printing purging
reports, 6-18 instrument, 5-23
probe, 9-10 system, 5-48
accuracy test
performing, 5-33
Q
QC information report, 6-8
alignment
QC tab
checking, 5-12
test options, 10-31
calibrating, 5-35
qualified personnel, 12-9, A-4
cleaning, 5-31

racks – removing Index
order, NA-43, EU-56, JP-43

R query, NA-43, EU-55, JP-43
racks, 1-5 header record, NA-30, EU-39, JP-30
icons, 1-6 order record, NA-33, EU-42, JP-33
reagent action code table, NA-36, EU-46, JP-36
removing, 5-48 instrument assay code table, NA-43, EU-52, JP-34
sample priority code table, NA-35, EU-46, JP-46
removing, 5-48 patient record, NA-31, EU-40, JP-31
scanners request information record, NA-40, EU-53, JP-40
rack result record, NA-36, EU-47, JP-36
turning on/off, 3-31 analyte code table, NA-37, EU-48, JP-38
sizes, 1-5 measurement values table, NA-39, EU-51,
JP-39
reader
result status code table, NA-40, EU-52, JP-40
camera, 9-14
terminator record, NA-41, EU-54, JP-41
description, 9-14
termination code table, NA-42, EU-54, JP-42
recovery
reagent, 1-5
clot detection
barcodes, 1-4
process, 7-9
IDs
from initialization failure, 7-10
manual data entry, 3-18
troubleshooting, 7-1
loading bay, 9-4
refilling
instrument map, 2-13, 2-14
PBS supply container, 5-6
technical data, 9-4
reflex testing, NA-7, EU-8, JP-7
performance
basic concepts, NA-7, EU-8, JP-7
report, 6-12
features, NA-7, EU-8, JP-7
quality control (QC)
general, NA-8, EU-9, JP-8
performing, 5-16
screen reflex, NA-8, EU-9, JP-8
racks
weak D reflex test, NA-8, EU-9, JP-8
removing, 5-48
reflex tests tab
usage
test options, 10-28
report, 6-9
reloading
record structure
micro-well strips, 3-32
ASTM, NA-30, EU-39, JP-30
removing
comment record, NA-41, EU-53, JP-41
examples, NA-42, EU-55, JP-42 1000 μL and 100 μL syringes, 8-10
result, NA-42, EU-55, JP-42 centrifuge, 8-13
crossmatch, NA-42, EU-55, JP-42 system liquid waste, 3-33
donor, NA-43, JP-43 micro-well strips, 5-48
group screen, NA-42, JP-42 peri-pump, 8-12

Index repackaging – results
probe, 8-4 record structure, NA-40, EU-53, JP-40
reagent racks, 5-48 requesting
rinse station, 8-24 assays
sample racks, 5-48 additional, 3-32
wash manifold, 8-8 requests
repackaging downloading from LIS, 3-25
Echo Lumena, A-11 requirements
replacing electrical
1000 μL and 100 μL syringes, 8-10 power supply, 12-9, A-3, A-8, QSG-5
centrifuge, 8-13 sample, 3-4
peri-pump, 8-12 reset
probe, 8-4, 8-7 password, 11-7
wash manifold, 8-8 result record
replenishing record structure, NA-36, EU-47, JP-36
reagents and controls, 3-32 analyte code table, NA-37, EU-48, JP-38
system liquid, 3-33 measurement values table, NA-39, EU-51,

JP-39
reports
result status code table, NA-40, EU-52, JP-40
camera, 6-3
result summary
categories, 6-2
report, 6-11
accessing, 6-2
results
event log, 6-5
archiving and deleting from the database, 5-20
instrument status, 6-6
bar, 2-10, 4-2
maintenance history, 6-7
button descriptions, 2-10, 4-3
printing, 6-18
expected, 1-7
QC information, 6-8
panel, 2-10, 4-2
reagent performance, 6-12
tab
reagent usage, 6-9
general options, 10-18
result summary, 6-11
test, 4-1
statistics, 6-10
approving, 4-5
strip performance, 6-13
system, 6-14
editing, 4-7
tab
default settings, A-8
exporting, 4-6
general options, A-8
test history, 6-15
interpretation, NA-20, EU-26, JP-20
details, 6-15
report example, 4-4
summary, 6-15
viewing, 4-5
request information record

retrieving – service warning Index
retrieving event logs
strip holders, 5-41 viewing, 4-9
rinse station finding, 4-10
cleaning, 8-24 using common reagents, 4-11
instructions, 8-24 using common strips, 4-12
installing, 8-24 using sample identifcation, 4-10
instructions, 8-27 IDs
removing, 8-24 manual data entry, 3-12
instructions, 8-25 loading, 3-6
run test wizard additional, 3-32
crossmatch selection, 3-29 loading bay
using, 3-26 instrument map, 2-13

technical data
S sample and reagent, 9-5
safety strip, 9-6
laser beam, 3-2, QSG-4 processing
user, A-5 preparing for, 3-2
safety features starting, 3-30
camera reader, 9-15 racks
centrifuge, 9-14 removing, 5-48
fluidics module, 9-10 requirements, 3-4
incubators tab, 10-3
ambient, 9-8 scanners
elevated temperature, 9-8 rack
loading bays turning on/off, 3-31
sample and reagent, 9-5 sample/reagent barcode, 9-6
strip, 9-7 technical data, 9-6
personal computer, 9-4 screen
pipetting system, 9-12 layout, 2-5
transport system, 9-12 common buttons, 2-3
washer, 9-13 confirmation dialog boxes, 2-2
sample/reagent barcode scanner instrument map, 2-12
technical data, 9-6 progress bar, 2-11
sample and reagent loading bays, 9-4 pull-down menu, 2-6
sample name results bar, 2-10, 4-2
data entry results panel, 2-10, 4-2
using sample names, 3-15 status bar, 2-12
samples toolbar, 2-8
barcodes, 1-5 service warning, 12-9, A-4

Index service tab – system liquid
service tab IDs
general options, 10-25 manual data entry, 3-23
settings loading bay
default instrument map, 2-13, 2-15
general options configuration, A-8 micro-well
setting up barcodes, 1-5
system, A-8 performance
shutting down report, 6-13
computer, 5-19, 5-48 priming
Echo Lumena, 5-19 installing the holder, 5-42
for long periods, 5-48 trays
monitor, 5-19, 5-48 unlocking, 5-40
system, 5-19, 5-48 supply container
signals PBS
indicator LED, 1-3 filling, 3-3
software support
emergency restart, 7-9 technical, 7-2
installing, A-8 symbols
system commonly used, 4-3
navigation, 2-1 syringes
solution 1000 μL and 100 μL
cleaning replacing, 8-10
recommended, 12-9, A-4 removing, 8-10
specifications system
environmental conditions, A-3 basic concepts, 1-3
starting decontaminating, 5-23
processing, 3-30 flushing, 5-23
starting up purging, 5-23
Echo Lumena, 3-2 report, 6-14
statistics setting up, A-8
report, 6-10 shutdown, 5-48
status bar, 2-12 tab
stop general options, 10-21
emergency, 3-31 system liquid, NA-5, EU-5, JP-5
strips container, A-7
holders filling, 5-6
retrieving, 5-41 PBS
identification, NA-9, EU-10, JP-9 replenishing, 3-33

technical – tools submenu Index
weak D reflex test features, NA-8, EU-9, JP-8

T test results
technical approving, 4-5
data alternative method, 4-8
camera reader, 9-14 commonly used symbols, 4-3
centrifuge, 9-14 editing, 4-7
connections, 9-3 alternative method, 4-8
dimensions, 9-2 exporting, 4-6
fluidics module, 9-9 alternative method, 4-8
fluidics system, 9-9 report
general, 9-2 example, 4-4
incubation time, 9-7 viewing, 4-4
incubator, 9-7 alternative method, 4-8
main instrument, 9-4 tests
personal computer, 9-3 history
pipetting system, 9-10 details report, 6-15
power requirements, 9-2 report, 6-15
probe, 9-10 summary report, 6-15
reagent loading bay, 9-5 options, 10-27
sample loading bay, 9-5 general tab, 10-27
sample/reagent barcode scanner, 9-6 menu tab, 10-28
software, 9-4 profiles tab, 10-29
strip loading bay, 9-6 QC tab, 10-31
transport system, 9-12 reflex tests tab, 10-28
washer, 9-13 processing, 3-6
weight, 9-3 results
support, 7-2 interpretation, NA-20, EU-26, JP-20
terminating well scores
data transfer viewing, 4-9
LIS interface, NA-28, EU-37, JP-28 toolbar, 2-8
terminator record button descriptions, 2-9
record structure, NA-41, EU-54, JP-41 help button, 2-9, 2-19
termination code table, NA-42, EU-54, JP-42 print button, 2-9, 2-19
testing tools submenu
reflex, NA-7, EU-8, JP-7 barcode options, 10-2
basic concepts, NA-7, EU-12, JP-7 event log entry, 2-18
features, NA-7, EU-12, JP-7 general options, 10-6
general features, NA-8, EU-9, JP-8 maintenance, 2-18
screen reflex features, NA-8, EU-9, JP-8 test options, 10-27

Index touch screen – washer
touch screen, 2-2 users
transferring access rights
data assigning, 11-2
LIS interface, NA-27, EU-34, JP-25 adding, 11-3
transport system, 9-12 defining
description, 9-12 with associated access rights, 11-2
safety features, 9-12 deleting, 11-5
troubleshooting editing, 11-6
error codes, 7-4 user safety, A-5
error messages (5000 series), 7-6 using
information balloon messages (2000 series), blud_direct help, 7-4

7-5 online help manual, 7-3
information messages (1000 series), 7-5 run test wizard, 3-26
instrument error messages (6000 series), 7-6 uninterruptible power supply (UPS), A-8
warning balloon messages (4000 series), 7-5
warning error balloon messages (8000 series), 7-6
V
warning messages (3000 series), 7-5 validating
yes or no messages (7000 series), 7-6 installation, A-10
guide, 7-1 viewing
recovery, 7-6 sample based test event logs, 4-9
error codes and, 7-4 test results, 4-5
from initialization failure, 7-10 alternative method, 4-8

test well scores, 4-9
U voltage
uninterruptible power supply (UPS), A-8 internal, 12-9, A-3
unlocking volume control, 10-22
strip trays, 5-40
unspecified use, 12-9, A-4
W
uploads warnings
message structure, NA-29, EU-38, JP-29 limitations and, 12-1
query, NA-29, EU-38, JP-29 warranty
results, NA-29, EU-38, JP-29 voiding, 9-4, 12-10, A-5
UPS (uninterruptible power supply), A-8 wash manifold
using, A-8 removing, 8-8
use replacing, 8-8
unspecified, 12-9, A-4 washer, 9-13
user name basic test
assigning, 11-2 performing, 5-37
editing, 11-6 description, 9-13

waste – wiping down Index
dispense accuracy test

performing, 5-29
priming, 5-39
residual volume test
performing
visual, 5-15
measured, 5-27
waste
container
emptying, 3-4, 3-33
instrument map, 2-13, 2-16
weight
technical data, 9-3
well scores
test
viewing, 4-9
windows
maintenance
accessing, 5-3
wiping down
probe splash guard, 5-26

Index touch screen – washer

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Operator Manual

Echo Lumena Operator Manual EC2-001-100 i

ii EC2-001-100 Echo Lumena Operator Manual

Echo Lumena Operator Manual EC2-001-100 iii

iv EC2-001-100 Echo Lumena Operator Manual

Echo Lumena Operator Manual EC2-001-100 v

vi EC2-001-100 Echo Lumena Operator Manual

Echo Lumena Operator Manual EC2-001-100 vii

About This Manual

Echo Lumena Operator Manual EC2-001-100 About This Manual-1

Limitations of Use and Warnings

Alternating current: Related to power supply.

Direct current: Related to power supply.

Protective conductor terminal: Related to power supply.

On (supply): Related to power supply.

About This Manual-2 EC2-001-100 Echo Lumena Operator Manual

Off (supply): Related to power supply.

Warning or limitation: These comments alert you to potentially damaging or dangerous

Avoid exposure to direct sunlight

Ambient Temperature should be within 18°C and 30°C

Relative humidity range is 10% to 80%

Consult instructions for use

Separate collection for electrical and electronic equipment: Disposal information.

Authorized Representative in the European Community

Echo Lumena Operator Manual EC2-001-100 About This Manual-3

About This Manual-4 EC2-001-100 Echo Lumena Operator Manual

Chapter 1: Introduction to the Echo Lumena

Echo Lumena Operator Manual EC2-001-100 1-1

1-2 EC2-001-100 Echo Lumena Operator Manual

Echo Lumena Operator Manual EC2-001-100 1-3

Basic System Concepts

Indicator LED Signals

This table describes the LED signals.

Color State Meaning

Continuous You can safely add or remove racks or trays.

Flashing Error occurred or action required.

1-4 EC2-001-100 Echo Lumena Operator Manual

Limitation: Barcodes should be between three and 18 characters in length.

The minimum number of barcode characters is three.

Echo Lumena Operator Manual EC2-001-100 1-5

Micro-well Strip Barcodes

Barcode identification includes:

Two-dimensional barcode located on the bottom of micro-well strip tab

1-6 EC2-001-100 Echo Lumena Operator Manual

There are two sizes of Echo Lumena racks:

Collection of rack icons

Echo Lumena Operator Manual EC2-001-100 1-7

1-8 EC2-001-100 Echo Lumena Operator Manual

Chapter 2: System Software Navigation

Echo Lumena Operator Manual EC2-001-100 2-1

Keyboard and Mouse

2-2 EC2-001-100 Echo Lumena Operator Manual

Confirmation Dialog Boxes

Example of confirmation dialog box: computer shutdown

Click OK to close the dialog box and to save any

Click Cancel to close the dialog box without saving

Click Close to close the dialog box.

Logging In and Out

1. Click the Log in button from the toolbar.

Echo Lumena Operator Manual EC2-001-100 2-3

2-4 EC2-001-100 Echo Lumena Operator Manual

Log off confirmation dialog box with Instrument Map closed

Log off confirmation dialogbox with Instrument Map open